cyrilzakka/clinical-trials huggingface dataset:
Examination of Double-Lumen Tube Placement by Functional Electrical Impedance Tomography

The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation.


Eligibility Criteria:
Inclusion Criteria:

* consent of the patient
* intubation with left- or right-sided double-lumen tube
* age \>= 18 years

Exclusion Criteria:

* refusal by the patient
* contraindications for EIT-measurement (e.g. pacemaker, pregnancy)
Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving DAPT Undergoing Dental Procedure.

This is a prospective randomized open-label blinded endpoint (PROBE) The study will be conducted in Maharaj Nakorn Chiang Mai hospital. The patients with dual-antipletlet who need dental procedure between Febuary 2017 until Febuary 2018 will be included in the study. Baseline characteristics of the enrolled patients including bleeding complication will be collected in each patient. To compare rate of significant bleeding from dental procedure between patient who need two antiplatelet and who stop P2Y12 inhibitors before procedure.

Treatment of coronary artery disease is re-open the occluded artery by many ways such as removed clot and coronary stenting. Which needed two antiplatelet after the procedure at least a month to a year. Some patient must have life long period to prevent the stent occlude and stenosis. But dental problem is commonly found in real life practice. Many people suffered from toothache and have to wait until a year, just to prevent bleeding. Physicians often be consulted with this dilemma. To continue there are some risk to bleed but discontinue antipletlet can cause recurrent myocardial ischemia. Which the highest risk factor of stent thrombosis is early stop anti platelet. Since there is no clinical practice guideline in Thailand, this study is to compare rate of dental bleeding between patient who continue two antoplatelet and who stop only P2Y12 inhibitor. The study include immediate bleeding, 24 hour and a week after procedure, follow up for major cardiovascular event such as myocardial ischemia, stroke and death. In order to create further clinical practice for this specific group.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Need DAPT
* Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling

Exclusion Criteria:

* patient with coagulopathy
* patient with Hemophilia
* patient with cirrhosis and renal pailure( BUN \> 60, Cr \> 6.0)
* patient who unable to come for medical visit in emergency condition such as severe bleeding
* patient with severe disease eg. advance stage cancer.
* patient with history of ACS less than 6 month
* patient who was be PCI wit DESless than 6 month
* patient with DAPT but planned to be CABG within a year.
* patient with anticoagulant
* patient who've got bisphosphonate within 2 years
Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects

The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children.

The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim?

Participants will

* Complete questionnaires at three timepoints
* Participate in focus group interviews

Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.

Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.

The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.

The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.

Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
* Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
* Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
* Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care

Exclusion Criteria:

* No signed informed consent form available
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices

This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.

This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Solicited reactions will be assessed for first 14 days after vaccination and unsolicited adverse events will be assessed till 84 days after vaccination. Subjects will be followed for 180 days for any SAEs.

Eligibility Criteria:
Inclusion Criteria:

* Male adults of age of 18-45 years.
* Measles immune, as determined by IgG antibody levels.
* Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters.
* Signed informed consent for participation in trial and for HIV screening.

Exclusion Criteria:

* Medical history of immunodeficiency/suppression or subject with history of close contact with immunocompromised/ immunosuppressed person.
* Chronic administration of immunosuppressants or other immune modifying agents
* Acute febrile illness or suspected measles illness or acute infectious disease
* Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives
* History of seizure disorders
* Major congenital defects
* Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction
* Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
* Known hypersensitivity to any component of the study vaccine
Effects of Remote Cardiac Ischemic Preconditioning

A heart attack occurs when blood flow is disrupted to the heart and is related to both the blockage and flow restoration (reperfusion injury). An occlusion during a heart attack can be cleared (mostly via stents), but there are no methods to decrease reperfusion injury even though animal studies have found that "preconditioning" has powerful protective effects. Through the observation of Jewish men wearing tefillin the investigators have discovered a method of bringing preconditioning to patients at risk for heart attacks. This study will focus on women as the majority of people who wear tefillin (and have been studied) are men.

Remote ischemic preconditioning (RIPC) is a process via which short bursts of ischemia result in dramatic subsequent protection in remote organs from a prolonged ischemic injury such as myocardial infarction from reperfusion injury. The translation of RIPC stimuli to clinically relevant therapies has not been successful as almost all prior research on RIPC (animal and human) involved the full blockage of blood flow to an organ or extremity (in humans commonly with full inflation cycles of a blood pressure cuff). Our laboratory's key translational insight involved the Jewish tradition of donning tefillin (phylacteries) that is traditionally worn on an almost daily basis by Jewish orthodox men on the non-dominant arm in a non-obstructive manner (NOB).

My laboratory has made substantial progress by demonstrating that tefillin induced NOB induces an RIPC phenotype in healthy (mostly) men. The overarching hypothesis of this proposal is that full arm NOB via tefillin results in a preconditioning stimulus in women that is sufficient to induce an RIPC phenotype. The sole aim will test the hypothesis that full arm NOB (in healthy females) results in an inducible RIPC phenotype that increases over time as measured via clinically relevant variables derived from heart rate variability monitoring and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Females over 18 years of age

Exclusion Criteria:

* Current medication use for medical condition or active medical condition
The Global cVAD Study

The intent of the Global cVAD Study is to utilize observational data of the ABIOMED, Inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a tool to measure and improve the quality of patient care and to serve as a resource for future research and regulatory filings.

Ongoing, observational, multicenter, records review of patients receiving the ABIOMED, Inc. hemodynamic support device(s). To collect in-hospital data, a waiver of consent and authorization will be requested to avoid significant biases in data reporting due to the extremely high mortality. To collect the post-discharge data on subjects who survive the index hospitalization, an informed consent will be obtained from those subjects or a waiver of informed consent will be used to collect data if the subject was implanted greater than a year from enrollment. Data will be collected through the review of existing medical records and subject telephone interview. Clinical follow-up as an office visit is not required for this study protocol. However, clinical follow-up and event-driven visits (e.g. re-hospitalizations) may occur as clinically warranted. At each follow-up time point, a telephone call to the subject will be attempted to obtain updated medical history and self-assessed cardiac function. In addition to the telephone call, the subject's medical records at the study site will be reviewed for cardiac-related clinic visits and/or cardiac-related re-hospitalization, including echocardiographic imaging. All data collected for this study will be reported on study specific electronic Case Report Forms (eCRFs) and entered into a controlled 21CFRPart11 compliant Electronic Data Capture (EDC) System by the designee at the participating site. Monitoring of the study data will be performed according to the study monitoring plan. Monitoring may be performed on-site or remotely and will not be conducted by anyone involved in data collection. A Clinical Events Committee (CEC) may be formed by the Sponsor. If convened, the CEC, an independent adjudication body composed of cardiologists and cardiac surgeons will adjudicate whether the site-reported adverse events and/or MACCE meet the study definitions for these events, and the relatedness of the events to the procedure and the device. A Steering Committee composed of internationally recognized investigators and experts in the field of interventional cardiology, cardiovascular surgery, cardiac electrophysiology, heart failure and mechanical circulatory support was established to provide technical and scientific oversight of the study.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects in the study population are eligible for enrollment at the time of receiving support from an ABIOMED, Inc. hemodynamic support device, or at the time of attempt to implant an ABIOMED, Inc. hemodynamic support device.

Exclusion Criteria:

1. Patients in whom an attempt to implant an ABIOMED, Inc. hemodynamic support device did not occur.
An Intervention for Eating and Body Image Concerns Among Young Adult Women

The primary aim of the current study is to assess acceptability and feasibility of online body image exposure and self-compassion interventions before conducting a larger RCT.

This study will determine the feasibility and effectiveness of delivering an online therapy for eating pathology and body image disturbance. It will address body image and eating pathology in a non-clinical group of young adult women, who are at risk of developing such problems . The feasibility study will determine whether there are any difficulties that would need to be addressed in recruitment, online delivery and assessment of those treatments.

Eligibility Criteria:
Inclusion Criteria:

* Body shape questionnaire score \> 25
* Age ≥18
* Self-identified women
* Be able to use a computer and having an Internet connection and webcam

Exclusion Criteria:

* Insufficient knowledge of English
* Learning disability, severe mental illness or alcohol/substance dependence, history of self-injuries, current eating disorder, current clinical depression
* Psychiatric illness requiring secondary care intervention
* Male
* Under 18 years old
* Body mass index below 18.5
* Currently undergoing psychological therapies
* No access to a tablet or computer with an internet connection
Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

The goal of this clinical trial is to assess whether Roxadustat can reduce perioperative blood transfusions in patients with anemia undergoing elective lumbar interbody fusion surgery. It will also evaluate the safety of Roxadustat in this context. The main questions it aims to answer are:

* Does Roxadustat reduce the need for perioperative red blood cell transfusions?
* Is Roxadustat safe for use in patients during the perioperative period?

Researchers will compare Roxadustat to standard clinical care without Roxadustat to determine its effectiveness and safety.

Participants will:

* Take Roxadustat orally three times a week for three weeks (two weeks before surgery and one week post-surgery).
* Undergo regular blood tests and follow-up monitoring during the hospital stay and up to 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, no upper age limit, sex unrestricted.
* Scheduled for elective lumbar interbody fusion surgery.
* Diagnosed with anemia (Hemoglobin levels: male \<130g/L, female \<120g/L).
* Willing to participate and able to voluntarily sign an informed consent form.

Exclusion Criteria:

* Patients admitted on an emergency basis.
* Patients with moderate to severe anemia (Hemoglobin levels \<90g/L).
* Patients already enrolled in another clinical study.
* Patients unable to comply with the study protocol due to cognitive or language barriers.
* Pregnant or breastfeeding women.
* Patients who have already received erythropoiesis-stimulating agents, iron supplements, or other treatments to increase hemoglobin levels.
* Patients with severe infections.
* Patients with a history of acute coronary syndrome, heart failure, or cerebrovascular events within the last 3 months.
* Any other medical condition that may pose a safety risk, confound efficacy or safety evaluations, or interfere with study participation.
Aripiprazole Augmentation Therapy in Treatment-resistant Depression

20 therapy-refractory patients with major depression will be treated for 3 weeks with Aripiprazole 10 mg/d. Effectivity will be assessed using a pre-post comparison of different psychopathological rating scales and patient adherence.

This will be an open pilot study using pre-post comparison. 20 treatment-refractory patients with major depression diagnosed by DSM-IV will be included. Psychotic features of depression will be excluded by a score of 2 or less in the PANSS subscales P1, P3 and P6. Treatment resistance as defined by history of non-response to two antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. If possible, treatment compliance should be confirmed by plasma level examination. After informed consent, visit 1 is performed on day 0 (inclusion criteria, history, demographics, physical examination, vital signs, HAMD, MADRS, CGI, BDI, lab). Study medication is started on day 1, the antidepressive therapy is continued at stable dose until the end of the study. Patients will receive an adjunctive augmentation therapy of 10 mg/d aripiprazole. Study visits will be performed on days 3, 7, 14 and 21 (visits 2-5: vital signs, HAMD, MADRS, CGI, BDI, lab). In addition to the HAM-D and MADRS scores, patients will perform a self-rating (BDI). Aripiprazole plasma levels will be measured at the end of the treatment period to assess compliance and to detect a putative correlation between drug plasma levels and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* major depression without psychotic features (DSM-IV definition)
* therapy resistance (two courses of antidepressants from different classes for more than 3 weeks in adequate dose)
* HAM-D score greater/equal than 17
* age 18-70

Exclusion Criteria:

* bipolar disorder
* active alcohol or illicit drug use
* female without effective contraception
* severe medical conditions
* psychotic features
Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.

Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* urge urinary incontinence or symptoms thereof
* 18 years old or older
* Compliance regarding data collection, therapy and follow-up
* written informed consent
* simultaneous performance of surgical colporrhaphy permitted

Exclusion Criteria:

* pelvic organ prolapse without symptoms of urinary urge
* age less than 18 years
* no informed consent
* lack of compliance
* adverse reaction to polypropylene
* life expectancy less than anticipated duration of protocol
* ASA 4
BIOFLOW III Satellite-ELADIS Orsiro Stent System

This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is≥18 years of age.

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
* Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint is not yet reached.
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or nor pregnant or lactating female outpatients, 18 years of age or older.
* A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

  1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
  2. Presence of one or more of the following signs:

  i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
* A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

  1. complete or partial opacification
  2. an air/fluid level

Two or more of the following:

1. fever, as defined by temperature: \>38ºC
2. leukocytosis \[White Blood Cell (WBC) \>10,000/mm3 or \>15% band forms\], ECR;
3. headache,
4. nasal congestion and post nasal drainage.

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.