cyrilzakka/clinical-trials huggingface dataset:
Single-center Prospective Longitudinal Study of Taste in Patients with Cognitive Disorders At Different Stages of Severity (isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials

The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 4 following groups of participants:

* Healthy subjects
* Participants with isolated cognitive complaint
* Participants with minor neurocognitive disorder
* Participants with mild and moderate Alzheimer-type major neurocognitive disorders

For this purpose, we want to compare the results of the following tests:

* Subjective taste tests (tasting solutions, answering food preference questionnaires),
* Gustatory evoked potential (GEP) parameters, recorded by electrodes placed on the scalp,
* And nutritional parameters (hormones of food intake by blood test, measurement of the global body composition).

Identifying and following the evolution of early taste disorders in case of cognitive disorders could improve the diagnosis of Alzheimer\&#39;s disease in two ways:

* To allow an early diagnosis of Alzheimer\&#39;s disease, and thus improve its management,
* To define groups of subjects at risk of developing Alzheimer\&#39;s disease in later years.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given oral consent.
* For patients with mild to moderate Alzheimer\&#39;s disease, the primary caregiver and the patient will be asked to provide oral consent
* Person of legal age
* Body Mass Index (BMI) \&lt; 30 kg/m².
* For the healthy group: absence of cognitive complaints and normal neurological assessment
* Patients meeting the criteria for isolated cognitive complaint: presence of cognitive complaint but normal neuropsychological evaluation
* Patients meeting diagnostic criteria for minor cognitive impairment: imaging (brain MRI) and neuropsychological assessment with a Clinical Dementia Rating (CDR) score of 0.5
* Patients meeting diagnostic criteria for mild to moderate Alzheimer\&#39;s disease: imaging (brain MRI), neuropsychobiological criteria (consultation with neuropsychological assessment, CSF biomarkers), MMSE score ≥ 20 and CDR score of 1 or 1.5
* Fasting for at least 2 hours before GEP measurement

Exclusion Criteria:

* MMSE score\&lt;15
* Known COVID-19 infection within 6 months prior to inclusion
* Person not affiliated to national health insurance system
* Person under a legal protection measure (curatorship, guardianship)
* Person subject to a measure of legal protection
* Pregnant, parturient or breastfeeding women
* Subjects with a pacemaker (contraindication to bioelectrical impedance measurement)
* Adult unable to express consent or to perform cognitive tests.
* Active smoker (\&gt; 4 cigarettes per day on a regular basis)
* Diabetic subject (type 1 or type 2)
* Subject with acute or chronic ENT disease
* Treatment interfering with gustation
* Brain MRI showing another cause of neurocognitive disorder (except for vascular lesions Fazekas 1 accepted)
/Autism Spectrum Disorder(ASD)Hearing Abnormalities Study

Co morbidity rates of hearing loss in children with autism spectrum disorder are high and increasing.

Investigators are aiming to:

1. evaluate peripheral auditory and brain stem auditory function in children with autism spectrum disorder.
2. compare communication capabilities in autistic children having hearing abnormalities and autistic children with normal hearing.

Full audiological evaluation is carried out to all participants including:

* pure tone and speech audiometry.
* Tympanometry and acoustic reflex threshold evaluation.
* Threshold auditory brain stem response for threshold determination in non co operative children not respond to pure tone,speech audiometry.
* Auditory brain stem response for neuro-otologic diagnosis.
* Transient evoked otoacoustic emissions in children proved to have normal hearing to detect minimal cochlear affection .
* Transient evoked otoacoustic emissions with contralateral masking. Communication evaluation is carried out to all participants using arabic language test(kotby et al,1995).

Investigators use childhood autism rating scale for (CARS) for diagnosis of autism spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less)

Exclusion Criteria:

* children with otitis media with effusion.
* Associated neurological deficit .
Bioavailability of Blackberry Juice Anthocyanins

The main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.

Anthocyanins (ANT), a particular class of flavonoids that can be found in red wine and red fruits, have been associated with relevant health benefits. It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising from them after absorption. Therefore, it is important to identify which ANT metabolites are responsible for their health benefits. Since ANT can prevent/treat some of the metabolic features of obesity it is also crucial to study whether ANT bioavailability is not compromised in obesity.

An anthropometric evaluation will allow the classification of subjects according to their body mass index (BMI). A complete medical examination including the assessment of clinical laboratory parameters will also be performed to characterize the health status of recruited subjects.

Before the beginning of the study, the last fecal sample obtained will be collected. Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice ingestion. Another urine sample will be collected at 120 min. The first fecal sample obtained at least 6 h after juice ingestion will be collected. Blood pressure (0 and 120 min) and glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit.

Ethanol was added to the blackberry juice to mimic the concentration presented in red wine (12%).

