cyrilzakka/clinical-trials huggingface dataset:
Model-informed Precision Dosing of Vancomycin in Adults

The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.

Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the individual patient is challenging.

Currently, the vancomycin dose is adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.

This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in non-critically ill adults, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney and a reduction in patient burden.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* admitted to a participating ward unit
* a suspected or confirmed Gram positive infection
* planned to start of started on intravenous continuous infusion vancomycin treatment
* participant or legal representative signed the informed consent form
* not previously enrolled in this trial

Exclusion Criteria:

* serum creatinine level at inclusion is above 2.5 mg/dL
* undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
* patient death is deemed imminent and inevitable.
Familial Clustering of Vitamin D Deficiency Via Shared Environment: The Korean National Health And Nutrition Examination Survey 2008-2012

Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based studies, mostly from Caucasian parent-offspring pairs. However, data on the familial association of 25(OH)D in extended family structure and the relative contribution of genetic and shared environmental factors on serum 25(OH)D level are limited in Asian populations. In this study, the investigators aimed to assess the relative contribution of additive genetic and environmental components on serum 25(OH)D level by variance components method in a nationwide family-based cohort. Further, the investigators will evaluate the association of vitamin D status of index individual with prevalent vitamin D deficiency of each family member including spouse, offspring, sibling, and grand-offspring. Additive influences of paternal and maternal vitamin D status on offspring will be also investigated.

From the Korean National Health and Nutritional Examination Survey (KNHANES) conducted between 2008 and 2012, familial correlations for 25(OH)D will be estimated in different types of family relation pairs in 28551 subjects from 10882 families. The relative contribution of additive genetic and shared or individual environmental factors for variance of 25(OH)D level will be calculated using variance component method. Interactions between paternal and maternal vitamin D status for 25(OH)D level of offspring will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* KNHANES(Korean National Health and Nutrition Examination Survey) 2008-2012 participants

Exclusion Criteria:

* missing value on 25-hydroxyvitamin D levels
* data on another household member was unavailable
* the precise family relationship between the subjects was unclear
Evaluation of the Contribution of Basketball-specific Target Shooting Exercises to Strength, Position Sense, Stability and Endurance in Young Basketball Players

The aim of this study is to examine the effects of open kinetic chain proprioception exercises on joint position sense, strength, functional stability and endurance in adolescent basketball players

Adolescent basketball players, aged 13-16, were randomly divided into two groups as exercise group (n = 11) and control group (n = 11). Exercise group performed open kinetic chain functional proprioception exercises twice a week for 6 weeks. Control group did not participate in any exercise program. Before and after the exercise program all athletes were subjected to the proprioception test and isokinetic muscle strength test on the isokinetic dynamometer, closed kinetic chain upper extremity stability test and modified push-up test.

Eligibility Criteria:
Inclusion Criteria:

* being 13-16 years old
* being male
* playing basketball regularly

Exclusion Criteria:

* having any upper extremity muscle injury in the last 6 months,
* having a limitation in the shoulder girdle range of motion,
* having a shoulder, elbow, wrist dislocation problems
The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.

Research question:

In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?

Research hypothesis:

In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

Eligibility Criteria:
Inclusion Criteria:

* Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.

Exclusion Criteria:

* Hb \< 11 g/dL, platelets \< 150.000/mm3
* Patient taking anticoagulant.
* Patient taking NSAID in the 10 days before procedure.
* Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
* Active cervical or uterine infection.
Pilot Study for the Urinary Incontinence Treatment

Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises

A non invasive study to improve the urinary incontinence performed in 36 women from two groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor muscles exercises with a restorative pelvic floor device every day for two months using the Magic Kegel app download in their mobile devices

Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence diagnosis

Exclusion Criteria:

* No urinary infection
* No surgery for urinary incontinence
Reduced Intensity Conditioning (RIC) Regimen for Patients With Non-malignant Disorders

This is a Phase II pilot study to evaluate engraftment and toxicity of patients with non-malignant diseases using a reduced intensity conditioning regimen in the setting of allogeneic transplant for non malignant diseases. Bone Marrow or cord blood will be acceptable as a stem cell source.

Recently, reduced intensity conditioning (RIC) regimens have been used for both adult patients with leukemias and pediatric patients with non-malignant diseases. These regimens are better tolerated, resulting in less transplant related morbidity and mortality. Stable mixed chimerism, while insufficient for eradication of leukemias, may be sufficient to cure patients with non-malignant diseases.

There are two conditioning regimens in this protocol for children \>6 months. Alemtuzumab (Campath), Fludarabine and Melphalan are used. The regimens differ by the timing and dosing of Alemtuzumab (Campath). The two timings are distal and intermediate.

* Distal campath is initiated 22 days prior to the allogeneic transplant.
* Intermediate campath is initiated 14 days prior to allogeneic transplant.

The conditioning regimen for children with immunodeficiencies \<6 months omits melphalan, and substitutes two days of busulfan. This regimen is successfully used in the United Kingdom, and has been successful in a 3 month old infant at the Children's Hospital of Philadelphia (CHOP) who engrafted with a haploidentical donor.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>6 months- 25 years
2. Diseases eligible for Distal Alemtuzumab:

   * Immunodysregulation polyendocrinopathy enteropathy X-linked (IPEX) syndrome
   * Sickle cell disease
   * Thalassemia major
   * Bone marrow failure
3. Diseases eligible for Intermediate Alemtuzumab

   * Hemophagocytic lymphohistiocytosis other macrophage activation syndromes, severe Langerhans histiocytosis
   * Severe combined immune deficiency, adenosine deaminase deficiency, common variable immunodeficiency
   * Wiskott-Aldrich syndrome
4. Organ criteria:

   * Cardiac: Echocardiogram shortening fraction \>27%
   * Renal: Serum creatinine less than 1.5 times the upper limit of normal for age
   * Hepatic: liver function tests must be less than 5 times the upper limit of normal
5. No active infections

Exclusion criteria

1. Uncontrolled bacterial, fungal or viral infections
Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients

Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.

This study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy.

The data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient plans to participate in an interventional clinical trial for the condition of diabetic neuropathy
* Patient has been diagnosed with a type of diabetic neuropathy
* Patient is a minimum of 18 years of age
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form
* Patient has an ECOG score of 4 or higher
REFLECT Scoliosis System Post Approval Study

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval

The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.

The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.

A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive idiopathic scoliosis
* Preoperative major Cobb angle 30°-65°
* Preoperative flexibility to ≤30° on side bending radiograph (left or right)
* Skeletally immature at the time of surgery with Risser sign \<5 or Sanders score \<8
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
* Signed informed consent and/or assent forms specific to this study

Exclusion Criteria:

* Prior spinal surgery at the level(s) to be treated
* Documented poor bone quality, defined as a T-score of -1.5 or less
* Presence of any systemic infection, local infection, or skin compromise at the surgical site
* Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
* Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
* Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study;
* Agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\];
* Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
* Sign the informed consent.

Exclusion Criteria:

* Have peripheral vascular disease;
* Have insulin dependent diabetes mellitus;
* Be known to have a blood clotting disorder;
* Be receiving antibiotic therapy for pre-existing condition or infection;
* Be known to be HIV-positive or otherwise immunocompromised;
* Have known personal or family history of keloid formation or hypertrophy;
* Be currently taking systemic steroids;
* Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
* Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
* Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.
Follicular Steroid Genesis in Controlled Ovarian Stimulation

Serum concentrations of the different hormones involved in follicular steroid genesis during a cycle of controlled ovarian stimulation with recombinant FSH or HMG will be compared in this study. Serum Progesterone (P) levels at the end of Controlled Ovarian Stimulation (i.e. the day of triggering) have been related to cycle outcome, in terms of ongoing pregnancy and live birth rates. Large cohort studies show that P levels above a certain threshold are associated with poorer cycle outcome. The mechanisms behind P elevation are not well understood yet. It has been shown that P levels are positively related to ovarian response and to the dose of FSH given during COS. Furthermore, it has been well documented that P levels at the end of stimulation are significantly higher when recombinant (r) FSH is used for COS when compared to HMG, either in a GnRH agonist long protocol or in a GnRH antagonist protocol. Some authors suggest that this finding is explained by the fact that COS with rFSH provides a higher oocyte yield than when hMG is given, so the higher P levels observed would be explained by the larger number of follicles developed when rFSH is used. On the other hand, other authors explain this event by a different follicular esteroidogenesis when HMG is used for COS compared to rFSH The hypotheisis behind this assumption is that rFSH enhances P synthesis from its precursor pregnenolone in the granulosa cells. This P is unable to be further metabolized into androgens because of the lack of 17-20 lyase in the human granulosa cells, and therefore is delivered into circulation. On the other hand, when HMG is given for COS, the ∆4 pathway is promoted, and pregnenolone will be catabolized in to Dehidroepiandrostenodione (DHEA), in the theca cells, and this one to Androstenodione, which will be finally aromatized in to estrogens. This mechanism will explain the lower P and higher E2 levels observed in HMG cycles in comparison to rFSH cycles.


Eligibility Criteria:
Inclusion Criteria:

* Good physical and psychological condition
* Normal menstrual cycle (25-35 days)
* Normal ovarian reserve defined by serum ANH010-30 pMol/L
* All other criteria to fulfill by oocyte donors

Exclusion Criteria:

* Kidney failure
* Ovarian Polyquistic syndrome
* Any systemic or metabolic disfunction that counter indicates the use of gonadotrophins
* Any other reason that involves exclusion of the oocyte donation program
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Histologically or cytologically documented non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
* Radiologically measurable or evaluable disease No prior chemotherapy
* 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
* Tumor tissue block or fine needle aspirate

Exclusion Criteria:

* Any concurrent anticancer therapy or radiation
* Other active malignancy
* Uncontrolled brain metastases
* GI abnormalities
* Severe abnormalities of the cornea
* Significant cardiac disease
* Active infection
Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery

The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds

The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds were irrigated with normal saline solution thorough a bulb syringe. In both subgroup specimens for bacterial culture were harvested by swabs from surgical site before and after irrigation of the wounds.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Patients candidated to spinal surgery for spinal surgery
* Primary spinal surgery procedure

Exclusion Criteria:

* Clinical signs of infection before surgery
* Previous spinal surgery
Does Modified Ultrafiltration Affect Thromboelastography Results?

The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.

The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery.

After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG sample will be taken. The components studied are Reaction time (R), Coagulation time (K), Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another TEG sample will be taken after finishing modified ultrafiltration and before protamine is given. The different components will be compared pre and after modified ultrafiltration. The Primary end points are the changes of the different TEG components after modified ultrafiltration. The secondary end points are the utilization of different blood products (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.

Eligibility Criteria:
Inclusion Criteria: - neonates

* congenital heart disease
* pediatric cardiac operation with cardiopulmonary bypass
* modified ultrafiltration done at the end of cardiopulmonary bypass

Exclusion Criteria: -patients older than 1 month.

* Cardiopulmonary bypass is not used
* Modified ultrafiltration is not performed
Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity

this work aims to investigate the effect of intrathecal administration of Morphine, Dexmedetomidine or both in combination on cellular immunity and cytokine production in patients undergoing major abdominal cancer surgeries.

Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative analgesia thereby reducing the requirement of postoperative supplemental analgesics. The incorporation of adjuvants also lowers the overall dose of local anesthetic and hence associated side effects. Morphine has been used widely to alleviate various types of pain and to supplement general anesthesia. On the other hand, morphine has been reported to possess some immunosuppressive effects. Postoperative immunity is also important in conjunction with defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been shown in a few clinical studies. In addition, current insights have identified that dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients scheduled for major abdominal cancer surgeries

Exclusion Criteria:

* patients with known allergy to the study drugs,
* significant cardiac, respiratory, renal or hepatic disease,
* drug or alcohol abuse,
* psychiatric illness that would interfere with perception and assessment of pain.