cyrilzakka/clinical-trials huggingface dataset:
Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study

The purpose of this study was to assess the predictive value of the incremental shuttle walk test on rates of hospital acquired pneumonia for patients undergoing oesophagectomy.

Field tests to objectively measure functional capacity are becoming of greater importance when looking to assess an individual's fitness for surgery. One such field test is the incremental shuttle walk test (ISWT). An externally paced, maximal excursion test, the ISWT is a simple and easily reproducible test that is widely used within cardiac and pulmonary populations and shown to correlate well with Vo2 mas on a cardiopulmonary exercise test. Previous studies looking at the benefit of the ISWT in predicting post-operative outcomes within the oesophagastric population have demonstrated that walking less than 350 meters has been associated with significantly higher rates of mortality at 30 days and 3 years. No correlation between ISWT and postoperative respiratory complications in this surgical population has been previously reported.

This study aims to assess whether walking \<350 meters on an ISWT predicts the development of hospital acquired pneumonias following an elective oesophagectomy

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a diagnosis of oesophagogastric cancer listed for an elective oesophagectomy at a large UK tertiary hospital

Exclusion Criteria:

* Patients who were unable to complete the walking test
* patients deemed not fit for surgery
* patients with a significant neurological event peri or post operatively
Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.

Patients with pulmonary hypertension (PH) complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pulmonary fibrosis and an advanced PH phenotype.

Eligibility Criteria:
Inclusion Criteria:

Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented on standard of care right-heart catheterization (RHC) and planned to receive therapy with treprostinil as recommended by the treating physician.

1. All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (UIP).
2. Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mPAP) \> 35 mm Hg; AND pulmonary vascular resistance (PVR) \> 3 woods-units; AND pulmonary capillary wedge pressure (PCWP) \< 18 mm Hg by right-heart catheterization (RHC) performed as part of standard of care evaluation.
3. All subjects must be planned to receive treprostinil therapy as recommended by their treating physician.

Exclusion Criteria:

1. Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6MWT).
2. Six-minute walk distance (6MWD) \< 50 meters at screening or baseline standard of care evaluations
3. Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio \< 0.65
4. Standard of care pulmonary function test (PFT) showing a residual volume \>120% predicted
5. Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent \> 30%
6. Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
7. Change in dose of treatment for IPF - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents, within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
8. Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
9. Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
10. Pulmonary rehabilitation initiated within 30 days of baseline.
Early Enteral Nutrition for Severe Acute Pancreatitis

There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are inconclusive. The researchers of this study aim to investigate the impact of early enteral nutrition on the clinical outcomes of SAP patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe acute pancreatitis
* Consent informed

Exclusion Criteria:

* Diabetes mellitus
* Allergy for any ingredient of PN or EN regimen
* Pregnancy
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support

To determine if an asthma navigator is helpful in improving communication between care providers and improving patient adherence to asthma medications after an asthma exacerbation.

This study will aim to use technology to evaluate the effectiveness of a patient navigator for childhood asthma. The Investigators will place adherence monitoring devices on patient inhalers, and track use of patient asthma medicines. The Investigators will also utilize an asthma navigator who will discuss adherence with families and help to address any barriers to adherence that families identify. Additionally, the navigator will communicate patient specific adherence information to the patient's primary care physician (PCP) and school nurse. The adherence monitor will monitor communications between these providers.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years old,
* Admission to Children's Hospital Colorado with an asthma exacerbation between Jan 1 2017 and Dec 31 2017.

Exclusion Criteria:

* Language other than English or Spanish (application for monitoring adherence is only available in these languages)
* Presence of other complex medical problems including:

  * Cystic Fibrosis,
  * Tracheostomy/ventilator dependence,
  * other severe chronic lung disease, and
  * significant developmental delays.
* Home schooled or not in school
* Following up with an allergy or pulmonary provider outside the CHCO system after hospital discharge.
Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement

This study will test if applying calcium silicate cements (Biodentine) to restore cervical carious lesions might adversely affect the gingival health in comparison with conventionally used tooth colored material (GIC)

The study will compare two different dental materials on dental lesions near the gum line. . The study will determine if one material is more effective in gingival health, after the placement of the two different dental materials.The oral hygiene and the gingival health of the restored teeth will be evaluated clinically at 1, 3 and 6-month intervals.

Eligibility Criteria:
Inclusion Criteria:

1. good general health;
2. good oral hygiene; and
3. age range 18-60 years old.

Patients with the following criteria were excluded:

1. current smokers;
2. pregnant females;
3. or patient with periodontal diseases; and
4. those who had a history of poorly controlled diabetes, liver disease, malignancy, radiotherapy.

Exclusion Criteria:

1. Pregnant women
2. Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
3. Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
4. Complicated medical history (\>4 concurrent treatment for systemic diseases)
5. Lesion \>1mm below the gum line
Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada

The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada
* Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP

Exclusion Criteria:

* Aged \<18 years
* Did not receive concurrent chemoradiotherapy prior to surgery
* Positive margins following resection
* No residual disease following complete resection
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea

This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.

This prospective, single-arm single center study will provide clinical data for the Neuwave Medical Microwave Ablation System and accessories.

Individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled.

The enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis.

The subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation
2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only;
3. Scheduled for microwave ablation of the liver;
4. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
5. Functional hepatic reserve based on the Child-Pugh score (Class A or B);
6. American Society of Anesthesiologists (ASA) score \< 3;
7. Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule;
8. At least 19 years of age

Exclusion Criteria:

1. Active bacterial infection or fungal infection;
2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure;
3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure;
4. Subject with implantable pacemakers or other electronic implants;
5. Planned/ scheduled liver surgery.
6. Subject with a platelet count of less than 20,000/mm3;
7. Subject with an INR greater than 1.5;
8. Subject with renal failure on renal dialysis;
9. Scheduled concurrent procedure other than microwave ablation in the liver;
10. Pregnant or lactating;
11. Physical or psychological condition which would impair study participation;
12. Participation in any other clinical study concurrently or within the last 3 months;
13. The subject is judged unsuitable for study participation by the Investigator for any other reason;
14. Unable or unwilling to attend follow-up visits and examinations.
Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.

In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.

The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40 and 60 years old.
* With Child score B or C
* Presented for elective gastrointestinal endoscopy

Exclusion Criteria:

* Emergent condition like hematemesis.
* Patients with moderate to severe hepatic encephalopathy.
* Patients with hepatopulmonary syndrome.
* Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 years or older.
* Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
* One diseased parathyroid gland, visualized by ultrasonography.
* The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
* Normal pretreatment nasofibroscopy.
* Voluntary signed informed consent.

Exclusion Criteria:

* Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:

  * Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
  * Targeted area located less than 3 mm laterally from the trachea,
  * Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
* Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
* Known spondylitis of the neck vertebrae
* Head and/or neck disease that prevents hyperextension of neck.
* Known history of parathyroid or other neoplasias in the neck region.
* History of neck irradiation
* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
* Pregnant or lactating woman.
* Female patient of childbearing age if not having a suitable contraception method.
* Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.
A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria
* Peripheral blast count \< 10%
* Requires therapy for MF in the opinion of the investigator
* Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive weeks and experienced treatment interruption because of lossof response or adverse event
* Patients adhering to the Screening phase assessments and undergoing a a ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks
* ECOG performance status 0, 1, 2, or 3
* Adequate bone marrow function
* Written informed consent

Exclusion Criteria:

* Patients not initially responding (primary resistance) to ruxolitinib therapy
* Patients who underwent a splenectomy or spleen radiation
* Patients currently scheduled for bone marrow transplant
* Patients who have discontinued ruxolitinib \< 14 days prior to screening
* Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose
* Leukemic transformation
* Inadequate renal function
* Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy
* Previous history of Progressive Multifocal Leuko-encephalopathy (PML)
* Clinically significant cardiac disease or significant concurrent medical condition
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction complicated by cardiongenic shock
* Patients on mechanical ventilation at time of randomization

Exclusion Criteria:

* Out of hospital resuscitation with indication for mild hypothermia
* mechanical complications after acute myocardial infarction
* duration of cardiogenic shock \> 12 hours
* age \> 90 years
2024 Tirzepatide-Bariatric Surgery

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.

The major objectives are:

1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery.

Participants will:

Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.

Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.

Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.


Eligibility Criteria:
Inclusion Criteria:

* adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy
* BMI greater than or equal to 45 kg/m2 with one or more obesity-related comorbidities
* have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
* have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy
* enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Exclusion Criteria:

* any contraindication to the use of tirzepatide (per package insert)
* Personal or family history of medullary thyroid carcinoma
* Patients with Multiple Endocrine Neoplasm syndrome type 2
* Hypersensitivity to tirzepatide
* History of pancreatitis
* Type 1 Diabetes
* patients with active, untreated or symptomatic cholelithiasis or jaundice
* current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days
* a history of prior metabolic and bariatric surgery
* diagnosed autoimmune disease
* current use of immunosuppressive agents or use within the past 30 days
* moderate or severe substance use disorder according to DSM-5 criteria
* uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
* female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
* a prisoner
Deep Learning Radiomics Model for Predicting Post-cystectomy Outcome in Muscle Invasive Bladder Cancer

Muscle invasive bladder cancer (MIBC) has a poor prognosis even after radical cystectomy. Postoperative survival stratification based on radiomics and deep learning may be useful for treatment decisions to improve prognosis. This study was aimed to develop and validate a deep learning radiomics model based on preoperative enhanced CT to predict postoperative survival in MIBC.


Eligibility Criteria:
Inclusion Criteria:

* patients with pathologically confirmed MIBC after radical cystectomy;
* contrast-CT scan less than two weeks before surgery;
* complete CT image data and clinical data.

Exclusion Criteria:

* patients who received neoadjuvant therapy;
* non-urothelial carcinoma;
* poor quality of CT images;
* incomplete clinical and follow-up data.