cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Use of Medical Scribes in VAMC Emergency Departments and Specialty Care Clinics

Background and study aims: Medical scribes are trained paraprofessionals that assist providers with documenting patient encounters. Prior evidence suggests that scribes may be effective in increasing provider productivity and satisfaction, and decreasing provider time spent on documentation without negatively affecting patient satisfaction. Section 507 of the MISSION Act of 2018 mandated a two-year pilot of medical scribes, which will begin in March 2020 in specialty clinics and emergency departments (EDs) of twelve VA Medical Centers (VAMCs) across the country. The aims of this study are to understand how the introduction of scribes and scribe training affect provider efficiency, patient and provider satisfaction, wait times, and daily patient volume in the VA context.

Who can participate? Urban and rural VAMCs willing to be assigned medical scribes for use in EDs or selected high wait time specialty clinics (cardiology, orthopedics).

What does the study involve? Four medical scribes will be assigned to each of the 12 VAMC sites randomized into treatment with the VA hiring half as new employees and contracting out for the remaining half. 30% of the scribes will be assigned to emergency departments and the other 70% will be assigned to specialty care. Remaining sites that expressed interest in the pilot but were not randomized treatment will be used as comparators. Provider productivity, patient volume, wait times, and patient satisfaction from the treated sites will be compared to baseline (pre-scribe) data as well as data from comparison sites.

What are the possible benefits and risks of participating? VAMCs where medical scribes are introduced may see gains in provider efficiency, reduced wait times, and increased patient satisfaction due to the shifting of administrative burdens associated with documenting patient encounters in electronic health records from providers to these trained professionals. The introduction of medical scribes could complicate patient encounters by making some patients and/or providers uncomfortable.

Where is the study run from? This study is being coordinated by the Partnered Evidence-based Policy Resource Center (PEPReC) at the VA Boston Healthcare System in collaboration with the VA Office of Veterans Access to Care (OVAC).

When is the study starting and how long is it expected to run for? March 2020 to February 2022

Who is funding the study? U.S. Veterans Health Administration


Eligibility Criteria:
Inclusion Criteria:

• Expression of interest by VAMC

Exclusion Criteria:

• Lack of appropriate site capabilities

The VA Office of Veterans Access to Care developed a list of 32 interested VAMCs based on email surveying, which were categorized based on location (urban, rural), desired scribe deployment (ED, specialty care), and underserved (based on high new patient specialty care wait times). 12 VAMCs were then randomly selected for the treatment, accounting for the requirements of the law, OVAC preferences, and site capabilities, with the remainder used as comparison sites.
Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.

The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, caucasian males aged 25-50 years in possession of a valid driver's license for the last 5 years.
* Recreational alcohol drinkers without alcohol dependence or abuse, no traffic-related convictions or alcohol-influenced behavioural disturbances.
* 1 or 0 points on the modified Apfel scale for predicting post-operative nausea/vomiting (non-smoker, previously experienced nausea/vomiting post-operatively, previously experienced motion sickness)

Exclusion Criteria:

* Females (risk of teratogenicity)
* Non-caucasian ethnicity (possibility of deviant ethanol metabolism)
* Previous strong reactions such as nausea, fainting etc. during blood sampling
* Previous abnormal reactions to ethanol
* Previous convictions related to drug intoxication
* Previous excessive drug use
* Regular use of prescription drugs
* Two points or more according to the modified Apfel criteria
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body

This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with \[14C\]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or history of suicide attempts)
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Effects of Sleep Deprivation on Food Intake and Motor Activity in Man

Evidence that shortened period of sleep could be a risk factor for weight gain and obesity has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a shortened night has direct effect on energy metabolism during the following day.

This study is set up to determine whether a partial sleep deprivation night has an impact on appetite and food energy intake and, concomitantly, on physical activity, during the following day.


Eligibility Criteria:
Inclusion Criteria:

* male
* age between 18 and 30
* healthy
* non smoker
* less than 5 hour of sport per week
* BMI between 20 and 25 kg/m/m

Exclusion Criteria:

* eating disorders,
* dieting or fasting
* restrained (score \>9), disinhibited (score \>11) or hungry subjects (score \>9), according to the Three-Factor Eating Questionnaire general healthiness,
* food-snacking (more than twice a day),
Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)

This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder.

The purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory(BDI), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. Resting state electroencephalography and TMS-EEG testing will be conducted before and after tDCS treatment.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-50 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16
* \>or＝9 years education

Exclusion Criteria:

* any additional current psychiatric comorbidity
* The inability to receive tDCS because of metallic implants, or history of seizures，history of head injury, or history of neurosurgery.
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
* Any current significant medical condition.
* serious suicide risk
Visible Abdominal Distension

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.

Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.

Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

* episodes of visible abdominal distension triggered by meal ingestion

Exclusion Criteria:

* organic cause detected by clinical work-up
* constipation
* abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation
Prognostic Value of Body Composition in Lung Cancer

The effect of body composition on the survival rate is one of the research topics of interest in cancer patients and gaining attention in the last years. Body mass index is often used a proxy measure of total adiposity and previous studies examining the relationship between BMI and cancer outcomes have been showed distinct results . Obese patients with malignancies such as colorectal, breast, and pancreatic cancers, have been shown to have a worse prognosis than normal-weight patients . Nevertheless, obese patients with non small cell lung cancer(NSCLC) have been observed to have a better clinical outcome than normal/low-weight cancer patients . In this study, we examined the effects of subcutaneous adipose tissue, visceral adipose tissue and skeletal muscle volumes on survival in metastatic NSCLC patients under different treatment regimens. Since there is no standard method for adipose tissue measurement, we evaluated the abdominal cavity with multi-slice and single-slice computed tomography measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Having a pathological diagnosis of non small cell lung cancer
2. Having a stage-IV disease
3. To have received at least one course of treatment
4. Presence of positron emission tomography /computed tomography (PET/CT) examination before treatment and having it taken in our hospital
5. The data about the study can be accessed in our center.
6. To be over 18 years old

Exclusion Criteria:

1. Unable to access patients data
2. PET/CT CDs cannot be accessed or are not suitable for evaluation.
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial

After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed.

The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer.

This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>=18 years-old) who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure

Exclusion Criteria:

* Patients from whom clear and informed consent cannot be obtained
* Patients unable to read and comprehend English or French
* Patients who cannot be contacted by telephone
* Patients who have undergone major colonic resection in addition to their proctectomy
* Patients on active chemotherapy or radiotherapy treatment
A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer

The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm

The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction

Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<75
* Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
* The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
* It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
* Preoperative ECOG performance status score 0/1
* Nutrition risk screening（NRS2002）
* Preoperative ASA score I-III
* Patient informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Severe mental illness
* History of upper abdominal surgery
* History of gastric surgery (including ESD/EMR for gastric cancer)
* 3 years of history of other malignant diseases；
* Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
* A history of unstable angina or myocardial infarction within 6 months
* History of cerebral infarction or cerebral hemorrhage within 6 months
* There is a history of sustained systemic corticosteroid treatment within 1 month
* Needs simultaneous surgical treatment of other diseases；
* Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
* Pulmonary function test FEV\<1 predicted value 50%
Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).

The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC). This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution. The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care. The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC. Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC). However, with new technical and physician expertise, this option is now available at our institution. PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Undergone EUS-guided liver biopsy at MDMC

Exclusion Criteria:

* Below 18 years of age
* Did not undergo EUS-guided liver biopsy at MDMC
Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

Eligibility Criteria:
Inclusion Criteria:

* rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
* KPS status no less than 70; Charlson comorbidity no more than 3.
* life expectancy more than 6 months.
* hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
* do not have allergy history to thymidine phosphorylase.
* do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
* no previously pelvic irradiation history
* informed consent signed

Exclusion Criteria:

* other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
* previous pelvic irradiation history
* receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
* allergy history to thymidine phosphorylase
* active infection existed
* severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
* anticipate other clinical trials in four weeks before enrollment
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department

To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old and \<100 years old.
* Patients seen in the Emergency Department at Henry Ford Macomb hospital.
* Patients that are A+Ox3.
* Patients who have typical presentation for renal colic.

Exclusion Criteria:

* Age \<18 years.
* Patients with a history of dementia, acute delirium or altered mental status.
* Patients with inability to consent to study or inability to fill questionnaire independently.
* Patients with chronic kidney disease and allergies to study drugs.
* Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
* Patients with stroke activation or symptoms.
* Patients with trauma activations.
* Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
* Imaging study does not show evidence of ureteral stone.
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.

This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.

Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Is serum negative for HBV antibodies

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Any previous HBV infection
* Previous vaccination with any HBV vaccine (1 or more doses)
* Any autoimmune disease
* Received any blood products or antibodies within 3 months prior to study entry
* Ever received an injection with DNA plasmids or oligonucleotides
* Received any vaccines within 4 weeks prior to study entry
* Received any other investigational medicinal agent within 4 weeks prior to study entry