cyrilzakka/clinical-trials huggingface dataset:
MISSION-CJ for Justice-Involved Homeless Veterans

The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, employment, community integration) among justice-involved, homeless Veterans with a co-occurring substance use and mental health disorder.

VHA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs) serve Veterans with an estimated 50% having criminal justice involvement annually. Justice-involved Veterans (JIVs) receive assistance with their addiction and behavioral health needs, but MH RRTP programs do not directly address their antisocial behaviors and cognitions. Furthermore, MH RRTP discharge is a vulnerable transition and no national transitional approach facilitates Veteran's engagement in prosocial community behaviors that sustain MH RRTP gains, ultimately reducing revolving door service use.

Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a new case manager and peer delivered team-based treatment for JIVs with a co-occurring substance use and mental health disorder (COD). While MISSION-CJ derives in part from an evidence-based treatment for homeless individuals (MISSION), it includes a new conceptual framework and numerous new and differentiating features for a CJ population including: (1) a treatment planning tool focused on criminogenic needs that monitors progress and tunes service delivery elements; (2) a prosocial treatment curriculum; and (3) tools/resources to address JIVs' legal issues. With MISSION-CJ, this study attempts to change the practice paradigm and transform care for JIVs by moving beyond the current model of linking Veterans to VA care and tracking behavioral health outcomes, to a hybrid treatment/linkage approach that addresses criminogenic needs, supports engagement in VA and non-VA care, and targets recidivism as an outcome-the gold standard for CJ research.

Using a Hybrid Type 1 design, this project will test the effectiveness of MISSION-CJ in a three-site RCT (Bedford, Palo Alto, and Little Rock VAs) with JIVs with a COD, admitted to an MH RRTP, and previously arrested and charged and/or released from incarceration in the past 5-years.

Eligibility Criteria:
Inclusion Criteria:

* (a) are entering a Mental Health Residential Rehabilitation Treatment Program (MH RRTP)
* (b) were arrested and charged and/or released from incarceration in the past 5 years
* (c) have a co-occurring substance use and mental health disorder (COD)

Exclusion Criteria:

* The only exclusion criterion is being too cognitively impaired to understand the informed-consent process and other study procedures.
Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.

Cardiovascular response to exercise affects the capacity of all body organs depending upon intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank with treadmill moderate intensity exercises on heart rate variability in normal participants.

A one hundred thirty male volunteers were equally and randomly assigned to; Group-I: Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Group-II: Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Halter heart rate monitor and automatic sphygmomanometer were used to measure heart beat intervals and arterial blood pressure respectively.

Eligibility Criteria:
Inclusion Criteria:

* Normal adult non-obese male subjects , their age ranges from 25-36 years.
* They were asymptomatic for cardiovascular and respiratory diseases.
* They currently did not receive any medical prescriptions.
* All participants were asked to avoid strenuous exercise, give up caffeine and alcohol beverages to have sufficient rest for 2 days before measurement sessions to avoid any carry over effects of stimulants or depressants on autonomic functions

Exclusion Criteria:

* Any participant had medical history of cardiovascular and pulmonary disorders or received any interfering medications with study was excluded
Effect of Donepezil on the Reorganization of Cognitive Neural Network in Patients With Post-Stroke Cognitive Impairment

The purpose of this study is to demonstrate the efficacy and safety of donepezil on the recovery of cognitive function in patients with stroke and to delineate the neurophysiologic mechanisms of the therapeutic effect of donepezil on the recovery of cognitive network using functional neuroimaging technique.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke in the territory of right or left middle cerebral artery
* Post-onset duration of the recent-onset stroke is over 3 months
* Cognitive deficit ranged from 10 to 26 by minimal mental status examination (MMSE) score
* Disturbance in activities of daily living (ADL) ranged 0.5 \~ 2.0 by clinical dementia rating (CDR) scale

Exclusion Criteria:

* Severe internal carotid artery stenosis on the lesion side
* Cardiac pacemaker or intracranial metal insertion
* Post-stroke seizure disorder or any evidence of epileptic spikes on electroencephalography (EEG)
Blood-brain Barrier Permeability Study in Adults With Meningitis

The purpose of the study is to confirm the applicability and usefulness of the novel method of assessment of the permeability of the blood-brain barrier and in monitoring of the treatment of patients with meningitis. The proposed technique is based on evaluation of the kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared spectroscopy (NIRS). Usefulness of the NIRS-based method will be analyzed in relation to the reference method, which is contrast-enhanced magnetic resonance imaging (MRI).

