cyrilzakka/clinical-trials huggingface dataset:
Electronic Medical Record-Based Nudge to Reduce SLNB

The goal of this prospective, historically-controlled, quality improvement project is to determine whether and to what extent an electronic health record (EHR)-based nudge affects rates of sentinel lymph node biopsy (SLNB) in older women with ER+, early-stage, clinically node negative breast cancer.

Society of Surgical Oncology (SSO) adopted a series of Choosing Wisely recommendations in an effort to reduce low-value surgeries. One such recommendation, first released in 2016, advocates against routine use of sentinel lymph node biopsy (SLNB) for axillary staging in older women (≥ 70 years old) with early-stage, estrogen receptor positive (ER+), clinically node-negative breast cancer. Data supporting this recommendation were largely retrospective in nature as there were no direct randomized trials testing de-escalation of SLNB in this population of patients. This has led to variability in de-implementation of SLNB, with rates of SLNB use still reaching 50%-60% in some centers.

To address this, the investigators designed an electronic medical record-based column nudge that flags patients meeting Choosing Wisely criteria for omission of SLNB. This was designed to target surgeons in the moments leading up to the first clinic visit with patients where surgical decision-making is planned. In this study, the investigators deployed the column nudge for a 12 month period.

The enrollment number reflects the number of surgeons participating in the study (whom the nudge was deployed to); it is anticipated this group of surgeons will see over 400 patients between the pre-nudge and post-nudge periods.

Eligibility Criteria:
Inclusion Criteria:

* early-stage (stages I-III) breast cancer
* clinically node-negative
* ER+ and/or PR+, HER2 not-amplified
* non-metastatic at diagnosis

Exclusion Criteria:

* under 70 years of age
* breast cancer is that is not ER+ or PR+
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults

Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.

Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.

Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.

Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.

The data collected in this study is recorded by the researcher in the eCRF, including:

1. Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data;
2. Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ-Ⅲ grade;
2. age 18-65 years old;
3. gender is not limited;
4. planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
5. operation time No more than 90min.

Exclusion Criteria:

- Emergency surgery;

1. abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
2. abnormal liver function;
3. hypovolemia, shock or coma;
4. suffering from mental illness and long-term use of psychotropic drugs;
5. cognition Dysfunction;
6. those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
7. have a history of drug dependence;
8. have used other sedatives in the past week;
9. have been a subject within the past 3 months Participated in drug clinical trials
The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection

Objectives: Injection pain and hypotension are two main adverse effects of propofol which distresses patient. The aim of this prospective double blind study was to compare the effect of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and hemodynamic changes due to propofol induction.

Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30), ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation


Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologists(ASA)physical statusIandII

Exclusion Criteria:

* patients with difficulty in communication
* history of allergic, neurologic or cardiovascular disease
* patients who had received an analgesic medication within 24 hr before surgery
Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease

The purpose of this study is to understand how a Best Practice Advisory (BPA) for high-intensity statin therapy in patients with Peripheral Artery Disease impacts prescription rates.

The central hypothesis is that an automated best practice advisory embedded within the electronic medical record (EMR) will improve prescription of high-intensity statins among hospitalized patients with Peripheral Artery Disease (PAD).

Aim 1: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on high-intensity statin prescription among hospitalized patients with PAD.

Aim 2: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on short-term cardiovascular outcomes among hospitalized patients with PAD.

Eligibility Criteria:
Inclusion Criteria:

* Primary hospital diagnosis of PAD defined by ICD/CPT codes
* Inpatient status at the adult hospital at Vanderbilt University Medical Center
* Not currently prescribed a high-intensity statin (atorvastatin 40-80mg daily or rosuvastatin 20-40mg daily)

Exclusion Criteria:

* On comfort measures
* History of statin allergy or intolerance recorded in the EMR
* History of rhabdomyolysis defined by International Classification of Diseases/Current Procedural Terminology (ICD/CPT) codes
* History of hepatitis A, B, or C defined by ICD/CPT codes
* Pregnant
* Aspartate aminotransferase \>120 units/L within 30 days of alert
* Alanine aminotransferase \>165 units/L within 30 days of alert
* Primary hospital diagnosis of acute myocardial infarction defined by ICD/CPT codes
* Primary hospital diagnosis of acute stroke defined by ICD/CPT codes
Evaluation of the Manifestation of Patient Aggresivity in an Emergency Department

The main objective of this study is to determine the average total number of violent events per observation period occurring in the emergency department at the Nîmes University Hospital. The list of violent events is pre-determined and based on a series of interviews with emergency department staff.

