cyrilzakka/clinical-trials huggingface dataset:
Pain Control in Bariatric Patients: EXPAREL(R) vs. the On-Q(R) Pain Ball

This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.

The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80, male or female

Exclusion Criteria:

* Pregnant women
Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery

This pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.

During hospitalization, beginning after orthopedic surgery, study participants will be asked to wear a small motion detector on their wrist. A computer vision system which analyzes both whole-body movement as well as facial expressions will be used at the bedside to compare common signs and symptoms of post op pain to patient pain scores.

Up to 30 study participants will be selected.

Study participants will be asked to complete a written pain diary during waking hours.This information will be compared to the pain scores found in the patient's medical record and/or the amount and frequency of pain medications they receive.

Eligibility Criteria:
Inclusion Criteria:

* Recovery following Orthopedic Surgery
* Non-vulnerable adult patient
* Residing on the 6th floor of the South Tower of UF Health Shands Hospital
* Under the care of the acute pain service

Exclusion Criteria:

* Inability to understand pain assessments
* Inability to wear a motion tracking device
* Amputation of limb
* Vulnerable subject status
* Anticipated discharge from hospital within 24 hours following enrollment
* \< 21 years of age
Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants

Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
* Winter epidemic period from November, the 15th, to March the 15th
* Age \< 12 months
* Admission Wang score included between 4 and 8
* Infant hospitalized for gravity clinical criteria of severity
* Nebulized 3 % hypertonic saline treatment since less than 24 hours
* Infant with social security card coverage
* Free consent of at least one of the parental authority holder

Exclusion Criteria:

* Pulmonary, cardiac or neurologic chronic underlying disease
* Prematurity \< 32 GW
* Asthma (3rd episode or more)
* Admission oxygen saturation level \< 85 %, Wang score ≥ 9
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be undergoing an EGD.
* Patients must be over the age of 18.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
* OR patients with a history of hemostasis disorders.
* OR patients with esophageal strictures.
Testing of a Tool to Elicit Patient Preferences for CTS

This study will complete a randomized controlled trial to quantitatively measure patient decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool compared to 150 patients treated with standard care. The investigators hypothesize patients treated for CTS will have lower decisional conflict with the tool.

The investigators will measure decisional conflict in 150 new patients being evaluated for CTS with the tool compared to 150 patients being evaluated for CTS with standard care. Those patients randomized to receiving the tool will use it to identify their preferences for certain attributes of care. Patients will then be presented with their preference data and the surgeon will have a discussion with the patient regarding CTS. Surgeons will have their standard discussion with the patients randomized to the standard care group (no tool). The tool will be operationalized on a Health Insurance Portability and Accountability Act compliant data platform, such as Qualtrics, and no identifiable data will be collected. De-identified data will be shared from study cites with our team at Stanford. This data will be backed up on a computer encrypted by Stanford.

Eligibility Criteria:
Inclusion Criteria:

* New patient
* English fluency and literacy
* Able to take informed consent
* clinical diagnosis of carpal tunnel syndrome

Exclusion Criteria:

* Prior diagnostic testing for carpal tunnel (nerve test, ultrasound)
* Prior carpal tunnel release
* Diagnosis of C5/6 radiculopathy (double crush)
* Peripheral neuropathy (ex: diabetic)
* Worker Compensation/EMG Required
* Symptoms of Cubital tunnel syndrome
Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis

The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.


Eligibility Criteria:
Inclusion Criteria:

* isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Exclusion Criteria:

* below 65 years of age
* coronary revascularization within 4 months before the index procedure
* concomitant heart surgery
Role of the Posterior Parietal Cortex in the Processing of Sensory Information

Although the primary motor cortex is considered has the common final pathway of motor commands, it is influenced by several structures as, for example, the premotor cortex and the posterior parietal cortex which are involved in motor planning and programming and which integrates movement-induced sensory impute (parieto-frontal circuits). Several studies have shown that there are some direct functional connections between the premotor cortex and the posterior parietal cortex and from these two regions to the primary motor cortex. The posterior parietal cortex can then be considered as a sensorimotor interface whose function in planification and motor control of upper limb is well demonstrated. The hypothesis is that the posterior parietal cortex could participate to the modulation of motor cortex excitability by proprioceptive sensory inputs namely long latency afferent inhibition and afferent induced facilitation.


Eligibility Criteria:
Inclusion Criteria:

* Right handed
* No neurological troubles
* Informed consent signed
* Affiliated to a social security

Exclusion Criteria:

* Psychiatric antecedent
* Neurological disease
* Contra-indication to TMS
* Under psychiatric treatment
* Pregnancy
* Contra-indication to MRI
Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial

The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation

Exclusion Criteria:

* preexisting hoarseness or sore throat, upper respiratory tract infection
* steroid therapy or immunocompromised patients
* chronic treatment with calcium channel blocker or magnesium
* allergy to magnesium sulphate
* Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
* fail to tracheal intubation at first trial
* reduced kidney function
* Diabetes mellitus
Increasing Adoption of Fruits and Vegetables Into Family Diet

The investigators are interested in maximizing the consumption of fruits and vegetables (F\&V) in elementary school children by increasing the access to F\&V by providing them in the home environment via direct delivery (F\&V bag \& recipes) and a gift card to purchase preferred choices. This also decreases barriers to trying F\&V and switching to a more F\&V-focused diet, e.g., access, cost, knowledge of what to do with fruits and vegetables by their families in household diet, and a period of time to try and get used to more F\&V in the diet without worrying about access and cost.

We hypothesize that at the end of 4 weeks, children in families that were given access to a F\&V produce box with associated recipes, a gift card to purchase preferred choices, and a cooking incentive kit, consumed significantly better diets as measured with a diet composite score compared with children in families who did not receive increased F\&V access.


Eligibility Criteria:
Inclusion Criteria:

1. Families must be participants in the Boys and Girls "Club on the Go" program. They could sign up to become a participant while we are recruiting.
2. Caregiver must be able to come to the same "Club on the Go" site every week.
3. At least one child in the family must be k-5 student.
4. Caregiver must be able to read and write in English or Spanish to answer assessments.

Exclusion Criteria:

1. Reference child with any medical condition in which they have to follow a specific diet.
2. Caregiver cannot read and write in English or Spanish.
3. Reference child not living with caregiver for majority of time (75% or greater).
4. Families that do not meet the inclusion criteria
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.


Eligibility Criteria:
Inclusion Criteria:

1. ≥60 years old
2. undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days

Exclusion Criteria:

1. Blind, deaf, or inability to understand English as these conditions would preclude the ability to perform the proposed comprehensive program and prevent assessment with the study instruments
2. Prisoners
3. Severe frailty or physical impairment that prohibits participation in the program
4. Cognitively unable to consent for surgery (i.e., dementia or cognitive impairment of a severity that precludes ability to self-consent and, thus, also participation in study interventions)
5. Inability to obtain informed consent ≥2 weeks before scheduled surgery
6. Surgical team unwilling to allow physical activity or other components of the intervention
7. Inability or unwillingness to utilize a tablet device, laptop, or email
8. Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
Bright Light Therapy for Post-COVID-19 Fatigue

This is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-COVID-19 fatigue.

This randomized placebo-controlled trial aims to evaluate the efficacy of BLT in reducing fatigue symptoms after COVID-19 infection. The second aim of the study is to explore the effects of BLT on insomnia, depression and anxiety symptoms.

Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) dim red light (placebo) treatment for 30-minutes daily at their habitual wake time for a total of two weeks. Participants will be evaluated at baseline, 2nd (end of treatment), and 4th week (post-treatment 2-week) for fatigue and other symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Capable to give informed consent
* COVID-19 infection confirmed by PCR test or a Rapid Antigen Test (RAT) with onset of at least three months
* Reports new onset or exacerbation of fatigue after onset of COVID-19 and lasted for over two months
* Scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the Brief Fatigue Inventory

Exclusion Criteria:

* A current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder.
* Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma.
* Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
* Regular shift-workers
* Trans-meridian flight in the past 3 months and during the study
* Currently receiving any structured psychotherapy
* Self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders)
* Enrolment in another clinical trial of an investigational medicinal product or device.
Study of Adolescent Immunization Recall Systems

The purpose of this study is to determine whether contacting the parents of adolescents overdue for routine vaccines or contacting both the parents AND adolescents overdue to routine vaccines improves immunization rates as compared to usual care.

This randomized controlled trial is a 3-armed study designed to evaluate an immunization recall system in adolescents. In the control arm (Group 1), the adolescents will receive usual care, in which they will primarily receive immunizations at annual physical exams, or as recommended by providers at urgent care visits. In one intervention arm (Group 2), the parent/guardian will receive a telephone call informing them that the adolescent is overdue for one or more immunizations (conjugated Neisseria meningitidis (MCV4) vaccine, tetanus-diphtheria-pertussis (Tdap) booster, and/or the second varicella (VZV) vaccine). In the second intervention arm (Group 3), both the parent/guardian and the adolescent will receive a telephone call informing them that the adolescent is overdue for one or more immunizations. Immunization rates will be compared between the 3 groups at a four week and a twelve month follow up period.

Eligibility Criteria:
Inclusion Criteria:

* at least 13 years of age and under 18 years of age
* had a billing code for an annual physical exam in the past 3 years at the Adolescent/Young Adult Medical Practice at Children's Hospital Boston
* immunization record shows one of the following: no tetanus containing vaccine in the previous 5 years; no MCV4 vaccine; and/or has received the 1st VZV vaccine but not the 2nd VZV vaccine and has no documented history of the chicken pox

Exclusion Criteria:

* immunization record shows no vaccines or only influenza vaccines
* sibling enrolled in the study
* in the custody of the Department of Youth Services
* in the custody of the Department of Child and Family Services
Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D


Eligibility Criteria:
Inclusion Criteria:

1. Female 18-65 years of age (inclusive)
2. Diagnosed with IBS based on the following criteria (Rome III criteria):

   * Symptom onset at least 6 months prior to diagnosis, and
   * Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
   * Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
   * improvement with defecation
   * onset associated with a change in frequency of stool/defecation
   * onset associated with a change in form (appearance) of stool
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations

Exclusion Criteria:

* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
* History of Chron's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
Independent Walking Onset of Children With Cerebral Palsy

This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.


Eligibility Criteria:
Inclusion Criteria:

* Maximum age of 3 years old
* Independent walking experience of maximum 6 months
* Ability to walk 5 m without falling or needing a technical assistance
* A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years

Exclusion Criteria:

* History of lower limb musculoskeletal trauma in the last 6 months
* A known skin allergy to any adhesive product
* History of lower limb musculoskeletal surgery
* History of BTX injections into the lower limbs muscles in the last 3 months
Acupuncture for Chronic Lymphedema

This study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph system fluid that causes swelling in the arm. The swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. It can develop right after breast cancer treatment or weeks, months or even years later. In our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup.

This study will include a larger group of patients. Patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older
* Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist
* Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years. This timeframe allows ample time for any surgically related non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study.
* The affected arm must be \>2cm larger than the unaffected arm. Differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant. Each affected arm will be measured in two areas: upper arm and forearm.

The larger of the two measures-upper arm or forearm- will be used for analysis.

* Classified as International Society of Lymphology (ISL) stage II or higher as determined by an MSKCC Certified Lymphedema Therapist (CLT).

Exclusion Criteria:

* Bilateral lymphedema
* Previous acupuncture treatment for lymphedema
* Concurrent diuretic use
* History of primary (congenital) lymphedema
* Pregnant or planning to become pregnant during the course of the study
* Has an implanted electronically charged medical device