cyrilzakka/clinical-trials huggingface dataset:
Foster Teens' Risk During Transition

The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. The proposed LINKS intervention marries the goals of child welfare and educational systems. The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.


Eligibility Criteria:
Inclusion Criteria:

* the focal youth will be transitioning into middle school
* the focal youth is in either a foster or kinship care home
* the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).

Exclusion Criteria:

* youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.

A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) will be selected from the total population that participated in the Encuesta Nacional de Salud y Nutrición (ENSANUT) 2012 in Mexico.

Data (through structured questionnaires and interviews) and stored serum samples of the selected subjects obtained from the ENSANUT 2012 will be used in this study. A subset database will be designed by the National Institute of Public Health (NIPH) for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in this database.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for the ENSANUT 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (LAR) of the subject.
* A male or female between and including 10 and 25 years of age, who previously participated in the ENSANUT 2012 in Mexico.

Exclusion Criteria:

* Information required for the study is not available or incomplete.
* Inadequate or insufficient serum sample to perform the laboratory tests for this study.
* Serum sample is wrongly identified.
Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation

The purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.

Diabetes mellitus (DM) is a common chronic disease that is rapidly rising in prevalence, affecting upwards of 35,000 adults in the Hamilton, Ontario region (population 400,000). The magnitude and growth of the problem and its serious health consequences suggest that:

1. diabetes is now a major public health problem; and
2. interventions at the community level are needed to mitigate its health impact.

During the last 5 years, Diabetes Hamilton was successfully piloted as a free community-based program available to anyone with diabetes. It promotes diabetes self-management, self-efficacy and awareness through the provision of generalized diabetes information (e.g. newsletters, workshops, forums, resource directories) to consumers, local physicians and other health professionals.

This trial will determine if supplementing Diabetes Hamilton with an automated tailored feedback system that:

1. provides information;
2. generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
3. copies this communication to the patient's designated physician;
4. facilitates access to community resources; and
5. provides a simple way for the patient to track changes in indicators of health can improve A1c and other diabetes care indicators more than Diabetes Hamilton alone.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes of 1 or more years duration
* Health insurance coverage within Ontario
* Ages 40 or older
* Registered in, or willing to register in Diabetes Hamilton
* Able to read and understand English and provide informed consent in English
* Have home access to either mail, e-mail or the internet
* Have a baseline A1c \>= 7%

Exclusion Criteria:

* Current pregnancy
* Residence in an institution that provides diabetes care
* Cohabiting with study participant
* Residence outside the city of Hamilton
* Inability to read or understand English
* Inability/unwillingness to sign the informed consent or comply with protocol
Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged over 18
* Patients signed written informed consent
* Mediastinal or hilar enlarged lymph nodes (\>10mm) in short axis radiological or clinical findings likely for lung cancer

Exclusion Criteria:

* Severe impairment of any organs, with do not enable anaesthesia
* Quick \<80%, INR \>1,5, thrombocytes \<50/nl or PTT\>120sec
* Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
* Insufficient language ability (spoken and written German)
Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder

The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.

While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Major Depressive Disorder
* Must be able to swallow tablets

Exclusion Criteria:

* pregnant
* breastfeeding
Spinal Cord Injury: Impact on Sensory, Motor, Behavioral and Cognitive Functions

Spinal cord injury (SCI) causes a variety of sensory-motor deficits and neuropsychological consequences. Magnetic resonance imaging (MRI) reveals a reduction in the volume of the somato-sensory and motor cortices, as well as atrophy in the white matter bundles. In addition, disturbances in cerebral activity are observed in several areas, notably the motor cortex and the prefrontal cortex. The aim of this study is to understand the evolution of brain function after SCI in comparison with a control group of healthy volunteers.

We distinguish between patients with incomplete sensorimotor deficits (ASIA B,C,D) and complete sensorimotor deficits (ASIA A).

Both patient groups will have a multimodal assessment at 1 week, 3 months and 12 months after SCI with MRI and neuropsychological tests.

The group of healthy volunteers will only perform one MRI.

