cyrilzakka/clinical-trials huggingface dataset:
Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

The object of the present project is to promote the prevention of disability by providing 1) a feed-back and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The device consists of a smart, removable insole. It measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. The insole transmits wireless the collected data to a storage server through a touchpad. Data will then be available for at distance consultations by users (i.e., patients or physicians). The investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. The evaluation of the prototypes will preliminary takes place at the Blagnac smart house. 10 healthy volunteers will test the device. The second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. Comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 65 or more, living at home;
* Presenting a frailty syndrome for the second phase, and robust volunteers for the first phase;
* Informed and written consent by the patient or the legal representative or the reliable person when appropriate.

Exclusion Criteria:

* No access to ADSL;
* Patient's life expectancy less than 12 months;
* Patient presenting disability with an Activity of Daily Living score \< 4/6 and/or a Mini Mental State \<24/30;
* Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
Radiotherapy of Head and Neck Cancer Using an Intraoral Stent

Radiotherapy of oral cavity cancer and sinonasal cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent is not a significant bother to the patients.

The investigators have previously performed a pilot study on the feasibility of the intraoral stent in patients receiving radiotherapy for tongue cancer. It was found that most of the patients tolerated the stent. The mean radiation dose to the hard palate was reduced by 61% (absolute percentage) as compared with a control group not using the stent. Based on these results, the investigators wish to perform a study on a larger cohort to confirm that the intraoral stent will not lead to increased symptoms towards the end of the radiotherapy period.

Eligibility Criteria:
Inclusion Criteria:

* Radiation dose 30 Gy or higher
* Cancer in the inferior part of the oral cavity (e.g. tongue or floor of mouth cancer) or superior part of the oral cavity (e.g. hard palate) or sinonasal cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* Ability to understand and answer questionnaire

Exclusion Criteria: None
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation

To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Primary Objectives

- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.

Secondary Objectives

* Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination.
* Determine the impact of radiation modality on serologic responses to pneumococcal vaccination.
* Determine the impact of radiation modality on systemic immunity.
* Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine.
* Determine the impact of radiation modality on pathologic response.
* Determine the impact of radiation modality on intratumoral immunity.
* Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response)
* Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Group 1A

   a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
2. Group 1B

   a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
3. Group 2A

   a. Participants currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.
4. Group 2B

   a. Participants currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.
5. Group 3

   a. Healthy age- and gender- matched individuals
6. All Groups

   1. Participants of all genders, races and nationalities will be solicited.
   2. Age \>18 years
   3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy

  a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Participants receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
* Participants with previous pneumococcal vaccination
* Participants with severe allergy to any of the vaccine components
Plasma Biomarkers P-DAC, V1

This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.

This study will involve two cohort groups, all patients involved will have PDAC.

Cohort A: Target is 80 resectable PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy

Cohort B:

* Cohort B1 = Target is 80 unresectable locally advanced PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.
* Cohort B2 = Target is metastatic PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.

Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment.

Blood samples will be taken at the following time points:

* prior to resection, whenever feasible for cohort A
* prior to CT, for both cohort A and B
* during CT, for both cohort A and B
* follow-up, approximately every 3 to 6 months for two years for cohort A

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Ability to give written informed consent
* Histologically or cytologically-confirmed PDAC
* Patients who will receive standard treatment of CT +/- radiotherapy and present with:

Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer

* Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2

Exclusion Criteria:

* Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study
Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis.

Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics.

Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Adult Emergency Department of CH Le Mans,CHU Angers, CHU Nantes or Beaujon Hospital.
* Over 18 years old
* Having had a lumbar puncture during their stay in the Adult Emergency Department
* Having had a diagnosis of meningitis defined as a pleocytosis ≥ 5leukocytes/mm3 after correction with CSF red blood cells at a standardized ratio of 500/1.

Exclusion Criteria:

* Antibiotic therapy within 72 hours of inclusion
* Immunosuppression from any cause
* Presence of petechiae or purpura
* History of recent neurosurgery or head trauma
* Other associated bacterial infection
* Inability to collect information for the BMS score calculation or primary endpoint (e.g., transfer to another facility)
* Minor or adult patient under guardianship or protection
The Effect of PACAP27 on the Extra- and Intracerebral Arteries Assessed by Magnetic Resonance Angiography (MRA) on Healthy Volunteers

Studying Pituitary adenylate cyclase-activating peptide 27 (PACAP27) effects on extra- and intracerebral arteries assessed by MRA on healthy volunteers.

PACAP neuropeptide, which belongs to the vasoactive intestinal polypeptide (VIP)/glucagon/secretin family. PACAP exists in two forms: Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38), which consists of 38 amino acids and PACAP27 which contains 27 amino acids at its N-terminus. PACAP38 is implicated in migraine pathophysiology however PACAP27 is not studied well. Therefore, the investigators will study PACAP27's effect on extra- and intracerebral arteries assessed by MRA on healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 dag /month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the half-life for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Primary relatives with current or previous migraine
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib

To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib


Eligibility Criteria:
Inclusion Criteria:

(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records

Exclusion Criteria:

* Has uncontrolled or significant cardiovascular disease
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening

The aim of study is to evaluate the sensitivity and specificity of using mobile phone photographs versus conventional clinical examination as a screening tool for early detection of oral cancer.

