cyrilzakka/clinical-trials huggingface dataset:
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis

The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.


Eligibility Criteria:
Inclusion criteria:

* Unilateral transfemoral or knee-disarticulation amputee
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Current use of and experience with the C-Leg for at least 1 year
* Ability to descend stairs and hills without caregiver and assistive devices
* Be able to independently provide informed consent
* Be willing to comply with study procedures.

Exclusion criteria:

* History of chronic skin breakdown on the residual limb
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions
Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP

Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative care is recommended for effective postoperative analgesia in children. However, intravenous ketoprofen doesn't have the marketing authorization for use in children less than 15 years old and its use is mainly justified by the absence of therapeutic alternatives. Recently, findings from published studies suggest that dexamethasone (DXM), which is actually recommended to prevent PONV for children "at risk", at a dose of 0.1mg/kg, would have analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).

Main objective :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).

Secondary objectives :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the consumption of rescue analgesics and the side effects in the first 24 hours after surgery.

Methodology :

Non inferiority, phase III, therapeutic trial. Prospective, randomized double-blinded, monocentric study. Inclusion of 567 patients. Inclusion will be performed by the anesthesiologist, the day of surgery during the preoperative visit.

Each patient will be randomised to receive intraoperative DXM (0.2mg/kg), DXM (0.4mg/kg) (max 20mg) or ketoprofen (1mg/kg) (max 100mg).

The clinical data will be collected prospectively in an electronic database. If the hypothesis of non-inferiority is verified, it is planned to test the superiority of the hypothesis secondarily.

Treatment :

Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.2 mg / kg or 0.4 mg/kg or single injection of ketoprofen (Medac ketoprofen ® 100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and before surgery incision.

Eligibility Criteria:
Inclusion Criteria:

* Children, aged 1 to 16 years
* Undergoing surgery (orchiopexy, inguinal hernia, circumcision, adenoidectomy, tonsillectomy or orthopedic act with osteosynthesis)
* Parental consent

Exclusion Criteria:

* Contraindication to NSAI or DXM
* Hypersensitivity to ketoprofen, DXM, hypnovel or atarax
* Porphyria
* Long QT Syndrome
* Renal or hepatic impairment
* Corticosteroid consumption the week before surgery
* NSAI consumption within 48 hours before surgery
* IV induction for full stomach or myopathic patient.
* French language not spoken by parents.
* Simultaneous participation in biomedical research on health products
Medical College of Georgia FitKid Project

This project will determine whether exposing youths to a "fitogenic" after-school environment that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and cardiovascular disease risk profile. The environmental intervention will be provided in nine schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison schools. Children in the 3rd grade will be recruited to participate. They will be followed for 3 years, through the 5th grade. Measurements will be made at the beginning and end of each school year. The 2-hour after-school intervention will be offered every school day. It will consist of three components: (1) homework assistance; (2) a healthy snack; and (3) exercise designed to improve skills and fitness.


Eligibility Criteria:
3rd graders in schools chosen to participate.
Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients

The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.

Many patients undergoing surgery experience anxiety in the preoperative setting. Pharmacologic anxiolytics require monitoring and cause excess sedation which often interferes with the ability to assess and obtain consent from a patient in the preoperative holding area. Lavender aromatherapy is an alternative treatment for anxiety which is safe, inexpensive, easy to administer, and not overly sedating. In addition to its benefits in the preoperative setting, anxiolysis and reduction in sympathetic drive can lead to reduction in the intraoperative anesthetic and postoperative analgesic requirements. This in turn can lead to faster recovery and expedited discharge from the post anesthesia care unit.

In the proposed study, we would evaluate the efficacy of aromatherapy with lavender oil in reducing anxiety prior to breast surgery. The study group would receive lavender oil preoperatively and the placebo group would receive unscented oil preoperatively. Before and after treatment, anxiety level would be measured using the Spielberger State-Trait Anxiety Inventory. Additionally, vital signs and Bispectral index (BIS) will be measured before and after treatment, as further indicators of anxiety level. We hypothesize that lavender aromatherapy will decrease anxiety and subsequently will reduce blood pressure, heart rate, and BIS.

Eligibility Criteria:
Inclusion Criteria: Female; Age 18+; American Society of Anesthesiologists (ASA) I-III; undergoing elective breast surgery

Exclusion Criteria: Male; History of asthma/bronchitis/Chronic Obstructive Pulmonary Disease (COPD)/contact dermatitis to cosmetic fragrances/pregnancy; significant laboratory abnormalities.
Troponin POCT in the Diagnosis of an Acute Myocardial Infarction

Thoracic pain can be caused by a life threatening disease as for instance a heart attack. Fast diagnosis and treatment is necessary for an advantageous clinical outcome. When a patient enters the emergency unit, an electrocardiogram (ECG) can diagnose a heart attack by recording the electrical activity of the patients' heart. However, an increasing number of patients with an acute myocardial infarction (AMI) are presenting without significant abnormalities on ECG In the latter group, diagnosis is dependent of elevated biochemical markers of myocardiocyte necrosis in the blood such as troponin. Generally, troponins are determined in blood and are analyzed by radiometry or at the hospital's laboratory. Time loss in the acquisition of troponin levels can occur during the workflow due to blood sampling difficulties, transport of the blood samples, processing in the laboratory, and processes inherent to the measuring assays. Roche developed a portable point-of-care (POC) device that determines troponin-T in a few minutes by using small volumes of the patient's blood with the added value that this device can be used in a pre-hospital setting which might save a significant amount of time in determining troponin levels.In this way, a faster diagnosis of AMI can be made improving patients' outcome.

