cyrilzakka/clinical-trials huggingface dataset:
ECMO Treatment of Children in China in the Past 10 Years

It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.

ECMO treatment in children is still in its infancy in China, and it has made considerable progress in recent years. In order to further understand the development of ECMO treatment in critically ill children, the investigator conduct this cross-sectional research through questionnaires. The investigator collect general information of the hospital and ECMO equipment, etiology, compilation, and mode of ECMO.

Eligibility Criteria:
Inclusion Criteria:

* age of 1d to 18 years old;
* children supported by ECMO in mainland China in the past 10 years

Exclusion Criteria:

* none
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
* Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

Exclusion Criteria:

* Active participation in other clinical trials.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* History of seizures or progressive neurological disease.
* Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
* Child in care.
The Effect of White Noise Sleep Mask on Patients' Sleep Quality and Comfort After Transurethral Resection of the Prostate (TUR-P) Surgery

One of the greatest challenges patients face in the postoperative period is the deterioration of sleep quality. Decreased sleep quality in the postoperative period is commonly observed due to pain, stress, anxiety, hospital environment noise, and environmental factors. Poor sleep quality can have negative effects on tissue healing, immune system activity, and overall well-being.

Transurethral prostate resection (TUR-P) is one of the most commonly performed surgical procedures for the treatment of benign prostatic hyperplasia (BPH). Patients undergoing TUR-P surgery may experience sleep problems in the postoperative period due to the use of urinary catheters, discomfort in the pelvic region, frequent urination urges, bladder spasms, and factors related to the hospital environment. Improving comfort and sleep quality during the recovery process for these patients may contribute to the improvement of their overall health status. White noise is a type of sound that contains all frequencies at equal intensity and helps mask environmental noises, allowing individuals to have a more restful sleep experience . Literature has reported positive effects of white noise, such as increasing sleep duration, reducing sleep onset time, and decreasing nighttime awakenings. Studies have shown that the use of white noise, particularly in hospital settings, improves sleep quality. For example, a study conducted in an intensive care unit reported that white noise significantly improved sleep quality by masking disruptive sounds in the hospital environment. Similarly, findings suggest that the use of white noise in the postoperative period helps patients experience deeper and uninterrupted sleep. White noise sleep masks can support the sleep process by both blocking environmental sounds and minimizing visual stimuli. Considering that factors such as lighting and noise in the hospital environment can lead to sleep disturbances, it is believed that white noise sleep masks may be effective in improving sleep quality in the postoperative period. This study aims to evaluate the effect of using a white noise sleep mask on sleep quality and comfort in patients after TUR-P surgery. The current literature on non-pharmacological approaches to improving sleep quality in patients after TUR-P is limited. Therefore, evaluating the effectiveness of white noise sleep masks is an important new intervention area that may contribute to postoperative patient care

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* No hearing and perception problems,
* No visual impairment,
* Will undergo elective TUR-P

Exclusion Criteria:

* Use of any sleep/hypnotic medication or antidepressants before or after the procedure,
* Having a psychiatric disorder.
* Urgent surgery
* Suffering from sleep apnea
Massive Transfusion Protocol With Coagulation Algorithm

In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.

Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.

In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) devices including ROTEM.

Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution over three years (2008-2010)

Eligibility Criteria:
Inclusion Criteria:

* Massive transfusion

Exclusion Criteria:

* non
Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary function: FEV1 \< 45 %, RV \> 150 %, TLC \> 100 %
* heterogeneous emphysema

Exclusion Criteria:

* homogeneous emphysema
* significant bronchiectasis
* severe concomitant diseases
* pregnancy
Pharmacokinetics and Safety Study of Apetrol ES

A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.

\[Part 1\] fasting \[Part 2\] fed

Eligibility Criteria:
Inclusion Criteria:

* Is a healty male between 20 and 55 years old.
* In a ± 20% than ideal body weight. \[ideal body weight(kg) = height(cm)-100) x 0.9 (Broca's rule)
* Subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ECG result.
* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Agrees to use an adequate means of contraception during clinical trials
* Subject who has voluntarily decided to participate in this clinical trial and consented in writing.

