cyrilzakka/clinical-trials huggingface dataset:
Does a Portable Biofeedback Tool Reduce Physician Stress?

Given the nature of their work duties and work environment, physicians often experience stress within the workplace and chronic stress negatively impacts physician wellness. Physician wellness is now linked to quality of patient care. The stress response can be broken down into four components: the stressor, the reaction, the physiological response and the experience of the physiological response. Stress can also be absolute (e.g. threat to life) and relative (e.g. I have 3 more consults to see). Stress management refers to a range of processes that are intended to mitigate one or more aspects of the psychobiology of stress. Biofeedback is a useful way of providing guidance and reinforcement for successful management of the physiological response to stress. It is important to provide physicians with effective tools for stress management. The objective of this study is to compare measures of stress and well-being among physicians allocated to learn a relaxation breathing technique and to use a biofeedback tool (referred to as a portable stress management device or PSMD) for 28 days (intervention group) and those allocated to standard care for 28 days (control group).

After completion of the 28 day RCT with a control group and an intervention group, we conducted a trial extension for an additional 28 days. During that time, the original control group was trained in the use of the portable stress management device and used it, without support of the research team, for 28 days. Also during that time, the original intervention group were told that they could keep the PSMD and use it as they like. At the end of the 28 day trial extension, stress, and physiological parameters were measured again. For the initial control group, this allowed us to test effectiveness of the PSMD (real life 1 hr training on the device then unsupported use). For the initial intervention group, this allowed us to see if any effects of using the PSMD were maintained for an additional 28 days, without ongoing support from the research team.

Eligibility Criteria:
Inclusion Criteria:

* all staff physicians at the university hospital

Exclusion Criteria:

* any physician who screens positive for major depression
Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.

This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.

Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.

Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.

Material and methods :

This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:

* Conventional group: insufflation pressure at 12mmHg and conventional instrumentation
* LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.

Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.

Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.

Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product

Exclusion Criteria:

* coagulopathy or thrombopathy
* arguments for a complicated appendicitis: fever\> 38.5 ° C, hyperleucytosis\> 15,000, CRP\> 100, presence of an intraperitoneal abscess, a plastron, a fluid effusion of medium or great abundance or '' a pneumoperitoneum on the CT scan
* History of abdominal surgery by laparotomy
* Obese patients (BMI\> 30kg / m2)
* minor patients
* patients without health insurance
* pregnant patient
* patient incarcerated or in detention
* patient under guardianship or curatorship
* rapid sequence induction with the use of ketamine
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 80 years, inclusive.
* Body mass index between 18 and 45 kg/m2, inclusive.
* Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
* Stage 3 CKD
* MSSBP ≥130 mmHg
* Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria:

* Urinary albumin: UACR \> 3500 mg/g
* History of a renal transplant
* MSSBP \>180 mmHg or a MSDBP of \>120 mmHg on two occasions during screening or run-in periods
* History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
Cethrin in Acute Cervical Spinal Cord Injury

This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, ages 18-62, inclusive
* Acute cervical spinal cord injury at a neurological level of C4-C6
* AIS Grade A or B
* Scheduled to undergo decompression/stabilization surgery within five days of injury
* Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits

Exclusion Criteria:

* Participation in any other clinical trial for acute SCI, including previous Cethrin trial
* Inability to receive study medication within five days of injury
* Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
* Significant hemorrhage on MRI/CT scan
* Females who are breastfeeding or have a positive serum pregnancy test
* Body mass index (BMI) of ≥ 35 kg/m2 at screening
* History of an adverse reaction to a fibrin sealant or its human or bovine components
* Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
* Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
* Unconsciousness or other impairment that precludes reliable ASIA examination
* Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
* Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease
Promoting Resilience in Teens With ASD

Interventions for Autism Spectrum Disorder (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable impact. This study offers the first pilot randomized controlled trial (RCT) of whether a single session intervention, shown to reduce internalizing problems in typically-developing youth, may improve core and co-occuring symptoms of ASD.

