cyrilzakka/clinical-trials huggingface dataset:
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo primary unilateral TKA under general anesthesia.
* Has not previously undergone TKA in either knee.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

* Has a planned concurrent surgical procedure (eg, bilateral TKA).
* Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken NSAIDs within 10 days prior to the scheduled surgery.
* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
* Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
* Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.
* Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
* Has undergone 3 or more surgeries within 12 months.
* Has a body mass index (BMI) \>38 kg/m2.
Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)

This study will assess any side effects that may occur when QPI-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. This study will also test whether QPI-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.

This is a Phase IIa double-masked, single dose, randomized, sham-controlled study evaluating the safety and tolerability, and pharmacokinetics of QPI-1007 versus Control (sham procedure) in subjects with an acute attack of primary angle-closure glaucoma.

Subjects will be randomized at a ratio of 1:1 into one of two study arms: 1.5 QPI-1007 arm or Control arm (sham procedure). The study will enroll approximately 30 subjects into each arm. Randomization will be stratified by time from symptom onset to the study drug administration or sham procedure (≤72 hours and \>72 hours).

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged at least 40 years or older.
* Onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration.
* Best-corrected visual acuity (BCVA) 20/40 or better in the study eye after resolution of the acute attack.
* Received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye \<25mm Hg.
* Sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye.
* Female subjects must be: (1) post menopausal, (2) surgically sterile, or (3) using an effective means of contraception.

Exclusion Criteria:

* Previously diagnosed with glaucoma in either eye.
* The time planned for study drug administration is more than 120 hours from the onset of the symptoms.
* History of chronic angle-closure in either eye.
* Secondary angle-closure/secondary angle-closure glaucoma in the study eye.
* Monocular subjects.
* Prior incisional intraocular surgery.
* Inability to perform a reliable visual field test on Day 0 in the study eye.
* History of panretinal photocoagulation or macular laser photocoagulation in the study eye.
* History of active malignancy within the last 5 years (however, non facial, basal cell carcinoma is allowed).
* History of myocardial infarction within the last 6 months.
* Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
* Women who are pregnant or lactating.
* Participating in a concurrent interventional study with the last intervention occurring within 30 days prior to planned dosing with QPI-1007.
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results

In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination.

Shoulder pain is a common problem in the Norwegian population. Rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. Arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. Good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. There is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome.

In this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. The investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.

10 years after surgery: A cohort study of 733 participants with rotator cuff tear operated arthroscopically at Lovisenberg Diaconal Hospital during 2010-2014. The investigators will ask the participants included at the time of surgery to participate in a ten-year follow-up. The investigators will ask them to submit validated patient reported outcome measurements (PROMs): Western Ontario Rotator Cuff Index, EQ-5D-5L, Subjective Shoulder Value. The investigators will also evaluate the radiological result and signs of cuff arthropathy on x-ray according to Hamada-Fukuda and Seebauer classification.

The main objective is to quantify the relative importance of preoperative and perioperative prognostic factors on functional outcomes ten years after rotator cuff repair. The secondary objective is to identify and quantify patients who need shoulder replacement surgery ten years after rotator cuff surgery as a measure of failure.

Eligibility Criteria:
Inclusion Criteria:

* Operated at Lovisenberg Diaconal Hospital in the time period 2010-2014 with an arthroscopic rotator cuff repair
* Included in the rotator cuff registry at Lovisenberg Diaconal Hospital
* Able to read and write Norwegian

Exclusion Criteria:

* Lack of competence to consent
* Not able to submit patient reported outcome measurements in any way and not able to undergo x-ray
* Patient is unwilling to participate
Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients

The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients.

Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the healing of leg ulcers in diabetic patients.

Diabetes predisposes to ulceration of the foot through a variety of processes, including neuropathy and peripheral arterial disease. Once the skin is broken, healing is frequently delayed and the ulcer develops the biology of a chronic wound. The factors underlaying delayed healing in chronic wounds are not well understood but include the effects of repeated trauma, tissue ischemia, infection, defective white cell function, altered immune processes, and altered expression of tissue cytokines and enzymes.

