cyrilzakka/clinical-trials huggingface dataset:
XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)

The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.

Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.

The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.

Eligibility Criteria:
1. Inclusion criteria

   1. Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
   2. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.

      * The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.
      * A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.
      * The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.
      * Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
      * A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.
2. Exclusion criteria

   1. If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
   2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.
3. A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.
Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,


Eligibility Criteria:
Inclusion Criteria:

1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
2. Patients must be ≥ 18，male
3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
6. ECOG PS：0-1

Exclusion Criteria:

1. Imaging or biopsy confirmed distant Metastatic lesion
2. The number of regional lymph nodes metastasis \>3
3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients

To study the efficacy of Gum Arabic as an anti-oxidant, anti-inflammatory and Fetal Hemoglobin-inducing agent among Sickle Cell Disease children. Half of participants will receive Gum Arabic and the other half will receive placebo

Polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . Fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . Gum Arabic is soluble fibers with prebiotic properties. It increased the level of serum butyrate which is short chain fatty acid. The latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. And also has strong anti-inflammatory properties. So our aim to test whether oral digestion of Gum Arabic will induce fetal hemoglobin among sickle cell pediatric patients

Eligibility Criteria:
Inclusion Criteria:

* Homozygous for Sickle Cell Disease (SS) as documented by Haemoglobin electrophoresis.

Subjects whom medications and dosages had been stable for 2 weeks before study entry.

Subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention.

Exclusion Criteria:

* Patients with history of Gum Arabic allergy. Patients who have ischemic heart disease, liver dysfunction or hepatitis. Pregnant female patients who plan to conceive in the next 4 months and fertile female patients who are not using an effective contraception method.

Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease

Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.

This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; \<6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control.

In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC.

All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age ≥18
2. Diagnosis of advanced liver disease, defined as either (must meet either a or b)

   1. cirrhosis based on (either i or ii):

      * biopsy
      * characteristic clinical, laboratory, and imaging findings
   2. acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as

      * onset of jaundice (serum bilirubin \>3.0 mg/dL) in prior 8 weeks
      * consumption of \>40 (female) or 60 (male) g alcohol/day for ≥6 months, with \<60 days abstinence before jaundice onset,
      * AST\>50 IU/L, AST/ALT\>1.5, and both values \<400 IU/L
      * liver biopsy confirmation in patients with confounding factors
3. Has at least one of the following complications due to advanced liver disease occurring during hospitalization:

   1. ascites requiring diuretics or paracentesis
   2. hepatic encephalopathy requiring lactulose or rifaximin
   3. gastrointestinal bleeding due to portal hypertension
   4. jaundice
4. Has planned discharge alive to home or a facility within 72 hours of informed consent
5. Able and willing to provide informed consent

Exclusion Criteria:

1. discharge under hospice
2. listed for liver transplant with MELD-Na ≥ 35
3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually
4. unable to speak or understand English and/or Spanish
5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
6. lack of access to a telephone
7. incarcerated
8. concurrent enrollment in an interventional research study
Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy

A randomized controlled trial (RCT), 60 HNC patients who underwent radiotherapy (RT) with or without chemotherapy represented the sample of the study. They were assigned randomly into two equal groups, control group (CG) and study group (SG). Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups CG and SG. The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.

This current study will be designed to prove the effect of photon therapy face mask on dermatitis post radiotherapy in patient with head and neck cancer. The measurements procedures will be conducted two times, before treatment application (pre-treatment) and after six weeks of treatment application (post-treatment). RTOG SCALE will be used to asset the patient before and after end of therapeutic procedures. Therapeutic intervention for the study was started at the same time for all groups of the study as following; Photon therapy will be applied from the first until the last day of RT (3×/week, 14 sessions). During the Photon therapy sessions, the whole irradiated area will be treated with 630 nm LED phototherapy. Treatment time will be 3 sessions per week for 30 min. set at 4 J/cm2 . Patients who will receive photon therapy during radiotherapy treatment within 2 weeks in addition to medical treatment and routine methods of nursing will be given during radiotherapy, including health education, skin self-care, and skin protective agent. 0.9% normal saline cotton balls will be used to gently clean the wound and remove necrotic tissue, and the wound will be dried with sterile gauze.

Eligibility Criteria:
Inclusion Criteria:

* All patients were free from any skin diseases, All patients enrolled to this study signed their informed consent,All the patients who had Nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by MRI, C.T and laboratory investigations).

Exclusion Criteria:

* patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases
TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

After being informed about the study and potential risks, all participants providing written informed consent will undergo screening to determine eligibility for study entry. On day 0, participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to receive tDCS targeting the left dorsolateral prefrontal cortex (lDLPFC), tDCS targeting the right ventrolateral prefrontal cortex (rVLPFC), or Sham stimulation (10 sessions in 2 weeks). At baseline, after 2 weeks of stimulation, and at follow-up after 1 month and 3 months, participants will be assessed for brain network function, depressive symptoms, emotional status and social interactions.

Eligibility Criteria:
Inclusion Criteria:

* 1) Be between the ages of 12-25;
* 2) is right-handed on the Edinburgh Handedness Inventory;
* 3) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
* 4) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \&lt; 24 points;
* 5) Gender is not limited;
* 6) Subjects and their families voluntarily participate and sign the informed consent form.

Exclusion Criteria:

* 1) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
* 2) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
* 3) Severe or unstable physical illness;
* 4) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
* 5) Received transcranial direct current stimulation in the past three months (continuous intervention time: \&gt;2 weeks);
* 6) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
* 7) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.
Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia

To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.

To analyze the intubation time, intubation condition, intubation process, intubation times and success rate of patients with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, the degree of respiratory improvement and survival rate of patients, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Wuhan residents;
* novel coronavirus pneumonia was found to be characterized by fever and cough. Laboratory tests revealed leukocyte or lymphocyte decrease, chest CT examination showed viral pneumonia changes, and was diagnosed as COVID-19 pneumonia according to the national health and Health Committee's new coronavirus pneumonia diagnosis and treatment plan (trial version fifth Revision).
* Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation;
* Sign informed consent.

Exclusion Criteria:

* Suspected patients with covid-19 pneumonia;
* Patients who need emergency endotracheal intubation due to other causes of respiratory failure;
* The family refused to sign the informed consent.
Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function

It is often assumed that levels of caffeine found in 'decaffeinated' beverages are below any psychopharmacological threshold. However, recent findings indicate that caffeine doses as low as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours post-administration. The study aimed to establish the lowest active dose of caffeine, and to ascertain the duration of any effects.

The majority of recent caffeine studies have evaluated doses in the range of 75 - 150 mg or 1 - 2 mg/kg (approximately 130 - 260 ml fresh coffee). Such doses produce well characterised effects; including increased 'alertness', and improvements to measures of reaction time and sustained attention. A previous study has demonstrated improvements to performance following 9 mg caffeine, which represents the lowest known psychoactive dose of caffeine. A number of these effects, including elevated salivary caffeine levels, were still apparent at 6 hours post-caffeine consumption (9). Findings showing effects of 12.5 and 9 mg caffeine are important as these are approaching the levels found in decaffeinated beverages, which are assumed to have no behavioural or physiological effects. However, despite extensive research in this area, the lower threshold for psychoactive effects has not been established. A randomised, placebo-controlled, double-blind, balanced crossover study was undertaken. 20 young men and women (13 female, mean age 20.7 years, standard deviation 2.4) undertook computerised assessments of memory and attention and rated subjective mood. Autonomic activity and salivary caffeine were co-monitored. Assessment took place at baseline, 1, 3, 6, and 9 hours post-administration of placebo, 2.5, 5, and 10 mg caffeine (on separate days) administered in 150 ml fruit juice.

Eligibility Criteria:
Inclusion Criteria:

* native English speaker

Exclusion Criteria:

* pregnancy
* medication
* anaemia
* heart disorder
* diabetes
* respiratory disorder
* epilepsy
* asthma
* panic attacks
* habitual smoking
* food allergy
Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease

Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public health problems, becoming a global epidemic. It is also known that the amount of displacement of overnight rostral fluid, from the lower limbs, is related to increased neck circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease. Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be performed before and after the hemodialysis session. Discussion: The incidence of CKD has increased, due to the increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the weight gain due to volume overload, observed in the interdialytic period, will exert a negative influence on the degree of collapsibility of the upper airways predispose to OSA in CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged 18 to 80 years;
* chronic kidney failure;
* candidate for kidney transplant with indication for dialysis;
* cognitive level sufficient for understanding the procedures and following the instructions;
* absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent.
* and agreement to participate by signing a statement of informed consent.

Exclusion Criteria:

* craniofacial abnormalities;
* undergoing active treatment of sleep apnea;
* active malignancy;
* active alcohol and/or drug abuse;
Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases

Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology.

The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis by the American College of Rheumatology (ACR) 2010 criteria or
* Diagnosis of Giant Cell Arteritis by the International League of Associations for Rheumatology (ILAR) criteria or
* Diagnosis of Still disease by classification criteria (Yamaguchi et al.) or
* Diagnosis of Idiopathic Juvenile Arthritis by ACR 1990 criteria.
* All of the previous must have been treated with anti-IL-6R monoclonal antibodies in the last 5 years

Exclusion Criteria:

* \<18 years at recruitment
* Another rheumatic disease different of the ones in the inclusion criteria