cyrilzakka/clinical-trials huggingface dataset:
Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.

All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.


Eligibility Criteria:
Inclusion Criteria:

1. Complete ACL rupture
2. Age 15-55

Exclusion Criteria:

1. Persons who cannot tolerate knee joint TENS.
2. Persons who have a known allergy to cryotherapy
3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies


Eligibility Criteria:
Inclusion Criteria:

* Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
* WHO performance status 0-1
* Patients must be able to swallow AZD6244 capsules

Exclusion Criteria:

* Prior treatment with a MEK inhibitor
* Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
* Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids
Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years

Background: Recent evidence from several countries has emerged suggesting that the increase in the prevalence of childhood obesity has slowed down substantially, or even leveled off. Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls, respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively, being overweight or obese. Further trend analyses are necessary to confirm that the stabilizing trend observed reflects a long-term change in the rates of childhood overweight and obesity.

Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland during this 5 respectively 10 year time period. Height and weight will be measured and used to calculate body mass index (BMI). BMI references form the Centers for Disease Control and Prevention will be used to determine the prevalence of underweight (\< 5th percentile), overweight (≥ 85th and \< 95th percentile) and obesity (≥ 95th percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and bioelectrical impedance analysis will be performed to calculate body fat percentage.


Eligibility Criteria:
Inclusion Criteria:

* age 6-12 years
* child is attending one of the selected classrooms

Exclusion Criteria:

* age below 6 or above 12 years
Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects

The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.

Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes (diagnose confirmed by general practitioner)
* Controls with no diabetes (confirmed by blood testing).

Exclusion Criteria:

* Glaucoma
* Uveitis (current or previous)
* Corneal scaring
* Previous eye surgery
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia.

In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.

The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.


Eligibility Criteria:
Inclusion Criteria:

* patients with idiopathic macular telangiectasia
* patient consent

Exclusion Criteria:

* heart attack or cerebrovascular attack
* previous treatment for others retinopathy
* media opacities that preclude visualization of the fundus
* inability to understands the implications of the protocol
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs


Eligibility Criteria:
Inclusion Criteria:

* Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)
* Willing and able, as evaluated by the PI, to provide Informed Consent
* Willing to undergo up to 5 years of clinical follow up visits as scheduled
* Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
* Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
* The patient must be \>18 years of age
* Target lesion(s) is located at or below the level of the superficial femoral artery
* Target lesion(s) is \>50% stenosed by quantitative vascular angiography
* Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy

Exclusion Criteria:

* Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate
* Patient has terminal or Stage 4 cancer
* Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
* Previous stent in the target lesion
* Active infection at planned incision site
* The patient is a pregnant woman
* The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure
* Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification
AdheRence to Inhaled Corticosteroids in Asthma

It is widely recognized that asthma in adult African American patients is a significant health problem, which is partly affected by relatively low inhaled corticosteroid (ICS) adherence rates. The goal of this study is to pilot test an ICS adherence intervention, ARICA, that aims to improve ICS adherence in adult African Americans.

The investigators will evaluate ARICA in Duke primary care clinics to study its feasibility and acceptability using a quasi-experimental pre-post study design. The study will enroll between 32 and 48 adult African Americans with persistent asthma and suboptimal ICS adherence, and their health care providers, to study the use of the intervention and key indicators of the intervention's potential effectiveness.

Eligibility Criteria:
Inclusion Criteria

* At least 18 years of age
* Self-identifying African American
* Self-reported current asthma
* Prescribed an inhaled corticosteroid (alone or combination) for ≥ 1 month
* Presented at a Duke Primary Care clinic visit within the past 3 years or is establishing care at Duke Primary Care
* Follow up Duke Primary Care visit within the next 6 months

Exclusion Criteria:

* Unable or unwilling to provide informed consent
The Caudal Space in Children: Ultrasound Evaluation

Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery.

An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block.

The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery.

Exclusion Criteria:

* Patients with any contraindication to caudal epidural block were excluded.

  * coagulopathy
  * allergy to local anesthetics
  * infection at the puncture site
Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes

Determine if an intervention consisting of future-thinking improves different facets of memory/executive function and/or decision-making.

The aim of this study is to determine if a cognitive intervention is an efficacious method for improving medication adherence in adults with prediabetes or type 2 diabetes. Participants in this study will complete assessment sessions, as well as intervention sessions over a 15 week period. During this time, medication adherence will be monitored using a MEMS cap. The investigators hypothesize that, following the cognitive intervention, there will be improvements in participants' medication adherence, as well as in facets of memory.

Eligibility Criteria:
Inclusion Criteria:

Adults over the age of 18 with prediabetes or Type 2 Diabetes currently prescribed at least one oral medication for blood glucose regulation, or for related comorbidities e.g., hypertension, hyperlipidemia, and are relatively non-adherent to taking them (\< 80% of prescribed doses taken), but are motivated and/or have the intent to better comply with their medication regimen, will be studied.

Prediabetes and Type 2 Diabetes: Participants must have a diagnosis of prediabetes or Type 2 Diabetes within the last 2 years or meet criteria for prediabetes or Type 2 Diabetes. The American Diabetes Association guidelines (Group, 2003) defines prediabetes and Type 2 Diabetes as Fasting Plasma Glucose (FPG) 100mg/dl or greater, 2h glucose 140mg/dl or greater after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) of approximately 5.4% or greater.

Exclusion Criteria:

Pregnancy: Women who are pregnant or lactating will be excluded from participation.

Substance use, abuse, or dependence: Individuals that currently have problems with substance dependence, addiction, or problematic substance use that would limit participation (e.g., binge drinkers, alcoholics, daily stimulant/opiate users) will be excluded.

Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; unmanaged psychiatric disorder (e.g., depression, anxiety, attention deficit hyperactivity disorder, schizophrenia), cognitive impairment that would impact memory (e.g., symptomatic concussion), or an intellectual impairment that would impact study adherence. Additionally, participants should be able to attend to all intervention sessions. If a participant is not able to make most sessions (e.g. participant is out of town during most of the study for work or vacation travel), they may be excluded from the study Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.

Use of medication adherence aids: individuals who currently use aids to assist with medication adherence (e.g., pill organizers, reminder apps)may be excluded
Desensitization With Bortezomib Before a Living Kidney Donation

The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.

The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 70 years old
* awaiting a living kidney donation
* but with a least one DSA titer between 1000 MFI and 3000 MFI

Exclusion Criteria:

* positive cell dependent cytotoxicity CM,
* DSA level above 3000 MFI
* and every condition that is a contre indication for bortezomib treatment
Pre-post Erector Spine Plane Block-spinal Surgery

Spinal surgery patients generally have chronic pain in the preoperative period and are exposed to widespread and severe acute pain postoperatively. In spinal surgery patients, providing postoperative analgesia is important not only for the patient's comfort but also for preventing the negative effects of pain on the systems, allowing early mobilization, reducing hospital stay and especially reducing chronic pain syndrome.

Although ESP block is routinely used in spinal analgesia, the answer to the question of whether investigators should perform the block after putting the patient to sleep or before waking the patient after completing the surgery is not clear. Preference varies among anesthesiologists.YOU investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2).

investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2). Blind patients and postoperative follow-ups will not know which group the patient is in the study. The study will be conducted at Adnan Menderes University hospital with the approval of the ethics committee and the written consent of the patients. The study will be registered on the ClinicalTrials.gov website before the first patient is enrolled.

Preoperative Visit Documentation of eligibility and consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication use. They will fill out the QR-40 quality compilation survey form.

intraoperative The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with.

Group 1: Following induction of anesthesia, ESP block will be performed before the surgery begins, Group 2: ESP block will be performed before waking the patient at the end of surgery.

Postoperative The peroperative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol was determined as 1 g and tramadol was determined as 1 mg/kg. Then it is paracetamol every eight hours and tramadol from PCA.

At the end of the operation, patients' pain levels will be determined and recorded with the Numeric Rating Scale (NRS) system at postoperative intervals.

The quality of recovery (QoR-40) of both groups of patients at the 24th postoperative hour will be evaluated with a scoring system.

Eligibility Criteria:
Inclusion Criteria:

1. Spinal surgery performed under elective conditions
2. ASA I-III 3.18-75 years old

Exclusion Criteria:

1. Rejection during registration
2. Request for dismissal from employment
3. Inability to give informed consent
4. Emergency surgery
5. Bleeding diathesis
6. Presence of contraindications to the LA agents used in this study
7. Chronic use of opioids
8. Psychiatric disorders
9. Presence of infection at the injection site
Improvement of Information to Cancer Patients' Caregivers

The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.


Eligibility Criteria:
Patient Inclusion Criteria:

* Cancer patient
* Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
* Written informed consent

Caregiver Inclusion Criteria:

* Attends the first visit in the Department of Oncology with the patient
* Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
* Written informed consent

Exclusion Criteria:

* Patient and/or caregiver do not understand Danish well enough to participate in the study
* The patient has an expected survival of less than six months
Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function such as stroke volume variation (SVV) that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.

This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function, such as stroke volume variation (SVV), that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.

Specific Aims:

* Determine the threshold for the predictive response of SVV with respect to increasing cardiac output for patients with and without diastolic dysfunction.
* Compare the trans thoracic ultrasound assessment of left ventricular diastolic function before and after the induction of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients Undergoing Elective surgical procedures where invasive arterial line pressure monitoring is a planned part of the intraoperative management
* Age greater than or equal to 18
* Procedures requiring general anesthesia and mechanical ventilation

Exclusion Criteria:

* Adults unable to provide consent
* Atrial Fibrillation or other significant active arrhythmia
* Emergency Procedures
* Hemodynamic instability requiring vasopressor and/or inotropic infusions
* Presence of an intra-aortic balloon pump
* Open thoracic procedures
* Extremes of BMI less than 20 or greater than 40
* Pregnancy
* Prisoners
* Patient Refusal
Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure

Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* HbA1c\> 6.5%
* Estimated GF\> 45 ml / min
* BMI: ≥25 Kg / m2
* Stable pharmacological treatment of Heart Failure in the last 3 months

Exclusion Criteria:

* Diabetes type 1 or type LADA (presence of antibodies against GAD and/or IA-2 positive)
* DM2 with C-peptide \<1 ng / mL
* GEF \<45 ml / min
* Recurrent urinary tract infections
Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants

The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the neonatal intensive care unit (NICU).

A NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.

The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU. Being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants.

This is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research.

In this study the intervention being tested is the use of hearing protection in infants. The ear is employed in certain periods of the day. These periods established by the Neonatal Intensive Care Unit (ICU), are intended to promote environmental noise control and manipulation of the NB.

Levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborn male or female;
* Inside the incubator;
* Clinically stable;
* No change in evoked otoacoustic emissions;
* Current weight between 1200 to 2000g.

Exclusion Criteria:

* In phototherapy;
* In invasive mechanical ventilation and noninvasive;
* With any type of congenital malformation;
* Periventricular hemorrhage with grade II, III and IV;
* In using any medication depressant, analgesic or corticosteroid in last 24 hours;
* Premature newborn whose mother has a history of illicit drug use during pregnancy.