cyrilzakka/clinical-trials huggingface dataset:
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy

This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. Epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy.

PRIMARY OBJECTIVE:

I. To determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia (TEA) for patients undergoing pancreatoduodenectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP EPIDURAL (E): Prior to pancreatoduodenectomy, patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively. Patients also receive iopamidol via epidural and undergo x-ray imaging on study.

GROUP RECTUS SHEATH (RS): Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study

Exclusion Criteria:

* Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)
* Patients with chronic opioid use (at least 30 milligram morphine equivalents \[MME\] for 3 or more weeks leading up to surgery)
* Patients unable to understand the quality of recovery survey intellectual barriers. This will be determined by the primary investigator/attending anesthesiologist's discretion
* Patient refusal and those who have opted out of research
* Pregnant patients - will be assessed through review of the medical record
Redesigned Process in the Operating Room

The main purpose of the study is to examine whether operating room (OR) efficiency will be improved by significantly decreasing non operative time. This study also aims: 1) to evaluate whether a decrease in non-operative time will result in increased surgeon and staff satisfaction, 2) to determine whether there is an increase in the complication rate during the redesigned process perioperatively and until discharge from the post anesthesia care unit, and 3) to rate patient satisfaction.

The study aims to examine whether operating room efficiency will be improved by decreasing non operative time while ensuring patient safety.

Patients will be randomized into one of two groups:

In group A (new process): patients will be inducted in the induction room. At the end of surgery and after placement of the surgical dressing, the registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room. The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR. In group B (the current practice at AUBMC), patients will be treated as follows: patients will be induced in the operating room and at the end of surgery will be reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg. Once extubated and rolled out of the room, the house keeper team will start cleaning the operating room. Induction time (IT), emergence time (ET), and turn over time (TOT) will be recorded for both groups.

We expect to show that OR efficiency will be improved by significantly decreasing non operative time while ensuring patient safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients, above 18 years of age, undergoing general surgery for surgeon X under general anesthesia
* Patients undergoing only the following general surgeries: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries
* American Society of Anesthesiologist Physical Status (ASA) I or II
* Research participant willing to sign informed written consent.

Exclusion Criteria:

* Patients under 18 years of age
* Patients undergoing general surgery for surgeon X under regional or spinal anesthesia
* Patients undergoing surgeries other than the following: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries
* American Society of Anesthesiologist Physical Status (ASA) III, IV, V, and VI
* Emergency and lifesaving Cases
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Inability to bring the next patient to the induction room for uncontrollable reasons such as failure of equipment, late arrival to the hospital, or late financial or medical clearance.
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"

Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.

The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction in the nasopharynx causing less mucosal damage than standard nasotracheal tubes.

The investigators aim to test whether mucosal injury during nasotracheal intubation in children undergoing general anesthesia for dental procedures can thus be minimized taking into consideration adenoid size, and differences in nasopharyngeal diameter.

Eligibility Criteria:
Inclusion Criteria:

* children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation.

Exclusion Criteria:

* ASA \>3
* known bleeding disorders
* recent or ongoing treatment with blood-thinning medicines
* frequent epistaxis
* active URI/congestion/rhinorrhea
* craniofacial abnormalities prohibiting NTI
* known difficult airway
* prior nasal surgery/trauma
* allergies to any of the medicines used in this study.
Treadmill Exercise in Metabolic Syndrome

The main purpose of this study is to better understand the effects of two types of treadmill exercise programs that include education and/or techniques that may be helpful for exercise among individuals with, or at risk for, metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Referred by healthcare provider and given medical clearance for moderate-intensity exercise
2. Metabolic syndrome, defined as meeting three or more of the following criteria:

   * Obesity or overweight defined as BMI \> 25
   * Impaired glycemia (fasting blood sugar of ≥ 100 \[5.6 mmol/L\] or glycated hemoglobin \[A1C\] of ≥ 5.7)
   * Increased blood pressure (130/85 mmHg or higher) or if you take medicine for high blood pressure
   * Increased fasting levels of triglycerides (≥ 150 or 1.7 mmol/L) or decreased fasting high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL or 1 mmol/L for men or 50 mg/dL or 1.3 mmol/L for women) or if you take any medicines for dyslipidemia
3. Between the ages of 18-65
4. No regular physical activity (≥ 3 or more days per week) for the past 3 months

