cyrilzakka/clinical-trials huggingface dataset:
Ocular Safety and Usability Study for FYB203 PFS

The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

1. Study eye deemed to be indicated for aflibercept IVT injection therapy at the discretion of the Investigator.
2. Written and signed informed consent form (ICF) obtained before any study-related procedures.
3. Had a confirmed diagnosis in one or both eyes of neovascular (wet) AMD or macular edema following RVO or DME or DR.
4. Qualified for treatment with aflibercept according to the United States Prescribing Information.
5. Aged ≥18 years at the time of signing ICF.
6. If a subject was already on an aflibercept regimen, timing of study participation was correlated with the regimen.
7. Male study subject (if his female spouse/partner was of childbearing potential) must have confirmed that he was using two acceptable methods for contraception (one of which must be a barrier method) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration. Male study subject must have agreed to inform his partner of participation in the study and the need to avoid pregnancy. Surgically sterilized and non sexually active male subjects did not require any additional use of contraception.
8. Male study subject agreed not to donate sperm starting from screening and throughout the clinical study period and for 3 months after IP administration.
9. Female study subject was categorized by at least one of the following:

   * Not a woman of childbearing potential as described in Appendix 3 of the study protocol prior to signing ICF, or
   * Surgically sterile or had undergone a hysterectomy as categorized in Appendix 3 of the study protocol at least 1 month prior to signing ICF, or
   * Was using a highly effective contraception. All females of childbearing potential were required to use highly effective contraception (as described in Appendix 3 of the study protocol) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.
10. Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after IP administration.
11. Female study subject must not donate ova starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.

Exclusion Criteria:

1. Had received IVT injection in the study eye within 3 months prior to Day 1 with any anti vascular endothelial growth factor therapy other than aflibercept products (ege.g., Eylea).
2. Intraocular corticosteroid administration in the study eye within 30 days prior to Day 1.
3. Had fever or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non cutaneous) infection within 1 week prior to Day 1.
4. History or evidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in the last month prior to signing ICF or had been in confirmed contact with SARS-CoV-2 positive subjects in the last 2 weeks before dosing.
Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)

The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy.
* Male and female patients who meet all criteria listed below are eligible to be enrolled in this study:
* Diagnosed with schizophrenia
* Willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study

Exclusion Criteria:

* Progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study
* Previously randomized to study medication and enrolled in this study
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome

The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.

For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.
* Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.
* Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.
* Patients must not be in an acute phase of illness.

Exclusion Criteria:

* Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.
* Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.
* Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
* Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.
* Patients who are allergic to compounds that are similar to NGX267.
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.

Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.

Karolinska will be the coordinating center for data collection.

Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).

Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).

Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).

Eligibility Criteria:
Inclusion Criteria:

* that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).

Exclusion Criteria:

* None
AiCR : Artificial Intelligence in Cardiac aRrest

The overall incidence of cardiorespiratory arrest in Europe is estimated at 350,000 to 700,000 cases per year. Survival rate is estimated at 10.7% for all rhythm disorders combined.

Several examples of AI application in the medical field exist. Ting et al have developed a computer tool capable of diagnosing the presence of diabetic retinopathy with excellent power. In resuscitation, Celi et al proposed a tool capable of predicting the need for crystalloid vascular filling during a systemic inflammatory state. In Nature in 2018, Komorowski demonstrated the efficacy of AI in the hemodynamic management of sepsis. In a study of the renal response to fluid challenge, Zhang et al. demonstrate the effectiveness of the learning machine.

Objectives: Determination of an algorithm capable of predicting the mortality of patients admitted to intensive care units (ICU) for ACR from hospitalization reports (CRH). Also use of the algorithm to predict the risk of recurrence of the arrest, the duration of mechanical ventilation, the appearance of sepsis, the development of organ failure, prediction of the CPC (Cerebral Performance Category), time to obtain catecholamine withdrawal, the appearance of acute renal failure with or without the need for extra-renal purification (EER) and duration under EER, the average length of stay.

This project is part of a larger, nationwide project with greater power, and includes all the data generated during hospitalization in intensive care.

Method: an estimated total number of patients included in this study to be between 300 and 500. The population will come from the intensive care units of Nice, Antibes, Cannes, Grasse.

Inclusion will be retrospective, on CRH, CR of CT imaging (cerebral and thoraco-abdomino-pelvic), MRI, EEG, and daily follow-up words, from 2014 to the end of 2020.

After anonymisation, application of semantisation using natural language processing (NLP) methods. The data to be extracted are entered in a document written by intensive care physicians. These data will then be stored in a database. In order to meet the main objective, we will develop a computer algorithm capable of predicting mortality in the study population. This algorithm, based on a large database, can be designed using machine learning or even deep learning techniques depending on the amount of data to be processed.


Eligibility Criteria:
Inclusion Criteria:

* OCA recovered from: hypoxic, ischemic, pulmonary embolism, tamponade, rhythm or conduction disorder, shockable or not, intra or extra-hospital.
* CR computerized, typed in PDF format

Exclusion Criteria:

-
A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers

The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.

This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female who is 18 to 65 years old,
* Weight \>50 kg and ≤110 kg at Screening
* Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
* In generally good health
* Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months

Exclusion Criteria:

* Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
* Pregnant or breastfeeding
* eGFR \<90 mL/minute
* Abnormal ECG
* Abnormal laboratory results
* Positive test result for HIV, Hepatitis B, Hepatitis C, or COVID-19
* History of substance dependency (alcohol or other drugs of abuse) in the last 2 years
* Use of study drug in any clinical trial within 30 days of admission to the research center, or in the active follow-up phase of another clinical trial involving study drug
Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.

The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of either gender;
* 35-75 years old;
* Chronic joint/muscle related pain for at least past 6 months;
* Body mass index (BMI) at or below 34.9 kg/m2.

Exclusion Criteria:

* Bariatric surgery;
* Diagnosed with diabetes Type I;
* Taking medication for diabetes Type II;
* Known serious chronic health condition;
* Serious active illness within past 12 months;
* Major surgery within the past 3 months;
* Major trauma within the past 3 months;
* Alcohol consumption of more than four standard units/day (for example more than four regular 12 oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits), or more than 28 units per week;
* Daily consumption of Nopalea or similar juice products during the past month;
* Currently taking anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
* Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable);
* Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
* Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
* Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
* Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
* Known allergies to ingredients in the test and placebo products.
A Study of Oral Kavalactones Effect on Nurses

This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.


Eligibility Criteria:
Inclusion Criteria:

* Surgical services nurses at Mayo Clinic in Rochester, MN.
* Able to participate fully in all aspects of the study.
* Willing to use birth control for the duration of the study (if of childbearing potential).
* Understood and signed study informed consent.

Exclusion Criteria:

* Pregnant, nursing, or trying to conceive.
* Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
* Use of kava or kava-containing products within the past 8 weeks.
* Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
* Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
* Use of oral corticosteroids (e.g., hydrocortisone) or other steroids (e.g., prednisone).
* Alcohol use greater than 1 drink per day.
* Use of kratom within the past 8 weeks.
* Recent history of clinical depression or anxiety diagnosis.
* Known significant liver disease or dysfunction.
* Known significant kidney disease or dysfunction.
* Known Addison's or Cushing's Disease.
* Known catecholamine imbalance or medication use which influences catecholamine levels.
* History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis).
* Recent history or acute disease or unstable medical condition.
* Surgery planned during the course of the trial.
* A known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Bioequivalence Study in Healthy Volunteers

Primary: To determine the bioequivalence between the new formulation and the current formulation of the investigational drug, MOA-728.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Interest and Feasibility of the DIGItracking Technique for the Early Diagnosis of COGnitive Disorders

The main objective is to assess the usability of a novel tool of neurocognitive disorders detection, called the Digitracking, by the elderly population. The Digitracking technique is based on the eye tracking concept to assess cognitive decline (Lio et al. 2019). Instead of capturing eye movements, the new device captures the finger trajectory while exploring a blurred picture on a tablet. The usability of such a technology is assessed through objective and subjective metrics, such as the user experience.

Methods for cognitive decline diagnosis in elderly patients using simple, fun and ecological tests remain a major health issue. The objective is the early diagnosis of disorders in order to offer quick management of the decline of cognitive functions.

Eye tracking is a proven technique to study perceptual and cognitive functions in children and adults. It has recently been highlighted that it was also relevant to analyze the perceptual and cognitive functions of elderly people at different stages of neurocognitive disorders. Although very precise, this technique remains restrictive since it requires expensive equipment, technical skills, and long and repetitive tests while the patient stays motionless.

A new approach using the digit-tracking, named Digitrack (Lio et al. 2019), has shown excellent correlation with the eye tracking. The general principle is as follows: a blurred image is displayed on a touchpad screen. This degraded image reproduces the spatial resolution of the peripheral retina. While the patient put his finger on the screen, the area around the finger is unblurred, simulating the foveal region (central region) of the eye. By sliding his finger, the subject moves the unblurred window and can explore the image. The exploration trajectory, like the eye movement trajectory with eye tracking, is recorded and reveals the subjective regions of interest contained in the image which help to assess the user's neurocognitive functions.

The advantage of the Digitrack process is to require a cheap and easy-to-use device to assess the cognitive status of patients in a fun way and close to real conditions.

To date, its usability has not been demonstrated in elderly patients with or without neurocognitive disorders.

The investigators formulate the main hypothesis that patients visiting or hospitalized in the acute care geriatrics department, with or without cognitive disorders, can use the Digitrack process.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 75 years old
* Consultation or hospitalization in geriatrics department
* Subjects who can give written consent to participate in the study

Exclusion Criteria:

* Photosensitive epilepsy
* Uncorrected visual deficiency
* Any significative impairment at the upper limb level preventing from manipulating the device
* Persons deprived of their liberty by administrative or judicial decision, persons under psychiatric care under duress, adults subject to a legal protection measure or unable to express their consent
HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II

The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in patients with active RA. Furthermore, the trial is designed to identify the dose levels to be used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS responses).

This trial consists of a double-blind, placebo controlled, dose escalation part with randomization to trial treatment within each of three sequential cohorts (Part A), and a parallel group part with randomization into one of four treatment arms (Part B). Patients in Parts A and B will receive two infusions of either HuMax-CD20 (300 mg, 700 mg, or 1000 mg) or placebo and will be followed for safety, efficacy, and pharmacokinetic measurements for 24 weeks. Hereafter patients will be followed every 12 weeks until B-cells (CD19+ cells) have returned to baseline levels. For patients in Part B, the follow-up visits at 36 and 48 weeks after initial trial treatment (Follow-up Visits 1 and 2) will include additional measurements of safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Active rheumatoid arthritis according to the American College of Rheumatology of at least six months duration with six or more swollen and six or more tender joints (of 28 joints) and Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/h and/or C-Reactive Protein (CRP) ≥ 10 mg/L (1 mg/dL).
* Treatment failure to one or more DMARDs.
* Treatment with methotrexate (7.5-25 mg/wk) for at least 12 weeks and at a stable dose for at least 4 weeks prior to planned start of trial treatment.

Exclusion Criteria:

* Use of DMARDs other than methotrexate.
* Current or previous (within four weeks of screening) participation in any other clinical trial.
* Previous exposure to other biological products within 4 weeks prior to planned start of trial treatment, and/or exposure to anti-CD20 antibodies within two years before screening for this trial.
* Any use of cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents within five years before screening for this trial.
* Active autoimmune disease (other than RA and RA-associated secondary diseases) requiring immunosuppressive therapy.
* Past or current malignancy, except for resected cervical carcinoma Stage 1B or less, non-invasive basal cell and squamous cell skin carcinoma, malignant melanoma with a complete response of a duration of \> 10 years, or other cancer diagnoses with a complete response of a duration of \> 5 years.
* Chronic or current infectious disease including known or suspected positive serology for HIV, hepatitis B, or hepatitis C.
* Clinically significant cardiac disease, or history of significant cerebrovascular disease.
* Significant concurrent, uncontrolled medical condition including, but not limited to: renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
* Breast feeding women, women with a positive pregnancy test at screening, or women of childbearing potential not willing to use adequate contraception during the trial.