cyrilzakka/clinical-trials huggingface dataset:
"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

Abstract:

Complex regional pain syndrome (CRPS) is a significant complication in operated osteoarticular pathology and may adversely affect patient's quality of life. Vitamin C is an anti-oxidant and a neuro-modulating agent. Intake of vitamin C appears to be the only preventative factor. The objective of this study seeks to assess the effectiveness of liposomal conditioning of vitamin-C in reducing CRPS and to show evidence that it is more effective than taking vitamin C in its usual form.

Methods:

Three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. The first group took vitamin C in liposomal form. The second one took classical vitamin C tablets while the third one received placebo pills. Comparison was made between both groups which were identical in number and were the same average age. Results were compared and analysed at the end of one-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Female, Age \> 18 years
* The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later)
* Consenting patient
* Agrees to maintain the current level of physical activity throughout the study.
* Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study.
* Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study
* Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol.

Exclusion Criteria:

* Pregnant, breastfeeding or considering pregnancy during the trial
* Diabetic women
* No renal lithiasis
* No deficiency Glucose-6-phosphate dehydrogenase
* Unstable medical conditions
* Immunocompromised persons such as subjects who have undergone organ transplantation
* Subjects who planned surgery during the clinical study
* History of blood disorders / bleeding
* Alcohol abuse (\> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months
* Participation in a clinical research trial within 30 days of randomization
* Allergy or sensitivity to the product during the clinical study.
* Persons who have a cognitive impairment and/or are unable to give an informed opinion.
* Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.

Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders or immediate implant reconstruction, a surgical site infection involving the implant can result in its removal and a failed reconstruction.

The primary aim of the study is to determine if chlorhexidine disk application and irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite solution)after tissue expander breast reconstruction or immediate implant reconstruction, effectively decreases rates of bacterial colonization in drain fluid compared to standard care.

Methods:

Patients undergoing bilateral immediate reconstruction with tissue expander placement will have one surgical site treated with standard drain care and the other treated with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures: 1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).

All patients will undergo semiquantitative cultures of the drain bulb at one week postoperatively. This culture will be repeated at the time of drain removal, with simultaneous cultures of the fluid in the bulb as well as an internal segment of each removed drainage tube. All patients will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Females or males age 18-90 able to give informed consent
* Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction
* May have either malignant or benign breast condition

Exclusion Criteria:

* Antibiotic use in the fourteen days prior to surgical date
* Undergoing unilateral tissue expander reconstruction
* Documented allergy to chlorhexidine gluconate
* Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)
* Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin
* Pregnant women
* Vulnerable subjects - prisoners, institutionalized individuals
* Non-English speaking patients without adequate interpreter assistance
Adopting a Physically Active Lifestyle Through Organized Walk Events Among Joslin Clinic Patients

Can participation in group physical activity, such as a community-based organized group walk, help adult diabetes patients develop a physically active lifestyle? Can such engagement ultimately lead to an improvement in hemoglobin A1c? To address this question, the investigators have designed this pilot study with the aim to investigate the effect of community-based group walks among Joslin adults with diabetes on the development of a physically active lifestyle and glycemic level. The investigators hypothesize that participation in group walking events helps Joslin adults with diabetes engage in physical activity and improves glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Joslin Clinic patients
* 18 years or older
* A1C between 7.5% - 12.0%
* Received physician clearance indicating safe to participate in the walk club events
* Reside within Boston and Greater Boston Area
* Ability to communicate in English and/or Chinese
* Agree to participate in the intervention walk club for 6 consecutive weeks

Exclusion Criteria:

* Pregnant or breast feeding
* Unstable angina or myocardial infarction within 1 month prior to screening
* Unstable gait, severe neuropathy, or deformed foot.
* Enrolled in another investigational study within 1 month prior to screening for this study
* On medications such as prednisone that will affect blood glucose
A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects

An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
4. Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
5. Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.

Exclusion Criteria:

1. Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
2. Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
3. Exposure to any investigational drug or placebo within 4 weeks of study drug administration.
Acupuncture for Tonsillectomy Pain

Pain after tonsillectomy can be severe and last ten days.

Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. Pain medication is often prescribed which can cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department.

"Battlefield acupuncture " has been recently developed by the US Air Force and is now being used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma. This protocol consists of five acupuncture points on the outer ear.

A recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day.

The investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. These findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.


Eligibility Criteria:
Inclusion Criteria:

* Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)

Exclusion Criteria:

* Developmental Delay
REcovery from DEXmedetomidine-induced Unconsciousness

This pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 65
* Normal body weight and habitus, body mass index (BMI) 18 to 30 kg/m2
* Non-smoker
* No history of taking stimulants or substance abuse
* For women: either use of hormonal contraception, or \> 45 years old and last menstrual period \> 12 months ago in the absence of any contraceptives.
* American Society of Anesthesiologists (ASA) physical status classification 1 (ASA 1)
* Fluent in English (sufficient to communicate with the study team and understand the consent form)

Exclusion Criteria:

* Neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), Meniere's disease, Parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder
* Psychiatric: history or treatment for an active psychiatric problem (including Attention-Deficit / Hyperactivity Disorder (ADHD) and anxiety disorder)
* Cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death
* Respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea
* Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
* Hepatic: hepatitis, jaundice, ascites
* Renal: acute or chronic severe renal insufficiency
* Reproductive: pregnancy, breast-feeding
* Endocrine: diabetes, thyroid disease, adrenal gland disease
* Hematologic: blood dyscrasias, anemia, coagulopathies
* Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
* Medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception
* Allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate

Potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).
Relapse Prevention to Reduce HIV Among Women Prisoners

This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.

Eligibility Criteria:
Inclusion Criteria:

* female,
* history of opioid dependence,
* released back to the community from a controlled environment,
* criminal justice involvement.

Exclusion Criteria:

* under age 19,
* medical contraindications,
* major psychiatric problems.
Impact of Rational Control of Fluid Balance in the Intensive Care Unit

Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid balance over a very short period of time. This positive fluid balance is the consequence of different organ failures (pulmonary, cardio-vascular, kidney...) or aggressive fluid resuscitation, which is mandatory in the early phase of ICU course. However recent data strongly suggest that an excessive fluid balance could be detrimental per se (increase of ICU morbidity or even mortality). There are controversies regarding the potential benefit of controlling this fluid balance with diuretics which are commonly used worldwide in various indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature data are lacking, regarding the possible advantages and drawbacks of diuretics in this indication. The aim of our study is to test an algorithm with furosemide to reduce fluid overload in severe ICU-patients.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or more
* Patients receiving endo-tracheal intubation and mechanical ventilation during their stay in the ICU
* Weight increase of at least 3 % during the stay. Baseline weight is regarded as the weight at the 24th hour after ICU admission
* FiO2 \< 60 %, PEEP \< 10cmH20
* No administration of catecholamines other than dobutamine at a dose of 10 microg.Kg-1.min-1

Exclusion Criteria:

* Pregnancy
* Patient with a moribund state at ICU arrival
* Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, intra-cerebral bleeding, stroke, meningo-encephalitis, coma from medication origin)
* Chronic kidney disease defined as creatinin clearance \< 30mL.min-1 and/or with chronic dialysis
* Mandatory administration of diuretics (cardiogenic pulmonary oedema, LVEF \< 30 %)
A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty
* patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure

Exclusion Criteria:

* patients who were previously treated with knee arthroplasty
Effectiveness of Telerehabilitation in Continuity With Outpatient Physiotherapy After Total Hip Replacement.

Total arthroplasty (THA) is the treatment of choice for severe osteoarthritis of the hip joint. Following this type of intervention, a multidisciplinary rehabilitation approach allows you to reduce pain and improve the ability to carry out activities of daily living (ADL), but it is not clear what the optimal rehabilitation program is. Recently, the use of telerehabilitation has increased over the years. Specifically, in treatment of patients following THA surgery, telerehabilitation is able to give similar results to the treatment performed in person terms of pain and function. The aim of this study is to verify whether telerehabilitation associated with In-person treatment is comparable in terms of pain, recovery functionality and patient participation and satisfaction, compared to those provided by rehabilitation alone in the presence of patients undergoing THA surgery.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone total hip replacement surgery (THA)
* Start outpatient treatment within 7 days of discharge from the Orthopedic Department
* Age between 50 and 80 years.
* Continuation of rehabilitation treatments at the IOR Physical Medicine and Rehabilitation service in Argenta.
* The subjects or any caregivers must be able to use an electronic device (PC, tablet, smartphone).

Exclusion Criteria:

* patients undergoing revision of previous prosthesis surgery
* difficulty understanding the Italian language/language barrier
* unavailability stable wi-fi connection by the patient
Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients

Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient.

The purpose of the Follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. However this offer does not focus on nutrition in particular. This is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. Our hypothesis is that adding a systematic nutritional focus to the Follow-home intervention programme will promote the rehabilitation of the elderly patient further.

The nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. The intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.

The study is designed as a 12 week randomized, controlled intervention study. The study sample will consist of 80 geriatric patients admitted to a medical ward at Herlev University Hospital in Copenhagen, Denmark. The patients will be equally distributed into the control and the intervention group. The control group will follow the usual follow-home programme. The intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. Interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations.

Before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric medical patients
* Age +70 years
* Nutritional risk according to the level 1 screen in Nutritional Risk Screening 2002 (NRS2002)
* Nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period
* Participation in the standard Follow-home programme

Exclusion Criteria:

* Dementia
* Expected readmissions
* Terminal disease
* Non-danish speaking
* Not able to perform Hand grip test
* Planning weight reducing diet