Exclusion Criteria:

1. Contraindications for treadmill exercise determined by their physician (e.g., cardiopulmonary limitations or diagnoses) or other inability to do treadmill exercise (e.g., musculoskeletal restrictions or severe balance impairment)
2. Confirmed diagnosis of coronary artery disease
3. Confirmed diagnosis of diabetes
4. Currently taking a beta blocker or calcium channel blocker medication
5. Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
6. Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
7. Self-reported psychotic disorder
8. Current practice of mindfulness mediation or mindful movement (e.g., yoga or tai chi), defined as regular daily practice or \>2 classes or self-guided sessions per week in the past three months.
9. Non-English speaking
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years of age
* Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
* Subjects who are candidate for routine, uncomplicated cataract surgery.
* Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
* Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or its components.
* Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (\>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
* Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
* Women who are pregnant or breast feeding.
* Subjects who have participated in an investigational drug or device study within the last 30 days.
* Subjects previously randomized in this study.
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and \< 5 years on bronchial asthma in daily clinical usage.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Pulmicort Respules for the first time due to bronchial asthma
* Children of \>= 6 months and \< 5 years old age at the start of study treatment
Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers

Background: Obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals.

Objective: we assess the effect of two different calorie restriction with MediterrAsian diet on weight loss of FTO rs9939609 carriers with overweight.

Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly allocated in two interventional group \[group 1: Mediterrasian diet according to adjusted ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories restriction (NRD)+ Moderate physical activity\]. Anthropometric indices will be assesses for all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly. Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30 and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in two intervention groups to find out which calorie restriction is appropriate for each genotype. Significant p-value is less than 0.05.

no data yet

Eligibility Criteria:
Minimum age: 20 years Maximum age: 45 years Gender: Both Accepts Healthy Volunteers?: Yes

Criteria: Inclusion Criteria:

* BMI range: 24.9-29.9 (overweight)
* Ethnicity: Persian

Exclusion Criteria:

* History of any metabolic diseases like Diabetes, CVD, Thyroid problems and ... .
* History of depression
* Pregnancy, trying to become pregnant or breast feeding
* Smoking
* Use of alcohol
* Significant weight loos during last two months (\>5 kilograms)
* being on a diet during last two months
* Use of any drug or supplement
The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus

The effects of Coronavirus Disease (COVID-19), a multisystem disease, on the body system and functions are being investigated all over the world. Examining the effect of exercise capacity, which is an important marker of cardiovascular risk in young individuals with COVID-19, will allow the planning of exercise and physical activity programs according to the needs of that specific population. The objectives of this project are:(1) To compare the submaximal and maximal exercise capacity of young adults aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise capacity evaluated by two different tests in young adults survived from COVID-19.

The effects of COVID-19, a multisystem disease, on the body system and functions are being investigated worldwide. For young adults, exercise capacity is vital in the workforce, cardiovascular risk factors and long-term health perception. Determining exercise capacity, which is an essential indicator of cardiovascular risk in the long term, and determining the factors affecting exercise capacity in cases with COVID-19 will allow the planning of exercise and physical activity programs according to young people's needs. The objectives of this project are:(1) To compare the submaximal and maximal exercise capacity of young adults aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise capacity evaluated by two different tests in young adults survived from COVID-19. There is no study in the literature evaluating the exercise capacity and the factors affecting the prolonged COVID-19 symptoms for patients with COVID-19. This project can provide objective evidence on this subject and includes controlled multi-directional measurement.

Eligibility Criteria:
Inclusion Criteria:

* For cases with COVID-19:

Confirmed COVID-19 infection - For healthy individuals of the same age group who have not had COVID-19: Individuals who have not been diagnosed with COVID-19 as of March 11, 2020 and who have not been in contact and risky according to the "Life Fits Into Home" application

- For all participants; Answering "No" to all questions in the Physical Activity Readiness Questionnaire.

