cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.


Eligibility Criteria:
Inclusion Criteria:

* Primary Monosymptomatic nocturnal enuresis
* Failed treatment with desmopressin.
* The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation.
* All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy.
* Severe enuresis with at least seven wet nights out of 14

Exclusion Criteria:

* Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
* Depression
* Severe psychiatric diseases
* Untreated constipation
Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction

Diaphyseal femoral fracture in children \<6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. The aim of this study is to confirm, via EOS imaging, the absence of residual deformities 3 years after the end of treatment in children treated in Amiens hospital department.


Eligibility Criteria:
Inclusion Criteria:

* \<6 years old at the time of the fracture
* treatment by skin zenith traction
* femoral shaft fracture, traumatic, unilateral

Exclusion Criteria:

* Multiple fracture
* pathological fracture
* history of lower limb fracture
* contraindication to zenith traction
Increasing Treatment Seeking Among Suicidal Veterans Calling the Crisis Line

The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans who call the Crisis Line but are resistant to behavioral health services.

The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans who call the Crisis Line but are resistant to behavioral health services. This randomized controlled trial will recruit 80 Veterans who report current suicidal ideation at the time of the Crisis Line call and are resistant to seeking behavioral health treatment. Half of the participants will receive the brief, individualized CB intervention and half will receive standardized procedures from VA's Crisis Line (i.e., usual care). The effectiveness of the intervention will be tested on 1) attitudes toward behavioral health treatment rates, and 2) initiation of and adherence to treatment (assessed by the number of sessions attended). The investigators will also assess the impact of the intervention on suicidal ideation (SI) and explore the impact on the most common symptoms observed in Veteran suicide decedents (e.g., depression).

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the study are as follows:

* individuals 18 and older who call the Veteran Crisis Line
* have a phone number where they can be reached, be it a land line or a cell phone
* deemed by the Crisis Line responder to be at risk for suicide, but not imminent risk
* refuse a referral to the SPC or to a behavioral health treatment provider during the call
* report current suicidal ideation (SI) during the call based on administration of a standard item
* have not been in behavioral health treatment in the past. Presence of SI will be subsequently confirmed by the research assistant using the Columbia Suicide Severity Rating Scale, a validated instrument.

Exclusion Criteria:

Exclusion criteria are being judged by the Crisis Line responder to show:

* debilitating cognitive impairment
* active psychosis or mania
* acute alcohol or drug intoxication
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)

This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population.

The objectives of the UCB AED Pregnancy Registry are:

* To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome
* To review reported cases of possible birth defects
* To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy

This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).


Eligibility Criteria:
Inclusion Criteria:

The subjects must meet the following criteria for registration:

* Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
* Exposure to Keppra® and Keppra XR® on or after the first day of the patient's last menstrual period (verified by date or gestational age of exposure)
* For patient-initiated enrollments, provide verbal or written consent to participate in the Registry
* For patient-initiated enrollments, provide contact information for herself, her HCP, and the infant's HCP (as applicable)
Balanced Knee System Clinical Protocol for IRB Approval

The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.

The rationale is based on the potential effectiveness of the BKS to:

* Return patient to normal activities or increase mobility by restoring knee function.
* Provide stability to enhance rehabilitation without external support.
* Eliminate or reduce knee pain.
* Assess the clinical efficacy after total knee replacement.
* Determine implant survivorship and viability.
* Evaluate patient function and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Loss of joint configuration and joint function.
* Osteoarthritis of the knee joint.
* Rheumatoid arthritis of the knee joint.
* Post-traumatic arthritis of the knee joint.
* Moderate valgus, varus, or flexion deformities.

Exclusion Criteria:

* Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
* Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
* Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
* Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
* Rapid joint destruction or bone absorption apparent on roentgenograms.
* Neuromuscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits gained by the patient from usage of the prosthesis.
* Mental disorders which would compromise essential patient post-operative care.
* A painless, stable arthrodesis in a functional position.
* Allergic reactions to implant materials, and/or tissue reactions to the products of corrosion or wear.
* Skeletal immaturity.
* Any patient who is unwilling or unable to comply with post-operative instructions or clinical study requirements.
Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery

The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.

This study is a retrospective chart review of 800 intervention charts each for consecutive laparoscopic sleeve gastrectomies compared to consecutive laparoscopic gastric bypasses performed by two surgeons in a Louisiana private practice. This retrospective chart review will evaluate the safety of the two procedures during the operative and 6-week post-operative periods, compare the insurance patients to the private pay patients having the gastric bypass, and comparative weight loss in subjects with a follow-up of at least 18 months. This offers the unique opportunity to compare any differences in surgical complications in subjects paying by insurance versus those paying personally for the gastric bypass operation.

