cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through EEG recordings while listening to an auditory cognitive assessment tool. EEG recordings will be analyzed using proprietary computational analyses.

One of the major problems in the prevention and treatment of neurological disorders, is the lack of cost effective and reliable tools to assess neurodegeneration on a large scale at a very early stage. Although current imaging methods give a clear image of the brain atrophy involved in neurodegenerative disorders, there are deficiencies prohibiting their usage for prevention-scanning of large high-risk population such as high price, long set-up time and the need for trained personnel to conduct the test. Therefore, the development of a reliable tool to assess brain neurodegeneration, associated with cognitive decline independent of personal interpretation and/or variance between clinicians and between medical facilities would be highly valuable. This tool would allow the healthcare team to make appropriate treatment decisions that could aid in neurodegenerative disease prevention.

The Neurosteer system provides objective neurological biomarkers using a wearable easy-to-use affordable system. The system facilitate the capture and interpretation of EEG data with only a single patch of electrodes, attached on the subject's forehead. Neurosteer examination includes completing auditory tasks while measuring brain activity with the device. The data is analyzed using machine learning methods to produce biomarkers, enabling a report of the patient's activity in real time and offline. The examination is easy to preform and can be conducted in every clinic or in patients' homes.

In this study, clinical staff will identify potential subjects and will examine the eligibility of subject according to inclusion and exclusion criteria. Research staff will inform the patient on study's objective and design. Patients will sign the Informed Consent Form (ICF). Research staff will set up an initial session using the Neurosteer system. In this session the patient will perform auditory cognitive assessment tasks. The patient will be re-examined in the same experimental setting over the next 7 days and at least 1 day later. Level of cognition will be assessed by the Neurosteer technology.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 50.
* MMSE ≥ 24.
* Patient is able to collaborate.
* No other cognitive comorbidity.
* No seizure events.

Exclusion Criteria:

* MMSE \< 24.
* Any verbal or non-verbal form of objection from patient or form patient's family member or significant other.
* Presence of several cognitive comorbidity.
* Damage to integrity of scalp and/or skull.
* Skin irritation in the facial and forehead area.
* Significant hearing impairments.
* History of drug abuse.
A Biobehavioral Model of Diabetes Risk in Chinese Immigrants

This prospective, longitudinal study of Chinese American immigrants will examine whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time, and whether such associations are mediated by inflammatory pathways.

It is now well-documented that immigration to the US leads to increased risk for various chronic diseases, including type 2 diabetes. The increased diabetes risk observed among Chinese immigrants has been primarily attributed to changes in diet and weight gain following immigration, but these changes can only partially explain disparities in disease risk. Models of immigrant health suggest that the stress of adapting to life in a new country has a considerable impact on physical health. However, few studies have considered the psychosocial impact of immigration upon biomarkers of health and disease risk. Therefore, this longitudinal study of US Chinese immigrant men and women will examine: (1) whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time; and (2) whether the association between psychosocial factors and diabetes risk markers is mediated by inflammatory pathways.

Eligibility Criteria:
Inclusion Criteria:

* Chinese heritage;
* migration from Asia in adulthood (aged 18 years or older); and
* age 35-65 years

Exclusion Criteria:

* Current or prior history of diabetes
* Self-reported conditions of cancer, auto-immune disorders, HIV, or psychiatric illness
* Use of medications that may impact study outcomes (e.g., steroidal or non-steroidal anti-inflammatory medications)
* Inability to provide informed consent.
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.


Eligibility Criteria:
Inclusion Criteria:

* In general good health
* Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion Criteria:

* History of Hepatitis B Infection or vaccination
* Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
* Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
* Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
* Participation on prior study using an investigational drug or vaccine in prior 3 months
* Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
* Pregnant or nursing women or women planning to become pregnant within the study period
Treatment of Low Bone Density in Cystic Fibrosis.

Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000 individuals worldwide, including about 3,800 in Italy -- is often associated with low bone mineral mass. The current aggressive therapies have ensured a much longer survival of CF patients but this has led to a higher frequency of osteoporosis and bone fractures, a serious problem which not only affects quality of life, but also hinders further therapeutic measures.

The aim of this study, conducted on a large group of children, adolescents and young adults with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and efficacy of alendronate treatment (for another year) in patients not responding to calcium + 25-OH vitamin D alone.

The study included 2 phases.

