cyrilzakka/clinical-trials huggingface dataset:
Enhanced Recovery After Surgery in Orthopaedic Spine Surgery

This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.

In orthopaedic surgery, ERAS programs have profoundly impacted outcomes in hip and knee replacement surgery.4 Large, prospective studies have demonstrated a reduction in mortality rate, median length of stay, and blood transfusion rates with no change in re-admission rates.5,6 However, there is a paucity of data evaluating the application of ERAS principles in other orthopaedic subspecialties, especially elective spine surgery. With over 35,000 cervical spine procedures performed in 2011, almost 200,000 elective lumbar fusion surgeries performed in 2015, and 83.7 million people estimated to be ≥ 65 years old in 2050, the demand for elective spine surgery is high and will continue to grow placing a significant economic burden on the health care system.This increasing demand in conjunction with prolonged hospital stays, extensive postoperative pain regimens, and the advent of minimally invasive procedures provides a compelling argument for the suitability of ERAS protocols in elective spine surgery.

While distinct components of the ERAS pathway have been investigated in spine surgery including preoperative education, multimodal pain management, surgical approach, nutrition, and physical therapy, few studies have investigated the collective application of these interventions. Furthermore, these studies have been retrospective in nature, limiting their generalizability.The goal of this study is to perform a prospective, randomized trial to evaluate the efficacy and cost-effectiveness of oral versus intravenous medications preoperatively. The investigators also plan to evaluate the effect of the implementation of the standard of care ERAS principles on the outcome of patients undergoing elective spine surgery.

Eligibility Criteria:
Inclusion Criteria:

· Surgery scheduled for lumbar decompression and fusions 1 to 3 levels

Exclusion Criteria:

* Cervical, thoracic, or lumbar trauma
* Oncologic procedures
* Patient's with comorbidities preventing early postoperative mobilization
* Patients with contraindications to tranexamic acid (TXA) administration including but not limited to patients with a history of thromboembolic or ischemic events (PE, DVT, CVA, MI). Additional contraindications are decided by treating orthopaedic surgeon
Band Together: Randomized Control Trial

The study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old

Older adults in the US are in a difficult situation that is historically unprecedented. People born in 1930 were expected to live to age 59, yet they will live to an average age of 79. These dramatic survival increases, due to immunizations, antibiotics and other innovations \[Centers for Disease, 2011\], have occurred at the same time as dramatic reductions in daily energy expenditures, due to automobiles, washing machines and other labor-saving devices \[Archer, 2013\]. This has left adults living longer, yet weaker, less fit and more obese. In fact, most residents of nursing homes are not there because of dementia. Only 40% of long-term care facility residents in 2010 were diagnosed with dementia \[Caffrey, 2012\] and many of whom had a level of dementia which would not require nursing home placement by itself. Most residents of long-term care facilities, rather, are there because they lack the strength and fitness to care for themselves. As baby boomers retire, these factors are anticipated to greatly increase the need for long-term care, highlighted in a report from a Deloitte Consulting in 2010: "Medicaid Long-term Care: The ticking time bomb" \[Keckley, 2010\]. This pilot study will measure a significant increase in strength with the use of a 12 week strength training program.

Eligibility Criteria:
Inclusion Criteria:

* Fluently read and speak English
* Willing to drive 3 times a week to Hershey Medical Center for most weeks
* Have a primary care physician
* Currently exercise ≤60 min per week

Exclusion Criteria:

* Doctor has said you have a heart condition and should only do physical activity recommended by doctor
* Feel pain in chest when doing physical activity
* Unable to obtain doctor's consent
* Currently participating in an exercise program
* Plans to move in the next 6 months
* Weight \> 250
* Currently exercise ≥60 min per week
Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy

The aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.

The aim of the study is to assess the safety of an oral food challenge test with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with food allergies after introducing cow's milk into the diet.

The study covers children over 12 months of age diagnosed with cow's milk allergy, treated with a non-dairy elimination diet based on extensively-hydrolyzed formulas or amino acid formulas, admitted to the Department of Pediatrics, Gastroenterology and Nutrition to conduct an open oral food challenge. In all children, after appropriate assessment and qualification (interview, physical examination, skin prick tests, results of allergen - specific immunoglobulin E (IgE), total blood count, fecal calprotectin and lactoferrin), an oral food challenge test with cow's milk will be performed. The oral food challenge test will be carried out in accordance with current standards and with child protection in the event of an adverse reactions. During the food challenge test (first 24 hours), after 2 weeks (phone survey) and 3 months after the test (visit to the Department) the frequency, severity and type of allergic reactions and cow's milk protein tolerance will be assessed. The safety of oral food challenge with cow's milk protein in children previously fed with extensively - hydrolyzed formulas or amino acid formulas will be compared. The results of allergy tests, total blood count and intestinal inflammatory markers (fecal calprotectin and fecal lactoferrin) will also be assessed before and 12 weeks after oral food challenge. The assessment of the incidence and severity of allergic reactions and tolerance of cow's milk proteins after introduction into the diet in children challenged with cow's milk proteins may help to establish guidelines on the qualifications and how to conduct an oral challenge test.

