cyrilzakka/clinical-trials huggingface dataset:
Predictors of Readmission in Patients Undergoing PNL

To identify predictors of patients postoperative readmission after PNL

Percutaneous nephrolithotomy (PCNL) is a minimally-invasive procedure to remove stones from the kidney by a small puncture wound (up to about 1 cm) through the skin. It is usually done under general anesthesia or spinal anesthesia. Despite the advancements in endoscopic technologies technique and training, the procedure is still associated with complications, which can occur during the intervention or in the early or late postoperative period. Known complications to PCNL are fever (2.8-32.1%), bleeding requiring transfusion (0- 45%), organ injury (0-1.7%) and sepsis (0.3-1.5%) these complications consider life threatening and increase risk of patient readmission Readmission is defined as a state when the patient is admitted to the same or a different hospital after being discharged from the applicable hospital to a non-acute setting, such as his home within a specified time period . Hospital readmissions are frequent and costly, and are estimated to cost the US health care system \> $12-17 billion annually . Readmissions occurring within the first week after discharge are often related to the stress of acute illness as well as heightened self-care needs, new medications, and impaired function while those occurring later reflect chronic illness Nurses could play a pivotal role in preventing readmissions through appropriate discharge teaching and following up with the patients after discharge through telephone conversations. Early identification of patients' problems and taking appropriate measures to handle these problems at an early stage helps to prevent further post-discharge complications and improves patient outcomes.

Nurse should emphasize to the patient the importance of reporting symptoms to physician immediately. Postoperative care should include: close monitoring of vital signs, close observation of urine output and color changes, wound care and careful observation for dressing and tube drainage.

Many studies have been found in the literature on readmissions after urological surgeries and their causes in recent years . These studies include general urological surgical procedures, and there are limited studies examining potential predictive factors for endourology and stone surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients
* patients shechedled for PNL
* age range from)18-65(years

Exclusion Criteria:

* Failed PNL
* psychiatric patients
* coagulopathy
* patients refused to participate in the study
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization

1. Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
2. Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
3. Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
* The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
* Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
* Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
* The corneal neovascularization was refractory to other medical treatment
* The patient had received PKP or other corneal surgeries more than half a year ago and was not in the acute post-operation phase
* The patient had no active endopthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases
* The patient signed inform consent to have regular follow up and treatment

Exclusion Criteria:

* The neovascularization had clinical improvement three months before the first injection
* The lipid keratopathy had clinical improvement three months before the first injection
* The patient that suspected to have poor visual outcome or had already been light sense negative
* Glaucoma patient that had uncontrolled intraocular pressure
* Poor corneal epithelialization
* Post-PKP patient that had graft failure or rejection
* Patient that had systemic disease which was not suitable for bevacizumab use
* Pregnant patient
Deep Brain Stimulation in Treating Patients With Dystonia

RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.

PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.

PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.

Patients are followed every 3 months as long as the brain stimulation system remains in place.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --Prior/Concurrent Therapy-- All medical therapy must be stable within the past month Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior destructive neurosurgical procedure Other: At least 3 months since prior botulinum toxin injections --Patient Characteristics-- Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No demand cardiac pacemaker Other: No history of substance abuse
Helping Educational Leadership Mobilize Evidence

Many universal, evidence-based prevention practices (EBPPs) have been developed to prevent SEB problems, typically in elementary schools, but progress toward widespread implementation has been slow and few efforts have been made to develop and test interventions to enhance EBPP implementation in schools. Schools leaders (e.g., principals) are key to decision making and implementation of EBPPs, and their leadership has been shown to be consistently linked to student outcomes through their intentional efforts to support teacher adoption and use of innovative programs. Helping Educational Leaders Mobilize (HELM) Evidence is a pragmatic, multifaceted, organizationally-focused implementation strategy targeting the implementation leadership and implementation climate of school buildings (through principals) to enhance the adoption and delivery of EBPPs in elementary schools. This pilot study, part of the larger HELM project to adapt and test the strategy based on an existing leadership intervention, Leadership and Organizational Change for Implementation (LOCI), will be implemented in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce disruptive behavior and increase academic engagement.


Eligibility Criteria:
Inclusion Criteria:

* Being a K-5th elementary school
* Being a K-5th principal or assistant principal at an elementary school
* Being a K-5th grade teacher, paraeducator, or specialist (e.g., reading) at an elementary school, and not a teacher in a special education-only classroom

Exclusion Criteria:

* School building or teacher that is currently implementing PGD
Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, HIV-negative volunteers

Exclusion Criteria:

* Currently active or chronic cardiovascular, hepatic, renal, pancreatic, gastrointestinal, neurologic, hematologic, psychiatric, metabolic, respiratory, inflammatory, or infectious disease
* Chronic pancreatitis
* History of rhabdomyolysis
* History of statin-associated myopathy
* Active malignancy
* History of significant skin disease, food allergy, drug allergy, dermatitis, eczema, psoriasis
* Pregnancy/breastfeeding
* HIV positive and/or AIDS
* serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range \[ULN\]);
* hemoglobin grade 1 or greater (≤ 10.9 g/dL);
* platelet count grade 1 or greater (≤ 124.999 x 109/L);
* absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN);
* total bilirubin grade 1 or greater (≥ 1.1 x ULN)
* serum lipase grade 1 or greater (≥ 1.1 x ULN)
* serum amylase grade 1 or greater (≥ 1.1 x ULN)
* any other laboratory abnormality of grade 2 or above
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.

This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
* In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
* Had a systolic blood pressure of \<=180 mm Hg and a diastolic blood pressure \<=100 mm Hg
* Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria:
* Currently taking any any protocol-defined prohibited medications
* Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors
* In the opinion of the Investigator is incapable of following the study schedule for any reason
Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children

The purpose of this study is to determine if a collaborative centralized population-based reminder/recall intervention is more effective than a traditional practice-based reminder/recall intervention at increasing immunizations among young children.

The study proposed is of immense importance in directing future methodology for bringing children who have not received needed immunizations up to date. The proposed study builds on the success of a previous trial and incorporates data from providers and patients to further improve the intervention. In this study the investigators aim to increase the effectiveness, cost effectiveness, and acceptability to practices and families of population-based R/R by introducing a strong private-public collaboration and maximizing health information technologies that allow practices to interface with Colorado's Immunization Services System (CIIS). Two real-world approaches will be compared: one approach will provide primary care practices the tools to conduct recall and educational interventions. In the other approach, population-based centralized recall by the state immunization registry will be conducted in collaboration with practices. Determining which of these methods is most effective in reaching the most children and comparing the cost of each will provide data critical in guiding future national efforts to assure that children entering school are fully vaccinated. Because the trial will be conducted at the level of both urban and rural counties throughout the state and will include all types of providers, the investigators expect our findings to be nationally generalizable.

Eligibility Criteria:
Inclusion Criteria:

* 19-35 months at time of recall
* has an address in a specified study county listed in the state immunization registry
* child is in need of at least one immunization at time of study

Exclusion Criteria:

* Opted out of the Colorado Immunization Information System (CIIS)
* child is up-to-date on all immunizations
Acute Effect of Exercise on Vascular Function

The study objectives are the following: 1) To examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) To examine the influence of age and gender on these responses.

The type, intensity and duration of exercise, fitness state, and timing of measurements have been reported to influence the acute vascular responses to exercise. However, little is known regarding the influence of interval training, aging and gender on these responses. The objectives of this study are: 1) to examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) to examine the influence of age and gender on these responses. Subjects will perform the following 3 types of treadmill exercise in a random order: 1) slow-pace walking; 2) moderate-pace walking; and 3) interval training. Flow mediated dilation using high resolution ultrasonography and arterial stiffness using applanation tonometry will be measured before, immediately after and 1-hour after each acute bout of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 79 years of age
* Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
* Premenopausal women will be eumenorrheic.
* Able to give consent.

Exclusion Criteria:

* History of hepatic disease or infection with hepatitis B, C or HIV
* History of other relevant on-going or recurrent illness
* Recent (within 3 months) or recurrent hospitalizations
* Current intake of medications that may affect study results
* Use of tobacco products
* Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
* Pregnancy (positive urine pregnancy test) or lactation
* Perimenopausal women
Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Early Diagnosis of Asthma in Young Children

The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
* Children aged 2-3 years, with no or minor respiratory symptoms

Exclusion Criteria:

* Mental retardation
* Cardiac anomalies
* Congenital malformations
* Other diseases of the lungs/airways
* Chronic systemic inflammatory diseases like M. Crohn
* The inability to perform lung function measurements and/or exhaled air collection
Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China

* To find out the gap between real-world clinical practice and guideline recommendations in initial management of DTC patients
* To observe the characteristics of patients who achieved and did not achieve TSH target value after one year follow-up
* To assess response to initial therapy in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up (according to an modified dynamic risk stratification system)
* To observe the recurrence status after one year follow-up

Multi-center, prospective, registry study

2000 DTC patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited. Doctors can treat the patients based on disease conditions. Investigators will record data which are related to study endpoints.

Primary endpoint(s):

1. Proportion of patients who underwent total/near-total thyroidectomy
2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
3. Proportion of patients who achieved serum TSH target value
4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy

Secondary endpoint(s):

1. Time to achieve serum TSH target value
2. Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
4. Proportion of excellent response/Acceptable response/Biochemical incomplete response/Structural incomplete response to initial management in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up
5. Recurrence rate after one year follow-up
6. AEs related to L-T4 (or thyroid tablet)treatment

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed as DTC (the diagnosis should base on pre-operative examinations and post-operative pathology report)
2. Patients who undergo the first-time thyroidectomy
3. Patients who are identified as intermediate-risk or high-risk of recurrence after thyroidectomy (according to the recurrence risk stratification of Chinese management guideline for patients with thyroid nodules and differentiated thyroid cancer published in 2012)
4. Patients who have Chinese nationality
5. Patients who have signed an informed consent form

Exclusion Criteria:

1. History of thyroid surgery
2. Other malignant tumors
3. Severe organ damage such as heart failure of New York Heart Association classes III-IV, liverfailure, respiratory failure, renal failure, etc.
4. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
5. Legal incapacity or limited legal capacity
6. Unwilling to be followed up
Suicide Prevention by Lithium - the Lithium Intervention Study

The purpose of this study is to examine the proposed suicide preventive effects of lithium in a randomized controlled trial within a group of individuals with depressive disorders. The hypothesis being tested is that lithium treatment will significantly reduce the risk for another suicide attempt.

Several studies have shown that there is a significantly increased risk of suicide related mortality in patients with a positive history of suicide attempts. This study is the first prospective, randomized, double-blind, placebo controlled multi-center trial focussing on the proposed suicide preventive effects of lithium in patients with suicidal behavior but not suffering from bipolar disorder or recurrent major depressive disorder. Patients with a recent history of a suicide attempt are treated with lithium or placebo during a 12 month-period. The hypothesis is that lithium treatment will lead to a 50 % reduction of suicidal behavior.

Eligibility Criteria:
Inclusion Criteria:

* suicide attempt within 3 months prior to the first drug administration
* occurrence of suicide attempt within the context of an affective spectrum disorder
* minimum age of 18 years
* ability to complete screening and baseline assessment
* ability to understand and provide informed consent

Exclusion Criteria:

* diagnosis of schizophrenia, borderline personality disorder, substance related disorders
* indication for long-term lithium treatment
* thyroid disease
* pregnancy and lactation
Effects of Antenatal Exercises on Maternal Birth Outcomes

The study is aimed to determine the effects of pelvic floor stretching Vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.

The effects of pelvic floor muscle exercises on the symptoms of postpartum urinary distress is not known, so there is a need to determine whether strengthening or stretching of pelvic floor muscles help in reducing the risk of developing urogenital distress in postpartum period of females. The positive effect of pelvic floor muscle training on duration of labor and maternal birth outcomes is understood. As stated in a systemic review of pelvic floor interventions during pregnancy. The researches done on effect of pelvic floor muscle exercises, included once a week supervised session of sustained pelvic floor muscle contractions with rest intervals and fast contractions with respective rest intervals along with daily home sessions of the same exercises.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida

Exclusion Criteria:

* Any Contraindications to performing an exercise during pregnancy based on recommendations of the American College of Obstetricians and Gynecologists (ACOG)
* females opting for Elective C section