In this prospective pilot study, 70 patients will be recruited over a time period of one year, with non-traumatic thoracic pain in a pre-hospital setting. While the ambulance or MUG is transporting such a patient, he/she is asked (informed consent) if an extra blood sample can be taken for measuring troponin levels by the portable device of Roche (cobas h232®). This can be done during the same venipuncture needed for standard-of-care analysis of the two other blood samples used for troponin-T by the radiometer and the laboratory. An ECG is performed in the ambulance and when it is positive, a patient is diagnosed immediately with acute myocardial infarction (AMI) and will be to transported as fast as possible to the coronary care unit. The blood samples retrieved in the ambulance are transported to the lab and to the table top radiometer in the emergency unit. As stated before, an increasing number of patients with AMI are presenting without significant abnormalities on ECG. Therefore, the troponin-T levels in the blood sample will provide extra information to make an appropriate diagnosis. It is our hypothesis, that the Cobas h232 device will provide faster results and thus a faster diagnosis of AMI which benefit patients' outcome.

Eligibility Criteria:
Inclusion Criteria:

* Non-traumatic thoracic pain
* Transportation via ambulance or MUG
* Written informed consent form (ICF) has to be obtained from the patient

Exclusion Criteria:

* Age \<18 years
Family Research Study: Metabolism of Fats and Proteins in Specific Ethnic Groups

The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease.

The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.

During the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.

Eligibility Criteria:
Inclusion Criteria:

* Of Caucasian or African descent
* Families must have 2 natural/biological parents and 2 natural/biological offspring
* 6 years old or older

Exclusion Criteria:

* Races other than African American or Caucasian
* Families without 2 natural/biological parents and 2 natural/biological offspring
* younger that 6 years old
The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea

The study aimed to examine the effect of stretching and relaxation exercises on pain and quality of life in women with primary dysmenorrhea.

While dysmenorrhea is a frequent gynecologic condition that affects women of reproductive age, young women are generally unaware of it. Dysmenorrhea is divided into two main types based on its pathophysiology:

* Primary dysmenorrhea (PD), is menstrual discomfort coupled with regular ovulatory cycles and a defined physiological explanation. Adolescents and young adults are the most affected.
* Secondary dysmenorrhea (SD), is defined as menstruation discomfort caused by a disease (endometriosis, fibroids, adenomyosis, pelvic adhesions, endometrial polyps, pelvic inflammatory disease) or the use of an intrauterine contraceptive device.

Dysmenorrhea is a type of persistent, cyclic pelvic pain that can be accompanied by nausea, vomiting, diarrhea, headache, exhaustion, back pain, and dizziness. In studies conducted on university students in Turkey in 2009 and 2010, 87.7% and 72.7% (respectively) of the students reported that they had pain during the menstrual period.

The release of prostaglandins into the uterine tissue is assumed to be the cause of dysmenorrhea. As a result, nonsteroidal anti-inflammatory drugs (NSAIDs) are the usual first-line treatment for dysmenorrhea. Oral contraceptives, acupuncture, acupressure, yoga, and vitamin B1 are among the additional treatments that have been suggested.

It has been suggested that exercise can help with dysmenorrhea. Physical exercise has been suggested as a medical treatment for the treatment of dysmenorrhea and related symptoms by several writers. Billig was one of the first to advocate for exercise as a treatment for dysmenorrhea; he devised a set of stretching exercises and found a reduction in dysmenorrheic symptoms.

H1: There is a significant difference in pain and quality of life in the group with stretching and relaxation exercises compared to the group with stretching exercises.

Eligibility Criteria:
Inclusion Criteria:

* participants in the study voluntarily.
* participants in ages between 18-25 years of age.
* participants have a sedentary lifestyle.
* participant's pain intensity of more than 40 mm during the menstrual period according to the VAS.

