cyrilzakka/clinical-trials huggingface dataset:
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier

Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.

No vaccine will be administered in this study.

Eligibility Criteria:
Inclusion Criteria :

* For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
* For subjects aged \< 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
* Subject (and parent/legal guardian if subject is \< 18 years of age) able to attend the scheduled visit and comply with all trial procedures
* For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
* For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
* For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine

Exclusion Criteria :

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy \> 2 weeks
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
* Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
* History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
* For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
* Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
Study of Kuvan Treatment in Adults With GTPCH Deficiency

The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression, fatigue, trouble concentrating, or memory loss. This will be a phase one study. The investigators will monitor patients over a period of three to six months while on the medication. Medication levels will be monitored by measuring the BH4 levels in cerebral spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar punctures for this purpose. The investigators will also monitor emotional function and motor function.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of GTPCH deficiency, supported by appropriate family history, CSF neurotransmitter studies, skin fibroblast enzyme assay and/or mutation analysis
* minimum age 18 years
* identified by self or others to have symptoms of anxiety, depression, fatigue, or other neurocognitive dysfunction (trouble concentrating, memory loss, etc)
* willingness to undergo at least 2 CSF evaluations for BH4 and neurotransmitter levels over an 8 to 12 week period

Exclusion Criteria:

* age \< 18 years old
* unwillingness to undergo repeated CSF analysis
* lack of supporting diagnostic criteria
* concomitant medical problems or medications which would increase risk of Kuvan®
* concomitant psychiatric state, such as severe depression with suicidal ideation that requires immediate referral and alternative treatment intervention
* prior history of back surgery, abnormality or chronic pain that in the opinion of the investigator would increase risks associated with lumbar puncture
* significant obesity that might increase difficulty or risk in performing lumbar puncture
* if female, unwillingness to use birth control during the period of study drug administration
Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.

This observational study will include new or current Depo Provera users who express interest in attempting subcutaneous self administration of depot medroxyprogesterone acetate. Candidates will be taught self administration by a clinic assistant at Planned Parenthood of Southwest and Central Florida. Patients who are able to correctly self administer the medication and wish to attempt to continue home self administration, will be provided the supplies and educational materials to do so. Continuation rates and satisfaction with this method will be assessed using preaddressed surveys that patients will return with the above information.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older
* Can understand written and spoken English
* Current or past user of DMPA or desires initiation of DMPA for contraception
* Provider has approved DMPA use in this woman
* Willing to consider/attempt DMPA self-injection.
* Willing to receive phone calls/letter for follow up
* Willing to return letters for follow up

Exclusion Criteria:

Has contraindications to DMPA use:

* Vaginal bleeding of unknown etiology
* Medication use for Cushing's syndrome
* Currently pregnant
* Blood pressure \>160/100
* Intolerance to the idea of irregular or absent menses
Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's Quality of Life Hospital Environment

The quality of life of carriers detected infected or colonized by emerging highly resistant bacteria (BHRe) following the implementation of specific hygiene measures during the discovery of the microorganism has been little studied. To date, there have been no studies to determine the quality of life (QoL) in France of patients with hospitalized HBHRD.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Have a positive BHRe screening during the hospital stay and / or have a positive BHRe clinical sample during the hospital stay
* Conscious patients
* All types of stays in the hospital sector
* All pathologies

Exclusion Criteria:

* Known patients with BHRe before hospitalization
* PCH immediately upon admission (history of hospitalization abroad, patients contacted during a previous hospitalization)
* Cognitive problem
* Patients not proficient in French (requiring an interpreter)
* Patients under guardianship
Natural Progesterone and Preterm Birth in Twins

To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.

Objective: To assess the effectiveness of natural progesterone supplementation in preventing preterm births in twins.

Study Design: National multicenter randomized double blind controlled clinical trial.

Setting: Six tertiary hospitals in the east of Spain (communities of Valencia and Murcia): Instituto Universitario IVI Valencia, Hospital Universitario La Fe (Valencia), Hospital Universitario Dr. Peset (Valencia), Hospital General Universitario (Alicante), Hospital Vega Baja de Orihuela (Alicante) y Hospital Virgen de la Arrixaca (Murcia).

Population: 246 bichorionic biamniotic twin pregnant women divided in three groups according to the allocated randomized treatment: (I) placebo (N=82); (II) 200 mg progesterone (N=82); and (III) 400 mg progesterone (N=82).

Methods: All participant women will self-administer two vaginal pessaries at bedtime containing the allocated treatment. Vaginal pessaries will be identical externally but will contain either placebo or 200 mg of natural progesterone (Laboratorios Effik, Madrid, Spain). The treatment will be applied from the 20th week until the 34th week (or until delivery if it occurred earlier). Control visits will be performed at 24, 28, 32 and 34 weeks. Pregnancies will be managed according to each local protocol. An external statistical analysis will be performed on intention to treat basis.

Main outcome measure: Preterm birth rate (\<37 weeks). Secondary outcome measures: very preterm birth rate (\<32 weeks); cervical length measured by vaginal ultrasound at each control visit; need for tocolytic treatments; rate of preterm premature rupture of membranes; and perinatal morbidity and mortality.

Estimated period of study: 2006-2008.

Eligibility Criteria:
Inclusion Criteria:

* Bichorionic biamniotic twin pregnant women
* = or \> 18 years old

Exclusion Criteria:

* Single pregnancy or monochorionic twin pregnancy or triplets
* Chronic hepatic pathology, previous alterations in hepatic analysis during anti-contraceptive treatment; or gestational cholestasis in in previous pregnancies.Basal alterations in hepatic analysis profile.
* Profylactic cerclage until week 14.
* Basal alterations in renal analysis profile
* Local allergy to micronized natural progesterone
* Genital pathology not allowing for correct absorption of medication
* Fetal anomoly diagnosed after sonograph week 12 and/or 20.
* Smokers of more than 10 cigarettes/day
* Consumers of illegal substances
Efficacy and Safety of Meloxicam (Mobicox®) in Mexican Population With Rheumatic Diseases

Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases.


Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* Hypersensitivity to meloxicam or to other NSAIDS
* History of asthma, angioedema or urticaria secondary to NSAIDS
* Pregnancy or lactation
* Recent or current history of peptic ulcer disease, severe renal failure, severe hepatic failure
* Age below of 12 years.
Irinotecan in Treating Patients With Recurrent Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma.

OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate the pharmacological parameters with toxicity and response to therapy.

OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any time. Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary brain glioma Astrocytoma Gliosarcoma Oligodendroglioma Oligoastrocytoma Tumor progression by CT scan or MRI following radiotherapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal No prior Gilbert's syndrome Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of myocardial infarction within 6 months No congestive heart failure requiring therapy Other: No concurrent active second malignancy No uncontrolled infection No other severe concurrent disease Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior adjuvant chemotherapy regimen and 1 for recurrence (Gliadel is considered 1 regimen) At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas No prior irinotecan, topotecan, or aminocamptothecin Endocrine therapy: At least 2 weeks on fixed dose of corticosteroids (or no corticosteroids) prior to baseline scan Radiotherapy: At least 8 weeks since prior radiotherapy Surgery: No surgical resection between last radiotherapy or chemotherapy and study therapy, unless unequivocal tumor growth since surgery
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.

Eligibility Criteria:
Inclusion Criteria:

* case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320

Exclusion Criteria:

* no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
* CVA in past 12 months blood sugar above 250
* active infection in extraocular adnexa
Psychosocial Intervention to Reduce Self-stigma and Improve Quality of Life Among People With Mental Illness in Chile

The principal objective of this pilot trial is to evaluate the effectiveness of a psychosocial intervention to reduce self-stigma and improve treatment adherence and quality of life among people with a severe mental illness who attend to Community Mental Health Centers in Chile. The intervention is based on recovery and narrative therapy and considers 10 group sessions, mainly with patients, but also integrating relatives and professionals in some of the activities.

It has been shown that stigma is one of the main barriers faced by individuals with mental illness, negatively impacting their service use and continuity of treatment. Additionally, given its impact on self-esteem, personal empowerment, and social inclusion, stigma greatly affects the quality of life of this population.