Management is based on regular cleansing and debridement, off-loading and treatment of intercurrent infection with antibiotics. There are no interventions in routine use, which target aspects of chronic wound biology directly.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Age\>= 18 years
* Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
* Study wound located on the foot or lower leg
* Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
* Adequate circulation to the foot, evidenced by a palpable pulse on the study foot
* Study wound \> 1.0cm2 but \< 20.0cm2
* Written informed consent

Exclusion Criteria:

* Pregnancy, lactation or absence of adequate contraception for fertile women
* Ankle/Brachial Index \< 0.7
* Severe malnutrition
* Clinical evidence of gangrene on any part of the foot with the study wound
* Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0
* One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study
* Active osteomyelitis of the foot with the study wound
* Necrotic toes on the foot with the study wound
* Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening
* Study wound over a Charcot's joint
* Evidence of deep tissue infection of the study wound at day 0
* Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0
* Random blood sugar reading \> 450 mg/dL
* Alcohol or drug abuse
* Participation in other clinical studies in the last 4 weeks
Determinants of Respiratory Health in Young Adults

To measure lung function and respiratory symptom status in a large cohort of healthy, non-smoking 18-22 year old subjects, and relate these measurements to past histories of passive smoke and air pollution exposures.

BACKGROUND:

While the natural history of human lung function growth and decline has been studied intensively over the past 30 years, relatively few data have been collected during the period in which peak volumetric function is achieved, i.e., around the age of 20. As a result, very little is known about the factors, both demographic and environmental, which influence maximal attained lung function.

DESIGN NARRATIVE:

The longitudinal study collected information on the history of respiratory illness, residential history, parental smoking, socio-economic status and home characteristics via an initial questionnaire administered to cadets enrolling at West Point. A sequence of four annual measurements of lung function (by spirometry), and prior-year respiratory health status and activity patterns was obtained in the spring of each year. Pollution exposures were estimated by matching residential histories with historical pollution data stored at the Environmental Protection Agency. Data on meteorological variables (temperature, relative humidity, wind speed) and altitude were obtained for each residential location. The four annual lung function measurements provided precise estimates of individual mean levels of FVC, FEV1, FEF25-75, PEFR, and flow rates at 50 percent and 75 percent of expired FVC. Subject-specific lung function level was analyzed in relation to history of parental smoking and prior exposure to air pollution using analysis of variance methods, controlling for potential confounding variables. In addition to testing these hypotheses regarding the respiratory effects of passive smoking and air pollution exposure, the study also explored the effects of these exposures on the change in lung function between the ages of 18 and 22 and on respiratory illness and symptom experience while at West Point. Finally, the study established a cohort which could be followed in future years.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Crystalloid Fluids and Cardiac Surgery

All cardiac patients admitted to the intensive care unit after surgery received crystalloid fluids as standard care procedure. 3 crystalloid fluids can be used during their stay: Normal Saline, PlasmaLyte or Ringer's Lactate. They differ in their respective composition, mainly in chloride and sodium concentrations. Inflammatory consequences of the crystalloid fluids used in this population are unknown. The investigators plan to evaluate which one of the three fluids mentioned above is advantageous in cardiac surgery patients with regards to reduced rate of infection and renal failure.

Inflamed patients admitted to the intensive care unit after cardiac surgery received large volumes of crystalloid fluids as standard care procedure. The goal is to control the balance between the initial pro-inflammatory phase and the subsequent/compensatory anti-inflammatory phase, the later being associated to immune fatigue and the apparition or re-activation of infections. Infectious complications are responsible for the increased rate of morbidity and mortality in this cardiac surgery population. The inflammatory impacts of each of the crystalloid fluids administered to the patient are still ill-defined and represent an opportunity to better control the hyperinflammation and/or immunosuppression often observed following cardiac surgery. Hence, the investigators will evaluate the activation of the immune system following crystalloid fluid (either Normal saline (NS), PlasmaLyte (PL) or Ringer's Lactate (RL)) administration in this population with regard to one recurrent clinical issue, i.e renal failure.

The hypothesis is that LR is less ''immuno-activator'' on monocytes than NS and PL. The objectives are: 1-evaluate the inflammatory profiles of each of the crystalloid fluids in consent cardiac surgery patients during their stay in the intensive care unit by studying white blood cell phenotypes and inflammatory cytokines present in plasma and 2-evaluate the impacts of crystalloid fluids in vitro using white blood cell from cardiac surgery patients obtained before surgery.

