cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting

To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to provide written informed consent
* Subject is 18 years of age or older
* Subject is presenting with symptoms suggestive of bacterial infection
* Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):

  * Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
  * Heart rate greater than 90 beats per minute;
  * Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
  * White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
  * A normal white blood cell count with the presence of greater
  * than 10% immature neutrophils.

Exclusion Criteria:

* Subjects less than 18 years of age;
* Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
* Subjects unable or unwilling to provide written informed consent
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma

Exclusion Criteria:

* Under 18
Modelling of Correlation Between Emergency Department Admissions and Location-specific Air Quality and Weather in the Florence Urban Area

The goal of this observational study is to evaluate the impact of primary air pollutants and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

This is a retrospective, single-center, observational cohort study aimed at investigate the impact of primary air pollutant concentrations and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

Anonymous data for each individual ED visit is retrieved from the hospital medical record. The daily concentrations of PM2.5, PM10, NO2, SO2 and O3 and the levels of atmospheric pressure, humidity and temperature are recorded by stations of the dedicated local agencies. The relationship between ED daily visits and pollutant concentrations or weather parameters are investigated.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive emergency department visits within the study period

Exclusion Criteria:

* Patients resident outside the metropolitan area investigated
* Patients admitted to the emergency department for traumatic injuries
A Study to Improve the Awareness of Mucopolysaccharidosis Type II in Brazil

The main aims of the study are to learn about the percentage of mucopolysaccharidosis type II (MPS II) in adults in Brazil as well as about the diagnosis process. No study medicines will be provided to participants in this study. The data available for participants diagnosed with MPS II in DATASUS (a database of the Informatics Department of Brazilian Health System) will be reviewed. No clinic visits will be required as part of participation in this study.


Eligibility Criteria:
Inclusion Criteria:

All MPS II cases of (International Classification of Diseases, 10th revision \[ICD-10\] E76.1) at any age reported in DATASUS from January 1st, 2008 to September 30th, 2020 will be included.

Exclusion Criteria:

MPS II cases reported outside this period will be excluded.
Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation

Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ED). Although many techniques have been suggested to verify the ETT placement, there is currently no entirely reliable method. Ultrasonography (US) is an indispensable and easily accessible tool in ED. Several studies of ultrasonographic confirmation of ETT position provided promising results in cadaver model or patient in a controlled operating room setting.In this study, the investigators have proposed a protocol called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in emergency intubation. This method provided a fast, real-time examination to prevent esophageal or endotracheal intubation.

Establishing a definite airway, endotracheal tube placement, is an important component for resuscitation. A high rate of morbidity and mortality was reported for unrecognized esophageal intubation. Therefore, early detection of esophageal intubation is essential for emergency airway management. There are several methods being used for endotracheal tube confirmation, such as auscultation of breathing sound, chest X-ray and capnography.2 However, all of these methods had false-negative rates and not entirely reliable during resuscitation. Ultrasound is an indispensable and easily accessible tool in emergency department. Recent studies showed that ultrasound can be used to confirm endotracheal tube placement in cadaver model. In this prospective study, we investigate the sensitivity and specificity of ultrasound for endotracheal tube confirmation in emergency intubation The study is conducted in the emergency department at National Taiwan University Hospital and approved by the hospital institutional review board. During resuscitation, the duty emergency resuscitation team performs the intubation and confirms the endotracheal tube position by auscultation and end-tidal capnography. Meanwhile, the researcher performs ultrasonography examinations for endotracheal tube position. A curvilinear ultrasonography transducer is used and placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax. The result of ultrasonography will be compared with auscultation, capnography and chest X-ray. Sensitivity and specificity of ultrasonography examination is computed to determine the accuracy and effectiveness of clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Patients required intubation

Exclusion Criteria:

* Head and Neck trauma
* Head and Neck tumor
* Status post tracheostomy
* Status post neck surgery
* Children (\<18 years old)
Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Documental congenital FXIII deficiency
* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
* If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
* Negative drug and alcohol screens

Exclusion Criteria:

* Received blood products or FXIII concentrates within 4 weeks of study enrollment
* Known antibodies to FXIII
* Hereditary or acquired coagulation disorder other than FXIII deficiency
* Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
* Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
* Received treatment with any experimental agent within 30 days of study enrollment
* Any surgical procedure in the 30 days prior to enrollment
* Donated blood within 30 days prior to enrollment
Behavioral Treatment of Weight Gain in CF

The current study examines the efficacy of two treatments to help children with cystic fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended daily allowance of energy and the effect of these treatments on weight gain and maintenance. One treatment provides children with CF and their parents nutrition education about the best foods for meeting their dietary needs. The second treatment gives children with CF and their families similar nutritional information plus behavioral parenting methods for motivating children to eat the recommended foods. Children with CF and their families are seen weekly for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then followed for 2 years after treatment in order to better understand how long the treatments are effective and to determine the health benefits of better nutrition status and weight gain.


Eligibility Criteria:
Inclusion Criteria:

* Weight percentile for age or height below 40th for age and sex
* Pancreatic insufficiency

Exclusion Criteria:

* Developmental delays
* Pseudomonas cepacia
* Supplemental enteral or parenteral nutrition
Paraesternal Blockade and Lactate Serum Levels in Patients with Cardiac Surgery.

Parasternal blockade has been related to a reduction of the postoperative inflammatory response, by inhibition of the stress response, leading to a better prognosis. Increased lactate level is a useful parameter in identifying patients at risk of postoperative morbidity and mortality. The objective was to evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans- and post-anesthesia. 86 patients between 60-70 years of age participated. An association was found between the application of parasternal blockade in cardiac surgery and the presence of lower trans and postanesthetic serum lactate levels.

An analytical cross-sectional study in adult patients who underwent elective cardiac surgery. A total sample of 86 patients was obtained, 43 in the case group and 43 in the control group. Adult patients older than 18 years, of either sex, with ASA II-III, patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass were included.

Eligibility Criteria:
Inclusion criteria

* Adult patients over 18 years of age
* Either sex
* ASA II-IV
* Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.

Elimination criteria

- Patients with pre-existing conditions that could independently affect serum lactate levels
Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Aged 18 to 65 years, inclusive
* Body mass index (BMI) of 18 to 32kg/m\^2 inclusive at Screening
* Non-smoker or no tobacco/nicotine usage with 30 days of Screening

Exclusion Criteria:

* Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
* Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in
Bridge Device for Surgical Pain for Rotator Cuff Surgery

The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

The interscalene block is the gold standard for postoperative pain management following rotator cuff surgery. However, the duration of the block does not cover rehabilitation. Therefore, in most cases, patients are discharged from the surgical center with an opioid prescription. There is a growing need to investigate complementary, non-pharmacologic pain-management methods. The Bridge device, which provides auricular neuromodulation of various cutaneous nerves near the ear, is manufactured by Masimo and previously FDA-approved to reduce symptoms of opioid withdrawal. It is a promising technology that could help relieve post-operative pain without exposing patients to the adverse effects of opioids or other pain-relieving medications. The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation. Those enrolled will be assigned to a study group and compared to historic cohort (control group). Historic control group involves patients that underwent same surgical procedure performed at the surgical center involved in the study, by the same surgical operator, between 2020 and 2023.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Willing and able to provide informed consent
* Scheduled to undergo elective rotator cuff surgery at UPMC
* No pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)

Exclusion Criteria:

* Opioids dependence
* Chronic pain condition with daily opioid use
* Anatomical malformation, which may interfere with placement of the nerve block
* Raynaud's disease diagnosis
* Vasculopathy
* Hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin
* Patient refusal
* Pacemaker
* Pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
* Psoriasis vulgaris
Treating the Endothelium to Restore Insulin Sensitivity

A study of 12 weeks' treatment with losartan or placebo, to test the hypothesis that RAS inhibition will improve insulin' vascular actions and therefore improve insulin sensitivity in skeletal muscle.

Recent studies suggesting an effect of cardiovascular therapies to prevent diabetes remain unexplained. We hypothesize that these therapies improve vascular endothelial function allowing improved actions of insulin in the vasculature, which comprise a significant portion of insulin's metabolic action. We therefore propose to measure insulin-mediated glucose disposal and insulin-mediated vasodilation before and after 12 weeks' therapy with Losartan (an angiotensin receptor blocker) or placebo, in a randomized design. Subjects will include 28 subjects with impaired glucose tolerance, which is generally accompanied by both insulin resistance and impaired vascular function. With this number of participants we have a 90% chance of showing a statistically significant and clinically meaningful effect of insulin on leg vascular resistance, and an even higher chance of showing a difference in insulin's metabolic effects. Exclusion criteria will include frank hypertension, diabetes, or hypercholesterolemia, and biochemical or other contraindications to losartan therapy. The primary endpoint for statistical analysis will be the invasive measure of insulin-stimulated endothelial function. We anticipate an improvement in both vascular and metabolic measures of insulin action following Losartan therapy but no change from untreated baseline following placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 20-55
* Male and female
* Obese, defined as Males: BMI \>28 or \> 30% fat by DEXA scan or Bod Pod; Females: BMI \>30 or \> 33% fat by DEXA scan or Bod Pod
* Weight stable over at least 4 months

Exclusion Criteria:

* Diabetes mellitus (ADA criteria)
* Age \<20 or \> 55 yrs
* Blood pressure \>160/90 or \< 90/65 mmHg
* Total cholesterol \>240 or LDL cholesterol \>160 mg/dL
* Baseline elevations in AST or ALT \> 3X ULN
* Baseline elevation in creatinine \>1.6 ng/mL
* Unexplained baseline elevation in creatine kinase \> 3X ULN
* Concurrent significant chronic medical illness including, but not limited to, human immunodeficiency virus infection, Syphilis, hepatitis B infection, or hepatitis C infection
* Pregnancy
* Known hypersensitivity or intolerance to the study agents
The Kilimanjaro Cervical Screening Project

Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Over 18 years of age

Exclusion Criteria:

* Previous removal of uterus
Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament

Objective: To study the clinical effect of double-beam anatomical reconstruction of medial patellofemoral ligament under arthroscopy.

Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was performed under arthroscopy in patients admitted to our hospital for treatment of recurrent patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.

Expected results: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament can effectively restore the stability of the patella and the motor function of the knee joint.

Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial patellofemoral ligament is an effective minimally invasive technique.

Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction; arthroscopy


Eligibility Criteria:
Inclusion Criteria:

* 17\<age\<60 years
* Recurrent patellar dislocation or instability

Exclusion Criteria:

- Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the pulley.
Cross-education in Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.

Fifty voluntary patients who underwent arthroscopic rotator cuff repair, aged between 35-64 years will be randomly divided into two groups: Cross-education group and standard rehabilitation group. Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline, at the end of the 8-week intervention and 1-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status will be evaluated by Constant-Murley Score (CMS) and American Shoulder and Elbow Surgeons (ASES) Score. Health-related quality of life will be assessed with Short Form-12 (SF-12). The Global Rating of Change will be used to evaluate patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish

Exclusion Criteria:

Revision surgery or previous shoulder surgery Having undergone subscapularis tendon repair in addition to arthroscopic rotator cuff repair Having scoliosis surgery or a health problem that will cause limitation in spinal mobility Restriction of movement or absence of limb in the opposite upper extremity Having frozen shoulder Presence of glenohumeral instability Having been diagnosed with thoracic outlet syndrome Presence of upper extremity fracture or tumor Having been diagnosed with cervical radiculopathy Having been diagnosed with any malignant condition, systemic, neurological or rheumatological disease Having a skin disease or hearing-vision problem that will affect the evaluation process
The Incretin Effect in Patients With Chronic Pancreatitis

The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pancreatitis with secondary diabetes mellitus
* Diagnosis of chronic pancreatitis with normal glucose tolerance
* Diagnosis of type 2 diabetes
* Normal level of hemoglobin
* Normal level of se-creatinine

Exclusion Criteria:

* GAD-65 autoantibodies
* ICA autoantibodies
* Albuminuria
Coenzyme Q10 in Older Athletes Treated With Statin Medications

The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 50 years of age, male or female.
* Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
* Self-Described Athletes with any of the following characteristics:

  * Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment
  * Regular exercise activity of at least 45 minutes duration 5 times per week

Exclusion Criteria:

* Use of coenzyme Q10 during the preceding two months.
* CPK level at baseline greater than two times the upper limits of normal
* LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
* LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent