cyrilzakka/clinical-trials huggingface dataset:
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients with Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.

PRIMARY OBJECTIVE:

I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

SECONDARY OBJECTIVES:

I. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.

II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.

III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care NSM on study.

ARM II: Patients undergo neurotization during standard of care NSM on study.

After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Female patients age \>= 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Planned nipple sparing mastectomy (NSM)
* Ideal NSM candidates would meet the following criteria:

  * Cup size A-C
  * BMI \<34
  * Ptosis grade \< 2
  * Clinical stage 0 - T2N0
  * Final planned implant volume \< 400cc
  * Inframammary or lateral mammary incision
  * Tumor \> 0.5cm from the nipple areolar complex (NAC)
  * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
  * No prior breast radiation on side of planned NSM
  * Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
  * No planned post mastectomy radiation (PMRT)
  * No nicotine use within 4 weeks of surgical date

Exclusion Criteria:

* Planned autologous reconstruction (immediate or delayed)
* Pregnancy
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.

A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System.

Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery.

One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom.

A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication.

Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned for Laparoscopic Gynecological Surgery (LGS)
* Patient is 18 years of age or older
* Signed written informed consent.

Exclusion Criteria:

* Patient is pregnant, or planning on becoming pregnant
* Obese patients (BMI \>35)
* Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
* Patient with operations planned for longer than 4 hours
* Subjects are considered ineligible for the study as judged by the investigator.
Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.


Eligibility Criteria:
Inclusion Criteria:

* have ADRD and clinically-meaningful behavioral symptoms
* have a caregiver willing to participate in the study
* can speak and read English
* have stable doses of medications for at least one month

Exclusion Criteria:

* any unstable concurrent medical conditions
* history of brain surgery
* seizure
* intracranial metal implantation
* current alcohol/substance use disorder
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient

Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient


Eligibility Criteria:
Inclusion Criteria:

* \>18
* patient under haemodialysis treatment
* patient not objecting to study

Exclusion Criteria:

* Patient with known cardiac arrythmias
Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus

The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population.

The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2.

The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (≥ 18 years old), male or female
* Patient with systemic lupus according to ACR 1997 criteria
* Patient followed by the National Reference Center "Rare Systemic Autoimmune Diseases" of the University Hospitals of Strasbourg
* Patient who agreed to be vaccinated against SARS-CoV-2
* Subject having expressed his non-opposition to the research
* Subject affiliated to a social health insurance protection scheme

Exclusion Criteria:

* Patient treated by:

  * Corticosteroids (\> = 10mg / day)
  * Immunosuppressant (azathioprine, mycophenolate mofetil, cyclophosphamide) to control lupus activity
  * A biomedicine targeting B cells (rituximab, belumimab).
* Inability to provide informed information about the subject (subject in an emergency, difficulty in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship
Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus.

We will also assess the psychological impact of the pandemic in patients but also in caregivers


Eligibility Criteria:
Inclusion Criteria:

For Patients:

* Adult patient, treated for a solid or hematological tumor
* will be treated ou actually treated by oncological treatment carried out at the hospital in day unit of the participating centers: treatment initiated before or during the pandemic with COVID-19

For the Caregivers:

- Medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital
Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg

Detailed Description:

The specific aim is to conduct a randomized, single dose, three-period crossover bioequivalence study in at least 18 healthy male and female subjects at a single study center to evaluate the in vivo performance of two formulations of Nitisinone 10 mg and the reference product Orfadin under fasting.

A total of 4 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to a treatment sequence, before administration of investigational nitinosine

Determination of succinylacetone (SA) in blood (serum/plasma) and/or urine will be performed. Results from samples analyzed at the central laboratory, including determination of nitisinone, will be used in the evaluation of pharmacokinetics, efficacy and safety during the two treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* All HT-1 patients receiving Orfadin treatment are eligible for entry.
* Male and female patients of all ages diagnosed with HT-1.
* Stable lab values, including liver values \<2 ULN (ALP, ALT, AST, bilirubin, INR).
* Women of childbearing potential willing to use adequate contraception
* Signed informed consent/assent.

Exclusion Criteria:

* Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
* Enrollment in another concurrent clinical interventional study within three months prior to inclusion in this study.
* Pregnant women.
* Lactating women. .Known hepatitis B, hepatitis C or HIV infection.
* Foreseeable inability to cooperate with given instructions or study procedures.
LEO19123 Cream in the Treatment of Hand Eczema

To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hand eczema with or without atopic etiology/background
* Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
* Patients should be Caucasian males aged from 18 years
* Attending a hospital outpatient clinic or the private practise of a dermatologist.
* Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.

Exclusion Criteria:

* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used).
* PUVA or UVB therapy on the hands within 4 weeks prior to randomisation.
* Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
* Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
* Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
* Concurrent skin diseases on the hands.
* Current diagnosis of exfoliative dermatitis.
* Significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment.
* Known or suspected hypersensitivity to component(s) of the investigational product.
* Positive patch test as defined in protocol
* Known or suspected severe renal insufficiency or severe hepatic disorders.
* Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia.
* Patients with history of cancer except for basal cell carcinoma.
* Current participation in any other interventional clinical trial.
* Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.
* Previously randomised in this study.
* Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

Investigators will test the effectiveness of oculomotor cognitive training using eye tracker-based device during rehabilitation course in patients with a degree of disability no more than 3 points on a scale Rankin.

After a stroke, a wide range of neurological disorders can occur. One of them is impairments of the visual-oculomotor system in 8-31% of cases. Such patients experience loss of visual fields, hemianopia, tunnel vision, diplopia. All this causes great difficulties for returning to everyday life, as well as to professional activity. The eye tracking method allows to diagnose and evaluate the effectiveness of training aimed at improving the functioning of the saccadic system, reducing the volume of visual deficit. Currently, eye tracking is represented by a variety of technological solutions, but not all of them are used in the clinic.

