cyrilzakka/clinical-trials huggingface dataset:
Inflammatory Response After One-lung Ventilation According to Ventilation Methods

Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~II

Exclusion Criteria:

* preoperative inflammation (CRP\>10ng/㎖, WBC\>10,000/mm3, body temperature \>38℃)
* steroid administration within 1 month
* hematologic / autoimmune disease
* congestive heart failure (NYHA class III\~IV) or significant arrhythmia
* severe obstructive / restrictive pulmonary disease
* previous history of thoracic surgery
* BMI \>28kg/m2
* expected difficult airway
Genetic Study of Familial Factors in Patients With Colon Cancer

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

OBJECTIVES:

* Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
* Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
* Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
* Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer or polyps at age 70 or under
* Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
* No history of familial adenomatous polyposis syndrome
* No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
* No known I1370K adenomatous polyposis of the colon susceptibility variant
* Enrolled on 1 of the following clinical trials:

  * CLB-9581
  * CLB-89803
  * CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.

PATIENT CHARACTERISTICS:

Age

* 70 and under at diagnosis

Other

* No significant psychiatric illness that would preclude giving informed consent
* No inflammatory bowel disease (in patient or sibling)
Sit Down and Play India

To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.


Eligibility Criteria:
Inclusion Criteria:

Parents/legal guardians will be eligible if they:

* Are over the age of 18 years
* Have a child between 6 and 10 weeks
* Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and
* Self-identify as the "primary caregiver.

Exclusion Criteria:

Parents/legal guardians will be ineligible if they:

* Are less than the age of 18 years
* Have a child who is not between 6 and 10 weeks or
* Have a child who is sick at the time of visit
Exercise-induced High-sensitivity Troponin Levels as a Predictor for Obstructive Coronary Artery Disease

1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients without CAD
2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)
3. To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT level in predicting CAD, either alone or in relation to traditional patient-related and exercise test-related metrics


Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected CAD, planned for diagnostic coronary angiogram
2. Patients with previous revascularization, suspected of recurrent ischemia

Exclusion Criteria:

1. Congestive cardiomyopathy with LV EF \< 35%
2. Renal failure with eGFR \< 30 ml/min
3. Known structural or severe valvular heart disease
4. Prior CABG
5. Previous ACS \< 6 weeks
6. Known incomplete revascularization after previous PCI
7. Unstable angina or ACS (defined as unstable anginal symptoms + ECG changes or hs-TnT \> 0.053 ng/L)
Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer

This clinical trial compares the use of a new screening tool designed to evaluate patients' information needs, preferences, and illness understanding to the usual care to improve illness understanding in patients with lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or for which no curative treatment is currently available (incurable). Goal concordant care is a model of care that aligns a patient's medical care with their values, preferences, and goals. Often, patients may not fully understand their illness and prognosis, but this information is important so that they can make fully informed decisions regarding their care that are consistent with their values, preferences, and goals. Completing the Information Needs, Preferences, and Understanding Trial (INPUT) screening tool may allow for more frequent and regular discussions regarding disease status and treatment goals, ultimately resulting in improved patient illness understanding and goal concordant care for patients with metastatic or incurable lung cancer.

Primary Objectives To estimate the within group effect of perception of curability over 3 months in both the systematic screening group and the usual care group among patients with metastatic or incurable lung cancer who present to the thoracic medical oncology clinic at The University of Texas MD Anderson Cancer Center.

Eligibility Criteria:
Inclusion Criteria:

* Within 3 months of biopsy-confirmed diagnosis of stage IV lung cancer
* Age 18 or over
* English speaking
* Attending a follow-up visit at the thoracic medical oncology clinic
* Plans to receive or actively undergoing cancer-directed systemic treatment at MD Anderson

Exclusion Criteria:

• Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent and sign HIPAA form
* Be willing and able to follow all instructions and attend all study visits
* Be able and willing to discontinue wearing contact lenses throughout the study period
* Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit
* Have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period
* Have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the Screening visit

Exclusion Criteria:

* • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders

  * Have any ocular condition that in the opinion of the Investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection)
  * Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
  * Use of systemic, inhaled, or nasal steroids
  * Use of new systemic antihistamine use within 30 days of Screening visit
  * Use of ocular or topical non-steroidal anti-inflammatory drugs (NSAIDs)
  * Use of lid scrubs
  * Use of decongestants
  * Use of immunotherapeutic agents
  * Use of monoamine oxidase inhibitors (MAOIs)
  * Have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of DEXTENZA
The Effect of Reading Therapy on Newborns

The primary purpose of this pilot study is to specifically examine the effect of parental reading on the ANS of mother and neonate in the hospital setting. The investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns.