Clinical trials in healthy volunteers and in patients with diagnosed blood-brain barrier disruption:

* Performing a lumbar puncture as a routine diagnostic procedure in a patient with suspected neuroinfection. Biochemical assessment of the degree of the blood-brain barrier disruption based on the albumin ratio.
* Enrollment of patients diagnosed with neuroinfection to the study and obtaining informed consent.
* Performing the measurement involving fixation of the NIRS probes on the patient's head while intravenously injecting optical contrast agent - ICG (5-10 mg in a bolus). The measurement time is about 15 min. Monitoring of the patient's condition during the examination using a pulse oximeter monitor. The examination should be performed no later than 12 hours after the lumbar puncture to obtain a reliable correlation of results between the methods. The party responsible for the technical aspect of the investigation will be the Sponsor while the party responsible for the medical aspect (including the injection of the contrast agent) will be the Principal Investigator.
* Conducting a magnetic resonance test. The MRI imaging can be carried out before or after the test by the optical method, but with only a slight time delay (not more than 24h). The gadolinium will be injected at 5 mL/s (20 mL per patient). Calculating the cerebral blood flow and the cerebrovascular permeability coefficient and passing the information to the patient's doctor.

  3. The assessment of the contrast agent outflow kinetics parameters obtained with use of the optical method 4. The correlation of the results of the of the evaluation of the blood-brain barrier condition by MRI, biochemical assessment of the cerebro-spinal fluid and optical method.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* diagnosed with meningitis in the examination of cerebrospinal fluid

Exclusion Criteria:

* allergic to any of the contrast agents
* a lack of consent to the test
* liver failure and kidney failure
A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI

A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI

Study Objective:

To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.

Efficacy Endpoints:

The endpoints of this study are:

* Decrease in transition zone volume
* Monitor size and location of ablative lesions
* Monitor change in time of lesions
* Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.

Eligibility Criteria:
Inclusion Criteria:

* Subject signed informed consent form (ICF)
* Age 40 and above- Male with symptomatic BPH.
* IPSS symptom severity score ≥ 13
* Peak urinary flow of \< 12 ml/sec
* Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
* Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
* Subject able to comply with the study protocol
* Normal urinalysis and negative urine culture
* Subjects that are able to undergo MRI.

Exclusion Criteria:

* A post void residual (PVR) volume \> 250 ml measured by ultrasound or acute urinary retention
* Confirmed or suspected bladder cancer;
* Recent (within 3 months) cystolithiasis or hematuria;
* Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
* An active urinary tract infection.
* Enrolled in another treatment trial for any disease within the past 30 days.
* Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
* Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
* Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
* Median lobe obstruction of the prostate (larger than 1cm).
* Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years)
* Patient with renal dysfunction
* Any serious medical condition likely to impede successful completion of the study
Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant

Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia interventions are at high-risk of a second relapse. Previous studies from investigators reported an association between a positive minimal residual disease (MRD)-test after transplant and an increased risk of subsequent relapse. Also, patients developing chronic graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia relapse after a first allotransplant have a lower likelihood of a second relapse compared with similar patients not developing chronic GvHD. And, our previous study also reported patients with chronic GvHD after DLI was associated with a greater frequency of a negative MRD-test and lower likelihood of subsequent relapse compared with similar persons not developing chronic GvHD. Based on these data the investigators designed a randomized control study to determine whether giving additional consolidation chemotherapy and DLI might decrease likelihood of second relapse in persons without chronic GvHD or with a positive MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.


Eligibility Criteria:
Inclusion Criteria:

* (1) acute leukemia in first complete or second complete remission;
* (2) relapse after an allotransplant;
* (3) had full or partial donor chimerism;
* (4) received re-induction chemotherapy and DLI and achieved a negative MRD-test.

Exclusion Criteria:

* (1) active GvHD
* (2) active infection
* (3) organ dysfunction
Institut Paoli Calmettes Cardia Cancer Database

Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cardia cancer

Exclusion Criteria:

-
Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer

Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
* Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
* PET-CT study within 4 weeks of next available DECT study.
* Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
* Kidney function sufficient to tolerate iodine-based CT contrast.
* No allergy to iodine-based contrast.
* Ability to understand and the willingness to sign informed consent.