The aim of the study is the application of an eye tracking-based device in cerebral stroke survivors for the correction of oculomotor disorders and visual attention functions.

Stroke patients participate in the study in Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency, Moscow, Russia. The study has been conducted since January, 10 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stay in a 24-hour hospital and undergo a rehabilitation course. For 3 weeks, patients receive daily training on the C-Eye Pro device, AssisTech Sp. z. o. o, Poland. The patients interact with the device only by using eye movements. Participants undergo a primary assessment of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions). According to the results of the diagnosis, participants are offered a scheme of correctional training and secondary assessment at the end of the training. Correction training consists, firstly, of 10-minute exercise at the beginning of each session, aimed at improving visual functions and attention. Patients have to follow the spontaneously moving object. The result is evaluated qualitatively using heat and scanpath maps. Secondly, the correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in assessment).

Eligibility Criteria:
Inclusion Criteria:

* signed consent
* at least 3 points on the Rankin scale;
* the presence of disorders of the visual-oculomotor system, visual attention;
* understanding and following instructions; stable vegetative and hemodynamic parameters;
* on the MOOCA scale \>22;
* patients should be fully examined for the underlying and concomitant disease (examination by a neurologist, ophthalmologist, physiotherapist);

Exclusion Criteria:

* 4, 5 points on the Rankin scale;
* unstable hemodynamics;
* time after stroke is less than 2 weeks;
* presence of epileptic activity;
* serious ophthalmological disorders (for example, partial atrophy of the optic nerve);
Impact of Immune Challenge on Triple Network Connectivity in Humans

Acquiring, processing and utilising "information" is crucial to any mental function -including seemingly simple daily functions. Collectively called 'cognitive functions', these processes are a result of different regions of the brain acting together.

Disruption of these cognitive functions increases the risk of development of mental health problem. Recently it has been proposed that inflammatory pathways may contribute to disorders of cognition and behaviour like depression.

This is largely due to research showing that those with inflammatory conditions like arthritis are more likely to develop mental health problems like depression. Conversely, those who suffer from mental health problems (even in the absence of inflammatory conditions) have large amounts of inflammatory molecules in the blood. Studies in animals suggest that inflammation outside the brain can reach and affect the brain in a number of ways. So, does inflammation play a role in the development of cognitive and behavioural symptoms? What are the pathways involved?

The current project tries to address this question. Specifically, the investigators intend to use modern scanning techniques to examine the effect of inducing a low grade inflammation (using a commonly used typhoid vaccine) to see how the inflammation affects how different regions of the act together to perform cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Aged 18 - 50 years old
3. Male

Exclusion Criteria:

1. Female
2. History/family history of medical or/and Axis I DSM IV condition
3. Received typhoid vaccination within the last 3 years
4. Taken oral antibiotics/antiinflammatory agents within the previous 2 weeks
5. Current Smokers
6. Contraindication for MRI scans
7. Contraindication for Salmonella typhi vaccination
8. Known hypersensitivity to a Vi antigen containing vaccine.
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury

The purpose of this study is to learn more about how participants heal from acute spinal cord injury.

In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury.

The investigators want to learn:

The effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes.

How safe TPM is for participants.

Eligibility Criteria:
Inclusion Criteria:

1. Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.
2. Subject is 18 years of age or older.

Exclusion Criteria:

1. Penetrating SCI injury.
2. Isolated cauda equina syndrome or injury at bony level Th9 or below.
3. Pre-existing motor deficit secondary to chronic myelopathy.
4. History of demyelinating disease or central nervous system autoimmune disorder.
5. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).
6. Acute, evolving or recent (30 days) myocardial infarction.
7. Chronic renal failure requiring dialysis.
8. Suspected or confirmed pregnancy.
9. Severe terminal disease with life expectancy less than 6 months.
10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging.
11. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.
12. Non-English or Non-Spanish Speaking.
13. Refusal of consent.
Multicomponent Exercise Training in Frail Elderly

The aim of the present study will be to assess the effectiveness of the multicomponent exercise training in frail for the physical function, frailty and performance.

All the individuals will be assessed two times.

This will be a experimental, randomized controlled intervention study in frail. Subjects will be recruited at the Albertia Care Center, Madrid. The exercise training group will developed a concurrent training 3 days per week during 6 weeks. The control group will follow an usual care also for 6 weeks.

The main variables will be as follows:

* Ultrasound imaging measurements for the lower limb: core muscles, vastus medialis, rectus femoris, vastus intermedius, gastrocnemius, soleus. We will employed a General Electric (GE) Ultrasound device in B mode to assess the thickness of the muscles.
* Heart rate variability with a Suunto smart bell.
* Activities of daily living with the Bartel index.
* Force-velocity profile and muscle power.
* Frailty with the Linda´s frailty criteria.

The exercise program was applied for 6 weeks. A total of 18 sessions were distributed in 3 weekly sessions. The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular high intensity interval training (HIIT) exercise walking on a treadmill.

One measurements will be taken (pre), the second (post) measurements will be performed at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 75 years or more,
* 2 or more points in the Short Physical Performance Battery (SPPB)
* Capability of walking (alone or assisted)

Exclusion Criteria:

* Severity cognitive alterations
* Severe disability on the Barthel score
* Surgeries in the previous 6 months
* Other any disorder that exclude for the exercise group.
Mortality Among Children With Congenital Heart Defects in Norway

To describe mortality among children with congenital heart defects in Norway


Eligibility Criteria:
Inclusion Criteria:

* children with congenital heart defects

Exclusion Criteria:

* no