cyrilzakka/clinical-trials huggingface dataset:
Self-harming Behaviors Study of Adolescents in a Juvenile Detention House

Incarcerated adolescents engage in suicide ideation, self-harming behaviors and have poor coping abilities, suggesting a need for mental health intervention and treatment. Previous research on self-harm among community adolescents revealed that self-harmers were more likely than non-self-harmers to report suicidal ideation, and having made a suicide plan.

This study plans to evaluate the suicidal intent of self-harming and non-self harming adolescent admitted at juvenile detention house in Taiwan. Furthermore, this study also plans to identify the prevalence and types of self-harming activities of incarcerated youths. Another purpose is to investigate the coping abilities of incarcerated youth, with evaluation of efficacy of short problem-solving skills therapy intervention by trained psychologists of three sessions for adolescents with poor coping adjustment; referral to adolescent psychiatrist when severe mental disorder or poor coping abilities were found.

By analyzing their suicidal ideation, self-harming behaviors, and coping adjustment, the investigators will be able to give timely intervention and identify effective means and methods for better serving this population. This study hopes to help the incarcerated youth to replace their self-destructive behaviors with effective coping adjustment abilities.

Suicide among youth ranked third in Taiwan. According to a study by Lin, stressors include family, school and friends. Psychiatric symptoms also played a role (Lin, 2002) . Incarcerated adolescents with poor coping adjustment will be referred to psychologists. The psychologists were trained by the juvenile detention adolescent psychiatrist.

Taiwanese adolescents have very high rate of self-harming activities, furthermore, incarcerated adolescents are expected to have a higher rate of self-harming activities. There are few studies done on self-harming activities, suicidal intent and coping style of incarcerated youth in Taiwan. According to a study on self-harming adolescents in a juvenile correctional facility, these youth have higher rates of suicide attempts and use more violent methods of attempt than adolescents in the general population (Penn, 2003). They also have poor problem-solving skills. We hope to study their suicidal ideations, self-harming behaviors, and coping styles in order to offer appropriate and timely intervention. We can then offer skills to deal with similar triggering events in the future.

Furthermore, it is hoped that recidivism can be reduced after psychopathological intervention.

Eligibility Criteria:
Inclusion Criteria:

* youth admitted at juvenile detention center on Jan 1,2010 up to Dec 31,2010

Exclusion Criteria:

* currently emotionally unstable, are suffering from active psychotic process like schizophrenia, mentally retarded, illiterate or refuse to participate.
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (18-75 years of age)
* At least two cardiovascular disease risk factors
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
* Abnormal pancreatic, liver or renal function
* Abnormal serum creatine kinase (CK) above the pre-specified level
Antipsychotic Medicine and Metabolic Syndrome

The purpose of the study is to determine whether antipsychotic treatment is influence psychiatric patients due to endocrine and metabolic status and a quality of life.

The investigators expect, that 30-50% of patients will show pharmacon - gene induced weight gain (\> 7% of initial bodyweight) while the rest of patients will maintain unaltered bodyweight.

The primary aim of this study is to investigate status of neuro-and enteroendocrine axes with focus on beta - cell function in relation to insulin resistance, lipid profile abnormalities and inflammations adipokins in patients during treatment with antipsychotics (AP) in relation to weight gain.

The second aim is to evaluate the connection between weight gain and patients´ own perception of their quality of life and health.

Eligibility Criteria:
Inclusion Criteria:

* gender : male
* age: 18-45
* treatment with minimum one Antipsychotic drug (AP)
* ethnicity: caucasians
* consent given to take part in the project

Exclusion Criteria:

One criteria is sufficient to exclude patients from the study:

* compliance problems
* unable to read, write and talk Danish
* patients with major lung-,heart-, lever- and kidney problems
* patients with diagnose and treatment for Diabetes 1 and 2
* patients taking cholesterol-reducing, weight-reducing and antihypertensive medication
* patients with abuse of alcohol or drugs
* patients who are under duress §
* patients who have been mentally ill for more than 15 years
* patients with diagnosis/treatment for NIDDM/IDDM
Fusion Targeted Biopsy of the Prostate

The objective of the proposed study is to evaluate a new, molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D) ultrasound images and has sampling errors thus some cancers can be missed from the standard 2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound scanner. The clinician can use the 3D images to guide biopsy, record the core location of the biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination. This system can also use images from magnetic resonance imaging (MRI) or positron emission tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy technology will help to improve the accuracy of the current systematic biopsy approach for prostate cancer detection.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older
* Abnormal uptake in prostate necessitating a biopsy
* Able to provide informed consent

Exclusion Criteria:

* Age less than 18
* Cannot provide informed consent
* Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation)
Enhancing Attention in Adults With Compulsive Hoarding

Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.