Supporting infant ANS development has been implicated in their improved cardiorespiratory and neuropsychiatric outcome; furthermore, improved parasympathetic activity, a branch of ANS, is a predictor of the mother-infant relationship, and the best marker for caregiving behavior. In Feldman and Eidelman's 2003 study, they demonstrated that mother-infant skin-to-skin contact, also known as Kangaroo Care, accelerates ANS maturation in pre-term infants, which is critical for their recovery. If reading is shown to have a positive effect on mother infant ANS, hospitals will be able to incorporate this into practice as a feasible alternative for when Kangaroo Care isn't possible. The investigators hope to learn if these reading interventions will help to mitigate distress symptoms, among both mother and baby, within the hospital. The investigators will examine the association of reading therapy with the infant's crying patterns, length of stay in the hospital, weight gain, and behavior compared to before the reading was done.

Seeing that Scala's findings from 2018 is the only indication of physiologic benefits of reading to infants in the hospital, additional research is required in this particular area. The testing and application of reading therapy in the Neonatal Intensive Care Unit (NICU) would improve a high-stress environment for both parents and infants. Data collected from this project will not only add some much-needed information to the limited knowledge of the physiological effects of reading on neonates, but also demonstrate how infant outcomes can be improved in a cost-effective, efficient manner within the hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Tulane-Lakeside Hospital Newborn Nursery
* Corrected gestational age 34 weeks or older
* No identified hearing disorder
* Do not have a diagnosed developmental disability (i.e. Down Syndrome)
* Do not have Fetal Alcohol Syndrome
* Medically cleared to participate in the study
* Biological mother able/willing to give consent in English \& complete surveys.

Exclusion Criteria:

* Corrected gestational age \< 34 weeks old
* Has an identified or potential hearing disorder (i.e, failed hearing screen)
* Has diagnosed developmental disability (i.e. Down syndrome)
* Has Fetal Alcohol Syndrome
* Is not medically cleared to participate in the study
* Biological mother unable/unwilling to give consent.
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cystic Fibrosis
* To be listed for lung transplant
* Has purchased home spirometer

Exclusion Criteria:

* Diagnosis other than Cystic Fibrosis
* Unable to read
* Unable to use computer or smartphone device to access mobile application
Blood Pressure and Glucose Lowering Diet for Taiwanese

Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly prescribed with medications without comprehensive instructions on dietary therapy. DASH diet has been proven to be an effective dietary approach to reduce blood pressure for hypertension patients in US. However, dietary difference and patient profiles across countries are evident. In addition, hypertensive patients are often combined with hyperglycemia. Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and test their efficacy on both blood pressure and fasting glucose lowering.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-65 years, weight 50-80 kg(±5kg)
* Two blood pressure readings and fasting blood glucose measurements:

  1. fasting blood glucose of 100-125 ml/dL and not using antidiabetic medication.
  2. systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg and not using antihypertensive medication.

Exclusion Criteria:

* (a) taking blood glucose lowering, antihypertensive or oral steroid medications.

  (b) history of stroke, cardiovascular disease, abnormal liver function, cancer, stomach ulcer, inflammatory bowel disease or other chronic diseases that will influence the diet of participants.

  (c) Major surgery in the past year or about to undergo major surgery.

  (d) Is the holder of a major illness card.

  (e) Takes antipsychotics.

  (f) Harmful drinker (more than 14 drinks per week)

  (g) Has food allergies or food intolerance.

  (h) Pregnant or breastfeeding.

  (i) Unwilling to cease intake of vitamin or mineral supplements or antacids containing magnesium or calcium for the duration of the study.

  (j) Other medications or physiological states influencing the absorption of nutrients.

  (k) Other individuals deemed unsuitable to participate in the intervention by their treating physician.
Early Identification of Malignant Brain Edema in laRge Artery oCclusive Stroke After Endovascular Therapy (EMBRACE Study)

To design and validate a predictive model for malignant brain edema after endovascular thrombectomy.

Stroke is a significant global cause of death and disability. Endovascular thrombectomy (EVT) is currently the best treatment for acute large vessel occlusion stroke (ALVOS), as it can greatly reduce mortality and improve patient outcomes. However, only half of patients who undergo EVT achieve functional independence, and malignant brain edema (MBE), a severe complication, can occur after the procedure, leading to a poor prognosis. Previous studies have confirmed the effectiveness of early decompressive hemicraniectomy in reducing morbidity and mortality in patients with malignant brain edema. Therefore, identifying high-risk patients for MBE can help clinicians make appropriate triage and early intervention decisions, potentially saving patients' lives.

Predictive factors for post-ischemic stroke brain edema have been widely discussed, and reliable early predictive indicators have been identified, such as age, early consciousness disorders, baseline National Institutes of Health Stroke Scale (NIHSS), atrial fibrillation, hypertension, baseline blood glucose, and the level of reperfusion after EVT. Radiological factors, such as the Alberta Stroke Program Early CT Score (ASPECTS), collateral circulation rating of arteries, venous outflow status, CT perfusion core infarct volume, perfusion-based collateral status, and clot burden, are closely associated with the occurrence of MBE post-EVT. However, due to individual differences and multiple factors affecting MBE, a single factor cannot effectively predict MBE. Establishing a clinical risk prediction model can effectively identify high-risk populations for MBE at an early stage.

