cyrilzakka/clinical-trials huggingface dataset:
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings

This is a single-blind, open-label, randomized, active comparator (TAU) controlled clinical trial to examine the effects of clozapine vs. TAU on the risk for violent acts as measured by the MacArthur Community Violence Interview (MCVI) and to examine the effects of clozapine vs. TAU on the Excitement Factor of the PANSS. Adults age 18-65 with schizophrenia or schizoaffective disorder who have committed a violent act within 6 months and are appropriate for treatment with clozapine or TAU will receive treatment for 24 weeks which will be naturalistically administered. Participants will also participate in assessments and appropriate medical monitoring which will include blood draws, pharmacokinetic blood samples, and physical exams, etc. Cox proportional hazards survival modeling will be used to test the association between treatment group and time until first violent act after randomization (i.e., number of weeks form randomization to violent act).

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)
* commission of a minor or serious act of violence as measured by the MCVI in the last six months
* willing and able to provide informed consent
* medically stable in judgment of physician providing study treatment
* appropriate for treatment with either clozapine or TAU, i.e., that there is clinical equipoise between the two treatment options. Individuals who are currently medication free or on any antipsychotic, with the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible

Exclusion Criteria:

* An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow
* A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)
* A history of intellectual impairment
* pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control
* Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine
* Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial
Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study

Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.

Exclusion Criteria:

* 1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.
Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

In this study investigator's aim to assess the effect of a type of non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in conjunction with fluoxetine on motor recovery after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic infarction within the past 2 years post event that has caused hemiparesis or hemiplegia, as self-reported and/or confirmed by medical record.
* Older than 18 years old.
* Upper extremity weakness defined as a score of \>11 and ≤56 on the arm motor Fugl-Mayer motor scale.
* Minimal pre-stroke disability defined as a score of \<3 in the Modified Rankin Scale.
* Subjects need to be able to follow directions and participate in 2 hours of testing with short breaks.
* Subjects need to be able to provide informed consent.

Exclusion Criteria:

* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instruction for motor testing
* Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects), as self reported
* Contraindications to single pulse TMS (will be used to measure cortical excitability) such as: history of seizures, unexplained loss of consciousness, any metal implants in the head, frequent or severe headaches or neck pain, any other electronic implanted medical devices such as pacemakers, defibrillators, or implant medication pump.
* Patients who have taken fluoxetine in the past 5 weeks.
* Patients taking any other SSRI at the time of enrollment or in the previous month.
* Patients taking any other medication likely to have adverse interaction with SSRIs (all the medications the patient is taking will be carefully reviewed, as noted below in "Monitoring of important drug interactions").
* Active depression on admission to SRH defined by a score of 24 or higher in the Hamilton Depression Rating Scale (HAM-D)
* Concurrent medical condition likely to worsen patient's functional status in the next 6 months such as: cancer, terminal heart, kidney or liver disease, as self-reported and/or confirmed by medical record.
* Pregnancy.
Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period

Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region


Eligibility Criteria:
Inclusion Criteria:

* Lp(a) ≥ 70 mg/dL at the screening visit
* Optimal LDL-cholesterol lowering treatment
* Optimal treatment of other CV risk factors
* Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
* Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
* Clinically significant symptomatic peripheral artery disease

Exclusion Criteria:

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per μL
* Active liver disease or hepatic dysfunction
Multicenter Trial Assessing an Innovative VAS of Pain Among Deaf People

The purpose of this study is to assess an innovative Visual Analogue Scale of pain (pictorial VAS) versus the usual VAS (VAS) among Deaf People.

The assumption of this study is that pictorial VAS is more suited to Deaf people than usual VAS.

Indeed French literature showed that 80% of Deaf people are illiterate. Moreover, lip-reading only allows to recognize one third of words.

Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.

Eligibility Criteria:
Inclusion Criteria:

* people aged over 18 years old
* Deaf people
* affiliation to the french social security system or equivalent
* people who signed the consent form

Exclusion Criteria:

* hearing people
* people who became deaf
* pregnant or breastfeeding women
* people deprived of freedom
* people hospitalized without consent
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

Approximately 90 subjects will be enrolled in this study. Subjects will be assigned to study drug (tinlarebant 5 mg/placebo) with treatment period of upto 24 months with 28 days of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 12 to 20 years old, inclusive.
* Subject must have clinically diagnosed STGD1 (Stargardt disease 1) with at least 1 mutation identified in the ABCA4 gene.
* Subject must have a defined aggregate atrophic lesion size within 3 disc areas (7.62 mm2), as imaged by FAF in the study eye Subjects must have a BCVA of 20/200 or better for the study eye based on ETDRS letter score
* Subject and their parent(s) or legal guardian are willing to provide their consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Human Research Ethics Committee (HREC)-approved informed consent form (ICF) prior to participating in any study-related procedures.
* Subject agrees to comply with all protocol requirements.

Exclusion Criteria:

* Any ocular disease other than Stargardt (STGD1) at baseline that, in the opinion of the investigator, would complicate assessment of a treatment effect.
* History of ocular surgery in the study eye in the last 3 months.
* Investigational drug use of any kind in the last 3 months or within 5 half-lives of the investigational drug, whichever is shorter.
* Any prior gene therapy.
* Vitamin A (retinol) deficiency as defined as a retinol serum level less than 20 mcg/dL (=0.7 μmol/L).
Mechanisms Involved in the Developement of Sports Addiction Among Military Personnel

Sport addiction (or exercise addiction) has been recognized as a pathology by the World Health Organization since 2011. However, it is still relatively under-researched. It is one of the so-called behavioral addictions and has long-term negative consequences for physical, psychological and social health, such as : isolation ; frequent injuries; co-addiction with or as a result of sports'.

The study is aimed in particular at military physicians and will target a population where sport is an integral part of the job and where sporting performance is valued: military personnel.

The aim of this study is to explain and try to understand this pathology through the experiences of those who suffer from it. Therefore, investigators have chosen to conduct a qualitative study inspired by the embedded theory. Semi-structured individual interviews will be conducted using an interview guide. This guide, consisting of 5 or 6 open-ended questions, will help to set the general direction of the interview without preventing the participant from deviating. The interview guide may evolve as the interviews progress, enriched by any new ideas or themes that emerge.


Eligibility Criteria:
Inclusion Criteria:

* Serving or reservist military personnel
* Perceive themselves as "addicted to sport" and say so

Exclusion Criteria:

* Minor
* Incapable major
* Patient unaware of diagnosis
* Pregnant woman
* Legionnaire not rectified
Transformative Audio Storytelling

Pilot testing the feasibility of the Transformative Audio Storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver (family members or significant other person who provides primary care for the patients visiting or being hospitalized in the Rehabilitation Ward)
* Age ≥18 years
* Native speaker of the Italian language
* Having voluntarily agreed to participate in the study and having signed the informed consent in all its points.

Exclusion Criteria:

* Informal caregiver for children
* Informal caregiver who does not personally play this role (primary caregiver)
* Informal caregiver of adults with a tumor pathological condition
Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity

The study evaluates an intervention, The CIrCLE of Life Initiative, which was developed to address HIV and obesity prevention. We evaluated whether the combined HIV and obesity intervention increased knowledge, enhanced skills, and/or promoted healthy behaviour among pre-adolescent students (9-12 years old) and their parents.

The CIrCLE of Life Initiative had both a school and home component, each comprising a learning curriculum, environmental support, and activity-based constituents that aimed to increase student knowledge and skills, and to engage parents. Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools. The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons. Students were asked to communicate their learnings to their parents at home. Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content. The workbook contained shared student-parent homework activities that took approximately 30 minutes per week.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
24-hr Intraocular Pressure Control With SIMBRINZA ®

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either open-angle glaucoma or ocular hypertension;
* Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
* Willing and able to sign an informed consent form;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
* Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
* Ocular surgeries or procedures excluded by the protocol;
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
* Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
* Other protocol-specific exclusion criteria may apply.
Erector Spina Plane Block and Radiofrequency Treatmen

ESP is the deepest back muscle originating from the transverse processes of the vertebrae. Blocks applied to this region are effective for a longer time and in the broader area than those applied to superficial muscles. Recently, pulsed radiofrequency treatments have also been performed in myofascial pain, and successful results have been obtained. The investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy.

Trigger point injections and erector spina planus muscle (ESP) blocks are used to treat back pain related to myofascial pain syndrome. ESP is the deepest back muscle originating from the transverse processes of the vertebrae. Blocks applied to this region are effective for a longer time and in the broader area than those applied to superficial muscles. Recently, pulsed radiofrequency treatments have also been performed in myofascial pain, and successful results have been obtained.

Deep and superficial back muscles, transverse processes of the vertebrae, costume, and pleural movement are identified by ultrasonographic examination. The investigators perform the intervention through the transverse processes. The investigators give 20 ccs of fluid (bupivacaine, steroids, saline). The patients to whom The investigators apply pulsed radiofrequency complete the procedure by giving 20 ccs of fluid after the radiofrequency application on the transverse processes and during the procedure, using 10 cm, 21 gauge radiofrequency needles with an active tip of 10 mm. The radiofrequency wave is applied at 2 Hz, ten milliseconds, and 55 volts for 5+5 for 10 minutes.

The investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy. For this reason, the Visual Pain Scale of each patient will be recorded before the procedure, the second week after the procedure, and the first month. The Centrality of Pain Scale will be applied to these patients at the controls. The correlation between the results of this scale, which evaluates the emotional and physical state of the patients, and the post-treatment pain scales will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* myofascial pain
* normal thoracic examination

Exclusion Criteria:

* additional cardiac disease
* lung disease
* malignancy
Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons

The overall hypothesis of this trial is that screening for chronic kidney disease, followed by education or treatment program will improve blood pressure control among hypertensive non-diabetic persons.

To evaluate a CKD screen-and-educate program in primary care for improving blood pressure management compared with usual care, among non-diabetic adults with hypertension.

Eligibility Criteria:
Inclusion Criteria:

The entire primary care medical practice at SFVAMC will be considered. Randomization will occur at the team (nurse) level. Within each team, individual patients will be considered eligible for chronic kidney disease screening by this protocol and inclusion in our trial if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of chronic kidney disease. Hypertension will be defined as systolic blood pressure \>140 or diastolic blood pressure \>90 mmHg at more than two encounters (any encounter) within the previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9 code). Diagnosed chronic kidney disease will be defined as a documentation of chronic kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We define diagnosed chronic kidney disease without consideration of estimated glomerular filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the medical record, since work from our group and others has shown that awareness and recognition of chronic kidney disease is extremely low, even among persons with documented reduced estimated glomerular filtration rate or albuminuria. Persons will be required to have seen their physician at least one time within the past 18 months.

Exclusion Criteria:

Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular filtration rate \<15 ml/min/1.73 m2 will be excluded from this study as they likely need specialty care for uncontrolled hypertension. Persons aged \>80 will be excluded because data on aggressive blood pressure lowering in this population are less clear and adverse effects associated with aggressive blood pressure control have been well documented. We will exclude persons with New York Heart Association class III or IV heart failure, known ejection fraction \<25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin II Receptor Blockers. Other exclusion criteria relate to the required ability to communicate with providers and provide informed consent: prevalent dementia, impaired cognition or severe mental illness; expected life expectancy \<6 months; severe visual impairment in the absence of an available caretaker who can read.
The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application

This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.

The randomized controlled and experimental study will be conducted with 70 women who apply to a Maternal and Child Health and Family Planning Center to have an Intrauterine Device (IUD). Women in the experimental group (n=35) will listen to music before, during and after the IUD application process, and the control group (n=35) will undergo routine IUD application. Information Form containing sociodemographic information, Situational Anxiety

Eligibility Criteria:
Inclusion Criteria:

* Knowing how to read and write,
* Not having had an IUD inserted before,
* Being between the ages of 18-49,
* No hearing-related problems,
* Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
* Voluntarily participating in the study,

Exclusion Criteria:

* The woman has a cognitive and auditory problem
* Having a history of cervical surgery
Online TP (Training Program) on SC (Social Cognition) for Schizophrenia

Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. Fifty-seven met criteria and agreed to participate in the study. The conditions of cognitive rehabilitation were assigned randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program was used. Two groups were followed at 8 and 12 months after the baseline.

This work was developed in the island of Tenerife (Spain) within a public service specialised in labour integration of people with disabilities in which an IPS team was set up in 2005. The study was carried out in collaboration with the units of community mental health of the island. These units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. All research procedures were approved by the Medicine Committee of Canary Health Services.

The follow-up period for the data collection was set between 2013 and 2014. Employment specialists belong to a public institution specialized in work disability.Sixty-five participants but only 57 signed written informed consent and completed the baseline. Two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with IPS alone

Eligibility Criteria:
Inclusion Criteria:

Participants had to:

1. comply with the state definitions of severe mental illness (SMI), which includes an ICD-10 (World Health Organization, 1992) diagnosis of F20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and F31-F32.3 (major mood affective disorders)
2. have previous difficulties to maintain a job
3. currently want a competitive job and
4. accept the job search starts

Exclusion Criteria:

People with no Severe mental illness and not want to participate