cyrilzakka/clinical-trials huggingface dataset:
Feasibility Testing and Pilot Study of V-MOTIVE Protocol Software Version 1

This is a project to be funded by a Fast-Track Small Business Innovative Research to build and test the feasibility of a new software prototype called V-Motive which will facilitate the combination of two proven autism behavioral interventions: Applied Behavior Analysis therapy (ABA) and Video Modeling (VM). The investigators will conduct a Phase I feasibility analysis and Phase II pilot study of the V-Motive Prototype by observing a community therapy providers' use of the prototype in a therapy setting. Investigators will observe the users and record the success or failure of the performance of key functions of the software. Investigators will also administer surveys. The study will answer research questions about V-Motive's ability to perform its intended function: allowing interventionists to feasibly leverage video modeling within ABA therapy with a minimal amount of overhead and labor.

Investigators will conduct a within-subject pilot study of 6 tutors and 6 children to answer research questions about V-Motive's ability to perform its intended function. The goal is to evaluate the feasibility, usability, and the potential of V-Motive to deliver comprehensive, individualized video modeling that is integrated with a child's program. Investigators will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their ABA therapy. However, these data are NOT intended to show cause or to show effectiveness. The study will answer the following questions: 1) 3) Can V-Motive be feasibly used during ABA therapy to positively impact a child's performance within 4 weeks? 2) How laborious is it to construct a fully-indexed video repository from therapy footage using V-Motive? 3) How accurate is the system in suggesting and cueing up appropriate video for playback on demand?

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 10 years old
* Clinical diagnosis of Autism Spectrum Disorder
* Currently receiving Applied Behavioral Analysis therapy
* Must be developmentally capable of basic imitation behavior

Exclusion Criteria:

- none
The Liver in the World Trade Center Health Program General Responder Cohort and Controls

This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.

This is a prospective cross-sectional study of liver disease in individuals who meet the United States Preventive Services Task Forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. Liver disease will be compared between individuals who are members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort. The basic objective is to determine whether exposure to the WTC attack increased liver disease.

Data will be obtained from the World Trade Center Data Center, from Mount Sinai Medical records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be collected from the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 55 and 80 years of age
* 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years.
* Individuals who are members of the World Trade Center General Responder Cohort or Subjects who meet the United States Preventive Services Task Forces guidelines for lung cancer screening

Exclusion Criteria:

* None
Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments.

Patients with mild cognitive impairment who are being treated with a TAVR can choose to take part in this trial. This trial will prospectively enroll patients at 4 Baylor Scott \& White facilities. 80 patients will be enrolled between all sites. The mini MoCA will be conducted at the following time points: pre TAVR, 30 days post TAVR, and 6 months post TAVR. All other data will be collected from patient charts and are considered standard part of their care.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Undergoing a TAVR procedure
3. Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:

   1. MMSE \< 27
   2. History of MCI, dementia, or stroke (CVA or TIA)
   3. History of prescription treatment for MCI
   4. Discretion of the investigator, physician, or clinic staff
4. Scores 25 or less on the mini MoCA exam

Exclusion Criteria:

1. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing

This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported primary residence within the pre-identified communities
2. Age\> 8 years at enrollment
3. Provision of signed and dated informed consent form

Exclusion Criteria: None if above are met

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Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision

Office-based optometrist centres equipped with low-cost OCT devices can be used for screening of age-related macular degeneration. Matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries.

The aim of the study is to detect AMD in a next-door office-based setting on an individual level using low-cost OCT, through a telemedicine feedback loop.

The specific aims of this study are:

* Setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population.
* Identify imaging biomarkers of age-related macular degeneration from OCT imaging.
* Give a risk estimation of progression using a one-time low-cost OCT scan


Eligibility Criteria:
Inclusion Criteria:

* Age: 55-99 years old
* Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes

Exclusion Criteria:

* Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.
Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses

A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design

The objectives of the study are

1. to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
2. to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is of Caucasian heritage;
5. Habitually wears soft spherical daily disposable contact lenses with a power between

   -0.50 to -2.75D (inclusive);
6. Demonstrates an acceptable fit with both study CL designs (initial \& modified);
7. Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
8. Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
9. Should own a wearable pair of spectacles. -

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery; -
Early PONV - a Registry Based Study in Sweden.

The study is an registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV). The study will explore several cohorts (for example a specific procedure) on a national basis, report the risk for early PONV and identify associated factors.

The study is a registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV).

Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019 there are almost 1.7 million procedures in the registry for patients \>18years. Data will be extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time periods and/or type of surgical procedure) during the study period.

There is an option for hospitals to register nausea and vomiting occurring at the recovery unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset, all patients at their unit needs to be registered either with \[No_Nausea or Vomiting\], \[Nausea\] or \[Nausea or Vomiting\]. In the year 2019, more than 50% of procedures under anesthesia in the registry had registration of PONV. The strength with this system is that if a unit uses the variable, all cases will be classified either as "noPONV" or "PONV".

The investigators aim to use the variable PONV at the recovery unit to describe the risk for early PONV and explore associated factors in several cohorts of surgical procedures in Sweden.

The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May 2019 and during the period June 2019- May 2020, the dataset was used to build up a model for the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.

An updated dataset (all cases 2016-2019) was retrieved from SPOR on June 3 2020 and further analysis and reporting is based on the most updated dataset (yearly basis).

Eligibility Criteria:
Inclusion Criteria:

* Procedure under general or regional anaesthesia
* Age \>=18 years at the day of the procedure.

Exclusion Criteria:

* No entry of the PONV-variable in the SPOR-registry
Radial Access for Abdominopelvic Vascular Intervention

To evaluate the safety and efficacy of R.A.V.I.(radial access for abdominopelvic vascular intervention), and evaluate the feasibility and safety of repeated radial artery intervention

This is a prospective, multicenter clinical study with 1143 patients scheduled to enroll based on data from 10 hospitals for any abdominopelvic vascular intervention that can be performed via a radial approach。 The investigators conducted abdominopelvic vascular interventional therapy via radial artery approach according to the lesions and conditions of the subjects.

All subjects underwent Barbeau tests before surgery to examine the flow traffic of the radial and ulnar arteries, and to measure the diameter of the radial artery (inner diameter) by Doppler ultrasound to evaluate its compatibility with the outer diameter of the vascular sheath.

All enrolled subjects were followed up within 24 hours and 1 month after unsheathing to observe the clinical outcome of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Patients who need abdominopelvic transarterial interventions
3. Preoperative ultrasound assessment of radial artery diameter ≥2mm;
4. Those with good radial pulse and normal Barbeau test (non-D wave);
5. There was no infection, redness swelling or ulceration near the puncture site;
6. Patients and(or) family members agreed to participate in the clinical study and signed informed consent

Exclusion Criteria:

1. Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
2. Absence or occlusion of the radial artery pulse;
3. Need large sheath (≥6Fr);
4. Previous history of stroke;
5. Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
6. Previous history of interventional procedure through radial artery approach (re-intervention of enrolled patients is not included);
7. The investigator believes that the aortic calcification is severe. and the risk of plaque detachment is existed;
8. Patients and(or) family members do not agree to join the clinical trials and sign the informed consent ;
9. According to the investigator's judgment, there are other conditions that are not suitable for participating in this clinical study.
Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

To enroll in Cohort A, a subject must:

* Be 45-80 years of age (inclusive) at the time of screening.
* Be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion.

To enroll in Cohort B, a subject must:

* Be 45-80 years of age (inclusive) at the time of screening.
* Be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent.

Exclusion Criteria:

To enroll in Cohort A, a subject must NOT have:

* Inflammatory bowel disease (IBD)
* Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes

To enroll in Cohort B, a subject must NOT have:

* Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
* Personal or family history of Familial adenomatous polyposis (FAP).
* Personal or family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome).
* Positive fecal occult blood testing (FOBT) within the previous 6 months.
* Positive fecal immunochemical testing (FIT) in the previous 6 months.
* Colorectal resection for any reason other than sigmoid diverticular disease.
* Overt rectal bleeding within the previous 30 days.
* Personal history of any cancer diagnosed \<5 years prior.
* Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease.
* Colonoscopy within the previous 9 years.
* Barium enema, computed tomographic colonography, or sigmoidoscopy within the previous 5 years.
* ≥ 2 first-degree relatives who have been diagnosed with colorectal cancer (Note: First degree relatives include parents, siblings and offspring).
* 1 first-degree relative with CRC diagnosed before the age of 60.
* Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 30 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
* Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
Timing of Acute Palliative Care Consultation in Critically Ill Patients

A prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (Ig) versus later palliative care consultations in the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 65 years old
* Treated in a resuscitation room for unstable vital signs or respiratory compromise
* One or more of the following:
* Advanced or metastatic solid organ cancer
* End stage organ failure of the heart, lung/COPD, kidney on dialysis, hepatic encephalopathy
* Suspected sepsis
* Advanced dementia, end-state multiple sclerosis or Parkinson's disease
* Status post cardiac arrest with coma (Glascow coma score \<7)
* Patient is from a skilled nursing facility

Exclusion Criteria:

* Lack decision capacity and have no relative available during ED stay to consent to the study (legally authorized representative-LAR)
* Enrolled in hospice care prior to randomization
* A copy of a completed advance directive which names a designated proxy provided physically to the medical team prior to randomization
* Wearing a DNR bracelet
* Have been previously enrolled in this study
Short Term and Long Term Effects of Single Stent and Embedded Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesions

At the same time in the side branch stent expansion vessels were embedded and balloon dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h, 24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine months after surgery, coronary angiography, quantitative coronary angiography, evaluation of each main branch and side branch of the lesion degree of stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade; using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months follow-up. Cardiovascular events included total cause of death, cardiac death, total re hospitalization rate, recurrent myocardial infarction or unstable angina.


Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria: selected patients aged 18-80 years of intervention in patients. Baseline characteristics of the patients with screening and recorded by a case by coronary artery angiography of each coronary bifurcation lesions according to the Medina classification method to classify, only select the 1.1.1 type, type 1.0.1 or 0.1.1 type III lesions, a total of 80, respectively, of the type of bifurcation lesions, the random number method lesions were divided into according to the ratio of 1:3 established traditional surgical PCI group 20 lesions and a new operative method for 60 lesions group and interventional therapy. All patients who were involved in the treatment before treatment (sign) or their family members agreed to and signed informed consent. All patients were pre evaluated for long-term oral aspirin (100 mg/, once daily) and clopidogrel (75 mg/ times a day) for at least 1 years

Exclusion Criteria:

Be of aspirin or clopidogrel allergy or intolerance are; the illness history of stroke or visceral hemorrhage within six months; serious liver disease and (or) coagulation abnormality; with antiplatelet treatment contraindications or recently proposed surgical person; valvular heart disease, cardiomyopathy, myocarditis, congenital heart disease, peripheral vascular disease, infection endocarditis; late kidney function not whole, tumor and chronic heart failure seriously affect the short-term prognosis of disease.Patients unable to complete follow-up.
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.


Eligibility Criteria:
Inclusion Criteria for enrolled subjects and cases :

* A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.
* Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.
* Onset of SGE \<= 14 days prior to admission.
* Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.
* Written informed consent obtained from the parent or guardian of the subject.

Inclusion criteria for controls:

* Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only.
* Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only.
* At least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. If the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks.
* Written informed consent obtained from the parent or guardian of the child.

Exclusion Criteria for enrolled subjects and cases:

* Subject has previously participated as case or control in this study.
* Hospitalisation is unrelated to GE.
* Onset of SGE \> 48 hours after admission to the hospital (nosocomial infections).

Exclusion criteria for controls:

* For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian.

OR

* For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian.
* Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus Influenzae Type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
* Child has participated in the past as a case or control in this study.
* Child living in the same house as the case. Note: This criterion is applicable to neighbourhood controls only