cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy Participants

This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A is to evaluate the effect of food on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a strong Cytochrome P450 3A \[CYP3A\] inducer) on pharmacokinetics (PK) of single oral doses of E7090 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

Participants who meet all of the following criteria will be eligible for participation in the study

1. Body mass index (BMI) between 18.5 to 25.0 kilogram per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Following ocular disorders

   1. Current evidence of Grade 2 or higher corneal disorder
   2. Current evidence of active macular disorder (example, age-related macular degeneration, central serous chorioretinal disease)
2. Any clinically abnormal symptom or organ impairment found by medical history at screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at screening
3. A prolonged QT/QTc interval (QT interval with Fridericia's correction \[QTcF\] greater than \[\>\] 480 millisecond \[ms\]) demonstrated on ECG at screening or baseline
4. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at screening
5. Known history of allergies or reactions to rabeprazole or rifampin or known anaphylactic reaction to any drugs at screening
Autologous Conditioned Plasma (ACP) for Patients With Plantar Fasciitis

Plantar fasciitis presents clinically as pain in the inner heal, which is the result of degeneration of the plantar fascia, an arch supporting ligament of the foot. It manifests predominantly in those subjected to sustained weight bearing or repetitive pounding activities. Plantar fasciitis is the most common cause of inferior foot pain. Although most cases resolving within 6 months, traditional treatment regiments such as orthotics and physiotherapy are occasionally unsuccessful in treating this limitation leading to chronic symptoms (Neufeld \& Cerrato, 2008; Rompe, 2009; Roxas, 2005).

Platelets are central players in clotting, inflammation and the wound healing response. Research has shown the potential of platelet rich plasma to accelerate wound healing in a variety of conditions including maxillo-fascial and plastic surgery, chronic wound healing and orthopaedics. Autologous Conditioned Plasma (ACP) is a novel treatment that may accelerate the healing of injured tissue. Treatment with ACP involves taking a blood sample from the patient, isolating the platelets and injecting them back into that patient at the injury site


Eligibility Criteria:
Inclusion Criteria:

* Painful inner heel pain for longer than three months
* at least six weeks since last corticosteroid injection
* four weeks since the last anaesthetic injection, iontophoresis, ultrasound and electromyostimulation
* one week since the last NSAIDs taken
* two days since the last analgesic, heat, ice, message, stretching, or modification of night splints and orthosis.
* scores greater or equal to 5 on the VAS PFPD scale
* scores greater or equal 30 on the AOFAS scale
* scores of greater or equal to 5 on the VAS PFPD scale and 30 on the AOFAS scale

Exclusion Criteria:

* tendon rupture
* neurological or vascular insufficiencies in the painful heel
* bilateral heel pain
* Paget's disease or calcaneal fat pad atrophy
* osteomyelitis, fracture of the calcaneus, ankle inflammation
* recent infection in the treatment area, history of rheumatic diseases
* collagenosis or metabolic disorders
* immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids
* previous heel surgery
* malignant disease, diabetes mellitus, severe cardiac or respiratory disease, significant abnormalities in hepatic function
* participation in another clinical study at the same time.
Correlation Between Seminal Vesicle Size and Duration of Sexual Abstinence

The seminal vesicles (SV) are glands that open into the prostatic urethra and secrete seminal fluid, which makes up 50 to 80% of semen. They play an essential role in the male reproductive function. In adults, the size of a seminal vesicle varies from one individual to another. On average, it is 5 to 6 cm long, 1.5 cm wide and 0.5 cm thick. It has a close anatomical relationship with Walsh's vascular-nervous pedicle, which extends the sacro-genital-pubic blades, and is responsible for erection. The reference treatment for localized prostate cancer can consist of two alternatives: either intensity-modulated pelvic radiotherapy with treatment of the entire prostate volume and VS, or surgical removal of the vesiculo-prostatic block in monobloc. It is therefore always extended to the VS.

Magnetic resonance imaging (MRI) is now routinely performed for the initial workup of prostate cancer, with a diagnostic and prognostic role, as invasion of the VS by cancer is recognized as a poor prognostic factor. Some radiology centers recommend 3 days of sexual abstinence to allow a proper seminal vesicle study. Various factors, such as serum testosterone levels, autosomal dominant polycystic kidney disease, smoking, and certain drugs such as SILODOSINE, have been identified as factors that can independently vary seminal vesicle size.

The duration of sexual abstinence since the last ejaculation also appears to be correlated with seminal vesicle volume. Two recent studies found a correlation between the duration of sexual abstinence and seminal vesicle volume measured on MRI in a young population (median age 35.9 and 46.45 years). This population is not superimposable to that of patients managed for prostate cancer whose average age at diagnosis is 70 years.

However, the control and knowledge of the volume of VS, in this specific population, could have an interest in the treatment of prostate cancer:

* In case of pelvic radiotherapy in order to limit the volume of the organ to be irradiated, the toxicity induced to the adjacent organs being directly associated to the delivered dose.
* In case of radical vesiculo-prostatectomy, by surgical way, the lateral dissection of the vasculo-nerveous bands is made more difficult in case of voluminous seminal vesicles with an increased risk of nerve damage.

Investigators hypothesize that the volume of the VS is correlated with the duration of abstinence. Thus, evacuation of seminal fluid by ejaculation at a defined time before curative treatment of prostate cancer, could improve the functional results of pelvic radiotherapy or surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 45 years
* French speaking patient
* Patient performing a prostate MRI for suspected prostate cancer

Exclusion Criteria:

* History of curative treatment for prostate cancer (radical prostatectomy, external radiotherapy, brachytherapy, HIFU, cryotherapy)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his or her data for this research
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform

The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.

objectives:

1. evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
2. Reconfirm the parameter settings for each of the aforementioned clinical applications.
3. Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.

Background:

The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelegths longer than these of the filters are transmitted.

Material and Methods:

The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head.

Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590.

Following every treatment the subjects will be asked how much pain was felt , using a score of 1-5.

Photographs will be taken before each treatments . Every subject will be treated 5 treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:

1. No clearance
2. 0-25%
3. 25-50%
4. 50-75%
5. 75-100%

Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects, presenting with at least one of the clinical indications mentioned above
* Willing and being able to comply with all visit and evaluation requirements
* Willing and being able to provide signed Informed Consent

Exclusion Criteria:

* A history of keloid scar formation or poor wound healing
* Wounded or tanned in area to be treated
* Pregnant or intending to become pregnant during the evaluation period
* Subjects with a bleeding disorder or who take anticoagulation medications
* Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure
* Significant concurrent skin conditions affecting area to be treated
* Having a history of skin cancer or any other cancer in the area to be treated
* History of immunosuppressive disease
Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that had been present for at least 3 years before the screening visit;
3. Eczema Area and Severity Index (EASI) score ≥ 12 at the screening and baseline visits;
4. Investigator's Global Assessment (IGA) score ≥ 3 at the screening and baseline visits;
5. ≥ 10% body surface area (BSA) of AD involvement at the screening and baseline visits;
6. History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria:

1. Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit;
3. Treatment with leukotriene inhibitors within 4 weeks before the baseline visit;
4. Treatment with systemic corticosteroids within 4 weeks before the baseline visit;
5. Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit;
6. Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit;
7. Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit;
8. Known history of human immunodeficiency virus (HIV) infection;
9. History of clinical parasite infection, other than treated trichomoniasis;
10. History of malignancy within 5 years before the baseline visit, with the following exceptions: participants with a history of completely treated carcinoma in-situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin were allowed;
11. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
12. Pregnant or breast-feeding women;
13. Unwilling to use adequate birth control, if of reproductive potential and sexually active.
Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors

Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.

Longitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.

Description of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.


Eligibility Criteria:
Inclusion Criteria:

* all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors

Exclusion Criteria:

* none
Thermographic Imaging in Epidural Anesthesia

The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients

Patients will recive standard anesthesia care for epidural placement and additionally, thermographic imaging will be obtained at baseline and up to 30 min after the epidural blockade is performed.

Eligibility Criteria:
Inclusion Criteria:

* Parturients in active labor requesting epidural anesthesia for normal vaginal delivery

Exclusion Criteria:

* Patients with lower extremity skin disorders like active infections like cellulitis, ,dermatitis, psoriasis or connective tissue disorders like scleroderma or Raynaud's phenomenon
* Patients with diagnosed peripheral vascular disease ,venous stasis , deep venous thrombosis.
* Patients with Severe preeclampsia with significant lower extremity edema
* Patient on vasoactive agents like vasodilators, calcium channels blockers.
Perturbation Based Neuromuscular Training Effects on Peroneal Strength, Fatigue and Functional Performance Parameters

In the literature neuromuscular exercise programs are often used for prevention in sport players. Literature lacks of perturbation exercises and its effects on peroneal's muscle strength, fatigue and individual's performance parameters. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations.

Chronic ankle instability is very common in adolescent female basketball players. In the literature neuromuscular exercise programs are often used for prevention in sport players that usually contains of strength and/or balance exercises. Perturbation exercises are oftenly used in sport players for returning the sport or prevention but literature lacks of its effects statistically. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations. Strength and fatigue evaluations will be made with Cybex dynanometer. Dynamic balance evaluations will be made with Y-Balance Tests. Individual's performance parameter evaluations will be made with vertical jump test, cross jump test and side hop test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-injured within the 6 months female basketball players that are willing to join the research

Exclusion Criteria:

* That has a injury within 6 months with missing trainings at least 2 times in a row or having vestibuler dysfunction
Advanced Grandparental Age as a Risk Factor for Autism

The Division of Medical Genetics at the University of Mississippi Medical Center is recruiting parents of children with a pervasive developmental disorder (including autism, autistic spectrum disorder, PDD-NOS, Asperger syndrome, childhood disintegrative disorder, and Rett syndrome) to participate in a study to help determine potential causes of the increasing prevalence of these disorders. The study is being conducted using an anonymous on-line survey available to parents through a secure link.

The study consists of approximately 90 questions about the affected child, siblings, parents, and grandparents, which will take roughly 10-15 minutes to complete. Several families will also be invited to participate in a phone interview. Both the survey and the phone interview are conducted using a self-designated code to protect anonymity and patient privacy. No identifying information such as name, date of birth, address, or phone number will be asked. Only questions regarding the year of birth of family members will be asked.

Autism is a genetically heterogeneous entity. Although numerous studies have demonstrated a strong genetic basis, no clear etiology has been identified to date. Recently, two studies have demonstrated an increased risk of autism in children born to fathers over the age of 40. However, given the large male-to-female predominance of autism, it is likely that new mutations on the X chromosome account for a significant number of affected cases. Due to the maternal origin of the X chromosome in males, we hypothesize that advanced maternal-grandpaternal age may also be a risk factor for autism. Precedence for this theory exists with other X-linked disorders such as Duchenne muscular dystrophy and Rett syndrome. Additionally, it has been demonstrated that maternal psychiatric illness, but not paternal psychiatric illness, is more prevalent among parents of children with autism. Using anonymous surveys of families with autistic children, we seek to identify the ages of grandparents at the time the parents were born in order to determine if advanced maternal-grandpaternal age is associated with an increased risk for autism when adjusted for advanced maternal and paternal age. Additionally, we will seek out sister-pairs in order to identify any statistical significance between the ages of the maternal grandfather at delivery of each sister. If advanced maternal-grandpaternal age is, in fact, a risk factor, it would help direct molecular researchers towards genes on the X chromosome as potential etiologies for autism. Also, further study of potential mutagenic exposures in the environment of grandparents may help elucidate the reason for the increasing incidence of autism in recent decades.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of any age with autism, autistic disorder, autistic spectrum disorder, Asperger syndrome, pervasive developmental disorder, PDD-NOS, Rett syndrome, or Childhood disintegrative disorder
Heart Rate Informed Changes in Care for Non-Communicating Patients

The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.

Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42

Eligibility Criteria:
Inclusion Criteria:

* Between 5 and 70 years of age at the time of data collection
* Autism spectrum disorder as evaluated by clinical psychologist
* Communication difficulties
* Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week.
* Written informed consent is obtained from the subjects' legal representative.

Exclusion Criteria:

- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Immediate Load of Dental Implants, Placed in Atrophic Upper and/or Lower Jaw of Partial or Complete Edentate Patients, According to Flapless Technique

This study will evaluate the placement of implants with minimal invasive techniques. Immediately after the placement of the implants, functional loaded synthetic teeth will be placed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
Music to Reduce Use of Smoking in Patients With Schizophrenia

The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.


Eligibility Criteria:
Inclusion Criteria:

* clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
* smoked at least 10 cigarettes per day for the past month
* score of 4 or more on the Fagerstrom Test for Nicotine Dependence73
* psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)
* the capacity to participate in the informed consent process

Exclusion Criteria:

* being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)
* report active substance abuse or testing positive drug or alcohol use
* taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment
* participating in any treatment or activity that includes music as a focus
* having a seizure disorder, other neurological illnesses, or a family history of seizures