cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are at high risk for HCC.
2. The ages of patients are between 18 and 80.
3. Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3.
4. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days.
5. Patient signs the informed consent. -

Exclusion Criteria:

1. Patient is with lesions confirmed by pathology or follow-up, or hemangiomas.
2. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE.
3. Patient is with severe cardiopulmonary insufficiency.
4. Patient is a pregnant or breastfeeding women.
5. Patient is considered to be unsuitable to participate in the study.
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305

This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
* Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
* Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines

Exclusion Criteria:

* Potassium level below 3.8 mmol/L measured in serum or plasma
* QTcF interval \>440 ms
Evaluation of CloudCare in the Treatment of Type 1 Diabetes

CloudCare is an eHealth application to help health care professionals (HCP) in the management/treatment of type 1 diabetes. The application will automatically check all uploaded glucose parameters from patients glucose monitoring devices and present all these data in a categorized way (using a so called dashboard) to the HCP. In this way the HCP has a direct overview of the condition of her/his patients, and can determine which data request direct action towards the patient and which data do not. It is expected that this system improves outcome and patient experience.

In this study this expectation will be studied by measuring the effect of CloudCare on patients' treatment satisfaction, glucose control, HCP satisfaction and the impact on costs.

Diabeter offers a Conformité Européenne (CE) marked eHealth application called CloudCare. This is a customizable care management and decision support system that uses algorithms and automation to help triage clinically relevant cases from all incoming data transmission (data uploads) and improve clinical workflows. This should complement existing clinical care models, like face-to-face meetings. The CloudCare application offers the Health Care Professional (HCP) a better and accurate oversight of the patient's condition, which enables the HCP to contact the patient in a timely manner. CloudCare enables improved use of clinically relevant data by both patients and care team and is expected to improve outcomes and patient experience.

This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on patients' treatment satisfaction, glycaemic control ('glucometric'), HCP satisfaction and the impact on costs.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the study informed consent form prior to any data collection for this study
* Clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months.
* Age between 16 and 75 years old.
* Use of multiple daily injections of insulin (MDI, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (CSII) with Flash or Continuous Glucose Monitoring (FGM/CGM), but without CloudCare for at least three months.
* Receiving CloudCare as part of their standard care for at least 6 months.

Exclusion Criteria:

* Patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin.
* Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
Long-term Follow up of Patient With Anti-GABAbr Antibodies Associated-encephalitis.

First described in 2010, GABA-B-receptor antibodies-associated encephalitis is a disease with a severe vital and functional prognosis. Indeed, functional status is mostly altered by encephalitis and it induced consequences while vital status is mostly engaged by cancer very often associated in the course of the disease, mostly small-cell lung cancer (SCLC).

While knowledge is growing on clinical features at each stage of the disease, long-term outcome data is still lacking even if known to be pejorative.

In this study, we aimed to describe long-term follow up of all patients who were diagnosed a GABAb-receptor antibodies-associated encephalitis in the French Paraneoplastic Neurological Syndrome Reference Center until now.


Eligibility Criteria:
Inclusion Criteria:

* encephalitis tested positive to GABAbr-antibodies after the examination of CSF samples tested for autoimmune encephalitis at the French Paraneoplastic Neurological Syndrome Reference Center from January 2011 to January 2022.

Exclusion Criteria:

* tested positive to another onconeural antibody.
A Study to Assess THN391 in Subjects with Alzheimer's Disease

This is a Phase 1b study to evaluate different doses of the drug and see whether a drug is safe and how it behaves in the body.

THN391 has already been assessed in healthy people without Alzheimer's disease. This is the first study of THN391 in patients with Early Alzheimer's disease. Later studies will evaluate THN391 to see if it is effective for the treatment of Alzheimer's disease.

In this study, THN391 will be compared with a placebo (a look-alike substance that contains no drug). The study duration is approximately 6 months in which the participants will visit the clinic approximately 13 times and have 2 telephone calls with the site.

Patients who fulfill all criteria to participate in the study, will receive 3 times a monthly dose of THN391 or placebo in the clinic.

Assessments that will be done at several timepoints during the study will be blood collection, physical examinations and neurological examinations, 4x an MRI-scan of the head, 2x a spinal tap and some testing of the memory and thinking skills.

This is a Phase 1b, randomized, double-blind, multi-center, placebo-controlled, multiple ascending dose trial in male and female participants, aged 65 to 85 years with Early Alzheimer's disease and cSVD.

The study duration is 6-8 months: first screening to assess eligibility, then 2 months' treatment period (3 monthly doses), followed by a 4 month follow-up period.

The trial will investigate THN391 in at least 3 dose cohorts, Depending on preliminary, blinded results of the first two cohorts, the sample sizes of the following dose cohort may be increased and/or additional dose cohorts may be added.

Eligible participants will be randomized to receive either THN391 or placebo.

Three dose administrations will be provided monthly. Participants will undergo clinical and laboratory-based safety-related assessments, as well as Pharmacodynamics (PD), immunogenicity, and blood Pharmacokinetic (PK) collections at different time points.

Assessments will include 4 brain MRIs (Magnetic Resonance Imaging), 2 spinal taps, electrocardiograms (ECGs), vital signs, physical and neurological examinations, adverse event recordings, monitoring of mental health, and tests to determine the severity of Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
* 65 to 85 years of age (inclusive at the time of informed consent).
* Diagnosis of Early Alzheimer's Disease (AD)
* Diagnosis of cerebral Small Vessel Disease (cSVD), and having at least one of the following vascular risk factors: hypertension, Type 2 diabetes mellitus, or hyperlipidemia

Exclusion criteria:

* Diagnosis of moderate or severe dementia
* Any other medical condition except for early AD (e.g. any clinically significant neurological, psychiatric or large vessel disease) that could affect interpretation of study assessments
* Use of anticoagulant, except for either clopidogrel or low dose aspirin, unless taken simultaneously
Comparing the Effects of Mobilization With Movement (MWM), Self MWM, and Dynamic Stretching on Hip Internal Rotation)

This study is looking to address the effectiveness of three different intervention on hip range of motion. There will be a therapist performed mobilization group, a self mobilization group, and a dynamic stretching group. Participants will be recruited from the University of South Carolina and randomly assigned between the three groups to have equal distribution and limit any biases. Participants will come in on two different days in order to receive the intervention on the first and have hip range of motion measured on both days. The investigators will be assessing if there is any significant difference between the three groups.

The goal of this study is to compare the efficacy of three clinical interventions intended to treat hip dysfunctions such as hip osteoarthritis. Physical therapists utilize mobilization with movement clinically to increase range of motion that has been limited by hip pathology. This study will compare mobilization with movement administered by a physical therapist, self-administered mobilization with movement, in which patients are instructed in the maneuver and then perform it at home, and dynamic stretching as instructed by a physical therapist. Efficacy will be judged through changes in hip internal rotation range of motion, a motion which is typically limited in patients with hip pathology.

The objectives of the study are to quantify the effects of two different modalities of hip mobilization with movement and dynamic stretching in terms of hip internal rotation increases, and to inform current physical therapy practice by filling gaps in the literature surrounding the therapeutic effects of hip mobilization with movement. This study is intended to better equip physical therapists to select the most appropriate evidence-based interventions, thereby increasing the quality of patient care.

Eligibility Criteria:
Inclusion Criteria:

* \<30 degrees hip internal rotation in at least 1 hip

Exclusion Criteria:

* Traumatic injury in last 6 months
* FAI
* fracture
* surgery within last 6 months
* positive FADDIR/FABER
* symptomatic OA
* RA
* Neurologic conditions
Study to Characterize Rate of Ureagenesis in Patients With Ornithine Transcarbamylase (OTC) Deficiency

The objectives of the study are to characterize urea production rates in patients with OTC, characterize the association of rate of ureagenesis and disease severity in OTC patients, characterize the association of rate of ureagenesis and executive and verbal function and characterize the association of rate of ureagenesis and patient-reported functional status.

Study DTX301-CL102 is a noninterventional, observational study to characterize the rate of ureagenesis and to assess neurocognition and functional status in the spectrum of OTC deficiency and their association with biochemical characteristics. \[1-13C\]Sodium acetate will be administered orally as a tracer to measure the rate of ureagenesis.

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent.
* For symptomatic patients:
* Confirmed clinical diagnosis of OTC deficiency and enzymatic, biochemical, or molecular testing.
* Documented history of ≥ 1 symptomatic hyperammonemic episode with ammonia level ≥ 100 μmol/L
* Patients on ongoing daily ammonia scavenger therapy must be at a stable dose(s) for ≥ 4 weeks prior to Visit 1 (Baseline)
* For asymptomatic patients: confirmed diagnosis of OTC deficiency by family history and documented by molecular testing.
* Willing and able to comply with the study procedures and requirements, including clinic visits, blood and urine collections, questionnaires, and cognitive assessments.

