cyrilzakka/clinical-trials huggingface dataset:
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "

Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired


Eligibility Criteria:
Inclusion Criteria:

Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux

Exclusion Criteria:

* Abnormal neurological examination
* Taking drugs targeting the central nervous system
* Any unhealed injury
* History of head trauma, or other notion of central nervous system injury
* History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
* Family history of epilepsy
* Contraindication to MRI: head circumference\> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body - refusal to be informed of an anomaly detected with MRI
* Individuals under legal protection or unable of giving their informed consent
Use of Synvisc® in Knee Osteoarthritis - Medico-economical Study

The USAGE study aims at assessing on a long-term period (two years in average) the outcome in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with Synvisc®, in the 1139.4 clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients have already been followed up on a nine-month period in a pragmatic medica-economical clinical trial (BI Trial No.: 1139.4)

Exclusion Criteria:

* none
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer

Study Hypothesis: The peri-operative enteral administration of a proprietary immune-enhancing feed (IMPACT) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the Head and neck (SCCHN).

Patients who present with SCCHN for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. One group will receive IMPACT, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. In both groups patients will be fed enterally. The feeds will be prepared in identical bottles to facilitate blinding. Primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. Follow-up will be for 30 days postsurgery.

As above

Eligibility Criteria:
Inclusion Criteria:

Patients who were to undergo either of the following procedures

* partial (external approach) or total laryngectomy
* partial pharyngectomy with primary closure or free-flap reconstruction
* total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction)
* oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap

Exclusion Criteria:

Patients with

* malabsorption syndromes
* primary immune disorders
* active infection on presentation
* patients undergoing secondary surgical reconstruction
* patients undergoing palliative surgery
* patients aged under 18 years old
* patients who were pregnant or breast feeding
Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke

Previous studies discussed the effects of music therapy and task oriented training on motor functions of stroke separately but no study is found in which effects of both techniques are studied. In this study, we are going to find the effects of task oriented training with or without music therapy.

Stroke is a neurological condition, which can promote disability and increase the susceptibility to secondary complications along the patient's life. Stroke issue incorporates motor dysfunction, Cognition, daily activity and sensory weaknesses. Music Therapy appears to affect physiological phenomena such as blood pressure, heartbeat, respiration, and mydriasis as well as emotional aspects such as mood and feelings. Task-oriented training is aimed at improving the control strategy by solving difficulties through various measures.

In general, a variety of techniques, including Bobath approach, Roods approach, Proprioceptive neuromuscular facilitation techniques, motor relearning program, functional approaches, stretching exercises, therapeutic massage, constrain induced movement therapy, range of motion exercises, myofascial release, and strengthening exercises have been in practice for recovery of the affected limb functional mobility in patients with stroke. This study will evaluate the effects of music therapy along with task oriented training on balance and functional independence in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

Age 40-60 years Both males and females Diagnosed stroke patients Chronic stage (after 6 months of onset) Individuals with Burg Balance Score ≥ 20 ≤ 40 Functional Independence Measure score up to 3 (moderate assistance) Able to understand command Mini mental status examination score of over 20

Exclusion Criteria:

Systematic Disorder e.g. Rheumatoid arthritis Unstable Angina Coexisting physical impairments e.g. limb amputation Any previous history of neurological disease other than stroke e.g. Parkinson's Any previous history of fractures Hearing or perception deficits
Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia

The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in poststroke nonfluent aphasia patients.

In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 yrs old
* Right-handed
* Radiologically confirmed left hemisphere stroke
* Fluent in Korean
* First ever stroke
* More than 1 year from stroke onset
* Non-fluent (motor-dominant) aphasia
* Written informed consent

Exclusion Criteria:

* Previous medical histories of stroke, cerebral vascular operation, seizure
* Patients with traumatic brain injury
* Unable to perform the language task
* Severe cognitive impairment (MMSE less than 16)
* Skin lesion in the stimulation site of scalp
* Metal implants in the body (cardiac pacemaker or aneurysm clip)
* Pregnancy, Breastfeeding
Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease

This study evaluates an educational brochure tailored to caregivers of people with Alzheimer's disease, Parkinson's disease dementia, Lewy body disease, frontotemporal dementia, and vascular disease dementia. The goal of the brochure is educating caregivers about the decreased ability to detect emotion and decreased empathy that can be seen in dementia, increasing caregiver competence in providing care, and teaching caregivers ways to manage over time that lessens burden and improves quality of life.

The 1.5-hour initial visit will involve the caregiver completing questionnaires, structured interviews, and a computer task, and the person with dementia completing a computer task. A 20-30 minute follow-up phone call with the caregiver one month after the initial visit will involve completing questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* All caregivers who visit the UHN Memory Clinic with a patient with a neurodegenerative disease will be asked to participate.
* The patient must be aged 50 to 95 (inclusive) and speak English
* The caregiver must be aged 30 to 95 (inclusive) and speak English.
* The patients must have a diagnosis of one of the following conditions: Alzheimer's Disease, Parkinson's Disease/Dementia with Lewy Body, Frontotemporal Lobar Degeneration-syndromes or Vascular Dementia.
* The patient must have a Montreal Cognitive Assessment (MOCA) score of 10-25

Exclusion Criteria:

* Not English speaking.
* Patients who do not have a caregiver that would be able to participate in the study.
* Caregivers who do not have a patient being followed at the UHN Memory Clinic
Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli

The objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, N-acetyl cysteine (NAC), in mitigating the development of pruritus (skin itching). The study is designed to have all subjects treated with a seven-day regimen of both NAC and placebo. NAC will be prescribed at a dose of 1,500 mg twice daily for seven days. Subjects will initially be randomly assigned (1:1) to either the NAC or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. The study will encompass a period of approximately 11 weeks (about 2 and a half months).


