cyrilzakka/clinical-trials huggingface dataset:
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions

This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 35 international sites. The investigators aim to enroll 556 subjects with complex coronary bifurcation lesions in native coronary arterial segments.

All patients with complex coronary bifurcation lesions suitable for DES implantation will undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using a randomization schedule blocked by site.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography before DES implantation. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years and older;
3. Established indication for PCI according to the guidelines of ACC/AHA;
4. Native coronary lesion suitable for drug-eluting stent placement;
5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm
6. Reference vessel diameter in side branch \> 2.5mm by visual estimation;
7. Complex bifurcation lesions based on the DEFINITION study.

Exclusion Criteria:

1. Pregnancy and breast feeding mother;
2. Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
3. Scheduled surgery interrupting antiplatelet medications in the next 6 months;
4. Intolerable to DAPT;
5. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
6. Unable to provide written informed consent, or fail to follow the protocol;
7. Previous enrolment in coronary intervention device investigation during the study period;
8. Lesion cannot be covered by 2 longest stents;
9. Restenotic bifurcation lesions；
10. Severe calcification requiring rotational atherectomy;
11. Acute myocardial infarction less than 24 hours;
12. Chronic total occlusion which is not recanalized;
13. Simple bifurcation lesions;
14. Renal failure requiring or during dialysis;
15. Hemoglobin \<9g/L
16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg)
17. Severe heart failure (LVEF\<30%)
18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg, and PVR\>3.0 WU)
19. Patients with hypertrophic obstructive cardiomyopathy.
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


Eligibility Criteria:
Inclusion Criteria:

* COVID-19-positive subject
* Horowitz index ≤ 200
* Bilateral opacities on frontal chest radiograph, and
* requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
* no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
* Subject's Age ≥ 18 years

Exclusion Criteria:

* COVID-19-negative subject
* Subject's Age \< 18 years
* More than 7 days since initiation of mechanical ventilation
* Patient, surrogate or physician not committed to full intensive care support.
* Positive Pregnancy test at the time of screening.
* Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing

The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing.

This study is an observational, cross-sectional study. A representative sample of 2800 eligible women with different occupations such as farmers, service providers, workers, professional specialists, students and civil servants will be recruited. A cluster sampling method with probability proportional to the distribution of occupation in women in Beijing will be used. Demographic data will be collected by questionnaire. Menstrual bleeding will be evaluated by Pictorial Blood loss Assessment Chart (PBAC). According to the international definition of HMB, a PBAC score more than 100 is considered as HMB.

Eligibility Criteria:
Inclusion Criteria:

* Females aged between 18 and 50 years (inclusive)
* Stay in Beijing for more than 6 months
* Signed ICF was obtained

Exclusion Criteria:

* Not achieve the menarche
* With the last menstruation more than one year ago
* Experienced amenorrhea, currently take hormone therapy to induce menstruation
* Had undergone a hysterectomy
* Currently breastfeeding a baby
* Being pregnant
Non-Surgical Rhinoplasty Using PDO Threads

To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical revision rhinoplasty on first impressions and quality of life (FACE-Q scale) in 10 patients who desire further changes to their nasal tip and/or nasal dorsum


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of ages 18 and above.
2. Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

Exclusion Criteria:

1. Males and females below age of 18.
2. Subjects who have had previous surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Patients with any prior nasal implants
4. Subjects who are pregnant or nursing.
5. Subjects with a known allergy or sensitivity to any component of the study ingredients.
6. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
7. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
8. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose
9. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
Non-interventional Study With Nab-Paclitaxel (Abraxane®)

The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.

The main focus of this non-interventional study is set on answering the following questions:

* Can the results observed in controlled clinical trials regarding efficacy and safety be reproduced in the routine clinical setting?
* Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the previously described safety-profile in terms of frequency and intensity?
* What are the main reasons for modification or termination of the nab-paclitaxel therapy?
* How does nab-paclitaxel therapy influence the patients' quality of life?
* What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast cancer?

Eligibility Criteria:
Inclusion Criteria:

* Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)

Exclusion Criteria:

* Contraindication according to the summary of product characteristics of Abraxane®
* No signed patient informed consent form available
* pregnant or breastfeeding patients.
Application of Vitamin E on Anal Fissure

Patients were randomized into 2 groups:

* Vitamin E: Vitamin E ointment will be applied during 8 weeks
* Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks

Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Healing rate of chronic anal fissure was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of chronic anal fissure

Exclusion Criteria:

* patients with associated anal pathologies
* intestinal inflammation disorders
* immunosuppression
* fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
* patients with a history of headaches, heart disease, or intolerance to nitrates
* pregnant or lactating women
* patients with closed angle glaucoma
IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients

Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes

The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern the epidemic has put public health systems under severe strain both in western countries and in the developing world. SARS-CoV-2 displays a more efficient transmission pattern when compared with SARS-CoV and MERS-CoV. Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome.

IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes. It contributes to the pathogenesis of inflammatory or autoimmunity diseases. Excessive production of IL-6 leads to serious disease progression in viral infection. The IL-6 gene is located on chromosome 7 and several polymorphisms have been reported. The most frequently studied polymorphism is the single nucleotide polymorphism (SNP) 174C and - 174G in the promoter region, which has been associated with transcription rates of IL6. The incidence of IL-6-174C alleles is approximately 40%among the general Population. The G allele 174 SNP is coupled with the increased transcription upon endotoxin and IL-1β stimulation, IL-6 -174C allele carrier status is associated with higher level of IL-6 production and more severe forms of 4 pneumonia in general. This analysis strengthens the notion that IL-6 plays a pivotal role in novel coronavirus pneumonia (NCP) progression, it was IL-6-174 C allele rather than G allele that contributed to the risk of sepsis induced by Pneumonia

Eligibility Criteria:
Inclusion Criteria:

* Patients proved to be COVID-19 positive
* clinical correlation with positive PCR.
* clinical correlation with positive rapid antigen detection test.

Exclusion Criteria:

* Patients with chronic infections including hepatitis B or C infection.
* Immunodeficiency virus (HIV) infections.
* Autoimmune diseases including systemic lupus erthromatosus and rheumatoid arthritis.
* Any malignancy or chronic inflammation
* Any other chest diseases (TB)
Comparison of Between ThinSeed™ and OncoSeed™ for Permanent Prostate Brachytherapy

This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
* Greater than or equal to 40 years of age
* Low and Low- Intermediate Risk prostate cancer
* Prostate volumes by TRUS ≤ 60 cc
* I-PSS score \< 25 (alpha blockers allowed)
* Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

* Lymph node involvement (N1)
* Evidence of distant metastases (M1)
* Radical surgery for carcinoma of the prostate
* Prior pelvic radiation
* Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
* Hip prosthesis
* Inability or refusal to provide informed consent
* Evidence of Previous TURP
* Prior hormone therapy
* Prior TURP
An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \> 18 years of age
* Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria
* Treatment with RoActemra/Actemra

Exclusion Criteria:

* Participation in interventional clinical studies
Mindfulness for Burnout Prevention in Primary Care Providers

Burnout Syndrome is one of the major challenges for health systems worldwide. This study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables.

The development of stepped-care interventions allows for the development of new strategies within mindfulness-based approaches, classically described as a weekly two-hour commitment which lasts eight weeks. Such approaches might reach larger and stratified groups, more suitable for usage in Brazilian health-system context. For such evaluations, the investigators will use a 3-arms randomized clinical trial design, with Sociodemographic and Labor variables, such as age, sex, number of offspring, adherence to the program, adherence to the mindfulness practices, Burnout Clinical Subtype Questionnaire -(BCSQ-36), Maslach Burnout Inventory (MBI-GS), Mindfulness Attention Awareness Scale (MAAS), Freiburg Mindfulness Inventory adapted for Brazil (FMI-Br-13), Five-Facet Mindfulness Questionnaire (FFMQ-Br). DNA methylation will be measured by Methylase-reaction, and BDNF (brain-derived neurotrophic factor) will be quantified by ELISA-sandwich. The primary outcome will be the effectiveness of such programs on different clinical subtypes of Burnout symptoms (frenetic, under challenged and worn-out). The secondary outcome will be mindfulness levels, and adherence to the program and to the mindfulness practice, and on inflammation and epigenetic variables.

Eligibility Criteria:
Inclusion Criteria:

* Active Primary Care Providers

Exclusion Criteria:

* Acute disease (physical or mental)
* Schizophrenia or other psychotic symptoms
* Concomitant use of medication causing attentional, cognitive or concentration impairments
* Having practiced mindfulness or other contemplative techniques in the previous 12 months of the study.
Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial

Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service


Eligibility Criteria:
Inclusion Criteria:

* Successful revascularisation following STEMI
* Zwolle score \<=3
* No bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible)

Exclusion Criteria:

* Haemodynamic instability (Killip class \>I)
* Left ventricular ejection fraction \<45%\<40%
* Sustained ventricular or atrial arrhythmias requiring intervention
* No support at home or social or physical circumstances preventing early discharge
* Unable to use home monitoring equipment
* Unwilling to consent or follow instructions
* Patients visiting from out of our catchment area
* Out-of hospital cardiac arrest
* Patients repatriated to their local hospital within 24 hours
* New or worsening renal failure (i.e. creatinine \>=1.5x baseline)
Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)

In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* scheduled for elective coronary artery bypass grafting.
* preoperative estimated glomerular filtration rate (eGFR) : 30 \~ 89 %
* LVEF \< 35%
* NYHA class III or IV
* age \> 70
* DM
* reoperation

Exclusion Criteria:

* acute renal impairment
* patients who receive dialysis
* patients who receive steroid ( \> 10mg/day prednisolon or equivalent)
* hemo-alkalosis
* hypernatremia
* pulmonary edema
* Hemoglobin \< 10 mg/dL
Blood-Bile Ratio Tacrolimus After Liver Transplantation

Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2 hours), is found in the circulation bound mainly to erythrocytes and, after being metabolized by CYP3A4, is eliminated through the bile. The importance of the tacrolimus blood dosage is now widely recognized for detecting the immunosuppressive capacity reached in the individual patient or the eventual overdose of the drug. In the use of Tacrolimus after Liver Transplantation, however, it is interesting to note that the biochemical pathway for metabolism and excretion of the drug is present in the transplanted organ, the main object of immunological and functional surveillance. The excretory capacity of Tacrolimus by the liver through the bile, therefore, could be a useful tool for recognizing the early liver failure from a functional point of view, before the onset of hepatoecrosis.

Prospective monocentric randomized study comparing two parallel groups:

liver transplanted patients with early (10 POD) organ rejection (experimental arm); liver transplanted patients without early (10 POD) organ rejection (control arm) Primary Objective: Evaluation of a correlation between the reduction of Tacrolimus biliary excretion and the early liver failure Primary Endpoint: Increase of Tacrolimus blood-bile ratio measured before the onset of laboratory hepatonecrosis Secondary Objective: Analysis of the cause of any drug-related toxicity Secondary Endpoint: correlation study between drug dosage and biliary excretion level in case of blood overdose or clinical evidence of pharmacological toxicity

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* History of recent liver transplant (less than 10 days)
* Placement of kehr tube in the biliary tract during liver transplant
* Immunosuppressive therapy with Tacrolimus
* Functioning of kehr tube

Exclusion Criteria:

* Age - Age ≥18 years
* History of liver transplant for more than 10 days
* Liver transplant without positioning of kehr tube
* Immunosuppressive therapy with a drug different from Tacrolimus
* No functioning of kehr tube18 years
* History of liver transplant for more than 10 days
* Liver transplant without positioning of kehr tube
* Immunosuppressive therapy with a drug different from Tacrolimus
* No functioning of kehr tube
Inflammatory Cytokines Associated With Perinatal Brain Injury

This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

Inflammatory cytokines \[interleukin-1 (IL-1β), IL-8, IL-9, tumor necrosis factor-α (TNF-α), and RANTES\] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (PVL) and cerebral palsy (CP) in near term and term infants. However, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. Furthermore, very low birth weight infants who are at the highest risk have not been studies.

The goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. Blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. Neurodevelopmental assessments were conducted at 18-22 months corrected age.

Eligibility Criteria:
Inclusion Criteria:

* Infants 401-1,000 grams at birth

Exclusion Criteria:

* \>72 hours of age