Eligibility Criteria:
Inclusion Criteria:

* children aged from 13 months to 15 years
* children diagnosed with cow's milk allergy treated with a dairy-free diet
* informed consent of the child's parents/legal guardians to participate in the study

Exclusion Criteria:

* occurrence of anaphylactic reaction after ingestion cow's milk proteins less than 12 months
* positive skin prick test with cow's milk proteins
* milk specific serum IgE values \> 17,5 kU/L
* age below 13 moths
* no consent of the child's parents/legal guardians to participate in the study
Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients

Chronic Obstructive Pulmonary Disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. The symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. Due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. Patient will also feel breathless just sitting or relaxing. Active Cycle of breathing technique can be used to mobilize and clear secretions. It will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. Acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. A randomized control trial will be conducted at Gosha e Shifa hospital and General hospital Lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with active cycle of breathing exercises/techniques and Group B will be treated with Acapella device with active cycle of breathing exercise .Outcome measure will be conducted through Modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform Pulmonary function test .Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of COPD.


Eligibility Criteria:
Inclusion Criteria:

* Both men and women age between 35-50 years.
* Having smoking history .(1)
* Dyspnea MRC scale grade 2 and grade 3.(20)
* Gold standard COPD grade 2

Exclusion Criteria:

* Any kind of infective pulmonary condition .
* Restrictive lung disease.(20)
* Pregnancy.
* Any severe heart disease
Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues

The purpose of this study is to investigate mechanisms which cause acute asthma exacerbations by examining blood and airway secretions during an acute onset (sputum or tracheal aspirates). This pilot study is intended to uncover new mechanisms of asthma exacerbation and to generate hypotheses for future study. By collaborating with Genentech, we (scientists at UCSF) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for asthma.

Asthma is a common airway disease with persistent unmet needs in terms of treatment. Although many asthmatics enjoy good control of their disease by using regularly scheduled corticosteroid treatment, a significant minority do not achieve optimal control with steroids and suffer asthma exacerbations which can be severe and even fatal. Asthma pathophysiology is complex and involves multiple cell types and multiple signaling mechanisms. One approach to this complexity has been to study responses of isolated airway cells to experimental conditions which model asthmatic inflammation; another has been genetic manipulations of candidate mediators of asthma in inbred mice. These studies have yielded important insights about possible mechanisms of asthma in humans, but the relevance of these mechanisms to human disease has not always been proven, and it is possible that unsuspected mechanisms have not yet been revealed by these approaches.

In the current study, we propose to collect samples of airway secretions and blood from asthmatic subjects when their asthma is uncontrolled and they are being treated in the hospital or emergency room. Our goal will be to identify abnormal gene expression profiles and protein concentration abnormalities in these biological fluids. We will then study them again 6-10 weeks later when their asthma is controlled. This study design will allow us to compare airway and blood biomarkers of asthma exacerbation during acute asthma and recovery. "

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 18 - 70 years
2. Medical history of asthma
3. Currently experiencing an acute exacerbation of asthma
4. Ability to provide informed consent or have a surrogate provide consent.
5. Ability to provide sputum.

Exclusion Criteria:

1. Cigarette smoking: Subjects must be non-smokers. Non-smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs.
2. Pregnant women.
Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest

Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage, cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells. Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored, ischemia-reperfusion injury develops in cardiac arrest survivors.

Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been proven effective in acute myocardial infarction.

This study aims to perform a randomized controlled trial to determine whether RIPoC has a neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest patients after restoration of spontaneous circulation.

Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will be measured as a primary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adult (19 years and older)
* comatose out-of-hospital cardiac arrest with sustained restoration of spontaneous circulation
* Undergoing targeted temperature management
* Time of enrollment ≤ 6hrs from restoration of spontaneous circulation
* cardiac arrest from medical cause (cardiac or other medical cause)

Exclusion Criteria:

* Pre-existing dementia, brain injury, or dependence on others (cerebral performance category scale greater than 3)
* Traumatic etiology for cardiac arrest
* Protected population (pregnant, prisoner)
* in-hospital cardiac arrest
* Known bleeding diathesis
* suspected or confirmed acute intracranial hemorrhage
* suspected or confirmed acute ischemic stroke
* Known limitations in therapy and do-not-resuscitate order
* known disease making 180-day survival unlikely
* \>6 hours from restoration of spontaneous circulation to randomization
* cardiac arrest from asphyxia (hanging, foreign body airway obstruction), drowning, drug overdose, or electrocution
* peripheral vascular disease (Deep vein thrombosis, arteriosclerosis obliterans)
* systolic blood pressure \< 80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication
Initial Stability of Posterior Maxillary Implants With Bicortical Fixation

The primary purpose of this study is to

1. determine whether dental implant engaging both the alveolar crest cortical bone and sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation) increases initial implant stability compared to the short implants engaging only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both crest and sinus floor but with green stick fracture (indirect sinus lift technique),
2. study whether different surgical techniques, residual bone height, bone density, and length and width of the implants used affect initial implant stability in posterior maxilla. In addition, this study will continue to
3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year follow-up from the restoration and
4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer tomogram) scan and evaluate safety and potential post-operative complications of bi-cortical fixation and indirect sinus lift technique reported throughout the follow up periods.

The clinical trial will evaluate initial implant stability as a primary outcome measured by resonance frequency analysis (RFA) employing dental implants surgically placed in posterior maxillary bone by engaging alveolar crest and the sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation), engaging only the alveolar crest (uni-cortical fixation), and engaging alveolar crest and the sinus floor using indirect sinus lift technique (indirect sinus lift technique). The surgical procedures compared in this experiment include 3 groups:

* Group 1 (15 implants) Short implants placed in proximity of the sinus without sinus floor involvement (unicortical fixation)
* Group 2 (15 implants) Implants placed using indirect sinus lift technique (indirect sinus lift technique)
* Group 3 (15 implants) Bi-cortically fixed implants intentionally engaging sinus floor beyond up to 1-2mm without graft but using stopper drill and self-threading concept (bi-cortical fixation)

Eligibility Criteria:
Inclusion Criteria:

* Eligible volunteers must be at least 18 years old, partially edentulous in maxillary posterior region with 7-11 mm residual bone height under the sinus floor and be indicated for CBCT scan for diagnosis and treatment planning, and of a medical risk of ASA I or II classification to participate.

Exclusion Criteria:

* Patients with bone pathology, sinus infection, and who are pregnant will be excluded. Implants requiring tapping, site of an implant replacement, and implant with dehiscence and/or fenestration will be excluded.
Breast Reconstruction Following Breast Cancer in Very High Risk Patients

The purpose of this study is to:

1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Primary Endpoint(s)

1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
2. Compare immediate and delayed reconstruction outcome metrics through retrospective review

Secondary Endpoint(s)

1. Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
2. Compare complications and reoperations between immediate versus delayed reconstruction.
3. Compare the hospital costs between immediate versus delayed reconstruction
4. Evaluate the effectiveness of risk reduction strategies

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
* Subjects must be breast reconstruction candidates using implant based breast reconstruction.
* Subjects must have a pre-operative risk \>20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior breast cancer surgical treatment
* Prior breast reconstruction
* Inability to provide written consent
Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI

The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task

Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.

Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+
* Diagnosed as suffering from MCI
* No impaired judgement
* Verbal and written proficiency in Hebrew
* Normal or corrected-to-normal vision and hearing ability
* Independent in ADL function
* Lives in the community
* Able to perform task of shopping.

Exclusion Criteria:

* Suffering from other coexistent neurological diseases (e.g. stroke, muscular dystrophy)
* Has acute arthritis
* Poorly controlled hypothyroidism
* Suffering from physical or sensory limitations, as by self-report or noted by the investigator, that may limit the use of a computer's mouse
* No skills in performing shopping task
* Defined as suffering from depression as determined by the rating scale for depression
* Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
Pediatric Parental Feeding Video Education Program

The goal of this clinical trial is to learn about the acceptability and feasibility of nutrition education videos among food-insecure parents and caregivers of young children (under 8 years old).

Participants will:

* Watch short nutrition education videos weekly for 8 weeks.
* Complete demographic and nutrition behavior questionnaires at week 1 and week 8.
* Participate in three motivational interview phone calls with a nutrition educator lasting 20 minutes over the course of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Screen positive for food insecurity at Hasbro Children's Hospital Primary Care Clinic.
* Parent or caregiver of at least one child between 3-8 years old.
* Speak English or Spanish fluently.

Exclusion Criteria:

* None.