cyrilzakka/clinical-trials huggingface dataset:
Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis

Despite high mortality and morbidity, the best treatment strategies for prosthetic valve thrombosis (PVT) have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different thrombolytic strategies.Transesophageal echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between 1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA) (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital mortality and non-fatal complication rates.

One hundred and eighty two consecutive in-hospital patients with 220 episodes of PVT between 1993 and 2009 were included in the study. The patients were enrolled after informed consent if there was no contraindication, to thrombolysis. The study was approved by the local Ethics Board. The patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, NYHA functional capacity, leading symptoms and international normalization ratio (INR) values at the time of admission were prospectively entered into a database.The diagnosis of PVT was verified each time by transesophageal echocardiography (TEE) when a patient was admitted with thromboembolism or persistently low INR for the preceding consecutive 3 months and when a transthoracic echocardiography (TTE) documented prosthetic valve dysfunction or thrombus. All patients underwent TTE and TEE examination before and after the thrombolysis sessions. The cross sectional area and the longest diameter of the thrombus were measured on TEE recordings

Eligibility Criteria:
Inclusion Criteria:

* Patients with prosthetic valve thrombosis

Exclusion Criteria:

* Large left atrial thrombus
* Recent (\<3 weeks) ischemic stroke
* Hemorrhagic stroke
* Early (\<4 days) postoperative period
* Traumatic accident \<4 weeks
* Bleeding diathesis †
* İntracranial mass
* Active internal bleed
* Aortic dissection
A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma

The purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac PET scan results (in patients receiving radiation therapy). This is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Stage I-III, HER2-neu positive invasive ductal carcinoma
2. Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
3. Scheduled to receive adjuvant Trastuzumab
4. ECOG Performance status 0-2
5. Adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. Additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac PET scans.

Exclusion Criteria:

1. Prior anthracycline chemotherapy
2. History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
3. Life expectancy less than 15 months
4. Pregnant or lactating women
5. Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
6. Previous chest wall/breast or nodal radiation.
Accuracy of Intraoral Photogrammetry Scanner in Complete Arch Digital Implant Impression

Intra oral scanning can perform a full digital workflow right on the patient's mouth. Recently an intra-oral photogrammetry scanner has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.

Intraoral scanning had several advantages to intraoral direct scanning, including less storage and transportation needs, faster scanning times, and increased patient comfort. The intraoral scan bodies are used as digital fixture locators when using IOSs for implant impressions.

Photogrammetry is the science and technology of obtaining reliable information about physical objects through the process of recording, measuring, and interpreting photographic images and patterns of electromagnetic radiant imagery. The utilization of photogrammetry in the dental field leads to exclusion of intraoral dental and gingival anatomies while scanning the implant coordinates. In addition, no need for stitching during full arch implant scanning which is reflected in the trueness and precision of the scanned object. Exclusion of unstable mucosa during scanning and avoidance of stitching make the passive seating of implant prosthesis a more predictable procedure especially when compared with intra-oral scanning only.

Up to this moment, all photogrammetry systems available in the market are considered extraoral systems that require an additional impression for soft tissue capture whether conventional or digital. Recently an intra-oral photogrammetry scanner (IPS) has been introduced in the market that can make intra-oral tissue scanning in addition to a built-in photogrammetry technology so that it can capture fixture locations through special intra-oral scan flags.

Eligibility Criteria:
Inclusion Criteria:

* participants had received 4-6 implants in 1 edentulous arch.
* Participants had received 1-piece implant-supported complete-arch fixed dental prostheses.

Exclusion Criteria:

* Systemic conditions as diabetes.
* Osteoporosis patients.
* Immunocompromised patients.
Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants

This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant capacity of the body.The healthy volunteers will receive wet cupping application and their initial venous blood samples and samples after the treatment will be evaluated for oxidative stress.

