cyrilzakka/clinical-trials huggingface dataset:
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children with Autism

Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
* Outpatients between 2.0 and 4.11 years of age of either gender,
* Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\],
* Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
* Stable treatment \[Applied Behavior Analysis (ABA), Floortime, or other interventions\], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
* No more than 60 minutes of 1:1 speech therapy per week,
* The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
* The availability of at least one parent who can consistently participate in the training sessions and related activities, and
* Successful completion of baseline brain scan.

Exclusion Criteria:

* Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
* Genetic abnormality (e.g., Fragile X)
* Presence of active medical problem (e.g., unstable seizure disorder),
* Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
* Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
* Previous adequate Pivotal Response Treatment (PRT) trial.
Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers

This is a randomized, double-blind, single dose, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection) administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans will be acquired to measure radiographic density in regions of interest (ROI) at times from 3-5 hours and up to 72 hours following NCTX administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonsmoking men and women 18 to 55 years of age
* Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
* Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater

Exclusion Criteria:

* Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing
* History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials
* History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation
* Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL
* Pregnant or nursing women
* Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in
Adolescent Projections During Transition in Prader-Willi Syndrome

Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.


Eligibility Criteria:
Inclusion Criteria:

* Patients with genetically confirmed Prader-Willi syndrome
* Patients affiliated or beneficiaries of a social security system
* Patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions

Exclusion Criteria:

* Refusal of family participation (if minor)
* Refusal of participation by the patient or his guardian (if of legal age)
Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training

Gait problems in hemineglect patient post stroke , vestibuloocular training plays a role in improving gait function, gait assessment using a model based study (Microsoft Kinect) for pre and post training assesment.

The syndrome of visuospatial neglect is a common consequence of unilateral brain injury. It is most often associated with stroke and is more severe and persistent following right hemisphere damage, with reported frequencies in the acute stage of up to 80%. This may result in gait disturbance, high levels of energy expenditure and increase the risk of falls. Vestibuleo-ocular training techniques are aimed at improving or even restoring visual function by training patients to detect stimuli in the blind hemifield and increase their overall sensitivity to them. The investigators propose a model based (Microsoft Kinect), a device can be used for assessment of spatiotemporal gait variables as well as gait kinematics.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age will range from (60-70) years old.
* Patients who had a stroke at least six months prior.
* Patients who had visual field defects post stroke.
* Patients who could walk without caretaker assistance or no severe dyskinesias.
* Adequate hearing (hearing aid if required).
* Patients who had no problem with their state of consciousness and absence of dementia
* Patients who had no orthopedic problems that may affect gait.
* Patients will be chosen in both sexes.
* Clinically and medically stable.

Exclusion Criteria:

Patients who will meet one of the following criteria will be excluded from the study:

* Only one functional eye.
* Neurological problem or any severe co-morbidity likely to affect gait.
* Intact visual field.
* Instability of patient's medical condition.
* Obese ( BMI ≥ 30 Kg∕m2 ).
* Association with another medical problem that can affect patient
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)

This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases.

Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.

This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side.

Each patient (or side if a bilateral case) will be randomly assigned to one of two groups: Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex and any race greater than 18 years of age
* Patients for whom a decision has already been made to augment one or both maxillary sinuses for the purpose of placing dental implants in a maxillary ridge no less than 3 mm high and no greater than 5 mm in height
* Patients must be physically able to tolerate conventional surgical and restorative procedures.
* Patients must agree to be evaluated for each study visit, especially the yearly follow-up visit

Exclusion Criteria:

* Patients with active infection or severe inflammation in the areas intended for implant placement.
* Patients with a \>10 cigarettes per day smoking habit.
* Patients with uncontrolled diabetes mellitus.
* Treatment with therapeutic radiation to the head within the past 12 months.
* Patients who are pregnant at the screening visit.
* Patients with evidence of severe para-functional habits such as bruxing or clenching.
Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial

The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).

The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.


Eligibility Criteria:
Inclusion Criteria:

* Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
* Informed consent

Exclusion Criteria:

* Intolerance to used medication
* Recurrent disease
* Neck dissection, sternotomy
* Emergency surgery
Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics))

This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure.