This observational study will take place via a representative sample of 90 observation periods. One observation period consists of 7.5 consecutive hours between two team rotations during the day and 10 consecutive hours at night. These observational periods include the moment when health-care teams are debriefed during a shift-change, which we suspect to be a sensitive time point.

Observation periods are randomly selected over a period of 1 year, and stratified for time of day (morning, afternoon, evening), day of the week and month.

The secondary objectives of the observation phase are to identify factors associated with the average number of violent events per work period (number of patients attending the emergency department, time of staff debriefing during shift change, time of day, week or weekend, individual patient characteristics (gender, age, patient or accompanying a patient, waiting time from arrival in the emergency room to emergency consultation, reason for consultation), characteristics of victims of violence, characteristics of the health care team ...)

The anticipated total number of violent events is unknown at the beginning of the study; we indicated '50' as a guess.

Eligibility Criteria:
Inclusion Criteria:

* Persons manifesting violence according to a pre-determined list of watched-for events will be observed
* The victims of the above-mentioned violence will also be observed and interviewed

Exclusion Criteria:

* Persons not manifesting violence according to a pre-determined list of watched-for events
An Internet-based Information Platform for Vulvodynia Patients

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.


Eligibility Criteria:
Inclusion Criteria:

* Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study

Exclusion Criteria:

* inability to read and understand Swedish
* severe mental illness
* currently in treatment for vulvodynia
Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics

Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.

Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.

Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital

Exclusion Criteria:

* Congenital heart disease
* Known major congenital anomalies of the kidney and urinary tract
* Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist
Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion

The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.

In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed long bone nonunion
* age from 18 years old

Exclusion Criteria:

* active infection
* cancer patients
* concomitant serious illness
* pregnant women
* evidences of mental illness
* previous alcohol or drug dependences
* previous malignant disease during last 5 years, except for basal carcinoma
Effectiveness of Virtual Reality in Hand Therapy

The purpose of this study is to determine if the use of Virtual Reality as an intervention for patients following specific hand injuries will positively affect patients with decreased hand function and reduce pain and improve outcomes. Participants will be recruited from 3 different clinics in central Kentucky.

Participants will participate in four sessions of therapy treatment over a 2-3 week time span of schedule therapy appointments during their active phase of rehabilitation for approximately 1-hour virtual reality (VR) training dosage which will be recorded. The specific virtual reality games within the Oculus Quest 2 VR system will be selected by the therapist providing interventions each session.

In addition to the Virtual Reality intervention noted above, participants will participate in a pre and post-test outcome measure session (25-30 minutes) with a research team member. (See outcome measure section for more details).

Eligibility Criteria:
Inclusion Criteria:

1. Attending hand therapy for rehabilitation of an upper extremity injury with a diagnosis of distal radius fracture, complex regional pain syndrome or tendon ruptures
2. Must be in an active exercise phase of rehabilitation

Exclusion Criteria:

1. Not in a phase in their rehabilitation in which they can perform active exercises
2. Having arm injury due to a neurological disorder (stroke, Multiple sclerosis, spinal cord injury, other)
3. Non-English speaking
4. Patient reporting a history of severe claustrophobia or motion sickness
Psychiatric Comorbidity and Quality of Life in Patients With Obsessive Compulsive Disorder(Case Control Study )

Psychiatric Comorbidity and quality of life in patients with Obsessive Compulsive Disorder(case control study )