Tele-dentistry is a method of providing oral healthcare and dental services through real-time transmission of clinical information using electronic medical records, digital imaging, photography, ICT, and the internet. Oral medicine is a dental specialty that uses tele-dentistry services to manage patients with systemic diseases and comorbidities. However, some oral disorders may have systemic consequences, necessitating additional diagnostic techniques and skilled doctors. Issues such as lack of oral medicine specialists, inexperienced community health workers, and inadequate training for managing complex oral conditions also pose challenges. Delayed diagnosis of oral cancers in underserved communities, poor patient management, high transportation costs, and lengthy waiting lists are some of the challenges faced by patients.

The COVID-19 pandemic has further complicated these issues, causing disruptions in educational programs and access to oral medicine services. Tele-dentistry can facilitate efficient communication between patients and healthcare professionals for various purposes. There is limited research on using tele-dentistry in oral medicine, especially for results like accuracy. Consequently, the present study is designed to evaluate the sensitivity and specificity of using mobile phone images versus conventional clinical examination as a screening tool for early detection of oral cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients have any visible oral mucosal lesions including:

  1. Normal Variants
  2. Reactive and inflammatory lesions
  3. Potentially malignant lesions (PML)
  4. Oral cancer

Exclusion Criteria:

- 1. Patients unable to open their mouth properly due to trismus, pain, fibrosis or scleroderma.

2. Patients unable to follow instructions such as mental disability and children below 12-year-old.
A Comparison of ThermaWedge™ Device and Achilles Tendon Stretching for the Treatment of Plantar Fasciopathy

The investigators will compare Achilles tendon stretching with a new product called a ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and exercises, in the treatment of chronic plantar fasciopathy. There will be 2 groups each of 25 - 30 participants who have chronic plantar fasciopathy, which is a common cause of foot pain. Exercises will be done for 6 weeks and then each group will do the other exercise protocol for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index scale and numerical analog pain scale and the Global Rating of Change Scale prior to any treatment, weekly during treatment and post treatment. The investigators' hypothesis is that use of the ThermaWedge™ device will result in decreased pain and disability when compared to achilles tendon stretching.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of plantar fasciopathy which has persisted (chronic) for at least 12 months.
* participants need to be able to understand simple instructions about the stretches which will likely include both verbal instructions and pictures and participants need to be able to do all the necessary exercises.
* Participants must have current British Columbia (BC) Medical Service Plan (MSP) health coverage so that if they become injured, they are covered medically.
* Participants must be able to fill out surveys online.
* Participants must also pass a clinical screen where a senior medical student or a physiotherapist, Scott Fraser, will assess the patient for for plantar fasciopathy/fasciitis.

Exclusion Criteria:

* Previous ankle or foot trauma or surgery
* duration of pain of less than 12 months,
* those receiving adjuvant treatment such as injections during the time of the study,
* those who are unable to do the necessary exercises required in the study
* Those who do not have current BC MSP health insurance coverage.
Early Rehabilitation After Hip Fracture

The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.

The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.

Subjects:

The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who reach a Folstein Mini Mental Status of less than 15 are excluded.

Design:

Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy. Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.

Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Acute hip fracture admitted to one hospital center

Exclusion Criteria:

* A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
* Primary hyperparathyroidism
* Current cancer with wasting or bone metastases
* Hyperparathyroidism
* Sarcoidosis
* A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
* Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
* non-surgical treatment
* no German language skills
* severe hearing or visual impairment
Optic Nerve and Retinal Functions With Bevacizumab

The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.

To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked Potentials (VEP). Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.

Eligibility Criteria:
Inclusion Criteria:

* CNV

Exclusion Criteria:

* Previous Intravitreal Injections
Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD

The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge gap. Additionally, this research holds significant importance for understanding the etiology of Crohn's disease and predicting treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease undergoing endoscopic examination
* Healthy individuals with no symptoms undergoing colonoscopy without any lesions detected
* Patients undergoing small intestinal endoscopy due to symptoms but with negative examination results.
* Age between 18 and 80 years.
* Patients or authorized family members sign the relevant informed consent forms.

Exclusion Criteria:

* Patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases.
* Patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases.
* Patients who have taken probiotics or antibiotics within the past week.
* Patients with psychiatric disorders or other conditions that prevent them from cooperating with the study.
* Patients participating in other clinical trials that may interfere with the results of this study.
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes

The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
2. Patients who require surgery in both eyes by same surgeon
3. Able to understand English and complete a pain assessment

Exclusion Criteria:

1. Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
2. Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
3. Pre-existing uncontrolled glaucoma/high IOP
4. Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
5. Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
6. Patients under 40, severe obesity (BMI \>35)
7. Chronic pain/narcotics/Recreational/medical marijuana