Exclusion Criteria:

* Individuals with orthopedic or neurological disabilities that may interfere with exercise testing,
* Individuals with a fever\> 38 ° C and / or resting blood pressure \<90/60 mmHg or\> 140/90 mmHg and/or oxygen saturation ≤95%,
* Individuals who have been involved in a physiotherapy and rehabilitation program within the last 3 months,
* Individuals with insufficient cooperation
* Individuals with blood coagulation disorders contraindicated for blood lactate analysis,
* Pregnant women or individuals with suspected pregnancy
Outflow Facility AIT vs Microshunt

The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.

Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.

No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).

In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
* patients suffering from open-angle glaucoma

Exclusion Criteria:

* Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
* patients suffering from angle-closure glaucoma
The Spatiotemporal Gait Parameters in LDH Patient

The aim of this study was to assessment on the interaction of spatial and temporal gait parameters and gait asymmetry in patients with Lumbar Disc Herniation (LDH) before and 15 days after surgery.

The participants were divided into LDH and healthy control groups. The analysis of the spatiotemporal gait parameters was performed using the "Win-Track" gait analysis platform system for two groups. In addition, the analysis of spatiotemporal gait parameters of 60 participants who had the planned lumbar discectomy surgery, was tested before and 15 days after surgery. The pain intensity of the patients was recorded by the Visual Analog Scale (VAS) immediately before performing the analysis. After then participants completed ten passes on the "Win-Track" Gait Analysis Platform at their self-selected walking speed. The arithmetic mean of the three flawless walking data was used for analysis. The gait symmetry index was used to calculate the walking asymmetry.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were diagnosed with LDH by a specialist;
* Patients had a medical history and proven by MRI with more or less evidence of degenerative lumbar disc;
* Aged between 25-80 years old;
* Pain symptom on the lumbal area or lower extremity.

Exclusion Criteria:

* Patients who have previously received surgery or physical therapy treatment;
* Having congenital deformity in the spine or lower extremity;
* History of spinal surgery or other diseases affecting gait;
* Pregnancy;
* Situations that may cause gait balance problems;
* Using assistive gait appliance.
Statin Therapy Results in the Real World Practice in the Czech Republic

Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular diseases. Statins also have enough evidence to demonstrate decrease of morbidity and mortality from cardiovascular diseases. Even though statin therapy is effective treatment of dyslipidaemia not all patients reach the goal levels.

The aim of the study is to estimate proportion of patients who achieved the therapeutic goal (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a statin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented statin therapy for at least 12 months
* Available two LDL-C values: one at the beginning of statin therapy or at the time when patient comes to a specialist; and the other one at least after 12 months of treatment. The latter value should not be older than 6 months.

Exclusion Criteria:

-
Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer

This clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer

OBJECTIVES:

I. To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.

OUTLINE:

Patients undergo colposcopy and cervical Papanicolaou test with Human papillomavirus (HPV) test followed by anal Papanicolaou test and high resolution anoscopy. Patients with dysplastic anal lesions undergo repeat anoscopy at 3, 9, 15, and 24 months. Patients with normal anoscopy are followed up at 1 and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of cervical, vaginal or vulvar intraepithelial neoplasia or cancer are included
* Individuals treated with prior radiation therapy and/or chemotherapy are allowed
* Women with high-grade dysplasia (carcinoma in situ) are eligible, regardless of their dysplasia free interval
* HIV-positive (Human Immunodeficiency Virus) and HIV-negative women will be enrolled; HIV testing will not be performed as part of the study

Exclusion Criteria:

* Women who are not able to consent are excluded
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.

II. Compare the relative protection of each vaccine against atypical or subclinical pertussis infection.

III. Analyze possible laboratory correlates to vaccine protection.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT) and filamentous hemagglutin (FHA).

The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and agglutinogen 3.

The third group receives a whole-cell pertussis vaccine. The fourth group receives a diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age.

Close surveillance of infants and families continues for 2-3 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Population Characteristics--

* Infants aged 2 months at planned date of first vaccination
* No prior pertussis confirmed by culture
* The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination

--Patient Characteristics--

* Age: Under 3 months
* Renal: No renal failure
* Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier