cyrilzakka/clinical-trials huggingface dataset:
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression

The aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone.

Further we shall evaluate cost-effectiveness of the two treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Single symptomatic metastatic epidural spinal compression at any level confirmed by MRI
* Age 18 and more
* Able and willing to give written informed consent to participate in the study
* Able to read and write English on an elementary level

Exclusion Criteria:

* Multiple symptomatic spinal metastases
* Radiosensitive tumors
* Radioresistant tumors
* Primary cancer site in CNS or spine
* Poor life expectancy (\< 3 months)
* Patients with a tumor that has compressed only the cauda equina or spinal roots
* Has a recent history of substance abuse
* Is a prisoner
* Currently involved in another study
* has a disease or condition that would preclude accurate evaluation
Assessing the Effects of Patient Self-Rating of Voice Quality on Voice Therapy Attendance and Outcomes

The purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. One of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. The researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.

Attendance and adherence are established as consistent challenges in voice therapy. Specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. The authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. The authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* English-speaking
* Have access to technology, including Internet
* Diagnosed with dysphonia with a recommended treatment of voice therapy.
* Willingness to complete all clinical/research assessments
* Ability to give informed consent

Exclusion Criteria:

* Patients who undergo surgical intervention during the course of therapy Contraindications for participation in voice therapy
* Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
* Previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student
* Visual impairments that would prevent the completion of an online module.
* Those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study
* Inability to give informed consent
Effect of Sham Anti-inflammatory Diet on Inflammation After Spinal Cord Injury

This pilot study will evaluate the effects of a placebo anti-inflammatory diet in individuals with spinal cord injury. It is being performed to ensure that the placebo diet does not induce reductions in inflammation and also adequately conceals group allocation.

Anti-inflammatory diet is a novel treatment that may be beneficial for managing chronic inflammation and neuropathic pain (NP) after Spinal Cord Injury (SCI). NP is a common complication following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications.

As pain is a subjective outcome, awareness of group allocation could influence treatment expectations and participant rated scores of neuropathic pain. It is therefore important to ensure that an adequate placebo intervention is utilized. This pilot study will assess whether the placebo diet to be used in an upcoming RCT provides sufficient group allocation concealment (i.e. ensure participants are unaware of whether they are on the anti-inflammatory diet or placebo diet). This pilot study will also assess whether the placebo diet is in fact inflammation neutral (ie. induces no reductions in inflammation).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent obtained prior to any study-related activities
2. A spinal cord injury at least 6 months duration, nonprogressive for at least 6 months
3. Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.

Exclusion Criteria:

1. Current infection of any kind.
2. Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
3. Currently enrolled in another clinical trial
4. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
5. Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study
Functional Electrical Stimulation Cycling for Managing Mobility Disability in People with Multiple Sclerosis

Mobility impairment is one of the most common, poorly managed, and life altering consequences of MS. Current therapies for managing MS do not prevent the long-term accumulation of mobility impairment, highlighting the need for alternative strategies that prevent or slow progressive mobility disability. The proposed trial will test the efficacy and lasting effects of functional electrical stimulation (FES) cycling as an exercise-based rehabilitation strategy for managing mobility impairment and associated consequences in MS.

The study is an assessor-blinded RCT for examining the efficacy and lasting effects of 24 weeks of supervised FES cycling exercise compared to passive leg cycling on mobility and secondary outcomes in people with MS with mobility impairment. Participants who meet the eligibility criteria will undergo the informed consent process and baseline assessment. Participants will then be randomized to either the FES or passive leg cycling program. Following baseline assessment, participants will complete a 24-week leg cycling program, with a mid-point assessment at 12 weeks. At 24 weeks, participants will undergo a post-intervention assessment. Following a 12-week follow-up period, participants will undergo a final assessment. Each participant will be involved in the study for approximately 10 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of multiple sclerosis
* relapse free in the past 30 days
* stable course of disease-modifying therapies over the past 6 months
* ability to communicate in English
* willing to come to the University of Ottawa to complete testing and training sessions
* EDSS score 5.0 - 7.0
* asymptomatic based on a physical activity pre-participation screening tool

Exclusion Criteria:

* presence of any contraindication to FES including epilepsy, a pacemaker, implanted defibrillator, unstable fracture, or pregnancy
* diagnosis of other neurological condition(s)
* participation in FES cycling exercise or other mobility-based exercise rehabilitation program within the past 6 months
* current use of dalfampridine within the past month
Severe Lung Disease in Childhood

Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few.

