cyrilzakka/clinical-trials huggingface dataset:
Experiential and Relaxation VR as a Tool for Easing Anxiety in Seriously Ill Children

The goal of this clinical trial is to assess the use of experiential and relaxation virtual reality (VR) interventions in easing anxiety and other distress symptoms in children with life-limiting and/or life-threatening conditions (LLC/LTC). The main questions it aims to answer are:

1. Does experiential and relaxation VR help to decrease anxiety in severely ill children?
2. What effect does it have on pain and fear?
3. Is there a difference between experiential and relaxation VR in the observed outcome measures?
4. How is the newly developed relaxation VR app BreezeTerraVR perceived by children with LLC/LTC?
5. How do caregivers of the patients perceive VR as an intervention tool for psychological distress? Researchers will compare baseline levels of outcome measures (e.g., anxiety) to post-intervention levels to determine if there is an effect.

Participants will:

* Experience both types of VR interventions-experiential and relaxation VR-for 7 to 15 minutes in two sessions (the number of days between sessions will depend on each child's medical plan), the order of interventions is psedurandomized.
* Fill out a set of short questionnaires before and after each intervention (approximately 5 minutes per phase).


Eligibility Criteria:
Inclusion Criteria:

* a) age 8-17 years, b) sufficient level of contact with the environment and ability to cooperate, c) children and parents fluent in Czech, d) diagnosis of a life-threatening or life-limiting disease according to the internationally accepted list of palliatively relevant diagnoses (Fraser et al., 2020), e) pediatric patients treated at the University Hospital in Motol

Exclusion Criteria:

* a) age below 8 or above 17 years, b) unstable health status, c) inability to speak Czech, and d) absence of parental consent for participation in the study
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 70 years old;
* Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
* ECOG (Eastern Cooperative Oncology Group) 0\~1;
* Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
* Got ICF (Informed Consent Form) before enrollment;
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Pregnant or breast-feeding women or positive serum pregnancy test;
* Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
* Participation in any investigational drug study within 4 weeks preceding treatment start;
* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
* Serious uncontrolled intercurrent infections;
* Poor compliance
Hyperuricemia and Left Ventricular Diastolic Function

Metabolic syndrome and hyperuricemia were both associated with inflammation, leading to diversities of cardiovascular disease such as left ventricular diastolic dysfunction, but the relationship among these entities remained unclear. The aim of the present study focuses on the association among hyperuricemia, diastolic dysfunction and inflammatory biomarkers in apparently healthy individuals with metabolic syndrome

Apparently healthy individuals with metabolic syndrome were prospectively and consecutively enrolled since August 2017. Blood samples were obtained after participants are fasting for at least 12 hours, including serum uric acid, high-sensitivity C-reactive protein, high-sensitivity interleukin-6, tumor necrotizing factor alpha, fasting glucose, glycosylated hemoglobin, insulin, lipid profile, creatinine, alanine aminotransferase, sodium, potassium, and calcium. All echocardiographic parameters were measured in accordance with the American Society of Echocardiography guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 to 75 years
2. Metabolic syndrome

Exclusion Criteria:

1. Left ventricular ejection fraction \<40%
2. Severe valvular heart disease
3. Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease
4. Persistent or chronic atrial fibrillation
5. Status post cardiac surgery, including coronary artery bypass surgery of valve intervention
6. Status post intra-cardiac device implantation
7. Chronic obstructive pulmonary disease
8. Severe anemia
9. An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome
Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients

This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.

This study investigates the effects of blinded lithium treatment longitudinally in patients with bipolar disorder. At baseline and at multiple time points following the initiation of lithium treatment over 4 or more weeks, measures of signal transduction pathways, gene expression and brain neurochemistry and structure were obtained. It is hypothesized that modulation of these measures will be predictive of lithium treatment responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for Bipolar Mood Disorder determined by DSM-IV (SCID)

Exclusion Criteria:

* Meeting criteria for any other DSM-IV axis I disorder
* Psychoactive substance abuse or dependence within the past 1 year
* Medical conditions placing patients at increased risk for lithium treatment (including renal disease, hepatic disease, hematological disease)
* Devices/implants or conditions which preclude MRI investigation (including cardiac pacemaker/ICD, aneurysm clips, neurostimulator device, metallic fragments in or near the eye,claustrophobia)
The Efficacy of External Warming During Laparoscopic Bariatric Surgery

External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.

The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.

The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last \<2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for bariatric surgery
* Surgery time estimated to be \< 2 hours

Exclusion Criteria:

* Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
* Surgery time estimated to be more than 2 hours
A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)

The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.

This is a retrospective, cross-sectional, and non-interventional study of participants with IBD. The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe CD or UC.

The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with management of IBD.

The study will enroll approximately 246 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Argentina. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment based on clinical or endoscopic or image criteria.

Exclusion Criteria:

1. Indeterminate or not classified colitis.
2. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

This will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed and symptomatic isolated eosinophilic esophagitis.
* Relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load \>= 20 eos/hpf in 8 biopsies at the baseline visit.
* Able to swallow placebo medication successfully under supervision in the clinic
* Free of all medications for EoE (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. A proton-pump inhibitor is allowed if required for treatment of secondary acid reflux.

Exclusion Criteria:

* Other causes of esophagitis (GERD, peptic ulceration, infection etc.)
* Other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, GERD)
* The patient's EoE is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season.
* History of abnormal gastric or duodenal eosinophilia (e.g. HES, Churg Strauss vasculitis, EG or a parasitic infection)
* Receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.
A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of otorrhea after ear-drop administration of YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.

Patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation. Screening should be completed within 7 days prior to randomization.

patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation at randomization visit will be randomized in one of the defined groups.

Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent A detailed explanation about the study, including the study purpose and procedures and drug properties, had been provided, and the patient gave voluntary written informed consent.
* Target Population Patients with otitis media presenting with otorrhea, as evidenced by otoscopy, who had tympanostomy tube insertion or tympanic perforation
* Sex and age Male or female patients 19 years of age or older at screening Women of childbearing potential (WOCBP) must have 'negative' pregnancy test at screening, and use an acceptable method of contraception throughout the study.

Exclusion Criteria:

* Excluded Disease

  1. Patients diagnosed with otitis media with cholesteatoma, otitis media with effusion or otitis externa at screening
  2. Patients who had a otologic surgery within 1 year prior to screening (except for tympanostomy tube insertion)
  3. Subjects who previously had cholesteatoma or mastoid surgery
* Medical History and Concurrent Disease

  1. Patients with complication of labyrinthine fistula at screening
  2. Patients with clinically significant medical or mental illness.
  3. Patients with infectious disease requiring the use of systemic antimicrobial therapy
* Physical and Laboratory Test Results

  a)Clinically significant finding based on the principal investigator/investigator's opinion.
* Allergies and Adverse Drug Reactions

  1. Known drug allergy (e.g., a history of anaphylaxis or hepatotoxicity)
  2. History of hypersensitivity to penicillins or -lactamase inhibitors.
  3. History of serious skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrosis
* Prohibited Therapies and/or Medication

  1. Patients undergoing a ventilation tube insertion on the day of screening
  2. Patients with ventilation tube containing silver oxide or silver salt (e.g., T-type tube)
* Reproductive status, Women only

  a)Woman of childbearing potential (WOCBP) who is unable, or unwilling to use an acceptable method of contraception during the study
* Other Exclusion Criteria

  1. History of alcohol or drug abuse/addiction within the last 1 year prior to the study entry
  2. Patient who, in the investigator's opinion, is not suitable for the study for any reason (e.g., ECG or hepatitis test results at screening)
Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model

The physical, social and psychological effects of Behcet's disease necessitate the patient's adaptation in many areas. This study was conducted to examine the effect of psychoeducation given to Behcet's patients in the context of the Roy Adaptation Model on illness adjustment, dyadic adjustment, self-esteem, and psychiatric symptoms. The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design. The study was conducted with 70 Behcet's patients including 35 interventions and 35 controls. The data of the study were collected using the "Patient Information Form", " Adaptation to Chronic Illness Scale", "Dyadic Adjustment Scale", "Rosenberg Self-Esteem Scale" and "Brief Symptom Inventory" in pre-test, post-test and follow-up measurements. A 7-session psychoeducation program was applied to the intervention group.

The research was carried out by using quantitative research methods, quasi-experimental (pre-test, post-test, follow-up, control group) research method.The study was conducted with patients followed-up in eye, dermatology and rheumatology clinics of 6 state-owned hospitals in Ankara, Turkey. The sample size of the study was calculated with the PASS (Power Analysis and Sample Size) statistical package program. It was calculated that our study could be performed with 5% error and 90% power with 35 interventions and 35 control groups, with 70 patients in total. Thus, the research was completed with 70 patients, 35 interventions and 35 control groups.The 7-session psychoeducation program prepared on the basis of the Roy Adaptation Model was applied to the intervention group once a week for 90-120 minutes. Psychoeducation was conducted in 3 groups of 10-12 people, and make-up sessions were held for those who did not attend two consecutive psychoeducation sessions or did not attend two sessions in total. The contents of the psychoeducation sessions were created by the researcher, based on the Roy Adaptation Model, by examining the relevant literature. After the ethics committee report with the permission number GO16 / 229-21 was obtained from the Non-Interventional Clinical Research Ethics Committee of Hacettepe University, the application permission was obtained from the hospitals where the study will be conducted in order to be able to apply the study. Before starting the intervention, the patients were informed about the purpose and scope of the study, and written informed consent was obtained from the patients who agreed to participate in the study. For the control group, after the necessary information was given to the patients, their written informed consent was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Married or had a partner life,
* Were 18 years old

Exclusion Criteria:

* Hearing and speech impairment
* A psychiatric diagnosis
* Neurological involvement
Magnetic Resonance Imaging (MRI ) Versus Ultrasound in Placenta Accreta Diagnosis

This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.

Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on histopathology it is divided into three grades: placenta accreta (the chorionic villi are in contact with the myometrium), placenta increta (the chorionic villi invade the myometrium), and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is steadily increasing in frequency.

Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications as it allows a preplanned treatment of the condition . Gray-scale and colour Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.

Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder ( UB ) have been detected .

The most magnetic resonance imaging characteristic findings seen in placenta accreta are nodular thickening in the dark zone of placenta-uterine interface together with extensions of dark bands through the placenta, outer uterine bulge causing from the mass effect of the placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences due to large placental lakes and vessels.

Eligibility Criteria:
Inclusion Criteria:

* Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).
* Maternal age : 20-40 years old.
* BMI : 18-29.9 kg/m2.

Exclusion Criteria:

* Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in the body, and patient's refusal for MRI evaluation.
* Haemodynamically unstable patients.
Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders

In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone

This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator 1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will provide online training on how to recognize an opioid overdose and respond using naloxone. There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and naloxone knowledge, naloxone dispensings, and overdose rates.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater prescribed chronic opioid therapy

Exclusion Criteria:

* Non-English speaking, hospice enrollment, do-not-resuscitate order, receipt of naloxone in the last 12 months, no internet access, not planning to continue to receive care in the same setting for the next 4 months.
Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it. The MC is a little known entity. These patients wish to grow for her and others. Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.

This project aims to overfed MCs and follow the control parameters of energy metabolism. We will look for abnormalities in the adaptation to overnutrition in subjects with genetic background of thinness, which could explain the resistance to weight gain. The answer could possibly help to understand obesity.

Eligibility Criteria:
Inclusion Criteria:

* consent form the study signed
* consent form for genetic study signed
* normal laboratory values for liver enzymes, glucose, lipid

Exclusion Criteria (common to the two groups):

* pregnant
* vegetarian
* heavy smoking
* heavy alcohol
* depressive
* taking hypolipidemic or antihypertensive drugs
* dyslipidemia