Lesions of the spinal cord induce sensory-motor deficits and have various neuropsychological effects. MRI shows a reduction in the volume of the somatosensory and motor cortices, as well as atrophy of the white matter bundles.

Disturbances in brain activity are observed in several critical areas. Patients may experience cognitive impairment and an increased risk of depression and anxiety. Although deep brain stimulation and transcranial magnetic stimulation have shown positive effects, the efficacy of these treatments remains limited, partly due to insufficient understanding of post-SCI brain changes.

The cognitive and behavioral consequences of spinal cord injury are poorly understood and mainly treated by symptomatic therapies, which are often ineffective and may have side effects.

A better understanding of brain networks and their plasticity after spinal cord injury could facilitate the development of targeted therapies, such as cortical or deep basal ganglia stimulation.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 to 80
* informed consent
* patient with MCT in the previous week
* clinical neurological examination demonstrating a sensory-motor deficit (the severity of which will define the group to which the patient belongs) associated with MCT.

Exclusion criteria:

* Impossibility of following the patient during the study period
* Consent not obtained (adults, non-emancipated minors, persons unable to give consent, research carried out in emergency situations, etc.),
* Not affiliated to a social security scheme,
* Persons under court protection,
* Other life-threatening systemic impairment,
* Prior cognitive impairment,
* Contraindication to MRI (pacemaker, metallic foreign body, etc.).
Body Awareness Therapy and Biomarkers in Fibromyalgia

A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of stretching. Sessions of BBAT lasted 90 min each and took place twice a week form 12 weeks. The primary end point is a change in the biomarkers and neurotransmitters and the Fibromyalgia Impact Questionnaire and the secondary end points include Visual Analog Scale, State Trait Anxiety inventory, Beck Depression Inventory. All assessments will be repeated at post treatment, 12 and 24 weeks and 1 year follow-up.

This work is a clinical trial of randomized and controlled groups. The hypothesis of study is that BBAT applied in patients with fibromyalgia improves, more than stretching exercises, the pain, normalization biomarkers, improve in psychological state and quality life.

The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in Consorci Sociosanitari of Anoia, the patients will be divided in 2 groups, control and treatment group. The groups will be examined at the begin, at 2 weeks, at the end of treatment and 3, 6 and 12 months follow-up.

The dependence measurements will be biomarkers serotonin, dopamine and cortisol, also Visual Analog Scale, State Trait Anxiety Inventory (STAI A/R), Beck Depression Inventory (BDI-II) and Fibromyalgia Impact Questionnaire (FIQ). The independence measurements will be demographic items: sex, age, country, level of studies, social status...

Eligibility Criteria:
Inclusion Criteria:

* whose diagnosed of fibromyalgia almost 6 months before
* whose could be in different position such as lying, sitting, and stand-up

Exclusion Criteria:

* whose are diagnosed of disease that it worse the pain
* pregnancy
* whose are diagnosed of other disease such as rheumatology, neurology, cardiac problems o another internal medical condition,malignant disease or acute infections
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device

The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox.

ViOptix probes will be secured to the arm and hand. The recording process on the ViOptix machine will begin and obtain baseline StO2 levels for 5 minutes. After 5 minutes, a blood pressure cuff will be inflated on one arm. This blood pressure cuff will be left inflated for 10-20 minutes. Every 2 minutes a pulse check or doppler exam will be performed at your wrist. Last, the cuff will be deflated and the you will be free to leave the study room.

The rate of decline and pattern seen in tissue oxygenation as quantified by a NIRS device (ViOptiox T.Ox) can be quantified and described by a mathematical model which will allow earlier detection and identification of venous congestion in tissue. The vascular occlusion test has been established as a safe and accurate model to induce various states of vascular insufficiency and occlusion. Specifically the vascular occlusion test has been demonstrated to be an accurate model for inducing venous insufficiency on awake and aware patients. This study will aim to analyze the StO2 data output of the ViOptix in order to establish the earliest signs of tissue failure in various states of vascular compromise.

The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. The data collected will be used to formulate a mathematical model which will allow earlier detection and identification of venous congestion in tissue. Identifying these specific patterns will help to establish an evidence-based approach in recognizing specific problems and patterns associated with tissue compromise that can guide physicians to consider earlier flap salvage measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 volunteers

Exclusion Criteria:

* Subjects with a history of major cardiac disease, peripheral vascular disease including (vascular insufficiency), Raynaud syndrome, blood dyscrasias, pain syndromes, neurologic conditions, major upper extremity soft tissue trauma or previous vascular injury
The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. In this study the investigators would like to compare between these two methods in terms of implantation rate, pregnancy rate and delivery.

It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.

Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.

Not all embryos will always survive the thawing and sometimes they will all degenerate.

Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.

The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.

Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.

The purpose of the present study is to assess which technique will result in better pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent

Exclusion Criteria:

* IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial

Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric patients has not been investigated. This study was designed to determine the effect of perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients

150 children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine guided by ultrasound visualisation were randomly assigned to one of the five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). The primary endpoint was the minimum local anesthetic concentration (MLAC), which was determined using the Dixon up-and-down method. The secondary endpoints were the duration of analgesia and sedation

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II children, aged between 2 and 6 years, who were scheduled for arm and forearm surgery underwent supraclavicular brachial plexus blocks.

Exclusion Criteria:

* any subjects with neurological, neuromuscular, psychiatric, or blood clotting disorders, or known history of active and severe renal, hepatic, respiratory, or cardiac diseases, or known allergy to systemic or local anesthetics or dexmedetomidine
Recovery Management Checkups for Women Offenders

The proposed study is designed to test the effectiveness of recovery management checkups for women offenders (RMC-WO) released from jail to provide continuity of care immediately upon release and to help them manage their long-term recovery. The hypotheses in the first phase were: 1)women assigned to RMC (versus control) will a) return to treatment sooner after the initial release from jail and b) be more likely to receive treatment in the 90 days after release from jail; 2)women who received treatment in the first 90 days post release (vs. no treatment) will be more likely to sustain their abstinence through 90 days post release from a) any alcohol or drugs, b) alcohol, c) cannabis, d) cocaine, and e) opiates; 3)women who maintained their abstinence from any alcohol and other drugs through the first 90 days post release (vs. any relapse) will be less likely to have a) unprotected sex, b) commit any other illegal activity, and d) be re-incarcerated in jail or prison. In the second phase repeated exposure to these efforts on a quarterly basis is expected to further strengthen each of these effects.

The components of the recovery management checkups will include: on-going monitoring via a re-entry meeting, two monthly meetings and quarterly assessments for 3 years, personalized feedback on substance use and high risk behaviors, linkage to community-based substance abuse treatment (when needed), on-site HIV booster sessions (when needed), and treatment engagement and retention support. Motivational interviewing will provide the therapeutic approach to transition women from one step of the change process to another. Combined, these components and therapeutic milieu afford an opportunity for immediate linkage to community-based treatment and HIV prevention as well as ongoing monitoring for relapse and early re-intervention for both substance use and HIV risk behaviors (both public health priorities).

Eligibility Criteria:
Phase 1

Inclusion Criteria:

* adult women offenders with substance problems re-entering the community from county jail programs

Exclusion Criteria:

* had not used substances in the 90 days before incarceration
* had no abuse/dependence symptoms
* were under 18 years old
* lived or planned to move outside Chicago within the next 12 months
* were not fluent in English or Spanish
* were cognitively unable to provide informed consent and were released before the 14th day of incarceration Phase 2

Inclusion Criteria:

* released to the community
* agreed to participate in the study
* completed the initial interview
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent
Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025

This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025
* Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures
* Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
* No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025
* In the judgment of the investigator, extension treatment is in the best interest of the subject
* Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception \[including at least 1 barrier method\])
* Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible

Exclusion Criteria:

* Significant risk of suicidal or violent behavior in the judgment of the investigator
* Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
* Any condition that would make the subject in the judgment of the investigator unsuitable for the study
* Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study