This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database.

At a yearly follow up, data from the patient record will be registered. Informed consent from the patients and/or their parents will be obtained. Registered data will include height, weight, results of lung function tests and imaging diagnostics.

The study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.

Eligibility Criteria:
Inclusion Criteria: severe lung disease -

Exclusion Criteria: no informed consent

-
Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.

Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that are used to treat people with AD may impact on their driving abilities. Donepezil is a drug used to treat the memory problems associated with AD. While previous studies have shown that it slows the decline of activities of daily living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to perform on computerized flight simulators, no studies have examined the impact of donepezil on driving abilities in older adults.

The present investigation is a pilot study aiming to determine if donepezil helps healthy older drivers perform on driving simulators. Two Canadian academic centers have different driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or identical placebo for two weeks.

Using the driving simulator, we will assess various aspects of driving ability. These measures of driving performance will be compared between those who received the drug and those who received the placebo.

Eligibility Criteria:
Inclusion Criteria:

* valid Ontario driver's license
* active driver (greater than or equal to three times per week)
* written, informed consent
* lives in Toronto/Thunder Bay
* healthy
* Male between 65-75 years old

Exclusion Criteria:

* cognitive impairment
* psychiatric history
* sleep disorder history
* substance abuse
* neurological history
* medical illness
* ophthalmological disease
* psychoactive medications
* contra-indications to Donepezil
* experience car/motion sickness
Assistive Device Training in Multiple Sclerosis

The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.

40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.

The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis of any type,
* self-reported history of at least 1 fall in the previous year,
* able to walk at least 25 feet with or without an assistive device,
* clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment),
* intermittent or constant unilateral or bilateral assistance required to walk,
* right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.

Exclusion Criteria:

* serious psychiatric or medical conditions that would preclude reliable participation in the study,
* dementia (MMSE \<24),
* deafness,
* blindness,
* inability to follow directions in English,
* significant upper extremity tremor or weakness,
* more than 1 hour of assistive device training within the previous 3 years,
* any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).
Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position

In this study the changes in upper airway geometry and resistance between images, obtained in upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20 subjects. The upright morphology will be obtained using CBCT scan while the supine upper airway geometry will be determined using a standard High Resolution Computed Tomography (HRCT) scanner.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Male or female subject aged ≥ 18 years.
* BMI \< 25 kg/m2 (group 1), BMI ≥ 25 kg/m2 and \< 30 kg/m2 (group 2) and BMI ≥ 30 kg/m2 (group 3) at visit 0. BMI calculation should be repeated if the interval visit 0 - visit 1 \> 14 days.
* Female subject of childbearing potential who confirms that a contraception method was used at least two months before visit 1.

Exclusion Criteria:

* Subject is under the age of legal consent.
* Subject who is pregnant or is breast-feeding.
* Subject with a history of surgery of the upper airway.
* Subject with a history of any illness that, in opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.
* Subject is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
* Subject who received any investigational new drug within the last 4 weeks prior to visit 1.
* Subject who has claustrophobia.
Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism

BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (\>3.5 if Ca and P are expressed in mg/dl) from healthy subjects. The reliability of this index is based on the fact that serum Ca and P are inversely related together. However, other disorders of the Ca-P metabolism, such as hypophosphoremia (HypoP) not related to PHPT, might also impair the Ca/P ratio.

OBJECTIVE: To validate the accuracy of Ca/P ratio in the diagnosis of Ca-P metabolism disorders, including also patients with documented HypoP not related to PHPT.

METHODS: A single-center, retrospective, case-control study will be carried out.

