cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing

In this study, the investigators will evaluate the effect of a health system initiative aiming to change clinician opioid prescribing behaviors using two behavioral economic interventions - individual audit feedback and peer comparison feedback of clinicians.

Opioid-related abuse and overdose represent a growing national epidemic in the United States. Clinician practice patterns play an important role: opioid prescriptions impact the likelihood that patients will misuse or become dependent on these medications, with longer prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter Health System quality improvement initiative using monthly individual audit feedback and/or monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In partnership with Sutter Health System, this will be conducted using randomization to evaluate its effect. We will also conduct a process evaluation to understand factors associated with better or worse performance at the clinician level.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians

  1. Practiced primarily at participating emergency department or urgent care center
* Patients

  1. Presented to a participating emergency department or urgent care center during the study period
  2. Discharged to home from the visit

Exclusion Criteria:

* Clinicians

  1. Saw less than 100 patients in the prior year
  2. Practiced primarily at another site that is not in the main trial
  3. Did not practice at Sutter Health in the prior 90 days
* Patients

  1. Currently pregnant
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 80 years inclusive at the time of informed consent
* Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)
* Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
* Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration
* Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary

Exclusion Criteria:

* Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
* Evidence of active medical diseases affecting bowel transit
* History or presence of pelvic disorders that may be a cause of constipation
* Surgery (except for minor procedures) within 60 days of Screening
* History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)
* Subjects who have never taken laxatives for the treatment of OIC
* History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \[Nolvadex®\] and raloxifene \[Evista®\] when being used for prevention of breast cancer
* Current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists
Chest Computed Tomography (CT) Screening Study With Antibody Testing

The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in lung cancer detection and potential health economic outcomes.

EarlyCDT-Lung test and CT scan both for lung cancer detection and potential economic outcomes.

Eligibility Criteria:
* Persons 50-75
* Asymptomatic for lung cancer
* Current or former (stopped smoking less than 10 years ago) cigarette smokers
* History of cigarette smoking of at least 20 pack years
* History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years).
* Mentally competent individuals to sign an informed consent.
* Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy.
* A fully informed signed consent form must have been obtained.
The Effect of Phacoemulsification on Intraocular Pressure in Primary Angle Closure Glaucoma (PACG) Patients At Phanat Nikhom Hospital, Chonburi Province

BACKGROUND: Primary angle closure glaucoma (PACG) is one of a leading cause of blindness worldwide including Thailand. This problem impact to the overall health of people and health care system. Treatment guidelines of each stage is differenced. Therefore, factors that affect to treatment should be explored to plan for taking care patients in the future.

OBJECTIVES: The study aimed to examine the effects of cataract surgery by phaco- emulsification on intraocular pressure and to determine the factors associated with intraocular pressure among primary angle closure glaucoma patients.

BACKGROUND: Primary angle closure glaucoma (PACG) is one of a leading cause of blindness worldwide including Thailand. This problem impact to the overall health of people and health care system. Treatment guidelines of each stage is differenced. Therefore, factors that affect to treatment should be explored to plan for taking care patients in the future.

OBJECTIVES: The study aimed to examine the effects of cataract surgery by phaco- emulsification on intraocular pressure and to determine the factors associated with intraocular pressure among primary angle closure glaucoma patients.

METHODS: A retrospective descriptive study was conducted in 121 patients with primary angle closure glaucoma who underwent phacoemulsification between October 1st 2017 and September 30th 2022. The preoperative and postoperative record form were used as the research instrument. Visual acuity, intraocular pressure, the number of glaucoma medications and ocular biometric parameters were collected. The descriptive statistics, Paired sample t-test, Repeated measures ANOVA and Multiple linear regression were used to analyze the outcomes. A p-value \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* age more 18 years old and not complication of cataract surgey

Exclusion Criteria:

* other eye diseases affect to visual defect
* previous ocular surgery
* complication of cataract surgery
* data record incomplete
Breast Cancer and Resilience in Couple

This is a prospective pilot study examining the couple's dyadic attitudes from diagnosis to 24 months later when one member is affected by illness and the adaptive strategies the couple employs when stressful events occur.

The patients taking part in the study and their partners are examined from the time of the woman's breast cancer diagnosis up to 24 months later with the help of questionnaires and a focus group in order to understand the couple's coping strategies.

