cyrilzakka/clinical-trials huggingface dataset:
Assessment of Treatment Response Using PET/CT Scanner - Non Hodgkin's Lymphoma

In this study the treatment process will be closely monitored using a novel imaging technology, a PET/CT scanner. PET stands for Positron Emission Tomography and in this case it will be combined with a conventional x-ray Computerized Tomography (CT) scan. This is not a study of any particular form of treatment. The treatment you receive will be the most appropriate standard treatment whether you are in the study or not.

The goal of radiation therapy is to deliver a given amount of radiation dose to the area where there is a lymphoma tumour. We are doing this study to see which part of the tumour reacts to the radiation treatment, and which part does not react, by monitoring the progress of your treatment with a combined PET/CT scan. In particular, changes of the size and shape of the tumour that occur during the treatment can be detected and will be visible on the images. These images will be thoroughly analysed. The ability of the PET/CT scanner to detect these changes during a course of radiation treatment will be the subject of this study. We will also be able to see if this information will eventually relate to or predict whether lymphoma tumours will be completely eradicated by the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of NHL:Any histology
* Stage I-IV
* Measurable disease by CT scan (gross disease measuring at least 2 cm in any one dimension)
* Planned radiation dose prescription \>=30 gy, \>=20 fractions, \>=3weeks duration
* Informed consent
* Previous chemotherapy is allowed, provided the above eligibility criteria are me

Exclusion Criteria:

* To minimize effect from breathing motion, patients presenting with parenchymal lung tumours and tumours involving liver and stomach will be excluded
* Concurrent systemic chemotherapy (glucocorticoids when used alone is allowed)
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)

Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk.

The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Eligibility Criteria:
Inclusion Criteria:

Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings

* Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at \<90min of age (outborn patients)
* 5min APGAR-score ≤ 5
* Need for resuscitation after birth for \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH \>7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance

Exclusion Criteria:

gestational age \< 36 weeks

* age at time of screening \>2,5h
* congenital malformation
* missing or invalid informed parental consent
* unsuccessful resuscitation
* infant considered not-viable
* decision for palliative care only
Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer

Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer.

Compared to lymphadenectomy, it has several theoretical advantages:

* this is a sensitive technique with a detection rate of\> 90% and a false negative rate of \<5%.
* the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients.
* it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy.

Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% \[95% CI: 73-84\]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%.

It seemed useful to take stock of this technique using this new dye.


Eligibility Criteria:
Inclusion Criteria:

* Major patient, without guardianship or curatorship.
* patient with endometrial cancer confirmed by biopsy.
* Invasive cancer stage FIGO I at intermediate risk and high risk and II according to the FIGO classification.
* need for surgical staging.
* performing an endovaginal ultrasound or a pelvic MRI in preoperative, if contraindication to MRI, performing a CT scan.
* subject affiliated to a social health insurance scheme.
* speaking and reading French.
* subject having dated and signed informed consent.

Exclusion Criteria:

* pregnancy in progress.
* FIGO III and IV stage diagnosed preoperatively or intraoperatively.
* Cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy).
* MRI or CT scan of suspected lymph nodes.
Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days

The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.


Eligibility Criteria:
Inclusion Criteria:

* Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
* Physically and mentally healthy male volunteers

Exclusion Criteria:

* History of clinically significant diseases or illness.
* Participation in another study the last 3 months
* Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin

Peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced by therapeutics. Using Radial flow monitoring and myocardial perfusion magnetic resonance imaging, we designed a controlled randomized double blind study to test the hypothesis that endothelial dysfunction will be reversed following 3 months of Metformin administration vs gliclazide. 30 patients will be included.


Eligibility Criteria:
Inclusion Criteria:

18-70 years old, type 2 diabetes, non significant coronary atherosclerosis on inclusion coronary angiogram (ie no coronary stenosis \> 70%), HbA1c\<9%

Exclusion Criteria:

significant coronary stenosis (\>70%), lack of informed consent, unstable hypertension, renal failure, contra-indication to metformin or gliclazide, pregnancy, atrial fibrillation, contraindication to MRI, or to adenosine, brachial artery calcifications
A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

Primary Objective:

* To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.

