cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1: Influenza vaccinated concurrent comparator

Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows:

* Non-missing sex: (start of available data, 1 day prior to index)
* No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index)
* No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index)
* No receipt of any other COVID-19 vaccine: (90 days prior to index, index date)
* Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Cohort 2: Medically attended COVID-19 concurrent comparator

Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows:

* Non-missing sex: (start of available data, 1 day prior to index)
* No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index)
* No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index)
* No receipt of any other COVID-19 vaccine: (180 days prior to index, index date)
* Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Exclusion Criteria:

* Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort.
* For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women

To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

The effects of vitamin D supplementation on pregnancy outcomes and metabolic status of overweight and obese pregnant women remain uncertain. In particular, the dosage of vitamin D supplementation has not been defined in this high risk group of women. This study aims to examine whether oral supplement of vitamin D3 (cholecalciferol) in total dosage of 800 IU(prenatal multivitamin containing 400 IU vitamin D3 + 400 IU vitamin D3 alone) given to overweight and obese pregnant women since early pregnancy until delivery can improve maternal and neonatal outcomes, compared with those given prenatal multivitamin containing 400 IU vitamin D3 supplementation, a commonly given antenatal supplement in Singapore. The investigators' hypothesis is that higher dose vitamin D supplementation would lead to better outcomes in overweight and obese pregnant women. The investigators will conduct a two-arm, parallel non-blinded randomized controlled trial. Women with body mass index ≥25kg/m2 will be randomly assigned into groups with a 1:1 randomization ratio, receiving either 800 or 400 IU vitamin D3 supplementation. The study will be conducted at the antenatal clinics, KK Women's and Children's Hospital, Singapore. Measurements of serum 25-hydroxyvitamin D (25OHD), lipid profile and lifestyles information will be taken for all women at baseline (≤16 weeks gestation) and after three months of intervention (26-30 weeks gestation). All women will continue with the vitamin D3 supplementation until delivery. Primary outcomes include levels of maternal serum 25OHDconcentration and lipid profile at 26-30 gestation weeks as compared with the controls, adjusting for baseline measurements. Secondary outcomes include preeclampsia, gestational hypertension, gestational diabetes, glycaemic levels, caesarean section, gestational weight gain, preterm birth, low birth weight and small-for-gestational-age. This study will fill up the gap of knowledge regarding the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.

Eligibility Criteria:
Inclusion Criteria:

1. Gestation ≤16weeks (16 weeks + 6 days) upon intervention
2. Pre-pregnancy BMI ≥25 kg/m2
3. Aged 21-45 years
4. Willing and able to provide written, informed consent

Exclusion Criteria:

1. Having current or past hypo/hyperparathyroidism, hypercalciuria, hypercalcemia or osteomalacia
2. History of renal disease (including kidney stones and etc.), liver dysfunction, tuberculosis or sarcoidosis
3. Pre-existing diabetes mellitus or chronic hypertension
4. Taking lipid-lowering medicine
5. Gestational diabetes (as confirmed by oral glucose tolerance test) or gestational hypertensive disorder
6. Multiple pregnancy
Effects of an Intervention to Enhance Resilience in Physical Therapy Students

Health professional students experience high levels of psychological stress. Individuals with higher levels of resilience are better equipped to handle stress. The purpose of this study is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience, coping, protective factors, and symptomatology on students enrolled in a doctor of physical therapy (DPT) program.

Hypothesis: The curriculum will decrease stress levels, increase resilience, coping flexibility, protective factors (optimism, positive affect, and social support), and reduce symptomatology (negative affect, illness). Research on stress and its consequences experienced by physical therapy students in particular is limited. If the results of this study support this hypothesis, it may establish the benefit of adding a resilience component to the curriculum for students of physical therapy.

The study involves curriculum development and evaluation by randomized controlled trial. Participants will be randomized to the intervention group to receive a Resilience Curriculum or to a wait-list control group to receive a condensed version of the curriculum following the post-intervention assessments.