Eligibility Criteria:
INCLUSION CRITERIA:

* Woman diagnosed with stage 1, 2 or 3 breast cancer
* age\> 18 years (patient and partner)
* The partner must have lived with the woman for at least 6 months at diagnosis and treatment
* Patients under treatment at the radiotherapy clinic
* Subjects available and able to answer questionnaires, interviews, and / or participate in focus groups
* Informed consent

EXCLUSION CRITERIA:

Cognitive deficits and / or inability to comply with the provisions of the study
Small Intestinal Submucosa Scaffold Combined With Adipose-derived Stem Cells to Form an Adipocyte-containing Hypodermis

Human adipose tissues were obtained from five healthy adult women who underwent abdominal liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or endocrine diseases. Ten millilitres of discarded adipose tissue from the humans was used to gain the adipose-derived stem cells. In this study, the investigators will evaluate the potential of a small intestinal submucosa scaffold combined with adipose-derived stem cells to form an adipocyte-containing hypodermis.

Human adipose tissues were obtained from five healthy adult women who underwent abdominal liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or endocrine diseases. All protocols using human samples were approval by the Institutional Review Board of Nanfang Hospital (no.18502), and samples were obtained with written informed consent. Ten millilitres of discarded adipose tissue from the humans was washed extensively with equal volumes of phosphate-buffered saline (PBS); minced into a fine, homogeneous preparation; and digested at 37°C for 30 min with 0.125% type I collagenase. Enzyme activity was neutralized with Dulbecco's modified Eagle's medium (DMEM) containing 10% FBS. Then, the sample was filtered through a 200-mm nylon mesh to remove cellular debris and was centrifuged at 1500 revolutions per minute (rpm) for 5 min. The precipitate was resuspended in 6\~10 ml NH4Cl and incubated at room temperature for 10 min to lyse contaminating red blood cells. The compound was centrifuged at 1500 rpm for an additional 5 min. The ASCs were collected via centrifugation as described above, resuspended in 2 ml of control medium (DMEM containing 10% FBS and 1% antibiotic/antimycotic solution) and incubated at 37°C in a humidified chamber containing 5% CO2 for 48 h. Next, the plates were washed extensively with PBS to remove residual non-adherent red blood cells and debris. The resulting cell population was termed ASCs, and the cultures were expanded with media changes at 3-day intervals. Cells at passage 1 through 6 were used for all experiments.

Eligibility Criteria:
Inclusion Criteria:

* healthy people with no infectious diseases
* healthy people with no endocrine diseases

Exclusion Criteria:

* sick people
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants

From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g and without congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death, cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to observe the relationship between morbidities and poor outcomes. And the predictive effect on the number of the top three morbidities were analyzed by Logistic regression analysis.


Eligibility Criteria:
Inclusion Criteria:

From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included. The infants survived to a postmenstrual age of 36 week with birth weight less than 1500g.

Exclusion Criteria:

The very low birth weight infants didn't have any congenital disease.
Neuronal Inertia in Propofol Anesthesia

Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate, stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves, during a slow, steady-sate, stepped target controlled infusion of Propofol using Schnider's pharmacologic model. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

Eligibility Criteria:
Inclusion Criteria:

* american society of anesthesiologists status I or II age \>18 years fasted at least 8 hours BMI\<30

Exclusion Criteria:

* any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)
A Study of Aerobic Exercise for Patients With Bipolar Disorder

This study will investigate the effects of aerobic exercise on mental states, cognition, BDNF, and long-term outcomes in patients with bipolar disorder.

Multiple cognitive impairments are common in patients with bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in patients with mood disorders. This randomized controlled trial will investigate short-term (1 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (12 months) effects on decreasing the recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV defined bipolar disorder.
* Never accept aerobic exercise therapy.
* dextromanuality.

Exclusion Criteria:

* Diagnosed neurological or musculoskeletal disorder/injury,
* Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
* Diagnosed hypertension
* Other diagnosed serious medical conditions that are not suitable for cycling
* Severe suicidal ideation
* Mental retardation
* Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week
Bone Healing Study

The aim of the research is to identify structural tissue changes in the early fracture hematomas.

The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fractures of the upper and lower extremities
* Patients for whom the surgical bone reconstruction are indicated
Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis

The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.


