cyrilzakka/clinical-trials huggingface dataset:
Cognitive Rehabilitation in Older Adults With Neuron-up (CROAN)

Introduction. The application of new technologies for cognitive rehabilitation has increased over the last years and has enabled occupational therapists to work more efficiently, minimizing costs and time for analysis, management, and design of activities.

Objective. The purpose of the present study was to assess the effect of cognitive intervention using the web platform Neuronup in a group of elderly subjects; the study is based on the dependent variables (memory, attention, and language) analyzed with the abbreviated Barcelona Test.

Subjects and Methods. Aquasi-experimental design was carried out with subjects assigned to two groups: a control group (20 subjects) and an experimental group (20 subjects). The abbreviated Barcelona Test was administered to assess patients before and after the intervention with this software to draw conclusions.

Introduction. The application of new technologies for cognitive rehabilitation has increased over the last years and has enabled occupational therapists to work more efficiently, minimizing costs and time for analysis, management, and design of activities.

Objective. The purpose of the present study was to assess the effect of cognitive intervention using the web platform Neuronup in a group of elderly subjects; the study is based on the dependent variables (memory, attention, and language) analyzed with the abbreviated Barcelona Test.

Subjects and Methods. Aquasi-experimental design was carried out with subjects assigned to two groups: a control group (20 subjects) and an experimental group (20 subjects). The abbreviated Barcelona Test was administered to assess patients before and after the intervention with this software to draw conclusions.

Results. Analyses of variance (ANOVA), analyses of covariance (ANCOVA), and multivariate analyses of variance (MANOVA) were perfomed in the memory, orientation, reading, and language domains. Statistically signifcant differences were recorded in all domains except language where scores remained the same.

Conclusion. It has been demonstrated that Neuronup is an effective program for improving cognitive processes such as memory, attention, and orientation in older adults, hence it would be beneficial to implement technology-based treatments conducted by specialized professionals.

Eligibility Criteria:
Inclusion Criteria:

1. subjects between 75 and 85 years of age;
2. obtain a score greater than 20 points for the MEC (Lobo's cognitive mini-exam); and
3. attend occupational therapy sessions on a regular basis.

Exclusion Criteria:

1. presence of neurocognitive disorder (Alzheimer's-type dementia among others);
2. not be an institutionalized resident at a nursing home;
3. a family history of a psychiatric problem;
4. presence of polipathology; and
5. have lived at a nursing home for less than 2 months.
Molecular Characteristics of Early-onset Compared With Late-onset Colorectal Cancer

The distribution rate of microsatellite instability-high (MSI-H) was significantly higher in early-onset colorectal cancer, and early-onset colorectal cancer has a specific mutational profile and relatively high programmed cell death ligand 1(PD-L1) expression, which may be used to guide personalized treatment to better control the disease.

The prognosis of early-onset colorectal cancer (EOCRC) is worse than that of late-onset colorectal cancer (LOCRC), and the incidence has gradually increased in recent years, so it is necessary to study the pathogenesis and explore the target of early-onset colorectal cancer patients. In this study, investigators aimed to explore the specific molecular pathologic map of EOCRC by comparing LOCRC. This study enrolled 11,344 patients with colorectal cancer treated at the Colorectal Center of the First Affiliated Hospital of Nanjing Medical University from 2003 to 2022, of whom 578 were EOCRC and 10,766 were LOCRC. The tumor-related mutation status and tumor mutation burden (TMB) of patients were detected by next-generation sequencing technology. PD-L1 expression was detected by immunohistochemistry. The microsatellite instability was detected by polymerase chain reaction (PCR) coupled with capillary electrophoresis (2B3D NCI Panel) in all patients. Among the 11,344 patients, 180 patients with EOCRC and 90 patients with LOCRC patients underwent NGS investigation. Compared with LOCRC, EOCRC patients generally presented a later TNM stage, lower tumor differentiation, and poorer histological type. In LOCRC with MSI-H stupe, TNM stage is earlier than whom with MSI-L/MSS. In addition, the frequency of MSI-H was significantly higher in EOCRC (10.2%) than LOCRC (2.2%). The frequency of 7-mutation panel (ARID1A, FANCI, CASP8, DGFRA, DPYD, TSHR, and PRKCI) were relatively higher in LOCRC. In EOCRC group, the TNM stage of MSI-H subtype patients was earlier while harbored with worse tissue differentiation and higher proportion of mucinous adenocarcinoma. Besides, among the EOCRC patients, FBXW7, FAT1, ATM, ARID1A and KMT2B mutation frequencies were significantly increased in patients with MSI-H type. Comparing with MSI-H patients of LOCRC, the EOCRC patients with MSI-H presented a higher mutation frequencies of FGFBR2, PBRM1, RNF43, LRP1B, FBXW7, ATM and ARID1A. In addition, EOCRC patients were identified with higher tumor mutation burden, especially in the MSI-H type. PD-L1 expression calculated by tumor proportion score (TPS) was also elevated in EOCRC and correlated with MSI status.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-75 years old;
* Histologically proven colon or rectal adenocarcinoma.

Exclusion Criteria:

* Patients over 80 years of age;
* Recurrent colorectal cancer;
* Multiple primary tumors.
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%.

Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients.

Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound)
* This stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months
* Both doctor and patient were substantially uncertain whether to choose immediate CEA, or deferral of any CEA until a more definite need for it was thought to have arisen
* The patient had no known circumstance or condition likely to preclude long-term follow-up
* Neurologist's explicit consent to potentially perform CEA

Exclusion Criteria:

* Previous ipsilateral CEA
* Expectation of poor surgical risk (e.g., because of recent acute myocardial infarction)
* Some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli)
* Inability to provide informed consent
* Underlying disease other than atherosclerosis (inflammatory or autoimmune disease)
* Life expectancy \< 6 months
* Advanced dementia
* Advanced renal failure (serum creatinine \> 2.5 mg/dL)
* Unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure)
* Restenosis after prior CAS or CEA
* Atrial fibrillation
* Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)
Effectiveness of Customized Handle Toothbrush

People with special needs suffer from many difficulties, including mental, physical or motor, which increase the difficulty of obtaining good oral health.

Therefore, some adjustments must be made to help these patients maintain oral health.

The aim of the current research is to modify the traditional toothbrush grip by manufacturing a Customized Handle of every young child or people with special needs to improve oral health for those patients by relying on themselves with an effectively way.

Participants will be examined to ensure that the participants have met the sample entry criteria, then the participants will be randomly assigned to four groups each one according to a group:

1. A group of healthy children using conventional toothbrush (12 children).
2. A group of healthy children using toothbrush with Customized Handle (12 children).
3. A group of children with Down syndrome using conventional toothbrush (12 children).
4. A group of children with Down syndrome using toothbrush with Customized Handle (12 children).

Secondly,

1. Researcher will take an impression of the child hand grasp silicon impression material.
2. Researcher will scan the impression with a model scanner and copy it to the computer, then convert it -through a specialized program- to a 3D analog.
3. The program will print the digital analog via the 3D printer using Poly Lactic Acid compound and convert it into a model similar to the patient hand grasp, this model has a place to put the toothbrush.

Third, Brushing instructions:

1. The researcher will teach the participants how to brush by using (tell-show -do) technique.
2. The brushing method that will be used is the modified Stillman technique.
3. Brushing duration must be at least 3 minutes.
4. The brushing must be twice a day.
5. The amount of toothpaste is pea size.

Finally, Mechanism of examination and follow up:

After apply the plaque disclosing solution on the teeth with a bond brush, the plaque will be evaluated with Turesky Modification Quigley-Hein Plaque Index, checking on the buccal and lingual surfaces of all the teeth existing in the participant's mouth.

The participants will be observed in the same day, before and after brushing, and after one week and three weeks

Eligibility Criteria:
Inclusion criteria:

* Ages between 6-9 years old.
* Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.
* TMQHPI is at least 2.
* Cooperative participant (Positive according to Frankel's behavioral rating scale).
* Parents' consent.
* Participant with down syndrome must have been diagnosed by specialist.

Exclusion criteria:

* Children undergoing orthodontic treatment.
* Allergic to any of the toothpaste ingredient used the study.
* Participant used any toothbrush other than the conventional brush before.
* Healthy children Participant with systemic diseases
* Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously.
Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

The primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).