Key Exclusion Criteria:

* Liver transplant, including hepatocyte cell therapy/transplant.
* History of liver disease
* Significant hepatic inflammation or cirrhosis
* Participation in another investigational medicine study within 3 months of Screening
* Participation (current or previous) in another gene transfer study
* Pregnant or nursing

Other protocol specific criteria may apply
Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors

This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA)
* Moderate to severe disease activity of RA
* The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD)
* The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS)
* Male or female patients ≥ 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires)
* The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2
* Treatment is according to the Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* Known contraindications to Tumor Necrosis Factor (TNF) inhibitors
* Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra)
* Participation in an investigational study
European Cystinosis Cohort

Cystinosis is a generalized lysosomal storage disease with a reported incidence of about 1:180,000 live births. There are estimated 110-140 cases in France (approximately 500 in Western Europe). The disease is caused by mutations in the CTNS gene coding for cystinosin, a lysosomal carrier protein. The lysosomal cystine accumulation leads to cellular dysfunction in many organs. The first symptoms start at about 6 months of age. In the absence of specific therapy, end stage renal disease occurs between 6 and 12 years of age. Survival beyond this age is associated with the development of extra-renal complications.

Renal transplantation and the availability of cystine-depleting medical therapy, cysteamine (EU/1/97/039/001, EU/1/97/039/003), have radically altered the natural history of cystinosis. Cystinosis is a good example of a "paediatric" disease where patients now survive into adolescence and adulthood. These individuals have complex, multisystem problems that require on-going care.

Despite some progress in recent years there are still significant limitations in the knowledge of diagnostic and therapeutic procedures. A first European registry was launched in 2011, using the CEMARA application developed by the Banque Nationale de Données Maladies Rares (BNDMR, CNIL authorisation number: 1187326), allowing the collection of data from France, Belgium and Italy. The objective of the current study is to translate this database into a cohort study that will allow and facilitate the collection of a wider range of data including clinical, and personal data such as quality of life data, from an increased number of European countries, improve the monitoring, data-management and analysis of the data, offer the possibility for patients to actively participate to and benefit from the study by developing a module in which patients will enter their own data on quality of life with a direct feed-back on the general results.

This project is a unique opportunity for building a consensual European academic cohort not based on company driven, "drug-oriented" objectives.

The cohort will collect clinical details to analyse patient outcomes thus providing audit of patient care \& clinical effectiveness. It will be possible, through the cohort, to indicate where improvements need to be made and ultimately improve care to the highest standards.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystinosis (based on cystine dosage, presence of crystals at eye examination or molecular diagnosis)
* Signed informed consent

Exclusion Criteria:

* Patients not able to give their informed consent. No other criteria (patients with associated disease should be enrolled).
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.

This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at two dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C (optional) will evaluate the time course of receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 and 50 years old (inclusive);
* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
* Willingness to remain in the hospital research unit for the duration of the inpatient period.

Exclusion Criteria:

* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, supine SBP \> 140 mmHg or \< 90 mmHg, or supine DBP \>90 mmHg or \< 50 mmHg or pulse rate \> 100 bpm or \< 45 bpm at Screening;
* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
* Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners);
* Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan.
Combination Chemotherapy for Metastatic Breast Cancer

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* You are female in the age of 18 to 75 years old.
* You have been diagnosed with the metastatic breast cancer.
* You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
* You must sign this informed consent form

Exclusion Criteria:

* You are pregnant or breastfeeding.
* Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
* You have been diagnosed with serious concomitant or acute infectious disease.
* You have used experimental medications within the last month.
Impact of Physical Activities on Balance in Patient With Strabismic Amblyopia

The aim of this study is to determine the effect of physical activities on balance in patient with amblyopia after strabismus surgery. Patients with strabismus have more difficulty in maintaining postural control in the presence of misleading signals. Through this study the patients will apply physical therapy sessions to improve balance for strabismic amblyopic patient post-surgery.

* Patients will be informed about measurement and treatment procedure, also about the effect of physical activity on improving balance post strabismus surgery.
* Patients will be asked to follow physician instructions.
* Patients will be asked to avoid participation in any rehabilitation program prior to the study which may affect the result of the study.
* Measurement procedures will be applied for each patient.
* The therapeutic group will receive 2 sessions per week for 12 weeks. The duration of each session is 45 min.
* They will start the treatment program after 2 months of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients received strabismus operation.
* Patients are suffering from balance problem due to strabismus
* Patients are suffering from strabismus amblyopia
* They will be selected from Outpatient Clinic of Research Institute of Ophthalmology.
* Patients will begin the training program after 2 months of operation.
* Patient with intermittent exotropia

Exclusion Criteria:

* - Patients with a diagnosis of vestibular, neurological and psychiatric diseases
* Moderate and severe amblyopia,
* Any disease that can cause imbalance syndrome or limitation of movement
* A history of falling without a cause in the last 6 months and
* Using drugs affecting the central nervous system
* Patient who didn't complete the physiotherapy training program for 3 months.
* Muscular disorders that will impair performance during training.
* Any organic lesion in the eye.
* Malignant conditions.
* Children who can't understand the therapist's instructions and orders
* Amblyopia which is not related to strabismus condition