Exclusion Criteria:

* using regular drugs like NSAIDs
* presence of SD
* having an irregular menstrual cycle
* presence of chronic disease.
A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification to evaluate safety and effectiveness. The primary effectiveness endpoint is a complete capsulotomy in at least 95 percent of the cases. The primary safety endpoint is posterior capsular rupture and virtuous loss in 4 percent or less of the subjects. Other parameters to be captured during the study include anterior capsule tears, corneal touch, capsulotomy diameter, contraption of the Zepto capsulotomy, size of the corneal incision pre and post Zepto, interocular lens contraption and evaluation of zonular stability and the incidence and severity of adverse events. The criteria for patient success will be accessed based on the successful completion of a 360 degree capsulotomy without tissue bridges and no posterior capsule rupture and vitreous loss. The criteria for study success will be accessed based on a greater than or equal to 95 percent of the cases having a complete 360 degree capsulotomy without tissue bridges and less than 4 percent of subjects with posterior capsule rupture and vitreous loss.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be age 22 or older,
2. Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM capsulotomy,
3. Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.

Exclusion Criteria:

1. Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery),
2. Zonular abnormality,
3. Posterior polar cataract,
4. Fellow eye with acuity less than 20/200,
5. Any prior ocular surgery of the study eye,
6. Pupillary dilation during the pre-operative exam of less than 7 mm in diameter,
7. Proliferative diabetic retinopathy,
8. Disorders of the ocular muscles, such as nystagmus or strabismus,
9. Chronic uveitis,
10. Abnormal corneal endothelium,
11. Subjects on medications with, in the opinion of the surgeon, significant ocular side effects,
12. Pregnant or nursing (lactating) women,
13. Implanted ocular device or drug in the study eye,
14. Any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. documented diagnosis or treatment for symptoms associated with dementia, mental illness),
15. Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
* TWSTRS total score≥ 20; TWSTRS-severity subscale score\> 10;

Exclusion Criteria:

* In apparent remission from Cervical Dystonia
* Diagnosis of pure retrocollis or pure anterocollis
* For non-naïve subjects, previous poor response to either of the last two Botox treatments
* Known requirement of \<100U or \>200U of Botox injected into the neck muscles
Serum CTRP3 and RBP4 Levels in Obesity and Hypertension

Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines may play important roles in the pathogenesis of obesity, which are a link between obesity and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4 (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and essential hypertension.

Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly diagnosed obesity and essential hypertensive patients not taking anti-obese and antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All subjects were divided into two groups depending on body mass index (BMI), including NW group and obesity group, and then four subgroups were divided according to obesity and hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup (OB-HTN).

Eligibility Criteria:
Inclusion Criteria:

1. Hypertension not taking antihypertensive medications
2. Obesity not taking anti-obese or lipid-lowering medications

Exclusion Criteria:

1. Heart failure;
2. pregnant or lactating
3. diabetes
4. thyroid disease
5. fractures
6. osteoporosis
7. tumors;
Deep Parasternal Intercostal Plane (DPIP) Block

In this study, we aimed to compare the effects of this block, which is routinely applied in our hospital but has not been studied in our hospital or in the literature before, on the pain in the first 24 hours after the operation, between the single-level and the two-level block.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older
* American Society of Anesthesiologists physical status of II-III
* Undergoing elective coronary artery bypass grafting (CABG), valve repair/replacement, or combined CABG/valve procedure via median sternotomy

Exclusion Criteria:

* Patients who are unable to communicate
* Patients who have had emergency surgery, reoperation, thoracotomy or mastectomy
* Patients with a history of chronic pain
* Patients who are using chronic opioids or sedatives
* Patients who have had a re-sternotomy within 24 hours of surgery
* Patients with liver or kidney failure
* Patients who are using narcotics
Bergamo Lymphoid Cancer Registry

This registry has been established to gain a better understanding of the clinical and biological characteristics and outcome of patients with lymphoid cancer

Lymphoid cancer including Hodgkin disease, non-Hodgkin lymphomas (NHL) and myeloma, represents the most common hematologic malignancy. Despite the overall prognosis improved in the last 10 years, there are many open issues that need to be addressed, specifically refractoriness to standard treatment, disease recurrence and outcome with new drug in the so called "real world" setting. Since the Hematology and Bone Marrow Transplant Unit at "Ospedale Papa Giovanni XIII" of Bergamo has developed specific tools to collect clinical data thought fully validated electronic charts and biological specimens thanks to a regulatory compliant biobanking program, the aim of this study is to collect clinical and biological information of lymphoid cancer patients. The cohort of patients enrolled will permit to analyze the practice pattern, perform biological correlative studies of great translational potential with relevance to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older
* Written informed consent
* Confirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma

Exclusion Criteria:

- Unconfirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma
Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain

The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.

Scope:

To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.

* Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
* Verification of the quantitative accuracy of the imaging chain.
* Evaluate the performance and stability of the new system and its related quality control and calibration procedures.

Result (Expected):

The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.

Eligibility Criteria:
Inclusion:

* Patients already scheduled for an FDG test at SDMI
* 40 years and older
* Adult must be able to sign an informed consent form

Exclusion

* Patients not scheduled for an FDG test at SDMI
* 39 years or younger
* Pregnant adult female or plan to be pregnant
* Adult who is unable to sign the informed consent