Biochemical measurements will include parathormone (PTH), vitamin D, serum Ca and P, serum albumin and creatinine.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of primary hyperparathyroidism
* HIV-infected patients with reduced phosphorus but normal calcium
* subjects with normal Calcium-Phosphorus metabolism

Exclusion criteria for both cases and controls will be:

* age younger than 18 or older than 90 years
* severe renal and liver diseases (i.e. glomerular filtration rate (GFR) \<30 ml/min)
* hyperparathyroidism secondary to Vitamin D deficiency
* active metabolic bone disease (e.g. Paget's disease of the bone, osteomalacia, rickets, etc)
* any type of cancer
* malnutrition
* severe obesity (BMI \> 40 kg/m2)
* a history of gastrointestinal malabsorption
* sarcoidosis
* hypercortisolism
* diabetes insipidus
* hyperthyroidism
* pseudohypoparathyroidism
* familial hypocalciuric hypercalcemia (FHH)
* treatment with steroids, active forms of vitamin D (calcitriol, ergocalciferol, etc), thiazides, phosphate binders, lithium, cinacalcet, bisphosphonates, and denosumab.
Role of Oxytocin in Myocardial Infarction

60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to 2 groups. one group will receive the conventional treatment while the second group will receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will undergo echo and cMRI during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* current diagnosis of ST elevation myocardial infarction
* no previous episodes of acute coronary syndrome
* agreed to enter research

Exclusion Criteria:

* age \< 18 years
* congestive heart failure (acute or chronic)
* cardiomyopathy
* life threatening arrhythmia at presentation
* previous LV dysfunction
* hypotension (systolic \< 100mmHg, diastolic\<50mmHg, 15% less than patients normal values)
* tachycardia - pulse \> 100bpm
* bradycardia - pulse \< 55 ppm
* killip 3 or 4 at presentation
* current use of nitrates
* pregnancy
* females - history of pathological GU bleeding
* inability to give consent
Prospective Study Assessing Thyroidectomy Using Robot

The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery.

Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed.


Eligibility Criteria:
Inclusion Criteria:

1. Benign thyroid nodule or follicular or suspicious cytological (Bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic
2. Differentiated thyroid cancers - CN0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - CN1A / b with lymph node metastases \<or = 10 mm in areas VI, III and / or IV, detected on preoperative ultrasound - For which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting
3. Patient with no cons-indication to thyroid surgery or without dissection
4. Patient general condition of WHO grade 0-1
5. Patient age \> 18 years and able to comply with the protocol visits
6. Patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (Axillary or behind the ear channel)
7. Patient Information or his legal representative and signed consent enlightened
8. Patient affiliated to a system of social security or beneficiary of such a scheme

Exclusion Criteria:

1. A history of cervical surgery or external beam radiation therapy
2. Anomaly craniocervical hinge or symptomatic cervical spondylosis
3. Congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary )
4. paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively )
5. tumors with obvious extra- thyroid extension or suspected during preoperative ( cT3T4 )
6. metastatic cervical lymphadenopathy \> 10 mm during the preoperative
7. Pregnant women or during lactation
8. patient already included in another clinical trial with a molecule experimental
Computer Guided Placement of Zygomatic Implants in Two Different Approaches

Evaluation of computer guided placement of Zygomatic implants utilizing intra sinus versus extra sinus surgical approach for the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable approach for Zygomatic implant placement with the least postoperative complications

During the last ten years, there has been an increase in the number of edentulous patients looking for and seeking out rehabilitation. Formerly, individuals with edentulous maxilla and mandibles were rehabilitated with removable complete dentures, but it was associated with poor patients' satisfaction.

Alveolar bone atrophy results from loss of bony support due to the physiological process that naturally takes place after tooth loss, especially in the upper arch. Due to its shape and structure, the maxilla is an extremely challenging arch to reconstruct with dental implants.

Oral and Maxillofacial surgeons began utilizing alternative methods to replace missing teeth with osseointegrated dental implants in atrophic maxilla. As a result, different methods were developed for handling of this issue, including tilted implants, sinus elevation, the use of Pterygoid implants, the use of short implants and Zygomatic implants.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
3. Lacking posterior maxillary bone support due to significant sinus pneumatistion
4. Good systemic health (ASA score I-II)
5. Highly motivated patients.

Exclusion Criteria:

1. Patient not willing to give his/her informed consent.
2. Patients with systemic disease that did not permit the surgical procedure (including general anaesthesia).
3. Patients with uncontrolled diabetes or under bisphosphonate therapy.
4. Heavy smoker.(\> 20 cigarettes daily)
5. Patient with psychiatric problems, severe bruxism or other parafunctional habits.
6. Acute sinusitis.
7. Malignancy or pathology in Maxilla or Zygoma.