cyrilzakka/clinical-trials huggingface dataset:
Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM

Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be between the ages of 18-90 and must not be pregnant.
* Patients volunteer to participate in the study, with a written informed consent signed
* Affiliation to a national health insurance program
* First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
* Contralesional motor deficit
* Lesion sparing primary motor cortex
* Stroke onset \>1 month and \<6 months prior to study enrollment

Exclusion Criteria:

* Coexistent major neurological or psychiatric disease as to decrease number of confounders
* History of epilepsy before stroke (or episodes of seizures within the last six months)
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* Subjects with global aphasia and deficits of comprehension
* Excessive pain in any joint of the paretic extremity (VAS\>4)
* Contraindications to Tdcs : metal in the head, implanted brain medical devices
* Coexistent major neurological or psychiatric disease as to decrease number of confounders
* A history of significant alcohol or drug abuse in the prior 6 months
* Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
* Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
* Pregnancy
A Comparison of Infection Rates Between Two Surgical Sites

Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?

The intent of this proposed prospective observational cohort study is to determine if there is a difference in the incidence of corneal toxicity and/or ototoxicity in study subjects undergoing Mohs micrographic surgery (MMS) on the face if a povidone-iodine preparation is used pre-operatively as compared to a chlorhexidine-alcohol preparation. It has recently been found that the use of a chlorhexidine-alcohol preparation is superior to the use of a povidone-iodine preparation in preventing post-operative surgical-site infections (SSI) in patients undergoing clean-contaminated surgery. However, the use of chlorhexidine on the face has previously been associated with corneal toxicity and ototoxicity. This study will help to further define previously reported risks of corneal toxicity and ototoxicity associated with the use of a chlorhexidine solution on the face.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an outpatient cutaneous surgical procedure on the face.

Exclusion Criteria:

* Those who do not consent to participation
* Those undergoing cutaneous surgery for a lesion on the eyelid margin
* Patients with a history of ongoing eye pain
* History of a pre-existing corneal ulcer within 12 months prior to surgery
* History of a perforated tympanic membrane
* Patients with an active infection at the surgical site at the time of surgery.
* If post-operative follow-up is not completed, the study subject will be excluded from the analysis.
Whey Protein Supplementation in Patients With Parkinson's Disease

Many dietary supplementations are available to help people in balancing the protein intake and overcoming muscle mass loss. However, most of the products contain protein and could potentially affect levodopa action in people with Parkinson's disease (PWPD). The study aims at verify if whey protein supplementation interferes with dopamine replacement therapy efficacy in PWPD admitted at the clinic for a four weeks intensive multidisciplinary rehabilitation training.

Authors performed a randomised single blind monocentric study on PWPD admitted in the rehabilitative unit of the Moriggia Pelascini Hospital for a 4-week multidisciplinary intensive aerobic rehabilitation treatment. All patients received a standard protein redistribution dietary regimen plus a whey protein-based oral formula (N=26) or Magnesium (N=25) twice daily for 28 days.

Neurological assessment and physical evaluation were conducted before (T0) and after (T1) rehabilitative treatment; dopamine replacement therapy was recorded T0 and T1 as well. The delta of changes within groups in neurological (UPDRS III) and physical (TUG, 6MW) evaluation scales was compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease (UKBB criteria Hughes et al., 1992),
* H\&Y stage 2 or 3
* presence of motor fluctuations (by means of UPDRS III item 4.3≥1)

Exclusion Criteria:

* cognitive decline
Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

This trial aims to validate a novel clinical care strategy based on a electronic clinical decision support algorithm (CDSA) combined with point of care rapid diagnostic tests by evaluating its impact on antibiotic prescription and clinical outcome of children and adolescent presenting at primary healthcare facilities with non-severe acute illness compared to routine practice. The trial also aims to assess the usability of the CDSA strategy. The study will be conducted in primary healthcare facilities across different epidemiological regions of Senegal.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing fever or diarrhea
* ongoing fever will be defined objectively or as a reported fever, defined as : axillary temperature ≥37.5°C or tympanic, oral or rectal temperature ≥38.0°C; and fever duration ≤ 10 days
* ongoing diarrhea will be defined as at least 3 abnormal stools during the last 24hrs
* First consultation for the current illness
* Feasibility of contact between the patient (or his/her designated relative) and the study team at day 3 and day 7
* Written informed consent by the caretaker/legally acceptable representative

Exclusion Criteria:

* Infants less than 6 months of age
* Age ≥ 15 years
* Clinical status requiring immediate transfer to an appropriate care facility/ severe illness
Effect of Video-based Guided Self-reflection on Intraoperative Skills

While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined.

The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.

The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial with participants (surgical trainees) individually allocated on a 1:1 ratio to intervention group (guided video-based self-evaluation in addition to traditional intraoperative teaching by faculty surgeons) and a control group (traditional intraoperative teaching alone).

All the trainees participating in this trial will be asked to submit intra-operative video-recordings of 5 consecutive laparoscopic cholecystectomies performed by them as the primary operator.

In this trial the intervention group participants will be asked to perform a guided self-assessment of their intra-operative skills by watching their operative video-recording. The trainee's self-assessment will be guided by validated intra-operative performance assessment tools. The control group will not have access to their recorded video submissions during the duration of this study.

Outcomes assessed will include trainee's intra-operative performance and time to completion of surgical procedure, Information generated from the pilot study will help inform a full-scale RCT by testing the study procedures. Feasibility outcomes will include number of trainees and surgeons approached, consented and randomized and adherence with intervention(surgeons: intra-operative assessments; trainees: video-based assessments). Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT.

Eligibility Criteria:
Inclusion Criteria:

* All residents involved at the McGill General Surgery Program (total of 35 residents on clinical rotations)

Exclusion Criteria:

* None
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients

The aim of this study is to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance in patients with Multiple Sclerosis.

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFN-g, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.

Eligibility Criteria:
Inclusion Criteria:

Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months.
Iron Metabolism in Cystic Fibrosis

Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function.

Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold \< 30 µg/L). Previously published studies used less performant markers such as serum iron (\< 12 µmol/L) or transferrin saturation (\< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation.

The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis genetically proven.
* Age ≥ 18 years
* Systematic annual follow-up.

Exclusion Criteria:

* Dietary or drugs iron supplements
* Systemic inflammation or pulmonary exacerbation
* Lung transplantation
The Relationship Between Heart Function and Metabolism in HFpEF Patients

HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.

However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged ≥ 18 years old
* Patients diagnosed with HFpEF;

Diagnostic criteria including:

1. LVEF 50% or higher;
2. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
3. Presence of symptoms and/or signs of heart failure;
4. At least one additional criteria: relevant structure heart disease or diastolic dysfunction

Exclusion Criteria:

* Severe liver failure;
* Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;
* Primary pulmonary hypertension.
* Severe left valvular heart disease.
* Long-term bedridden or unable to move autonomously
* Age \< 18
A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease


Eligibility Criteria:
Inclusion Criteria:

* 1. Confirmed diagnosis of autoimmune bullous disease；
* 2. Age ≥18 years, regardless of gender；
* 3. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.

Exclusion Criteria:

* 1. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation；
* 2. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy；
* 3. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336；
* 4. Any other condition deemed by the investigator to render the subject unsuitable for study participation.
A Prediction Model of 28-day Mortality in Septic Shock

This clinical study adopts the design of cohort research, selects the sepsis shock patients admitted to our hospital ICU as the research object, takes the 28-day mortality rate as the outcome index, collects the baseline data of the patient, the severity of the disease, vital signs, the main infection site, the laboratory-related index, the treatment method and other data, screens out the risk factors affecting the sepsis shock 28-day mortality rate and constructs the prediction model accordingly, analyzes the prediction model with the subject's working characteristic curve (ROC). The recognition ability of the model is calculated by the area under the ROC curve (AUC) and the ability of the model to predict 28-day mortality with SOFA and APACHE II.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age, gender-neutral;
2. Diagnosed with sepsis shock;
3. ICU survives longer than 48 h;
4. The preservation of clinical data is complete;

Exclusion Criteria:

- Diagnosed with sepsis shock within 6 hours of emergency treatment; Combined with people with autoimmune diseases; 3. Organ transplantation or immunosuppressive treatment; 4. Severe heart, liver and kidney insufficiency; 5. Late stage of malignant tumor; 6. Maternity; 7. Referral or referral to another hospital;
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women

The purpose of the study is to evaluate whether hCG will result in a decrease in breast density.

High breast density has been associated with an increased risk in breast cancer. It has also been shown that decreasing density with a drug called tamoxifen has resulted in a decreased risk in breast cancer. The investigators are looking at the effect of hCG on breast density in people who are at increased risk of developing breast cancer and our theory postulates that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in breast density in patients who are treated with hCG and tamoxifen versus patients treated with tamoxifen alone. Using this data the investigators will be able to hypothesize that the treatment of hCG will result in a reduction in breast cancer rates in the population and thus make available another drug which can be used to decrease the rates of breast cancer in the population

Pregnancy has been associated with a decreased risk of breast cancer. This has been reproduced in multiple studies and has been seen in multiple races.

People have been evaluating different hormones and practices associated with pregnancy to determine what factors reduce the risk of developing breast cancer in these patients. These pronounced findings have been evaluated in great detail by multiple scientists and one of the hormones which we think might be associated with a reduction in breast cancer is hCG. This statement has been backed by multiple studies which have looked at the direct effect of hCG on the growth and death of breast cancer cells in the lab and in animal models of breast cancer.

We want to determine if hCG is given to patients who are at increased risk of breast cancer will result in an accentuated decrease in breast cancer risk above and beyond the effect received by conventional breast cancer reducing protocols. Our final outcome in this study will be breast density on mammographic evaluation which is considered a marker for breast cancer. So our study will evaluate whether or not hCG will have an effect on the mammographic breast density.

After recruitment there will be two groups in our study an intervention group and non intervention group. In the intervention group patients would undergo a period of hCG injections which would last a total of 60 days and consist of 30 subcutaneous injections. The non intervention group will continue their conventional chemoprevention medication. Both groups will be followed for teo years and the images, cytology and blood samples will be sent to our labs for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* On tamoxifen therapy for the treatment or prevention of breast cancer.
* Must have at least one remaining breast.

Exclusion Criteria:

* Pregnant or nursing.
* No history of allergic reactions to hCG.
* Patients who have had bilateral mastectomies.
* Uncontrolled thyroid disease.
* Cognitively impaired and unable to consent for the trial.
Capsaicin on Salty Gustatory Cortices

Excess dietary salt intake is closely associated with the development of hypertension and cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory cortices change. This study focuses on examining the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.

Hypertension and its related complications are common health problems that can lead to multiple organ damage and death. Excessive salt intake plays an important role in the development of hypertension.

The experimental design is a randomized, double-blind, interventional study to investigate the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 65 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with all study procedures.

Exclusion Criteria:

* High basic metabolic rate, tumor, epilepsia.
* Hypogeusia or loss due to neural system disease or oral and digestive disease.
* Capsaicin allergy and poor compliance.
* Recently oral diuretics and participate in other pharmacological experiment in 3 months.
* Acute infection, cancer, serious arrhythmias, drug or alcohol abuse.
* Currently have cold, fever, acidosis, dehydration, diarrhea, vomiting during the study.
* Unwilling or unable to communication due to the dysnoesia and language disorders.
* Severe neural or psychiatric diseases that would preclude fully understand and corporation in the study.
* History of allergic reaction attributed to 18F-FDG.
* Pregnancy or lactation.