cyrilzakka/clinical-trials huggingface dataset:
Hand Training & Brain Changes

10 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to McMaster, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.

This pilot study will investigate the potential changes in the brain area controlling hand movement following 15 days of exercises to improve hand function in participants with upper limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained Inc.) will be used to administer standardized exercises to improve hand function. To assess brain changes, transcranial magnetic stimulation pulses will be delivered to the motor cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be measured using electrodes on the hand. This study will test the feasibility of conducting motor therapy using this device while assessing potential changes in motor cortex function. Findings from this study will contribute to developing treatment trials aimed at improving impaired limb function in stroke patients and quality of life in these individuals

Eligibility Criteria:
Inclusion Criteria:

-Sustained a single stroke \>6months prior to start of study

Exclusion Criteria:

* Severe spasticity or contractures (2 or less in the CMSA)
* any other musculoskeletal or neuromuscular disorders that compromise sensation
* Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 23 or less).
Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening

A dental gel intended to relieve pain related to dentin hyper sensitivity is commercialized in several countries worlwide since May 2017. Its efficacy and tolerance has already been proven in dentin hyper sensitivity. In this new study, we assess the efficacy and tolerance of this tested product in a specific external agression, the teeth whitening.

Comparative open-label PMCF (Post-Market Clinical Follow-up) randomized controlled study will be conducted as multicentric trial in adult with dentin hypersensitivity during their teeth whitening. To evaluate the efficacy and tolerance of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity during teeth whitening

4 visits are planned:

* Visit 1 (V1) - Selection
* Visit 2 (V2) - Start of teeth whitening
* Visit 3 (V3) - Start of tested product application - Inclusion / Randomization
* Visit 4 (V4) - Study end

Eligibility Criteria:
Inclusion Criteria:

* Subject who has a pain score (i.e. maximum intensity felt while the whitening tray wear) of at least 3 on a NRS ranging from 0 (None) to 10 (Severe) evaluated since the beginning of his teeth whitening.
* Subject wishing to have a teeth whitening
* Subject with a healthy gum status according to the investigator
* Subject with at least 20 natural teeth

Exclusion Criteria:

Related to the teeth condition:

* Subject with active teeth decay
* Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel on the teeth to be studied and adjacent teeth
* Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease
* Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator
* Subject with an odontological condition, an acute chronic or progressive disease or history of disease considered by the investigator hazardous for the subject or incompatible with the study

Related to the treatment/product:

* Subject having undergone professional desensitizing therapy in the mouth
* Systemic treatment/product and topical treatment/product in the mouth liable to interfere with study data according to the investigator assessment
Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics

This study was designed to assess the accuracy of ultrasonographic parameters in combination to clinical parameters in the prediction of difficult airway in pediatric population.

All patients underwent a standard airway examination and sonographic airway assessment preoperatively and the predictive values for difficult airway of these methods were recorded.

Difficult airway in a pediatric patient is associated with more stresful situation than adults. Therefore, various clinical airways parameters have been investigated in the prediction of difficult airway. Sonographic evaluation to predict difficult airway is still primitive especially in pediatrics.

Ultrasonography and clinical parameters have been shown to be used in predicting difficult airway, but there is no study showing which is a better predictor.

Eligibility Criteria:
Inclusion Criteria:

* Children, aged between 1-12 years
* Children who required endotracheal intubation under general anesthesia for elective procedures
* written informed parental consent

Exclusion Criteria:

* children over the age of 12
* restrictive neck movement
* tracheostomized patient
* previous laryngeal surgery leading deformation of the laryngeal anatomy
Studies of the Angle Kappa and the Angle Alpha

Anatomical ophthalmological connections and their dynamics are still debated in the scientific community. However, their considering is essential in many surgeries (strabismus, cataract, refractive...) or in clinical practice.

The correlation between these biometric values would make it possible to refine the knowledge related to these landmarks and thus offer better ophthalmological management by integrating these variables into the clinical examination.

The aim of the study is to analyze the correlation between the angle alpha and the angle kappa in a healthy individual without ophthalmologic disorder.

The angle kappa corresponds to the angle formed between the visual axis (line between the point of fixation and the fovea: area of the retina allowing precise vision) and the pupillary axis (line passing through the center of the pupil and perpendicular to the cornea). The angle alpha corresponds to the angle formed between the visual axis and the optical axis (line passing through the nodal point of the eye and corneal center).

In theory, the angle kappa and angle alpha are equal; but physiological corectopy in the nasal position induces a variation between these two angles; the angle kappa being generally less than the angle alpha without a correlation being established. Also, pupillary constriction causes a variation in the position of the center of the pupil. The angle kappa therefore exhibits a variation depending on the expansion.

Anatomical ophthalmological connections and their dynamics are still debated in the scientific community. However, their considering is essential in many surgeries (strabismus, cataract, refractive ...) or in clinical practice.

The correlation between these biometric values would make it possible to refine the knowledge related to these landmarks and thus offer better ophthalmological management by integrating these variables into the clinical examination.

The aim of the study is to analyze the correlation between the angle alpha and the angle kappa in a healthy individual without an eye disorder.

Eligibility Criteria:
Inclusion Criteria:

- Informed major subject not opposing to their participation in the study

Exclusion Criteria:

- Subject with strabismus or organic ophthalmologic pathology
Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy

The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.


Eligibility Criteria:
Inclusion Criteria:

* Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
* Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.

Exclusion Criteria:

* Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.
* Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI

Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (LC).

Based on this known impact of ketamine on the sympathetic nervous system the aim of this study is to investigate the effects of intranasal esketamine on LC related attentional brain networks in task based functional MRI, to relate those attention network changes to behavioural measures and to predict ketamine related attention network changes by brain structure.


Eligibility Criteria:
Inclusion Criteria:

* General health (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
* Age 18 to 55 years
* Right-handedness (due to potential lateralization effects of left-handed subjects)
* Willingness and competence to sign the informed consent form

Exclusion Criteria:

* Current or history of psychiatric or neurological disease
* Current medical illness requiring treatment
* Current or former substance abuse
* Pregnancy or current breastfeeding
* Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
* Known aneurysmal vascular disease based on medical history (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including myocardial infarction (MI)
* Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity (BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability; history of an MI, haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV)
* Hyperthyroidism that has not been sufficiently treated
* History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure
* Child-Pugh class C (severe) hepatic impairment
* Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
* Failure to comply with the study protocol or to follow the instruction of the investigating team
Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies

This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.

The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of patients and to provide a safety profile of GCC2005 in target patient population. Phase 1b of the study is planned to conduct dose optimization to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
* Patients with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
* According to the Lugano classification, patients having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
* Patient has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Patients who satisfy the criteria defined in the protocol.
* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Has T-ALL/T-LBL or CTCL.
* Patient with CNS lymphoma or any involvement of the CNS.
* Patient who had a prior history of another malignancy over the last 3 years.
* Patients who have used hematopoietic growth factor therapy within 14 days prior to Screening.
* Patients who have had prior CAR-T or CAR-NK therapies.
* Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
* Patients with previous allogenic organ transplantation
* Patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
* Patients with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
* Patients with known active Hepatitis B or C
* Patients with presence of Grade 2 or greater toxicity from the previous treatment.
Treatment of Social Phobia With Cognitive Bias Modification

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided
* Diagnosed social phobia (according to DSM-IV criteria)
* Access to computer with internet connection, and printer

Exclusion Criteria:

* Severe depression (and/or suicidal behavior)
* Addiction and/or abuse
* Suffer from other severe psychiatric condition (e.g. psychosis)
* Non-stable use of medication
* Undergoing other, parallel psychological treatment
Tissue Sample Collection from Patients with Head and Neck Cancer and from Healthy Participants

RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.

OBJECTIVES:

* Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer.
* Develop a repository of biospecimens from these patients.

OUTLINE: Tumor tissue samples and/or bronchial washings are collected from patients undergoing planned surgery and/or bronchoscopy, respectively. Buccal swabs and/or mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter.

Healthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only.

Information about medical and family history and cancer risk factors is also collected.

PROJECTED ACCRUAL: No limit.

FOLLOW UP: Indefinite, until date of death or lost to follow up.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of head and neck cancer
  * Being treated at Vanderbilt University Medical Center for the cancer
  * Healthy participant

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis

In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.

In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.

The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.


Eligibility Criteria:
Inclusion Criteria:

1. history of physician-diagnosed SAR with at least 2 years of typical symptoms, and TNSS\>=6 at v0.
2. positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)

Exclusion Criteria:

1. oral steroids within 4 weeks prior to recruitment
2. nasal steroids and/or antihistamine 2 weeks prior to recruitment
3. perennial AR
4. any respiratory infection within the previous 4 weeks prior to recruitment
5. history of nasal polyps, asthma or autoimmune disorders
6. previously received acupuncture therapy for AR within 1 month prior to recruitment
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers

The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
* Signed informed consent.
* White

Exclusion Criteria:

* Unwilling or unable to give informed consent.
* As a result of the medical screening process, a study physician considers the subject unfit for the study.
* The subject has a history of drug or other allergy which contraindicated study participation.
* Female subjects who are pregnant or lactating.
* Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom control for many patients worldwide. However, long-term success rates remain suboptimal. Prior work indicates that distal connections between coronary sinus musculature and the left atrium exist and provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this trial, the investigators will examine the efficacy of elimination of distal connection(s) between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias.

Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted. However, long-term success rates fhave been reported to be as low as 50% and 20% for paroxysmal and persistent AF, respectively. To achieve permanent arrhythmia suppression, repeated ablation procedures are often needed. Prior work indicates that distal connections between coronary sinus musculature and the left atrium provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this prospective randomized trial the investigators will define the efficacy of elimination of distal connections between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias. Patients will be randomly assigned to standard of care ablation (pulmonary vein isolation and non pulmonary vein trigger ablations) alone, or standard of care ablation augmented by distal coronary sinus to left atrial connection elimination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent atrial fibrillation; AND Undergoing first AF ablation; AND Age ≥ 18 years.

Exclusion Criteria:

* Previous left atrial ablation; Women currently pregnant; Mental or physical inability to take part in the study; Known terminally ill patients.
Antimicrobial De-escalation Strategy in Medical Patients

The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.

This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation.

The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years and over
* Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin
* Subject admitted to SMH medical unit(s)
* Pregnant patient (or patients wishing to become pregnant)

Exclusion Criteria:

* Age less than 19 years
* Granulocytopenia (\< 1x109/L)
* Allergy or intolerance to meropenem or piperacillin-tazobactam.
* Febrile Neutropenia
* Cystic Fibrosis