Eligibility Criteria:
Inclusion Criteria:

* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy.
* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass.

Exclusion Criteria:

* Subjects having any other obesity surgical procedure
Use of Sevoflurane to Test Concept of Cognitive Reserve

Previous pilot study had demonstrated a correlation between cognitive reserve and BIS variability during steady state of anesthesia. This study, we intend to evaluate the association between BIS variability and emergence and recovery time from anesthesia.

Cognitive reserve (CR) refers to an individual's ability to resist damage to the brain and is thought to be associated with an individual's education, cognitive stimulation, and physical activity. Those with greater CR have protection against degenerative brain changes such as dementia. Currently, CR is evaluated through a host of proxy tests such as questionnaires aimed to assess various aspects of cognitive function. These ways of measuring CR test directly only on an individual's ability to perform certain tasks when the brain is in its "unchallenged" state. However, this approach poses significant limitations since CR is developed as a concept representing the physiological brain reserve that helps counter the clinical manifestation of a diseased or "challenged" brain. A method that simulates a state of "challenged" brain during CR measurement may provide a more precise assessment of CR.

Anesthetic agents are known to reversibly alter brain function resulting in a state of sedation or amnesia. Whether this way of brain "challenge" can provide information on CR is unknown.

A previous study showed preliminary evidence that patients with higher CR correlates with less variability in bispectral index (BIS) during steady state of anesthesia with inhaled anesthetic sevoflurane (1). While the result of this study is encouraging, further study is needed to develop the concept of using anesthetic agents to evaluate CR. Specifically, a study investigating the correlation between intraoperative BIS variability and timing of clinical recovery from anesthesia will be necessary. This will further elucidate how to use anesthetic agent for the evaluation of CR.

Building on the previous study result and the concept that higher CR means higher resilience against brain function in a "challenged" state, we hypothesize that less intraoperative BIS variability correlates with shorter recovery time from anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* - Minimal completion of high-school education
* Adult patient \< 85 years of age
* No prior known history of cognitive/brain disease
* ASA class I-II
* Undergoing general anesthesia with sevoflurane for maintenance anesthesia
* Same-day surgery
* Elective procedures
* No prior history of cardiac disease

Exclusion Criteria:

* - History of chronic pain
* Perioperative use of anesthetic agents other than propofol, fentanyl, dilaudid, and sevoflurane
* History of alcohol/substance druge abuse
* Psychiatric history
* Morbid history
* History of OSA, stroke, or TIA
* Blindness
* Deafness
Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.

The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.

After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.

This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hydrocephalus
* Instrumented with an Extraventricular drainage system

Exclusion Criteria:

* Not diagnosed with hydrocephalus
* Not instrumented with an extraventricular drainage system
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients with Breast Cancer Undergoing Breast Surgery

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

PRIMARY OBJECTIVES:

I. Obtain Comprehensive Score for financial Toxicity (COST) questionnaire data from the patients who are undergoing any form of mastectomy (with or without breast reconstruction).

II. To determine which patients are at higher risk of financial toxicity while pursuing breast reconstruction.

III. Assess if financial toxicity or distress is associated with worse BREAST-questionnaire (Q) performance as well as quality of life.

IV. Identify relationships between coronavirus disease 2019 (COVID-19) related productivity losses and financial toxicity.

OUTLINE:

Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.

After completion of study, patients will be followed up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (DCIS) or prophylaxis in the setting of genetic mutations or strong family history
* English-speaking
* Able to complete consent
* Able to fill out computer survey material

Exclusion Criteria:

* Non-English-speaking
* Those with recurrent or metastatic disease or concurrent primary cancers
* Patients undergoing breast conservation therapy will also be excluded from the study
PRP Effectiveness in Knee Osteoarthritis

The aim of our study is to determine the effects of intra-articular Platelet Rich Plasma (PRP) prepared with two different techniques on pain intensity, functional status, quality of life, functional balance and femoral cartilage thickness in patients with knee osteoarthritis.

Osteoarthritis (OA) is the most common form of chronic joint disease. Platelet Rich Plasma (PRP) is an injection therapy used to treat chronic painful musculoskeletal conditions, including knee OA. In this prospective, randomized controlled, single blind, interventional study, a total of 75 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers.The patients to be included in the study will be randomized into three groups and the first group will be given platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT, the second group will be given PRP prepared with T-LAB PRP INJECTION SYRINGA, and the third group will be given saline injection. Home exercise program for knee osteoarthritis will be given to all three groups and the exercise program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments, not to make changes in their activities of daily living. Participants are going to evaluate before injection, and at the 1-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time, change in femoral cartilage thickness measurement by ultrasound and the change in the patient's daily activities with the numerical global patient assessment scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic symptomatic knee pain between the ages of 30-75 years
* Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
* Functional ambulation scale stage 4-5

Exclusion Criteria:

* Intra-articular knee injection within the last six months
* History of severe trauma to the knee within the past six months
* Concomitant severe meniscus or ligament injury, surgery applied to the knee area
* Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
* Having a bleeding disorder and / or using warfarin
* Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
* Presence of cardiac or systemic disease that may affect exercise
* The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
* Body Mass Index ≥35 kg / m²
Effective Antimicrobial StewaRdship StrategIES (ARIES)

Background Prospective review and feedback (PRF) of antibiotic prescriptions is a labor-intensive core strategy of antimicrobial stewardship (AMS). The investigators hypothesized that a computerized decision support system (CDSS) providing recommendations for antibiotics, investigations and referrals would reduce the requirement for PRF without causing harm.

Methods A parallel-group, 1:1 block-cluster randomized, cross-over study was conducted in 32 medical and surgical wards from March to August 2017. The intervention arm comprised voluntary use of CDSS at first prescription of piperacillin-tazobactam or a carbapenem, while the control arm was compulsory CDSS. PRF was continued for both arms. Primary outcome was 30-day mortality.

Increasing antimicrobial resistance due to inappropriate antimicrobial use is a global concern. Multi-disciplinary antimicrobial stewardship teams have become an integral part of the response to this issue. Through prospective review of antibiotic prescriptions and feedback (PRF) to healthcare providers, antimicrobial stewardship has been shown to improve clinical response, reduce adverse effects and mortality. However, this strategy is labor-intensive to implement and skilled healthcare workers are an expensive and scarce resource. Antibiotic computerized decision support systems (CDSS) have been used to facilitate these processes and may circumvent the limitations of lack of manpower. In previous studies, CDSS led to increased susceptibility of Pseudomonas aeruginosa to imipenem and Enterobacteriaceae to gentamicin and ciprofloxacin, and an overall reduction in broad-spectrum antibiotic use. CDSS could improve clinical outcomes. Currently, there are limited studies comparing the combined effects of these two strategies.

At Tan Tock Seng Hospital, a university teaching hospital in Singapore, antimicrobial stewardship has focused on PRF by a multi-disciplinary team since 2009. This team reviews piperacillin-tazobactam and carbapenem orders against hospital antibiotic guidelines from day two of antibiotic prescription. In March 2010, we implemented CDSS triggered at the point of antibiotic ordering and compulsory for the prescriber to review. Prescribers are free to accept or reject the CDSS recommendations. While PRF and CDSS are performed following the same institutional guidelines, there may be differences in physicians' acceptance of recommendations and the accessibility to recommendations between these two interventions. In previous studies, PRF recommendations had an acceptance of 60-70% while compulsory CDSS was 40%. The investigators hypothesized that compulsory CDSS and PRF would improve clinical outcomes compared with voluntary CDSS and PRF, and compulsory CDSS would improve appropriate antibiotic practice and reduce the requirement for subsequent PRF.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are started on the 1st episode of piperacillin-tazobactam or carbapenem during the study period.
* Medical and surgical wards

Exclusion Criteria:

* Intensive care unit (ICU), high dependency and step-down care wards
Influence of Cooling on the Effect of Strength Training

The aim of this study is to investigate if regular cold water immersion after strength training has a negative influence on the desired training-induced performance enhancement.

Recovery strategies represent a not sufficiently investigated chance in elite training control to optimize the complete training process. Coaches and athletes are confronted with numerous potentially effective recovery methods, e.g. cooling, warming, active recovery, compression, massage or power naps. However, the effectivity of these methods has rarely been investigated under controlled scientific conditions. Based on the state of the art,so far hardly any definite practical conclusions regarding effective recovery methods can be drawn, especially regarding sport-specific strategies and settings. Currently, cold water immersion is a particularly popular recovery strategy. However, there are hints that repeated cooling interventions after training can impair the training effect. This could potentially be caused by a faster reconstitution of homeostasis due to cooling. For fast recovery of performance, this effect would be desirable, but at the same time these homeostatic disturbances are the basis of signal processes leading to training adaptations.

The aim of this study is to investigate if regular cold water immersion after strength training has a negative influence on the desired training-induced performance enhancement.

Eligibility Criteria:
Inclusion Criteria:

* healthy, 18-40 years, strength training experience, 8 weeks no leg strength training

Exclusion Criteria:

-
Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta