cyrilzakka/clinical-trials huggingface dataset:
Histolog Comparison to Standard Histology

This is a clinical device trial to assess the accuracy of margin assessment for a confocal scanning device (Histolog Scanner) at assessing the margins of breast tissue following wide local excision surgery.

Currently a 15-20% of breast cancer patients have cancer cells seen at the edge of the tissue removed following. These patient will need to undergo a second operation to ensure all the cancer cells are removed, which has psychological, cosmetic and cost implications. Several technologies have been designed to allow the edges of tissue to be tested during surgery, with the most accurate being those that involve assessing the tissue edge at a cellular level. However, these techniques are time consuming which makes their use in routine work impractical.

The Histolog system uses pinhole (confocal) microscopy to capture cellular level images of the edge of tissue intra-operatively. The first generation of the device has been shown to be accurate for assessing breast tissue biopsies and skin cancer. The second generation of the device has an 8cm plate for scanning tissue and is CE marked for the assessment of tissue margins. This project is to show that the device is accurate for the assessment of margins, with further assessment in relation to the time for images to be captured and ease of interpretation to assess overall feasibility. The study would recruit at a single high volume breast cancer centre. The study will recruit patients with a diagnosis of breast cancer who are due to undergo breast conservation surgery (lumpectomy) with inclusion criteria of female patients over the age of 18 who are able to give informed consent. The study would involve the edges of removed tissue being imaged following surgery. These images would be reported by a consultant histopathologist and compared to the routine gold standard histology. There is no change to patient care and the device will not be used to change the surgery performed. There are no questionnaires or additional demands placed on the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patient capable of providing informed consent
* Female
* Have a diagnosis of invasive breast cancer or ductal carcinoma in-situ
* Have been discussed within the multidisciplinary meeting with a recommendation that the patient is suitable for breast conservation therapy
* Any localisation technique can be used of impalpable lesions (eg if the wire impairs the image quality, this will inform for full scale research)
* Patient undergoing breast conservation surgery
* Patient undergoing further breast conservation surgery for positive margins after previous surgery
* Patient's will be able to participate for a re-excision of margin, even if they did not participate for their initial operation

Exclusion Criteria:

Patient undergoing mastectomy, including completion mastectomy due to involved margins

* Patients undergoing excision biopsies
* Male patients
* Patients under the age of 18
* Unable to provide valid consent in English language
Immunological and Functional Characterization of Cellular Population CD45+ Infiltrating Human Glioblastoma

Despite advances in neurosurgery , radiotherapy and chemotherapy, the median survival in GBM patients is only 15 months from diagnosis. Immunotherapy by checkpoint inhibitors (PD1 /PDL-1) appears as a promising treatment for many cancers. However, first clinical results are disappointing for GBM. An hypothesis is the immunosuppressive activity from infiltrating non-tumor cells. Conversion of non-tumor cells from an immunosuppressive to an immuno-activating phenotype could be attempted in a therapeutic perspective.

An important and constant infiltration of cells marked with CD45 has been observed in 77 GBM studied for the prognostic value of PDL1 and IL17 infiltration (in association with Pr Ghiringhelli ; INSERM ; Dijon) . However, CD45 is present at the surface of all leucocytes. The purpose of this project is to better characterize the nature and functionality of the CD45+ cells that infiltrate GBM (lymphocytes and their sub-types, macrophages, microglial cells). Formalin-fixed paraffin-embedded GBM samples will be studied. A panel of immune cell antibody will be used for the immuno-histological (IH) study. Furthermore, the investigator will compare these data with those obtained by the nanoString technology, a multiplexed measurement of gene expression.

Eligibility Criteria:
Inclusion Criteria:

* Formalin-fixed paraffin-embedded GBM samples from tumor bank of the pathological laboratory of the University Hospital of Amiens-Picardie.
* Histologic diagnosis of a glioblastoma according to the WHO classification of central nervous system
* Radical surgical removal in order to have enough histological material and to homogenize the main prognostic factor that is the surgical removal.
* Patients with more than 18 years old.
* Patients informed who have signed a consent form for using the tumor for research purposes without personal benefit. If patients were died, absence of objection known for the anonymous use of the tumor for scientific purpose.
* Be insured under one social security system.
* Committee for the protection of persons approval.

Exclusion Criteria:

* Relapsed GBM
* Other brain tumors.
* Medical, psychological or social conditions not allowing the comprehension of the conduct of the study for patients able to give their opinion.
* Patient under curatorship.
Brain Network Activation Analysis in Epilepsy

This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.

BNA technology is based on a network model to depict functional connectivity. The descriptive network model approach provides insights regarding inter-connectivity of brain networks and can describe the temporal-spatial brain activation patterns applied to various types of data-sets including EEG, MEG and fMRI.