Multicenter study, including patients aged 75 and over, hospitalized in geriatrics and having suffered heart failure in the geriatric wards of 3 centers. The following elements will be collected:

* Demographic data
* History (comorbidities)
* Type of heart disease
* Frailty criteria
* Clinical signs of heart failure
* Geriatric syndromes (falls, cognitive disorders, (MMSE) confusion, malnutrition, loss of autonomy (ADL, IADL), bedsores)
* Biology available (CBC, ionogram, creatinine, NT pro BNP, BHC, troponin, TSH, HBA1C)
* ECG and echocardiography data
* Treatment on admission, during stay and on discharge
* Mode of discharge and length of stay
* Follow-up at 3, 6, 9 months and one year, through telephone calls with the patient, caregiver or attending physician. Questions will cover various aspects of health and quality of life, physical activity limitations, autonomy, symptoms, anxiety, depression, as well as neurocognitive status (using adapted questions).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient

Exclusion Criteria:

* Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice
Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.

This is a Phase 3, Pragmatic, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazilian Ministry of Health.

Patients were randomized (1:1) using stratified randomization by hospital and severity at the moment of randomization (stipulated by use of mechanical ventilation or not) into two arms: Intervention and Control. Intervention group recieved a loading dose of 900mg of Chloroquine or 800mg of Hydroxycloroquine in the first day, followed by 450mg of chloroquine of 400mg of hydroxychloroquine. Primary and secondary outcomes were evaluated on the 5th, 7th, 10th, 14th, 28th day after randomization.

Although the outcomes presented in the latest version were updated late on ClinicalTrials.org, on October 23, 2020, these outcomes were already present in the trial protocol approved by the Brazilian National Commission for Ethics in Research on April 8, 2020 (approval number: 3960331) and amending the protocol, approved by the same National Commission on May 25, 2020 (approval number: 4044848)

Eligibility Criteria:
Inclusion Criteria:

* Adult Males and non-pregnant females that accept and sign the informed consent.
* Hospitalized with COVID-19 suspection that has collected the confirmatory test
* To have at least one of thes symptoms: Fever, coughing, throat ache or runny nose.
* To have at least one of these findings: radiological findings that indicates COVID-10 (bilatareal ground grass images); O2 saturation lower than 94% without supplementation and crackles in lung auscultation; Need of O2 supplementation; Need of Mechanical Ventilation.
* Female patients must also agree to use efficient counterceptive methods during the evaluation period.

Exclusion Criteria:

* Patients with psoriasis or other exfoliative disease, porphyria, epilepsy, myasthenia gravis, advanced liver failure or glucose-6-phosphate dehydrogenase deficiency.
* ALT / AST\> 5 times the upper limit of normal.
* Severe chronic kidney disease in stage 4 or requiring dialysis (ie, eGFR \<30).
* Pregnancy or breastfeeding.
* Early transfer to another hospital that is not a study site within 72 hours.
* Severe heart disease and / or a history of cardiac arrhythmia.
* Allergy to Chloroquine and / or Hydroxychloroquine.
Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP

The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of healthy mothers.

In order to prevent severe thrombocytopenia in infants born to mothers with ITP.

Samples of breastfeeding milk and sera will be collected from 10 lactating women diagnosed with ITP and from 10 healthy women in the same stage after giving birth. Antibodies against platelets in the samples will be examined by using anti human IgM/G/A antibody following incubation of the serum/milk samples with platelets. The platelets will be from leftovers of samples send to platelets functionality test and found to be normal (the platelets samples will be taken without any identification and be marked only with lab number). The measurement will be done by flow cytometer. Sample will be consider as positive when the signal will be greater than 2 fold of control samples standard deviation. In addition, the presence of antibodies in different times from the birth will be checked in breastfeeding milk and sera of ITP patients. If the milk proteins and lipids will disturb the exam, the immunoglobulins from the milk will be isolated using Ig isolation kit from plasma.

Eligibility Criteria:
Inclusion Criteria:

* Maternal ITP
* Newborns above 35W and above 2.5 kg

Exclusion Criteria:

* mothers who do not breast feeding
* Thrombocytopenia from other reasons
The Young Adults' Experiences With Virtual Reality (YAES VR) Study

The purpose of this study is to test the effect of virtual reality (VR) food marketing exposure (versus VR non-food control) on snack consumption, purchase intention, hunger, and arousal in black and white young adults. Participants will be randomized to either the VR food marketing condition or VR non-food control. Study participation duration will be 2 hours during a one-time, single visit.

