cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Block for Thoracic Surgery

The aim of this study is to determine if erector spinae injections with bolus infusions with local anesthetic decrease postsurgical pain and opioid consumption in patients undergoing pulmonary resection surgery.

The research hypothesis for the ESB Thoracic study is that erector spinae blocks with boluses of bupivacaine infusions will decrease patients' postsurgical pain, and thereby decrease the amount of narcotic pain medication used. This will be of particular use in patients who have an anticoagulation need and are not able to receive more invasive nerve blocks.To achieve appropriate exposure for pulmonary resection surgery, whether open or video-assisted, patients have surgical incision in the lateral thoracic region, including disruption to the tributaries of the spinal nerves. Due to this dissection, patients frequently experience significant pain post-operatively. Erector spinae blocks with bupivacaine or ropivacaine with bolus infusion therapy have been shown to treat this spinal nerve pain effectively in rib fractures, thoracoscopic surgeries, and breast surgeries. However, there have been no definitive studies evaluating the effectiveness of erector spinae blocks in postoperative pulmonary resection surgery patients.

It is expected that patients with erector spinae blocks (ESB) will have lower pain visual analogue scores (VAS) and lower total opioid consumption. Learning more about the effectiveness of ESB can help in providing adjunct therapy and thereby minimize post-operative opioids, use of which can add further complications in this group of patients through decreased ventilation and increased atelectasis and hypercarbia. As well, current neuraxial local anesthetic therapy involving epidurals and paravertebral blocks require an absence of anticoagulation in the patient; as a fascial plane block, erector spinae blocks can be safely placed in patients on anticoagulation.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary resection
* 18\<age\<90

Exclusion Criteria:

* pleurodesis
* decortication
* emergent surgery
* local anesthetic allergy
* intraoperative complication (inadvertent hemorrhage or conversion to open surgery)
* bilateral pulmonary resection
The Effect of Repeated Simulation in Developing Social Justice Advocacy Attitudes and Skills on Nursing Student

It is a randomized controlled experimental and single-blind study with a pretest-posttest control group design.

It is a randomized controlled experimental and single-blind study with a pretest-posttest control group design, planned to examine the effect of repeated simulation (standard patient simulation) on improving nursing students' social justice advocacy attitudes and skills.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research Being a 4th year undergraduate nursing student Having completed the theoretical education for vocational courses

Exclusion Criteria:

* Being a foreign national (due to Turkish speaking/understanding problem)
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.

This study will enroll infants undergoing cardiothoracic surgery requiring deep hypothermic circulatory arrest (DHCA) at the University of Michigan's C.S. Mott Children's Hospital. Patients that are eligible will be randomized to receive either one dose surfactant or the sham (air) arm after the surgical procedure. Patients will be monitored for an additional 30 days after the breathing tube is removed. It is possible that subjects may be discharged prior to the last assessment, therefore for subjects who have been discharged a member of the study team will contact the parent (s) or legal authorized representative by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Patients less than or equal to 12 weeks of age with hypoplastic left heart syndrome (HLHS) undergoing cardiothoracic surgical correction (Norwood) requiring DHCA.
* Infants weighing 2500 grams or greater at the time of surgery.
* Written informed consent from parent(s) or legally appointed representative (LAR).

Exclusion Criteria:

* Patients who are less than 36 weeks Post Menstrual Age (PMA) at the time of surgical correction.
* Underlying craniofacial, airway or lung anomalies which could compromise administration of surfactant.
* Infants weighing less than 2500 grams at the time of the surgical correction.
* Mechanical ventilation for\> 7 days prior to surgical correction.
Inflammatory Mediators of Acute Kidney Injury in Intensive Care

Acute kidney injury (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of AKI. In this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for AKI.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the intensive/post operative care unit

* with septic shock or
* post major surgery or
* after intoxication with a chemical compund

Exclusion Criteria:

* Pregnancy or
* Breast feeding or
* Chronic kidney disease or
* intoxication with nephrotoxic compund or
* lack of informed consent
Rehabilitation Coordinators in Specialist Psychiatry

REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are on sick leave due to mental illness.