Consequently, a pilot randomized controlled trial (RCT) with two arms (intervention group vs. control group) was designed and implemented. Participants were identified and recruited from two community mental health centers located in Central Chile. The intervention group, in addition to usual care, received a psychosocial intervention based on narrative therapy, recovery and psychoeducation which was specially tailored for this population by the authors.

The sample corresponds to 76 individuals with a severe mental illness (ICD-10), currently treated in the two participating Community Mental Health Centers (COSAM). The category "severe mental illness" includes patients with diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder and severe depressive disorder with psychotic symptoms. Finally, those two clinics were chosen by convenience in order to facilitate the implementation of this study.

Before and after the intervention, the participants' self-stigma (Internalized Stigma of Mental Illness, ISMI), treatment adherence (weeks in treatment), and quality of life (Sevilla Quality of Life Scale) were measured. In addition, the following control variables were also evaluated, due to their influence on the principal outcomes: 1) sociodemographic information, 2) symptom presence and severity (Positive and Negative Syndrome Scale, PANSS), and 3) alcohol consumption (The Alcohol Use Disorders Identification Test, AUDIT).

Eligibility Criteria:
Inclusion Criteria:

* People with diagnosis of severe mental illness, including the following ICD-10 disorders: schizophrenia, schizoaffective disorder, bipolar disorder, severe depressive episode with psychotic symptoms.
* No longer than 5 years since the diagnosis since the first visit to a mental health clinic.

Exclusion Criteria:

* Expressing active suicidal ideation.
* Having substance abuse or dependence alone (may have psychotic symptoms but does not meet criteria for diagnoses included).
* Presenting cognitive or other sensorial impairment which is likely to preclude reliable assessment via our interview procedures
A Role for Brown Adipose Tissue in Postprandial Thermogenesis?

Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and human babies that is capable of extremely high rates of energy burning. We now know that in adult humans it is present and also able to burn energy.

In addition to increased energy expenditure during cold exposure, energy burning is also increased after consuming a meal. Animal studies have shown that part of this additional energy consumption is contributed by BAT. In the present study we will aim to examine whether BAT activity is increased after a meal.

The purpose of this project is to measure whether BAT activity (during which BAT increases energy burning) increases in response to ingestion of a meal.

BAT is one of two types of fat, (the other being white fat), which is found in humans and other mammals. In this study we aim to further our understanding of how BAT works in humans. Studies in animals show that in addition to cold exposure, BAT is also activated by ingestion of a meal, and to different amounts depending on the meal composition, and more importantly, total energy content. However we have only a very limited understanding of BAT function in response to meals in humans. Since BAT function is defective in obesity, and its activity and function are impacted by diet, here we will find out whether a single high energy meal composed entirely of lipid (fat) can increase BAT activity. In future these findings and those of subsequent studies may have important implications for the management of obesity and related diseases.

A total of 20 people will participate in this project. Participation will involve a total of 3 visits, including a screening visit, 2 experimental visits consumption of the treatment meal on one visit, and the placebo (dummy) on the other in a randomised order.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 19 - 35 years
* Unmedicated for the previous 2 months
* No major illness
* BMI 17-40 kg/m2

Exclusion Criteria:

* Unable to give informed consent
* Smokers
* Participant in research projects involving ionising radiation within the past 5 years, excluding dual energy x-ray absorptiometry scans conducted in prior studies
* Claustrophobia
* Fasting plasma glucose \> 6.0 mmol/L
Histology of Functional Density in Premenopausal Breast

The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.

The specific aims are:

* In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast.
* In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue

Eligibility Criteria:
Inclusion Criteria:

* Ages 40 - 55 years
* Considered premenopausal or peri-menopausal
* Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
* Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
* No proliferative benign lesions (e.g. fibroadenomas) identified
* Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
* MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
* No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
* Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)

Exclusion criteria:

* Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
* Prior diagnosis of bilateral breast cancer.
* Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
* Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
* Current breast symptoms
* Breast implants
* Known allergy to local anesthetic.
* History of bleeding complications from prior interventions
* Current use of anticoagulants (e.g., Coumadin or other blood thinners)
* Major medical condition