Food marketing has been unequivocally linked to poor diet and risk of excessive weight gain in young people. Food companies disproportionately target Black consumers with more advertisements ("ads") and the least healthy ads, contributing to nutritional disparities and nutrition-related diseases. To expand their reach, food companies have developed virtual reality (VR) marketing experiences that are engaging, highly sophisticated, and may more powerfully elicit biological signals precipitating a motivation to consume foods. Yet, little is known about how exposure to VR food marketing influences biological and behavioral outcomes among Black young adults. The interactional role of food/nutrition insecurity and exposure to VR food marketing among Black young adults is also unknown. There is a critical need to understand the biological and behavioral effects of VR food marketing among Black communities while the technology is in its infancy.

Eligibility Criteria:
Inclusion Criteria:

1. 18-24 years old;
2. self-identify as Black or white in order to determine racial/ethnic differences in responses to unhealthy VR-based food and beverage marketing;
3. self-report normal or corrected-to-normal vision from glasses or contacts;
4. self-report comfort and ability to walk around within a VR paradigm;
5. able to read, write, understand, and respond to all study materials (including the VR paradigm) in English
6. residing in the NYC-metropolitan area in order to be available for in-person study
7. capacity and willingness to provide consent

Exclusion Criteria:

1. report a history of disorders causing motion sickness or have a history of significant motion sickness, which could be triggered within the VR paradigm
2. self-report dietary restriction, such as food allergies or veganism, which may lead to different effects when exposed to food marketing;
3. Self-report disliking 50% or more of the snacks that will be offered during the laboratory test snack as determined by a score of 5 or less on the food preferences questionnaire, which may have a confounding effect on consumption;
4. report being pregnant or breastfeeding, which may affect hunger;
5. smoke or consume tobacco, which decreases salivary flow; or
6. self-report being very hungry based on 100 mm VAS hunger rating, which minimizes the burden to participants to fast prior to the visit and maximizes the ability to detect differences between groups.Those excluded for being very hungry will have the option of returning to the visit on a different day.
Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment.

The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable.

Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.

A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The goal will be to assess antibodies throughout the subject's disease course compared to controls.

Eligibility Criteria:
Inclusion Criteria:

Subject must meet all of the following criteria to be eligible for treatment in the study:

1. Subject or legal representative understands the nature of the procedure and has signed the Subject Informed Consent Form prior to study procedures
2. For the COVID-19 Cohort

   * Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR
3. For the PUI Cohort

   * Subject has suspected COVID-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested negative by RT-PCR)

Exclusion Criteria:

* Subject or legal representative not willing to consent
Therapeutic Exploratory Study of CWP-0403

Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age of≥25 and \<75 with typeⅡ DM patients
* Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
* In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
* BMI between 20kg/㎡ and 40kg/㎡
* Out patients
* patients who agree the trial participation with written informed consent

Exclusion Criteria:

* TypeⅠDM, Gestational diabetes.
* Patients who are being treated with insulin
* Fasting glucose level over 250mg/dL
* Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
* Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
* Severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl
* Severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening
* Chronic pulmonary disease or pulmonary infarction
* Pancreatitis patients
* Patients who are being treated for life threatening disease such as cancer, severe trauma or infection.
* Uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis)
* Severe ketosis or experience of diabetic coma
* Intestinal disease affecting digestion or absorption or history of GI dissection surgery except for appendectomy.
* Pregnant, expecting to be pregnant or nursing female
* Excessive alcohol consumption (Over 80g of alcohol/day: Over 1 bottle of 360ml Soju/day)
* Participants of other clinical trials within 3 months of screening
* Patients medicated with following non-concomitant medications Insulins or oral antidiabetics Oral (for more than 1 week) or IV corticosteroids (External and inhaled corticosteroids excluded) appetite suppressant exenatide or other GLP-1 analogues Other medications in development
* Hypersensitive or intolerance to DPP4 inhibitory
* patients who are decided to be inappropriate for this trial subject by the investigators