cyrilzakka/clinical-trials huggingface dataset:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up

In this study we will examine patients who have undergone unilateral ACL reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.

The purpose of this study is identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery; including patient characteristics (age, gender, body mass index (BMI), activity level, clinical knee alignment), their injuries ("pop" heard at the time of injury, concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g. meniscus and articular cartilage treatments.)

Primary outcome measures will be the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and stiffness subscales and joint space width measured on weight-bearing radiographs.

Secondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) and Kellgren-Lawrence grading from weight-bearing radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Had primary unilateral ACL reconstruction performed by Dr. Kurt Spindler (Vanderbilt University), Dr. Christopher Kaeding (The Ohio State University), Dr. Rick Parker (Cleveland Clinic), Dr. Jack Andrish (Cleveland Clinic), Dr. Rick Wright (Washington University in St. Louis), or Dr. Matthew Matava (Washington University in St. Louis)
* 14-55 years of age at the time of follow-up

Exclusion Criteria:

* less than 14 years or greater than 55 years
* non-active or unable to participate for health reasons
Lollipop COVID-19 Testing Study

This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.

This study will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the study team will work with local community testing sites to incorporate a lollipop swab for PCR at the time a symptomatic individual receives a nasal swab for PCR that is part of the DHS program. The study will address the following two key questions:

1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs?
2. Will lollipop swabs perform as well as nasal swabs with PCR-based testing?

Participants with at least one COVID-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. They then will be asked which COVID-19 PCR testing they would prefer if they had to do the testing again, nasal PCR versus lollipop PCR.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 years or above
* Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site

Exclusion Criteria:

* Positive COVID-19 test in the past 3 months for a previous illness
Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study

Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.

Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age, more than 24 hours on IMV, and prepared for weaning

Exclusion Criteria:

* A spinal cord injury that exceeded T8, arrhythmias, heart failure, hemodynamic instability, terminal extubation, pregnancy, pneumothorax, pneumomediastinum, COPD, thoracostomy, chest injuries that impeded ultrasound, pleural lesions, or neuromuscular diseases
Liraglutide as add-on to Insulin in Type 1 Diabetes

The purpose of this study is to:

Part 1:

To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

Part 2:

To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years
* BMI: 18-28
* HbA1c ≥ 8 %
* No residual β-cell function (glucagon test with c-peptide \< 60 pM)
* Caucasian
* Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
* Remission phase must be completed
* Female participants must use adequate contraception
* Informed consent

Exclusion Criteria:

* Overt diabetes complications; creatinin \> 130 µM, proliferative retinopathy, macroalbuminuria.
* Autonomic neuropathy (RR-variation \</=10 beats/min) and/or Orthostatic hypotension (OH).
* Anemia, Hb concentration; female \<7.0 mmol/l, male\<8.0 mmol/l
* Pregnancy or lactation
* Epilepsy
* Use of antiepileptic medication
* Use of beta blockers
* Previously apoplexy cerebri.
* Any use of benzodiazepine within the last month
* Any use of neuroleptic drugs within the last six months
* Self-perceived hearing loss
* Alcohol or drug abuse
* Allergy to the medication or placebo.
* Treatment with any medication affecting glucose metabolism.
* Any disorder which in the investigators opinion could interfere with the safety and results of the trial
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement

This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Patients diagnosed with primary osteoarthritis of the knee assessed locally for whom a total knee replacement is planned
* General health status acceptable for total knee replacement surgery in the opinion of the investigator
* Stable medications within 3 months prior to enrollment (such as appropriate pain medication, antibiotics prophylaxis) and standard of care

Key Exclusion Criteria:

* Presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
* Prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (ACI) or else, at the same knee
* Any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 2 months prior to enrollment
* BMI \> 40; presence of uncontrolled diabetes or hyperthyroidism
* Large effusion in the knee to be replaced, more than (\>)1 cm fluid in the suprapatellar space at the midline
* Corticosteroid use by any route except topical and nasal in the 3 months prior to enrollment
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)

InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries).

This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs. Persons will be enrolled within one day (before or after) of receipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19 vaccination at local clinics and/or study sites.

This is a multicenter study of COVID-19 vaccine immunogenicity and durability, and breakthrough serious acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections in people who receive a COVID-19 vaccine through their country's national vaccination programs. Participants will be enrolled upon signing the informed consent within a day of receipt of a COVID-19 vaccine (before or after). The study team will not be administering the vaccine; receipt of vaccine will be provided through each country's vaccine program. Blood specimens will be collected to measure the immune response to the vaccine. Participants may be asked to contact study staff at any time during the study for evaluation if they develop symptoms consistent with SARS-CoV-2 infection, at which time they will be counseled about the need for a medical evaluation that may include collection of an upper airway swab for diagnosis (and research) and a blood sample for research. Infections will be confirmed by molecular or antigen (Ag) testing at the time of symptoms, and swabs will be collected and stored for viral sequencing and analyses.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Ability to provide informed consent.
* Enrollment within one day (before or after) of receipt of COVID-19 vaccine.
* Willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with SARS-CoV-2 infection during the study period.
* Willingness to allow storage of biological samples for research testing as outlined in this protocol.

Exclusion Criteria:

* Any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness.
* Inability to comply with study visits.
Intravenous Lidocaine in Open Lung Resection Surgery

Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in colorectal surgery.

However, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. The present study aims to evaluate the influence of IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) scores of I, II or III.
* Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).

Exclusion Criteria:

* patient's refusal to participate
* ASA score of IV or higher
* severe hepatic or renal insufficiency
* allergy to lidocaine, morphine or NSAIDs
* cardiac arrhythmias or
* epilepsy,
* delayed extubation for more than 2 h postoperatively
* urgent surgery
Optimizing Medical "Teaming" on Resident Based Teams

The main objective of this study is to evaluate the colocalization of internal medicine residents on one clinical inpatient hospital floor for all general medicine block rotations during the 2019-2020 academic year. Specifically, the aims of the study are to determine if co-localization improves familiarity with nursing staff, which in turn, improves team work, psychological safety, patient care and reduces burnout. The investigators' hypothesis is that co-localization will increase familiarity between residents and nurses and result in improved psychological safety, team work and patient outcomes.

Teamwork is critical in delivering high quality medical care. Failures in team communication and coordination have been cited as significant contributors to medical errors. In large teaching hospitals, patients receive care from transiently formed teams of nurses and residents who may only work together for as little as two weeks, as residents rotate through many clinical floors due to the complexity of resident scheduling. Unlike more established teams that work together over long periods of time, these transient groups are called "teaming;" a process where a group of diverse providers, with different roles, outlooks and levels of professional training transiently come together to carry out complex tasks. (Reference: Dr. Amy Edmondson, Harvard Business School) A key risk in "teaming" is the lack of familiarity of team members as studies suggest familiarity promotes an environment of psychological safety, where team members feel safe speaking up, asking for help and admitting errors. These skills are important for both team work and patient safety. The investigators hypothesize that in large residency programs where resident rotate on multiple floors, it is possible to improve the quality of "teaming" by increasing the frequency with which smaller groups of residents and nurses work together. As a result, the investigators propose a randomized controlled trial on an inpatient general medical floor to study the effect of co-localizing residents with nursing staff. One cohort of residents will be assigned to complete all general medical rotations on a single floor for the academic year. The investigators will assess the impact on psychological safety, team work and patient care. The investigators hypothesize by co-localizing residents with nursing, while these "teaming" are still transient, the slight increase in familiarity will promote a culture of psychological safety and improve team work. If benefits are found, resident scheduling can be adjusted in subsequent years.

Eligibility Criteria:
Inclusion Criteria:

* All incoming PGY-1 residents who volunteer to be randomized

Exclusion Criteria:

* Any incoming PGY-1 resident who declines to be randomized
Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.

The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.

Eligibility Criteria:
Inclusion Criteria:

* Wilson's disease(adult, infant, pregnant woman)

Exclusion Criteria:

* Acute hepatitis
* Malignant tumor
Effect of MTX Discontinuation on Shingrix Response in RA

The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:

Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?

Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups.

Participants will:

Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination.

Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.


Eligibility Criteria:
Inclusion Criteria:

* fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
* age over 19 years
* methotrexate user
* agree for vaccination with shingrix

Exclusion Criteria:

* have other form of inflammatory arthritis or autoimmune-mediated disease
* malignancy, current infection, pregnancy
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation. This may require inpatient hospitalization several days prior to and after the procedure, potentially increasing medical costs and patient inconvenience. Patients undergoing such a process are initiated on heparin while their INRs drift to normal levels. Immediately prior to surgery, heparin is discontinued and restarted several hours after the procedure. Unfortunately, this process has resulted in a high incidence of surgical wound hematomas and other bleeding complications often requiring longer periods of discontinued anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce the incidence of wound hematomas by prolonging the time from surgical wound closure to the reinitiation of heparin. A small randomized trial demonstrated that there was no significant difference in the incidence of wound hematomas whether heparin was started 6 hours or 24 hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent retrospective observational study demonstrated that the incidence of wound hematomas in patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE 2004;27:358-60). Furthermore, a more recent, larger retrospective observational study reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting demonstrated that not only is performing pacemaker and ICD implantations safe without reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly smaller as compared to the strategy of reversing warfarin and initiating periprocedural heparin.

Given these findings, the hypothesis of this randomized study is that pacemaker and ICD implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study will have significant implications on the clinical practice of pacemaker or ICD implantation in this patient population given that no randomized study on this subject has been performed to date.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for clinically indicated permanent pacemaker or implantable cardioverter-defibrillator
* currently on chronic warfarin therapy

Exclusion Criteria:

* unwilling to participate in trial
Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload causing damage of different important organs like heart, liver, pancreas and joints. Complications and symptoms can regress by intensive treatment reducing the iron overload stores.Different genes have been identified playing a role in the pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y, located on chromosome 6. Phlebotomy is currently the standard therapy which consists of removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L. Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.

For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.

Research question: The primary objective is to determine the effectiveness and cost effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron overload in HH patients.

Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center, Maastricht university medical center ) and hospital in Belgium (University Hospital Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up will be one year.

Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the ferritin level is measured and decided if the patient need a phlebotomy (Ferritin \>100 µg/L).


Eligibility Criteria:
Inclusion Criteria:

* Patients with hereditary hemochromatosis (HH), homozygous for C282Y, currently treated with phlebotomy as maintenance therapy for at least 12 months with ≥ 3 phlebotomies per year.
* Ferritin level between 50-100 μg/L at start of the inclusion.
* Age: 18 years- 60 years and weight \> 50 kg.

Exclusion Criteria:

* Patients receiving other therapies such as chelating therapy or forced dietary regimen.
* Patients younger than 18 years.
* HH patients with excessive overweight (BMI \> 35).
* Patients who are mentally incapacitated.
* Women being pregnant or expecting/ planning to become pregnant during the one year period of the study.
* Patients with a malignancy.
* Patients already on PPI treatment.
* Patients who experienced side effects of PPI's.