cyrilzakka/clinical-trials huggingface dataset:
Quantifying the Influence of Expert Modeling

The purpose of this study is to learn more about the effects of various types of simulation preparation methods on novice nurses' competence and self-efficacy. Participants will be recruited from an academic course (N424 Integrated Practicum). Participants will be randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint, and traditional readings). All participants will complete self-efficacy surveys and two simulations. During simulation, participants will be scored based on their competence according to a performance rubric. The hypothesis is that participants in the expert modeling group will demonstrate more change in competence and report more change in self-efficacy scores than participants in other groups.

Investigators will compare self-confidence and competence scores between the three groups after the pre-test and posttest simulations. The self-efficacy survey is an 7-item scale that involves participants rating their self-efficacy about providing care for multiple patients. Participants rate their self-efficacy on a 1 to 5 (not confident to very confident scale). The survey takes 5 minutes to complete. The self-efficacy survey has been used in many simulation research studies previously with novice nurses. Competence will be measured with a rater-observation measure which has previously been used in simulation research.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in capstone clinical course
* Oregon Consortium for Nursing Education curriculum
* Ashland, OR

Exclusion Criteria:

* No exclusion criteria
A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC
* At least one measurable lesion (RECIST criteria)
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal, hepatic and coagulation function
* Written informed consent

Exclusion Criteria:

* With uncontrollable malignant pleural effusion or ascites
* Thoracic or abdominal surgery within 28 days prior to study entry
* History of cerebral stroke or TIA within 6 months prior to study entry
* With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy
* Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> NYHA class II)
* With serious infection (\> NCI CTC grade 2)
* Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry
* Symptomatic brain metastases
* Patient who has epilepsy
* History of HIV infection or chronic hepatitis B or C
* Allergic to any of the study drugs
* Pregnant or lactating women
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes

Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with neurological disorder
* Patient with antibodies or not in sera or CSF

Exclusion Criteria:

- No available clinical data
a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease

Many studies reveal that infliximab (IFX, an immunoglobulin gamma-1 antibody)can response well to Crohn's Disease(CD) patients who are intolerant of corticosteroids and immunosuppressant,or steroids-dependent .More over,A complex fistula in CD is an indication for early IFX therapy in conjunction with surgical drainage.Some papers claim that IFX may prevent enterectomy CD patients from relapsing. Those with risk factors which at diagnosis associated with " disabling disease "include age \< 40 years, initial need for steroid therapy, and the presence of perianal disease are recommended to use IFX early.

IFX is approved by State Food And Drug Administration(SFDA) in 2007 ,but the safety is still controversial by then.Some studies proclaim that the side effect may be infections,acute infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart failure,abortion and demyelination,etc.

So some problems still need to be settled as follows:1)all the the infliximab dates are from other countries,there is rare date from the Chinese,especially the large quantity of random controlled studies and the CD patients with enterectomy.2)despite of the large number of databases from the international ,when to stop and the predictor of the response is still obscure.3)The high cost of IFX may hinder its applications,especially for the moderate to severe active CD patients who take mesalazine and/or immunosuppressant to maintain remission.In addition,the pathogenic age segments in the occurence of CD: from 15\~ 50 years old ,so they suffer from the disability of self-improvements.

The main object of the clinical trial is to complete the database of Chinese CD patients ,especially the safety and efficacy of IFX and those with enterectomy.Then we can record the clinical manifestations of the moderate to severe CD patients with the use of IFX or conventional drugs,including the dose,course and Concomitant treatment.We can also study the predictor and the appropriate time to stop using IFX .We can make the mode of cost-benefit help the patients choose the best project.


Eligibility Criteria:
Inclusion Criteria:

* CD patients excluded from other diseases who are documented diagnosed with the tissue biopsy from colonoscopy or surgery,or those without tissue biopsy are followed over 6-12months finding that the clinical changs are in line with CD.
* The moderate to severe CD patients (Best Crohn's disease activity index\>220）

Exclusion Criteria:

* Patients who are not willing to anticipate the trial
The Misoprostol Vaginal Insert for Labour Induction

Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.

Design: Non-interventional observational case control study.

Setting: Tertiary-care academic centre in Germany.

Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.

Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.


Eligibility Criteria:
Inclusion Criteria:

* gynecologist's indication for induction
* informed consent
* ≥ 37 weeks of gestation
* singleton pregnancies
* cephalic presentation
* cervical Bishop score of \< 5 before priming reassuring fetal heart rate

Exclusion Criteria:

* known hypersensitivity to prostaglandins
* uterine scar
* parity \> 5
* any contraindication for vaginal delivery
* cephalopelvic disproportion
* placenta praevia
* chorioamnionitis
* antepartum bleeding of unknown etiology
* cardiopulmonary, renal, hepatic maternal disease
* glaucoma
* fetal congenital abnormalities
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Written informed parental consent and assent will be obtained for all subjects. The PI or Co-I will administer ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), the PCSS (Post Concussion Symptom Scale), and the VOMS (Vestibular Ocular Motor Screening) to each subject during their first clinical visit. In addition to demographic variables such as age and gender, groups will be matched based on ImPACT and VOMS performance as well as the number, type, and severity of symptoms reported on the PCSS. Subjects will be assigned to receive either the currently accepted standard of care (Heart Rate Exertion group) or the newly developed exertion protocol (Dynamic Exertion Group). Participants will be matched according to PCSS total, VOMS symptom report, and by demographic variables including age and gender. The first participant will be assigned to the dynamic exertion group and the next to the standard of care group, alternating accordingly as covariates allow. The physical therapists will be responsible for administering the assigned exertion protocol to each subject across four time points (one week between each session). Follow-up data regarding recovery time (i.e., clinical return to normal activity) will also be collected. Neurocognitive testing will take place on 3-4 week intervals as is consistent with clinical practice. The current study will include a pre-exertion neurocognitive evaluation and a post-exertion protocol neurocognitive evaluation.

Eligibility Criteria:
Inclusion Criteria:

* 14-17 years of age
* Referred to exertion physical therapy within 6 weeks of sport related concussion

Exclusion Criteria:

* Family history of mood or anxiety disorder
* Diagnosis or treatment of migraine
* Diagnosed history of learning disability, ADHD (Attention Deficit Hyperactivity Disorder)
* Concussion history of 3 or more
* Other factors that would prevent subject from completing exertion protocol
ElectroNic Hydroxyurea AdhereNCE: A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease

HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU can reduce SCD related symptoms, but only 50% of patients take it as often as they should. This limits how much HU can help reduce SCD symptoms.

Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a program that uses cell phone reminder messages, videos, feedback messages, and incentives will help patients with SCD take HU as prescribed.

This is a 12-month, single-arm, cross-over study for pediatric and adolescent patients with SCD who are prescribed HU at Nationwide Children's Hospital in order to compare HU adherence prior to the study, during Mobile Dot use and after using Mobile DOT.

Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). Multiple clinical trials show that HU can reduce SCD-related complications but only 50% of pediatric patients adhere to HU at the rates achieved in clinical trials. This poor adherence limits its clinical effectiveness and results in increased costs and in lower patient-reported quality of life.

An innovative, practical, inexpensive, and efficient strategy is needed to improve HU adherence in pediatric patients with SCD. Electronic directly observed therapy (Mobile DOT) is a pilot-tested, multi-dimensional tool that is a feasible and acceptable strategy and can achieve \>90% HU adherence rates in a small cohort of pediatric patients with SCD. This study will provide further testing to confirm if Mobile DOT can improve adherence and improve clinical outcomes in patients with SCD.

Mobile DOT uses patients' smart phones and computers to provide electronic reminder alerts and to video-record patients' daily HU administrations. Patients are provided with text (SMS) messages, e-mails, and phone call communications to encourage adherence and they receive monetary incentives when they reach adherence goals.

Researchers will determine if video adherence correlates with self-report, biomarker, and refill adherence. Also, surveys will be completed by participants to determine if their self-management skills improve with Mobile DOT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sickle Cell Disease (SCD), any genotype
* Prescribed HU for at least the previous 6 months
* Plans to receive SCD-related care at Nationwide Children's Hospital for the study duration
* For participants ≥18 years: participant must have access to a smart-phone or computer capable of recording and submitting videos to Mobile DOT
* For participants \<18 years: consenting adult must have access to a smart-phone or computer capable of recording and submitting videos to Mobile DOT AND agrees to enter into a mutual agreement to participate in the daily medication administration routine
* Patient and/or consenting adult must speak English
* Access to a working phone (smart phone or landline)

Exclusion Criteria:

* Current chronic transfusion therapy or apheresis
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment

The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
* Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
* When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.

Exclusion Criteria:

* A history (past or present) of erosive esophagitis verified by endoscopy.
* The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
* Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis

The purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being.

The study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.


Eligibility Criteria:
Inclusion Criteria:

* Have physician-diagnosis of Systemic sclerosis (SSc) (any subtype)
* A score of ≥ 10 on the Perceived Deficits Questionnaire
* A score of ≤ 7 on the 6-Item Cognitive Impairment Test
* Have access to a reliable, internet-connected device (e.g. computer, smartphone, tablet)
* Visual acuity with correction sufficient to work on a computer, smartphone, tablet or screen
* Be able to read, speak, and understand English

Exclusion Criteria:

* Diagnosis of dementia or head injury
* Other neurological disorders that might impact cognition
* Have major psychiatric disorder such as major depression and schizophrenia
* Complex, unstable health issues that would preclude full participation in the study (like a planned surgery or active cancer treatment)
Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
* Laceration \<5 cm in total length
* Require simple suture laceration repair

Exclusion Criteria:

* Allergies/intolerance/contraindication to the study drugs
* Lacerations requiring complex (multilayer) repair or total laceration length\>5cm
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients

This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).

Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months


Eligibility Criteria:
Inclusion Criteria:

* First line chemotherapy for solid tumor with:
* Metastatic disease or
* Involved nodes or
* Unresectable tumor
* Indication for Implantable device for central venous access
* Potential survival \> 3 months
* ECOG performance status 0 to 2 (WHO)
* Age between 18 and 75 years.
* Social security guaranteed
* Normal laboratory assessments (platelets\> 100000/mm3, TP 60%, spontaneous TCA with M/T\<1.5, TGO and TGP \< 2xN, serum creatinin\<120µmol/l)
* Informed consent signed

Exclusion Criteria:

* Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
* Acute infectious endocarditis
* History related with heparin allergy or thrombopenia due to heparin
* Uncontrolled high blood pressure (systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg)
* Hemorrhagic syndrome ongoing
* Patient with platelet inhibitors treatment
* Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level
* Patient with liver failure (TP\<60%) or renal insufficiency (creatinin clearance\< 20 ml/mn)
* Women with pregnancy and lactating Pathology-related criteria
* deep venous thrombosis history or pulmonary embolism (\< 6 months)
* Clinical suspicious of brain metastasis
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.

OBJECTIVES:

* Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5 days (standard dose).
* Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.

Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident.

Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA.

Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL)
* Newly diagnosed HCL or progressive disease after prior treatment

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* NCI 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 2.3 mg/dL

Other:

* HIV negative
* Not pregnant
* No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since any prior therapy and recovered

Biologic therapy:

* Not specified

Chemotherapy:

* No concurrent cytoreductive therapy
* No prior cladribine

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less

Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients
* Solitary HCC ≤ 3cm
* Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
* Treatment received between Feb-2000 and Nov-2018

Exclusion Criteria:

* Pathology other than hepatocellular carcinoma (HCC)
* Receipt of prior treatment (i.e., not treatment naive)
* Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
* Platelet count \<100,000 before treatment
* Alpha-1 fetoprotein (AFP) level \> 1000 before treatment
* Age \> 70 years
* Child-Pugh score C
* Esophageal varices grade greater than 2
* Model for End-stage Liver Disease (MELD) score before treatment exceeding 15
* Presence of ascites pretreatment
* Presence of encephalopathy pretreatment
* Spleen size greater than 12 cm