cyrilzakka/clinical-trials huggingface dataset:
The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing monitoring as part of standard of care. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

Our study is designed to test the following hypotheses:

Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at VUMC.

Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the incidence of short- and long-term postoperative complications at VUMC.

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. Physiological data suggest that PORC impairs normal respiratory function, and compelling evidence suggests PORC impairs clinical recovery in the immediate postoperative period and prolongs PACU length of stay. However, despite the widespread use of NMBDs and the frequent occurrence of PORC, limitations in the literature prevent an understanding of their full impact on clinical outcomes. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

The incidence of PORC and postoperative complications after the introduction of monitoring in the PACU will be determined by measuring TOF ratios and tracking the postoperative outcomes in the surgical patients over time.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients \> 18 years of age
* Received one or more NMBDs during surgery
* Surgery took place during the first 120 days following the introduction of TOF monitoring in the PACU

Exclusion Criteria:

* Surgical patients \< 18 years of age
* Received no NMBDs during surgery
* Transfer from the OR to the PACU was delayed (by high PACU volume, for example)
* Had a procedure or has a preexisting condition that prevents accurate monitoring
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety

The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic state. Prior research has shown that the SSP can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with Autism Spectrum Disorders. This observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the SSP for trauma treatment.

This study will enroll clients at the Spencer Psychology clinic who are set to take part in SSP under the supervision of their therapist. Because the therapists have participated in the design of the protocol and will participate in data collection and analysis, SSP will be considered a research procedure. In addition to taking part in SSP, subjects complete a set of questionnaires and have their pulse measured before starting the SSP intervention, after having completed 2/5 hours of the SSP, one week after completing all 5 hours of the SSP, and one month after completing the SSP intervention. The investigators will also pull relevant information from Spencer Psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. Clients who are receiving psychotherapy but not the SSP will be recruited as a comparison group.


Eligibility Criteria:
SSP Intervention Arm:

Inclusion Criteria:

* Client at Spencer Psychology in Bloomington, Indiana
* Diagnosed with PTSD or trauma not otherwise specified
* Already have agreed with therapist to administer SSP as a part of therapy

Exclusion Criteria:

* Tinnitus or hearing loss
* Diagnosed with cardiac arrhythmia
* At high risk for 2019 novel coronavirus (COVID-19) complications based on Center for Disease Control (CDC) guidelines, unless vaccinated

Comparison (Treatment As Usual) Arm Additional Criteria:

Inclusion Criteria:

1. 18 years of age or older
2. Active psychotherapy client at Spencer Psychology
3. Diagnosis of PTSD or trauma not otherwise specified
4. Match range of PCL-5 baseline scores with treatment arm during screener survey

Exclusion criteria:

1. Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy
2. Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)
Doll Therapy in Dementia

Behavioral and psychologic symptoms in dementia (BPSD) are frequent and represent a burden for patients and caregivers, the use of a first line non-pharmacologic approach is highly recommended. DESCRIBE is a randomized controlled trial on the effect of doll therapy (DT) on BPSD in different clinical settings.

The investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and BPSD. Subjects will be randomized to DT or standard treatment (ST), The investigators will measured agitation, delirium and caregiver burden with standard clinical scales at baseline and during treatment. Nursing home residents will be evaluated after 45 and 90 days of treatment, in-patients will be evaluated at baseline and at hospital discharge. In acute in-patients, a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of DT withdrawal.

Primary outcomes will be the reduction of BPSD and the reduction of professional caregiver burden Secondary outcome will be the reduction of delirium and of effect of family caregiver burden.


Eligibility Criteria:
Inclusion Criteria:

* age ≥65 years;
* diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2;
* presence of agitation and/or aggressiveness;
* manual and visual abilities sufficient in order to interact with the doll.

Exclusion Criteria:

* age \<65 years;
* refuse to participate;
* mild forms of dementia (CDR\<2);
* contraindication for DT as experience of mournful or traumatic events related to parental experience;
* life expectancy lower than 3 months;
* negative interaction with the doll.
Indomethacin and Mechanisms Underlying Risk of Falling

The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.

A lot of (epidemiologic) research is done on causes for falls and factors contributing to falling. Most of this research was conducted on the elderly, either community-dwelling or institutionalised. It became clear that the elderly have a greater risk at falling because of:

* physiological changes due to increasing age \[Gerdhem et al., 2005\]
* previous falls \[Myers et al., 1991; Lipsitz et al., 1992\]
* comorbidity (including RA) \[Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al., 2003\]
* polypharmacy \[Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005\] and/or
* use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs \[Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987\].

