cyrilzakka/clinical-trials huggingface dataset:
Meniscus Surgery Registry

The purpose of this study is to create a data registry of arthroscopic partial meniscectomies performed at our institution. This information will then be used to examine trends over time, predictive factors, and outcomes of arthroscopic partial meniscectomy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo arthroscopic partial meniscectomy with one of the study investigators at University at Buffalo Medical Doctors Orthopaedics and Sports Medicine

Exclusion Criteria:

* Non-english speaking
Opioid Use After Thyroid and Parathyroid Surgeries

Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.

BACKGROUND: New and persistent opioid use after minor and major surgery is common, and the duration of opioid use following surgery is associated with opioid dependence, abuse, and overdose. Most patients undergoing thyroid or parathyroid surgery do not require opioid discharge prescriptions for effective pain management. If opioids are prescribed for these surgeries, up to 7% of patients will use opioids 3 to 6 months after surgery. Previously published quality programs that optimized perioperative multimodal analgesia (MMA) regimens, provider education, patient education, and shared decision making successfully reduced the proportion of patients discharged with opioid prescriptions to less than 5% following thyroid and parathyroid surgery.

STUDY DESIGN: This quasi-experimental, quality improvement study compares opioid discharge prescribing practices before and after implementation of the quality improvement bundle. The quality improvement bundle includes patient education, provider education, and EHR enhancements. Patients who undergo a thyroidectomy or parathyroidectomy procedure will be included in the study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 4 to 6 months following bundle implementation. The primary outcome is the proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes the continuation of previous, chronic opioid therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing a primary thyroidectomy or parathyroidectomy procedure at Houston Methodist Hospital during the study period. Only index surgeries during the study time frame were included.

Exclusion Criteria:

* Patients with a hospital length of stay after surgery \>2 days
Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.

Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.

Eligibility Criteria:
Inclusion Criteria:

* Have a planned of resection of rectum
* Have signed approved informed consent form for the study.

Exclusion Criteria:

* Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
* Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
* Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min)
* Allergy on the study drugs .
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities
Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure

The primary purpose of the study is to establish the degree and duration of pain relief following minimally invasive surgery for a painful degenerative disc.

The investigators will study patient recovery (outcome measures) in patients who have had minimally invasive surgery for implantation of human meniscus allograft (HMA) to replace the nucleus pulposus of a degenerative intervertebral disc.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of degenerative disk disease at L3-L4, L4-L5, or L5-S1
* low back for no more that one year prior to enrollment

Exclusion Criteria:

* Osteoporosis
* Degenerative changes of vertebral endplates (obvious fractures, osteophytes)
* Modic Type II changes indicative of advanced bony degeneration
* Facet arthrosis (loss of facet joint cartilage, increased synovial fluid collection, or presence of osteophytes in inferior or superior plates)
* Discs classified with stage I or II degeneration
* Patients unable to have an MRI (pacemaker, claustrophobia, etc.)
A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly (for participants entering from WA22762) or every two weeks (for participants entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
* Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for \>/= 4 weeks prior to baseline
* Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
* Receiving treatment on an outpatient basis
* Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception

Exclusion Criteria:

* Participants who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason
* Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
* History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies
* Evidence of serious uncontrolled concomitant disease
* Current liver disease as determined by the principal investigator
* History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
* Known active current or history of recurrent infections
* Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
* Active tuberculosis requiring treatment within the previous 3 years
* Primary or secondary immunodeficiency (history of or currently active)
* Pregnant or breast feeding women
* Body weight \> 150 kilogram (kg)
* Inadequate renal, hepatic or hematologic function
* Positive for hepatitis B or hepatitis C
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
* Subjects with moderately to severely active UC based on Mayo score criteria.
* Subjects must have failed or be intolerant of at least one of the following treatments for UC:

  * Corticosteroids (oral or intravenous).
  * Azathioprine or 6 mercaptopurine (6 MP).
  * Anti TNF-alpha therapy.

Exclusion Criteria:

* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects with disease limited to distal 15 cm.
* Subjects without previous treatment for UC (ie, treatment naïve).
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
3D Printed Enlarged Carpal Models for Anatomy Training

3D modeling enables medical professionals or students to better understand complex structures. In many studies, 3D printed models have been used in the training, treatment and surgery of medical disciplines such as neuroscience, cardiovascular surgery and otolaryngology. In addition, 3D modeling allows patients' magnetic resonance imaging (MRI) and computed tomography (CT) images to be transferred to 3D printers to print these complex structures.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Titmus stereopsis score \>40 arc/s

Exclusion Criteria:

* Previous experience of carpal bones models either in real world or virtual reality
* History of upper extremity trauma in past 6 months
* Total or partial eye sight lost
Active Surveillance Magnetic Resonance Imaging Study

This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmation of adenocarcinoma of the prostate
* candidate for active surveillance (favourable risk prostate cancer) as defined by the following:

  * Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
  * Clinical (diagnostic biopsy) Gleason sum \< 6
  * PSA \< 10.0 ng/ml (ug/L)

Exclusion Criteria:

* Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization
* Planned anti-androgen therapy
* Inability to undergo TRUS biopsy
* Inability to undergo multi-parametric MRI
Lichen Planus and Mean Platelet Volum

70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. The blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample. A surgical biopsy will be performed for histopathological assessment.

70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included for conventional clinical examination under incandescent projected light. Using biopsy as a gold standard, all patients will be biopsied.

Blood Samples For all participants, the blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample that will be collected in tubes containing EDTA. Complete blood cell analysis will be performed in hematology laboratory, New Kasr Al-Aini Teaching Hospital, Faculty of Medicine, Cairo University. For reliable MPV measurement, the investigator will standardize the time delay between sampling and analysis to \<2 hours for all patients.

Biopsy preparation A surgical biopsy will be performed for histopathological assessment. All clinically identified lesions underwent biopsies where specimens will be placed in 10% buffered formalin for fixation. Paraffin embedded material will be cut into 4 μm thick sections and will be stained with haematoxylin + eosin then submitted for histopathological evaluation by a senior oral pathologist blinded to the clinical findings.

Statistical analysis

The collected data will be entered through the SPSS version 18.0 software. Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and Accuracy were calculated for MPV. The results will be compared with histopathological results using Chi-Square test with p value set as \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria is suspected oral lichen planus, age 18-60

Exclusion Criteria:

* Foreseeable missing opportunity of follow-up examination, Pregnancy, heart-, pulmonary, liver- and kidney disease, chronic pain syndrome nursing, drug addiction, recent operations, and diseases like heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics
Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters

The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected obstructive ventilation disorder
* clinical indication for bronchodilator testing

Exclusion Criteria:

* pregnancy
* inability to participate
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root
* Patients assessed as positive in the SLR test
* Patients with sciatica in either lower leg
* Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block

Exclusion Criteria:

* Patients who have 2 or more lumbar disc herniations as assessed by MRI
* Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI
* Patients who have received nerve block within 3 weeks before screening
* Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy
Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion

Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion.

The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs.

The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.


Eligibility Criteria:
Experienced Wheelchair Users:

Inclusion Criteria:

* Have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study;
* SCI at or below T1 (complete or incomplete);
* Use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion);
* SCI after age 18
* Have 24 inch diameter wheels with quick-release axles.

Exclusion Criteria:

* History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
* Upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy;
* Pregnant women;
* Shoulder pain that a MWU describes as limiting their ability to propel a manual wheelchair;
* History of neurologic disorder other than spinal cord injury (e.g. brain injury).

Inexperienced Manual Wheelchair Users:

Inclusion Criteria:

* Be between the ages of 18 and 65 years of age.

Exclusion Criteria:

* History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
* Have a musculoskeletal disorder;
* Pregnant women;
* Shoulder pain that limits their ability to propel a manual wheelchair.
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development

We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.

Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.

Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity of 6/5 in each eye
* Myopia in each meridian of at least 0.50 D
* Willingness to give consent
* Willingness to undertake any treatment option

Exclusion Criteria:

* History of systemic/ocular pathology
* History of any ocular surgery
* More than 10D of myopia
* Astigmatism more than 1.00 D
Plasma Myeloperoxidase Levels in Patients With Coronary Artery Disease

The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among patients with stable and unstable CAD patients and control subjects, and correlate with inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.

Elevation of the leukocyte enzyme myeloperoxidase (MPO) in stable coronary artery disease (CAD) patients in contrast to unstable CAD patients is controversial and its relationship with some inflammatory and noninflammatory markers such as oxidized LDL (ox-LDL) and nitric oxide (NO) in the CAD patients has not been evaluated yet. Evaluation of these relationships is the aim of the study.Also the relationships between MPO and some other inflammatory biomarker such as leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine are examined. This study includes 50 stable CAD, 50 unstable CAD patients and 50 controls. Plasma MPO, ox-LDL, leptin, adiponectin, sPLA2 levels are determined using enzyme immunoassay.Homocysteine and 3-nitrotyrosine are measured using HPLC-fluorescence method. Plasma total NO and other risk factors such as lipid profile, hypertension, smoking, diabetes mellitus and familial history of CAD are also determined in the patients. Results are statistically analysed and the association between all markers are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Stable and unstable patients with angiographically documented coronary artery disease.
* Control subjects without angiographically documented coronary artery disease.

All subjects Exclusion Criteria:

* Patients with recent (with in 6 month) myocardial infarction or cardiovascular events,
* surgery (with in 3 month),
* cancer and
* infective or inflammatory diseases were not included in the study.
Vanguard Rocc Post Market Surveillance

The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

The Vanguard rotating platform knee prosthesis (Vanguard ROCC) was launched in March 2009. Therefore there is a need to show the safety and performance of the Vanguard ROCC at long term.

A maximum of 10 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria should be in accordance with Indications for Use for Vanguard-ROCC® Knee

System specifically:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, or arthrodesis.

Additional inclusion criteria include:

* Male or female.
* 18 years of age or older
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

Exclusion criteria should be in accordance with Absolute and Relative Contraindications for Use for Vanguard-ROCC Knee system: Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* Metabolic disorders which may impair bone formation,
* Osteomalacia,
* Distant foci of infections which may spread to the implant site,
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* Vascular insufficiency, muscular atrophy, neuromuscular disease,
* Incomplete or deficient soft tissue surrounding the knee.