Pre- and post-intervention assessments will be administered to both groups, with baseline assessments administered in the first two weeks of the semester. The assessments will include measures of stress levels, levels of resilience, coping flexibility, optimism, positive and negative emotions, social support, and symptoms of illness. The intervention, the presentation of a resilience curriculum, will be delivered to the intervention group during the week following the baseline assessments and it will last for four weeks.

The resilience curriculum will provide education for participants about methods to increase protective factors against stress, the use of effective coping strategies, and the importance of accessing social support, with the goal of better managing stress and enhancing resilience. The intervention will include a didactic component, skills-building training, and homework exercises to encourage the application of the skills. The curriculum will be delivered in four 2-hour modules, with one module delivered each week. The follow-up assessments will occur after midterm examinations are concluded. An abbreviated curriculum which will last approximately two hours will be delivered to the wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Current enrollment in Doctor of Physical Therapy program at either Indiana University or the University of Indianapolis

Exclusion Criteria:

* None
VIBration Training in EpicondylitiS

A number of different therapeutic approaches to treat lateral epicondylitis have been tested partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A injections, braces, surgery and topical NO patches.

One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy) have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al., J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.)

Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The investigators hypothesize that a dedicated proprioceptive intervention might be able to reduce pain and improve function.

As such a RCT is planned with two intervention arms with proprioceptive training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) over twelve weeks.

The investigators sought to evaluate the clinical effects of either a vibration training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) in a randomized trial among patients suffering lateral elbow tendinopathy (lateral epicondylitis).

Primary outcome measure of this clinical trial is pain on a visual analogue scale (VAS 0-10) before and after 12 weeks of training.

Secondary outcome parameters involve DASH score before and after, grip strength (JAMAR), vibration and two-point discrimination (mm).

Eligibility Criteria:
Inclusion Criteria:

* lateral elbow tendinopathy
* informed consent
* ability to run at least 40-60min per week with a XCO-Trainer device

Exclusion Criteria:

* other sources of lateral elbow pain (joint instabilities, fractures)
* no consent
* no ability to run at least 40-60min per week using a XCO-Trainer device
NuMask Versus Traditional Mask Ventilation During Routine Care

The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.


Eligibility Criteria:
Inclusion Criteria:

* 44 adults total
* ASA status I-III
* aged 18-64
* elective surgery at the University of Utah under general anesthesia
* Bearded, BMI \>35 or edentulous

Exclusion Criteria:

* ASA IV or higher
* Oropharyngeal or facial pathology
* Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
* Known and/or documented difficulty placing an endotracheal tube in the past
* Limited neck extension or flexion
* Personal or familial history of malignant hyperthermia
* Known or predicted severe respiratory disease or compromise
* Pregnancy
Triathlon Tritanium Cone Augments Outcomes Study

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation.
* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 45.
* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Imaging Biomarkers in ALS

The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* 21 to 75 years of age inclusive.
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

ALS patients:

* A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.

Exclusion Criteria:

* Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
* Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
* Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.
* The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.
Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcimoma

Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers

Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Although the best efforts of experienced surgeons, The local recurrence rate is 3 to 33% in conventional surgery, while total mesorectal excision (TME) results indicate a recurrence rate of less than 10%

The evolution of the concept of TME which was first revealed by Heald.in 1982 made a major shift in the treatment strategies (Rodriguez-Luna et al,2015). The concept of TME was the most important event in surgery for rectal cancer in the last two decades, because even without a curative approach, the local recurrence decreased to 6 to 12%, and 5-year survival improved by 53-87% TME described clear definitions of distal resection margin (DRM), circumferential resection margin (CRM), and least number of harvested lymph nodes, so oncological outcomes improved, locoregional recurrence and survival rates also influenced .