Eligibility Criteria:
Inclusion Criteria:

* (1)Age \> 18 years old; (2)Onset of stroke to hospital admission \< 24 hours; (3)Admission with a head CT scan ruling out hemorrhage; (4)Patients undergoing CT perfusion scan before treatment; (5)Confirmation of internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion or tandem occlusion by Digital Subtraction Angiography (DSA) and subsequent EVT; (6)complete 3-months follow-up.

Exclusion Criteria:

* (1)Poor quality of preoperative CT perfusion imaging; (2)Posterior circulation occlusion or isolated anterior cerebral artery occlusion; (3)Presence of other severe diseases such as malignant tumors, severe organ failure, or other life-threatening conditions with an expected survival period of less than 90 days; (4)Incomplete imaging and clinical data.
Treatment of Reperfusion Event by Vitamin C Infusion

Primary Hypothesis: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, assessed by measurements of cardiac biomarkers, during acute myocardial infarction.

Secondary Hypotheses: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, as measured by the area of delayed hyperenhancement that was seen on cardiac magnetic resonance imaging (MRI), assessed on day 5 after infarction, during acute myocardial infarction.

This is a multicenter, prospective, controlled, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be randomized to receive during surgical procedure an intravenous infusion of Vitamin C or Placebo.

Patients will have repeat clinical follow-up to 5 days, 3 and 6 months and 1 year.

The new angiography evaluation will be done if necessary. The study population will consist of at least 100 patients who presented within 12 hours after the onset of chest pain, who had ST-segment elevation of more than 0.1 mV in two contiguous leads, and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). Following confirmation of eligibility criteria, patients will be randomized in a 1:1 ratio to receive prophylactic infusion of Vitamin C or Placebo. The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary Angiography.

The incidence of clinical events, including death, myocardial infarction, target vessel revascularization, stent thrombosis, will be evaluated at 1, 3, 6 and, 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who presented within 12 hours after the onset of chest pain, who had ST-segment elevation of more than 0.1 mV in two contiguous leads, and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI)
* Patients will be eligible for the study whether they were undergoing primary PCI.
* Signed written informed consent

Exclusion Criteria:

* Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous acute myocardial infarction, or angina within 48 hours before infarction were not included in the study
* Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on initial coronary angiography (at the time of admission) will be excluded
* The patient has impaired renal function (creatinine \> 3.0 mg/dl)
* The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, contrast media or stainless steel that cannot be managed medically
* The patient needs therapy with warfarin
* The patient has a life expectancy less than 12 months
* Recipient of heart transplant
* The patient is currently participating in an investigational drug or another device study
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

The duration of treatment is 8 weeks.

Eligibility Criteria:
Patients with Major Depressive Disorder
The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life

The aim of this study was to examine the effect of the tele-exercise program applied to children with cystic fibrosis in the Covid-19 pandemic on the quality of life and the symptoms experienced during exercise

Cystic fibrosis is a chronic, progressive, life-shortening, genetic, complex disease that affects multiple organs and systems. The care and treatment process of cystic fibrosis disease requires a multidisciplinary approach. Regular exercise (as it is an important component of therapeutic treatment) improves respiratory function in children with cystic fibrosis. However, the treatment burden of the disease in the child and the serious respiratory system complications caused by the Covid-19 infection during the pandemic process cause patients with cystic fibrosis to be in the high risk group. Since it is thought that it is difficult for children with cystic fibrosis to exercise during the pandemic process, home exercise programs have gained importance. With the developing technology, patients are consulted remotely, training and consultancy services are provided and they can be followed continuously through phone calls and video conferences. Nurses are an important part of the multidisciplinary team responsible for the protection, development and maintenance of the health of the individual in every period of life. They have assumed the roles of educator, consultant, decision-maker, therapeutic, caregiver and researcher in order to protect the quality of life of children with exercise programs and to ensure that they lead an active life. In order for nurses to make exercise a part of the lives of children with cystic fibrosis, they should determine the knowledge level, awareness and needs of children and their families, and provide adequate and effective counseling so that they can meet their individual needs.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary to participate in the study
* Getting consent from parents
* Being a child with cystic fibrosis between the ages of 10-18
* Having no psychological health problems
* No physical problems that would prevent the child from exercising"
* Computer/ owning a smart phone and being able to use these devices and having an internet connection at home".

Exclusion Criteria:

* Not participating in the exercise regularly (at least 2 times)",
* Not wanting to continue working out".
* Not being willing to participate in the study
* Not being able to get consent from their parents
* Being under the age of 10, over the age of 18 with a diagnosis of Cystic Fibrosis
* Having a psychological health problem
* Having a physical problem that prevents the child from exercising
* Using a computer/smartphone not having and not being able to use these devices
* Not having an internet connection at home".