cyrilzakka/clinical-trials huggingface dataset:
Digital Assessment of Speech and Fine Motor Control in ALS

This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) \[1\]. We will also compare assessment data between the patient and control groups.

ALS is a progressive neuromuscular disease that causes weakness and inevitably affecting multiple motor processes within the body. To assess changes in functional mobility, clinicians and clinical investigators often rely on the ALS Functional Rating Scale - Revised (ALSFRS-R), a standardized 12-item questionnaire that has been in use for decades. Although thoroughly validated, this scale has received criticism for providing a coarse reflection of a patient's disease, scaling non-linearly within and across functional domains, and without the sensitivity to reflect day-to-day variability or small but meaningful changes.

This study includes collection of digital speech and fine motor control assessment data at a single study visit. Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data. We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in ALS and the related motor neuron diseases of PLS and PMA that are regularly treated in the ALS clinic.

Eligibility Criteria:
Inclusion Criteria:

1. \[Patient Group Only\] Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[Brooks2000\], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
2. \[Patient Group Only\] at least minimal speech or handwriting ability

   1. ALSFRS-R speech score of 2 ("intelligible speech with repeating") or greater, OR
   2. ALSFRS-R handwriting score of 2 ("not all words are legible") or greater.
3. \[Control Group Only\] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
4. 18 years of age or older;
5. Fluent in written and spoken English.

Exclusion Criteria:

1. Currently or previously enrolled in STUDY00013892 (NCT05271435)
2. Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
3. Pregnant or nursing woman
4. Prisoner or institutionalized individuals
5. Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment

Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.

Patients in the medical intensive care unit (MICU) often receive arterial lines as standard of care, however there are little data to support this practice. Investigators will randomly assign consecutive weeks to either current practice(control) or to a more conservative practice of not placing invasive arterial lines except for limited indication indications as defined below (intervention). Patients entering during an intervention week will be treated according to the intervention practice throughout their ICU stay. Likewise, patients entering during a control week will be treated according to current standard practice.

Permuted block randomization will be used to assure equal numbers of intervention and control weeks. All outcome measures will be obtained through EPIC data analytics and post-hospitalization phone calls. Weekly randomization codes will be generated by the study statisticians and delivered to MICU staff via sealed envelopes to be opened at the beginning of each week.

Eligibility Criteria:
Inclusion Criteria:

* All subjects admitted to the medical intensive care unit

Exclusion Criterion:

* All subjects \<18 years of age.
Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH

Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary.

The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH.

The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.

Prospective study interventional but non invasive Bicentric in two universitarian hospitals in France On a cohort of patients presenting at least two out of three symptoms of the classic triad (urinary symptoms, cognitive symptoms and gait disturbance) and enlargement of ventricles non explained by cortical atrophy.

Participants are offered, as routine care, a diagnostic evaluation of the effect of depletive lumbar puncture on these triad symptoms (this exam is part of routine care).

Before the planned lumbar puncture, the participants are requested to participate to the study, with written consent and information given. The participants are requested to fill in a USP (urinary symptoms profile, validated international questionnaire) questionnaire and a micturition calendar. The same urinary evaluation is made 5 days after lumbar puncture. Gait and cognition are evaluated as in routine practice.

Of the participants initially evaluated, some will be proposed shunt surgery (routine care). These participants will be proposed to fill in the same questionnaire and micturition calendar around 3 months after shunt surgery (post operative evaluation).

Eligibility Criteria:
Inclusion Criteria:

* 2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms
* Ventricular enlargement non explained by cortical atrophy

Exclusion Criteria:

* analphabetism or not french speaking
* Cognitive disability making understanding of study impossible (as informed consent)
Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination

This research focuses on men who have sex with men (MSM) who are at higher risk of anal cancer. The survey will evaluate their beliefs about anal and oral cancer, their knowledge about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of HPV vaccination and anal Pap smears. Approximately 12% of subjects will be HIV-positive.

Little research has examined men's understanding of what causes anal and oral cancers and whether HPV vaccination can play a potential protective role. This research focuses on men who have sex with men (MSM) who are at notably elevated risk of anal cancer, and seeks to characterize their beliefs about anal and oral cancer, knowledge about the etiological role of HPV infection in these cancers, as well as their knowledge of HPV vaccination and anal Pap smears. We will also study heterosexual men.

Eligibility Criteria:
Inclusion Criteria:

* male
* aged 18-59
* answered question about sexual orientation

Exclusion Criteria:

* none
a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants

This aim of this study is to compare different oral hygiene aids for the ability to remove plaque in patients who went through dental implant treatment and are currently on a maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba, Faculty of Dentistry.

Home care and Oral hygiene regimes are as well an important aspect of short and long term dental implant survival and success. The investigators profession demands us to educate the patients about the risk of peri implantitis and peri mucositis in plaque infected dentitions. In periodontal patients the areas of most ineffective plaque removal are typically the palatal/lingual and interdental areas.

there is therefore a need to developing scientific evidence to form a framework for professionals to follow when educating patients about their home care.

Eligibility Criteria:
Inclusion Criteria:

* Non smokers, with clinical probing depth around implants is less than or equal to 6mm and are currently maintained every 3 months at the graduate periodontal program

Exclusion Criteria:

* Smokers
* Probing Depth 6 or \> 6mm
* Non compliant patients and patients with severe systemic conditions
Screening of Septo-optic Dysplasia During a Fetal Examination at 16-20 Weeks of Gestation

Evaluation of prenatal optic chiasm (OC) is important for the differential diagnosis of septo-optic dysplasia (SOD), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (CSP). Septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, CSP agenesis, and developmental delay.

Up to now, optic chiasm measurement were all done in the third trimester. in the present study, OC will be measure directly in a 2D ultrasound in coronal plane within the second trimester. In fetuses with SP agenesis, the morphology and width of the OC visual pathway may be a suitable tool to assess its development. It can also assist in the difficult task of providing prenatal counseling when faced with a diagnosis of CP agenesis. therefore In the present study, it was planned to show the optic chiasm in the screening of septooptic dysplasia by ultrasound between 16-20 weeks of gestation, and to measure the optic chiasma width and length, and to determine the mean values in the second trimester.

Eligibility Criteria:
Inclusion Criteria:

* aged greater than 18 years old
* having singleton pregnancy

Exclusion Criteria:

* being under the age of 18
* having IVF pregnancy
* having multiple pregnancy
* comorbidity during pregnancy
* smoking history
* presence of familial genetic disease
Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation


Eligibility Criteria:
Inclusion Criteria:

* Histologically conformation of liver malignancy
* Solitary or multiple liver tumors amenable to SBRT
* No jaundice or liver dysfunction
* For metastases, the primary tumor site has been adequately treated.
* For primary hepatoma, no extra-hepatic disease
* Karnofsky \> 70

Exclusion Criteria:

* no extra-hepatic disease
* Liver failure or inadequate liver function
* Ascites
* Previous radiation therapy to the liver
* lesions invading major blood vessels in the porta region
* Contraindication to receive radiation therapy in the liver
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
* Prior enrollment in BrainGate2 clinical trial (NCT00912041)

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)
The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ambulatory outpatients 18 to 85 of age at screening
* Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment.
* Qualifying blood pressure criteria for study entry and for randomization
* Willing to adhere to exercise stress (treadmill) tests

Exclusion Criteria:

* Unstable angina within 7 days of screening
* Potential coronary surgical/intervention within the next 6 months
* Have any form of secondary hypertension
* Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker
Peer Education on Core Health Outcomes Specific for Burn Patients

Evaluate the Effectiveness of Peer Education on Core Health Outcomes Specific for Burn Patients

A randomized controlled study will done in the Plastic \& Reconstructive Burn Center at Mansoura University Hospitals. the first phase includes the systematic collection of data to assess patient's health status and determine any actual or potential health problems after necessary permission taken.

The researcher will design the proposed peer education and educational media based on the findings of the assessment.

After peers training, implementing peer education for the study group. The final step of data collection is evaluating the patient's response to the proposed program and the extent to which the outcomes have been achieved.

Eligibility Criteria:
Inclusion Criteria for patients:

Recently admitted patients

* Hemodynamically stable and Free from chronic disease
* Conscious, able to communicate

Inclusion criteria for peer:

* old burns injury patients at least have a diploma degree

Exclusion Criteria:

-
Rituximab to Prevent Recurrence of Proteinuria

The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.

A total of 60 patients will be enrolled in the study.

Eligibility Criteria:
Inclusion:

1. Patient has been fully informed and has signed a dated IRB-approval informed consent form.
2. Age 7-65 years.
3. Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not required once the physician confirms the diagnosis. Transcribed reports from referring physicians are also valid.

Exclusion:

1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
2. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
3. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
4. Patient is pregnant or lactating.
5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
6. Patients with a defined genetic cause of FSGS.
Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound care.

The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.

Eligibility Criteria:
Inclusion Criteria:

* Arteriovenous chronic leg ulcer
* Present beyond 4 months
* Conservative treatment not leading to progress
* Wound size between 2-30cm2
* ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure \> 60 mmHg or toe pressure \> 40 mmHg
* Written informed consent

Exclusion Criteria:

* Uncontrolled wound infection
* Osteomyelitis
* Hemoglobin \<6.0mmol/L
* HbA1c \>80mmol/mol
* Underlying malignancy
* Pregnancy or lactating
* Renal insufficiency requiring dialysis
* Charcot foot
* Underlying malignancy
Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself

This trial will consist of two parts:

A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study.

The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40 years old;
* In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.
* Using a proper anticonception method (orally, subcutaneously);
* A negative pregnancy test.

Exclusion Criteria:

* Intolerance of Ritodrine;
* On chronic medication, except oral and subcutaneous contraception
* History or present presentation of cardiac arrythmias;
* Risk of being pregnant or less than 6 months postpartum;
* Giving breastfeeding;
* Previous uteral surgery;
* Using an intra-uteral device (IUD);
* A severe addiction: nicotine (\> 10 cigarettes/day), alcohol (\> 3 units/day), caffeine (\> 5 units/day) or any extralegally drugs.
Comparative Study of Circular Stapling Instruments

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Anterior resection for Rectal Cancer
* Informed consent

Exclusion Criteria:

* Can not give informed consent
* Patient can not be followed
CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged \< 70 years
* Patients with relapsed/refractory AML
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.
Effects of an Isometric Training Session on Post-exercise Neuromuscular Function When Compared to Dynamic Strength Training

The existing literature shows that maximum strength can be improved through both dynamic and isometric strength training. However, there is a perception that dynamic training has a negative effect on short-term neuromuscular performance in soccer players. Hence, the aim of this study was to compare the neuromuscular impairment after isometric and dynamic training sessions in young soccer players.


Eligibility Criteria:
Inclusion Criteria:

* soccer players
* Competing at national level

Exclusion Criteria:

* Injured or recently injured athletes