Eligibility Criteria:
Inclusion Criteria:

* patient for coronary artery bypass surgery with CPB (Cardiopulmonary bypass)

Exclusion Criteria:

* use of immunomodulating medication 6 months before surgery
* chemiotherapy/radiotherapy 6 months before surgery
* history of neoplasia
* auto-immune disorders
* pregnancy
* severe infection 1 month before surgery
* renal/hepatic failure
* left ventricular ejection fraction \<40%
* hepatitis C or HIV
* symptomatic peripheral vascular diseases
* chronic obstructive pulmonary disease
* cerebrovascular accident
* hemoglobin \<90g/L
* leukocytes \<6 or \>12x10e6/L
Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

The main goal of this study is to determine if static or dynamic \[18F\]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.

Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of \[18F\]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients.

Hypothesis: That \[18F\]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Chronic lower back pain with no concrete diagnosis after MRI and/or CT
* Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease

Exclusion Criteria:

* previous operation in the lower back area
* Known inflammatory related illness or progressive rheumatism
The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position

The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy

Exclusion Criteria:

* cardiac arrhythmia
* valvular heart disease
* ischemic heart disease
* left ventricular ejection fraction less than 40%
* Pulmonary disease
* esophageal disease
* upper gastrointestinal bleeding
* Body mass index more than 40 kg/m2.
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children

The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of AD, but not its efficacy and security to reduce or prevent relapses.

Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.

Patients 2-10 years of age with a history of mild to moderate AD will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of AD (\<30% affected body surface area; no head). After successful treatment of the flare in an acute phase, patients will receive either, FP twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. The primary study end point will be probability of a relapse of AD occurring. We will conduct survivor analysis of results.

Eligibility Criteria:
Inclusion Criteria:

* Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to 50) and no treatment for this episode of AD.
* written informed consent to patients' parents.

Exclusion Criteria:

* \>30% of affected body surface area AD.
* Head affected.
* Fluticasone o vehicle allergy.
* Patients with any medical condition for which topical corticosteroids were contraindicated
* Patients with other dermatological conditions that may have prevented accurate assessment of AD
* Patients with receiving any concomitant medications that might have affected the study's outcome.
* Other medical history that could interfere with the evaluation of study treatment.
A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist

The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.

There is a medical need for a product that is safe and can accelerate the rate of bone healing, leading to a reduction in immobilization time. Chrysalin, also known as TP508, is a synthetic peptide (protein) that is an exact copy of part of the human protein thrombin, which is a protein that occurs naturally in the body. Chrysalin can be used to mimic part of the thrombin response after injury without stimulating any of the events associated with blood clotting, and can therefore accelerate the normal process of healing.

Eligibility Criteria:
Inclusion Criteria:

* An unstable and/or displaced fracture of the distal radius
* Fracture classified as primary intra-articular or extra-articular
* Male, or non-pregnant, non-lactating female at least 18 years old. If female of childbearing potential, must have confirmed negative pregnancy test prior to administration of study product. Must agree to use a medically approved method of birth control for 6 months.
* Need ability to understand study requirements, provide written informed consent, and comply with study protocol
* Need ability to understand and provide written authorization for use and disclosure of health information per Health Insurance Portability and Accountability Act (HIPAA)

Exclusion Criteria:

* History of distal radius fracture of the affected limb 2 years prior to study enrollment
* History of uncontrolled Type I or Type II diabetes mellitus
* History or clinical evidence of any active medical disease or condition which would make the subject, in the opinion of the investigator, unsuitable for the study, or could potentially confound the results of the study
* Concurrent use of other investigational (non-Food and Drug Administration \[FDA\]-approved) agent or device
* Participation in any other clinical study within 90 days prior to treatment with the study drug
* Female subjects who are pregnant or nursing
Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension

β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* 25\~65 years old
* untreated essential hypertension
* SBP 140-160mmHg \& DBP 90-100mmHg
* Sinus rhythm
* Resting heart rate \>70bpm
* Can give written informed consent

Exclusion Criteria:

* Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade(AVBⅡ-Ⅲ) without pacemaker
* Bradyarrhythmia/ hypotensive
* Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
* Uncontrolled diabetes mellitus (DM)
* Bronchial asthma
* Gastro-intestinal ulcer or skin ulcer
* Liver dysfunction/ renal impairment
* Treated with CCB (Calcium antagonists) ( except amlodipine) or other beta blocker.
* Glaucoma
* Known allergic/ intolerance to beta blocker
* Pregnant or lactating women
* Participation in another clinical study within the last 3 months
* Legal incapacity or limited legal capacity