Obsessive-compulsive disorder (OCD) is a mental and behavioral disorder\[7\] in which a person has certain thoughts repeatedly (called "obsessions") and/or feels the need to perform certain routines repeatedly (called "compulsions") to an extent that generates distress or impairs general functioning.\[1\]\[2\] The person is unable to control either the thoughts or activities for more than a short period of time.\[1\] Common compulsions include excessive hand washing, the counting of things, and checking to see if a door is locked.\[1\] These activities occur to such a degree that the person's daily life is negatively affected,\[1\] often taking up more than an hour a day.\[2\] Most adults realize that the behaviors do not make sense.\[1\] The condition is associated with tics, anxiety disorder, and an increased risk of suicide.\[2\]\[3\] The cause is unknown.\[1\] There appear to be some genetic components, with both identical twins more often affected than both non-identical twins.\[2\] Risk factors include a history of child abuse or other stress-inducing event.\[2\] Some cases have been documented to occur following infections.\[2\] The diagnosis is based on the symptoms and requires ruling out other drug-related or medical causes.\[2\] Rating scales such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) can be used to assess the severity.\[8\] Other disorders with similar symptoms include anxiety disorder, major depressive disorder, eating disorders, tic disorders, and obsessive-compulsive personality disorder.\[2\]

Treatment may involve psychotherapy, such as cognitive behavioral therapy (CBT), and antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or clomipramine.\[4\]\[5\] CBT for OCD involves increasing exposure to fears and obsessions while preventing the compulsive behavior that would normally accompany the obsessions.\[4\] Contrary to this, metacognitive therapy encourages the ritual behaviors in order to alter the relationship to one's thoughts about them.\[9\] While clomipramine appears to work as well as do SSRIs, it has greater side effects and thus is typically reserved as a second-line treatment.\[4\] Atypical antipsychotics may be useful when used in addition to an SSRI in treatment-resistant cases but are also associated with an increased risk of side effects.\[5\]\[10\] Without treatment, the condition often lasts decades.\[2\]

Eligibility Criteria:
Inclusion Criteria:

* 1. both sex 2. age groups : 18 : 60 are included 3. accept to participate in the study

Exclusion Criteria:

- 1. presence of major neurological disease as head trauma and sensory or motor defect as blindness or deafness

2. Active psychiatric disordes 3. patients refuse to participate in the study
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Key inclusion criteria:
* Mild to moderate nail psoriasis on at least one fingernail

Exclusion Criteria:

Key exclusion criteria:

* any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;
* history of hypersensitivity to retinoids or to other components of the trial medication
* topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;
* systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial
* intralesional steroid injection before the treatment phase of the trial
* phototherapy before the treatment phase of the trial;
* any chronic infection or condition capable of interfering with the conduct of the trial;
* evidence of drug or alcohol abuse;
* symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;
* participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;
* pregnancy or nursing;
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation

The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:

* TAK-831 400 mg Fasted + TAK-831 400 mg Fed
* TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Weighs greater than or equal to (\>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening.

Exclusion Criteria:

1. Has received TAK-831 in a previous clinical study.
2. Has poor peripheral venous access.
3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug.
4. Has any dietary restrictions or preferences that may interfere with the conduct of the study.
LESS-TLH Versus LESS-LAVH

During the last 2 decades, several studies have tried to define the best surgical approach to hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal hysterectomy has a higher incidence of complications, a longer hospital stay and a slower convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is the absence of a wide abdominal scar, which results in fewer wound-related complications and in a significant decrease of postoperative pain.

Technologic advances in endoscopic instrumentation and optics have allowed the development of an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH) should be preferred. In particular, none has focused on postoperative pain as the primary outcome of the study. The investigators have therefore designed the randomized trial to investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.


Eligibility Criteria:
Inclusion Criteria:

* women with indication for hysterectomy for a supposed benign uterine disease
* women with an age of 18 years or older
* women who were not pregnant at the time of presentation
* women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

* uterine volume \> 18 weeks of gestation by pelvic examination
* suspicion of malignancy
* pelvic organ prolapse \> stage 1 according to POP-Q classification
* inability to understand and provide written informed consent.