Phase 1 (1-year open-label observational study): following baseline evaluation, bone mass changes have been studied with a simple therapy of adequate calcium intake and 25-OH vitamin D supplements in all eligible subjects (N=171).

Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study): the 128 subjects showing an insufficient response to calcium + 25-OH vitamin D alone (bone mass increase \<5%) at the end of Phase 1, were randomized into 2 groups and assigned to alendronate treatment (N=65) or placebo (N=63) (in addition to calcium and 25-OH vitamin D as during Phase 1).

The study has been carried out by the Coordinator's Institution (Istituto Auxologico Italiano)in collaboration with most Regional Reference Centers for CF in Italy.

Eligibility Criteria:
Inclusion Criteria:

* age 2-30 years
* clinically stable condition
* regular menses in females
* low Bone Mineral Apparent Density for age (defined as BMAD Z-score ≤-2.0 if age ≤18 years or ≤-2.5 if age \>18 years).

Exclusion Criteria:

* two or more episodes of hypercalcemia and/or hypercalciuria
* contraindications to 25-OH vitamin D or alendronate treatment
* recent transplantation
* other diseases or medications (glucocorticoids excepted) associated with bone loss.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825


Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female between 18 and 55 years of age, inclusive.
2. All female subjects must have a negative serum pregnancy test at screening and on Day -1.
3. The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive.
4. The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
5. The subject has a negative urine drug screen for alcohol, cotinine.

Exclusion Criteria:

1. Female subjects who are pregnant or lactating.
2. The subject has a past history of heart arrhythmias.
3. The subject has history of clinically significant diseases.
4. The subject has any history of a previous anaphylactic reaction.
5. Use of prescribed medication within 6 months of Day -1.
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects

This clinical study is designed as a multiple-ascending-dose, safety and tolerability study with IW-3300. The study drug will be administered as a low-volume \[20 mL\] enema. Study participants will be randomized in a 2:1 ratio to receive IW-3300 or placebo. Up to 3 different doses of IW-3300 will be studied. Safety reviews will be conducted before proceeding to each higher dose.

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose study of IW-3300 administered rectally, once-daily, for 7 days as a low-volume enema in healthy adult participants. This study will assess the effect of IW-3300 on safety and tolerability.

The study includes up to 4 treatments: placebo and up to 3 dose levels of IW-3300 which will be determined after safety reviews of previous cohorts.

The 9 participants within each cohort will be randomized to receive IW-3300 (6 subjects) or placebo (3 participants), administered rectally (as a low-volume \[20 mL\] enema). Participants in each dosing cohort will progress through 3 study periods: (1) Screening Period, (2) Clinic Period, and (3) Follow-up Period. Treatment duration will be 7 days; participants will be followed in the Phase 1 clinical research unit (CRU) for the duration of dosing, until at least 24 hours after the last dose of study drug and contacted by phone for follow-up approximately 2 weeks after the last dose. Total participant participation will be 29 to 57 days, including the Screening, Clinic, and Follow-up Periods.

Eligibility Criteria:
Inclusion Criteria:

* Males and female subjects of non-childbearing potential
* Ages 18 to 60 years
* Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Body mass index (BMI) within the range 18.5 to 35.0 kg/m\^2 (inclusive) at the Screening Visit.
* Male subjects and female partners are willing to use double-barrier method of contraception during the study.

Exclusion Criteria:

* Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
* History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
* History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
* Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
* Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
* Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C virus (HCV) antibodies at the Screening Visit.
Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial

The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique

The zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .

Eligibility Criteria:
Inclusion Criteria:

1. Male or female (\>18 y)
2. patient with At least 1 deep carious lesion
3. Clinical symptoms of reversible pulpitis with positive pulp response

Exclusion Criteria:

* 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)
International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients

The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal defects (ASD II).

Introduction: Interventional ASD closure is generally a safe procedure with only a small amount of severe side effects including mainly erosion of the atrial wall, embolizations and arrhythmias. The IRFACODE study has shown excellent results in Patients with various generations of the Occlutech devices. IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal defects (ASD II).

Methods: The IRFACODE II study is a retrospective, non-randomized open access study for centres with a minimum of about 50 patients to evaluate the safety and side effects of ASD closure with this device. A minimum of 2000 patients that have an ASD II closed with this device until 31. June 2016 will be enrolled, the follow-up will be until 31. June 2017. Primary outcome measures for safety are the amount of erosions over a minimum follow-up time of 12 months. Primary outcome measures for device performance will include the success of complete ASD closure. Secondary outcome measures for safety will include the technique of implantation, the success rate in anatomically difficult ASDs, the incidence of arrhythmias (AV block, atrial fibrillation or flutter), device embolization, embolic events or migraine. A subgroup analysis according to patients age and anatomy of the defect will be performed.

Outlook: The IRFACODE II study is the first trial intended to detect the actual incidence of erosion after ASD closure using the Flex II device. Although the trial is primarily designed to study the safety and device performance, the incidence of other potential side effects will be also evaluated.

Eligibility Criteria:
Inclusion Criteria: ASD for device closure

-

Exclusion Criteria:

* life expectancy \< 12 months
* participating in another study
The Effect of Diabetes Education Digital Games and Video Animation on Quality of Life

This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.

This research was conducted to examine the effects of diabetes education given to children with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and metabolic control. The study is a single-blind, randomized controlled trial. It was conducted with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27) and control group (n=28). Diabetes education was given to the experimental group with digital games and video animations. Data were collected before the training, at the 3rd and 6th months after the training. Research data were collected with "Descriptive Information Form", "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters Follow-up Form". Children in the control group received routine outpatient examination/check-up and diabetes education by a diabetes nurse. Children in the intervention group were given digital game and video animation-based training, as well as routine outpatient examination/check-up and training given by a diabetes nurse.

Eligibility Criteria:
Inclusion Criteria:

* Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
* Being between the ages of 8-12,
* Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
* To have regular follow-ups,
* No communication disability (speech, hearing, vision problems)
* It means having a device (computer) with internet connection at home and being able to use it.

Exclusion Criteria:

* Having any chronic disease together with diabetes,
* Using an insulin pump
LENS - Long-term Eltrombopag Observational Study

A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for enrolment in the study if they have previously participated in an eltrombopag study, either phase II or III, and meet all of the following criteria:

* Subject has signed and dated a written informed consent for this study.
* Subject has previously participated in a study evaluating eltrombopag, either phase II or III, and must have received at least one dose of study medication (either active drug or placebo). This excludes subjects from phase I studies (See Section 5.1).
* The prescribed follow-up ophthalmic assessment at 6 months post end of treatment should be completed as specified in the protocol for the previous study.
* Subject is able to understand and comply with protocol requirements and instructions.

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

* Subject has received surgery for cataracts and is aphakic or bilaterally pseudophakic.
* In some countries (i.e. France), a subject is neither affiliated with nor a beneficiary of a social security category.
Accuscreen Equipment Evaluation For Newborn Hearing Screening

An evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings to see if the new settings reduce unnecessary referrals for babies from newborn hearing screening.

Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

All newborn babies undergo hearing screening, usually within the first few days of life and some are tested with the automated auditory brainstem response test (AABR). This involves recording activity from the hearing nerve and parts of the brainstem from three small sensors placed on the baby's head and neck when a series of clicking sounds are played in to the ear.

In March 2015 we started using an 'Accuscreen New' to record the AABR, which is approved by the Newborn Hearing Screening Programme (NHSP) and used widely across the UK. However, since introducing the new equipment the 'screen refer' rate increased significantly in very young babies (less than 48 hours old) and diagnostic testing showed they had satisfactory hearing. The impact of the increased referral rate caused increased delays on diagnostic testing and also lead to unnecessarily increased parental anxiety in relation to the hearing of their new born baby.

The equipment suppliers (GN Otometrics) and the NHSP Programme centre have agreed to an evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings which we believe will reduce unnecessary referrals of so many young babies to Audiology (the modified equipment will test for up to 10 minutes to see if a response is present, instead of stopping after one or two minutes).

Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

Eligibility Criteria:
Inclusion Criteria:

* Babies requiring AABR testing through newborn hearing screening

Exclusion Criteria:

-
Iodine Status in Pregnant Women in Israel

Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes

New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.

Eligibility Criteria:
Inclusion Criteria: First trimester pregnant women with a singleton pregnancy

Exclusion Criteria:

1. Women with a known thyroid disease treated or untreated
2. Women who received contrast material in the year previous to the study
3. women with any chronic disease
4. Women who receive chronic medication not including vitamins