cyrilzakka/clinical-trials huggingface dataset:
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study

Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel, community-based, client-centred intervention where skills training is incorporated into social activities that users want to perform. The trainer also offers problem solving strategies to help manage environmental barriers and to promote social participation. This intervention is different from customary scooter training in that customary training is often very limited and focuses on learning discrete skills outside of the user's normal environment. The purpose of this study is to explore the feasibility of conducting a mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be strong enough to support the conduct of a subsequent multi-site trial with a sufficient sample size to enable us to quantify definitive outcomes such as adverse events (e.g., injuries and abandonment).


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Aged 60 or above
* Has acquired a scooter in the last month prior to enrollment in the study

Exclusion Criteria:

* Has a cognitive impairment that will prevent the individual from providing consent and reliably completing the study questionnaires
* Reside in a nursing home
* Plan to move outside Vancouver within the next year
The Influence of Age on EEG Signals and Consciousness During Anesthesia

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

A potential subject may be included for participation in the study if the subject has/is:

1. ≥18 years of age
2. American Society of Anesthesiologists (ASA) physical status I-III
3. Able and willing to participate in the study and sign the informed consent form
4. Will undergo non-ambulatory elective surgery under general anesthesia
5. Has an expected surgery time \>2 hours

Exclusion Criteria:

A potential subject will be excluded from participating in the study if the subject has/is:

1. Pregnant
2. Unwilling to undergo EEG measurement
3. Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
4. Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.
5. Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)
6. Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
7. Severe visual or auditory disorder
8. Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment
Post Static Cold Storage Normothermic Machine Liver Perfusion

The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.


Eligibility Criteria:
Donor Inclusion Criteria:

* Donors over the age of 16 years.
* Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.
* Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
* The perfusion should last a minimum of 4 hours and maximum of 24 hours.

Donor Exclusion Criteria:

* Living donors.
* Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).
* Liver intended for split transplant.
* Donor age \<16 years
* Liver which investigator is unwilling to recruit to study.
* Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.

Recipient Inclusion Criteria:

* Adult patients (18 years or more).
* Active on the waiting list for liver transplantation.
* Able to give informed consent.

Recipient Exclusion Criteria:

* Age less than 18 years.
* Acute/fulminant liver failure.
* Transplantation of more than one organ (e.g. liver and kidney).
* Refusal of informed consent.
* Unable to give informed consent.
Pulse Oximetry- Evaluating Resp Rate- PCBA-1

To assess performance of resp rate parameter in a monitoring system PCBA-1


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ages 18 or older.
2. Subject is willing and able to provide written consent.

Exclusion Criteria:

1. Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
2. Subjects with abnormalities that may prevent proper application of the device.
3. Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds).
4. Women who are pregnant or lactating.
Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using AI

The Aim of the study is to evaluate Accuracy of automated mandibular defect reconstruction using Artificial intelligence and assessing impact on aesthetic and occlusion outcomes using patient-specific reconstruction plates.

The digital surgical process often requires an expected mandibular reference model. Currently, the common digital surgery process, is to mirror repair or manually look for other similar mandibles for local data fusion and smoothing processing. A more accurate expected reference model is difficult to achieve, time consuming and difficult to promote in clinical practice. Moreover, rapid routing processing often has poor accuracy. For cumulative bilateral lesions, massive lesions, obvious displacement or lesions cross the middle line, there is still no effective method to predict the expected reference model in clinical practice.

The main objective for conducting this study is to propose an improved algorithm to overcome the drawbacks of recent studies using 3D Unet and to test the predictability and clinical value of virtually generated 3d models of defected mandible in real patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular tumors, cysts or any benign disease resulting in mandibular continuity defect.
* Age group: from 18 - 55 years old.
* No sex predilection.
* CTs or CBCTs of only healthy mandibles from an online database and real data.

Exclusion Criteria:

* Patients with mandibular malignant lesions.
* Children age group from 2-17.
* CTs Of maxilla.
* Elderly patients to be excluded due to the normal physiologic bony change.
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
* Adequately dialyzed (Kt/V ≥ 1.2).
* Age ≥ 18 years old.