Eligibility Criteria:
Inclusion Criteria:

* Be volunteers who are not seeking treatment for drug addiction.
* Be between 18 and 50 years-of-age.
* Meet Diagnostic and Statistical Manual (DSM-IV) - Text Revision (TR) criteria for current cocaine abuse as assessed using the MINI neuropsychiatric interview (version 6.0).
* Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
* Have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.
* Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
* Females must have a negative serum pregnancy test at screening and negative urine pregnancy test at intake prior to receiving the first dose of investigational drug. They must also be postmenopausal, have had a hysterectomy, been sterilized, have a partner with a vasectomy, or agree to use one of the following methods of birth control starting at least 14 days prior to clinic intake:

  1. diaphragm and condom by partner
  2. condom and spermicide by partner
  3. intrauterine device and condom by partner
  4. sponge and condom by partner
  5. complete abstinence from sexual intercourse
  6. oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive
* Be able to comply with protocol requirements, rules and regulations of the study site and be likely to complete all the study treatments.

Exclusion Criteria:

* Please contact site directly for more information
4D Phase Contrast MR: Hypertrophy in Liver Cancer

The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant liver tumor
* Clinically referred for portal vein embolization
* At least 18 years of age
* Willing and able to provide informed consent

Exclusion Criteria:

* Documented or reported contrast allergy
* Unable to receive or tolerate MRI scan after evaluation of MRI screening form
* GFR (glomerular filtration rate) \< 30 on labs drawn within 6 weeks of imaging.
Skin Self-Examination Education During Mammography

The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.

The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older
* Waiting to have a mammogram

Exclusion Criteria:

* Male
NoRCoRP Assessment Clinic

The main overarching aim of this study is to build a research clinic, as part of the NoRCoRP platform covering Nottingham and Nottinghamshire to facilitate learning and research in the whole population of patients who have had COVID-19.

The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2 / COVID-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. Frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. Additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity.

The majority of patients with COVID-19 were not admitted to hospital, and the longer-term consequences of infection with SARS-CoV-2 in this much larger patient group are unknown. Whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital.

In setting up a post COVID-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. We also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. We will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new General Practitioner (GP) referral research clinic.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) referred into the post COVID-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of COVID-19
* Adults discharged from hospital with a clinical diagnosis of COVID-19 (who are not included in the PHOSP-COVID study)

Exclusion Criteria:

* Children (\<18 years) referred into the post COVID-19 respiratory outpatient clinic. This clinic is only open to adults and referrals for children will not be accepted
* Adults discharged from hospital with a clinical diagnosis of COVID-19 and have been included in the PHOSP-COVID study
* Patients unable to provide informed consent by themselves
Dexmedetomidine Pharmacokinetics in the Obese

The aim of this study is to characterize, using two different modeling approaches, one based on purely statistic concept and one using a more mechanistic analysis, the influence of body weight and composition on the pharmacokinetic of dexmedetomidine.

Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed using nonlinear mixed-effects model.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiologist classification I-III patients
* between 18 and 60 years of age
* scheduled for elective laparoscopic surgery
* obese patients with a BMI \>35 kg m-2 (20 patients)
* non-obese patients (BMI 18.5-25 kg m-2)(20 patients)

Exclusion Criteria:

* known allergy to study drugs
* uncontrolled hypertension
* heart block greater than first degree
* those who had taken any drug acting in the central nervous system 24 h before surgery
A Systematic Review of Studies of the Effect of Influenza Vaccine Against Mismatched Strains

The purpose of this study is to consolidate the cross-protection offered by influenza vaccines against circulating influenza A or B viruses that are not antigenically well-matched to vaccine strains and to determine the degree of cross-protection separately for influenza A and influenza B, through a systematic review of the literature.

The research question of this project is: "what is the cross-protection afforded by vaccination (using an LAIV, TIV, or other type of vaccine) against influenza A or B and their subtypes and lineages?" The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement will be used to guide the reporting of this review. Studies reporting cross-protection data after vaccination with approved formulations of influenza vaccines with influenza A or B will be included. Inclusion will not be limited by publication status, or year of dissemination but will be limited to randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo. Only RCTs written in English will be included. A meta-analysis will be conducted if there is sufficient data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children, adults or the elderly will be included that participated in randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo.
* Placebo-controlled randomized clinical trials (RCTs) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating.
* All influenza vaccines will be included, and will be categorized as TIV, LAIV, and others (that is, non-TIV or non-LAIV).
* Only RCTs written in English will be included.

Exclusion Criteria:

* RCTs which are not providing any data will be excluded.
* Studies using rapid influenza diagnostic tests will not be included, as their sensitivity is low (especially during flu season) and false positives are common during low activity seasons.
* Laboratory-confirmed influenza through antibody assay as part of the primary outcome will not be included, as this is a less sensitive test than PCR and viral culture.