cyrilzakka/clinical-trials huggingface dataset:
Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.

The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD.

This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.

Eligibility Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* A US military Veteran
* 21 to 64 years old
* Have at least a high-school level of education or equivalent.
* Have a current DSM-5 diagnosis of Post-Traumatic Stress Disorder
* Have a CAPS-5 total severity score of ≥35 at baseline
* No antidepressant medications prior to enrollment
* Be judged by study team clinicians to be at low risk for suicidality
* Be medically stable
* Have limited lifetime use of hallucinogens

General medical exclusion criteria:

* Women who are pregnant
* Cardiovascular conditions
* Epilepsy with history of seizures
* Insulin-dependent diabetes
* Currently taking psychoactive prescription medication
* Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including Monoamine oxidase inhibitors..

Psychiatric Exclusion Criteria:

* Current or past history of schizophrenia or other psychotic disorders or Bipolar I or II Disorder
* Current or history within one year of a moderate or severe alcohol, tobacco, or other drug use disorder
* Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders or Bipolar I or II Disorder
* Has a psychiatric condition which precludes the establishment of therapeutic rapport
* History of a medically significant suicide attempt
* Current antidepressant use
NewBreez Safety and Efficacy Evaluation

The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
3. Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
4. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
5. Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

1. Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
2. Major swallowing disorder
3. Existing coagulation disorder
4. Previous esophageal stenting
5. Life-expectancy \< 12 months
6. Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment
The Turkish Version of the WUSPI

Wheelchair users frequently experience shoulder pain. It has been determined that in our country, the subjective assessment methods that will help to determine and monitor shoulder pain severity of wheelchair users are limited. The purpose of this study is to adapt the original English version of the Wheelchair Users Shoulder Pain Index into Turkish and to assess its validity and reliability.

Firstly, the original English version of WUSPI was translated into Turkish and culturally adapted, then applied to 100 wheelchair users to investigate the validity of the scale. The reliability of the scale was assessed by internal consistency and test-retest analysis and found a high internal consistency. Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. There was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES. As a result, it is determined tath the Turkish version of WUSPI-Tr is a valid and reliable tool.

The original version of WUSPI was translated into Turkish via multistep translation rules. It is culturally adapted into Turkish. The semantic equivalence of the new scale was evaluated and the Turkish version of the WUSPI (WUSPI-Tr) has been created. It is applied to 100 wheelchair users to investigate the validity of the scale. People who are at least for 1 year using a manual wheelchair as their primary means of mobility, cognitively unimpaired, literate, and older than 18 years are included in this study. The reliability of the scale was assessed by internal consistency and test-retest analysis. As a result of the analysis, the Cronbach Alfa value was calculated as 0.894, and WUSPI-Tr was found to have high internal consistency. The WUSPI-Tr questionnaire was re-administered to 50 participants for 7 to 14 days for the test-retest method and the results were compared with the Interclass Correlation Coefficient (ICC) method. WUSPI has been found to have high reliability (0.997). Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. The correlation coefficient of WUSPI-Tr with SPADI is 0.931 and with ASES was -0.812. These results show that there was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES (p \< 0,001). As a result, the Turkish version of WUSPI-Tr is a valid and reliable tool.

Eligibility Criteria:
Inclusion Criteria:

* accepting the participation
* using manual wheelchairs as the primary mobility tool for more than a year

Exclusion Criteria:

* being illiterate,
* having cognitive impairment
Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery

The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).

The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring

Exclusion Criteria:

* Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
* Patients with hepatic or renal disease with altered metabolism of vecuronium
* Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
Suicide Prevention in Prepubertal Children

Suicidal ideation and behaviors are estimated to be as high as 4-16% and 1.5% (respectively) in the general 6-12-year-old population. However, there are currently no validated suicide prevention interventions specifically developed for this population.

This study aims to: (1) test the feasibility and acceptability of the Safety Planning Intervention for prepubertal Children (C-SPI) in 30 children (ages 6-12) who have made a suicide threat, suicidal behavior or reported suicidal ideation, and their parents, and (2) improve the investigator's understanding of suicidal ideation and behaviors in this age group. The results from the current project will be used to further develop the C-SPI, and to develop preliminary guidance and associated policy for clinicians to use.