Compulsive hoarders perform significantly worse than healthy controls on standard attention tasks. These data suggest that the inability to sustain focus may interfere with hoarders' ability to organize, categorize and make decisions about discarding possessions. Stimulants are first-line treatments for ADHD, improve CPT performance in people with ADHD and enhance school performance in children with ADHD. Extended release formulations, such as methylphenidate ER, are associated with better medication compliance. Together, these data suggest that adjunctive methylphenidate ER might be a novel way to improve attention in compulsive hoarders which might improve hoarding symptoms.

The investigators hypothesis is that adjunctive methylphenidate ER will improve attention in compulsive hoarders aged 18-55. The investigators will also explore the safety of methylphenidate ER administration in compulsive hoarders.

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant compulsive hoarding (Proposed DSM-V criteria) that is principal (i.e. currently most severe and needing of treatment) and has been present for at least one year.
* At least moderate attentional difficulties.
* Able to provide consent.
* Patients can be on or off of serotonin reuptake inhibitors (SRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) but dose must be stable for 12 weeks prior to study.

Exclusion Criteria:

* Currently taking any psychotropic medications other than SRIs or SNRIs.
* Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder.
* Current major depression is permitted if clearly secondary in importance to the hoarding.
* Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors)
* Any cardiovascular abnormality that increases the risk of participation, including significant history of cardiovascular disease or family history of sudden death.
* Any medical or neurological disorder that increases the risk of participation or that is a medical contraindication for taking methylphenidate (e.g. glaucoma or Tourette's syndrome).
* Current use of any drug that is contraindicated with methylphenidate (e.g. monoamine oxidase inhibitors).
* Female patients who are pregnant or nursing.
* Current or previous treatment with methylphenidate or CBT for hoarding.
* Current ETOH/drug abuse or dependence disorder of dependency in the past 6 months.
* Individuals with mild cognitive impairments, dementia, or significant intellectual deficits.
Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level

The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.

All subjects are being studied using the same procedure. The study schedule takes place from 8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show up fasting overnight with a break in insulin and/or oral antidiabetic treatment.

The study eye of each subject will be selected by randomisation. We seek to have an equal distribution of right and left eyes overall.

A first set of images will be taken after 5 minutes in "standardised daylight", in a room without light from outside, which eliminates any concerns about weather variations. After this the room is completely darkened. 2 set of images will be taken in the dark adapted state after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same "photo session" as above with high blood glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic individuals.
* minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs

Exclusion Criteria:

* Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease
Examining the Genetic Predictors of Coronary Artery Calcification in African Americans

Coronary artery disease (CAD) is an important health concern for African Americans, who are diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will examine the possible genetic causes of coronary artery calcification in African Americans.

In the United States, more people die from CAD than any other disease, with African Americans, particularly women and young men, being more affected by CAD than European Americans. One cause of CAD is atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Coronary artery calcification occurs as a result of atherosclerosis and is characterized by calcium build up in the arteries. Non-invasive imaging, including computed tomography (CT) scans, of coronary artery calcification is an effective way to assess CAD risk. The Genetic Epidemiology Network of Arteriopathy (GENOA) study, which is part of the Family Blood Pressure Program (FBPP), is a study that examined siblings with high blood pressure during two exams conducted between 1995 and 2004. The purpose of this new GENOA study, which will enroll past GENOA participants, is to identify genetic factors that may lead to the development of coronary artery calcification in African Americans. Conducting genetic studies in the African American population will result in greater understanding of the mechanisms of atherosclerosis, and may lead to improved strategies for the early identification of people at risk for CAD and the development of new treatments for CAD.

This study will enroll people who have participated in the second GENOA exam and who live in Jackson, Mississippi. Participants will attend one study visit at the University of Mississippi Medical Center. During the study visit, participants will be interviewed by study staff about their medical and family health history; health behaviors; physical activity levels; and use of tobacco, alcohol, and medications. They will complete a walking activity and tasks to assess memory, thinking speed, and accuracy. Participants will also complete a questionnaire about their mood, a physical examination, a CT scan of the heart, and a blood collection. A portion of blood will be stored for future research studies.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the second GENOA exam in Jackson, Mississippi and is alive and willing to participate

Exclusion Criteria:

* Reported a history of heart attack, stroke, or coronary or non-coronary heart surgery
Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

The purpose of this study is to evaluate the safety of HLA-A\*2402 restricted epitope peptides CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\*2402 restricted epitope peptides derived from these molecules and identified that these peptides significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of these peptides. Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptides vaccine. Also we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent breast cancer
* Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*2402
* Laboratory values as follows

  * 2000/mm3\<WBC\<15000/mm3
  * Platelet count\>100000/mm3
  * Bilirubin \< 3.0mg/dl
  * Asparate transaminase \< 150IU/L
  * Alanine transaminase \< 150IU/L
  * Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
* Decision of unsuitableness by principal investigator or physician-in-charge
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"

A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
3. Signed written informed consent.
4. Adequate contraception in case of women with child-bearing potential

Exclusion Criteria:

1. Lymphoblastic lymphoma with bone marrow blasts\<20%.
2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
3. Major surgery within 4 weeks before enrollment.
4. Impaired cardiac function: ejection fraction \<40% on echocardiography, QTc interval \> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
6. Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
7. Serum creatinine \> 2 times the upper normal limit of the laboratory, total bilirubin\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \> 5 upper normal limit, unless related to Acute lymphoblastic leukemia
8. Intolerance to treatment with monoclonal antibody.
9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
10. Inability to obtain written informed consent.
11. Inability to comply with regular monitoring.
Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression

The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects experiencing a moderate to severe episode of depression.
2. Subjects experiencing a current episode of depression for at least 2 months.
3. Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
4. Male and Female participants 18 to 75 years of age at the time of consent.
5. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.

Key Exclusion Criteria:

1. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
2. Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
3. Subjects with a history of medical conditions that may interfere with the conduct of the study.
4. Females who are pregnant, breastfeeding or planning to become pregnant.
Extraction Routes of Intraocular Foreign Body

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis. The surgical approach for a posterior segment IOFB is pars plana vitrectomy and its extraction either through the pars plana. our study is to compare limbal route versus pars plana route for extraction of posterior segment IOFB associated with cataract as regard to safety and complications.

Penetrating ocular injuries with retained posterior segment intraocular foreign body (IOFB) are relatively common and account for 17% to 41% of ocular injuries.

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and sympathetic ophthalmia.

The surgical approach for a posterior segment IOFB is pars plana vitrectomy (PPV) and its extraction either through the pars plana or the limbus.

PPV and IOFB extraction through sclerotomy is the most commonly used approach. Most commonly retained posterior segment intra ocular foreign bodies (IOFB) are removed after enlarging one of the sclerotomy ports during pars plana vitrectomy. Intra operative complications reported during IOFB extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the wound, IOFB slippage. Reported post-operative complications were glaucoma and retinal detachment. Incidence of post-operative RD was reported to range from 22% to 79% with poor visual outcomes in most cases PPV and IOFB extraction through the limbal route is an alternative approach to remove IOFB. Complications reported were less frequent and include microscopic hyphema and vitreous hemorrhage. The incidence of post-operative retinal detachment after IOFB extraction through limbus was reported to range from 7.15% to 27.7 % The limbal route for retained posterior segment IOFB extraction can offer the following advantages: it allows visually controlled delivery of the IOFB from the posterior pole to the limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating a peripheral retinal break during extraction of intraocular foreign body, in contrast to the hidden part behind the iris when using the pars plana route.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with retained posterior segment intraocular foreign body associated with crystalline lens injury.
* Eyes with retained posterior segment intraocular foreign body associated with coexisting cataract.

Exclusion Criteria:

* Eyes with pre-operative retinal detachment
* Eyes with retained posterior segment IOFB with clear lens.
* Anterior segment IOFBs
* Severely damaged eyes with an initial visual acuity of no light perception where enucleation is the primary treatment
* Patients with severely traumatized cornea which can affect visualization during vitrectomy.
* Pseudophakic eyes.
* Eyes with endophthalmitis