Interventions for core and co-occurring symptoms of autism spectrum disorders (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable, population-level impact. One promising solution to this problem is a new class of evidence-based treatments, single-session interventions (SSIs), which have shown remarkable efficacy in treating a range of other developmental psychopathologies. No study to date has examined SSIs in youth with ASD, which, if even marginally effective, could dramatically reduce the cost and expand the public health impact of accessible intervention options for ASD. This study offers the first pilot randomized controlled trial (RCT) of whether an SSI shown to reduce internalizing problems in typically-developing youth may improve core and co-occurring symptoms of ASD.

Eligibility Criteria:
Inclusion Criteria:

* Youth between the ages of 11-16 (inclusive) at the time of study participation;
* Youth with one parent or legal guardian willing to participate in the study (i.e. to be present for the lab visit and to complete questionnaires throughout the study period);
* Youth speaks English well enough to complete online or virtual based intervention activities;
* Youth with IQ ≥ 70;
* Parent or legal guardian speaks English well enough to complete online questionnaires;
* Youth with SCQ \>10;
* Youth who meet criteria for autism or ASD on the ADOS-2.

Exclusion Criteria:

* Failure to meet the above inclusion criteria;
* Intellectual disability (IQ\<70), as this may undermine comprehension of intervention materials;
* Adolescent is non-English speaking;
* The presence of a known developmental disability aside from ASD that would interfere with study participation;
* The presence of a significant medical disability or disorder that would interfere with study participation.
A Trial of Project ImPACT in Early Intervention

Our pilot study will address a number of pressing questions, including: Can community clinicians successfully coach parents of children with ASD in evidence-based practice to achieve positive outcomes for their children and themselves? What dose is necessary to achieve change? And what is the cost effectiveness of implementing evidence-based interventions at different doses?

The investigators will partner with 6 of Philadelphias 13 agencies serving young children with ASD. The investigators will enroll 3 clinicians per agency (18 total) and 3 families per clinician (54 total). Agencies will be randomized to the 3 arms. The investigators will measure clinician fidelity and parent fidelity through direct observation and selfreport. The investigators will measure child and parent outcomes at baseline and 6 months using measures common to similar trials. Resource use for the economic evaluation will occur quarterly and will take a societal approach. The investigators will partner with a community advisory board to apply the findings from this pilot trial to the development of a larger, system-wide subsequent trial that is feasible and ecologically valid for Philadelphias EI system. The results will provide rigorous information about whether evidence-based autism interventions for young children can be implemented successfully with the resources available in cities like Philadelphia, the role of hours of treatment in improving child outcomes, and the cost-benefit implications for families and community agencies. This project has the potential to dramatically improve the services families of young children with ASD in Philadelphia receive, and significantly improve their long-term outcomes. This preliminary trial would provide the EI system with the information needed to bring this type of intervention to scale across the entire system. It also would serve as the foundation for an application for federal funds to conduct a system-wide study of Project ImPACT as implemented in all Philadelphia agencies serving children with ASD.

Eligibility Criteria:
Inclusion Criteria:

1. child is \<30 months of age (to receive 6 months of intervention)
2. a classification of autism or high autism risk as determined by the EI system;
3. receive early intervention services through the infant and toddler program; and
4. parent is willing to complete the parent measures that are part of this study.

Exclusion Criteria:

1) be over 30 months of age
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation

The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.

Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.

The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.

Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Eligibility Criteria:
Inclusion Criteria:

A) Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) \[31\]; B) Age 18-75 years; C) Able to read and write in Swedish.

Exclusion Criteria:

C) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -
Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study

The purpose of this study is to investigate the behavioral and neural correlates of stress exposure. Results from this study will enrich the understanding of how sociocultural, behavioral, and neural factors combine to influence alcohol use.


Eligibility Criteria:
Inclusion Criteria:

* Between 21 and 35 years of age (inclusive);
* Fluent in English;
* Right-handed

Exclusion Criteria:

* Younger than 21 years of age;
* Left-handed
Growth Hormone for the Treatment of Gastroparesis

The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms \> 6 months that have not responded satisfactorily to standard treatment.
* For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21

Exclusion Criteria:

* Known history of GH deficiency, hypothalamic or pituitary disease
* Diabetes
* Prior use of GH therapy
* Age-adjusted low serum IGF1
* Women on oral estrogen therapy6
* Pregnancy or nursing
* History of malignant solid tumors
* Obesity (BMI \> 30)History of coronary and thromboembolic diseases.
* History of sarcoidosis
* History of pituitary surgery
* History of thyroid nodules.
* Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
* Failure to give informed consent.
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision

The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers.

Participants will:

* Review an online education tool, Donor Plan Donor Choice.
* Discuss a Kidney Offer Plan with a transplant provider.
* Answer questions about willingness to consider different donor types.

Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.


Eligibility Criteria:
Inclusion Criteria:

* Candidate on the kidney transplant waiting list
* Greater than 3 months since listing for transplant
* 18 Years of age or older
* English-speaking

Exclusion Criteria:

* Non-English speaking
* \< 18 years of age
* Patients who choose to opt out of research.
* Unable to provide informed consent
Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions

This clinical trial will be conducted to compare the clinical performance of a new self-adhering flowable composite in restoring CLs compared to conventional flowable composite in geriatric patients over 12 months.

Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of restorative material in adhesive dentistry. Today, there are only two available products in the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable composite was introduced to address the time-consuming procedure used with traditional materials Their resin matrix contains acidic functional adhesive monomers mediating bonding with dental hard tissues and, therefore, separate etching and additional bonding are not required. SAFCs have been mainly advertised for the restoration of small Class I, Class III and V cavities, for cavity lining, and for use as a pit and fissure sealant.

Self-adhering flowable composite combines the merits of both adhesive and restorative material technologies in one product, bringing novel horizons to restorative techniques, as it is a direct composite resin restorative material that has an adhesive resin together with a flowable composite resin. It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin. This resin bonds chemically between the phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also, micromechanically between the polymerized monomers of the self-adhering flowable composite resin and the collagen fibers and smear layer of dentin.

Eligibility Criteria:
Inclusion Criteria:

* Cervical Class V carious lesions in anterior and premolars teeth.
* Age above 60 years.
* Males and females.

Exclusion Criteria:

* • patient less than 60 years with disabilities, systemic disease, severe medical conditions, rampant caries, and xerostomia.

  * In addition, teeth with potential prosthodontics restoration and nonvital or endodontically treated teeth.
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans

Participants will be randomly allocated to either Yakult ingestion or a control group. For the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.

The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Aged 18-30
* Physically active (exercising at least 3 times per week for more than 30 min at a time)
* Non-smoker
* Free from cardiovascular or metabolic disease
* Weight stable for at least 6 months
* Normal body mass index (BMI: 18.5-24.9 kg/m2)\*
* Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)

  * Note: If BMI is \>24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.

Exclusion Criteria:

* Using probiotic or prebiotic supplements within the previous 3 months
* Vegetarians and vegans
* Diagnosis of insulin resistance, pre-diabetes or full diabetes
* Underweight (determined as BMI less than 18.5 kg/m2)
* Overweight or obese (determined as BMI greater than 24.9 kg/m2)
* Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.
* Those who are unwilling to restrict their intake of fermented dairy products.
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
* Participation in another clinical trial
* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.
* Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.
* Participants who know they would not be available for all the lab visits during the 4-week study period.
Metabolic Health Improvement Program: Effects of a Workplace Sugary Beverages Sales Ban and Motivational Counseling

The purpose of the study is to test the impact of a multilevel workplace intervention (hospital-wide sales ban on sugar-sweetened beverages (SSBs) and individual-level brief counseling) on employee health.

This double-randomized controlled trial of a multilevel workplace intervention that combines an employer-sponsored sales ban on sugar-sweetened beverages (SSBs) with brief counseling to support reduced consumption will test how well each intervention works alone, whether they work better in combination than separately, and whether or not changes in SSB cravings mediate these effects. Sutter Health worksites will be randomly assigned to either a control condition or to implement a sales ban on SSBs. Within all sites, employees will be randomized to receive/not receive a brief counseling intervention focused on reducing SSB consumption. Participants will complete self-report questionnaires, give blood samples, and provide measurements of waist circumference, height, and weight. These data will be analyzed to determine the effects of the interventions, both separately and in combination.

Eligibility Criteria:
Inclusion Criteria:

* Full-time employee who works on campus at one of the Sutter Health participating sites
* Speaks and reads English
* Consumes three or more sugar-sweetened beverages (SSB) a week
* Agrees to participate in two fasting blood draws

Exclusion Criteria:

* Pregnant