cyrilzakka/clinical-trials huggingface dataset:
Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis

The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.

Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon.

The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.

Eligibility Criteria:
Inclusion Criteria:

* Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y

Exclusion Criteria:

* Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age \< 6 and \> 90y
The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy

The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status 1-3
* Patients undergoing thyroidectomy under general anesthesia
* Tumor size \< 2cm
* Patient who do not have any problem in the vocal cord

Exclusion Criteria:

* Patient who is expected difficult intubation (Mallampati class 3 or more)
* Patient who has respiratory disorder
* Previous hoarseness and sore throat history
* Obesity (BMI \> 30 kg/m2)
* Recurrent laryngeal injury during operation
* Operation history of oral and laryngeal surgery
Pannus Assistance Needed for Obstetric Ultrasound Studies

The goal of this randomized controlled trial is to evaluate whether use of a pannus retractor adhesive improves fetal anatomic ultrasound examinations. The primary question it aims to answer is:

• Does the use of a pannus retractor adhesive increase the rate of detailed anatomic survey completion, defined by satisfactory visualization of sixteen prespecified fetal anatomy views, for participants with a pannus and body mass index of at least 40 kg/m2?

Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. Ultrasound is a critical tool for the detection of congenital anomalies; however, adequate visualization of fetal anatomy by ultrasound decreases as body mass index increases. Placing a pannus retractor adhesive is a simple intervention that redistributes adiposity, providing better access to an important acoustic window for fetal ultrasound.

The investigators will conduct a randomized controlled trial comparing outcomes between groups that undergo fetal anatomy ultrasound examinations with or without use of a pannus retractor adhesive. The adequacy of ultrasound visualization is the primary outcome of interest. Secondary outcomes of interest include sonographer pain perception, participant satisfaction, adequacy of all detailed anatomy views, detection of fetal anomalies, skin to amniotic cavity depth, duration of ultrasound exam, and adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* BMI of at least 40.0 kg/2, calculated within 6 months of conception or at the first obstetric visit
* Pannus grade 1 or greater
* Gestational age between 18 weeks 0 days to 23 weeks 6 days, confirmed by prior ultrasound assessment

Exclusion Criteria:

* Patients who have already had a routinely timed anatomy ultrasound during the same pregnancy with Prisma Health Maternal-Fetal Medicine
* Patients with a known major fetal anomaly, confirmed by Prisma Health Maternal-Fetal Medicine
* Tape/adhesive allergy
* Multifetal gestation
* Intrauterine fetal demise
Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease

The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease.

The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.


Eligibility Criteria:
Inclusion criteria:

* Patients ≥18 years old
* Having a diagnosis of type 2 diabetes in 12 months before the index date (defined as the date of initiation of empagliflozin or Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) or Dipeptidyl Peptidate-4 inhibitor (DPP4i), based on the cohort evaluated), based on International Classification of Diseases (ICD)-9 and -10 codes and other available data
* Record of prescription for empagliflozin, any Sodium glucose co-transporter-2 inhibitors (SGLT2i), any DPP4 inhibitor, or any GLP1RA use between 1 January 2015 and 31 December 2020, and
* No record of any prescription for the drugs being compared during the 12 months + 30-day grace preceding the index date period, i.e.,

  * For the primary comparison of initiation of empagliflozin versus DPP4i, patients will not have any prescription for empagliflozin/any SGLT2i or DPP4i during the preceding 12 months + 30-day grace period.
  * For the comparison of initiation of SGLT2i versus GLP1RA, patients will not have any prescription for SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.
  * For the comparison of initiation of empagliflozin versus GLP1RA, patients will not have any prescription for empagliflozin/any SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.

Exclusion criteria:

* Aged \<18 years on the first prescription date of the qualifying prescription,
* Pre-existing diagnosis of type 1 diabetes mellitus (T1DM) during the 12 months before the index date,
* Having a disqualifying diagnosis during the 12 months before the index date, defined as having at least one of the following: estimated glomerular filtration rate (eGFR) \<30, dialysis, polycystic kidney disease or a kidney transplant,
* \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of drug use during this period, defined as not having at least 1 ambulatory visit and at least 1 medication prescription during the preceding 12 months, and
* Missing or ambiguous data on serum creatinine in the 12 months prior to the index date or sex
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.

Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)

Exclusion Criteria:

* Infants who need immediate medical interventions
Concurrent Single Gene and 24 Chromosome Aneuploidy Preimplantation Genetic Diagnosis (PGD)

Gene Security Network has developed a novel technology called Parental SupportTM (PS) which is used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the uterus, which have the best chance of developing into healthy children. The purpose of this study is to validate clinical use of PS to detect specific genetic mutation(s) known to cause severe inheritable diseases in embryos produced by at-risk couples. This may be done while simultaneously testing these embryos for aneuploidy. This study will allow for first of its kind commercial PGS/D testing to detect disease-associated genetic mutations together with aneuploidy screening.


Eligibility Criteria:
Inclusion Criteria:

* couple (mother and father)at risk to have a child with a single gene disorder (e.g. cystic fibrosis, Tay-Sachs, sickle cell anemia)
* Able to provide laboratory report from commercial CLIA certified laboratory confirming presence of disease associated mutation in mother and/or father
* couple planning to go through IVF and desiring PGD for the specified mutation
* Father (male) willing and able to provide sperm sample
* Maternal (female's) age \<40 years (e.g., 39 or younger)
* CVS/Amnio planned once the pregnancy occurs; willing/able to provide amnio/cvs sample for confirmatory testing or provide test results of confirmatory testing performed by an external CLIA certified laboratory.
* FSH \<10 (FSH = Follicle Stimulating Hormone. FSH is an indicator of egg quality and rough predictor of egg stimulation success. FSH is routinely measured by the IVF center prior to beginning an IVF cycle.)

Exclusion Criteria:

* Couples without prior documentation of genetic mutation as specified above
* Adult couples where the male partner is not willing, able, or available to provide a semen sample.
* Maternal age \>=40 years
* Couple unwilling to have amnio/cvs
Immersive Virtual Reality Exergames and Office Workers' Cardiometabolic Health

The worldwide increasing of prevalence of non-communicable diseases has grown the recognition of necessity for identifying the modifiable risk in preventing and managing these diseases. While, the office worker, as a representative group of physical inactivity, is exposed to risk factor of metabolic syndrome which is considered as the pathway of non-communicable diseases. This study mainly focuses on the purpose of examining the interventional efficacy of at-home immersive virtual reality exergame on several metabolic syndrome biomarkers among office workers. In addition, it purposes to determine the impacts of at-home immersive virtual reality exergame on lifestyle pattern of office workers. A 2-armed, single blinded randomized controlled trial (RCT) will be applied to examine the therapeutic effects of at-home immersive virtual reality exergame in this exploratory study. 120 Japanese office workers with less than 150 minutes per week of moderate to vigorous sports activities will be recruited by a convenience sample method. They are randomly allocated to two parallel groups, which including an intervention group: 12-week training of at least 150 minutes per week at-home immersive virtual reality exergame playing with a set device of Meta Quest 2, a control group: 12-week of maintaining regular exercise, eating, and working habits without making significant changes. During this 12-week trial, 3 main follow up steps are included at the timelines of 0 week, 6 weeks, 12 weeks. For each follow up, we will collect three types of variables, including major clinical risk factors of metabolic syndrome, lifestyle pattern factors of metabolic syndrome, and demographics (0 week only). To analysis the variance between intervention group and control group, mixed linear model will be applied to understand the efficacy result of this intervention. The variances of metabolic syndrome clinical risk factors between groups would be used to express the therapeutic effects of at-home immersive virtual reality exergame. The changes of lifestyle pattern factors would be applied to show the impacts of at-home immersive virtual reality exergame on lifestyle pattern.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* Capable of standing and exercising.
* Having no history of diagnosis of heart disease, cancer, or dementia.
* Being interested in playing with the exergames.
* Willingness of adhering to a 12-week interventional exergame treatment.

Exclusion Criteria:

* Individuals who are already engaged in more than 150 minutes per week of moderate to vigorous activities.
* Individuals with some pharmacological treatments, some surgery (bariatric surgery), and some traditional Chinese medicine.
Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department

This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led education for providers in the interpretation of these test results.

To determine if pharmacist-led education and procalcitonin testing as part of a stewardship intervention optimizes antiviral treatment and reduces antibiotic treatment for pediatric Emergency Department (ED) patients with suspected influenza v. standard care (i.e. rapid molecular influenza test without patient specific treatment recommendations) using a prospective, patient-randomized design.

Consented patients in the pediatric ED will be randomized into two arms: The intervention arm will receive a patient specific stewardship intervention and procalcitonin testing during the ED visit. The intervention will be pharmacist-led and include direct delivery to clinicians of information about interpreting test results and recommendations for antiviral-treatment for high-risk patients, and infection control precautions for patients being hospitalized with a positive RSV or influenza test. Clinician adherence to treatment guidelines with and without the educational intervention will be compared.

The second arm will be usual care (i.e. no procalcitonin test or pharmacist-led education). Results will be delivered via standard of care through the electronic medical record (EMR).

Physicians and patients will not be blinded to arm assignments. Tests will be performed on a real-time basis in the ED. For each of these groups, data of the frequency and duration of antibiotic administration, antiviral use, adherence to evidence based guidelines for treatment of influenza, isolation, hospitalizations, and unscheduled return visits or readmissions within a 30 day period will be collected and compared.

Research coordinators will contact patients and/or parents at 1 and 4 weeks after enrollment for self-reported secondary outcomes including symptom resolution, return to school/work, and follow up healthcare visits, medication adherence (to antibiotics and/or antivirals), and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients \<50 years of age who are evaluated in the emergency department for:
* suspected influenza, including symptoms of influenza-like illness (ILI - including fever \> 38 degrees Celsius and cough or sore throat), or
* non-specific upper respiratory infection (URI) for whom the clinician suspects the presence of RSV, or influenza, or lower respiratory infection LRI).
* Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test.

Exclusion Criteria:

* Patients who are pregnant
* Prisoners
* Patients who are unable to give informed consent in English or Spanish.
* Provider is unwilling to wait for procalcitonin results.
Central Sensitisation and Postoperative Pain

One out of 10 patients undergoing surgery develops persistent post-surgical pain (PPSP). Unfortunately, available therapies for treating this pain have limited success. It is therefore of great importance to find strategies to prevent PPSP. The goal of this project is to find new screening tools that identify patients that are at risk for developing PPSP.

Tissue injury and inflammation following surgery increase the excitability of spinal nociceptive neurons ("central sensitisation", CS) with pain hypersensitivity as consequence. It is thought that CS plays an important role in persistent pain.

The first objective of this project is to assess in human patients if the propensity to develop CS manifested as secondary hyperalgesia before surgery is predictive for PPSP.

In addition, we will test if the frequency content of the resting-state EEG reflecting the initial state of the brain will be related to the propensity for developing CS and to the presence of PPSP at two months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a lateral thoracotomy as treatment for primary lung cancer
* Ability to provide written informed consent

Exclusion Criteria:

* Evidence for a clinically-significant alteration of the skin of the volar forearms
* Pregnancy
* Having a pacemaker or implanted cardiac defibrillator
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.

A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.

Eligibility Criteria:
Inclusion criteria

* Patients (men and women) diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel
* Ability to understand and the willingness to sign a written informed consent document.
* Patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study.
* Concurrent standard and investigational agents are permissible with the standard chemotherapy drugs.

Exclusion Criteria

* Prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.)
* Prior taxane exposure at any time
* Preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy
* Pregnant or nursing women.
* Unable to give informed consent.
* Preexisting lower extremity amputation
* Inability to walk or stand without assistance due to any condition
* Neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible)
* Patients needing ambulatory assist devices
* Back or lower extremity surgery in the last 6 months
* Back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report
Trauma Services Intervention to Prevent Violence

Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests.

Allegheny County, PA continues to suffer between 100-120 homicides each year, with perhaps 2-3 times as many gunshot injuries that require hospitalization. Firearm homicides overwhelmingly affect African American men aged 15-35. Building on prior efforts in violence prevention, the investigators propose to launch a hospital trauma service intervention that will take advantage of a "teachable moment" in the emergency room. All four hospitals providing Level I Trauma services in Allegheny County have agreed to host the program, an evidence-based effort developed by the National Network of Hospital Violence Intervention (NNHVI). Adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. The investigators will offer the opportunity to participate in the research and receive the intervention to all gunshot victims identified in county Level I trauma services. Participants in the research protocol will be asked to recruit their high-risk social network members for the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18+
2. Gunshot victim treated and discharged from Level I trauma facility; or member of social network of gunshot victim who may be high risk of firearm violence -

Exclusion Criteria:

1. Gunshot wound because of suicide attempt
2. Gunshot wound because of non-violent episode (e.g., hunting accident)
3. Unable to participate in research interview because of cognitive deficit
4. Planning to leave community as result of shooting
5. Discharged from trauma service to prison
6. Unable to provide informed consent -
Validating and Optimizing Model of Antipsychotics Selection

This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance.

The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* An in-patient or out-patient (male or female) and aged ≥18 years
* A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine-5)
* Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures.
* Patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole.
* Baseline PANSS Total Score ≥70

Exclusion Criteria:

* Participation in other clinical studies.
* Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole.
* Use of clozapine within 28 days prior to randomization.
* Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.