Laparoscopic total mesorectal excision (LTME) may be associated with less blood loss, earlier recovery, and lower morbidity. Identification of the small nerves and vessels became easiear because of laparoscopic magnified view of pelvis and thus prevents these injuries (Sajid et al, 2019). Also, minimal surgical trauma will reduce the immunologic response and preserves postoperative immunologic defenses. This may lead to low rate of infections as well as low local recurrences and distant metastases in addition to, tissue handling with less manipulation, 'may reduces the spread of cancer cells

TME in obese males with low and anterior rectal tumors is technically challenging especially post neoadjuvant chemoradiotherapy due to distortion of the anatomical planes (Ng et al, 2014). In these patients, it is difficult to obtain a proper view of the dissection plane, in open technique which threatens the integrity of TME and carries the risk of positive margins, which is related to higher rates of local recurrence

LTME is a widely used approach for rectal cancers; although conversion rate varies from 1.2 to 17%, and it is higher if BMI is equal to or more than 30


Eligibility Criteria:
Inclusion Criteria:

* All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria.
* Both sexes will be included.
* Age: ranging from 20 to 70 years.

Exclusion Criteria:

* Patients with stage IV.
* Recurrent rectal cancers.
* Combined malignancy.
* Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage).
* Patients with contraindication for laparoscopic surgery.
* Unfit patients (ASA score \> II).
Effect of Transcranial Magnetic Stimulation on Free Will

This study will use transcranial magnetic stimulation (TMS) to investigate how the brain controls movement by sending messages to the spinal cord and muscles.

Healthy normal volunteers 21 years of age or older may participate in this study.

They must have no medical, neurological or psychiatric illnesses nor have been taking medications that affect nervous system function.

Participants will undergo transcranial magnetic stimulation. For this procedure, an insulated wire coil is placed on the scalp or skin. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. If the coil is placed over a nerve or area of the brain that controls muscles, it may cause a muscle twitch, possibly strong enough to move the limb. In other cases, the subject may have a feeling of movement or feel a tingling sensation in a limb. Stimulation over the muscles on the side of the head may cause some discomfort in that area or twitching of the jaw.

During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscle. In most cases, the study takes less than 3 hours.

The purpose of this study is to investigate the influence of transcranial magnetic stimulation (TMS) on free will to select movement. There have been debates that most of human voluntary movements are reflexive rather than volitional in nature, although most people feel that their movements are freely chosen. This issue is illuminated by previous TMS studies showing external bias of freely chosen movements by TMS. Recently, we tried to confirm these observations using a more reliable method with subthreshold TMS, but failed. Thus, in this study, we are planning to use suprathreshold TMS to test whether this type of stimulation on different motor areas influences free selection of movements or not.

Eligibility Criteria:
Normal adult volunteers who are 21 years or older will be eligible.

Volunteers who have either any medico-surgical, neurological and psychiatric illnesses, who have been taking any medication with potential influence on nervous system function, who have a pacemaker, an implanted medical pump, a metal plate or a metal object in the skull or eye (for example, after brain surgery), or who have a history of seizure disorder, will be excluded.
Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.

Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.

The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years
* Patients who have experienced a Stroke of more than one month
* Deficit out of the upper limb (Fugl Meyer member sup \<50/66)
* Presence of ECR muscle MEP
* Able to carry the motor imagery according to a test by measuring chronometer
* Patient who signed informed consent
* Subject affiliated to the social security system

Exclusion Criteria:

* history of epilepsy or seizure
* MEP Lack of ECR
* Presence of a cons-indication for use of magnetic stimulation or MRI:

  * Surgical Clips, metal sutures, staples, stent
  * Osteosynthesis devices on the head or neck
  * Pacemaker
  * Implanted hearing aid
  * Ocular foreign body, shrapnel, bullets
  * Metal Worker
  * Heart Valve, endovascular equipment
  * Ventricular bypass valve
  * Pace-maker or neurostimulator
* Claustrophobia
* incapable adult Patient, safeguard justice, guardianship or trusteeship
* Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)