cyrilzakka/clinical-trials huggingface dataset:
Dose-response of Cannabis and Driving

Epidemiological studies have established a link between collisions while driving and cannabis use. With the changing legal landscape around cannabis, there is much interest in determining per se limits of cannabis while driving. The present study will evaluate driving on a driving simulator after smoking placebo or cannabis with 3 different levels of THC. THC is the active component in cannabis and blood, urine and oral fluid levels of THC will be correlated with driving impairment.

Participants will attend the laboratory for 4 separate sessions, separated by about a week. In each session, participants will receive one of 3 doses of smoked cannabis or a placebo. Participants will not know which dose they are receiving. Participants will complete questionnaires, do cognitive tests and drive on a driving simulator before and after smoking the cannabis or placebo cigarette. Blood, urine and oral fluid will be collected throughout the 7-8 hour session to determine levels of THC and its metabolites. These values will be correlated with measures of driving impairment.

Eligibility Criteria:
Inclusion Criteria:

* Near daily use of cannabis (1-5 days/week) confirmed by self-report and urine screening
* Has held a class G2 or G licence (or equivalent from another jurisdiction) for at least 12 months
* Willing to abstain from using cannabis for 72 hours prior to each practice or test session
* Willing to abstain from alcohol for 48 hours prior to each session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session)
* Provides written and informed consent

Exclusion Criteria:

* Diagnosis of severe medical or psychiatric condition
* Meets criteria for current or lifetime alcohol or other substance use disorder, except tobacco use disorder and caffeine use disorder
* Regular user of medication that may affect cognitive functioning and/or driver performance
* Family history of schizophrenia or other psychotic disorder
* Pregnant, looking to become pregnant, or breastfeeding
Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting

To evaluate the impact of painPRIMER in a prospective six-month clinical investigation looking at clinical outcomes, health care professional and patient satisfaction, healthcare resource use, productivity and direct and indirect costs. The hypothesis is that early identification of the presence of neuropathic pain and back pain related comorbidities, to direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery, thereby reducing costs and productivity loss associated with these inefficiencies.


Eligibility Criteria:
Inclusion Criteria:

* Those aged 18 years of age
* Presenting to a HCP with low back pain
* Able to speak, write, and understand both verbal and written English

Exclusion Criteria:

* Conditions that may impede the patient's ability to participate in painPRIMER and complete the questionnaires, as per the HCP's discretion
* Patients presenting who have undergone surgery for back pain in the previous 12 months

  * Patients with Medicare as their primary insurance
A Nurse-led, Advance Care Planning Intervention in the Emergency Department

ED GOAL is a 6-minute, motivational interviewing, advance care planning intervention.

In this study, the investigators will pilot test (Part I) ED GOAL by training research nurses to demonstrate its intervention fidelity and acceptability on older adults with serious illness in the emergency department (ED). Upon demonstrating the intervention fidelity of this intervention in Part I, the investigators will collect patient-centered outcomes (Part II) of 100 older adults with serious illness after leaving the ED. Further in Part III, the investigators will conduct a survey to the participants' outpatient clinicians to find out how to optimize the care coordination from the ED to the outpatient office to facilitate advance care planning conversations.


Eligibility Criteria:
Part 1.

Inclusion Criteria:

* ≥50 years of age AND ≥1 Serious illness\* OR ED clinician would not be surprised if patient died in the next 12 months
* English-speaking
* Capacity to consent

Exclusion Criteria:

* Acute physical or emotional distress
* Determined by EM physician not to be appropriate
* Clearly documented goals for medical care\*\* (Unless the treating clinician recommends that the patient needs the intervention)
* Delirium (assessed using 3D-CAM)
* Mild cognitive impairment or dementia (assessed using MiniCog or SBT)
* Already enrolled in this study
* Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.

Part 2.

Inclusion Criteria:

* ≥50 years of age AND ≥1 Serious illness\* OR ED clinician would not be surprised if patient died in the next 12 months
* English-speaking
* Patient with mild cognitive impairment or mild dementia with caregiver has a capacity to consent
* Caregivers of patients with moderate/severe dementia has a capacity to consent

Exclusion Criteria:

* Acute physical or emotional distress
* Determined by EM physician not to be appropriate
* Clearly documented goals for medical care\*\* (Unless the treating clinician recommends that the patient needs the intervention)
* Delirium (assessed using 3D-CAM)
* Already enrolled in this study
* Unable/unwilling to schedule the follow-up outcomes assessment on the calendar.

(\*NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis, solid tumor cancer without metastasis will be included if recent hospitalization in the last 12 months exists.) (\*\*MOLST, medical order for life-sustaining treatment.)
Resistance Training and Injection Treatment for Achilles Enthesopathy

Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.

The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.

50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.

Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.

The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.

It is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.

50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.

Eligibility Criteria:
Inclusion criteria:

* Pain from the achilles tendon insertion/heel for at least 3 months
* Achilles entesopathy verified by ultrasound
* Between 18 and 65 years of age

Exclusion criteria:

* Prior surgery in the leg with the exception of knee arthroscopy
* Known medial conditions including diabetes or rheumatologic diseases
* Taking pain medication regularly
* Injection therapy for treatment of achilles entesopathy within the last 6 months
Music Effect on the Self-Injection, Testing Fear and Pain

Diabetes is a chronic and broad-spectrum metabolic disorder characterized by hyperglycemia that occurs due to relative or absolute insulin deficiency or "insulin resistance" developed against insulin action in peripheral tissues, affecting many organs and causing multisystem involvement. Metabolic function continues to deteriorate after diagnosis, leading to worsening glycemic control and insulin therapy becoming necessary. However, patients may have difficulty adhering to insulin therapy. Fears about injections are common in both adults and children and, as research shows, are a major reason why people with diabetes avoid taking insulin. Addressing these fears is an important part of helping patients reduce their risk of diabetes-related complications. Helping patients manage their replacement pain may help reduce the effects of needle fear in the future. There are a number of strategies that can ease the pain.The use of music in pain management has advantages such as being reliable, cheap, and having no side effects, as well as reducing postoperative pain reports. Music distracts the individual from negative stimuli and allows them to focus on something they enjoy, thus reducing pain and anxiety. Music therapy has also been shown to have sedative-protective effects and reduce stress hormone levels. Listening to preferred music can distract and reduce the pain and negative emotions associated with an unpleasant experience.

Research Type:

The research will be conducted as a randomized controlled experimental model.

Research Universe and Sample:

The research sample will consist of patients diagnosed with Type 2 Diabetes hospitalized in a State Hospital. The sample of the research is expected to consist of 100 volunteer Type 2 Diabetes patients who applied to the State Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least one year
* Self-administering insulin injection
* Self-administering glucometer, insulin pen or insulin pump

Exclusion Criteria:

* poor mental health
* Having gestational diabetes mellitus or Type 1 diabetes
* no hearing problems
Pain Perception at Laser Treatment

The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.

Purpose: To compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.

Methods: Thirty patients (60 eyes) were enrolled in the study. Each patient had one eye treated with infrared laser (diode, 810nm) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm). The laser treatment was performed following a standardized protocol. Immediately after photocoagulation, the patient was asked to grading pain perception according an 11-point (i.e. 0-10) numerical rating scale (NRS) 2,3, accompanied by the instructions "Please rate your pain by indicating the number that best describes it". This NRS is represented as a straight line (10 cm in length). The numbers between 0 and 10 are spaced at regular intervals along the line, at either end of the line are two poles that are defined as the extreme limits of the response to be measure, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'.

Eligibility Criteria:
Inclusion Criteria:

* horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease

Exclusion Criteria:

* severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.
Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia

The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia

This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.

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Eligibility Criteria:
Inclusion Criteria:

* Patients with painless uncomplicated primary bilateral inguinal hernias

Exclusion Criteria:

* Immune compromised patients
* Coagulopathy
* Chronic liver or renal disease
* High-risk patients unfit for major surgery (ASA III or IV),
* Massive scrotal hernias, Recurrent or Complicated hernias
* Groin pain due to any other pathology
* Previous infra-umbilical surgery
Single Palatal Temporary Anchorage Device for Anterior Open Bite

Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs

Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction

Eligibility Criteria:
Inclusion Criteria:

* Patients with AOB of 1-6mm
* Aged between (12 and 40 years).
* Able to consent.
* Patient due to undergo orthodontic treatment with fixed orthodontic braces.

Exclusion Criteria:

* Patient has previously had upper first permanent molar extraction.
* Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
* Patient with bone disease or taking medications that affect the bone quality or nature.
* Patient with an active digit sucking habit.
* Pregnant or breastfeeding women
Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have been aged 18 to 79 years, inclusive;
* Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial;
* Subjects must have been capable of understanding and following directions.

Exclusion Criteria:

* Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
* Subjects who had any visible skin disease that might be confused with a skin reaction to the test material;
* Subjects who were participating in another clinical trial at this facility or any other facility;
* Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
* Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products;
* Subjects judged by the PI to be inappropriate for the trial;
* Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.
Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients

This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad Teaching Hospital registry.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed RA patients.

  -≥18 years of age
* Did not receive previous another biological treatment

Exclusion Criteria:

* Had previous biological treatment
* Use of etanercept for less than 1 year
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.


Eligibility Criteria:
Inclusion Criteria:

Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.

All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
2. Is the subject above 50 years old?
3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
4. Does the subject have primary osteoporosis with a lumbar spine T score \< -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
5. Does the subject have a life expectancy of \>3 years?
6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System

To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).

To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).

Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a site EMU for video-EEG monitoring
* Age five and older at the time of enrollment
* Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures
* Willing and able to comply with study procedures

Exclusion Criteria:

* Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors
* Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch
* Inability or unwillingness to comply with study procedures
EZIO Compared to Central Venous Lines for Emergency Vascular Access

Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.


Eligibility Criteria:
Inclusion Criteria:

Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible

Exclusion Criteria:

Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English
Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)

Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness, but an inspiratory stridor is the most common symptom. For this reason, such patients are often misdiagnosed with refractory asthma, because of poor response to steroids and bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with laryngoscopy. The therapy consists of education, speech therapy and if necessary psychotherapy. The purpose of the investigators' study is to characterize children, adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric features.

VCD appears to be significantly more common among females. The episode of dyspnea underlies the paradoxical, intermittent adduction of the vocal cords during inspiration. Methacholine challenge testing combined with laryngoscopy is useful in differentiating vocal cord dysfunction from asthma during the asymptomatic period.

In one visit patients will be characterized with a questionnaire based on the ISAAC questionnaire. Furthermore, FeNO, eCO, skin prick testing and total serum IgE will be examined. The psychiatric condition of patients will be determined by CBCL/6-18 and YSR/11-18 behavior questionnaires. After initial fiberoptic laryngoscopy and pulmonary function testing, bronchoprovocation is performed using nebulized methacholine at increasing doses, until a 20% decline in the forced expiratory volume in 1 second is achieved (PD20FEV1). Each methacholine testing will be followed by a second laryngoscopy and pulmonary function testing. The visualization of paradoxical vocal cord motion during inspiration will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 7 to 30 Years
* Documented VCD or strong suspicion of VCD
* Pulmonary function test: FEV1 (% pred.) ≥ 70%

Exclusion Criteria:

* Age \< 7 and \> 30 Years
* Pulmonary function test: FEV1 (% pred.) \< 70%
* Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
* Pregnancy
* Documented alcohol, substance, and/or drug abuse
* Incapability to perform all study procedure
* Current participation in another clinical trial