The relation between benzodiazepines and falling has been extensively investigated in and affirmed by several fields of research and is practically common sense. However, the (possible) relation between NSAIDs and falling is much less investigated, even though there are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes the risk is even as high as with benzodiazepines \[Cumming R, 1998; Granek et al., 1987; Walker et al., 2005\].

Objective of the study:

NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases. They seem to be at a greater risk for falls than healthy persons because of their disease, age and medication use. Therefore it is very important to keep this risk as small as possible. In this study healthy adults are measured on reaction time, postural balance and obstacle avoidance with and without use of indometacin or placebo. This is done in order to gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50-70 years old
* Not using any non-steroidal anti-inflammatory drugs (NSAIDs) for at least 3 days prior to the test session

Exclusion Criteria:

* Neurological or orthopedic disorders
* Poor comprehension of Dutch language
* Hearing problems
* Severe problems with heart and/or blood vessels
* Acutely existing ulcus ventriculi and/or duodeni, or history of ulcus
* Allergy against indomethacin, aspirin, or other NSAIDs
* Patients with nasal polyps reacting with an angioedema to other NSAIDs
* Severe preexisting renal and liver damage
* Co-medication
* Over 100 kg of weight
Evaluation of Mineral Absorption in Infants Fed Infant Formula

The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, term infants

Exclusion Criteria:

* Breast fed infants
* Use of vitamin/mineral supplements
* Currently on medication
Manual Compression and Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae

To compare the effectiveness of manual compression and stretching for myofascial trigger points in upper trapezius and levator scapulae in male office workers


Eligibility Criteria:
Inclusion Criteria:

* male office workers with age of 25-45 working from Monday to Friday for 6-8 hours in a day.

Exclusion Criteria:

* male office workers having any past trauma, chronic illness, any recent surgery and systemic diseases.
Povidone-Iodine Versus Chlorhexidine in Surgical Wound Care

This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Povidone-iodine releases iodine, which acts broadly against bacteria, viruses, and fungi, while chlorhexidine disrupts cell membranes, providing rapid bactericidal action. Studies suggest that chlorhexidine may offer longer-lasting antibacterial effects, but povidone-iodine has a wider antimicrobial range. Optimal choice depends on patient needs, wound type, and potential for adverse reactions, emphasizing the need for tailored antiseptic strategies in wound care.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients undergoing surgical procedures resulting in iatrogenic wounds (surgical wounds of various specialties, such as abdominal, orthopedic, cardiovascular, etc.).
* Availability for follow-up during the postoperative period, ensuring attendance at medical check-ups for the evaluation of healing and prevention of infections.
* Ability to provide informed consent, understanding the objectives, risks and benefits of the study.
* Absence of previous infections at the surgical site, ensuring that the wounds are recent and derived from the current surgical procedure.

Exclusion Criteria:

* Known allergies or hypersensitivity to povidone iodine or chlorhexidine, to avoid risks of serious adverse reactions.
* Immunocompromised patients, such as those with advanced HIV, on immunosuppressant treatment, or with decompensated chronic diseases (poorly controlled diabetes, kidney failure, etc.), due to increased susceptibility to infections and altered healing.
* Patients with active infections or infected wounds prior to surgery, to avoid biasing the results by pre-existing infections.
* Pregnancy or breastfeeding, due to safety considerations and the possible alteration of healing and immunity processes during these stages.
* Use of other antiseptics or topical treatments at the wound site that may interfere with the efficacy of povidone iodine or chlorhexidine.
* Patients with known wound healing disorders (such as autoimmune diseases or hematological disorders), which may affect the results in terms of healing time and quality.
Connect Oncology Needs Evaluation Tool

The purpose of this research study is to evaluate a technology-based intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT), which may increase lung cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. The investigators will also determine their ability to recruit and keep patients and caregivers in the study.

The long-term goal of this program of research is to improve supportive care delivery and lung cancer caregiver and patient well-being through a caregiver delivered intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT). The investigators propose to evaluate a novel technology-based intervention, CONNECT, informed by theory with input from an advisory panel including a lung cancer caregiver and stakeholders. The purpose of CONNECT is to empower and educate caregivers about the benefits of supportive care resources and to systematically identify unmet needs and connect lung cancer caregivers with tailored supportive care resources. CONNECT is designed to be low cost and to capture the various resources offered in different oncology environments to support future adaptation and dissemination for heterogeneous healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

For Caregivers:

* Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to.
* Caregivers must be \> 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.