Secondary Objectives:

* To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel
* To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination
* To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease
* To evaluate the immunogenicity of IV aflibercept
* To measure endogenous free Vascular Endothelial Growth Factor (VEGF)

The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.

Eligibility Criteria:
Inclusion criteria :

* Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.

Exclusion criteria :

* Squamous histology/cytology lung cancer
* Need for a major surgical procedure or radiation therapy during the study
* Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
* Cumulative radiation therapy to \>25% of the total bone marrow
* History of brain metastases
* Eastern Cooperative Oncology Group(ECOG)\>1
* Prior docetaxel treatment but have not been appropriate for safety reasons
* Inadequate organ and bone marrow function
* Uncontrolled hypertension
* Evidence of clinically significant bleeding diathesis or underlying coagulopathy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.

The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* 20 \< body mass index \< 30 kg/m2.
* written and orally informed consent before enrollment.

Exclusion Criteria:

* participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
* allergy to soy products or eggs
* diabetes, any type
* epilepsy
* ongoing infection
* immune deficiency
* cardiovascular disease
* dysregulated hypertension
* primary muscles disease, congenital or acquired
Measuring the Treatment Preferences of Participants in Japan With Moderate-to-Severe Psoriasis (PsO) Using Discrete Choice Experiment

The purpose of this observational study is to identify and weight the treatment attributes from the moderate-to-severe Psoriasis (PsO) patients' perspective in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-to-severe Psoriasis (PsO) by physician (phase 1) or self-reported (phase 2)
* Currently taking systemic psoriasis treatment
* Japanese resident aged 20 years and older

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Diagnosis of guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

This randomized, partially masked, active-controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of ABBV-RGX-314 relative to an active comparator. The primary endpoint of this study is the mean change from baseline in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to ranibizumab at Week 54. Approximately 540 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years and ≤ 89 years
2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
5. Willing and able to provide written, signed informed consent for this study
6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to any causes other than AMD
2. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC
3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
5. Advanced glaucoma or history of secondary glaucoma in the study eye
6. History of intraocular surgery in the study eye within 12 weeks prior to randomization
7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1
8. Prior treatment with gene therapy
9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
Dietary Intervention Examining Tracking With Mobile Devices

The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.

This study will last approximately 6 months. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. Additional assessments will be conducted at 3 months and 6 months. Weekly questionnaires will be administered. Everyone in the study will be asked to listen to 2 podcasts per week. Each of the podcasts will take about 15 - 20 minutes to listen to and so participants should expect to spend 30 - 40 minutes each week listening to podcasts. Participants will also be randomized to either track diet with an app on their smartphone or using a device they wear on their wrist. Each week, participants will be sent an email as a reminder on how to use their diet tracking device. They will also be encouraged to monitor their exercise and body weight.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-65 years old
* Own and use a smartphone and/or a tablet with a data plan
* BMI must be between 25-49.9 kg/m2
* Must be willing to reduce caloric intake and increase physical activity
* Not currently participating in a weight loss study in a weight loss study that involved podcasts

Exclusion Criteria:

* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with stroke or heart attack
* Diagnosed with diabetes that is controlled using medication
tDCS for the Management of Multiple Sclerosis Related Fatigue

This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of \>36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.


Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis, all subtypes
* Fatigue Severity Scale score of 36 or greater
* Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver proxy required for those with scores of 7.5 or greater)
* Ability to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Primary neurologic, psychiatric or other medical disorder other than MS
* History of seizures or seizure disorder
* History of head trauma or medical device in head or neck
* Clinically significant abnormality on EKG
* Current symptomatic treatment for fatigue
* Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms
* WRAT-4 reading level below average (\<85) (estimated general intellectual function)
* Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10
* Current chronic headaches or migraines
* Skin disorder/sensitive near stimulation locations
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease

Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.

Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of liver disease requiring hospital admission

Exclusion Criteria:

1. Active COVID-19 infection at time of admission or acquiring during hospital stay.
Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart.

Heart conditions that have been described with HIV include

* Pericarditis,
* Pleural effusion
* Pulmonary hypertension (Venedic classification typ II)
* Dilated cardiomyopathy
* Heart failure
* Myocarditis
* Bacterial endocarditis
* Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research.

The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases.

Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects.

Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients.

The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Known HIV-infection
* Written informed consent

Exclusion Criteria:

* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy