cyrilzakka/clinical-trials huggingface dataset:
Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients

This research will assess the accuracy of the Toronto Bedside Swallowing Screening Test (TOR-BSST), a new dysphagia screening test for patients with stroke. The purpose of the TOR-BSST is to predict the presence of dysphagia in stroke patients across their continuum of care in a simple and efficient manner. This initial research will assess the accuracy of the TOR-BSST in the acute and rehabilitative settings using videofluoroscopy as the gold standard for comparison. The results from this research will also assess the stability of the TOR-BSST across nursing, its primary user, and generate an estimate for the prevalence of dysphagia in adult stroke patients in the acute and rehabilitative settings. Participants in this research will be 315 stroke patients from several teaching centres in Ontario, namely 105 acute patients from the University Health Network, Sunnybrook \& Women's College Health Sciences Centre, and Hamilton General Hospital, and 210 patients in the rehabilitation setting from the Toronto Rehabilitation Institute and Parkwood Hospital, London. Both the TOR-BSST and videofluoroscopic assessment will be administered within 24 hours of each other and interpreted according to published preferred practice guidelines for dysphagia. This research will be the first to implement and assess a standardised method for screening for dysphagia in stroke patients across the continuum of stroke recovery.


Eligibility Criteria:
Inclusion Criteria:

* patients with a new diagnosis of brainstem or cerebellar stroke
* patients with a new diagnosis of cortical stroke with NIH Stroke Scale score of 4 or above

Exclusion Criteria:

* patients with a previous history of stroke with dysphagia
* patients with a confirmed history of Parkinson's, Parkinsonian Syndrome, ALS, MSA, MS, dementia, or other neurodegenerative disease
* patients with a history of cranial neurosurgery
* patients with a known previous or current oropharyngeal dysphagia due to structural or neurological cause
* patients with active COPD or current pneumonia
Supporting Attendance for Facility Delivery and Infant Health

The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.

Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, \[mobile health or mhealth\] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).

Eligibility Criteria:
Inclusion Criteria:

* Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
* Plans to deliver in facility catchment area
* 18 years or older
* Able and willing to provide consent

Exclusion Criteria:

-
A Study of RO4995819 to Assess Bioavailability and Safety in Healthy Volunteers

This randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male and female volunteers, 18 to 65 years of age, inclusive.
* A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
* Able to participate and willing to give written informed consent and to comply with the study restrictions.
* Willing not to participate in any other clinical trial with an investigational drug or device for at least 3 months following the follow up visit.
* Male volunteers and their partners of childbearing potential must use two adequate methods of contraception. Female volunteers who are not either surgically sterile or postmenopausal must commit to use two adequate methods of contraception throughout the study and until at least 5 months after last dosing.

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder or cancer
* Significant past or present disorders of the central nervous system, psychiatric disorders, behavioral disturbances
* Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
* Any condition or disease detected during the medical interview / physical examination that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study in the opinion of the Investigator
* Clinically significant abnormalities in laboratory test results
* Confirmed resting pulse rate greater than 90 or less than 40 beats per minute (bpm) at screening
* Confirmed systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening
* Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days of study start
* Any confirmed allergic reaction against any drug or multiple allergies
* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Infection with hepatitis B, hepatitis C virus, or HIV 1 and HIV 2
Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.

There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.

There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.

Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.

Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature patients with closed fractures of phalanges and metacarpals.
2. Patients with open type I fractures of phalanges and metacarpals.

Exclusion Criteria:

1. Skeletally immature patients with open physis.
2. Patients with open type II or III fractures of phalanges or metacarpals.
3. Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.
Metabolism Des LAM

In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.

Primary goal of this study is to Evaluate the characteristics of regulatory networks of iron and redox balance in leukemic cells, to study the correlations between the prognosis of AML patients (in terms of response to induction chemotherapy and survival i) and metabolism of these markers. Secondary ones areto assess the impact of induction therapy on markers of oxidative stress and to correlate biological iron and redox metabolism with the molecular status of patients (eg Flt3/IDH/CEBPA/NPM...).

Eligibility criteria are patients at diagnostic of de novo acute myeloid leukemia (promyelocytic excluded) aged from 18 to 100 years.

Eligibility Criteria:
Inclusion Criteria:

de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis

Exclusion Criteria:

age under 18 years promelocytic leukemia secondary leukemia
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Between 2 and 14 years old
* Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
* Diagnosed with comorbid allergic rhinitis

Exclusion Criteria:

* Patients with suspected sinus infection
* Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases
Evaluation of Salivary Adseverin, 1-Alpha Defensin and sRANKL Levels of Individuals With Different Periodontal Diseases

: The aim of this study is; detection of Adseverin,1-alpha Defensin,sRANKL(soluble RANKL) levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine Adseverin,1-alpha Defensin,sRANKL(soluble RANKL) levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) At least twenty permanent teeth in the mouth Non-smoker No medication for continuous use Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.

Not in pregnancy or lactation period. For the periodontitis group that has not received periodontal treatment in the last 6 months For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

Any oral or systemic disease Regularly using a systemic medication During pregnancy or lactation Received periodontal treatment within the last 6 months. Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months Smokers are not included in the study
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).


Eligibility Criteria:
Key Inclusion Criteria:

* Completed study drug treatment in parent study (VX18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study

Key Exclusion Criteria:

* History of study drug intolerance in parent study

Other protocol defined Inclusion/Exclusion criteria may apply.
IV Acetaminophen After Cardiac Surgery - PILOT

Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.

The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age \< 60 or \>= 60.

Eligibility Criteria:
Inclusion Criteria:

* subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery

Exclusion Criteria:

* • Refusal by surgeon for inclusion of the patient

  * Requested late extubation by anesthesia or surgeon
  * Intra-aortic balloon pump
  * Sensitivity to acetaminophen
  * Pre-operative cognitive dysfunction
  * Psychiatric history with active treatment
  * Parkinson's disease
  * Alzheimer's disease
  * Medication for cognitive decline
  * History of recent seizures
  * Recent history of alcohol misuse
  * Creatinine clearance less than 30 ml/min
Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)

The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutations in RPE65 gene.


Eligibility Criteria:
Inclusion Criteria:

* Male or females between 6 and 50 years of age at the time of signing the informed consent form.
* Willing to adhere to protocol as evidenced by written informed consent or parental permission and subject assent.
* Clinical confirmed diagnosis of Leber congenital amaurosis (LCA) and molecular diagnosis of LCA due to RPE65 mutations.
* Ability to perform tests of visual and retinal function.
* Visual acuity of ≤ 20/80 or visual field less than 20 degrees in the eye to be injected.
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* Pre-existing eye conditions that would preclude the planned surgery or interfere with interpretation of study endpoints or complications of surgery (e.g., glaucoma requiring upcoming surgery, corneal or significant lenticular opacities).
* Presence of epiretinal membrane by OCT.
* Complicating systemic diseases or clinically significant abnormal baseline laboratory values.
* Complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter ocular function.
* Prior ocular surgery within six months.
* Prior gene therapy or oligonucleotide therapy treatments.
* Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.
Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain

Interventions focused on the scapula have been frequently used to treat shoulder pain. However, most studies do not assess the contribution of scapular movement alteration for the symptoms.

Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement Training and General Exercises.

This is a double-blinded randomized controlled trial. Sixty-four subjects with shoulder pain, scapular dyskinesis, and positive scapular assistance test will be randomized in two groups: 1) Scapular Movement Training, and 2) General Exercises. The Scapular Movement Training Group will receive the orientation about proper scapular position and movement, and will be trained to modify the scapular movement pattern. The General Exercises Group will perform scapulothoracic stretching and strengthening exercises.

Both groups will be treated twice a week for eight weeks. The following outcomes will be collected at baseline and follow-up: scapular kinematics, electromyographic muscle activity of the upper, middle and lower trapezius, and serratus anterior, as well as pain intensity, function, and fear avoidance beliefs. Also, pain intensity, function, and fear-avoidance beliefs will be assessed at the fourth week of follow-up after the end of treatment's period.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain intensity ≥ 3 points on Numerical Rating Scale;
* Shoulder pain lasting ≥ 3 months;
* Scapular dyskinesis;
* Positive Scapular Assistance Test;
* Arm elevation ≥ 150°;

Exclusion Criteria:

* Body Mass index \> 28Kg/m
* History of humerus, clavicle and scapula fracture and/or surgery;
* History of rotator cuff surgery or tears, shoulder dislocation, and instability;
* Frozen Shoulder;
* Neurological or systemic disease which may alter the muscle strength and sensibility;
* Positive Upper Limb Tension Test and/or Spurling's test
* Pregnancy;
* Physical therapy within 6 months;
* Corticosteroid injection within 3 months
* Transpore tape allergy;
Association of the Optic Nerve Sheath Diameter With Eyeball Transverse Diameter in Robot-assisted Prostatectomy

Robot-assisted laparoscopic radical prostatectomy (RALRP) is becoming a popular procedure due to its unique advantages.

Despite these advantages, pneumoperitoneum and steep trendelenburg position are associated with hemodynamic instability and elevated intracranial pressures (ICP).

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an indirect but also a generally accepted reliable and noninvasive measurement of elevated ICP. However, optimal cut-off values are highly inconsistent due to multiple factors (gender, height, weight). To eliminate the effects of these factors on the results; a ratio should be established in patients known to have elevated ICPs.

In a recent study ONSD/ eyeball transverse diameter(ETD) in healthy volunteers in a specific population was established.

60 patients without any history of ICP undergoing RALRP will be enrolled to the study. Ultrasonographic measurement of ONSD and ETD will be performed 10 minutes after induction of general anesthesia, 10 minutes after CO2 pneumoperitoneum with trendelenburg positioning and measurements will be repeated hourly and at last after returning to supine position without CO2 pneumoperitoneum at the end of the procedure.

Hemodynamic variables and BIS values on this specific times will be recorded and an arterial sample will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* 19-75 years patients undergoing RALP

Exclusion Criteria:

* a history of corneal surgery, open-angle or closed-angle glaucoma
* intraocular surgery
* history of elevated ICPs
Visual Feedback Balance Training System Combined with RFE in Stroke

The goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:

Does visual feedback balance training system combined with RFE reduce the fall risk of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?

Researchers will compare 3 groups (RFE, visual feedback balance training system under RFE, and conventional therapy) to see if visual feedback balance training system and RFE works to treat stroke.

Participants will:

Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment


Eligibility Criteria:
Inclusion Criteria:

* patients (18 to 74 years old) who suffered a first or second unilateral stroke
* chronic stroke (over 6 months from the onset)
* moderate or higher risk of falls (TUG \> 15s, or 10-MWT ≤ 0.8m/s)
* ability to understand and follow simple directions

Exclusion Criteria:

* pregnant or lactating
* lower extremity contracture, pain, or trauma
* perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
* unable to maintain standing posture
* cerebellar lesion
* clinically unstable medical disorders
* inability to provide informed consent
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are over 18 years of age
* Participants who have been diagnosed with OSA
* Participants who have been established on CPAP for ≥ 6 months
* Participants currently using a ResMed nasal pillows mask

Exclusion Criteria:

* Participants who are not able to provide written informed consent
* Participants who are unable to comprehend written and spoken English
* Participants who are pregnant
* Participants who are unsuitable to participate in the study in the opinion of the researcher
* Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants who are not established on a ResMed nasal pillows mask