Exclusion Criteria:

* Participants with a prior history of thoracic radiotherapy.
* Participants may not be receiving any other study agents.
* Inability to tolerate CT contrast
* Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.
Korus: a Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)

The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are:

* Can Korus accurately detect body position in bed (left, right, supine, prone)
* Can Korus reposition the subject from a prone to recovery (sideways) position? Participants will be asked to lie down on Korus and turn into various positions; when the prone position is detected, they will be repositioned.

Korus is a a smart mattress consisting entirely of pneumatically inflatable smartcells with embedded sensors. It is designed to detect a subject's body position an inflate the proper smartcells to reposition a subject from the prone to the recovery (sideways) position. Healthy control subjects will be recruited to test Korus' sensing system and its performance in repositioning the subject. Korus will utilize specialized sensors and a computer learning algorithm to detect the subject's body position. Based on this data, Korus will activate the appropriate smart cells to reposition the subject.

Eligibility Criteria:
Inclusion Criteria:

• Adults age 18-65; at least 30% of subjects will be self-identified as prone sleepers

Exclusion Criteria: any significant medical history for which body movements will potentially be harmful, including but not limited to:

* History of neurological dysfunction, including spinal cord abnormalities
* History of psychiatric disorder, including anxiety
* History of cardiac dysfunction
* History of osteoporosis or osteopenia
* History of significant orthopedic dysfunction
* History of falls
* History of sleep disorder
* Taking neuroactive medications
* Taking anticoagulants
* Current recreational drug use
* BMI under 18 or over 30
* Systolic BP \>180 or \<90
* Open wounds
Diagnostic Feasibility of 100 Hz Tetanic Stimulation

The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.

The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.

The clinical utilities of the study results are:

* Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring.
* To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3;
* BMI 18.5-25 (normal body weight);
* patient is in supine position with one arm accessible.

Exclusion Criteria:

* diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
* drugs affecting neuromuscular function (magnesium, aminoglycosides);
* pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
* breast-feeding;
* acute surgery
Investigating Preferred Nap Schedules for Adolescents

The aim of this study is to examine the neurobehavioural responses to two successive cycles of sleep manipulation nights and recovery nights in adolescents, and to determine the benefits of napping on cognitive performance, alertness and mood. Using a split-sleep design, 60 participants, aged 15 to 19 years old, are divided into a nap and a no-nap group. Both groups undergo two cycles of sleep manipulation nights and recovery nights over a period of 15 days. The no-nap group receives an 8-hour sleep opportunity on sleep restriction nights, with no daytime nap opportunity. The nap group receives a 6.5-hour sleep opportunity on sleep restriction nights, and has a 1.5-hour nap opportunity the following afternoon.

The present study investigates whether a continuous stretch of night time sleep (8 hours) will lead to better neurobehavioural outcomes relative to nocturnal sleep restriction (6.5 hours) and daytime nap (1.5 hours) of the same total duration. The 15-day protocol is conducted in a dormitory on 60 high school students, aged 15 to 19 years old. Participants are assigned to a nap or no-nap group. Both groups start with two 9-hour adaptation and baseline nights, followed by two successive cycles of sleep restriction (6.5-h time in bed (TIB); 00:15-06:45 or 8-h TIB; 23:30-07:30) and recovery (9-h TIB; 23:00-08:00). Following each sleep-restricted night, the nap group receives a 1.5-h nap opportunity, while participants in the no-nap group watch a documentary. Throughout the protocol, sleep-wake patterns are assessed with actigraphy and polysomnography. Sleepiness levels, mood, vigilance, working memory / executive functions, and speed of processing are assessed 3 times daily (10:00, 16:15, and 20:00).

All participants stay in air-conditioned, twin-share bedrooms with en-suite bathrooms. Bedroom windows are fitted with blackout panels to ensure participants are not woken up prematurely by sunlight. Earplugs are provided, and participants are allowed to adjust the temperature of their bedrooms to their personal comfort. Three main meals are served each day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and strenuous physical activities are prohibited.

Outside of scheduled sleep, meal, and cognitive testing times, participants spend the majority of their free time in a common room that is illuminated by natural and artificial lighting. They are allowed to read, play non-physically exerting games, watch videos, and interact with research staff and other participants. Participants are under constant supervision by the research staff.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* no sleep disorder
* body mass index not greater than 30

Exclusion Criteria:

* smoker
* habitual short sleeper (time in bed during term time of less than 6 hours and no sign of -
* sleep extension of greater than 1 hour on weekends)
* consumption of more than 5 cups of caffeinated beverages a day
* travelling across more than 2 time zones in the month prior to the study protocol
* diagnosed with any psychiatric conditions