cyrilzakka/clinical-trials huggingface dataset:
Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications

The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife.

The primary objective is to assess user satisfaction with a new cannulation knife for central venous catheter (CVC) insertion. Secondary objectives include assessing the frequency of skin incision revisions, frequency of procedures being aborted and restarted, frequency of reverting to the use of the scalpel customarily used to make the incision, frequency of bleeding around the catheter after completion of the procedure, assessment of time to final catheter placement, and the frequency of central line-associated bloodstream infections (CLABSI).

The cannulation knife will be studied in three clinical areas:

* Cardiovascular Operating Room
* Cardiovascular Surgical Intensive Care Unit
* Interventional Cardiology

A prospective cohort of 24 clinicians will be enrolled. Each clinician will be asked to perform a total of five observed cannulations, resulting in a combined 120 observed procedures.

In cases where both the clinician and patient are amenable, a video recording will be taken of the procedure to document the study variables of interest (duration of the procedure, need for revisions, the incidence of bleeding, size of the final incision, etc.) and allow for later review.

All clinicians will be given a survey. This survey is designed to assess the clinicians impression of the device's benefit and the need for 1) revisions of the incision or, 2) aborting the initial attempt. Clinicians will also be timed from procedure start to final catheter placement and will be monitored for incidence of common complications (back bleeding around the catheter, need to revise incision, need to abort/restart procedure) and need to revert to use of a standard scalpel. Although clinicians are the primary focus of this investigation, patients will also be consented to the study and will be monitored for the development of CLABSI post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires a 5 French, 7 French, or 12-14 French central venous catheter.
* Operator responsible for insertion of central venous catheter.

Exclusion Criteria:

* Patient unwilling to consent.
* Operator unwilling to complete the survey.
Evolution of Multiple Primary Lung Cancer (Evolution)

To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.

Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years

  1. Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment.
  2. No history of any malignancy in recent 5 years.
  3. No chemotherapy, radiotherapy or targeted therapy will be performed before surgery.
  4. Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.

Exclusion Criteria:

1. All lesions present as pure ground-glass opacities (GGOs) on CT scans.
2. Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
3. Unqualified blood samples.
4. Unable to comply with the study procedure
1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus

The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients with HbA1C \<7%, and glycemic excursions as assessed by the continuous glucose monitoring system compared to fructosamine.

1,5-Anhydroglucitol (AG) is a glucose analogue present in the plasma of healthy subjects. Physiologically, the plasma levels of 1,5-AG are very stable and only a small quantity is excreted in the urine. It is competitively reabsorbed with glucose in the renal tubules. Therefore, in the hyperglycemic state where glycosuria is present, glucose competitively inhibits renal tubular reabsorption of 1,5-AG and consequently the plasma 1,5-AG levels decrease. When glycemia is normalized and glycosuria is resolved, 1,5-AG levels increase.

The usefulness of 1, 5-AG in reflecting glycemic excursions have been demonstrated in moderately controlled patients to some extent, although some studies reveal controversial results.

Therefore, the aim of this study was to evaluate the association of 1,5-AG and postprandial hyperglycemia determined using the Continuous Glucose Monitoring System (CGMS) in DM patients with HbA1C\<7% and evaluate the usefulness of 1,5-AG as a marker of glycemic control compared to HbA1C and fructosamine.

Eligibility Criteria:
Inclusion Criteria:

* HbA1C \< 7%
* HbA1c modification \<0.5% in the previous 3 months
* no recent addition of oral hypoglycemic medications or change in insulin dose \>10% previous 3 months

Exclusion Criteria:

* pregnancy
* anemia (Hb \<10.0 g/dL)
* liver disease (ALT \>2 UNL)
* hypoalbuminemia (albumin \<3.5 g/dL)
* serum creatinine \>2 mg/dL
* acute or chronic renal tubulointerstitial disease
* severe medical illness
Evaluation of an Outpatient Modified Prescription Form

The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.

The broad goal of this proposal is to reduce outpatient prescribing errors in rural primary care practices. Although computerized technology is available for prescribing, it has not yet been implemented in most settings. Additionally, rural prescribers will likely be the last to have the means to adopt this technology. Due to the substantial morbidity and mortality in the United States caused by outpatient medication errors, there is an urgent need for low-cost solutions. This research plan will evaluate a modified paper prescription form that may be implemented in rural primary care settings cheaply and quickly with the goal of outpatient prescription error reduction.

