cyrilzakka/clinical-trials huggingface dataset:
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults

The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject between the ages of \>=18 and \<=40 years
* Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
* All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels \>=12.0 and \<=16.5 g/dL for female subjects and \>=13.0 and \<=18.5 g/dL for male subjects.
* Blood pressure: Systolic blood pressure \>90 and \<160 mm Hg; Diastolic blood pressure \>60 and \<95 mm Hg.
* Body weight \>=45 and \<=120 kg.
* Able to be contacted by telephone during the study period.

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Prior vaccination with a serogroup B meningococcal vaccine.
* A previous anaphylactic or severe vaccine-associated adverse reaction.
* A known hypersensitivity to any study vaccine components.
* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
* Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
* Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
* Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
* History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

* Review the outcomes of the Endovascular management of pediatric intracranial arteriovenous shunts.
* Give an effective treatment for pediatric intracranial arteriovenous shunts and can detect the best method could be used and assess safety and efficacy of different endovascular techniques in treatment of different AV shunts.
* Improve the outcome of these patients and decease rate of recurrence and complications.

Intracranial arteriovenous shunts (ICAVS) in young children are characterized by frequent high-flow fistulas. In association with high-flow fistulas and the physiological condition of the developing brain and heart, each ICAVS type tends to present at a certain age with unique symptoms.

Vein of Galen aneurysmal malformation (VGAM) and dural sinus malformation with arteriovenous (AV) shunt tend to present in the neonate with high output cardiac failure. In infancy, VGAM, pial arteriovenous fistula (AVF) and infantile dural AVF (DAVF) tend to present with hydrodynamic disorder such as macrocephaly, ventriculomegaly, prominent facial veins, and developmental delay.

Pial AVF, AV malformation, and infantile DAVF can present with focal neurological signs such as seizure or hemorrhage at older ages they are in the subpial space, as opposed to VGAM or DAVF, which are extrapial in location and tend to present with systemic symptoms .

Endovascular treatment is currently the first choice of treatment for most pediatric ICAVS. The treatment goal should be defined on a patient-by-patient basis, according to the unique physiological condition of the child.

Eligibility Criteria:
Inclusion Criteria:

* 1- clinical manifestation of AV shunt according to the pathology with radiological diagnosis by CT angiography or MRA 2- patient must be under 18 years old

Exclusion Criteria:

1. Any patient above 18 years old
2. Asymptomatic patients
Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Test of QLS Device to Detect Early Cataracts

This study will test the reliability of an instrument called the Quasi Elastic Laser Scattering Device (QLS) in detecting early changes in cataract formation.

Surgery is currently the only treatment for cataracts. Many laboratories, however, are researching drugs to reverse, delay or prevent cataract formation. Anti-cataract drugs presumably would be most effective given early in the course of disease. When clinical trials of these drugs are begun, dependable and standardized methods for documenting and monitoring lens opacities will be needed to test their effectiveness. The QLS was designed to detect the earliest molecular changes in cataract development. This study will evaluate the usefulness and reliability of this instrument in measuring these changes.

Normal volunteers and patients with cataracts in this study will have a standard eye examination, including a vision test and eye pressure measurement. The pupils will be dilated for QLS testing and for examination of the retina. Photographs of the retina may be taken. The QLS test uses a very dim laser light similar to that used to scan grocery items in the supermarket. The laser beam is projected into the lens of the eye, and the scattered light is collected and analyzed to determine normal and abnormal molecular interactions in the lens. Two measurements will be done for each eye. The test will be repeated in 6 months to determine reproducibility of the system.

Recently, a device has been created to determine molecular interactions that occur in the nucleus of the lens, called Quasi Elastic Laser Scattering Device (QLS). Preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract, at the stage where anticataract treatment would theoretically be most effective in reversing, delaying or preventing cataracts. A new miniaturized version of this device has been developed by NASA using low energy lasers and offered for further development and testing at the NEI. We therefore propose to conduct a preliminary study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes.

Eligibility Criteria:
Patients 18 years or older will be admitted to this study. There will be no gender or sex bias in the recruitment.

Three subjects who are normal volunteers below age 40 and three subjects who are normal volunteers above age 40 will be recruited. These normal volunteers should have clear lenses with LOCS II clinical score for nuclear opalescence of 0.5 or less.

In addition, 3 subjects who have early nuclear cataract (LOCS II/Nuclear opalescence -2) will also be recruited for the study.

QLS data will be obtained on each eye of the normal and cataractous subjects in the nuclear region.

No patients who have uveitis, glaucoma and who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used.
Outcome of Two Different Suture Methods for Achilles Tendon Rupture

The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.