A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points. Fecal samples will also be collected to evaluate the relationship between the presence of ANT metabolites and the gut microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18-40 years
* BMI\>18 kg/m2
* Willing and able to provide written consent

Exclusion Criteria:

* Subjects with current or previous CVD, diabetes or other severe chronic disease
* Subjects under prescription of any chronic medication
* Pregnant or breast-feeding subjects
* Intake of antibiotics in the last 3 months prior to the beginning of the intervention
* Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
* Subjects involved in any clinical or food study within the preceding month
* Subjects with a diagnosis of any digestive disease including functional bowel disorder such as IBS
Long-term Evaluation of Outcomes of Patients Undergoing Autologous Bone Marrow Concentrate Infiltration vs. Hyaluronic Acid

This is a prospective observational study for long-term clinical evaluation (minimum 4-year follow-up) in patients treated within the research protocol "OA-bi-blind" (Double-blind randomized trial on the treatment of bilateral knee osteoarthritis: Autologous bone marrow concentrate VS. hyaluronic acid)

60 patients treated within the "OA-bi-blind" research protocol from 2016 to 2019 at the II Orthopaedic and Trauma Clinic of the Rizzoli Orthopaedic Institute will be recruited. These are patients undergoing infiltration for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol.Prior to enrollment, patients will be contacted provided they have released their personal or legal guardian's e-mail address and/or personal or legal guardian's telephone number in advance and only after verifying the patient's consent to be contacted again for research purposes. If the patient is interested in participating in the study, arrangements will be made with him or her to send the Informed Consent and Disclosure Letter.

The patient will have to return (by means of a pre-stamped envelope that he will have received together with the consent itself) the Informed Consent completed in all its parts to the address given in the information letter. Only upon obtaining the fully completed Informed Consent may the investigator subject the patient to a telephone interview.

Alternatively, the patient may receive the Informed Consent and the questionnaire for clinical evaluations digitally.Clinical score data will be collected from the questionnaires conducted at long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up, will be used to evaluate the time course of outcomes after treatment with autologous bone marrow concentrate versus hyaluronic acid in patients who received either treatment as per the ''OA-bi-blind'' protocol.

Eligibility Criteria:
Inclusion Criteria:

-Patients undergoing injection for the treatment of bilateral gonarthrosis of autologous bone marrow concentrate vs. hyaluronic acid within the OA-bi-Blind Research protocol at the II Orthopedic and Trauma Clinic of the Rizzoli Orthopedic Institute.

Who met the following criteria at the time of treatment:

* Male or female patients, aged 18 to 75 years;
* Symptomatic bilateral knee osteoarthritis (Kellgren-Lawrence grade 1-4);
* Failure after at least 2 months of conservative treatment;
* Ability and consent of patients to actively participate in the rehabilitation protocol and clinic and radiological follow-up; And who meet the following criteria at the time of assessment by telephone or via telemedicine platform;
* Capable patients
* Signature of informed consent
* Availability

Exclusion Criteria:

* Patients no longer on call;
* Patients who do not agree to undergo evaluation
* Patients who have passed away.
QPlus Pediatric Reference Interval

Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.

Single center observational study of the pediatric patient population (\< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.

Eligibility Criteria:
Inclusion Criteria:

* \<18yrs
* Scheduled for procedure requiring anesthesia
* Access to blood sampling
* Consented

Exclusion Criteria:

* \>18yrs of age
* pre-term babies
* patients with know hematological disorders
* Difficult to obtain blood sampling
* Has received a blood product transfusion within the last 24hrs.
* Legal guardian unwilling to consent
Evaluation of Clinical Perfectionism in Parkinson Disease

Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety.

Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety. Also, clinicians reported that they exhibit specific personality traits (e.g., rigidity and perfectionism).

To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's disease showing promising results. Recently, perfectionism has received particular attention because of it association with many emotional disorders. Thus, some psychometric tools have been developed in order to evaluate different aspects of perfectionism. Yet, none of them has been used in people with Parkinson's disease.

The objective of this study is to investigate whether there is a direct link between Parkinson's disease and perfectionism by using psychometric tools from the CBT literature. Identifying such link would allow to justify the use of CBT in people with Parkinson's disease with the goal in mind to improve their care and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Score Mini Mental Scale (MMS) greater than 23
* For Parkinsonian, Parkinson disease be defined according to the criteria of the Unified Parkinson Disease Rating Scale (UPDRS), with a Hoehn and Yahr stage 1, 2 or 3
* The control patients present dystonias not within the scope of Parkinson
* Informed Consent Form signed
* Patient covered by social insurance

Exclusion Criteria:

* Proven Presence of neuropsychological disorders
* Patients with deep brain stimulation
* Diagnosis of somatic pathology diagnosed
* Private Patient freedom or protected adult (under guardianship)
BIA and Cardiac Implantable Electronic Devices

There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this group of patients to avoid any electromagnetic interference. These recommendations restrict the use of BIA in many patients with heart failure in whom BIA might be of great interest in detecting peripheral congestion and in guidance of treatment. However, it is not well known whether BIA can affect the function of cardiac devices. Investigators aimed to test the incidence of electromagnetic interference between BIA and CIEDs.

