cyrilzakka/clinical-trials huggingface dataset:
Hand Dominance in Fibromyalgia

Evaluating laterality changes in different psychiatric and neurodevelopmental diseases has recently been one of the popular perspectives of laterality studies. There are studies reporting changes in functional and structural hemispheric asymmetries in some neurodevelopmental and psychiatric diseases, and thus relations with atypical lateralization patterns or handedness. There is no study in the literature evaluating brain lateralization or handedness in fibromyalgia. The aim of our study is to evaluate the relationship between handedness, which is an indicator of brain lateralization, and fibromyalgia disease severity and functional outcomes related to fibromyalgia in patients with fibromyalgia. This cross-sectional study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria, and 40 healthy volunteers in the same age range as the control group. Information about the age, gender, height, weight, and comorbidities of the participants included in the study were recorded. In addition, information about the duration of fibromyalgia diagnosis and pharmacological and non-pharmacological treatments for fibromyalgia were also recorded in the patient group.

Handgrip strengths with Jamar-type hand dynamometer, tip pinch strengths with pinch meter, and hand dexterities with the Nine-Hole Peg Test were evaluated for both hands of all participants. The Edinburgh Handedness Inventory, Beck Depression Inventory, and Beck Anxiety Inventory were administered to all participants. In addition, the American College of Rheumatology 2016 Fibromyalgia Diagnostic Criteria was questioned in the patient group, and the Revised Fibromyalgia Impact Questionnaire was applied.


Eligibility Criteria:
Inclusion Criteria:

* This study included 40 fibromyalgia patients aged 20-50 years, meeting the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.

Exclusion Criteria:

* Exclusion criteria were defined as being younger than 20 years of age, older than 50 years of age, having systemic, inflammatory, degenerative, and neurological diseases that may lead to loss of hand and finger grip strength and dexterity, and a history of hand surgery or trauma in the last three months.
Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite

The study will be performed on human subjects with finished orthodontic treatment to see the failure rate(detachment) of fixed lingual retainer between two types of light cure resin composite

The study consists of two groups, the intervention involve performing bonding of fixed lingual retainer with light cured composite Transbond LR which is manufactured specific for the fixed lingual retainer while the control group involve bonding of fixed lingual retainer by light cured composite Transbond XT with follow up every month for 6 month to see the failure rate(detachment) between the two types of composite

Eligibility Criteria:
Inclusion Criteria:

* Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
* good oral hygiene
* medically free

Exclusion Criteria:

* Facial trauma
* onychophagia
* habit of biting pencils or pens
* tooth mobility
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning

Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.

The main objective is evaluation and validation of social cognition battery, characterizing the psychometric properties (validity, sensitivity to change) measures in a cohort of schizophrenic patients. Other objective is to demonstrate that the various components operating at T0 and T12 months of schizophrenic patients, as an external validator, are significantly explained by social cognition performance given the third known factors : neuropsychological, sociodemographic, disease course, and clinical status. Search and model relationships between the measured variables.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Age \> 18 years and \< 65 years
* Patient's state allows cognitive and neuropsychological assessment
* Affiliated to a social security system (beneficiary or legal).
* Informed consent signature (patients under guardianship may be included with written permission from their legal representative).

Exclusion Criteria:

* Alcohol dependence or current toxic
* Electroconvulsivotherapy (less than 6 months)
* Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary
* Invalidating and uncorrected visual disorder
* Invalidating and not paired hearing
* Actually hospitalized under constraint
* Patient not able to come to different evaluations, or who plan to change medical care in the following year
Influence of Oral Treatment with Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas with Proton Beam Therapy

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.

Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.

The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* uveal melanoma with posterior marge located at less than 3 mm of optic papilla
* uveal melanoma treated with proton beam therapy with irradiation of optic head nerve
* visual acuity before proton beam therapy over 30 letters (with ETDRS test)

Exclusion Criteria:

* antecedent of acute glaucoma with angle enclosure
* antecedent of chronical glaucoma with angle aperture
* antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins
* antecedent of neovascular glaucoma
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.

* In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions
* In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)
* In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)
* In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)
* In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).


Eligibility Criteria:
Inclusion Criteria:

* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Changes After Suprachoroidal Injection.

Changes after suprachoroidal injection are analyzed for statistical analysis.

Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.
* Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.

Exclusion Criteria:

* Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.
* Choroidal neovascularization that require anti-vascular endothelial growth factors.
* Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo

The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult nonsmokers
* onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment

Exclusion Criteria:

* smokers
* history of asthma or other respiratory disorders
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.


Eligibility Criteria:
Inclusion Criteria:

* patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system.
* best-corrected visual acuity ≥ 20/25
* exophoria at near at least 4 prism diopters (△) greater than at distance
* near point of convergence more than 6.0 cm break
* insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance.

Exclusion Criteria:

* amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI
Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

The purpose of this study is to evaluate the implementation and delivery of CAB/RPV LA to women with HRSN by adopting a pharmacist-led CDTM. The project primarily addresses the real-world use of CAB + RPV LA among women who are under-represented in clinical trials and assesses the feasibility and acceptability of CDTM+, and adoption of CAB/RPV LA among participants receiving the CDTM+ model.

