cyrilzakka/clinical-trials huggingface dataset:
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy

The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.

This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).

The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.

Eligibility Criteria:
Inclusion Criteria:

* Is scheduled for knee arthroscopy with or without chondroplasty.
* Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
* Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
* Is willing and able to sign an informed consent.

Exclusion Criteria:

* Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
* Has self-reported and/or documented previous hypersensitivity to acetaminophen.
* Has self-reported and/or documented history of hepatic disease or impairment.
* Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
* Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
* Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc...). May be self-reported or maybe per the judgment of the physician PI/Sub-I.
Mindfulness Intervention for Individuals With HIV and Chronic Pain

This project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training for individuals with HIV and chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pain
* Be HIV+
* 18 years of age or older
* Fluent English speaker
* Will commit to try no other new treatments during study duration

Exclusion Criteria:

* Not having HIV
* Being unable to follow tasks due to pain level
* Prior mindfulness training
Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients

Communication on telephone is challenging for people with hearing loss. For hearing aid users, for instance, the inventions for improving speech intelligibility on the phone range from an integrated tele coil and individual hearing programs to specially designed phone devices. No formal studies involving these devices have been carried out with CI users.

Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate different hearing solutions for communication on telephone in terms of intelligibility and ease of use.

Communication on telephone is challenging for people with hearing loss, due to a number of factors:

* The lack of visual cues (lip-reading),
* The lack of binaural abilities,
* The presence of (loud) background noise in a variety of listening situations,
* A modified speech signal due to reduced frequency bandwidth and
* Difficulties coupling the phone to the CI. For hearing aid users, for instance, the inventions for improving speech intelligibility on the phone range from an integrated tele coil and individual hearing programs to specially designed phone devices.

No formal studies involving these devices have been carried out with CI users.

Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate the different hearing solutions for communication on telephone in terms of intelligibility and ease of use:

* Phonak DECT - cordless telephone for HA-, CI- users and bimodal users
* Phonak EasyCall - accessories for Bluetooth capable mobile telephones for HA-, CI- and bimodal users
* Phonak DuoPhone - streaming function, which provides the speech signal to both ears

Eligibility Criteria:
Inclusion Criteria:

* Unilateral HA users with SRT of better (lower) than + 3 dB
* Bilateral HA users with SRT of better (lower) than 0 dB
* Unilateral CI users:

Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant

1-year acclimatization time after implantation at least 20% correct for a sentence test delivered with a SNR of + 10 dB, or a SRT of better (lower) than + 15 dB

* Bimodal (CI + HA) users:

Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant CI side: at least 20% correct for a sentence test delivered with a SNR of + 10 dB, or a SRT of better (lower) than + 15 dB HA side: unaided threshold ≤ 80 dB at least for frequencies up to 500 Hz

* All users:

Informed Consent as documented by signature Ability for speech understanding in the presence of competing noise without any assistance from lip-reading Ability to give subjective feedback in a certain listening situation First language: German or Swiss-German

Exclusion Criteria:

* All users:

Difficulties additional to hearing impairment that would interfere with the study procedures Acute inflammation or pain in head-/neck area Dizziness Age of participants \< 18 years Age of participants \> 80 years
Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus

to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus

Calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque.

Thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus.

The electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic field has an antimicrobial effect.

Electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation.

Previous studies have shown that Silk'n Toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening.

Study aim: to asses the effect of the electromagnetic field in a tooth brush (Silk'n Toothwave) on calculus accumulation and gingival parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 20-85 Years old
* Subject must have voluntarily signed the informed consent form before any study related action
* Presence of gingival inflammation (Gingival Index by Silness and Loe 1969)
* Presence of plaque on clinical crowns (calculation of area)
* Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline)
* Compliance with study schedules and arrival at study visits

Exclusion Criteria:

* A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers
* Pregnant or lactating women (\*If Male Please write N/A).
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a pacemaker that do not allow the use of an ultrasonic device.
* Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study).
* Systemic condition requiring prophylactic antibiotics.
* Patients taking NSAIDS for prolonged period.
Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas:

* walking ability and speed
* lower extremity strength, activation, and spasticity
* trunk control
* bowel and bladder function


Eligibility Criteria:
Inclusion Criteria:

* \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
* AIS C or D classification
* 18 years and older
* Height 5'0" to 6'4"
* Weight 220lbs or less
* Sufficient upper extremity strength to manage a stability aide
* Medical clearance for high intensity gait training
* Walking \<1.46 m/s
* Intact skin in on pelvis, lower extremities and back
* Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits

Exclusion Criteria:

* Unstable or symptomatic cardiac or respiratory issues
* Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study
* Received Botox injections to the lower extremities within the last six months
* Pregnancy
* Cauda Equina injury
* Any other issue that in the opinion of the investigator would impact study participation
* Non-English Speaking
Heparin-Induced Thrombocytopenia Registry

The purpose of the Heparin Induced Thrombocytopenia Registry is to explore the frequency of heparin-induced thrombocytopenia (HIT) at Brigham and Women's Hospital and to assess its mortality rate. Retrospective 3 years, looking forward prospectively.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse drug reaction with potentially fatal complications of venous and arterial thrombosis.

HIT with thrombosis causes prolonged hospital length of stay and is associated with catastrophic outcomes such as extremity amputation as well as death. The fear of HIT has led to some proposals to minimize hospital use of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) and to substitute other anticoagulants that have not been reported to cause HIT. Therefore, the frequency of confirmed HIT and the frequency of determining whether UFH or LMWH is the causative agent urgently require further investigation.

At BWH, we have placed patient safety at a premium. We have a Patient Safety Committee and a Patient Safety Officer. HIT has been identified as one of the primary problems requiring urgent policy decisions. Consequently, we have formed a multi-disciplinary team of physicians, pharmacists, nurses and physician's assistants to improve safe medication practices for patients receiving anticoagulation.

Our primary objectives are to establish an HIT registry which will provide information on:

1. Incidence of HIT associated with UFH and LMWH
2. Outcomes of patients with HIT
3. Adverse events associated with alternative anticoagulants used to treat HIT

We will obtain data with respect to: Drug, Dose, Route of administration, Duration of therapy, Platelet count, Platelet nadir, Co-morbidities (Coronary Artery Disease, Diabetes Mellitus, Myocardial Infarction, Hypertension, Pulmonary Disease, Chronic Renal Failure, Malignancy, Liver Disease, Surgery, Sepsis), Baseline characteristics (Age, Sex, Weight), Pregnancy status, Serum Creatinine, AST, ALT, Hematocrit, Hemoglobin, Venous and Arterial Thrombotic events (DVT, PE, CVC), 30-day mortality rate, alternative anticoagulant therapy, and duration of therapy.

Time and Method of Data Collection:

Chart Review for the duration of hospitalization: Hemorrhagic event, Thrombotic events, and 30-day Mortality Rate.

Eligibility Criteria:
All patients hospitalized at BWH who have a PF4-Positive antibody test
New Generation IGRA in Immunocompromised Individuals

Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients

This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.

Eligibility Criteria:
Inclusion Criteria:

* Individuals as specified for the study Population
* Written informed consent

Exclusion Criteria:

* \<18 years of age
BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon

Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias.

To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome.
* Patients must be on treatment with Betaferon or the decision to treat a patient with Betaferon has been made by the attending physician.
* Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device.
* Written informed consent must be obtained.

Exclusion Criteria:

* Patients receiving any other disease modifying drug.
* Contraindications of Betaferon described in the Summary of Product Characteristics.
Case Series With Saneso 3600 Colonoscope

Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal head. The objective of the present study is to evaluate clinical success of the Saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.

This study is a prospective, multi-center case series of per standard of care colonoscopy procedures using a nonsignificant risk Saneso 360 degree colonoscope. 40 cases were included at 3 clinical sites. Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. Enrolled subjects were followed for 7 days after their procedure. If the procedure was not successful with the study device, the endoscopist completed the procedure with a traditional colonoscope used at each facility. This study was approved by the institutional review board of respective sites. The clinical trial was conducted in accordance with the standards of Good Clinical Practice (GCP) and in accordance with the principles of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* 45 -74 years of age Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Scheduled for a clinically indicated routine colonoscopy procedure ASA class 1-3.

Exclusion Criteria:

* Altered colon anatomy Pregnant women, children under 18 years of age and adults over 75 years of age. Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.

Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor ASA class 4-5.
Aerobic Exercise and Oxygen Uptake Efficiency Slope in Coronary Artery Disease

Thus, the purpose of the present study was to evaluate the effects of continuos exercise training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope (OUES) in patients with coronary artery disease.

The oxygen uptake efficiency slope (OUES) is a submaximal index that incorporates cardiovascular, peripheral and pulmonary factors that determine ventilatory response to exercise. There is scarce information about the effects of the mode and intensity of exercise training on OUES in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise
Vascular Dysfunction and Antiangiogenic Therapy

project is a pilot prospective, longitudinal, before-after, open label multicentric study.

Antiangiogenic drugs and tyrosine kinase inhibitor (TKI) represent a new therapeutic issue in the treatment of several neoplasic tumors (colon, kidney, breast, lung, skin) and hemopathy. Antiangiogenic drugs acts through neutralization of the activity (e.g. bevacizumab) or the inhibition of post-receptor tyrosine kinase pathways (e.g. sunatinib, sorafenib), leading to a reduction and inhibition of the tumoral tissular neovascularization. Due to the ubiquitous role of and the systemic administration of the antiangiogenic drugs, almost all of them are responsible for several side effects, many involving the cardiovascular system (e.g. arterial hypertension, cardiomyopathies, proteinuria, bleedings,...) and leading to a reduction of the doses or withdrawal of the treatment. To date, the mechanism and the impact of these cardiovascular effects is not well understood involving structural (i.e. capillary rarefaction) and functional vascular dysfunction (i.e. vasomotor dysfunction, stiffening).

Eligibility Criteria:
Inclusion Criteria:

* Men and women \> 18 years old treated for a solid tumor (kidney, pancreas, breast, lungs, skin) with line antiangiogneic therapy and hemopathy
* Antiangiogneic therapy can be: bevacizumab, anti- (e.g. sunitinib, sorafenib), proteinate kinases inhibitor (e.g.temsirolimus ) or everolimus or any new allowed therapy with expected antiangiogenic properties and tyrosine kinase inhibitor.
* Expected life span \> 6 months
* Clinical state allowing investigations
* A blood glucose and lipid tests within the last 3 months

Exclusion Criteria:

* Informed consent not obtained
* Patients presenting a clinical state which does not allow for the performance of the vascular investigations (agitation, cutaneous wound, major asthenia, acute dyspnoea, cadiac arhythmia)
* Pregnant women
* Patients \> 18 yrs old protected by the french law
* Patients without national health insurance
* Patients included in another biomedical study (this criteria is relative to the other studies)
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.

Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of osteoarthritis
2. Elected to undergo primary TKA, THA, or TSA

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant or breastfeeding
3. Non-English speaking
4. Unable to give informed consent
5. Previous open hip, knee or shoulder surgery
6. Pre-determined patients discharging to ECF
7. Patients with allergies to bupivacaine
8. Patients currently taking opioid pain medication
9. Patients with contraindication to nerve blocks
10. Patients undergoing simultaneous bilateral joint replacement, as this would require \>1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
11. Patients with severe hepatic disease
12. Patients with chronic heart disease as defined as a decreased ejection fraction