cyrilzakka/clinical-trials huggingface dataset:
Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?

Ethanol based hand sanitizers do not raise blood alcohol levels to a measurable amount. This study will determine to what extent, if any, heavy use of ABHS changes blood alcohol levels.

Ethanol continues to be the most frequently abused intoxicant in the United States.4 Drug testing in various work environments has become commonplace during the past two decades and will at times include blood, breath, or urine alcohol testing.5 While valid reasons for false positive drug tests do occur, a plethora of unusual and dubious explanations have been likewise tendered. Medical Review Officers (MRO) involved in evaluating such reports rely on past case reports, knowledge of laboratory analytical techniques, and other scientific evidence to validate or negate claims of drug use in the workplace. ABHS are now found in most hospitals and health-care facilities.1,3 Only one human report of serum ethanol levels following frequent clinical use of the ABHS has been reported.7 This finding of a negative serum ethanol level in this case is likely to be reproducible in all clinical settings as the physician attempted to simulate the most extreme use of the product that would be consistent with labeling instructions. Since alcohol breathalyzer testing is based upon exhaled portions of ethanol found within the blood stream, this method of testing would likely be negative as well.

Participants will be the investigators and associate investigators of the study, who are all employees in the emergency department at Darnall Army Community Hospital. There will be no financial reward offered. Consent will be obtained on all participants. The study will be performed in the Darnall Emergency Department outside of regular duty hours. Enrolled subjects will apply 5 ml of the product (62% denatured ethanol alcohol manufactured by Kimberley-Clark) to both hands and rub until dry. This will be repeated 50 times over approximately 4 hours. Participants will have their blood drawn prior to, as well as, after completing the study. No other laboratory tests will be performed other than the alcohol level. Pre study blood alcohol levels will be ordered to assure a pre-study level of 0 mg/dl.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 50 years without liver or renal disease working in the emergency department to include residents and staff physicians.

Exclusion Criteria:

* Alcohol intake or exposure in the past 12 hours to include ABHS.
* Allergy to ABHS or any of its ingredients.
* Any rash on the extremities.
* Currently taking disulfiram , metronidazole, chloramphenicol, nitrofurantoin, tolbutamide, chlorpropamide, glyburide, glipizide, tolazamide, griseofulvin, chloral hydrate, acetohexamide, and third-generation cephalosporins.
* Liver or kidney disease.
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.

If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a planned surgery
* Anticipated indwelling bladder catheter placement for greater than 24 hours
* Anticipated post-op admission to a surgical ICU

Exclusion Criteria:

* Unstable renal function as self-reported
* Anticipated bandaged postoperative suprapubic incisions
* Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
* Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
* Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
* Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria:

* Prior allogeneic hematopoietic stem cell transplant
* Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
* Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
* Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)

Exclusion Criteria:

* Patient pregnant or lactating
* Microcalcifications within the lesion at the mammogram.
* History of breast cancer or history of laser or radiation therapy to the target breast
* Breast implant in the target breast.
* Fibroadenoma not clearly visible on the ultrasound images (in B mode)
* Patient participating in other trials using drugs or devices
Pilot Study: The Role of Macrophage Migration Inhibitory Factor (MIF) in Spinal Cord Injury

The purpose of the study is to investigate inflammatory and other substances that may be elevated in the blood and blood cells following spinal cord injury (SCI). These substances will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first week (acute) or at least one year ago (chronic). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF). MIF is released by cells and has a specific effect on the way cells behave, communicate and work together. In several other medical conditions, MIF is known to increase inflammation in the body. By comparing blood samples from individuals with spinal cord injury and uninjured (no spinal cord injury) individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples to measure other proteins that increase inflammation in the body and to see if the biological activities of MIF can be reduced in a test tube by adding other substances to the blood samples. It is hoped that this study of MIF and other proteins related to inflammation will help improve the treatment of SCI in the future.

We hope to enroll a total of 312 subjects in this study (50 with acute spinal cord injury, 125 with chronic spinal cord injury, and 137 uninjured individuals).

During the study visit the investigator will collect basic biographical information and health information, including some questionnaires, from the subjects and their medical record.

Acute SCI subjects will also have blood drawn once daily (First blood draw will approximately be 2 tablespoons and subsequent blood draws will approximately be 1 tablespoon) .

Chronic SCI subjects will have blood drawn per study visit (approximately 2 tablespoons) and will be asked to participate in two study visits, to take place 6 months apart.

Eligibility Criteria:
Inclusion Criteria:

SCI Subject Inclusion Criteria: To be eligible for prospective enrollment, subjects are required to meet the following inclusion criteria:

* ≥18 years of age
* History SCI (acute or chronic): All American Spinal Injury Association (ASIA) classifications A-D and all levels.

Healthy Control Subject Inclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to meet the following inclusion criteria:

* ≥18 years of age
* The absence of any current or previous medical conditions

To be eligible for prospective enrollment, SCI subjects are required to not meet the following exclusion criteria:

* \< 18 years of age
* No known SCI
* Concurrent infection such as UTI
* Deep pressure sores
* cancer, chemotherapy or neutropenia
* autoimmune disease

Healthy Control Subject Exclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to not meet the following exclusion criteria:

* \< 18 years of age
* Current or previous medical conditions
Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.

Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.

Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.

Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.

Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for perianal surgery under spinal anesthesia.

Exclusion Criteria:

* Allergy to the studied drugs.
* Patients with contraindications to spinal anesthesia.
* Patients with advanced cardiac, renal, or hepatic diseases.
* Previous voiding difficulty.
* Patients taking anticholinergic medications.
* Time of surgery exceeds 75 min.
Cerament Treatment of Fracture Defects

The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™\|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 \& B3)
* solitary trauma
* candidate for bone grafting
* patients between the age of 18 and 65 years
* written informed consent obtained before any study-related activities
* patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program

Exclusion Criteria:

* patients with multiple injuries
* polytrauma patients
* compartment syndrome
* previous iliac crest bone graft harvesting
* local infection at the site of implantation
* chronic pain disease
* malignancy
* rheumatoid arthritis
* chronic cortisone intake
* X-ray diagnostics not available, fracture cannot be classified
* clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
* a pre-existing calcium metabolism disorder (e.g. hypercalcemia)
* known hyperthyroidism or autonomous thyroid adenoma
* history of serious reaction to iodine based radio contrast agents
* women who are pregnant or breastfeeding
* irreversible coagulopathy or bleeding disorder
* history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications
* history of hypersensitivity to the investigational device or any of its ingredients
* participation in other clinical trials during the present clinical trial or within the last 1 month
Hamburg Edoxaban for Anticoagulation in COVID-19 Study

Hero-19 aims to evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin \[LMWH\], ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with COVID-19.

Coagulopathy in the context of COVID-19 is a major threat to affected patients due to deep vein thromboses and pulmonary embolisms. Actual data show an unexpectedly high incidence of partially fatal complications without any prior clinical evidence in some cases. Therefore, this prospective, randomized, assessor-blinded, multicenter, placebo-controlled, interventional trial will investigate whether therapeutic anticoagulation on top of SOC compared to prophylactic anticoagulation as part of SOC- can improve objective patient-relative endpoints, relevant for prognosis in patients with COVID-19. 172 eligible patients will be randomized 1:1 to experimental or control group. Patients enrolled to experimental group will receive therapeutic anticoagulation using LMWH body weight-adapted during course of hospital stay and oral anticoagulation using Edoxaban according to SmPC (60mg once a day) after being discharged from hospital / outpatient course. Patients enrolled to control group will receive prophylactic anticoagulation using LMWH as part of SOC whilst inpatient course, and placebo after discharge / outpatient course. Patients will be informed of their allocation to the placebo group, as it has been shown that the effect of placebo is still detectable.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 and hospitalization on ICU, or
* Diagnosis of COVID-19 and hospitalization on normal ward, or
* Diagnosis of COVID-19 (within 10 days) and troponin ≥ ULN and/or D-dimer ≥0.5 mg/L

Exclusion Criteria:

* Age below 18
* Life expectancy less than 3 months before COVID-19
* Resuscitation \> 30 minutes
* Hypersensitivity to the active substance, to Edoxaban or any of its excipients
* Significantly increased bleeding risk
* Other indication for anticoagulation beyond COVID-19
* GFR \< 15 ml/min
* Planned transfer of the patient to another clinic within the next 42 days
Antihypertensive Medications and the Risk of Sepsis

The primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other ARBs and with the other major antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan compared with other ARBs, ACEIs and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death


Eligibility Criteria:
Inclusion Criteria:

- Patients, 18 years or older, with at least two-year follow-up in United Kingdom's general practice research database (GPRD), who had a diagnosis of or treatment for hypertension

Exclusion Criteria:

- Sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry
Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

This study is designed to determine if an intracervical balloon catheter (IBC) is better than oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or breaking the bag of water prior to onset of labor. The investigators suspect that an intracervical balloon catheter will shorten the time interval from initiation of induction of labor to delivery.

There are not enough studies to support the use of intracervical balloon catheter (IBC) in term prelabor rupture of membranes (PROM). Prospective randomized studies comparing IBC placement to oxytocin use in induction of labor for term PROM do not exist. Intracervical Balloon Catheter has been shown to reduce duration of labor for women with intact membranes undergoing induction of labor. The practice at this institution is to use oxytocin to start contractions when a woman has PROM. This study will examine IBC compared to oxytocin use in term PROM. This will allow for the evaluation of a cervical ripening method for term PROM that may improve women's outcomes. Other outcomes for this study are rates of infection during labor, cesarean section, and adverse maternal and/or neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

Nulliparous women, Women aged 18-50 years, Singleton gestation, Vertex presentation, Live fetus, Rupture of membranes confirmed by sterile speculum examination \> 37 weeks of gestation at time of rupture of membranes, Bishop score \< 6

Exclusion Criteria:

Multiparous women, Bishop score \>6, Multifetal gestation, Contraindication to labor including placenta previa , Maternal fever prior to randomization: T \>100.4 F , Known fetal anomalies
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings

The purpose of this study is to assess the long-term symptomatic response (Visit 2 \[Week 1\] to Visit 14/Week 66 \[End of Study {EOS}\]) measured by change in the Clinical Global Impressions -Severity for Schizophrenia (CGI-SS) in participants with schizophrenia who are treated in Rwandan real-world healthcare settings with the antipsychotic regimen that starts with oral anti-psychotic (AP) formulation followed by continued treatment with (paliperidone palmitate 1-month \[PP1M\] and 3-month \[PP3M\] formulations).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by Mini International Neuropsychiatric Interview (MINI)-Screen / MINI (Module K) that requires treatment initiation or a change in treatment to better address safety, efficacy, or adherence limitations of current treatment
* Eligible for treatment in the Rwandan mental healthcare system
* At least moderately ill as measured by the Clinical Global Impression - Severity of Schizophrenia (CGI-SS) scale for schizophrenia (rating of greater than or equal to \[\>=\] 4). This criterion needs to be re-confirmed at Visit 2
* Has a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition, provide economic/cost of care information, and is expected to be with the participant for greater than \[\>\] 24 hours each week for the duration of the study)
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) during screening
* Able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable (LAI) formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver must sign their own informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* Has a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol
* History of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements
* Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or its excipients
* Received an investigational intervention including investigational vaccines or used an invasive investigational medical device within 30 days before the planned first dose of study intervention, or is currently enrolled in an investigational study
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study intervention
* Poor prior response to risperidone or paliperidone
The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.

This randomised controlled trial will evaluate the effect of a ketogenic diet vs a conventional diet on the symptoms of patients living with anxiety disorders using a validate self-reported inventory.

It has been theorized that ketogenic diet could improve symptom control in patients living with anxiety disorders. Animal models support this hypothesis but to this date, studies in humans are lacking.

The investigators will randomise patients with a confirmed diagnosis of anxiety disorders to follow a ketogenic diet (\<50 grs of carbohydrate per day) or a conventional diet (50% carbohydrate, 30% lipids, 20% protein) for one month.

Symptom control will be assessed weekly using Beck's inventory for Anxiety. Diet adherence will be measured using standardised food frequency logs and acetoacetate urine strips.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.

Exclusion Criteria:

* Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.