Patients enrollment were during routine face-to-face consultations, scheduled for PM and ICDs interrogations. Investigators recorded before and after each BIA measure, the battery voltage of the device, lead impedance and stimulation thresholds. The device electrograms were monitored during BIA measurements to detect any electromagnetic interference or oversensing.

Eligibility Criteria:
Inclusion Criteria:

* Patient having a cardiac device with or without cardiac resynchronization
* 18 years of age and above
* Patients with no pacing-dependent status
* Patients who read, understood and signed written informed consent letter

Exclusion Criteria:

* Patients with acute heart failure
* Patients implanted in less than 2 months
* Dysfunction of the device in a follow-up visit or in the inclusion visit
* Patients with a particular device lead model prone to develop electronical problems such as Sprint Fidelis of Medtronic (Minneapolis, USA) or Riata of St. Jude Medical (St. Paul, USA)
* Pregnancy
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results


Eligibility Criteria:
Inclusion Criteria:

* Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated.

Exclusion Criteria:

* Subjects with prior complete or partial hysterectomy involving removal of the cervix
* Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
* Year 3 visit can not exceed 3 years and 6 months from the baseline visit
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.

The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.

Eligibility Criteria:
Inclusion Criteria:

* Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
* Respiratory Sensor programmed "On"
* Classified as having NYHA Class III heart failure documented, in the past 12 months
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol

Exclusion Criteria:

* Inability or refusal to sign the patient Informed Consent
* Inability or refusal to comply with the follow-up schedule
* Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
* Patients prescribed to positive airway pressure therapy
* A life expectancy of less than 180 days, per physician discretion
* Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
* Women who are pregnant or plan to become pregnant in the next twelve months
Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Must have locally advanced/borderline resectable hepatocellular carcinoma.
2. Must have measurable disease.
3. Age ≥18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
6. Patients must have adequate liver remnant and function.
7. Antiviral therapy per local standard of care for hepatitis B.
8. Woman of child bearing potential must have a negative pregnancy test.
9. Must use acceptable form of birth control while on study.
10. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed HCC.
2. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
3. Concomitant Anticoagulation therapy.
4. Any GI or pulmonary risks of bleeding.
5. History of HIV Infection.
6. Active co-infection with hepatitis B and hepatitis C.
7. Active co-infection with hepatitis B and hepatitis D.
8. Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
9. History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
10. Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
11. Uncontrolled intercurrent illness.
12. Corrected QT interval calculated by the Fridericia formula.
13. Uncontrolled high blood pressure.
14. Are pregnant or breastfeeding.
15. Any gastrointestinal (GI) disorders.
16. Any certain study-specified heart conditions 6 months prior to enrollment.
17. Major surgery within 2 months before enrollment.
18. Have any evidence of moderate or severe ascites.
19. Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
20. Inability to swallow intact tablets.
21. Known or suspected hypersensitivity to study treatment.
The Ready and Healthy for Kindergarten Study

The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes.

All participants will be asked to complete surveys and assessments.

Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.

Education is a critical social determinant of health (SDOH). Latino dual language learners face large gaps in school readiness, which perpetuate inequities in academic achievement and subsequent health. Investigators developed an online family wellness program that uses anticipatory guidance on health topics intrinsically important to school readiness (e.g., nutrition, physical activity) to introduce basic language and literacy skills to Latino dual language learners, a fast- growing and particularly high-risk group, and their families. The online family wellness program was developed through a cross-sector partnership between educators and pediatric professionals and consists of parent-child workshops and reminder text messages. The program occurs during the transition into Kindergarten, a critical developmental stage, and uses promising approaches such as group structure, strategic use of technology, and partnerships. The program tightly integrates Bright Futures anticipatory guidance with the Kindergarten curriculum. During pilot testing, the investigators found that the family wellness program was feasible, well attended, and highly acceptable. The investigators now propose testing the effect of the family wellness program on child and parenting outcomes using a rigorous mixed methods and community-engaged approach. The investigators will conduct a randomized controlled trial testing the effects of the family wellness program on child language, literacy, and social-emotional outcomes as well home health and learning routines. The investigators will also conduct a mixed methods process evaluation, which will provide insight into reach and implementation as well as user experience.

Eligibility Criteria:
Inclusion Criteria:

* primary caregiver of a child entering Kindergarten (4-6 years old),
* primary caregiver identifies as Hispanic/Latino/Latinx,
* family speaks Spanish at home,
* cell phone ownership,
* willing to receive text messages,
* ability to pick up program materials locally, and
* willing to accept randomization

Exclusion Criteria:

-Individuals unable to provide informed consent