Eligibility Criteria:
Inclusion Criteria:

* Be on sick leave
* Have moderate to severe affective and / or moderate / severe anxiety disorder, such as: Bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability
* Enrolled at the Academic hospital in Uppsala

Exclusion Criteria:

* High suicidal risk
* Extensive somatic disorders (somatic multichannel)
* Patients outside Uppsala County
* Taking part in an ongoing vocational rehabilitation
Assess the Efficacy and Safety of Rhinocort Aqua

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
* At randomisation having nasal symptom scores as defined by the protocol.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specifies in the protocol.
Diet, Exercise, and Nutrition Challenges in Mexican Adults During COVID-19: a Study

The COVID-19 pandemic was particularly devastating in developing countries such as Mexico, where the nation reported some of the highest COVID-19 cases and a high prevalence of obesity. This study aimed to evaluate the food consumption among Mexican adults during the COVID-19 pandemic. A cross-sectional study was conducted, involving 1,082 Mexican adults recruited through online invitations containing a link to complete a survey. A 48-item questionnaire was designed to assess the frequency of food consumption and sociodemographic characteristics in a semi-quantitative manner. A retrospective instrument was used to evaluate physical activity (days/week and duration).

The COVID-19 pandemic had a particularly harsh impact on developing countries like Mexico, which reported some of the highest numbers of COVID-19 cases and a significant prevalence of obesity. This study aimed to examine the eating habits of Mexican adults during the COVID-19 pandemic. A cross-sectional survey was conducted, involving 1,082 Mexican adults who were recruited via online invitations that included a link to complete a questionnaire. A 48-item survey was created to evaluate the frequency of food consumption and sociodemographic factors semi-quantitatively. Physical activity was assessed using a retrospective tool to measure the frequency and duration of exercise per week.

The main discovery identified two dietary patterns: industrialized and healthy. The industrialized dietary pattern was more common and included the consumption of sugary dairy products, sugary drinks, alcoholic beverages, sweets, fried foods, and both red and processed meats. Men consumed significantly more ultra-processed foods (22.5%) compared to women (15.45%) based on a 2000 kcal diet. In addition, participants did not meet the recommended intake levels for fruits, vegetables, legumes, and natural dairy products. Intake of sugary drinks was three times higher than recommended for both genders. Regarding physical activity, only 29.7% of participants reported engaging in adequate physical activity.

The study also highlighted insufficient consumption of nuts and an excessive intake of red and processed meats. It underscored the necessity for intervention and educational initiatives to improve dietary choices, particularly among younger populations.

Eligibility Criteria:
Inclusion Criteria: Additional to the age, people living in Mexico during the COVID pandemics.

Exclusion Criteria: People who did not live in Mexico during the COVID pandemics

-
Transversus Abdominis Plane Block for Laparoscopic Hysterectomy

Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine requirements during the first 24 hours postoperatively.

Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:

1. Group treatment TAP (n=23) will receive the following analgesia:

   * US guided transversus abdominis plane block performed with 40ml of 0.375% levobupivacaine (20 ml per side) after general anaesthesia induction, before surgical start
   * Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest
2. Group control will receive:

   * Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest

Primary Outcome Measures:

Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control

Secondary Outcome Measures:

* Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain when resting in bed and during cough during the first 24 hours postoperatively
* Time to PACU dimission, evaluated as patient's achievement of a White's score \> or = 12/14
* Time to home discharge, evaluated as patient's achievement of a PADDS score \> or = 9
* Functional patient capacity as measured before surgery and whenever a White's score \> or = 12 will be reached (2minute walking test)
* Eventual side effects such as nausea/vomiting

After the start of the study, we had a higher drop out size than expected. We therefore added a 13% of patient to initial power calculation to compensate for drop outs.

Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the study = 44

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< age \< 70 years
* ASA I - II - III
* undergoing elective laparoscopic hysterectomy
* signed informed consent

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants
* surgical conversion to open abdominal hysterectomy
* urgent/emergent surgery
* postoperative transfer to the intensive care unit
* pregnancy or breast feeding
* known allergy to any drug medication
* local skin infection
* epilepsy
* high bilirubin level (\> 3mg/dl) or high hepatic enzymes levels (\> 250UI)
* high creatinin level (\> 1.4mg/dl)
* 18Kg/m2 \< BMI \< 30Kg/m2
* alcohol or drug abuse
Safe Infusion Device in Reducing Occupational Exposure of Nurses

Monocentric comparative before / after study to evaluate the efficacy of Safe Infusion Devices (SIDs) in reducing drug exposure to nurses compared to usual perfusion practices.

Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement.

A monocentric comparative before / after study was carried out in an oncology day hospital in order to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual perfusion practices (neutral solvent-purged infusers). The rate of nurses' gloves contamination was estimated. The eligible protocols must contain at least one disconnection step and one of the 10 drugs screened. To avoid false negatives, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate regression analysis.

The usual practice leaded to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 84% in multivariate analysis (Odds ratio=0.16; 95% confidence interval=0.05-0.47; p\<0.001). Topotecan was identified within 100% of the samples. Only one case of cross-contamination has occurred.

Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. This validated the environmental quality of the cytotoxic drug circuit. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

Eligibility Criteria:
Inclusion Criteria:

* Protocols which contained at least one of the 10 drugs of the dosing assay
* Protocols with at least one disconnection step.
* Given the large number of eligible protocols, we favored those with the most concentrated products (CPM, PMX) to maximize the chance of detecting contamination and also to extend inclusions over a longer period.

Exclusion Criteria:

- Drugs administrated with syringes (intravenously or subcutaneously) were not included because of the absence of impact of the SIDs on these modalities of administration.
A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese

The objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients.

Special aims are to:

1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
2. Identify factors that mediate or moderate the intervention effects. For example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.

This study is a randomized controlled trial aiming to test the effect of the culturally-tailored in-office based intervention on physicians. A total of 24 Chinese physicians in the Washington DC and Philadelphia areas and a total of 24 eligible Chinese patients from each physician will be recruited for this study. Physicians and their patients are randomized into two groups: A and B. Physician in the intervention group (A) will receive mailed printed materials including a CRC physician guide, patient brochure, flip chart and a poster and two sessions of in-office training aimed to reinforce learning of the topic covered by the mailed materials and provide physicians with hands-on experience in using communication skills with standardized patients. Physicians in the control group (B) will receive nothing until the end of the study. Patients will be followed 12-month later after their completion of the baseline survey and their self-reported CRC screening status will be verified by chart audit.

Eligibility Criteria:
Inclusion Criteria:

For Physicians

1. are Chinese American,
2. practice primary care,
3. have a least 75 Chinese patients aged 50 and older in their practice,
4. can communicate with patients in Chinese (Mandarin, Cantonese, etc.)

For Patients

1. visiting the participating physician at least once in the past 2 years,
2. are Chinese Americans,
3. are 50 years and older,
4. never had any CRC screening or are overdue for screening.

Exclusion Criteria:

For Patients:

1. have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative), and
2. had updated CRC screening (FOBT within one year, colonoscopy within 10 years, sigmoidoscopy within 5 years and double-contrast barium enema within 5 years).
C677T and A1298C MTHFR Polymorphisms and Fluoropyrimidine Effectiveness in Metastatic Colon Cancer

Fluoropyrimidines are the backbone of chemotherapy regimes used to treat metastatic colorectal cancer (CRC). These drugs act in different pathways of folate metabolism altering DNA synthesis mainly by inhibition of the tymidylate synthase. For this reaction the 5,10-methylenetetrahydrofolate acts as cofactor. It has been demonstrated that A1298C and C677T polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene result in reduced enzyme activity that leads to reduced availability of this important cofactor. Hence, we hypothesized that the presence of these polymorphisms are related to the efficacy and toxicity of fluoropyrimidines in patients with CRC.