Among the healthy individuals who applied for Wet Cupping Therapy (WCT) to Traditional and Complementary Therapies center in Karabuk Medical Faculty Education and Research Hospital for general wellbeing 24 volunteers were enrolled in the study. They will receive three concecutive WCT application in one month interval.Their venous blood samples obtained initially and after the completion of the three concecutive applications, will be evaluted in terms of Reactive Oxygen species and Antioxidant capacity.Additionally samples from the cupping blood during the first and the third WCT application will also be obtained and evaluated.

Eligibility Criteria:
Inclusion Criteria:

Healthy male adults

Must apply Traditional and complemantary medicine center for general well being.

Exclusion Criteria:

Any chronic disorder

Antiagregant drug usage

Bleeding disorders

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Translating Evidence Based Developmental Screening Into Pediatric Primary Care

The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.

The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age. The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.

Eligibility Criteria:
Inclusion Criteria:

1. Age birth to 30 months of age by the start of the intervention phase.
2. Child's Primary Care Physician has consented to participate in the study
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Premature Infants (less than 36 weeks of gestation)
2. Children with prior identified developmental delay.
3. Children with major congenital anomalies/genetic disorders
4. Children placed in foster care
Prospective Urban Rural Epidemiology Study

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

1. To examine the relationship between societal influences and prevalence of risk factors and chronic noncommunicable diseases. Societal determinants are measured by an index of measures from each of the 4 domains of interest: built environment, food and nutrition policy, psychosocial/socioeconomic factors, and tobacco.
2. To examine the relationship between societal determinants and incidence of chronic noncommunicable disease events (e.g. cardiovascular disease, cancer) and on changes in rates of selected risk factors (e.g. smoking)
3. To examine the relationship between health related behaviors (e.g. diet, physical activity, smoking, alcohol) and health outcomes (e.g. death, non-communicable diseases)
4. The quality of health systems across a diverse range of health resource settings, and how this impacts health outcomes
5. Genetic factors for non-communicable diseases

Eligibility Criteria:
Inclusion Criteria:

* consenting adults between 35-70 years of age

Exclusion Criteria:

* none
Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome

Thoracic outlet syndrome (TOS) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. The diagnostic approach of TOS is still controversial. The investigating team is interested in arterial TOS and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (TcpO2). The correlation between the measurement of TcpO2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. The evaluation the correlation between TcpO2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. The use of TcpO2 could be developed in the diagnosis assessment of TOS.


Eligibility Criteria:
Inclusion Criteria:

* patient suspected of having a thoracic outlet syndrome
* patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial Doppler or dynamic arteriography and venography
* patient having carried out a dynamic TcpO2 recording

Exclusion Criteria:

* patient under 18 year old
* non french speaker
* patient who expressed his/her refusal
Patients with Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention

Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response

The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
* Age \> 18 years
* ECOG performance status \<_ 2
* Signature of informed consent (to participate in the study and data processing)

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous head and neck cancer
Intervention Trial to Increase Meaning in Work and Reduce Burnout

Collegiality is a one of the great virtues of physician-hood. Mutual support from colleagues to help deal with the challenges of being a physician has long helped physicians manage the stress related to practicing medicine and helped physicians derive meaning from their work. Unfortunately, increased productivity expectations and other changes to the practice of medicine over the last several decades have decreased the time physicians have to interact with colleagues and eroded the fabric of collegiality. Recent studies suggest burnout affects nearly half of U.S. physicians at any given point in time and has substantial personal and professional consequences. The steps organizations can take to promote collegiality are unknown. The goal of the present study is to evaluate the ability of an organizational intervention to encourage collegiality, shared experience, connectedness, and mutual support. This study builds on two prior intervention studies directed by the Mayo Clinic Department of Medicine Program on Physician Well-Being, the first focusing on a small group facilitated well-being curriculum and the second focusing on individual electronic tasks to prompt positive reflection and gratitude.


Eligibility Criteria:
Inclusion Criteria:

* Senior Associate Consultants and Consultants in the Mayo Clinic Department of Medicine will be eligible for this study.

Exclusion Criteria:

* None beyond inclusion criteria.
Influence of the COVId-19 Pandemic on STRESS and Eating Habits

The Coronavirus has caused containment of more than a third of the world's population. Containment can drastically change lifestyle habits, including eating habits such as the number of meals, meal times or their composition. However, there is currently no data on the influence of confinement on eating habits.

This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made.

The self-administered questionnaire will assess stress, changes in eating habits, and relationships with socio-demographic or lifestyle factors.

This questionnaire includes 9 specific questions on nutrition and 40 general questions.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers who are screened

Exclusion Criteria:

* none
Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study

Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length \>1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.

Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult.

Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus.

The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation.

This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer patients between the age of 19\~79, who require anus preserving laparoscopic rectum resection surgery

Exclusion Criteria:

* Advanced rectal cancer that invades surrounding structures or has known distant metastasis
* Uncontrolled comorbidities
* Patients otherwise considered unsuitable for the study
Dose Optimization by Pharmacokinetic/Pharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital

The patients who infected with Carbapenem resistant Klebsiella pneumoniae were high mortality rate. Appropriate antibiotics therapy adjusted by Pharmacokinetic/Pharmacodynamic plays an important role in determining outcomes in Critically ill patients. Consequently, standard antibiotics dose may not be adequate to achieve pharmacokinetic/pharmacodynamic target in Critically ill patients. The purpose of this study is to compare the clinical outcomes between the critically ill patients who received antibiotics dose adjusted by pharmacokinetic/pharmacodynamic using Monte Carlo simulation and historical critically ill patients who received antibiotics from standard practice.


Eligibility Criteria:
Inclusion Criteria:

1. 20 years and older who admitted at Phramongkutklao Hospital
2. Patients who was diagnosed blood stream infection with CRKP between April 10th, 2023 to March 31st, 2024 (Prospective study) and January 1st, 2012 to March 31st, 2023 (Retrospective study); Historical group
3. Patients who had signs and symptoms at least 1 criteria following:

   3.1. Patients who had signs and symptoms of Systemic Inflammatory Response Syndrome (SIRS) at least 2 criteria:
   * Temperature above 38 oC or below 36 oC
   * Heart rate more than 90 beats/min
   * Respiratory rate more than 20 /min or PaCO2 less than 32 mmHg (4.3 kPa)
   * White blood cell more than 12,000 cell/mm3 or less than 4,000 cell/mm3 3.2. Patients who was diagnosed sepsis or SOFA score or qSOFA score at least 2 score 3.3. Patients who was diagnosed septic shock or who had hypotension with adequate fluid and need for vasopressor to maintain mean arterial pressure over 65 mmHg and serum lactate above 2 mmol/L
4. Patients who received antibiotics at least 48 hours which are as follow:

   * Ceftazidime-Avibactam or
   * Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline- Gentamicin, Tigecycline-Meropenem or Tigecycline-Colistin)

Exclusion Criteria:

1. Patients who were pregnancy or breastfeeding
2. Patients who had drug allergy (eg. Ceftazidime-Avibactam, Tigecycline, Amikacin, Gentamicin, Imipenem, Meropenem or Colistin)
3. Patients who not to received resuscitation.
4. Patients who were end stage cancer.
Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* 2 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
* Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. Six months or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
* Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
* ALT \< 2xULN; alkaline phosphatase and bilirubin \<= 1.5xULN
* Average of 3TNSS is \>= 3.0 in the last consecutive 4 days prior to Visit 2.
* Completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to Visit 2

Exclusion Criteria:

* Has a seasonal pollen as an allergen
* A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
* Bacterial or viral infection of upper respiratory tract or eye
* Concurrent disease/abnormalities: Clinically significant uncontrolled disease
* Known hypersensitivity to corticosteroids or any excipients in the investigational product
* Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
* Use of the following medication and/or its combination drug within the specified time:

Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1

* Affiliation with Investigator's Site: Relative or employee
* History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
* Bacterial or viral infection of upper respiratory tract or eye during the screening period.