The specific aims of this project are:

1. To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form
2. To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form
3. To determine prescriber satisfaction with the modified prescription form

Rural prescribers from four states will be randomly recruited to write prescriptions on standard and modified forms. Prescription duplicates of both types will be analyzed for errors. Prescriber satisfaction with the modified form will be evaluated using surveys and focus groups.

Medication errors are a public health problem. Low-cost technology that is shown to reduce medication errors would benefit all rural patients who receive prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* Must be a physician, nurse practitioner, or physician assistant with a current license to write outpatient prescriptions
* Must practice in Family Practice, Internal Medicine, or Pediatrics
* Must practice in rural Vermont, West Virginia, South Dakota, or Montana
* Must write outpatient paper prescriptions
* Must write prescriptions in English

Exclusion Criteria:

* Not licensed to write prescriptions
* Practice in a specialty, inpatient, or long term care setting
* Do not write paper prescriptions
* Do not write prescriptions in English
The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS

Thirty cases of amyotrophic lateral sclerosis patients were recruited from the neurology department of Ruijin Hospital, the pain department and the encephalopathy center of Luwan Branch of Ruijin Hospital. After the informed consent was signed, they were divided into a trial group and a control group. Each group contains 15 cases. The patients in the control group was treated with edaravone dissolved in saline during hospitalization, while the patients in the trial group was treated with edaravone, scopolamine, atropine and dexmedetomidine. Both groups of subjects were treated for 7 days within 3 weeks, followed by a buffer period of 3 weeks for observation, which was one treatment course. The total treatment protocol contains 3 treatment courses (or 18 weeks). Patients with amyotrophic lateral sclerosis were evaluated before treatment and 6, 12, 18, 24, 36, 48 weeks after treatment. The observations include whether the functional scores of patients with amyotrophic lateral sclerosis, Norris amyotrophic lateral sclerosis score, amyotrophic lateral sclerosis self-score, forced expiratory volume in one second, partial pressure of oxygen and maximum displacement of the hyoid were superior to those before treatment, and whether the partial pressure of carbon dioxide was inferior to those before treatment. Study hypothesis: Cholinergic receptor blocking therapy for amyotrophic lateral sclerosis is safe and effective in improving motor function and delaying disease progression in patients with amyotrophic lateral sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients should voluntarily participate in the experiment by signing an informed consent form.
2. Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.
3. Patients should be between 30 and 65 years of age, and both sexes are acceptable.
4. Patients should comply with the diagnostic criteria and exclusion criteria for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012.
5. Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
6. ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.

Exclusion Criteria:

1. Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.
2. High or low blood pressure: systolic blood pressure \>150 or \<110 mmHg; bradycardia (\<60 beats per minute).
3. Patients with ventilator-assisted ventilation.
4. Patients who are allergic to research intervention drugs.
5. Patients with obvious signs of dementia.
6. Female patients who are pregnant or breastfeeding or who have a plan to become pregnant in the near future.
7. Persons with other psychiatric disorders that may affect the assessment of their condition.
8. Severely obese patients (BMI \>35kg/m2).
Improving How People Living With Dementia Are Selected for Care Coordination

Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.

This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for PLWD.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiaries ≥65 years old who:
* Are attributed to the NewYork Quality Care accountable care organization by Medicare,
* Have dementia (as measured in claims using the Bynum standard 1-year definition),
* Reside in the community, and
* Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)

Exclusion Criteria:

* Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or
* Enrolled in home hospice
Higher vs. Lower Dose Heparin for PCI

HD PCI is a multicenter, randomized, registry-based, cluster crossover design trial of higher dose versus lower dose heparin in patients undergoing elective percutaneous coronary intervention (PCI).

The primary objective of HD PCI is to compare the effect of a policy of higher dose heparin (100 U/kg) use to a policy of lower dose heparin (70 U/kg) use on death, myocardial infarction (MI) or target vessel revascularization (TVR) in patients undergoing elective percutaneous coronary intervention (PCI).

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing elective PCI

Exclusion Criteria:

* Age \<18 years
* Planned chronic total occlusion PCI
* Non-resident precluding follow up through local registries

Hospital (Cluster) Eligibility Criteria

Hospitals will be eligible to participate if they meet the following criteria:

* Submit PCI procedure data to a compatible registry that is able to provide data for the trial
* Site agrees to manage patients as per the higher or lower dose heparin policy in place during the given crossover period
PRODIGY Registry in NYHA Class III Heart Failure Patients

This is an observational, prospective, single arm, multi-center registry to evaluate the Cordella™ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .

The subjects in this registry will participate in the Screening Visit, and Follow-Up Visits. After the Screening Visit, eligible subjects will be trained on at-home use of the CHFS to measure BP, HR, SpO2, weight and optional ECG.

They will be instructed to perform daily measurements of the parameters which will all be wirelessly transmitted to a secure website for review using the myCordella™ Patient Management Portal (PMP). Clinicians will be able to view Blood Pressure (BP), Heart Rate (HR), peripheral capillary oxygen saturation (SpO2), weight and Electrocardiogram (ECG) (optional) data through the myCordella™ PMP.

Subjects will return for follow up visits at 3, 6, and 12 months after enrollment or until study termination.

At Month 6, the primary endpoint will be assessed through evaluation of the subjects Quality of Life using the completed KCCQ Questions.

Assessment of secondary endpoints will be performed throughout the study duration, including evaluation of adverse events, and heart failure-related hospitalizations and medication changes. Additionally, Health Economics will be assessed per subject and per site via a detailed site questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has given written informed consent
2. Male or female complex CCM eligible patients or equivalent and at least 18 years of age
3. Diagnosis of HF ≥ 3 months and NYHA Class III HF at the time of Screening
4. Subject fluent in English (written and oral) and with sufficient eyesight, hearing, and mental capacity to respond to the Cordella™ Heart Failure System audio/visual cues and operate the Cordella™ Heart Failure System
5. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
6. Subject agrees:

   1. that the treating Investigator is their solely complex CCM physician
   2. to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion Criteria:

1. Subjects enrolled in another investigational trial.
2. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
3. Severe illness, other than heart disease, which would limit survival to \<1 year
Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL)

During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP.


Eligibility Criteria:
Inclusion Criteria:

* Children (\< 18 years) with cerebral palsy
* GMFCS I to III
* Independent walking with or without technical walking aids (walker, crutches, etc.)
* Able to understand the instructions of various clinical assessments and functional explorations
* Affiliated with a social security scheme

Exclusion Criteria:

Children with cerebral palsy

* Neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months
* Botulinum toxin A injections within the last 6 months
* Therapeutic intervention targeting trunk control last 6 months

Typically developing children

* Surgery on lower limbs or trunk last 12 months
* Neurological and/or orthopedic pathology that may influence gait
A Study of Esomeprazole in Children with Autism

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.


Eligibility Criteria:
Inclusion Criteria:

* outpatients 2 to 6 years of age;
* males and females who are physically healthy;
* diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule;
* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;
* ability of subject to swallow the compound;
* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);
* no planned changes in psychosocial interventions during the open-label trial.

Exclusion Criteria:

* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;
* prior adequate trial of Esomeprazole;
* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).
Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans

The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints.

The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.


Eligibility Criteria:
Inclusion Criteria for Persons with MCI:

* All patients diagnosed with MCI or Persons with Montreal Cognitive Assessment (MoCA) less or equal to 25
* Disease duration less or equal to 3 years
* Age older than 60 years
* Foreign-Born Arab origins, Language: Arabic or English
* Cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
* Participants who can provide consent or legally authorized representative who can provide consent on their behalf

Inclusion Criteria for Caretakers:

* Identified by the patients as the person that provides the most care for them with regards to medical care; may be a spouse, an adult child, a sibling, a relative, or family friend
* Above the age of 18 years Fluent in Arabic and/or English
* Can complete a self-report questionnaire by interview or self-report.

Exclusion Criteria Persons with MCI:

* History of traumatic brain injury (TBI)
* Diagnosed with Covid-19
* Patients with other neurosensory or neurodegenerative diseases
* Younger than 60 years
* Psychiatric disorders other than mild to moderate anxiety and depression
* Diagnosed sleep disorders
* Visual or auditory impairment
* Current or history of alcohol or substance abuse/dependence
* Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources, and referred to their primary care provider

Exclusion Criteria for Caretakers:

- Paid caregivers
iCORE: Collaborative Orthopedics Outcomes Registry

The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry.
* Patient must have the ability to understand the nature of the registry and give written informed consent.

Exclusion Criteria:

* There are no exclusion criteria for this Outcomes Registry.