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* All skin types (Fitzpatrick types I - VI)
* Age 18 - 40
* Able to comprehend procedures and risks

Exclusion Criteria:

* Currently taking immunosuppressive or immunomodulating or psychotropic medications.

This includes antihistamines and aspirin-like anti-inflammatory medications (NASIDs) for the past month.

* History of peripheral neuropathy, Charcot-Marie-Tooth, familial dysautonomia or heavy metal toxicity
* History of gastrointestinal abnormalities (including irritable bowel syndrome)
* History of inadequately controlled Diabetes Mellitus
* History of abnormal scarring
* History of skin infections within 6 weeks
* History of skin disease (atopic dermatitis, psoriasis, xerosis) or "sensitive skin"
* Pregnancy or nursing
* Other serious health issues, including liver or kidney disease
Margetuximab Expanded Access Program

The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

TerSera Therapeutics LLC (TerSera) will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for TerSera to supply margetuximab for single patient use.

Eligibility Criteria:
Inclusion Criteria:

* TerSera may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies.
* Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent.

Exclusion Criteria:
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GPPGA of 0 or 1 and a known and documented history of GPP per European Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) OR

  -- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN) criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN)
* Male or female patients, aged 18 to 75 years at screening.
* Signed and dated written informed consent prior to admission to the study in accordance with ICH GCP and local legislation prior to start of any screening procedures.
* Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
* Further inclusion criteria apply

Exclusion Criteria:

* Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.
* Patients with primary erythrodermic psoriasis vulgaris.
* Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
* Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
* Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or renal failure.
* Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin.
* Further exclusion criteria apply
Study of Dehydrex in Patients With Corneal Erosion

This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.

This study continues to provide Dehydrex to patients who have received it previously under other studies. Patients continue to be treated with their current dose of Dehydrex. Upward dose adjustments may be made as clinically indicated. Patients undergo eye exams every 3 to 4 months or more often. Downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. In patients who are able to discontinue the medication, duration of healing will be determined. In those patients who experience a recurrence after discontinuing the medication, Dehydrex will be restarted at a dose higher than the minimum effective dose. After at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. Further attempts to discontinue the medication will not be made.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion
* Not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses
* At least 3 episodes of erosion within the past 4 months documented by slit lamp examination

Exclusion criteria:

* Allergy to any component of the medications to be used
* Active ocular surface infection due to bacteria, virus, or fungus
* Chronic atopic disease affecting the ocular surface or adnexa
* Dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy
* Concurrent use of contact lenses
* Diagnosis of persistent epithelial defect in eye to be treated
* Concurrent use of topical medication to eye to be treated
* Any ocular eyelid surgery within the past 6 months
* Pre-existing corneal stromal edema
* Diabetes mellitus
* Postsurgical infection
* Dry eye condition of 16 or greater on Patient's Dry Eye Questionnaire
* Other investigational medications within the past 6 months
* Other corneal dystrophy
Interactive Power Toothbrush With or Without App vs Manual Toothbrush

It has been suggested that interactive power toothbrushes (PTBs), developed in recent years, provide more successful results in plaque control and effective use of brushing time by enabling patient collaboration and self-treatment, thanks to the application features associated with mobile phones. Interactive PTB synchronized with smartphones, including real-time feedback, session length, applications that prevent excessive brushing force, and focus brushing on specific areas with position detection technology, increases the brushing performance by increasing oral hygiene motivation.

Studies report that both power and manual toothbrushes cause gingival abrasion, a localized reversible lesion of the epithelium. While the opinions about the cause of gingival abrasion are not clear yet, the discussions regarding brush strength yet continue. While it is possible to control the interactive PTB force thanks to the mobile application, it is known that these high-speed rotating brushes control plaque effectively, but there is not enough evidence about its effect on gingival abrasion.

The primary purpose of this clinical study is to determine whether interactive PTB with application feature provides an additional benefit on plaque removal efficacy and reduction of gingival inflammation. In addition, this study aims to determine the effect of interactive power toothbrush with application on gingival abrasion by comparing it to interactive PTB without application and manual toothbrush. The study's null hypothesis in terms of gingival abrasion is that interactive PTB do not show a significant difference from other brushing methods.


Eligibility Criteria:
Inclusion Criteria:

* Dental students
* Diagnosed with gingivitis
* Clinical measurements: Probing pocket depths ≤3 mm, QHPI-TM ≥ 1.75 and with a bleeding site of at least 40% or more
* Aged between 18-25
* Non-smoker
* No systemic diseases
* Not undergoing orthodontic treatment
* No crowding
* No periodontal treatment in the last three months

Exclusion Criteria:

* Use of power toothbrush before
* Use of drugs that may affect the gingival tissues
* Having mucogingival problems
* Having carious teeth that require urgent treatment
* Probing pocket depths ˃ 3mm
Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:

* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
* Control group: Patients will receive a treatment with corticoid ointment, with endoanal application

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

Patients with hemorrohoids grade II and III were included.

Patients were randomized into 2 groups:

* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
* Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).

Eligibility Criteria:
Inclusion Criteria:

* Grade II and III hemorrhoids

Exclusion Criteria:

* Grade I or IV hemorrhoids
* Patients with previous anal surgeries
* Patients having received previous pharmacological treatments for hemorrhoids
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria:

* Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
* Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese or Japanese volunteers

Exclusion Criteria:

* Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
* Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)