cyrilzakka/clinical-trials huggingface dataset:
Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial

The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics


Eligibility Criteria:
Inclusion Criteria:

* Child between 4 years old (inclusive) and 10 years old (inclusive);
* Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
* Benefiting from a social security scheme;
* Whose parental authority has consented to participation in the research;
* Not having expressed their refusal to participate in the research;
* Understanding French;
* Ability to access the application being researched.

Exclusion Criteria:

* Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
* Poor understanding of oral French by the child;
* Poor understanding of the oral and/or written French language by the parent/legal representative;
* Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
* Patient with severe psychiatric disorders
Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass

During cardiopulmonary bypass (CPB) after heart surgery, a child's blood is exposed to many foreign entities. These conditions trigger the body's inflammatory response which results in leaky capillaries, increased swelling and possibly organ dysfunction. Since the early 1990's, modified ultrafiltration (MUF) has been shown to decrease excess swelling, reduce bleeding, improve heart function, and decrease hospital length of stay. Angiopoietins are a family of proteins necessary for both normal and abnormal blood vessel formation. They also appear to play a role in capillary leak. Though MUF has been shown to improve clinical outcome following CPB, there continues to be conflicting reports whether this is a result of the filtration of inflammatory proteins or simply from excess fluid removal. Since angiopoietins appear to play a role in both inflammation and capillary leak, the investigators hypothesize that the benefit seen after MUF is also secondary to its ability to filter out these proteins, especially angiopoietin-2.

During cardiopulmonary bypass (CPB) for corrective or palliative congenital heart surgery, a child's blood is subjected to hemodilution, hypothermia, nonpulsatile blood flow and exposure to foreign and non-endothelialized surfaces. These non-physiologic conditions trigger the host's innate systemic inflammatory response which results in capillary leak, increased total body water and can lead to end organ dysfunction. Since the early 1990's, modified ultrafiltration (MUF) has been shown to decrease excess tissue edema, reduce postoperative bleeding, improve cardiac contractility, maintain hemodynamic stability, and decrease hospital length of stay. Angiopoietins are a family of vascular growth factors necessary for both normal and abnormal blood vessel formation and appear to play a role in capillary leak. Though MUF has been shown to improve clinical outcome following CPB, there continues to be conflicting reports whether this is a result of the filtration of inflammatory cytokines or simply excess fluid removal. Since angiopoietins appear to play a role in both inflammation and capillary leak, the investigators aim to determine whether MUF's clinical benefit is also secondary to its ability to filter out these molecules, more specifically angiopoietin-2.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with congenital heart disease undergoing surgical intervention requiring cardiopulmonary bypass and modified ultrafiltration.

Exclusion Criteria:

* Any patients with congenital heart disease who will not require modified ultrafiltration.
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury

The purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (TBI).

This is a pilot study to examine how subjects with TBI feel about the virtual reality program as a treatment and to assess the effectiveness of the virtual reality program at increasing subjects' awareness and understanding of emotions.

Eligibility Criteria:
Inclusion Criteria:

* TBI (injury due to an external physical force);
* Moderate to severe TBI, defined either by74 Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes);
* ≥1 year post-injury;
* between 18-65 years old;
* Have a moderate to high alexithymia score (≥52) on the TAS-2070 at screening.

Exclusion criteria:

* Diagnosed with pre-morbid neurological disorders (e.g. stroke, autism, alzheimer's disease, Parkinson's disease);
* Formerly diagnosed with a developmental disability;
* Pre-morbid diagnosis of major psychiatric disorders (e.g. schizophrenia);
* Unable to follow directions;
* Uncorrected visual or hearing impairments that would prevent sufficient task participation;
* No access to reliable transportation.
Does Skyla Insertion Timing Impact Bleeding?

Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45
* Parous or nulliparous
* Desire Skyla for contraception
* Regular menstrual cycles (21-35 days)
* Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days

Exclusion Criteria:

* Vaginal or cesarean delivery in the past 12 weeks
* Abortion in the past 6 weeks
* Uterine anomaly distorting the uterus
* Acute pelvic inflammatory disease
* Uterine bleeding of unknown etiology
* Acute liver disease or tumor
* History of progestin-sensitive cancer
* Abnormal pap smear awaiting diagnostic or therapeutic intervention
Building Financial Wellness Randomized Controlled Trial

This study tests a psychosocial intervention to improve financial literacy and behaviors among adults with mental illnesses.

This study is designed to test the effectiveness of a financial education curriculum, called Building Financial Wellness (BFW), in promoting financial literacy and reducing economic strain among adults with a mental health condition. The design involves random assignment of adults who are receiving mental health services to the intervention plus services as usual, versus services as usual alone. Assessments at baseline, two months post-baseline, and three months later collect data to test the null hypotheses of no difference between intervention and control conditions on outcome measures in the following domains using longitudinal mixed-effects random regression analyses: 1) financial well-being; 2) financial strain; 3) financial capability; 4) financial self-sufficiency; and 5) financial literacy.

Eligibility Criteria:
Inclusion Criteria:

* age 18+
* access to computer, tablet or smart phone and an internet connection suitable for using Zoom
* receiving services and/or supports for a diagnosed mental health disorder
* ability to understand spoken English
* interest in learning money management skills.

Exclusion Criteria:

* Cognitive impairment preventing informed consent
* Unable to communicate in English
Gastric Bypass With Different Lengths of the Bilipancreatic Limb

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. However, more than 25% of patients do not obtain the expected result.

There is no uniform technique to perform a LRYGB, but traditionally it was constructed using a long alimentary limb (AL) and a short biliopancreatic limb (BPL). There is no current consensus on the ideal length of the LRYGB limbs.

The distal gastric bypass at the expense of a longer biliopancreatic limb (LBPL-GB) could induce more excess of weight loss (EWL%), but with possible protein malnutrition depending on the length of the remaining common limb.

The aim of this study is compare a LBPL-GB (BPL 150cm, AL 70cm) with LAL-GB (BPL 70cm, AL 150cm).

PRIMARY OUTCOME: to evaluate if there are differences in weight loss. SECONDARY OUTCOME: to assess whether there are differences in both groups in remission of the most common comorbidities and in quality of life.

DESIGN: multicenter, prospective, randomized study in blocks (1:1), blinded for the patient and to the surgeon up to the time of intervention, in patients with indication of RYGB for obesity (BMI\>35 with associated comorbidity or BMI\>40 with or without comorbidity, excluding those of BMI\>50). Intervention: LRYGB type 1 (LAL-GB: 150cm ALand 70cm BPL) or type 2 (LBPL-GB: 70cm AL and 150cm BPL).

The expected result is that the patients with LBPL-GB present better EWL%, and higher remission of their comorbidities than the comparison group


Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI 35-40 kg/m2 with associated medical problems (Diabetes Mellitus, Hipertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome) or 40-50 kg/m2 with or without associated medical problems, who comply with the regulatory rules for bariatric surgery in Spain (SECO and AEC)

Exclusion Criteria:

* General contraindications to kind of surgery
* BMI \> 50 kg/m2
* Known drug or alcohol abuse
* ASA (American Society of Anesthesiology) physical status classification \> III
* Inability to follow the procedures of the study
Effect of Methotrexate on Inflammatory Response in Adult Atopic Dermatitis Patients

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate can be used to treat refractory disease to conventional therapy.

It will be conducted a single arm trial with twelve adult patients with moderate to severe AD on methotrexate for 24 weeks.

Investigators intend to evaluate the effect methotrexate on cytokines and chemokines involved in the inflammatory response, on IgE levels, on pruritus, and on EASI and SCORAD severity scores.

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate (MTX) can be used to treat refractory disease to conventional therapy, but there are few studies showing its effect on the profile of cytokines involved in the inflammatory response.

Objectives: To assess the effect of MTX on the cytokines involved in the inflammatory response of adult AD patients treated with methotrexate for 24 weeks. As specific objectives, investigators intend to assess the evolution of serum IgE levels, the EASI (Eczema Area and Severity Index) and SCORAD (Scoring Atopic Dermatitis) severity scores and pruritus in them.

Methods: It will be conducted an open, prospective study with twelve adult patients with moderate to severe AD on MTX for 24 weeks. Each participant is expected to attend 7 visits during 6 months of follow-up. In clinical healthy and injured skin, two assessments will be performed: 1) mRNA expression of IL-4, IL-10, IL-17A, IL-22, IL-31, oncostatin M receptor (OSMR), alpha subunit IL-31 (IL-31RA) receptor, TNF-α, IFN-γ, TSLP, TARC and MDC by Real Time-PCR at the initial week and week 24; 2) expression of IL-31, IL-31RA, OSMR, TSLP and Ki67 by immunohistochemistry at the initial week and week 24.

Skin samples from non-atopic subjects will be utilized as controls for the assays, paired by gender and age.

Additional analysis of serum levels of IgE (nephelometric method) at the initial week and week 24 of the study will be performed.

AD severity scores (EASI and SCORAD) will be tested and pruritus will be analyzed by a visual analog scale at the initial, week 12 and week 24.

Eligibility Criteria:
Inclusion Criteria:

* AD (Hanifin and Rajka criteria) moderate to severe (EASI ≥ 7.1 and SCORAD ≥ 25);
* Age ≥ 18 years;
* Women without the potential to become pregnant or using an effective method of contraception and with a negative pregnancy blood test;
* Men without a desire of pregnancy and who use condom in sexual intercourse.