Eligibility Criteria:
Inclusion Criteria:

1. cystinosis
2. known CTNS mutation

Exclusion Criteria:

1. patient with corticotherapy treatment
2. patient with immunosuppressant treatment
Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.

It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.

PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.

During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age range of 26-36 weeks
* The baby should be between postnatal day 0 and 5 (Postnatal day of baby should be between 0 and 5 days.)
* Need for invasive mechanical ventilator support
* Need for endotracheal aspiration
* No analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration
* At least 2 hours passed since the last painful procedure

Exclusion Criteria:

* Receiving analgesic medication
* Major congenital anomaly
* Having a pneumothorax tube
* Stage III and intraparenchymal hemorrhage
* Receiving a sedative medication
3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women

Patients will be divided into two groups:

Group A: 30 pregnant women Group B: 30 non pregnant women as control group.

All patients will be subjected to the following:

1. Interview with women for detailed history taking and explaining the research. A written Consent will be obtained from them before their enrollment into the study.
2. To ensure standard conditions, the subjects will lie in a recumbent position and were evaluated between 08.00 and 11.00 a.m. To avoid anyexternal genital stimulation, subjects will be asked not to wear trousers or cross their legs on the morning of the ultrasound examination.
3. Furthermore, in order to minimize external effects on blood flow, all women will be scanned in a noiseless room with constant heat and light

Patients will be divided into two groups:

Group A: 30 pregnant women Group B: 30 non pregnant women as control group. Translabial ultrasound scanning will be performed for each woman with Sonographic measurements of the clitoral volume and labia minora thickness performed by using a RSP-16 multi frequency transducer. The transducer will be placed on the upper part of the vulva to assess the clitoris in a transverse section and on the labia majora for the sagittal view. To prevent artifacts, care will be taken to avoid excessive pressure on the clitoris. The clitoris was studied where the paired corpora join in a single body that projects into the glans. Volumes were measured by reporting length, width, and depth assuming the form to be an ellipsoid: V = π/6 × D1 × D2 × D3, where D1, D2, and D3 are the maximal longitudinal, anteroposterior, and transverse diameter, respectively. The same transducer will be sagittally placed on each labium major to measure labia minora thickness, ensuring that the minimum possible pressure is applied with the ultrasound probe on the skin.

Color Doppler ultrasonography will be used to identify, in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) will be visualized posterolaterally to the labia majora (at about 2 cm from the clitoral hood).

Eligibility Criteria:
Inclusion Criteria:

* Both pregnant and non pregnant women between 18 and 45 years old

Exclusion Criteria:

* Women with genital anomalies
* Virgins
* Women with gynecological disorders as endometriosis or pelvic pathology causing pelvic congestion
* Genital inflammations or mases Neurological or vascular disorders
Ice Popsicle for Thirst Relief of the Surgical Patient

The purpose of this study is to assess the efficacy of ice popsicle compared with water at room temperature in relieving thirst in the immediate postoperative period . The hypothesis of the study is that ice has 20% greater efficacy than water to relieve thirst in the immediate postoperative period.

There is evidence that ice is effective in relieving thirst in surgical patients, because, by stimulating the oral receptors sensitive to cold, ice decreases the need to ingest large volumes of liquids to satisfy thirst. This way, the risk of bronchoaspiration due to gastric fullness is avoided and discomfort with dry mouth is reduced. Preliminary evidence, therefore, indicates that the use of ice chips have greater efficacy than water at room temperature in relieving thirst. However, there is no scientific evidence from controlled studies with results that can be generalized with respect to a safe volume and adequate frequency of ice administered to reduce thirst in the immediate postoperative period.Considering that the gold standard for the study of a symptom is based on individuals' perceptions and their reports, this study is justified in order to assess the effectiveness of ice compared with water at room temperature in relieving thirst in the immediate postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years;
* undergoing more than eight-hour preoperative fasting;
* expressing thirst spontaneously or stimulated with intensity greater than or equal to three according to the numeric visual analogue scale;
* receiving opioids or anticholinergics during surgery;
* duration of anesthesia exceeding one hour;
* having been approved in the assessment by the Safety Protocol of Thirst Management;
* signing the informed consent during the preoperative period.

Exclusion Criteria:

* patients who had intake or swallowing restrictions.