Achilles tendon rupture is one of the most common tendon injuries in the adult population. The incidence of this injury is increasing as aging adults continue their participation in high-demand sports. Although the impact of an Achilles tendon rupture is substantial, often resulting in prolonged disability and rehabilitation. Studies have showed that the operation treatment of acute Achilles tendon ruptures had some advantages. But the rebuild of blood supply was not involved in previous studies. And the epitenon of tendon is the interior layer, closest to the endotenons which contains the vascular supply. Main difference of two suture methods were if the epitenon was repaired and sewed indirectly or unrepaired and sewed directly.

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women between 18 and 60 years of age.
* Closed rupture confirmed with ultrasound or magnetic resonance imaging (MRI).
* Operative within 14 days after injury.
* Willing and able to comply with and carry out the prescribed rehabilitation protocol.
* Providing informed consent.
* No other major trauma.

Exclusion Criteria:

* Refuse to participate.
* Refuse to participate.
* Additional ipsilateral injury.
* Open injury.
* Patients not suitable for surgery (i.e., mellitus diabetes, immunocompromised states, obesity (BMI.30), peripheral vascular disease or local/systemic dermatologic disorders) or have other surgical contraindications.
* Fluoroquinolone-associated rupture (i.e., rupture within 2 weeks after taking this medication).
* Achilles avulsion from the calcaneus or with bone fracture.
* Neurological or vascular disease requiring medications recognized to impair tendon healing.
Effects of Jing Si Herbal Tea on Quality of Life and Sleep in Dementia and Their Caregivers

Jing Si Herbal Tea has been found to be effective in improving health for the conditions of cancers, aging, depression, and sleep. Such evidence has been shown in animal models and clinical research with publications in the international journals. However, empirical evidence regarding the effectiveness of Jing Si Herbal Tea for patients with dementia and their caregivers on their quality of life and psychosocial health remains unclear. Therefore, the present project aims to investigate the feasibility of taking Jing Si Herbal Tea among patients with dementia; then, to investigate if Jing Si Herbal Tea could improve quality of life and psychosocial health for patients with dementia and their caregivers. The project will be three years. The first year will examine the feasibility for the patients with dementia. A total of 100 patients with dementia will be recruited and they will be informed to take the Jing Si Herbal Tea two times per day (one time in the morning and another time in the afternoon). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to have initial evidence of the improvements in quality of life and psychosocial health without having a control group. The second year will recruit 200 patients with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health. The third year will recruit 200 caregivers of patient with dementia and randomly assign them into a treatment group (taking Jing Si Herbal Tea) and a control group (taking placebo). All the participants will be measured for their quality of life and psychosocial health at baseline, three months after baseline, and six months after baseline, to investigate the strong evidence of Jing Si Herbal Tea on quality of life and psychosocial health.


Eligibility Criteria:
For people with dementia:

Inclusion Criteria:

* diagnosis of dementia
* 50 years or older
* with sufficient cognition to complete the questionnaires
* can communicate using Mandarin or Taiwanese

Exclusion Criteria:

* with renal function problems
* not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
* with the condition of change the commencement of guardianship (or commencement of assistance)

For caregivers:

Inclusion Criteria:

* caregivers of people with dementia for more than half years
* 20 years or older
* with sufficient cognition to complete the questionnaires
* can communicate using Mandarin or Taiwanese

Exclusion Criteria:

* with renal function problems
* not suitable for Jing Si Herbal Tea after evaluation from a psychiatrist/physician
* with the condition of change the commencement of guardianship (or commencement of assistance)
Atomoxetine in the Treatment of Binge Eating Disorder

The specific aim of this study is to assess the efficacy and safety of atomoxetine compared with placebo in outpatients with binge eating disorder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will meet the DSM-IV criteria for a diagnosis of binge-eating disorder for at least the last 6 months
* In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization

Exclusion Criteria:

* Have concurrent symptoms of bulimia nervosa or anorexia nervosa
* Women who are pregnant, lactating, or of child bearing potential who are not using adequate contraceptive measures
* Patients who are displaying clinically significant suicidality or homicidality
Revisiting Survey Investigating Why Patients Are Not Receiving Home Anti-convulsant Medication Prior to Surgery/or Procedure Involving General Anesthesia

Children with seizure disorder face unique challenges during the perioperative period. Fasting, sleep-deprivation, and missed doses of medications while patients are required to have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The incidence of seizures in this population is unknown but correlated with patient's underlying condition and missed doses of anti-convulsant. Previous work has determined this is not a unique problem.

The investigators initially found compliance extremely poor at 60%. The investigators have made improvement to about 80% compliance through various interventions: education of nursing, availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital NPO policy. The investigators feel that a new, more focused, survey will help identify, perioperative reasons for non-compliance on part of the parents. This information will be utilized to guide further interventions aimed at improving compliance.


Eligibility Criteria:
Inclusion Criteria:

* We plan to include all children 0-18 years of age on anticonvulsant(s) for seizure disorder.

Exclusion Criteria:

* None.
The Resistance Exercise Training for Worry Trial

This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder.

Recent meta-analyses support the chronic anxiolytic effects of resistance exercise training among women with diagnosed Generalized Anxiety Disorder. However, the effects of resistance exercise training among those with subclinical, or analogue-Generalized Anxiety Disorder is unknown. This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder. Analogue-Generalized Anxiety Disorder status was determined using validated cut-scores for both the Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder sub-scale score of 6 or greater, and the Penn State Worry Questionnaire score of 45 or greater. The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were age 18-40y; no medical contraindication to safe participation in resistance exercise training; and no current pregnancy or lactation.

Exclusion Criteria:

-
Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis

Body composition analysis and especially body fat distribution in regions of interest (android and in particular intra-abdominal region) provides some information on the risk of cardiovascular disease. There is little data available on the body composition analysis in psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in particular data on fat distribution in regions of interest regarding the risk of cardiovascular disease.

Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic properties that are interesting to explore in pathologies with a higher risk of cardiovascular disease like psoriasis or psoriatic arthritis.

Adipokines have been investigated in psoriasis but fat tissue and in particular its distribution (android/visceral or intra-abdominal) has not been studied in parallel. Moreover, relation between adipokines and psoriasis area or severity has been studied but the relation between adipokines and cardiovascular risk factors has not yet been investigated.

The aim of this study is to investigate relations between the body fat distribution, adipokines rates and the risk of cardiovascular disease of these patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psoriasis vulgaris or psoriasis pustulosa confirmed by a dermatologist or a diagnosis of psoriatic arthritis (CASPAR criteria) confirmed by a rheumatologist
* Age ≥ 18 and ≤ 80 years old
* Control group: patients matching with sex, age ± 5 years, BMI (4 groups), coming to the same hospital for a consultation.

(BMI groups : BMI \< 18,5 kg/m²; 18,5 ≤ BMI ≤ 24,99 kg/m²; 25≤ BMI ≤ 29,99 kg/m²; BMI ≥ 30 kg/m²) Control group patients for psoriatic arthritis will be included during a rheumatologist consultation. They may have a non-inflammatory common disco-vertebral pathology (lumbago, lumbosciatic, spinal stenosis, neck pain, cervical arthritis and cervicobrachial neuralgia).

Control group patients for psoriasis will be included during a dermatologist consultation. They may have a non-inflammatory skin disease (acne, acne rosacea, idiopathic Raynaud's phenomenon, basal cell carcinoma, acanthosis nigricans).

In case of recruitment difficulties, healthy volunteers can be included.

* Postmenopausal women (for at least 24 months), surgically sterilized, or for women of childbearing age, efficacy use of contraceptive methods (contraceptive pills, injections or patches, intra-uterine device, double-barrier contraception),
* Signature of informed consent form
* French social security Affiliation

Exclusion Criteria:

* Pregnant woman
* Corticosteroid therapy \>10 mg of prednisone or equivalent /day
* Patients taking biological therapy (anti-TNFalpha therapy: infliximab, etanercept, adalimumab, golimumab, certolizumab ; anti-Interleukin-12/Interleukin-23: ustekinumab).
* Legal incapacity or limited legal capacity
* Presence of any condition hampering compliance with the study protocol, at the discretion of the investigator
* No french social security affiliation
Impact of a Fermented Infant Formula in Weaning Babies

When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.


Eligibility Criteria:
Inclusion Criteria:

* Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
* Born at 37 weeks of amenorrhea or more
* Exclusively breastfed since birth
* Written informed consent given by both parents (or tutors) for study participation
* Parents (or tutors) agreeing on the follow-up by one of the study investigators

Exclusion Criteria:

* Infant with congenital or acquired immunodeficiency, whatever the aetiology
* Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
* Infant with congenital and/or chromosomal malformation,
* Infant having received antibiotic therapy within the 3 weeks before the inclusion visit
* infant receiving a treatment susceptible to interfere with the measure of study parameters
* Antibiotic therapy per/pre/post partum \> 48 h
* Infant needing the prescription of a specific milk (HA, without cow milk)
* Infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator.
Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women

The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects


Eligibility Criteria:
Inclusion Criteria:

* Clinically normal safety laboratory results

Exclusion Criteria:

* Standard contraindications for use of combined oral contraceptives (class label). Including:

  * Presence or history of thromboembolic process in veins (such as deep venous thrombosis, pulmonary embolism) or arteries (e.g., stroke, myocardial infarction) or a known genetic component (homozygous), venous thromboembolic event in a close relative (parents or siblings) at younger age (\</= 40 years)
* Acute and chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the start of the study medication.
* Use of preparations where experience shows affect on the activity of hepatic enzymes.