cyrilzakka/clinical-trials huggingface dataset:
Mental Health Services for Prisoners With SMI

Interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with serious mental illness (SMI) because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison, including improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes).

Interventions are urgently needed to improve the delivery and impact of mental health services for persons with serious mental illnesses (SMI) in prison. Treatments addressing the symptoms of mental illness form a critical component of the continuum of services needed by prisoners with SMI. However, a growing body of literature shows that mental health treatments need to be combined with treatments that directly address criminogenic risk factors (i.e., those factors most closely associated with criminal activities). Despite promising evidence, interventions that address criminogenic risk factors, such as Thinking for a Change (T4C), are not used with prisoners with SMI because of the neurocognitive and social impairments associated with SMI. This study examines the effectiveness of T4C with a modified delivery system designed specifically to address the unique needs of persons with SMI in prison. This small-scale randomized controlled trail (RCT) explores the potential effectiveness of T4C-SMI towards improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes). The study will also examine whether the treatment targets for T4C-SMI mediate the intervention's impact on outcomes.

The long-term goal is to grow the evidence-base for interventions with the capacity to improve prison and community-reentry outcomes for persons with SMI. This study will provide the data needed to implement a rigorous RCT in a future study and supports NIMH's mission to develop innovative interventions in mental health services.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features
* have moderate to high risk levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
* have at least one year or more remaining on their prison sentence at the time of the screening interview

Exclusion Criteria:

* has participated in T4C-SMI within 6 months prior to study
Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT).

The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing EGD

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* PPI intake
* antibiotic use, actual or within the last 4 weeks
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0.
* Subject must have a Nail Psoriasis Physical Functioning Severity score of \> 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of \>3.
* Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.
* Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.
* Target fingernail must have mNAPSI score of ≥ 8.
* Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months).

Exclusion Criteria:

* Prior adalimumab therapy.
* Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.
* Recent infection requiring treatment.
* Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
* History of cancer, except successfully treated skin cancer.
Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Degenerative Cervical Diseases

The study aims to compare the effectiveness of soft tissue, joint mobilization, and tele-rehabilitation within the scope of Manual Therapy to the exercise program.

60 subjects with cervical degenerative disease will be included in the study after a voluntary consent form is filled out. Subjects will randomly be divided into 3 groups according to the order.

Group 1:Home Exercise Program: After a general education is given to the patients, an exercise program will be taught. Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks, and fill in follow-up charts. In addition, reminder messages will be sent to these patients once a week by the physiotherapist.

Group 2: Manual Therapy Group: After a general education is given to the patients, the same exercise program will be taught. Soft tissue and joint mobilizations will be applied to the patients in this group within the scope of Manual Therapy (MT). Mobilizations of the cervical vertebrae, scapula, and thoracic vertebrae will be included. MT will be applied to the patients 2 days a week for 8 weeks.

Group 3: Tele-Rehabilitation Group: After general education, treatment will be given in the zoom environment. During the 8 weeks, regularly planned exercises will be done via Zoom for 30-45 minutes 2 days a week, accompanied by a physiotherapist. Patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, mobilization of the thoracic region with a foam roller. Patients will apply those self-mobilization at home in front of the physiotherapist in a visual environment. Patients in this group will regularly do the same home exercises on the other days without tele-rehabilitation.

Measurement and evaluation will be done four times, as pre-treatment, post-treatment (8th week), first follow-up (12 weeks), second follow-up (6th month).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 40-65
* Patients diagnosed with cervical degenerative disease
* Patients with neck pain who have had pain for at least three months
* Patients who can participate in the treatment program by following WhatsApp messages with tele-rehabilitation.

Exclusion Criteria:

* Patients with an indication for surgery for the cervical region and or a previous history of cervical surgery,
* Currently receiving treatment from another region,
* Having severe neurological loss,
* Having a primary or spinal metastatic malignancy,
* Having a vascular problem in the upper extremity,
* To be diagnosed with advanced osteoporosis,
* Being pregnant,
* Diagnosis of Diabetes Mellitus,
* Having an Inflammatory Disease (such as rheumatoid arthritis),
* Having a history of trauma,
* Those who have received physical therapy and rehabilitation for the cervical region in the last 6 months will not be included.
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias

Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia. In response certain Abbott (former St Jude Medical) pacemakers have a specific PVC response algorithm ''Atrial Pace''. In this algorithm the PVARP (Post Ventricular Atrial Refractory Period) is extended to 480ms but the initial 150ms of the PVARP is deemed absolute. If atrial sensed event occurs after absolute PVARP the PVARP terminates and atrial pace follows after 330ms alert period. Two case reports exists where patients atrial tachycardia were suspected to be induced by this algorithm. In Helsinki University Hospital an index patient with multiple atrial tachycardia episodes was recognized in late 2020 where the cause of the tachycardias was suspected to be the PVC response algorithm ''Atrial Pace''. After programming the algorithm from Atrial Pace to off mode the patient had none atrial tachycardias during 2021. After investigating all the patients with physiological ICD (Implantable Cardioverter Defibrillator) or CRT-D (Cardiac Resynchronization Therapy) device and analyzing remote monitoring transmissions from the year 2020 we found 25 patients with similar atrial tachycardia episodes possibly induced by the PVC response ''Atrial Pace''.

The device of the subjects participating to the study is interrogated and the PVC response algorithm is switched from ''Atrial Pace'' to ''Off'' mode.

Subjects are also requested to fulfill the EQ-5D-3L and ICD8 questionaries before the change in the device programming and after the 12 months surveillance.

Eligibility Criteria:
Inclusion Criteria:

* ST Jude Medical or Abbott physiological ICD or CRT-D device
* PVC response setting ''Atrial Pace''
* Atrial tachycardia episode duration \> 30s preceded by ventricular extrasystole and atrial pace in year 2020 or 2021

Exclusion Criteria:

* Permanent atrial fibrillation, duration ≥ 6 months before the enrollment to the study
* PVC response has been switched off before enrollment
The OneFreeze Study

The One Freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillation.

The One Freeze Trial is an investigator-initiated trial that has been developed by the Principals at the University of California, San Francisco (UCSF) and with full participation of the Steering Committee. One Freezel is a prospective multicenter randomized controlled trial with a goal to enroll and randomize a minimum of 90 study participants. Participants will be randomized in a 1:1 ratio to either PVI with a single freeze per pulmonary vein (1F Group) or to PVI with at least two freezes per pulmonary vein (2F Group). The One Freeze study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results in a lower composite adverse event score as compared to the traditional method of using two 3-minute cryoablations per pulmonary vein.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation
* Age ≥ 18 years
* Life expectancy ≥ 1 year
* Willing and able to return to and comply with scheduled follow-up visits
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of \> 5 electric cardioversions
* History of previous pulmonary vein isolation ablation for atrial fibrillation
* History of MAZE procedure
* Left ventricular EF ≤ 35% within the past 12 months
* Mechanical mitral valve
* Single PV \> 30 mm in diameter, unless deemed appropriate by the site PI
* Stroke/TIA within the past 6 months
* Creatinine \> 2.0 mg/dL within the past 6 months
* Pregnancy or desire to get pregnant within the next 12 months
* Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study
* Mental impairment or other conditions, which may not allow the participant to understand the nature, significance and scope of the study
* Any other condition or circumstance that in the judgment of the Clinical Site Investigator that makes the participant unsuitable for the study
Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 17 years of age
* Are scheduled for uncomplicated unilateral cataract surgery
* Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
* Are willing and able to follow all instructions and attend all study visits
* Are willing to avoid disallowed medication for the duration of the study
* If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
* Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
* Additional inclusion criteria also apply

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study drugs
* Have any sign of iritis or scleritis in the study eye
* Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
* Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
* Have known blood dyscrasia or bone marrow suppression
* Have any active corneal pathology in the study eye
* Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
* Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
* Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
* Use of any medication the investigator feels may interfere with the study parameters
* Additional exclusion criteria also apply
Vasopressin Deficiency in Hemorrhagic Shock

In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.

This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a male or female patient presumed to be at least 18 years of age;
* Patient has a reported or actual systolic blood pressure \< 90 mmHg within 1 hour of arrival to the Emergency Room;
* Patient has clinical evidence of acute traumatic injury;

Exclusion Criteria:

* Patient is asystolic or requires CPR prior to arrival;
* Patient was transferred from an outside facility
* Patient known to be pregnant
* Patient known to be prisoner
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness

The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.

In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.

Eligibility Criteria:
Inclusion Criteria:

* diabetes melittus
* sedentary
* inspiratory muscle weakness with PImax \< 70% of the predicted

Exclusion Criteria:

* mass index \> 33 kg/m2
* exercise-induced asthma history
* infectious disease
* osteoarticular disease
* regular alcohol or tobacco consumption in the past 6 months
* cardiac disease
* pulmonary disease
Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:

• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?

Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients from 3 to 7 years.
* American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
* Patients undergo squint surgery.

Exclusion Criteria:

* Declining to give written informed consent by patient legal guardian.
* Age younger than 3 years or older than 7 years.
* ASA classification ≥ III.
* History of allergy to the medications used in the study or egg products.
* Psychiatric disorder
* Other co-morbidities or congenital anomalies or neurological.
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.

This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting dermal melasma with Fritzpatrick skin type III to V
* Malaysian citizen
* Agreed to participate
* Provide informed consent

Exclusion Criteria:

* Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
* Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
* Patients who photosensitivity or taking drugs known to induce photosensitivity,
* Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
* Patients who could not attend follow-up treatments
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position

Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position.

Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary endpoint is the difference in maximal change of QTc interval between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robot-assisted laparoscopic prostatectomy
* Age more than 19 years

Exclusion Criteria:

* Preoperative electrocardiography (ECG) abnormalities, including a QTc interval of \>500 ms, ventricular conduction abnormalities, or arrhythmias
* History of cardiac disease such as pacemaker insertion, unstable angina
* Use of antiarrhythmic agents or medications that are known to prolong the QTc interval
* Abnormal levels of preoperative serum electrolyte