For Patients:

* Patients must have a current diagnosis of limited stage small cell or stage 1-4 nonsmall cell lung cancer.
* Patients must be currently receiving or planning to receive treatment for their cancer at the time of enrollment. For patients receiving surgery, the eligibility timeframe will include 6 weeks following the date of surgery to account for the acute recovery period.
* Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or 2.
* Patients must be \> 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.
* Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention.

Exclusion Criteria:

For Caregivers:

• Caregivers cannot read/ communicate in English.

For Patients:

* Patients who are post-treatment survivors at the time of study enrollment. For patients receiving surgery only, this includes the period beyond acute recovery (i.e. ≥ 7 weeks post-surgery).
* Caregivers cannot read/ communicate in English.

Eligibility to participate in the study is conditional on participation of both the caregiver and patient.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male patients, \>=18 years of age;
* hemophilia A;
* chronic hepatitis C;
* compensated liver disease.

Exclusion Criteria:

* therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months before start of study drug;
* hepatitis A, hepatitis B or HIV infection;
* chronic liver disease other than chronic hepatitis C.
ECPR for Refractory Out-Of-Hospital Cardiac Arrest

In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.

Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of treating cardiac arrest patients in order to improve survival.

The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. This practice is supported by the fact that all currently proven CPR therapies can be delivered by paramedics in the field.

However, promising new strategies have emerged that are more feasible to initiate in the hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR requires placement of catheters in large blood vessels and connected to a machine to take over the work of the heart and lungs.

This purpose of this study is to examine the feasibility and potential benefit of expedited transport with ongoing mechanical CPR for patients with refractory OHCA patients to an Emergency Department capable of initiating ECPR.

FDA approved this study as a staged feasibility study to enroll 15 participants and submit data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI chose not to pursue an amendment to enroll additional participants due to slow accrual and research restrictions related to COVID.

Eligibility Criteria:
Inclusion Criteria:

* OHCA of presumed non-traumatic etiology requiring CPR
* Predicted arrival time at ECPR-capable hospital within timeframe specified
* Witnessed arrest or initial shockable rhythm (VT or VF)
* Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)

Exclusion Criteria:

* Sustained return of spontaneous circulation (ROSC)
* Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI)
* Preexisting evidence of opting out of study
* Prisoner
* Pregnant (obvious or known)
* ECPR capable ED is not at the destination hospital as determined by EMS
* Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene
Psychological Factors In The Treatment Of Bipolar Mood Disorders

The aim of this study is to trial an intervention targeting potential deficits in an individual's ability to form, and reflect upon, ideas about themselves and others (known as metacognitive capacities), specifically in relation to individuals diagnosed with a bipolar mood disorder (BMD).

The proposed research will adopt a mixed qualitative and quantitative design. Participants will be recruited through hospital outpatient groups (i.e., Metro South Addiction \& Mental Health Services Woolloongabba Community Health Centre \& Beenleigh Community Health Centre in Brisbane, Queensland), and, as necessary, local non government organisations (NGOs), psychiatrists, general practitioners, online support networks (SANE Australia, Black Dog Institute), community mental health services(such as MINDNET), and/or social media groups (Facebook, Twitter) supporting people who meet criteria for a BMD. The research will then use clinical interviews and quantitative (survey) methods to: (1) confirm diagnosis of participants; and (2) confirm deficits in metacognitive capacities of participants. Following this, the research will then involve the implementation of an adapted intervention across a course of 12 months, aimed at improving the metacognitive capacities of participants with a diagnosis of a BMD.

The research will provide an enriched understanding of a dimension of people with BMDs that has not been previously explored. The research will help with gaining an understanding of the metacognitive processes of people with BMDs, and inform more targeted psychological interventions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a Bipolar Affective (mood) Disorder
* Medication has not been changed for at least the past one month
* No hospitalisations in the past month
* Able to provide informed consent

Exclusion Criteria:

* Diagnosed with an Intellectual Disability
* Diagnosed with Schizoaffective Disorder
* High risk of suicide; defined as current, daily suicidal ideation, or the presence of a current plan and intent to commit suicide