cyrilzakka/clinical-trials huggingface dataset:
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache

This randomized, double-blind trial will compare the clinical efficacy of IV acetaminophen to that of IV ketorolac as adjuncts to standard therapy (prochlorperazine and diphenhydramine) in the treatment of patients presenting to the emergency department with chief complaint of "headache" or variants thereof.

After initial assessment of the patient by the provider, including careful review of inclusion and exclusion criteria, informed consent will be obtained. If a patient does not wish to participate in this study, he/she will receive alternative treatment at the discretion of their ED provider.

The provider will place orders in the electronic medical record for "Headache study order set". This order set includes Compazine® 10 mg IV, Benadryl® 25 mg IV, and "study drug". Pharmacy will receive the order for the study drug. The research pharmacist will randomly assign participants to group A (1000 mg Ofirmev®) or group B (15 mg ketorolac). He/she will fill medication vials and IV bags in each "study kit". The kit for group A will contain a 100mL bag containing 1000 mg acetaminophen and a placebo vial of normal saline as well as both Compazine® and Benadryl®. The kit for group B will contain 100mL 0.9% normal saline and a vial containing 15 mg ketorolac as well as Compazine® and Benadryl®. The "study kit" will be sent to the emergency department via the tube system. When the study kit arrives, he/she will give each patient Compazine® and Benadryl®, hang the IV bag, and administer the contents of the vial. Therefore, every patient will receive a "push" of the contents in the vial (ketorolac or normal saline) and an 100mL infusion (Ofirmev or normal saline).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Presenting chief complaint of headache, migraine, tension headache, cluster headache, or headache not otherwise specified
* Report of pain 4 using a standard 11-point numerical scale (0 to 10; 0=no pain and 10=worst possible pain)

Exclusion Criteria:

* Age \< 18 years or \> 65 years
* Inability to provide informed consent
* Physical or mental disability hindering adequate response to assessment of pain
* Hemodynamic instability/medical condition requiring acute life-saving medical intervention
* Documented or suspected pregnancy or currently breastfeeding
* Known brain mass, intracranial hemorrhage, skull fracture
* Known allergy, hypersensitivity, or prior adverse reaction to acetaminophen, NSAIDs, diphenhydramine, or prochlorperazine
* Known contraindications to acetaminophen use

  * Severe hepatic impairment, severe active liver disease
* Known contraindications to ketorolac/NSAID use

  * Active bleeding, peptic ulcer disease, bleeding dyscrasias
* Known contraindication to diphenhydramine use
* Known contraindication to prochlorperazine use

  * Comatose states or in the presence of large amounts of CNS depressants
* Patients who have consumed

  * \> 2600 mg acetaminophen within the past 24 hours
  * \> 500 mg acetaminophen within the previous 4 hours
Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?

Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals.

The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.

Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.

This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.

Eligibility Criteria:
For Patients:

Inclusion Criteria:

* ability to Speak in English
* requesting epidural analgesia for labour
* having easily palpable spine (clinically 'easy' back)

Exclusion Criteria:

* contraindications to epidural analgesia
* patients with a history of difficult epidural insertions or spinal anesthetic
* Patients with a known history of back surgery
* patients with known significant kyph0scoliosis

For Anesthesiologists:

Inclusion Criteria:

* Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.
Comparison of Nutrition Risk Screens

This research study will compare two different screens for nutrition risk in patients who are in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as good and consistent as the standard NRS 2002 Nutrition Risk Screen.

This research study comparing the ThedaCare screen against the NRS 2002 screen will validate the accuracy and reliability of the ThedaCare Screen and the timeliness of nutrition intervention of patients with a diagnosis of malnutrition. Early nutrition intervention will positively affect the patient's clinical complication, LOS, and readmission.

Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age
* Hopitalized

Exclusion Criteria:

* Positve for Pregnancy
* Inability to give Consent
Improving Sleep in Rehabilitation After Stroke

This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.

Stroke is one of the leading causes of adult disability. Many stroke survivors report difficulties with sleep and our current research confirms this, indicating that chronic community dwelling stroke survivors experience poorer self-reported and objective sleep quality than age matched healthy controls.

"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. The efficacy of this intervention has been demonstrated in people with chronic insomnia but has not yet been tested in people with stroke. The study therefore aims to determine whether digital CBT-I is effective for improving sleep quality in chronic stroke survivors. Participants will be randomised to receive either digital (online) CBT-I or a leaflet with sleep hygiene information. The primary outcome is the change in self-reported sleep quality, assessed using the Sleep Condition Indicator. Secondary outcomes include changes in sleep fragmentation and wake after sleep onset assessed with actigraphy, self-reported sleep onset latency from the sleep diaries, anxiety and depression using the PHQ9 and GAD7, quality of life using the SIS-8 and EQ-5D-5L as well as changes in healthcare costs during the 8 week follow up.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* At least 18 years of age
* At least 3 months post stroke
* Interest in improving sleep
* Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).
* Reliable access to internet
* Currently living in the United Kingdom
* Current stable health

Exclusion Criteria:

* Serious physical health concerns with surgery scheduled in the next 5 months
* Undergoing a psychological treatment programme for insomnia (with a health professional or online)
* Pregnancy
* Uncontrolled seizures
* Untreated diagnosed obstructive sleep apnoea
* Habitual night shift, evening or rotating shift-workers
* Other serious clinical condition that may affect participation in the study
Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation

This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. The study will be conducted in forty older adults (≥60 years) with a diagnosis of executive dysfunction.

The proposed study using rTMS will build upon the investigators previous work demonstrating the link between cognitive impairment, particularly executive dysfunction, and mobility/gait abnormalities in older adults, even in those labeled as "cognitively normal". Emerging evidence demonstrates that executive dysfunction is an early phenomenon in the pathway to mobility disability and subtle changes in executive function are independently associated with future falls. The investigators have piloted studies showing that pharmacological enhancement of executive function, can improve gait-motor performance and, potentially, reduce mobility decline and risk of falls. This supports the rationale for a promising intervention: enhancing cognition to prevent mobility decline and reduce risk of falls. The long-term goal is to create a clinical research program to apply rTMS as an early novel intervention for cognitive/motor interaction to ultimately delay the onset of cognitive and mobility disabilities and their devastating consequences, dementia and falls, in older adults. However, it is first necessary to study a smaller group of seniors to plan for recruitment, study retention and compliance, and to gather preliminary data as proof of principle before proceeding to a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Having executive dysfunction (defined as score below 11 out of a possible 13 in the "Montreal Cognitive Assessment -MoCA- executive score index")
* Age 60 years and older
* English speaking
* Able to ambulate 10m independently without any gait aid (eg. walker, cane)

Exclusion Criteria:

* Unable to understand or communicate in English
* Parkinsonism or any neurological disorder with residual motor deficit (eg. Major stroke, epilepsy)
* Musculoskeletal disorder detected by clinical examination which affects gait performance -Active osteoarthritis affecting lower limbs (American College of Rheumatology criteria)
* Severe depression operationalized as Geriatric Depression Scale (GDS) score\>10

TMS specific exclusion criteria:

* Persons with metal anywhere in the head, excluding the mouth, including shrapnel, and screws and clips from surgical procedures
* Persons with cardiac pacemakers, implanted medication pumps, electrodes inside the heart
* Unstable heart disease
* Persons with increased intracranial pressure, as in acute large infarctions or trauma
* Previous major stroke, history seizure, Parkinson D, Huntington D.
* History of schizophrenia/schizo-affective disorder, substance use disorder within 1 year of study
Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power

To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.


Eligibility Criteria:
Inclusion Criteria:

* Integral buccal mucous (without oral pathologies);
* Normal odontological exams;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 15 days before the study;
* Being in odontological treatment;
* Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
* Personal history of allergic disease in the area to be treated;
* Allergic or atopic history;
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with erythropoietic protoporphyria
* Informed consent

Exclusion Criteria:

* None
Panic Disorder and Cardiac Risk

The reason for increased cardiac mortality in panic disorder has not been precisely identified, but possibly is due to chronic activation of the cardiac stimulant (sympathetic) nerves, which may predispose the individual with panic disorder to disorders of cardiac rhythm and coronary artery spasm. The uniqueness of this study lies in its comprehensive evaluation of a psychobiological approach to the treatment of panic disorder using change in biological, behavioural and psychological variables as criteria for efficacy. 50 patients aged between 18 and 60 years will be recruited; both males and females. They will be treated with either cognitive behavioural therapy (CBT) or SSRI (selective serotonin re-uptake inhibitor) antidepressants or a combination of both.

This project will firstly compare individuals with panic disorder who demonstrate abnormal brain transmitter (noradrenaline, serotonin) with those who demonstrate normal activity of these neurotransmitters, on interoceptive accuracy for changes in sympathetic nervous system arousal. It is predicted that individuals who demonstrate abnormal activity of these neurotransmitters will also demonstrate enhanced interoceptive ability to detect changes in arousal levels. Secondly, this project will evaluate the effects of a psychobiological treatment approach to panic disorder involving a combination of CBT and SSRI. This approach will be compared to the effects of both these interventions alone on a comprehensive array of measures related to panic disorder. It is predicted that the combined approach will be the most effective intervention on behavioural, psychological and biological variables, and cardiac risk. We will also be able to assess whether changes in panic disorder severity are associated with changes in interoceptive accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Panic disorder

Exclusion Criteria:

* Comorbid heart disease
* Comorbid significant psychiatric illness
* Significant suicide risk
* HIV/AIDS hepatitis B/c
Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy Subjects

GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Females should be of non-childbearing potential.
* A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
* A breast cancer resistance protein (BCRP) c421C/C genotype.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to the first sulfasalazine administration. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to the investigational product (IP) (GLPG3970), or sulfasalazine, or sulfa drugs, or to their ingredients, or history of a significant allergic reaction to IP or sulfasalazine ingredients as determined by the investigator.
* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of sulfasalazine.
* History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of sulfasalazine.
* Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) \<=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Subjects with an N-acetyltransferase 2 (NAT2) slow acetylator genotype.

This list only contains the key exclusion criteria.
Mindfulness Training in Healthy Older Veterans

Evidence shows the positive effects of Brain Health \& Wellness classes in younger individuals. The proposed study investigates the usefulness of these classes in older Veterans aged 50-85. We hope to show that such classes can lead to improvements in both thinking skills as well as stress levels.

The expansion of the aging Veteran population, in addition to the frequent presence of comorbidities (e.g., PTSD and TBI) that exacerbate age-associated cognitive and health declines, has generated substantial interest in interventions that promote brain health in older Veterans. A growing body of evidence shows the positive effects of Brain Health \& Wellness classes on brain health in younger and middle-aged adults, thus training might be able to enhance brain health in older Veterans and offset age-related declines. Such training holds particular promise in enhancing areas of cognition that are especially susceptible to aging processes (e.g. attention and executive control), potentially through multiple mechanistic pathways. It is in many respects a cognitive exercise and may strengthen neural networks involved in such processes. Additionally, there is evidence for further facilitating brain health in other ways related to, for instance, altering the stress response. Currently, there is little information regarding the potential brain health benefits in older adults. As a first step to understanding these potential beneficial effects in Veterans, the aim of the proposed pilot study is to evaluate the acceptability, feasibility and potential efficacy of two Brain Health \& Wellness classes in healthy older Veterans through a randomized, controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be Veterans age 50-85

Exclusion Criteria:

* moderate or severe TBI
* active alcohol or drug dependence or abuse by DSM-5 criteria (within previous 30 days)
* positive urine drug screen for illicit substances
* history of schizophrenia
* ADHD
* learning disability
* dementia
* Mild Cognitive Impairment and/or other psychiatric disturbances not including PTSD and/or depression
* participants with a history of psychiatric hospitalization (last five years)
* suicide attempt (last five years)
* imminent risk for suicidal or homicidal behavior, or severe medical illness requiring treatment will be excluded
* subjects with a history of neurological diagnosis, e.g.,:

  * brain tumor
  * clinical stroke
  * seizure
* Mini-Mental Status Exam score below 19 (suggesting moderate/severe cognitive impairment, a contraindication to MBSR participation) will be excluded
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.

Patients who have participated in the 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex for PTSD and have signed informed consent will be enrolled in a 24-week open-label divalproex continuation phase trial. Patients' symptoms, side effects and compliance will be assessed every two weeks for 4 weeks, then every 4 weeks, thereafter, up to 24-weeks. Based on symptomology and occurrence of side effects, the investigator will titrate the medication in 500 mg (one tablet) increments every four days, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 3000 mg/day. The dosing is twice daily, with the higher dose at bedtime. Compliance will be assessed by monthly pill count and valproic acid levels at the week(s) 4, 12 and 24. Patients are given supportive clinical management during the clinic visits. An investigator is available by telephone 24 hrs a day in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by the structured rating scales for depression, global function and assessment and PTSD. Results of this study will be used to evaluate the long-term efficacy of divalproex in the maintenance treatment of PTSD.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PTSD, confirmed by MINI and CAPS.
2. Participation in the placebo-controlled acute phase study with divalproex for PTSD
3. Age 19 or older
4. No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
5. Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.
6. Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, DepoProvera, or diaphragm with spermicide)
7. Signed informed consent
8. Male or female, any race or ethic origin

Exclusion Criteria:

1. Lifetime history of bipolar I, psychotic, or cognitive disorders
2. Actively suicidal, homicidal, or psychotic
3. History of sensitivity to divalproex
4. Unstable general medical conditions
5. Score ≥ 6 on Question #10 of MADRS
6. Women who are pregnant, planning to become pregnant or breastfeed during the study