Investigators will enhance the existing CDTM to reduce important social and structural barriers to CAB/RPV LA for women with HRSN, by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral (CDTM+), which is highly scalable. In addition to assessing engagement with the CDTM+ intervention and impact on key implementation (reach, feasibility, acceptability, uptake) and clinical outcomes (CAB/RPV LA initiation), investigators will also assess impact on patient engagement in non-HIV related care and psychological, sexual, and social well-being.

Eligibility Criteria:
Inclusion Criteria:

* Living with diagnosed HIV
* Receiving HIV care-related services from Yale New Haven Health (YNHH)
* Currently on oral ART and virally suppressed for at least 6 months (from electronic health review).
* Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 6 months (from self-report at screening).
* Able to converse comfortably in English or Spanish

Exclusion Criteria:

* Unable or unwilling to complete informed consent (e.g., have a conservator of person)
* Have initiated CAB/RPV oral lead-in prior to enrollment.
* Have a contraindication to CAB/RPV LA per label.
* Have known or suspected resistance to CAB/RPV
* Pregnant or breast-feeding
Synthetic Mesh Explant Study

The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 yrs
* Previous placement of hernia mesh material
* Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure

Exclusion criteria:

* Age \< 18 yrs
* No retained mesh prosthetic.
* Non surgical candidate
* Prisoner
Brain Stimulation During Arm Immobilisation

The research project explores how non-invasive brain stimulation can be used to detect and ameliorate loss of muscle strength after inactivity. At present, there is a limited understanding of how to maintain muscle strength during inactivity. Increasing evidence indicates that reduction in muscle strength following immobilisation is associated with reduced cortical motor output. Therefore, the aim of the study is to test if brain stimulation, can maintain cortical motor output and ameliorate the loss of muscle strength following immobilisation.


Eligibility Criteria:
Inclusion Criteria:

* Male
* right-handed
* aged 18-30
* healthy BMI

Exclusion Criteria:

* no primary muscle disorders
* no open wounds or skin conditions to arms and hands
* no neurological disorders or history of
* no history of fainting/convulsions
* no metal implanted into head/eye/neck
* non-smoker
* no arm, hand, fingers, shoulder injuries
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion

For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion may sometimes be very difficult because of the anatomical obstructions in the pharynx and uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used widely to assist the NGT insertion via direct visual assistance, working channels/guide wires, or suture fixation. Unfortunately, these tools are not easily assessed in the outpatient department. Here, we try to use a simpler method for the flexible endoscope to guide the NGT insertion.

NGT and fiberscope was combined to facilitate NG tube insertion

Eligibility Criteria:
Inclusion criteria: dysphagia patients who need nasogastric tube feeding Exclusion criteria: Patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath
Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis

Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Written consent

Exclusion Criteria:

* Current infection
* Cancer within 1 year
* Immune deficiency
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status.

The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design.

Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark.

Methods:

The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark.

Population:

Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007).

Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM).

One control of the general population were matched for each case on sex, age and municipality.

Outcome measures are: Cohabitation status, Education, income and socio-economic status.


Eligibility Criteria:
Inclusion Criteria:

* Concussion (ICD-10 S06.0) (primary diagnosis)(2003-2007)

Exclusion Criteria:

* Major neurological injuries and previous concussions (1998-2007)
* Not resident in Denmark (1998-2007)
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

The goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. The main questions it aims to answer are: • Will probiotic supplementation result in beneficial changes to different skin parameters? • Will probiotic supplementation result in alterations in the skin microbiome? Participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Fully informed with the study specifications.
* Signed consent form prior to commencing the study.
* Motivated for participation in the study, and available over the full test period.
* Healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition).
* Healthy gut (i.e., absence of irritable bowel diseases (IBD), irritable bowel syndrome (IBS), or any other type of inflammatory or autoimmune gut condition).
* No supplementation with probiotic, prebiotic or synbiotic products 2 weeks prior and/or during the whole study period.
* No supplementation with niacin (vitamin B3) 2 weeks prior and/or during the whole study period.
* No significant change in skin care routine (such as injectable cosmetics, skin tanning, etc.) throughout the whole study period.
* No significant change in the diet throughout the whole study period.

Exclusion Criteria:

* Not fulfilling the inclusion criteria.
* Pregnant or lactating 3 months prior to study commencement or during the study.
* Women post menopause.
* Use of antibiotics at least 4 weeks prior and/or during the whole study period.
* Sun-tanned facial skin.
* Participating in another clinical study that could interfere with the present research.
* Presented health problems or specific medications that could adversely affect the study outcome.
* Presented any cutaneous hypersensitivity or allergy to cosmetic products.
* Major surgery on the face one year prior to study commencement.
* Applied any cleansing, topical or moisturizing product (including all make-up products) to the measurement area the morning of assessments at Oriflame Cosmetic AB.
* Exposure to artificial UV light and/or to the sun during the study.
* Special diets (vegan, low carbohydrate, weight loss diet, etc.).
* Significant change in weight one month before or during the study period.