cyrilzakka/clinical-trials huggingface dataset:
Tyrosur® Gel-Investigation on Wound Healing Efficacy

This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.

This is a single-center, randomized, observer-blind phase IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.

In the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. These wounds will then be treated with the investigational products. The wound healing will be clinically assessed and photographs will be taken for documentation.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older with healthy skin in the test area
* The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant for the outcome of the clinical trial;
* Written informed consent obtained.

Exclusion Criteria:

* acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
* dark-skinned persons whose skin color prevents ready assessment of skin reactions;
* subjects with diabetes, psoriasis or lichen ruber planus;
* history of wound-healing complications, or keloid and hypertrophic scarring;
* evidence of drug or alcohol abuse;
* pregnancy or nursing;
* symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
* known allergic reactions to components of the investigational product/s;
* treatment with systemic or locally acting medications which might counter or influence the trial aim within two weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids);
* contraindications according to summary of product characteristics;
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia

The aim of this study is to

* detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep
* implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia

1. needs detection by means of survey and interviews
2. implementation of a 6 week program in day care facilities

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with early onset dementia before age of 65Y

Exclusion Criteria:

* severe dementia
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

Eligibility Criteria:
Inclusion Criteria:

* -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days.
* Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh
* Agreement of the study no-objection form
* Age greater than or equal to 18 years
* Patient affiliated to a social security scheme

Exclusion Criteria:

* -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.


Eligibility Criteria:
Inclusion Criteria:

* Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Exclusion Criteria:

* ileal loops or vesicoureteral reflux
* complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
* fungal urinary tract infection
* permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
* history hypersensitivity to study medication
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine

This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.

In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment

Eligibility Criteria:
Inclusion Criteria:

* Age 2 to 50 years
* Diagnosis of visceral leishmaniasis

Exclusion Criteria:

* Other acute or chronic diseases
* Use of immunosuppressive drugs
* AIDS
* History of allergy to NAC and/or pentavalent antimony
A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone.

The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study
* stable with respect to disease symptoms and other medical conditions
* if female, using birth control.

Exclusion Criteria:

* At risk to self or others
* use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days
* considered to be resistant to treatment
* pregnant or breast-feeding
* not using birth control.
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma

"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.

The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.

The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.

The study is expected to provide information about the accuracy of E-nose measurements for a child population.


Eligibility Criteria:
The inclusion criteria for asthmatic children are:

1. Moderate asthma (GINA 2015);
2. Age 6-11 years;
3. No upper airway respiratory infections or exacerbations in the last 4 weeks;
4. Steroid-naive asthma;
5. Positive bronchodilator response;
6. Non smoker.

The inclusion criteria for healthy children are:

1. Age 6-11 years;
2. No upper airway respiratory infections in the last 4 weeks;
3. Non smoker;
4. No history of asthma and respiratory diseases during the life;
5. Negative bronchodilator response.

The exclusion criteria are:

1. Symptoms of acute respiratory infection;
2. Immunological and metabolic systemic disease;
3. Major malformations of the upper airways;
4. Active smoker.
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* Contact lens wearer, spectacle wearer or non-spectacle wearer
* Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
* Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
* Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria:

* Previously used Hylocomod or Optive eyedrops
* Systemic allergy or eye allergy
* Systemic disease which might have an ocular component and/or interfere with contact lens wear
* Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
* Systemic medication which might have eye side effects and or interfere with contact lens wear
* Eye infection or use of eye medication
Multicomponent Intervention in Women at Risk of Sarcopenia

The goal of this quasi-experimental pilot study is to evaluate the effect of a multi-component intervention in women between 55 and 75 years old at risk of sarcopenia. The main question it aims to answer are: What is the effect of a multi-component intervention in women at risk of sarcopenia? Participants will twelve women between 55 and 75 years old with risk of sarcopenia, who agreed through written informed consent for participate 12 weeks with 24 sessions included dancing, resistance exercises, and nutritional education. The outcomes were muscle mass, grip strength, gait speed and body composition. The effects were measured before and after the intervention, under a self-controlled design.

Physical exercise, especially resistance exercise, is one of the best non-pharmacological treatment alternatives due to its multiple health benefits and could be a promoter for the prevention of sarcopenia by delaying muscle atrophy produced by the natural aging process. However, scientific literature shows that this activity when combined with other strategies has a better effect on sarcopenia indicators than alone. Dance is a social activity that is part of the culture and life history of human beings, however, current research has focused on studying the cognitive and visuospatial effects of this activity. It could be an activity with beneficial effects on the physical abilities of the individual since dancing improves flexibility, resistance and balance. However, the study of these two strategies, along with nutritional education has been little studied.

Therefore, a pilot test was proposed with the aim of knowing the possible effect of a multicomponent intervention on muscle, strength, performance, and body composition on women at risk of sarcopenia.

Eligibility Criteria:
Inclusion Criteria:

* Positive requested through written informed consent
* Current public health insurance
* Preserved physical and mental capacities (verified through data from the medical record)
* Having a lower grip strength, less or equal to 20.99 kg
* Appendicular skeletal muscle index (ASMI) maintained, greater or equal to 5.5 kg/m\^2
* Walking speed greater or equal to 0.8 m/s

Exclusion Criteria:

* Bioelectric activity add (osteosynthesis metal systems or devices, pacemakers, defibrillators)
* Alterations of body composition (history of cancer, uncontrolled chronic degenerative diseases, risk of malnutrition, respiratory insufficiency, asthma or chronic obstructive pulmonary disease, hospitalization in the year prior to the study; limitations in carrying out the basic activities of daily living; medical contraindication for physical activity, and or belonging to another physical activity group).
Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer

This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age ≥18 years
* An invasive primary breast cancer of any histology arising from breast parenchyma
* Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
* Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0.
* Patient signed study-specific consent form.

Exclusion Criteria:

* Patients with distant metastasis.
* Patients who are pregnant or breastfeeding.
* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
* Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
* Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
* Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
* Primary breast cancer is a lymphoma or sarcoma histology.
* Patients with a history of non-skin malignancy \<5 years prior to the diagnosis of breast cancer.
* Patients requiring radiation to the bilateral breasts.
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies

Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-45 years of age inclusive
* Subject is female
* Subject is pregnant
* Gestational age can be determined via IVF or IUI
* Subject is 36-42 days pregnant as determined by IVF transfer or IUI
* Subject agrees to provide 3 separate blood and urine samples

Exclusion Criteria:

* None
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants

The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.

The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy participants in order to evaluate the PK of single and multiple oral dose.

The study will enroll approximately 36 healthy participants. Participants will be assigned to one of the three treatment groups:

* TAK-438 10 mg tablet once daily
* TAK-438 20 mg tablet once daily
* TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet at the same time on Day 1 and Days 3-9.

This single-centre trial will be conducted in China. The overall time to participate in this study is 18 days. Participants will remain confined to the clinic from Day 1 up to Day 11 and will be followed-up by telephone or visit on Day 18.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy adult male or female Chinese participant.
2. Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m\^2), inclusive at Screening (Check-In Day -1).
4. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
5. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
6. Is willing to provide a sample for pharmacogenetic analysis (for cytochrome \[CYP2C19\] genotyping).

Exclusion Criteria:

1. Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
2. Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
3. Has poor peripheral venous access.
4. Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
5. Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly

The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. The purpose of the study is to determine that whether whole body vibrator is more evident or proprioceptive training is more effective for promoting functional independency and improving balance in older adults. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.

Elderly population is defined as 'people aged 65 or above'. Aging is a complex and challenging process of physiological changes and it is associated with decline of biological functions. Increasing age is linked with impairments in visual, proprioception, vestibular systems, decline in muscular strength and control of the lower limbs, balance/postural control, and of the mobility patterns which are known to be substantial hazards for fall, and these parameters have been found to be dynamically more disabled with getting older. Among all these factors, there is obvious decline in normal functioning and balance related issues, common in elderly population due to proprioceptive function loss that is the person is unable to sense his joint position and motion which ultimately results in mobility impairments.

Therefore, researchers have been looking for new approaches that are more feasible to improve the independence and physical mobility in older individuals and over the past decade the whole body vibrator (WBV) have been seeking attention for the beneficence of the elderly population. It is a neuromuscular training modality used to improve muscle strength, power, balance, mobility, cardiorespiratory rehabilitation, improves neuromuscular and musculoskeletal functions and general health both in healthy and as well as in orthopedic patients and neurologically diseased elderly population .Bilateral proprioceptive training is also used for impaired balance, proprioception loss and decreased ROM in elderly population. Proprioceptive receptors are present in our skin, muscles, tendons and joints with the help of which we can sense position and movement of limbs and trunk, sense of force and sense of heaviness in the absence of vision. The mechanoreceptors of the proprioception cause activation of central nervous system by initiating action potential through release of stored sodium in to the cells, this afferent sensory stimuli to the central nervous system is essential for the control of body movements

Eligibility Criteria:
Inclusion Criteria:

* Participants with balance and proprioception problems
* Those having BBS score between 21-54
* Intact cognition: MMSE \>25

Exclusion Criteria:

* Subjects with recent trauma or any other neurodegenerative disorder.
* Subjects with cognitive and hearing impairments
* Subjects who cannot follow my command.