Patients with metastatic colorectal cancer are invited to join this study at the start of treatment with any fluoropyrimidine used alone or in combination with oxaliplatin and/or irinotecan +/- bevacizumab, panitumumab or cetuximab. DNA extraction will be done from blood and tissue samples to determine the C677T (rs1801133) and 1298 A\>C (rs18011131) polymorphisms of the MTHFR gene.

The patient will be followed at least for one year during treatment to determine any toxicity related to the therapy and to determine the overall survival, progression-free survival and response rate. Patients will be categorized into different categories according to the genetic status of each polymorphism.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colorectal cancer receiving first line therapy with any fluoropyrimidine (capecitabine or 5-Fluorouracil) alone or in association with oxaliplatin, and/or irinotecan, plus either bevacizumab or cetuximab/panitumumab.

Exclusion Criteria:

* Any other malignant condition
Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug

The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in order to assess retention and replacement of the OTX Punctum Plug for this duration. At the Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum Plug is removed.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be greater than or equal to 40 years of age.
* Subject is in general good health with overall healthy eyes.
* Subject has been informed of the nature of the study and is able to comply with study requirements, the visit schedule and has provided written informed consent, approved by the appropriate IRB.

Exclusion Criteria:

* Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
* History of ocular trauma within the past 6 months in either eye.
* History of ocular infection (bacterial, viral, or fungal) or ocular inflammation within 3 months prior to the study in either eye.
* History of chronic or recurrent inflammatory eye disease (i.e., iritis, scleritis, uveitis, herpes keratitis) in either eye.
* History of clinically relevant or progressive retinal diseases such as retinal detachment, retinal degeneration, or diabetic retinopathy in either eye.
* History of any other severe ocular pathology (including severe dry eye) in either eye.
* History of any laser or incisional surgery within 6 weeks prior to the study or scheduled ocular surgery during the study.
Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

The central hypothesis is that a peer coach-delivered intervention that includes cognitive behavioral principles combined with theory-driven patient education will improve health-related quality of life (HRQOL) of patients with hypersensitivity pneumonitis (HP). The goal of this behavioral and educational intervention, RISE-HP, is to improve health-related quality of life in people who have hypersensitivity pneumonitis and assess feasibility and accessibility of this intervention.

Patients with hypersensitivity pneumonitis (HP) experience uncertainty, feelings of anxiety and depression, and marked disruption to their lifestyle and home environment. Poor health-related quality of life (HRQOL) in HP is also driven in part by patients' profound lack of knowledge about the disease. Existing interventions for patients with HP do not target improvement in quality of life. Participants will complete either RISE-HP, a 10-session peer coach delivered behavioral and educational intervention to improve HRQOL in HP, or Staying Well, a 10-session general health education program.


Eligibility Criteria:
Inclusion Criteria:

* Have documented diagnosis of Hypersensitivity Pneumonitis by treating clinician.
* Age 18 or older.
* English Speaking.
* Willing to work with a peer coach.
* Have a working smart phone or tablet.
* Have access to the internet.
* Reside or live in the United States.
* Endorse verbal approval from treating physician to participate in patients' goal movement/physical activity.
* Meet one or more of the following criteria:
* Baseline score on the PHQ8 of \>5 - \<20
* Baseline score on the GAD-7 of 5 or greater
* Baseline score on the FSS of 3 or greater

Exclusion Criteria:

* Does not have Hypersensitivity Pneumonitis
* Younger than age 18
* Severe cognitive impairment as determined by their treating physician.
* Participants with severe depression (PHQ-8 score ≥20) or severe anxiety (GAD-7 score ≥15) will be ineligible for the study and will be referred to alternative sources of care.
* Anyone with documentation in their medical chart of an eating disorder, active substance use disorder, suicidality, homicidality, acute posttraumatic stress disorder, or episodes of mania or psychosis.
* Anyone who is determined to be severely ill or moribund by the treating clinician.