Exclusion Criteria:

* Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history.
* Subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect ADME of investigational medicinal products.
* In the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmHg or a diastolic blood pressure of ≥ 100 mmHg).
* Diabetic patients or the patients who are abnormal of impaired glucose tolerance.
* The patients who have a history of Arterial Embolism.
* The patients who have a history of adrenal insufficiency like hypotension or nausea or vertigo or asthenia or etc.
* Subjects who have a history of drug abuse or shown positive reaction to drugs that may be abused from a urine drug screening
* Subjects who took any specialized drug or an herbal medication within 2 weeks before the date of first administration or took any over the counter (OTC) drug within 1 week (however, they may be included as subjects if appropriate depending on the investigator's discretion)
* Subjects who had whole blood donation within 2 months or component blood donation within 1 month before the clinical trial.
* Subjects who have abnormal diets that may affect ADME of investigational medicinal products.
* Subjects who have been drinking extremely alcohol and caffeine (more than caffeine 5 cups/day, soju 3 cups/day, beer 3 cups/day, liquors 2 cups/day, 10 cigarettes/day) or can't refrain from drinking during the clinical trial period.
* Subjects who had administration a barbiturates within 1 month before the date of first drug administration
* Subjects who already participated in other clinical trials within 2 months before this clinical trial.
* Subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment
Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).

The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes for more than 6 months
* on insulin pump or multiple daily injections without plans to change modality in next 6 months
* insured by CCS or Medi-Cal
* receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
* English or Spanish-speaking

Exclusion Criteria:

* major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
* current oral glucocorticoid use
* prior use of a CGM system
* hemoglobin A1C \<7.5% or \>12%
* no wireless internet access
Designing Team Clinic for Youth with Type 2 Diabetes

The goal of this clinical trial is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes.

The main question\[s\] it aims to answer are:

* Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management.
* Design the clinical workflow for implementation phase.

Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.


Eligibility Criteria:
AYA Advisory Council Inclusion Criteria

* Age 12 to 18 at time of study enrollment
* Receives care for type 2 diabetes
* Willingness to attend all meetings
* English-speaking

Exclusion Criteria • Non-verbal or unable to participate in group activities and discussions

Caregiver Advisory Council Inclusion Criteria

* Age 18 or above
* Caregiver of AYA with type 2 diabetes
* Willingness to attend all meetings
* English- or Spanish-speaking

Exclusion Criteria

* Non-verbal or unable to participate in group activities and discussions

Stakeholder Advisory Board Inclusion Criteria

* Age 18 or above
* On staff at CHLA or UCSF
* Clinical or administrative member of the diabetes clinic
* Willingness to participate in monthly meetings. If unable to attend, willingness to review meeting minutes.

Exclusion Criteria • None

Curriculum Reviewers Inclusion Criteria

* Age 18 or above
* CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic
* Clinical members of the diabetes clinic

Exclusion Criteria

• Member of the Stakeholder Advisory Board
A Mobile Chatbot with ARCS-V Motivation Theory on Learning Motivation

This study will implement a smartphone chatbot in medical-surgical nursing education to enhance nursing students' learning motivation and academic performance. T


Eligibility Criteria:
Inclusion Criteria:

* Second-year Nursing students
* Taking an adult nursing course
* Aged 18 or older
* Willing to voluntarily participate in this study

Exclusion Criteria:

* Students auditing the course
Fractionated CO2 Laser with and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus

This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women undergoing FxCO2-laser for vulvar lichen sclerosus.

Primary objective: To evaluate if women with LS who undergo FxCO2 laser therapy and concomitant TCS (clobetasol group) have higher treatment success (defined as a MCID of a ≥16 point improvement in Skindex-29 questionnaire) than those who undergo FxCO2 laser and placebo ointment (placebo group).

* Hypothesis: A higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo.
* Approach: The proportion of women in each cohort who obtain a ≥16 point improvement in Skindex-29 validated questionnaire score from baseline to final visit will be compared.

Secondary objectives: To compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group.

* Hypothesis: Women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo.
* Approach: Change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old with biopsy confirmed or clinically diagnosed+ LS
* English-speaking or Spanish-speaking
* Electing to undergo Fractionated CO2-laser therapy
* Willing and able to undergo concomitant 0.05% clobetasol propionate treatment

Exclusion Criteria:

* Prior surgery with placement vaginal mesh for repair of pelvic organ prolapse (does not include vaginal mesh for anti-incontinence procedure "sling" or prior mesh sacrocolpopexy)
* Prior laser, topical immunomodulators or systemic therapy for LS
* Active genital infection\^
* Suspicious vulvar lesion that has not been evaluated
* Known vulvar or vaginal malignancy or active treatment for other malignancy
* Planning pregnancy or pregnant
* Prior pelvic radiation therapy
* Topical corticosteroid use on the vulvovaginal tissues in the past 2 weeks\*
* Contraindication or allergy to clobetasol propionate 0.05%
* Currently breast-feeding or lactating
* History of poor wound healing, keloids or hypertrophic scarring
* History of a skin condition that could interfere with evaluation of efficacy and safety

  * Eligible for inclusion after washout period of 2 weeks \^Eligible for inclusion after treatment. For patients with known genital HSV we will instruct them to remain on suppression for the duration of the study.
Endometrial Scratching for Cryopreserved Embryo Transfer

Endometrial injury performed in a cycle preceding the one for embryo transfer is associated with an increased implantation and pregnancy rate when carried out during the month preceding that of ovulation induction and fresh embryo transfer. However, there is no evidence about the effect of this intervention on the transfer of cryopreserved embryos.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* At least one cryopreserved embryo

Exclusion Criteria:

* None
Cognitive Bias Modification for Youth Anxiety

Research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. Attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there have been minimal published studies of attention modification in youths with clinical levels of anxiety.

This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit of this low-cost, computerized attention modification intervention (Cognitive Bias Modification (CBM) computer application) for anxiety disorders and symptomatology in youth ages 12 to 17. This trial conducted will compare three intervention arms, all of which include underlying treatment as usual (TAU). The investigators directly test the level of clinical support ("scaffolding") needed to adequately deliver self-administered CBM to anxious youth, a finding that will be key to preparing for future deployment-focused trials. The investigators will compare an attention control version of the CBM program (Arm 1) to two active versions of the CBM intervention that have varying levels of patient clinical support: a self-administered CBM program that participants download and install on their home computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an adherence promotion (AP) component delivered via brief telephone calls from study "coaches," including as needed, brief motivational enhancement and/or technical assistance (Self-Administered CBM+AP; Arm 3).

The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety symptoms and functioning. The investigators will also complete a cost-effectiveness analysis to examine potential costs offset by this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Youth age between 12.0 and 17.9 years old
* Youth, parent able to complete assessments in English
* Youth performing at 7th-12th grade achievement level
* Youth vision sufficient to read book of typical size print
* Youth access to home computer, Internet for 3 months
* Assessment of Childhood Disorders (ADIS)-confirmed diagnosis of generalized anxiety disorder (GAD) and/or social phobia (SOP) and/or separation anxiety disorder (SAD)

Exclusion Criteria:

* Youth diagnosis of learning or processing problem
* Youth diagnosis of attention deficit hyperactivity disorder (ADHD), except if symptoms are stable and controlled by medication for \> 1 mo.
* Youth diagnosis of psychotic disorder
* Youth primary complaint of condition other than anxiety (as determined by the research interviewer during the baseline survey)
* psychotic features or delayed inform/visual processing
Perioperative Care and Short-term Outcomes of Colorectal Surgery in Addis Abeba

Observational cohort study of adult patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months.

Observational prospective cohort study, including all adult (≥18) patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months. Variables are patients' characteristics, risk factors, investigations, types of operations, level of training of surgeon, and postoperative management. The data collection is conducted at admission, day of surgery, and discharge. The primary outcomes are in-hospital complications and length of stay, and the secondary outcomes are perioperative management.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Willingness and ability to give informed consent
* Admitted to the surgical department at TASH (elective or in an emergency) and operated for a colorectal condition

Exclusion Criteria:

-Emergency conditions usually managed in general surgery, e.g., perianal conditions and adhesive small bowel obstruction
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer

This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
* Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
* If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
* Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
* Non-smoker, or smokes fewer than 10 cigarettes/day

Key Exclusion Criteria

* Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
* Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
* Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
* Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration