cyrilzakka/clinical-trials huggingface dataset:
Peripheral Endothelial Function in COPD Patients

The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function.

The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the FEV1 (forced expiratory volume in one second), the forced vital capacity (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. In addition, a relationship between peripheral endothelial function and the severity of COPD (classification according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2010 and GOLD 2011 and the COPD assessment test, the cardiovascular risk factors (SCORE INdex) and the smoker status will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* COPD : FEV1/FVC \< 70%
* Smokers or ex-smokers ( ≥ 10 pack-years)
* No COPD exacerbation in the last three months
* No history of asthma and no respiratory allergy

Exclusion Criteria:

* Pregnant or nursing women
* Treatment with pulmonary vasodilators
* Patients with a significant acute disease. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
Determining Changes in Brain Structure Associated With Symptoms of Late-life Depression

This study will determine the changes in brain structure and function that are responsible for mood and cognition changes that are sometimes associated with late-life depression.

The goal of this research study is to investigate the relationships among late-life depression (LLD), cognitive impairment and progressive neurodegeneration. The guiding hypothesis is that LLD patients have evolving cognitive impairments as a consequence of distinct underlying neuropathological changes, which frequently are expressed as Mild Cognitive Impairment (MCI). These neuropathological and cognitive changes are risk modifiers, lowering brain reserve capacity, and in turn, increasing risk of developing Alzheimer's Disease (AD). In order to pursue this goal we will enroll LLD, MCI, and normal control subjects to enrich our existing cohort to include a total of 150 elderly, non-demented, non-depressed subjects, 60 non-depressed MCI subjects and 270 LLD subjects. Using the joint infrastructure of the University of Pittsburgh's Advanced Center for Intervention and Services Research for Late-Life Mood Disorders and the Alzheimer's Disease Research Center, we will complete a detailed neurobehavioral evaluation, including clinical, neuropsychological, neuroimaging and biological markers, using these data to evaluate the factors associated with the development of MCI or dementia. Subjects will be studied annually for at least three years, allowing us to use longitudinal data to evaluate a series of linked hypotheses that postulate the pathways by which elderly, depressed patients develop cognitive impairment, and which may lead some to develop dementia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a mood disorder

Exclusion Criteria:

* Major acute medical illnesses or injuries known to have significant direct effects on cognitive functioning (e.g., metastatic cancer, multiple sclerosis, traumatic brain injury).
* Uncorrectable sensory handicap (e.g., blindness), because they are unable to complete the cognitive test battery.
* Exclusion criteria for MR scans include: cardiac pacemaker, aneurysm clip, cochlear implant, pregnancy, IUD, shrapnel, history of metal fragments in the eye, neurostimulators, weight of 250 lbs. or more, or claustrophobia.
Biomechanical and Morphological Changes in Dystrophic Muscle

The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets.

The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets. We suppose that there are muscular characteristics and predictive parameters of the loss of walk ability. The identification of these potential therapeutic targets would improve the surveillance and the clinical care but would also guide future clinical and fundamental trials too.

Eligibility Criteria:
Inclusion Criteria:

* Young man ou woman (5 to 17 years old) with Duchenne Muscular Dystrophy (confirmed by immunohistochimy on the muscular biopsy and/or mutation in the dystrophin confirmed by molecular biology)
* Time more than 7 secondes to test of 10 m and/or distance less than 330 m to walk test of 6 minutes. These values are recent markers to include children with a strong risk of loss of walking ability in 2 years.
* Parental inform sign consent and / or child inform consent

Exclusion Criteria:

* Recent orthopaedic surgery of lower limbs (6 months)
* Other chronic disease associated, which have an impact on the walking
* Cognitive Deficiency or behavior disorders limiting the understanding of the study
* Children who can benefit ATU (translarna ® or other) during the study
* All MRI contradications : pacemaker or neurosensory stimulator or implantable defibrillator, neurosurgical valves, cochlear implant or ferromagnetic implants near nervous structures, brace, metallic prostheses, not cooperative or agitated patients, patient claustrophobic, pregnant woman.
Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.

This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the BWH NICU in the study pods during the study period

Exclusion Criteria:

* Patients in other units, non-study pods, or outside of the study period
Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome

The goal of this randomized clinical trial is to evaluate the effect of Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome. The main questions it aims to answer are:

* How effective the Nusantara diet in reducing body mass index and body fat percentage?
* How effective the Nusantara diet in affecting lipid profile and insulin resistance?

Participants will be given this diet for a period of 56 days and undergo repeated outcome measurement. This study has a comparison group (no intervention) to see the difference of reduction or slope of changes in outcomes. We assumed that the Nusantara diet will reduce the metabolic syndrome indicators (anthropometry, lipid profile, and insulin resistance profile).

Design

a. Randomized controlled trial with pre-post design

Intervention :

1. Balance Nutrition with low calorie and low sodium. Low calorie means a diet with 500 kilocalories lower than the Basal Energy Expenditure, according to the Harris-Benedict formula. The daily limit of sodium is 2300 mg.
2. Organoleptic test for set menu
3. Given as a set for 56 days
4. Dietary counseling is given before intervention, followed by a 24-hour food recall every week.

Outcome

1. Body mass index
2. Blood chemistry test: Total Cholesterol, Low-Density Lipoprotein (LDL), High-density Lipoprotein, Triglyceride,

4. Glucose profile (Fasting blood glucose, and Homeostatic Model Assessment for Insulin Resistance / HOMA-IR) 3. Body Fat percentage using Bioelectrical Impedance Analyzer

Sample Size Estimation With the following assumption

1. Type I error: 5%
2. Power of Study: 80%
3. Superiority Trial
4. Equal allocation with two arms
5. Assuming that the reduction of LDL would be 30% of the average LDL level among metabolic syndrome individuals (106.4 mg/dL), the total sample would be 48 participants

Protocol Analysis

1. Intention-to-treat analysis
2. Sensitivity analysis and subgroup analysis
3. If the randomization obtains an equal baseline characteristic, an Independent T-test will be applied.
4. Regression model will be applied, adjusting any possible confounder.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the definition of metabolic syndrome

  1. Blood Pressure\>135/85 mmHg
  2. Central obesity with waist circumference for males\>90 cm or \>80 cm in females
  3. Triglyceride level \>150 mg/dL, followed by HDL\<40 mg/dL
  4. blood fasting glucose \>100 mg/dL

Exclusion Criteria:

1. pregnant or breastfeeding women
2. suffer from chronic disease
Plantar Faciitis and Diabetes Mellitus

Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).

OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese subjects without any metabolic disturbances as control were evaluated with lateral calcaneal x-ray in blinded fashion by a radiologist. All participants were informed and written consents have been obtained. Control cases were subjected to 75g glucose challenge test and glucose intolerant subjects were excluded.

RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs, P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073, respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24 in 42 (57%) in control group. Groups were significantly different according to existence of CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015, respectively). There was positive correlation between existence of calcaneal spur and peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of CS and glycolysed hemoglobin levels or diabetes duration (all P\>0.05).

CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with T2DM to avoid foot complications.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Diabetes mellitus
* Must be obese

Exclusion Criteria:

* Previous radiotherapy to the foot,
* previous trauma to the foot (fracture, rupture of tendon),
* rheumatic or vascular diseases,
* malign diseases,
* lymphatic edema.
Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin

This study is designed to test two separate strategies for treatment of anemia (low hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are being treated with pegylated interferon and ribavirin.

This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.

Eligibility Criteria:
Inclusion Criteria:

* hemoglobin \> 11
* absolute neutrophil count \>1,200
* naive to peg interferon and ribavirin

Exclusion Criteria:

* Prior treatment for hepatitis C
* Pregnant or nursing
Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Sugammadex

Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.

Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). The sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted.

Two questions have to be investigated. First, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? Second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.


Eligibility Criteria:
Inclusion Criteria:

* ASA clinical status 1 to 3
* Informed consent obtained before anesthesia induction

Exclusion Criteria:

* ASA clinical status 4
* Emergency surgery; scheduled surgery in prone position,
* Hepatic or renal disease,
* BMI higher than 35,
* Allergy to rocuronium or sugammadex
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers

The current study aimed to explore the associations between disability levels and occupational risk factors in computer-using office workers with neck pain.

This is a cross-sectional study. All participants will provide informed consent before participating in the study. The study will be conducted in accordance with the Helsinki Declaration criteria. Data will be collected using questionnaires, which include information on demographic, clinical, and occupational ergonomic conditions.

Patients will be divided into 2 groups as mild-moderate and severe disabled according to their neck disability index values and will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 55,
* working on computer,
* having neck pain at least three months.

Exclusion Criteria:

* reporting pregnancy,
* having a history of accidents,
* trauma or surgery in the neck region,
* congenital anomaly of the spine,
* rheumatologic disease,
* osteoporosis,
* spondylosis,
* spondylolisthesis,
* infection of the spine
* cervical disc herniation,
* tumor.
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.

The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.


Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing an elective cardiac or cardiovascular procedure;
* Subject is willing and able to give prior written informed consent for investigation participation; and
* Subject is \> 18 years of age.

Intraoperative inclusion criteria include:

• Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).

Exclusion Criteria:

* • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;

  * Subject with active infection (either systemic or in the repair region);
  * Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
  * Subject diagnosed with a coagulation disorder;
  * Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
  * Subject whose life expectancy is less than that required for the prescribed follow-up duration;
  * Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
  * Subject who is immunocompromised.

Intraoperative exclusion criteria include:

• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).
A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.

the study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular lesion that require segmental resection.
* Patients required coronoid processes resection within the safety margin of the lesion.
* Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.
* Complaisant patient that is able to complete at least 1 year follow up.

Exclusion Criteria:

* Composite mandibular defect.
* Malignant lesions that required postoperative adjunctive therapies (CT or RT).
"The Effect of Inhaled Nitroglycerin for COPD Patients

this study aims to investigative the benefits of using nebulized nitroglycerin in improving respiratory functions in patients of late stage COPD

the inhaled nitroglycerin is expected to make vasodilatation of the pulmonary arteries and arterioles which are constricted in late stages of COBD leading to ventilation/perfusion mismatching and further aggravating COPD. it will also help in delivering better antibiotic concentrations to the alveoli which help in better control of infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient's ≥ 18 years old COPD exacerbation with respiratory failure and Echo evidenced presence of pulmonary hypertension (defined as mean pulmonary artery pressure \> 20 mmHg)

Exclusion Criteria:

* Profound left ventricular failure, as the decrease in pulmonary vascular resistance results in an increase in left ventricular preload. This may worsen cardiogenic pulmonary edema.
* Pregnant female patients
* Patient with hypersensitivity to nitroglycerin
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures

Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.

Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.

The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.

Eligibility Criteria:
Inclusion Criteria:

* The patient has an unstable extra-articular metacarpal fracture that meets operative indications
* Informed consent is obtained from the patient or proxy
* Male or female who are 16 years of age or older

Exclusion Criteria:

* If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
* Pathological Fracture
* Greater than 21 days from fracture to definitive open reduction and internal fixation
* If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
* Highly comminuted diaphyseal fractures
* Articular fractures
* Multiple fractures involving bones other than another metacarpal in the same upper extremity
* The patient had a previous upper extremity injury that has limited hand function or finger range of motion