cyrilzakka/clinical-trials huggingface dataset:
The Emergency Department Sedation Pilot Trial

The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated emergency department patients at three academic medical centers: Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City, IA). The overall goal is to assess the feasibility of implementing targeted sedation (in terms of sedation depth) for mechanically ventilated ED patients in order to reduce the incidence of unnecessary deep sedation and improve clinical outcomes.

The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated ED patients at three academic medical centers. Patients in the before phase of the study will receive usual care after the initiation of mechanical ventilation. After 172 patients have been enrolled in the before phase, the investigators will begin educational initiatives to implement ED-based sedation protocols and order sets. The research team will educate providers on the importance of sedation protocols on patient outcome so that the existing protocols begin to be used effectively in the ED. This educational initiative will allow targeted sedation to be effectively used in the ED as well, allowing the intervention to be tested under real-world conditions. Participants in the after phase will also receive standard post-intubation care at the discretion of the treating team, though it will be after the educational initiative aimed at improving post-intubation sedation.

In order to more effectively use sedation in the ED, the investigators will collect voluntary and anonymous surveys from ED nurses and physicians to assess the potential facilitators and barriers to adherence to guideline-recommended sedation.

Eligibility Criteria:
Inclusion Criteria:

1. Mechanical ventilation via an endotracheal tube.
2. Age ≥ 18 years.

Exclusion Criteria:

1. Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure).
2. Ongoing neuromuscular blockade.
3. Death or transition to comfort measures within 24 hours.
4. Transfer to another hospital from the ED.
5. Chronic/home mechanical ventilation.
6. Transfer directly from the ED to the operating room.
Fatigue and Symptom Burden in Low-Risk Cancer Patients Undergoing Treatment for Febrile Neutropenia

This trial studies how fatigue and symptom burden in low-risk cancer patients undergoing treatment for febrile neutropenia. Cancer and numerous cancer treatments are associated with various symptoms including anemia, fever, and neutropenia, which may also be associated with fatigue. Treating low-risk cancer patients for febrile neutropenia may reduce levels of fatigue.

PRIMARY OBJECTIVES I. To determine whether fatigue improves as patients are treated for febrile neutropenia (Day #1, Day #2 and Day #6).

SECONDARY OBJECTIVES I. To identify clinical factors associated in cancer patients with low risk for outpatient treatment of febrile neutropenia on either outpatient febrile neutropenia treatment pathway presenting with moderate to severe fatigue.

II. To describe demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue while enrolled in either of two outpatient febrile neutropenia treatment pathways.

OUTLINE:

Patients complete a questionnaire on days 1, 2, and 6 regarding fatigue, sleep disturbance, depression, and other symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with solid tumors at low risk for outpatient treatment of febrile neutropenia evaluated in the EC and enrolled in outpatient febrile neutropenia pathways (pathway 1 or 2). Low risk is defined as hemodynamically stable solid tumor patients that do not have pneumonia or are on steroids. Febrile neutropenia is marked by a temperature greater than or equal to 38.3 degrees Celsius and an absolute neutrophil count (ANC) less than or equal to 1000 within 24 hours.
* Patients must be able to speak, read and write in English.
* Patients must be able to complete the required survey tools independently.
* Patients must report a moderate to severe fatigue level to question # 3 of the Brief Fatigue Inventory (BFI) (4 or greater on a 0-10 scale) on EC admission day.
* Pregnant women if they meet eligibility criteria of the febrile neutropenia (NF) pathway and are able to take the oral/intravenous (IV) antibiotic prescribed by the pathway.

Exclusion Criteria:

* Patients will be excluded from the study if they are not on the neutropenic pathway at the time of study entry.
A Study of the Effects of Sodium Citrate on Olfactory Thresholds

The study will be undertaken at the ENT department of the Leicester Royal Infirmary and in a research laboratory at the University of Leicester and also in the ENT department at the West Suffolk Hospital. One hundred subjects will be recruited. Subjects will be invited to undergo a series of smell tests using graded concentrations of 4 odours in 120ml bottles (1). This test has been described and validated by our previous work (2). The test will be fully explained to the subject beforehand by the researcher who will test the patient. The subject will be started with the smallest concentration of each odour and will ascend through the bottles until they detect 2 in a row, at which point the weaker concentration of the odour will be taken as their threshold. They will have a threshold levels determined for the odours phenethyl alcohol (roses), mercaptan (gas), acetic acid (vinegar) and eucalyptol (menthol).

Then, the subject will undergo a sodium citrate nasal douche at a specific concentration or will douche with sterile water. There will be three concentrations used (3%, 6% and 9%) and a control solution (sterile water). Patients will be randomly allocated to one of the four groups using a coded bottle system. Both patient and tester will be blinded to the solution used as these will be made in the pharmacy and coded for anonymity - the code will be broken at the end of the trial. Subjects will then be retested with the bottles and threshold levels will be observed for the four odours at 15 minute intervals over 2 hours. The purpose of the repeated tests is to determine the length of the effect (if present) of the citrate on the olfactory ability of the patients.

(N.B. Sodium citrate is a licensed product for use in body cavities (e.g. stomach, bladder) and can be found in the British National Formulary - the concentrations proposed do not exceed those used elsewhere.)

1. Wudarski TJ, Doty RL. Comparison of detection threshold values determined using glass sniff bottles and plastic squeeze bottles.Percept Mot Skills. 2004 Feb;98(1):192-6
2. Gaskin J, Robinson A, Philpott CM, Goodenough P, Murty G. Are patients cross-sensitive to odours in parallel threshold tests? Chemical Senses 2006; in progress


Eligibility Criteria:
Inclusion Criteria:

* Anosmia
* Hyposmia

Exclusion Criteria:

* Under age of 18 years of age
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.

Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.

Apart from the early localized presentation, with a well established treatment, Lyme borreliosis is a complex infection. Indeed, its presentation can be late and very polymorphic, which can evoke functional somatic disorders and make its management difficult. In 2016, the French Ministry of Health decided to launch a national plan to fight Lyme borreliosis. One of the objectives of this national plan was to improve management based on a specific multidisciplinary care pathway.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred to the reference center for tick-borne diseases by his attending physician
* Duration of symptoms \>6 months
* At the end of the initial assessment, the diagnosis of functional somatic disorders is retained after consensus between the physicians
* Patient practicing less than 150 minutes of regular physical activity per week (WHO recommendations)

Exclusion Criteria:

* Patients with cardiac or respiratory pathologies that contraindicate the practice of physical activity physical activity
* Important comorbidities contraindicating the practice of physical activity: associated cardiac pathologies associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies respiratory pathologies (obstructive or severe restrictive respiratory insufficiency), disabling joint pathologies joint pathologies (gonarthrosis or coxarthrosis limiting training on a treadmill or on a high-intensity bicycle). intensity cycling).
* Patients under guardianship or curatorship
Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

. To determine pattern and frequency of dyslipoproteinemia in patients with newly diagnosed juvenile SLE and to assess effect of disease activity on lipid profile of patients with juvenile SLE.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by multisystem inflammation and the presence of circulating autoantibodies against self-antigens leading to inflammatory damage of many target organs including the skin, joints, kidneys, blood cells, blood vessels, and the central nervous system.Premature atherosclerosis has been recognized as an important issue for patients with SLE since the mid-1970s. Among the traditional risk factors of atherosclerosis, a history of smoking, diabetes, hypertension, and abnormal lipid profile have been shown to be important (7). In patients with juvenile SLE, smoking, diabetes, and uncontrolled hypertension are not common and therefore abnormal lipid profiles may be the most important risk factor.The lipid profile of both children and adults with SLE is the result of a combination of the influences of active disease, therapies, and genetics. The best way to determine the maximal potential effect of disease activity itself would be to examine patients at the time of presentation of SLE, when they are likely to have high disease activity but no effect of corticosteroid therapy.Studies in patients with active SLE suggested that there is a distinct pattern of lipid abnormalities of increased very low-density lipoprotein (VLDL) and triglycerides and decreased high-density lipoprotein (HDL-C), cholesterol and apolipoprotein A1 levels ("active SLE pattern")

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed according to 2019 European League against Rheumatism (EULAR) /American College of Rheumatology (ACR) SLE classification criteria .
2. Patients diagnosed with jSLE between 5 and 18 years of age

Exclusion Criteria:

* 1. Patients on lipid lowering drugs for any other reason. 2. Patients with other autoimmune disease.
An EFS to Evaluate the CGuard Prime™ Carotid Stent in Acute Ischemic Stroke

The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.

A prospective, single-arm, open-label, nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime™ Carotid Stent in adults (18 years of age or older) with extracranial stenosis in the setting as an acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) \>/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).

Exclusion Criteria:

* Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS\<6; and any contraindication to dual antiplatelet therapy.
Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 and body weight is more than 40.0 kg at screening inspection
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
* History of drug and food allergy
* Other protocol defined exclusion criteria could apply
Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis

Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.

Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes.

What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)

Eligibility Criteria:
Inclusion Criteria:

* Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016

Exclusion Criteria:

* Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes
Ultrasound Guided Sciatic Nerve Block

The primary purpose of this study is to determine whether the leg positioning or distal tourniquet used during the injection of local anesthetic may decrease the onset time and prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with popliteal approach. Patients will be divided randomly into three groups: group 1 will receive sciatic nerve block, with leg kept in a neutral position after anesthesia (control group); group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot over a support placed on the OR table and maintained in that position for 15 min; and patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle) with the leg in a neutral position


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective foot surgery under ultrasound guided popliteal sciatic/saphenous block
* American Society of Anesthesiologist physical status 1-3, meaning patients who are either completely or their systemic disease(s), if they have is (are) under control with medications or other means.
* Have capacity to provide informed consent.

Exclusion Criteria:

* clinically significant coagulopathy (impaired blood clotting)
* infection at injection site
* allergy to local anesthetics
* severe cardiopulmonary disease (heart and lung disease)
* body mass index \>35 kg.m2
* known neuropathies (degenerative, infectious and traumatic peripheral nerve diseases)
* who are receiving opioids for chronic analgesic therapy at the time of contemplated surgery
* Patients with history of AIDS, tuberculosis, and other infections
* active and/or unstable cardiac, renal, pulmonary and neurologic disorders will be excluded from the study. This includes patients in heart failure having limited exercise ability, end stage renal failure on dialysis treatment, recent stroke etc.
* Vulnerable subjects (children, pregnant subjects, prisoners, mentally impaired) also will not be included in the study.
* Subjects who do not understand or speak English
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy

The purpose of this study is to find out if patients who have been taking a stable dose of opioids for chronic pain would experience any worsening pain, quality of life and functioning, as well as symptoms of depression and anxiety if their opioid medications are gradually and very slowly reduced.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide consent.
* Ability to participate in all aspects of this study.
* Using tablet or capsule form of one or two of the designated opioid preparations daily (at least 95% of days) during the previous 6 months, anticipated long term use and no active plans for tapering. Specific opioid preparations designated for inclusion will be based on the frequency of use by patients on the Chronic Opioid Registry as well as tablet or capsule characteristics which allow encapsulation by the Research Pharmacy. Participants who have been prescribed the following oral opioids will be recruited into the study: tramadol 50mg tablet or capsule; hydrocodone-acetaminophen (APAP) 5mg-325mg tablet or capsule; hydrocodone-APAP 7.5mg-325mg tablet or capsule; hydrocodone-APAP 10mg-325mg tablet or capsule; oxycodone 5mg tablet or capsule; oxycodone 10mg tablet or capsule; oxycodone-APAP 5mg-325mg tablet or capsule; oxycodone 10mg-325mg tablet or capsule; morphine sulfate extended release 15mg tablet or capsule; morphine sulfate extended release 30mg tablet or capsule; morphine sulfate immediate release 15mg tablet or capsule; morphine sulfate immediate release 30mg tablet or capsule.
* Primary care provider prescribing chronic opioid therapy within MCHS NW WI and in agreement with patient participation.
* Average daily morphine milligram equivalent (MME) dose at enrollment equal to or less than 90.

Exclusion Criteria:

* Daily or intermittent use of transdermal, liquid, intravenous or intramuscular forms of opioid during the last 6 months.
* Use of methadone or buprenorphine.
* Use of an opioid containing preparation with three or more active ingredients.
* Active cancer treatment, other than non-melanoma dermatological cancers. This includes patients either currently receiving or planning to receive any type of cancer treatment other than hormonal therapy.
* Active or planned pregnancy.
* COT being prescribed for indications other than chronic non-cancer pain (i.e., restless leg syndrome).
* Enrollment in hospice care.
* Active suicidal planning or intent as reported on PHQ9.
* Acquisition of controlled medications from clinicians other than PCP or associated clinicians in the previous 6 months as noted in the Prescription Drug Monitoring Program.
* Use of opioids and/or benzodiazepines other than those prescribed by PCP or associated clinicians, or the use of illicit substances other than THC, as found in urine drug testing within the previous 6 months.
* Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.

This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Presence of chronic abdominal or pelvic pain for more than 6 months
* \>6 mm pelvic venous caliber measured by transvaginal US
* Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US

Exclusion Criteria:

* Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma
* Glomerular filtration rate \<60 ml/min
* History of contrast reaction
* Patients not able to be followed up for at least one year
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion Criteria:

* Positive test for HIV or hepatitis B and C
* Treatment for Drug or alcohol abuse
* Any other important criteria in the protocol
Symptoms Associated with Chemotherapy-Induced Peripheral Neuropathy

Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.).

Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire within 1-2 months after completion of systemic chemotherapy. A simple data form was implemented in which patients' age, weight, height, marital status, smoking status, etc were investigated. In addition, the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area (BSA) and DuBois formulation as follows: BSA \[m2\] = Weight \[kg\]0.425 × height (cm)0.725 × 0.007184\]. The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen: Four cycles of Anthracycline were applied 14 days apart 60 mg/m2 intravenous (IV), 12 cycles of Paclitaxel were applied seven days apart 80 mg/m2 IV, and four cycles of Docetaxel were applied 21 days apart 75 mg/m2 IV.

Eligibility Criteria:
Inclusion Criteria:

* Being a volunteer to participate
* aged over 18 years old
* being female
* being a candidate for systemic chemotherapy

Exclusion Criteria:

* Having distant metastasis
* Having comorbidities that might contribute to or cause sensorial and motor deficits such as multiple sclerosis, diabetes, polyneuropathy, etc.,
* Prolonged surgical (if any) complications (i.e. pain, seroma, etc.)