The Safety Planning Intervention (SPI) is a brief, protocol-driven and individually tailored tool that uses evidence-based practices for suicide prevention. The SPI aims to provide the individual with quick distraction and coping tools to overcome a suicidal crisis without acting upon the suicidal thoughts. The SPI was used in the Treatment for Adolescents Suicide Attempters study in youth 12-19 and has been found to be feasible and acceptable among adult patients and staff as well as among clinicians who work with adolescents. Its effectiveness in reducing suicide risk among veterans has also been confirmed. The SPI could be a good fit for children, as it uses concrete ways for the person to recognize their reaction, as well as concrete methods to cope with distress, which fits with the developmental stage of prepubertal children. Moreover, the collaborative way in which the personal safety plan is tailored to the suicidal person will allow the engagement of the child in the intervention. The SPI is an intervention that is relatively easy to administer and, therefore, if found to be appropriate for this age group, it could be implemented in different child-focused settings, including schools. The aim of the study is to evaluate the acceptability and feasibility of the Safety Planning Intervention for prepubertal Children's (C-SPI) among suicidal children and their parents. Additionally, children will be interviewed and be assessed for impulsivity, attention bias, irritability and coping skills.

Eligibility Criteria:
Inclusion Criteria:

* Suicidal thoughts or threats in the last six month or suicidal behavior in lifetime
* The child and his parent/guardian are English speakers
* Having a parent /guardian consent to the child participating in this study
* The clinician confirmed that the parents are suitable to take part in the intervention

Exclusion Criteria:

* Diagnosis of a psychotic disorder
* Intellectual disability
Comprehensive Geriatric Assessment in Kidney Transplantation

This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.

Kidney transplantation represents the best therapeutical option in patients in end stage kidney disease. At present, increasing number of older patients are referred for kidney transplantation. Patients' functional status has been shown to be associated with transplant outcomes.

The comprehensive geriatric assessment (CGA) of functional and mental status in older kidney transplant candidates might play an important and supportive role in the pre-transplant evaluation process, including acceptance for transplantation. In kidney transplant recipients, this examination might be useful to evaluate the impact of pre-transplant status on post-transplant course. Also in KTR, CGA may contribute to the improvement of functional status and quality of life independently from the graft function.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplant candidates aged 60+ years
* kidney transplant recipients aged 60+ years

Exclusion Criteria:

* kidney transplant candidates aged below 60 years
* kidney transplant recipients aged below 60 years
ESP Block VS TAP in Laparoscopic Hysterectomy

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).

For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. \[10\]

For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected.

All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain.

Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital
* ASA class 1, 2, 3 or 4
* Age 18 or older, female
* Desires Regional anesthesia for postoperative pain control

Exclusion Criteria:

* History of substance abuse in the past 6 months.
* Patients on more than 30 mg morphine equivalents of opioids.
* Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
* Postoperative intubation.
* Any BMI greater than 40.0.
Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.


Eligibility Criteria:
Inclusion criteria:

* Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
* Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
* Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.

Exclusion criteria:

* Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
* Have active obstructive hydronephrosis.
* Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
* Have active infection requiring IV antibiotics.
* Have brain or leptomeningeal metastasis.
* Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
* Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive.
* Other criteria will be evaluated at the screening visit.
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation

This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\&E procedure, but doctors want to clarify how digoxin effects D\&E procedure time, if at all.


Eligibility Criteria:
Inclusion Criteria:

* 20 weeks 0 days-24 weeks 0 days gestation
* English or Spanish speaking
* 18 years or older

Exclusion Criteria:

* Under 18
* Contraindications to digoxin
Elastography in Chronic Liver Disease in Children

Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other,, Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.

Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other, The term chronic liver disease (CLD) implies a long standing irreversible change in the hepatic structure that may end in complications like cirrhosis leading to premature death. While liver needle biopsy is still recognised to be the gold standard for the assessment of liver fibrosis in the diagnosis and follow-up of chronic liver diseases, researchers tend to study non-invasive methods in the determination of liver fibrosis, as liver needle biopsy is an invasive, painful and expensive procedure, which can cause possible sampling errors and potential complications , Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.

Liver fibrosis is a result of chronic damage, and attacks and remissions throughout the course of the disease trigger the formation of fibrosis. Apart from being a direct indicator of liver damage, fibrosis has an important role in the development of hepatocyte dysfunction and portal hypertension. In a clinical aspect, knowing the state and progress of fibrosis is important in the assessment of treatment response for the severity and the prognosis of the disease. The degree of fibrosis in the liver is important in the determination of prognosis, and management of the process in chronic liver disease. Patients with fibrosis benefit from treatment in case of early diagnosis.

Ultrasound Elastography is a non-invasive method.

Eligibility Criteria:
Inclusion Criteria:

1 - all patients referred to the radiology department over the estimated period of the study. 2 - males and /or females from ( 0 to 18 years ) 3 - have clinical or laboratory or histopathological evidence of chronic liver disease 4 - had undergone liver biopsy.

Exclusion Criteria:

1. - Patients males and or females older than 18 years
2. - Patients who hadn't undergone liver biopsy previously
3. - Patients with acute liver disease
4. - Patients with human immune- deficiency virus (HIV) co infection.
5. - patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.