cyrilzakka/clinical-trials huggingface dataset:
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management

Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.

Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women
* age 18 years or older
* scheduled to have unilateral DIEP flap breast reconstruction.
* Must have ASA physical status classification of 1,2, or 3

Exclusion Criteria:

* concurrent or recent medical condition that could interfere with study participation
* history of any of the following:
* hepatitis
* alcohol/substance abuse
* uncontrolled psychiatric disorders
* known allergy/ contraindication to any of the following:
* amide-type local anesthetics
* opioids
* propofol
* Body weight of less than 50 kg
* have participated in another study involving an investigational medication with in the past 30 days
* taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery
CORONA Germany- Clinical Outcome and Risk in Hospitalized COVID-19 Patients - An Epidemiological Study From Germany

This is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. All hospitalized patients tested positive for SARS-CoV-2 will be included.

CORONA Germany is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in Germany, all part of a German hospital network. From January 1st till November 17th, 2020, all hospitalized patients tested positive for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) will be included. Demographical data and outcomes will be assessed in the entire study cohort. In a subgroup, consisting of 7 hospitals, further detailed data (e.g. baseline characteristics, laboratory values, medication, clinical events) will be assessed. Additionally, there will be subgroups of patients with cardiovascular events and prior or preexisting oncological diseases. There are two primary endpoints: 1. Combination of all-cause death and/or need for mechanical ventilation and/or allocation to intensive care unit (ICU). 2. Occurrence of a clinical manifest cardiovascular events. The aim of the study is the development of a prediction model for the primary endpoints, whereas the secondary endpoint is a comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave. All endpoints will be verified by an Endpoint Review Committee. A Steering Committee, consisting of representatives of the 45 hospitals, the trial statistician and members of the scientific department, takes responsibility of the study design and results.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients tested positive for SARS CoV-2 using a reliable test method (mostly polymerase chain reaction test)

Exclusion Criteria:

* Patients with negative SARS CoV-2 testing
Metabolic Manipulation in Chronic Heart Failure

Conventional measures used for the treatment of chronic heart failure act predominantly by reducing the work performed by the heart. In a recent study, the investigators showed that one drug (perhexiline) substantially improved symptoms and cardiac function in heart failure. The investigators wish to confirm these findings and test whether or not this drug acts by altering the heart's energy source thus augmenting the energetic status and work efficiency of the heart.

Perhexiline maleate is an antianginal agent which increases the efficiency of energy production by shifting substrate utilisation from free fatty acids towards glucose. We showed that perhexiline therapy was highly effective in improving exercise capacity, symptoms and cardiac function in patients with systolic heart failure of both ischaemic and non ischaemic aetiology. Perhexiline acts by inhibiting both carnitine palmitoyl transferase-1 (CPT-1) and CPT-2, which are key enzymes in mitochondrial free fatty acid uptake. This leads to increased myocardial glucose substrate utilization. Further we wish to ascertain whether or not this drug improves cardiac energetics and efficiency by altering substrate utilization. In this proposal we will assess the cardiac function (by cardiac Magnetic Resonance Imaging MRI), cardiac energetic status (by cardiac Magnetic Resonance Spectroscopy MRS), cardiac efficiency (via pressure-volume loops) and substrate utilization (via left and right heart catheterization), following one month of perhexiline therapy or placebo in patients with symptomatic idiopathic dilated cardiomyopathy on optimal conventional heart failure medications. An interim analysis is planned after 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* Optimally-medicated idiopathic dilated cardiomyopathy
* Symptomatic ( NYHA IIb-III)
* Impaired left ventricular systolic function (EF \< 40%)

Exclusion Criteria:

* Abnormal liver function tests (defined as above twice the upper limit of normal (ULN))
* Concomitant use of Amiodarone , Quinidine , Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme.
* Pre-existing evidence of peripheral neuropathy.
* Women of childbearing potential.
* Patients with implantable cardiac devices (or any other contraindication to MRI).
* Obesity ( BMI \> 32)
* Obstructive sleep apnea syndrome
* Patients with known hypersensitivity to perhexiline
* Patients with impaired renal function (Creatinine \> 250 µmol/L)
* Valvular heart disease defined as more than moderate valvular stenosis or regurgitation.
* Atrial Fibrillation
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with

   * stable angina or,
   * stabilized angina pectoris or,
   * atypical chest pain or no chest pain but with documented silent ischemia
2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
3. Eligible for PCI
4. Signed written informed consent

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG
2. Patients with left main coronary artery disease requiring revascularization
3. Patients with a recent STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF \< 30%
7. Severe LV hypertrophy
8. Planned need for concomitant cardiac surgery
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21
Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation

Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy.

The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.

A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.

The PRI is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. This facilitates the identification of meaningful T cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment.

Peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the T cells. Therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers.

Patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). Follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating Dupilumab treatment).

The blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Diagnosis of atopic dermatitis for ≥1 year
* Inadequate response to treatment with topical medications
* Confirmed dupilumab treatment

Exclusion Criteria:

* Age below 18
* Known or suspected allergy or reaction to any component of the dupilumab formulation
* Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
* Severe conjunctivitis or blepharitis
Active Games: Increasing the Attractiveness of Active Video Game Play for Youth

The purpose of this study is to look at the effects of active video game play on youth physical activity.

Child obesity is increasing worldwide and has major implications for health, both during youth and later in life. Physical activity declines sharply during adolescence, making ages 8-12 a critical period to encourage healthy exercise habits. Increased childhood weight has been linked to sedentary leisure time activities, such as video games. "Active video games" (AVGs) are now being studied as a method to increase children's interest and participation in physical activity. Although research indicates that AVG play may lead to energy expenditure comparable to light/ moderate physical activity, children prefer sedentary video games to AVGs and often find AVGs boring. Children do not play AVGs as often or with the same intensity as traditional games/sports and lose interest in them; efforts must be made to increase the appeal of AVGs so they are competitive with sedentary video games. This study will examine whether children's motivation to engage in AVG play may be increased with greater autonomy, as well as whether increasing children's motivation to play AVGs also increases their motivation to play sedentary video games.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle
* BMI between 5th and 95th percentile

Exclusion Criteria:

* taking any medications that affect energy use or eating
* actively trying to lose weight
* has any medical conditions that prevent him/her from safely joining in physical activity
* exercises more than three times per week for one hour at a time
* does not engage in more than 14 hours per week of screen-based activities
* does not own an active video game system
* plays active video games more than 30 minutes per week
A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)

The goal of the study is to learn what happens to levels of MK-0616 in the blood when MK-0616 is given in different forms. Researchers believe that there is no effect on a healthy person's body if MK-0616 is given in different forms.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.

A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Infectious disease
* Pregnancy/Nursing
Virtual Reality Approach in Subacromial Impingement Syndrome

The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Subacromial Impingement Syndrome (SIS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.

Subacromial Impingement Syndrome (SIS) is the result of contraction of the structures passing through the subacromial area. Problems in upper limb function in people with SIS adversely affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in SIS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. In addition, the diversity of virtual reality applications is increasing day by day so that participation of the patients and the interest in the treatment can be increased. Various measurements of the user's performance can be transferred to the clinician simultaneously with these systems. Also for most of these systems exercise modes, difficulty and duration are programmable so that the training sessions can be varied. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with SIS.

Eligibility Criteria:
Inclusion Criteria:

* Volunteered to participate in the study
* Aged 18-65 years,

Exclusion Criteria:

* Any visual or hearing problem,
* Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
* Having a physical disability or uncontrolled chronic systemic disease,
* Major trauma,
* Treatment for shoulder problems within the last 6 months,
* History of epileptic attacks
Physiotherapy for Arthrofibrosis Following Knee Replacement.

This research aims to develop an optimal physiotherapy intervention for people with arthrofibrosis (stiffness due to scar tissue) after total knee replacement (TKR). We will develop an optimal intervention by conducting:

1. A review of the evidence to identify what components could be included in the intervention, how effective they are and what outcomes have been measured by the research.
2. Interviews with patients with arthrofibrosis to understand the impact it has on their life and what outcomes are important to them and interviews with healthcare professionals (HCPs) to understand their experiences of treating patients with arthrofibrosis.
3. A Delphi study with a larger group of HCPs and patients to reach a consensus on what the optimal intervention should include. This involves a series of anonymous voting on a range of items that have been generated by the group and the results of the evidence review.
4. A workshop with patients, HCPs and health-care commissioners to finalise the intervention. During the workshop we will present our findings and work in small groups to agree the intervention


Eligibility Criteria:
Inclusion Criteria for Patients:

* adults (aged 18 and over) of any age who have undergone elective TKR with post- operative arthrofibrosis/stiffness who have undergone manipulation under anaesthetic (MUA) in the previous 24 months or are currently listed for a MUA.
* Ability to give informed consent

Exclusion Criteria:

* Patients with neurological or blood disorders

For HCP participants :

* at least 5 years of experience working with joint arthroplasty including the management of patients with arthrofibrosis or 3 years in the case of orthopaedic surgeons.
Predictors for Bronchoalveolar Lavage (BAL) Recovery Rate Derived From Quantified Computed Tomography (qCT)

Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates to find possible predictive markers.


Eligibility Criteria:
Inclusion Criteria:

* retrospective analysis of all patients undergoing BAL and complete documentation

Exclusion Criteria:

* incomplete documentation
Day-Night Rhythm in Human Skeletal Muscle

This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

Recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. The main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. Therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. During this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Healthy (as determined by dependent physician based on medical questionnaire)
* Male
* Age: 18-35 years
* Normal BMI (18-25 kg/m2)
* Regular sleeping time (normally 7-9h daily)

Exclusion Criteria:

* Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
* Heavily varying sleep-wake rhythm
* Shiftwork during last 3 months
* Travel across \>1 time zone in the last 3 months
* Engagement in exercise \> 2 hours total per week
* Using \>400mg caffeine daily
* Smoking
* Unstable body weight (weight gain or loss \> 3kg in the last 3 months)
* Significant food allergies/intolerance (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit
* Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
Preop Laxatives in Robotic Urologic Surgery

Minimally-invasive surgery, either laparoscopic or robotic, is commonly used in urology. Several urologic procedures including prostatectomy, radical nephrectomy, and partial nephrectomy are now commonly performed robotically. Patients undergoing these procedures often have delayed return of bowel function and persistent gastrointestinal symptoms including nausea/vomiting, abdominal distension, and bloating for several days to weeks after surgery. Postoperative stool softeners and laxatives are routinely used in an effort to minimize these symptoms, with varying degrees of success. The aim of this study will be to evaluate whether the use of a preoperative osmotic laxative will be beneficial in improving recovery of bowel function and alleviating postoperative gastrointestinal complaints in patients undergoing these procedures. Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery. Patients in both groups will receive the same postoperative bowel regimen including scheduled PEG both in the hospital and upon discharge until first bowel movement. Patients will be given a questionnaire and diary to record their postoperative gastrointestinal symptoms and time to first bowel movement. These questionnaires and diaries will then be analyzed to determine differences in time to first bowel movement and gastrointestinal complaints during their recovery from surgery.


Eligibility Criteria:
Inclusion criteria:

-Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy

Exclusion criteria:

* Patients under 30 years old
* Patients with a contraindication to receiving polyethylene glycol or other forms of laxatives
* People who regularly take Miralax
* Patients undergoing retroperitoneal radical or partial nephrectomy
* Patients with severe ulcerative colitis or Crohn's disease
* Patients with intestinal diversions (colostomy, ileostomy)
* Patients with prior abdominal or pelvic radiation
* Patients who will not follow up with UIHC postoperatively
* Patients who are incarcerated