Exclusion Criteria:

* Hepatic and / or renal insufficiency;
* Anemia, thrombocytopenia and / or leukopenia;
* Use of concomitant hepatotoxic drug;
* Active infection;
* Allergy to MTX;
* Excessive alcohol intake;
* Difficulty to understand how to take methotrexate;
* HIV infection or other immunosuppression condition;
* Therapy with UVA or UVB, corticoid, cyclosporine, immunobiological, azathioprine within 12 weeks prior to introduction of methotrexate.
Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Vascular ED for at least 6 months
* International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
* Positive response to PDE5-I (able to penetrate on demand=Responders)
* Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage = Non-responders)
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Hormonal, neurological or psychological pathology
* Past radical prostatectomy or extensive pelvic surgery
* Recovering from cancer during last 5 years
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Past radiotherapy treatment of the pelvic region
* International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)
E-cigarettes as a Harm Reduction Strategy

E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.

Between 84-94% of individuals with opioid use disorder (OUD) smoke cigarettes, a rate six times higher than the general US adult population. Despite the majority of smokers with OUD expressing motivation to quit, cessation rates remain extremely low, even with evidence-based medications. E-cigarettes have emerged as a harm reduction strategy for smokers unable or unwilling to quit. Research on the effectiveness of e-cigarettes for smoking reduction among individuals with OUD on buprenorphine/methadone maintenance treatment is scarce but promising. This study is an open-label single-arm clinical trial testing the use of e-cigarettes as a harm reduction strategy among smokers with OUD on buprenorphine in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥21)
* Report smoking ≥ 5 cigarettes per day for ≥ one year
* Interested in switching to e-cigarettes (self-reported)
* OUD diagnosis (DSM-V)(chart review)
* Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review)
* Plan to remain on buprenorphine for at least 3 months (duration of the study) (self-reported)
* Have a smartphone with internet access

Exclusion Criteria:

* Use of other tobacco or nicotine products other than cigarettes (≥9 days in the past 30)
* Used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression) (self-reported) (3)
* Having a severe medical condition, including decompensated cirrhosis, severe cardiovascular
* disease (myocardial infarction, percutaneous transluminal coronary angioplasty, unstable angina, coronary artery bypass graft, and/or serious arrhythmia in the
* prior 6 months) (chart review)
* Having severe asthma or chronic obstructive pulmonary disease requiring supplemental oxygen or hospitalization in the past 6 months (chart review)
* Being hospitalized for human immunodeficiency virus/acquired immunodeficiency syndromes-related illness in the past 6 months (chart
* review)
* Having a history of seizure disorder (chart review)
* Pregnancy (chart review) or breast-feeding (self-reported) for female participants
* Having current DSM-V criteria for mania, psychosis, or major depressive disorder (chart review)
* Current suicidal ideation or past year suicide attempt (PHQ-9; see protections against risk)
* Being hospitalized for psychiatric reasons in the past year (chart review)
* Being unable to independently read and/or comprehend the consent form or other study materials (unable to read study materials aloud)
* Being unable to read/speak English (inability to read and complete study materials)
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma

The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.

The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
* No prior systemic chemotherapy with taxane at least 6 months before the recruitment;
* At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Patients who are expected to live at least 3 months;
* Obtaining informed consent;

Exclusion Criteria:

* Receiving other chemotherapy or radiotherapy during the administration;
* Symptomatic metastatic brain tumor;
* Allergy to any study medication;
* Pregnancy or breast feeding;
* Severe heart diseases;
* Uncontrolled mental diseases;
* Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;
* Neutrophils（ANC）\<2000/μL;platelets\<100，000/μL;hemoglobin（HB）\<9.0 g/dL;
Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes

To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing.

To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing

Eligibility Criteria:
Inclusion Criteria:Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation

* Non-operative Cohort: Patients who underwent non-operative management of closed extra-articular metacarpal fractures at both the University of Colorado and Denver Health Medical Center will also be reviewed.

Exclusion Criteria: Open metacarpal fractures (defined as any fracture associated with a laceration or break in skin continuity near the fracture site)

* Patients with previous history of metacarpal nonunion or malunion corrections on the affected digit
* Metacarpal fractures with intraarticular extension
MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women

Objective :

To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.

Methods :

Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the emergency Physician or gynaecologist after a non contributive ultrasonography will be included.

After obtaining informed consent, all patients will undergo standard CT followed by an additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.

The gold standard or reference diagnosis will be established in consensus by an expert panel at 3 months follow up using a standardized diagnosis form.

A retrospective reading will be performed independently for CT and MRI by radiologists blinded to the reference diagnosis, using the same standardized diagnosis form.

CT and MRI accuracies will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-40 years old
* Women referred to CT following a non contributive ultrasonography
* Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)
* Women with informed consent
* Women with affiliation to health insurance

Exclusion Criteria:

* Women who underwent abdominopelvic surgery in the previous month
* Suspicion of vital emergency such as shock preventing any delayed management caused by MRI examination
* Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign bodies with risk of mobilization during MRI examination
* Women yet included in the study or included in another study
* Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
* Women unable to undergo informed consent (vulnerable or protected by law)