Exclusion Criteria:

* Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject.
* Pregnant women.
* Patients hospitalized within the last month prior to the study.
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.\[F-18\]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using \[11C\]MET tracer, immunohistochemical analysis and clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* adults aged between 18 and 70 years
* must have operable grade II, III or IV glioma, recurrent high grade glioma or brain metastases
* KPS \>= 70%
* must have the understanding and ability to sign an informed consent document
* must have adequate liver and kidney function
* be male or non-pregnant, non-lactating females
* patients who are fertile must agree to use an effective method of contraception during participation in the study
* the following laboratory results : absolute neutrophil count \>= 1500 cells/µl, platelet count \>= 100000 cells/µl, SGOT \<= 2.5 x ULN, serum creatinine \<= 1.5 x ULN.

Exclusion Criteria:

* contraindication to surgery
* concomitant radio-, chemo-, or immunotherapy
* history of significant dementia
* known diagnosis of Human Immunodeficiency Virus (HIV) infection
* patient with hepatitis B or C
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.

The post operative routine after Oculoplastic Surgery includes usage of cold compressions for symptomatic relief and decreasing of the edema and local hematomas in the first few days after the surgery. Khat (Catha edulis) is a plant that is used mainly for chewing and has a known stimulating effect, some patients report major improvement after including these leaves in the compressions they use after surgery. Khat contains the chemical ingredients Cathine and Cathinone, which are amphetamine-like alkaloids and probably the main contributors for its active effects. Our main goal is to use compressions that include the Khat leaves and check their effect on reducing the edema and hematomas after oculoplastic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent blepharoplasty and/or ptosis repair

Exclusion Criteria:

* Patients who were operated on one eye only
* Patients who underwent a different surgery in each eye
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Cystic Fibrosis diagnosed with neo-natal screening
* Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
* Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15

Exclusion Criteria:

* Patients with malignant tumor
* Patients with meconium ileus
* Patients with transplantation (pneumectomy or lobectomy)
* Patients involved in any other clinical trial
* Patients moved to another Clinical Center
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy.It can lead to dose-limiting and debilitating side effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In the mucosa, the immune system's T cells and B cells have position-specific phenotypes and functions that are influenced by the microbiota. These cells play pivotal parts in the maintenance of immune homeostasis by suppressing responses to harmless antigens and by enforcing the integrity of the barrier functions of the gut mucosa.We designed a randomized trial of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules in patients with Nasopharyngeal Carcinoma. The aim of this study was to determine if regulating intestinal tract flora was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis.In 2017, 40 patients are estimated to be recruited into the study at Jiangxi Cancer Hospitals, China.20 patients were randomized to receive Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules and 20 to receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

Karnofsky score ≥80 newly diagnosed NPC without distant metastasis confirmed by pathology without any other malignant disease history no any other anti-cancer treatment for NPC previously received radiotherapy and chemotherapy at our Cancer Center

Exclusion Criteria:

any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease
A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery

Current standard of care for complex head, neck and skull base surgery require navigation systems that allow instruments to be tracked optically or electromagnetically while registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy. Augmentation of endoscopic video by preoperative data can facilitate navigation around critical structures and robust target resection. The work presented here describes evaluation of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery. We adopt a modular design that can be extended for other video augmentation applications. The system supports fast automatic camera calibration, comparable in re-projection errors to standard camera calibration tools, while performing within appropriate run time for clinical use. Phantom studies have shown the registration accuracy of the system to be equivalent to that of conventional optical tracking. With this system we are proposing a clinical pilot study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility and to gather qualitative assessment of the video augmentation system.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age or older;
* Have an existing clinically ordered CT image within 2 weeks of the study; or
* Have an existing clinically ordered MR image within 2 weeks of the study;
* Provide written informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study;
* Be able to communicate effectively with clinical study personnel

Exclusion Criteria:

* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.


Eligibility Criteria:
Inclusion Criteria:

* adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion Criteria:

* elevated serum creatinine (Men \>1.4mg/dL, Women \>1.3mg/dL)
* previous diagnosis of congestive heart failure
* history of bowel obstruction
* history of solid organ transplant
* current pregnancy
* lactating mother
* participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT

This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and Sintilimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* 1. clinical diagnosis of HCC; 2. age between18 and 75 years; 3. refused to sorafenib treatment; 4. type I PVTT, type II PVTT, or type III PVTT. 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 8. Prothrombin time ≤18s or international normalized ratio \< 1.7. 9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

* 1. Diffuse HCC; 2. Extrahepatic metastasis; 3. Obstructive PVTT involving both the left and right portal vein or main portal vein.

  4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.

  9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Longitudinal Assessment of Bariatric Surgery

The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

The primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care

Funds are not available to pay for the surgery for patients, only to address research questions.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 years or older, eligible and undergoing bariatric surgery performed by a LABS-certified surgeon.

Exclusion Criteria:

* Patients who do not provide informed consent
Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness.

Background:

Patients with critical illness in the intensive care unit (ICU) experience marked skeletal muscle weakness, muscle atrophy and disability in physical function, commonly termed ICU-acquired weakness (ICU-AW). The pathophysiology of ICU-AW is complex, but a key feature of skeletal muscle wasting is disturbed protein metabolism reflected in both increased rate of muscle protein degradation and reduced synthesis. Treatment with 3-OHB seems a promising new anticatabolic treatment in patients with critical illness, preventing ICU-AW. To date, no data exist on the clinical and functional effects of ketone body modulation in patients with critical illness.

Objective:

The aim to investigate the effect of exogenous 3-OHB administration on muscle protein kinetics and lipolysis in patients with critical illness, aiming towards preventing ICU-AW.

Design:

A randomized double-blind isocaloric placebo-controlled cross-over study in 10 mechanically ventilated patients with critical illness in the ICU.

Methods:

Evaluation of whole-body and focal leg protein kinetics using labeled phenylalanine and tyrosine tracers. Assessment of free fatty acid (FFA) turnover using a labeled palmitate tracer. Femoral arterial blood flow (assessed with pulsed-wave Doppler ultrasound) is evaluated once per study period. Blood- and urinary samples are collected routinely throughout the study day. Whenever feasible, muscle and fat biopsies will be taken for analysis of protein and adipocyte metabolic signaling and mitochondrial function.

Perspectives: This investigation may grant essential knowledge on ketosis in critical illness. This may lead to larger clinical trials, and hopefully a new and better treatment strategy aimed at preserving muscle mass and function during and improving recovery after critical illness.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation via a cuffed endotracheal or tracheotomy tube.
* Expected survival of ICU admission.
* Adults (≥18 years).
* Multi-organ failure (Sequential Organ Failure Assessment Score \[SOFA\] score ≥2 in 2 or more domains).

Exclusion Criteria:

* Moribund or expected withholding treatment within 48 hours as judged by the investigator.
* Palliative goals of care.
* Contraindication for enteral nutrition.
* Pregnancy.
* Known severe musculoskeletal or neurological disability.
* Diabetic ketoacidosis.
* Phenylketonuria.
* BMI ≤17 or deemed malnourished as judged by the investigator.
* BMI \>40.
Excitability Protocol: Voltage-gated Ion Channels

The purpose of subproject 1 is to evaluate the accuracy of a nerve excitability protocol in healthy subjects before testing the protocol in diabetic neuropathy patients. The nerve excitability protocol has been derived by computational modeling to identify abnormalities of three subtypes of ion voltage-gated channels. These three ion channels are all altered in animal models of diabetic neuropathy and, therefore, are likely candidates for generating the altered excitability in diabetic neuropathy patients. The hypothesis for subproject 1 is that due to the unique dynamics of each subtype of voltage-gated ion channels, it is possible to identify abnormal voltage-gated ion channel alterations by altering the shape of the electrical stimulation.


Eligibility Criteria:
Inclusion Criteria: Healthy men and women in the age 18-80 years who speak and understand English.

Exclusion Criteria:

* Pregnancy or breast feeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
* Skin diseases
* Past history of conditions possibly leading to neuropathy
* Inability to cooperate
* Current use of medications that may affect the study, e.g., analgesics
* Previous traumatic experience of an electrical accident
* Consumption of alcohol or painkillers within the last 24 hours
* Participation in other pain studies throughout the study period
* Patients with cardiac diseases (e.g., pacemaker).