In this study it is proposed that synchronization in brain activity may be disrupted in patients who experience frequent seizures and may correspond to functional impairments (e.g., memory, processing speed). As such, BNA analysis may provide additional data that complement current functional assessments, inform clinical assessment and management of epilepsy, and identify subgroups of patients that might be at risk for poor treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be between ages 18-50 years old
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
* Willingness to participate and able to give informed consent
* If corrected vision: only Glasses should be used during the study testing

Exclusion Criteria:

* History of significant head trauma
* Evidence of other neurologic disease
* Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).
* Currently with lice or open wounds on scalp
* Significant sensory deficits
* Use of a hearing aid that occupies the ear canal
* Substance abuse in the last 3 months and any clinically significant substance dependency
* Additional exclusion criteria for controls are a history of any neurological disease or psychological illness.
Impact of Augmenting Exercise Intensity vs. Frequency

The purpose of this study is to compare the impact of augmenting exercise intensity and augmenting exercise frequency on peak work rate. Participants will complete exercise tests and provide 8 skeletal muscle samples following a within-subjects randomized crossover design utilizing single-leg cycling. Both training periods will be 4 weeks long and skeletal muscle biopsies will be collected from both legs before and after each training period. All exercise sessions will be supervised, take place in the investigator's laboratory, and occur on stationary bikes.


Eligibility Criteria:
Inclusion Criteria:

* Recreational active (\<3 hours per week of aerobic exercise)
* Willing to provide skeletal muscle biopsies

Exclusion Criteria:

* Cardiovascular or metabolic disease
* Athletes or individuals exceeding 3 hours per week of aerobic exercise
* Smokers
The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis

The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.

Patients with end-stage renal disease (ESRD) have a 20-fold increased risk of cardiovascular mortality compared to the general population. Arterial stiffness, likely due to vascular calcification (VC), has been shown to predict cardiovascular mortality in ESRD. Serum calcification propensity (T50) is a novel biomarker, which is believed to reflect the propensity toward ectopic calcification (e.g. VC). Increasing serum magnesium (sMg) should increase T50, which might in turn reduce the formation of VC in patients with ESRD. A cheap and easy way of achieving this would be to increase the concentration of Mg in the dialysate (dMg) of patients with ESRD treated with haemodialysis (HD).

The investigators wish to conduct a randomised controlled double-blind clinical trial to examine whether increasing dMg will improve T50 in subjects with ESRD treated with HD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Treatment with maintenance haemodialysis for more than 3 months.
* Dialysate magnesium of 0.5 mmol/L (standard concentration).
* Serum magnesium \< 1.2 mmol/L on average of previous measurements within the last 3 months.
* Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.
* Written informed consent.

Exclusion Criteria:

* Treatment with peritoneal dialysis.
* Parathyroid hormone \> 66 ρmol/L.
* Previous parathyroidectomy.
* Current treatment with magnesium containing medication or supplements.
* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
* Pregnancy or breastfeeding.
Vitamin D Treatment in Patients With Chronic Hepatitis C

We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C Genotype 1

Exclusion Criteria:

* Vitamin D intoxication Renal Failure Liver Failure Malignancy
Effect of VR Versus CT in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients

Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises.


Eligibility Criteria:
Inclusion Criteria

* Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).

Age:

* Upper Extremity Impairment:
* Ability to provide informed consent to participate in the study.

Exclusion Criteria

* Severe communication difficulties that would impede the ability to follow instructions during therapy.
* Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher).
* Other Neurological Conditions
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

This study is for people in South Korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Their cancer is locally advanced, unresectable, or metastatic. Locally advanced means the cancer has spread to tissue close by. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.

In South Korea, VYLOY is approved for the treatment of gastric cancer or GEJ cancer. The people in this study will receive VYLOY as part of their usual treatment for their cancer. In standard clinical practice VYLOY is given to people slowly through a tube into a vein.

The main aim of the study is to collect information in a real-world setting about the safety of VYLOY in people with gastric cancer or GEJ cancer in clinics in South Korea. This study will also help researchers learn how long people's gastric cancer or GEJ cancer stays stable.

This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). The study will last about 1 year (54 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive treatment with VYLOY injection, according to the approved local label.

Exclusion Criteria:

* Patients with any contraindication for VYLOY injection, according to the approved local label.
* Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.
Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd

To Evaluate the Outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease.

Patient education about the COPD and their medications.

Chronic obstructive pulmonary disease (COPD) is a common preventable and Treatable airway disorder characterized by symptoms such as dyspnea, chronic Cough, and sputum production along with persistent airflow limitation that is not fully Reversible.

Evidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate COPD patients.

Evidence concerning cardio selective B blockers. Over the past 20 years' non selective B blockers have largely been replaced with cardio selective blockers. Cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking B-1 receptors than B-2 receptors. At therapeutic doses the B-1 blocking effect, and therefore the risk of bronco constriction, is negligible. In addition there is strong evidence that B-blocked cause up-regulation and sensitization of B-receptors.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. informed consent.
3. Age \>40years.
4. FEVl/FVC\<70%.
5. diagnosed 3 month before enrollment (mild-moderate)
6. Reversability test pre-post bronchodilators FEVl predicted\<200ml/hr and less than 12%.

Exclusion Criteria:

1. Asthmatic patient.
2. patient already use B blockers.
3. Acute exacerbation.
4. Pregnency -lactation.
5. Advanced cardiac, renal or liver disease according to investigator opinion.
HalfLytely Bowel Prep System for Colonoscopy

The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients at least 18 years of age
* All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
* In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
* Patient is undergoing a colonoscopy for a routinely accepted indication

Exclusion Criteria:

* ileus
* possible intestinal obstruction or perforation
* prior alimentary tract surgery
* significant gastroparesis or gastric outlet obstruction
* impaired consciousness that predisposes a patient to pulmonary aspiration
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.

This is a pilot single center, open-labeled study. Patients with subarachnoid hemorrhage admitted to the hospital and who meet entry criteria will be offered enrollment into the study. The patients will be enrolled promptly after detection of the presence of cerebral vasospasm. Subjects will receive sodium nitrite infusion.

One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from a patient or legal representative before enrollment;
* Admission to hospital following subarachnoid hemorrhage;
* Aneurysm confirmed by digital subtraction angiography or CT-angiography after admission;
* Development of the clinical symptoms and /or signs of cerebral vasospasm and CT-angiography results warranting cerebral angiography.

Exclusion Criteria:

* Rupture of a fusiform, traumatic, or mycotic aneurysm;
* Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding;
* Methemoglobin \> 2%
* History of sickle cell disease, thalassemia, or other hemoglobinopathy;
* Anemia with hemoglobin level less than 6 g/dL;
* Significant acute or chronic concomitant diseases (including renal, hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 6 months;
* History of allergy to nitrites or allergy to other substances that could interfere with nitrite metabolism, within 30 days before screening;
* History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;
* Treatment with allopurinol, a medication that could interfere with nitrite metabolism, within 30 days before screening;
* Other investigational drug within the past 30 days;
* other cerebral injury within the past 30 days including previous subarachnoid hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants

The current study proposes to investigate the impact of a low glycaemic index (GI), fortified toddlers milkpowder on mood, behaviour and cognitive function in young children.

The current study proposes to investigate the impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children. In choosing the tests it should be remembered that the investigators looking for short-term changes in functioning, such as the ability to sustain attention or improved mood. As such the investigators are not looking for measures of general cognitive functioning, stage of development or general behaviour but rather measures that are capable of monitoring changes from hour to hour or day to day.

Eligibility Criteria:
Inclusion Criteria:

* The sample will consist of only Malay children, an equal number of boys and girls, and whose parents have consent to the child participating in this trial.

Exclusion Criteria:

* they will be excluded if underweight (BMI for age \< 2 S.D.);
* overweight (BMI for age \> 2 S.D.;
* have any chronic or serious illness or are currently not feeling well / taking medication;
* have a history of allergy (particularly to milk), thyroid disease or diabetes mellitus.

Children currently part of an iron/zinc supplementation programme will be excluded as will any who are still being breast fed as there is no intention to discourage breastfeeding
Improving Prospective Memory Via Telehealth

Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial.

The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MS
* Able to read, write, and speak in English
* Between the ages of 18 and 60
* All genders
* No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse
* No relapses within the past two months
* Access to the Internet and a web camera
* Not enrolled in a cognitive rehabilitation program within the past six months
* Self-reported issues "remembering places they have to be" and "things they have to do"

Exclusion Criteria:

* No diagnosis of MS
* Unable to complete the study protocol due to language barriers
* Younger than 18 or older than 61
* No gender exclusions
* History of other serious neurologic or psychiatric illness, including drug or alcohol misuse
* Had a relapse within the past two months
* No access to the Internet and/or a web camera
* Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months
* No self-reported issues with "remembering places they have to be" or "things they have to do"
Solace Stress Urinary inContinence Control Efficacy and Safety Study

The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.

All patients undergoing sham treatment are treated at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 years of age or older with stress urinary incontinence (SUI)
* Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
* Willing to undergo cystoscopic procedures required and 36 month follow-up
* On stable medication for a minimum of 3 months
* Free of local genital skin infection
* Positive Pad Weight Test
* Free of impassable urethral strictures, trauma or necrosis

Exclusion Criteria:

* Pregnant or planning to become pregnant during the study period
* Non-ambulatory or bedridden or physically unable to complete test exercises
* Morbidly obese (defined as BMI ≥ 40 kg/m2)
* Incontinence of neurogenic etiology
* Urge predominant Mixed Incontinence
* Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (UTI) within 3 months
* History of recurrent urinary tract infections
* Prior surgical procedure for incontinence within the past 6 months
* Is taking medications for urinary incontinence other than anticholinergics
* History of recurrent (\>1) or recent (within 5 years) kidney stone(s)
* Has a prosthetic heart valve
* Unable to tolerate any form of antibiotic
* Taking anticoagulation therapy, other than aspirin
* Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)