cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants

This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
* Participants must agree to comply with protocol-specified contraceptive requirements.

Exclusion Criteria:

* Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV) or acute hepatitis A virus (HAV).
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.
COVID-19 Amyotrophic Lateral Sclerosis (ALS) Registry

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal neurodegenerative disease characterized by progressive weakness involving limb, bulbar, and respiratory muscles.There is currently no information suggesting how COVID-19 affects patients diagnosed with amyotrophic lateral sclerosis (ALS). This is especially important as respiratory compromise is common in ALS patients and can complicate the clinical course as COVID-19 could lead to respiratory failure and need for intubation. We intend that this registry will guide our understanding of how COVID-19 affects patients with ALS.

The purpose of this registry is to assess the incidence and prevalence of COVID-19 in ALS patients, the effect of COVID-19 on ALS disease trajectory, and the impact, if any, of edaravone, riluzole and other concomitant medication used in ALS like Albuterol and dextromethorphan/quinidine (Nuedexta) on these parameters. COVID-19 incidence and prevalence in the ALS population will be assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS and
* A confirmed COVID-19 infection determined by:

  1. positive SARS-CoV-2 viral RNA PCR test and/or
  2. positive serology antibody testing for SARS-CoV-2

Exclusion Criteria:

* No ALS diagnosis
* No confirmed COVID-19 infection
Clareon Toric Study (T2-T9)

The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).

Subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign the informed consent form.
* Willing and able to attend all scheduled study visits as required per protocol.
* Cataract in one or both eyes with planned extraction by conventional phacoemulsification.
* Astigmatism in the operative eye(s).
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing.
* History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve.
* Clinically significant corneal disease that may, according to the Investigator's medical opinion, adversely affect visual outcomes.
* Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion.
* History of prior intraocular or corneal surgery.
* Other protocol-defined exclusion criteria may apply.
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.

The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) and satisfy the approved therapeutic indication for DMF (per the local DMF product information).
* Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.
* Have a recent complete blood count (CBC) that does not preclude the subject's participation in the study, in the judgment of the Investigator.

Key Exclusion Criteria:

* Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
* Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
* Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.
* Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.
* Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.
* Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS.
* Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.
* Current enrollment in any clinical trial except for the Biogen Idec DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.


Eligibility Criteria:
Inclusion Criteria:

* Displays signs and/or symptoms of respiratory infections
* Adult patients must provide informed consent
* Parental consent for children (\<18)

Exclusion Criteria:

* Adult patients unable to provide informed consent
* Children that are currently in foster care, or are wards of the state
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Eligibility Criteria:
Inclusion Criteria:

* relapse of atrial fibrillation

Exclusion Criteria:

* contraindication for ablation
TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.

Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older
* Diagnosis of Hepatocellular Carcinoma
* Portal Vein Thrombosis
* ECOG performance \< 2

  -\>4 weeks since prior radiation, surgery or chemotherapy.
* Life expectancy \> 3 months
* Able to provide written informed consent process in accordance with institutional review boards guidelines.

Exclusion Criteria:

* Contraindications to angiography and selective visceral catheterization.
* Evidence of blood flow to the lung from the liver greater than 16.5 mCi
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
* Significant extrahepatic disease.
* Severe liver disfunction of pulmonary insufficiency.
* Active uncontrolled infection.
* Significant underlying medical or psychiatric illness.
* Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
Screening for 3-D Visual Disorders in Preschool Children

Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.

Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 4 years
* Enrolled in kindergarten in the first section
* In the 19th district of Paris
* Who should benefit from visual screening via the school medical service

Exclusion Criteria:

* Children who do not speak French
* Children who are physically or cognitively unable to participate in the screening
CBCT-Guided Navigational Bronchoscopy For Lung Nodules

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.

The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.

The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.

This research study involves a screening period, a procedure and follow up visits.

The names of the study interventions involved in this study are:

* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone

Participants will receive the study procedure and will be followed for up to 6 months.

It is expected that about 136 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years old.
* Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist.
* Participants with higher risk lesions (pCA \> 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery.
* Participants are willing and able to provide informed consent.

Exclusion Criteria:

* The participant is pregnant as confirmed by urine or serum pregnancy testing.
* There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA).
* Lacked fitness according to physician judgement to undergo bronchoscopy.
* Contraindication for temporary interruption of the use of anticoagulant therapy.
* Uncontrolled or irreversible coagulopathy.
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent (\< 4 weeks) and/or uncontrolled cardiac disease.
* Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe).
* ASA classification ≥ 4.
* COVID-19 positive participant at the time of procedure.
Revealed Versus Concealed Cerebroplacental Ratio

The purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.

This is a multicenter, open-label randomized trial with groups in parallel. Singleton pregnancies are recruited after routine second trimester scan (19+0 to 22+6 weeks of gestation) and randomly allocated at that moment to revealed or concealed strategy. A routine scan will be booked at 36-37 weeks. For a reduction of the stillbirth rate of 3‰ (from 5‰ to 2‰), assuming a type I error of 5% and aiming for a power of 80% a total of 11,582 subjects (5791 per arm) were projected. The participating centers sum up 12,000 deliveries a year. It is not possible to blind participants, obstetricians, or outcome assessors to the study group.

General hypothesis: A proportion of fetuses with "normal" growth as per current standards have placental insufficiency and restriction of their growth potential. These fetuses exhibit biophysical changes expressed by abnormal cerebroplacental ratio. A combination of this marker with fetal biometry for the detection of fetuses affected by fetal growth restriction could identify a group of babies on which labor induction once term is reached may prevent the occurrence of adverse outcomes.

Specific hypothesis

* The cerebroplacental ratio has predictive value in late pregnancy for placental insufficiency.
* The cerebroplacental ratio could improve the effectiveness of late pregnancy screening for the prediction placental insufficiency-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Viable singleton non-malformed fetus
* Available first-trimester US dating
* Maternal age at recruitment ≥18 years
* No adverse medical or obstetrical history at booking
* Capacity to give informed consent

Exclusion Criteria:

* Abnormal karyotype
* Structural abnormalities
* Congenital infections
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/= 18 years of age
* Histologically confirmed adenocarcinoma of the colon or rectum
* Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
* Tumour tissue sample available for assessment of K-RAS and BRAF genes
* Prior radiotherapy must have been completed 4 weeks before randomization
* Adequate bone marrow, kidney and liver function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Previous chemotherapy for metastatic disease
* Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
* Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
* Clinical or radiographic evidence of brain metastases
* Clinically significant cardiovascular disease or disorder
* History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
* HIV, hepatitis B or C infection
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption

The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.

People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.

We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
* On insulin pump therapy for at least 3 months

Exclusion Criteria:

* Non-type 1 diabetes mellitus
* Any physical/psychological disease likely to interfere with the study
* Taking medication likely to interfere with interpretation of results
* Known/suspected allergy against insulin
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
* Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
* Current pregnancy/breastfeeding
* Total daily insulin dose \> 1.4 IU/kg
* HbA1C \> 10% within the last 3 months
* Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy

Chronic pain is a severe disabling problem within society, affecting 25-30% of the United States population.. Transcranial alternating current stimulation (tACS) has the potential to provide a treatment option that is safe, scientifically-supported, low-cost, and easy-to-administer method to effectively reduce symptoms in patients suffering from chronic pain. The purpose of this study is to test the feasibility of using tACS to treat patients with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for optimizing the design of subsequent large-scale studies. The treatment rationale is to renormalize the presumed pathological structure of alpha oscillations in the prefrontal cortex (PFC) of patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65
* Diagnosed with nonspecific chronic low back pain by clinician
* BMI is less than 30
* Suffered from chronic pain for \> 6 months
* Self-report pain measures \>4
* Meets criteria for low depression and suicide risk as defined by the Hamilton-Depression Rating Scale
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
* Not currently taking opioids, benzodiazepines, and anticonvulsant medications

Exclusion Criteria:

* Radicular Pain
* Traumatic brain injury, Any brain devices/implants, including cochlear implants and aneurysm clips
* History of major neurological or psychiatric illness, including epilepsy
* (For females) Pregnancy or breast feeding
* Diagnosis of eating disorder (current or within the past 6 months), Obsessive Compulsive Disorder (lifetime), or Attention-Deficit Hyperactivity Disorder (currently under treatment)