cyrilzakka/clinical-trials huggingface dataset:
Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.

This is study 1 of 3 - of the overall project: The ProneTection Quality Improvement Project.

The three aims of this study, study 1 are:

1. to establish the training needs critical care clinicians have regarding prone positioning,
2. to investigate the conditions for effective implementation as in an intensive care setting,
3. to develop an education and training package (The ProneTection package) for an interdisciplinary team of clinicians on skin damage prevention of patients in the prone position

Conduct a needs assessment by using semi-structured interviews with an interdisciplinary team of clinicians (Ghent University Hospital (UZ Gent), Brussels University Hospital (UZ Brussel) and several institutions in Sweden, mainly Örebro University Hospital).

Concurrently, investigate the conditions for effective implementation in a critical care facility using the same interviews and participants (interviewees).

Develop the education and training package (the ProneTection package). The ProneTection package will be based on

1. the results of our recently published gap-analysis study,
2. the needs assessment results from the interviews, keeping the optimal conditions (facilitators) in mind for successful implementation, and
3. the critical review and evaluation by eleven key opinion leaders from the established international expert panel

Eligibility Criteria:
Inclusion Criteria:

* • Clinicians (nurses, allied health professionals and doctors) working in intensive care units (ICU) are eligible to participate. This can include critical care nurses, respiratory therapists, physiotherapists etc.

and/or

* Nurses studying towards their speciality as critical care nurses. and/or
* Wound care specialists or those responsible for advising on skin damage prevention or managing skin damage/ wounds of the patient in the prone position.

and/or

• Educators / clinical training facilitators within the hospital or teaching at the university.

and/or

* Quality assurance managers or hospital managers. and
* Signed informed consent and voluntary participation.

Exclusion Criteria:

* Other than the inclusion criteria
Stimulation Galvanique Vestibulaire

Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.


Eligibility Criteria:
Inclusion Criteria:

* patient with right posterieur parietal lobe lesion
* patient with cerebral vascular stroke
* healthy volonteers Age greater than or equal to 18 written informed consent

Exclusion Criteria:

* patient's refusal to participate to the study
* inability to cooperate
* cognitive trouble
* epilepsy
The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.


Eligibility Criteria:
Inclusion Criteria:

* Carriers of a mutation in the BRCA1 gene
* Non-carriers of a mutation in the BRCA1 gene who come from a family with a BRCA1 mutation (a family in which at least one individual has tested positive for a BRCA1 mutation)
* Can participate after being free of DIM supplementation for one month

Exclusion Criteria:

* Have a personal history of cancer
* Currently pregnant or breast-feeding
Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets

The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes.

The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.

The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least one child between 6 months to 14 years old having permanent residence in selected household
* Having an adult caregiver willing to provide written consent for the household and clinical survey

Exclusion Criteria:

* Dwelling not found or vacant during the survey
* No adult caregiver capable to give informed consent
* Children severely ill
Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. A total of 54 female participants, phototype scale Fitzpatrick ll - lV will be recruited which will be distributed among two groups: Light + placebo Home Care cosmetic product and Light sham + Home Care cosmetic product with tranexamic acid. The treatments will consist of 90 days, with application of photobiomodulation (PBM) once a week and application of the cosmetic product twice a day.

This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of Melasma compared to the effect of tranexamic acid. The sample will be divided into 2 groups: Group 1 will receive PBM with amber Light Emitting Diode (LED) (DMC E-Light ABR), 20 J/cm² and placebo topical cosmetic for use in home care; Group 2 will receive PBM sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. A total of 54 women with facial Melasma, aged 35 to 50 will be included. The treatments will consist of 12 sessions, once a week for 3 months. The severity of Melasma will be evaluated through the Melasma Area and Severity Index (MASI index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (MELASQoL-PB) will also be made.

Eligibility Criteria:
Inclusion Criteria:

* Feminine gender
* Age between 35 to 50 years
* Phototypes l to lV of the Fitzpatrick scale
* Facial melasma
* Healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses)

Exclusion Criteria:

* Pre-existing systemic diseases, autoimmune diseases, digestive system disease
* Polycystic ovary
* Isotretinoin drug use (less than 6 months)
* Sequelae of an accident on the face that interferes with the facial treatment
* Undertakes any treatment for topical or oral Melasma at the time of the research or less than 3 months ago
* Uses retinoic acid, vitamin A derivatives, photosensitizing drugs
* Skin pathologies on the face
* Glaucoma, cataract, cancer patients, pregnant women, lactating women
* Uses oral or intrauterine contraceptives (IUD)
* Thyroid disorders
* Use of hormone replacement
* Bacterial, viral and fungal infections
* Tendency to form keloids
Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)

The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD


Eligibility Criteria:
Inclusion Criteria:

* diagnosis made by DSM-IV and K-SADS-PL
* IQ \> 71

Exclusion Criteria:

* genetic disorder
* history of acquired brain injury
* seizure disorder
* other neurologic disorder
* mental disorder, pervasive developmental disorder
* obsessive-Compulsive disorder
* communication disorder
* learning disorder
Physical Therapy Components for Maximum TKR Outcome

The overall goal of this study is to identify what Physical Therapy care components are associated with the best patient-reported functional outcome after Total Knee Replacement (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis
* Will receive outpatient PT from a participating physical therapist.
* Agree to record their exercise and activity for specific time points in the study.

Exclusion Criteria:

* Total knee replacement scheduled for indications other than OA (e.g., fracture, malignancy, infection, or revision or prior implant)
* The inability to obtain informed consent due to cognitive conditions.
* Non-English speakers as the materials used in this project have not yet been tested with non-English speakers
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
FORCEREPAIR - A Wound Exudate Investigation

The observational longitudinal study will collect wound exudate from twenty patients with venous leg ulcers. Wound exudate samples are collected using twenty-four-hour collection with polyurethane foam, bandages and the NovaSwab method. Each patient is seen four times where wound exudate and the bacteria microbiome are sampled and wound size is monitored with advanced planimetric tools.

This dual centre longitudinal observational study will run from January 2024 to January 2025. The investigation will include twenty patients over four weeks including four study visits. Sampling of wound exudate can take place on every visit and will be made with the polyurethane discs, the NovaSwab technique and waste bandages. The wound bacteria microbiome is sampled with routine bacterial swabs. Tape strips will be used to assess perilesional skin and control sites of normal skin and will primarily measure skin inflammation parameters. Clinical pictures are taken and analysed using advanced planimetric tools. Patients enrolled receive standard wound care; allowing all kinds of dressing. However when consenting to twenty-four-hour-collection patients will not be allowed to wear active bandages or receive antibiotic treatment for that period. Compression, wound dressings, and use of topical and oral antibiotics will be registered. For the storage of samples, a research biobank is used, and leftover material will be stored in a biobank for future research.

Eligibility Criteria:
Inclusion Criteria:

* Adults fulfilling all inclusion criteria
* Age \>18 years
* Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification)
* Wound Area equal to or above 1 cm2 (measured with a ruler length x width)
* Patient can understand Danish
* Patient can comply with protocol
* Patient is fully informed about the study and has given informed consent

Exclusion Criteria:

* Venous leg ulcer with communication to bone
* Known or suspected cancer in the wound
* Allergies towards products used in the study, e.g. polyurethane foam and tegaderm
* Dementia
* Judgement by the investigator that the patient is not suited for study participation
Gait Modification for Knee Osteoarthritis

This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.

Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.

Eligibility Criteria:
Inclusion Criteria:

* Be 50 years of age or greater
* Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
* Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
* Are comfortable walking intermittently for 30 minutes
* Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
* Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.

Exclusion Criteria:

* Any knee surgery or intraarticular injections within the past 6 months
* A history of joint replacement surgery or high tibial osteotomy
* Current or recent (within 6 weeks) corticosteroid injections
* Use of a gait aid
* Currently on a wait list for joint replacement surgery or high tibial osteotomy
* Any inflammatory arthritic condition
* Any other conditions that may affect normal gait or participation in an aerobic exercise program
* Cannot attend all required appointments.
Immersive Virtual Reality for Neuropathic Pain

Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb

Exclusion Criteria:

* Cognitive impairment leading to inability to make own medical decisions
* Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
* History of seizures within the last year
Accompanying ALZHEIMER CAREGIVER

Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.

This is a descriptive pilot study, non-interventional, before / after, mono-centric, evaluative, prospective cohort with type score description. The tool used is the grid "mini Zarit", she evaluates the caregiver burden. This grid is enabled in the French version and commonly used in these pathologies.

The evaluation of the quality of life of the caregiver will be performed with the scale "EQ-5D". This tool is easy to use phone, it contains few items. Also there is very little evidence referring to the suffering or negative feelings. It therefore avoids inducing to helping unknown team consultation memory an emotionally negative discourse.

There is no validated tool measuring the service delivered to a nurse hotline. The investigators offer a nurse questionnaire 7 items grouping expectations for the first consultation memory (consultation period, diagnosis, course of the consultation, organization of monitoring). It also provides an update on the daily experiences of the caregiver relative to the organization of care and helped the organization of domestic life of helped.

Nursing questionnaire will assess whether the responses of the nurse in relation to questions about the memory request for consultation were understood in relation to the items. Also, if the caregiver is in support of application in everyday life, the questionnaire will determine if the nursing accompaniment allows the caregiver to acquire knowledge or skills, or better organization of everyday life. The question of the entourage of the caregiver assesses the isolation level of the caregiver and whether the environment is not mobilized or after an update with the nurse.

If help is hospitalized, the pattern will be recovered. The Scientific Council will assess whether the information collected and the information provided would have prevented it.

Eligibility Criteria:
Inclusion Criteria:

* Helping with age ≥ 18 years
* Helping speak and understand the French
* Help available to accompany the patient to the consultation
* Helping calling for the first time the memory center
* Helping who noticed a cognitive disorder in assisted
* Age over 75 years
* beneficiary or affiliated to a social security scheme Patient
* Patient with a cognitive disorder noticed by the caregiver

Exclusion Criteria:

* Helping placed under judicial protection
* Any medical or paramedical personnel in connection with the care of a nursing home eligible patient (Accommodation Establishment for dependent elderly, hospital, SSR (Care and Rehabilitation Services), institutional caregivers,
* private health professionals, such as neighborhood (doctor, nurse liberal, physiotherapist
* Neighborhood.
Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* under 18 years
Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Patient operated on a fracture of the upper extremity of the femur
* Patient, family or close relative who does not object to participation in the study
* Patient affiliated to a social security system
* Patient who can be monitored as part of the protocol

Exclusion Criteria:

* Refusal to participate in the study (patient, family or trusted relative)
* Patient with support on the operated limb not authorized by the surgeon
* Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
* Patient with a pathologic fracture
* Patient included in Category 1 interventional research (involving a drug or medical device)
* Patient deprived of liberty
* Patient not affiliated to a social security system
A Healthy Female and Male Volunteers Aspirin Study

This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 20 to 50 years inclusive.
* Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
* Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
* History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.