cyrilzakka/clinical-trials huggingface dataset:
A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC
* Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib.
* Any number of prior chemotherapy regimens is permitted.
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* KPS \>/= 70%
* Age \>18 years old
* Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of \> 10 unstained slides)
* Left ventricular Ejection Fraction \>/= the lower limit of normal by ECHO or MUGA
* Adequate organ function:
* AST, ALT \</= 2.5 x ULN
* Total bilirubin \</= 1.5 x ULN
* Albumin\>/=2.6g/dL - Creatinine \< 1.5 x ULN OR calculated creatinine clearance \>/=50mL/min
* Absolute neutrophil count (ANC) \>/= 1,200 cells/mm3
* Hemoglobin\>/=9.0 g/dL
* Platelets \>/=100,000/mm3

Exclusion Criteria:

* Patients with symptomatic brain metastasis requiring escalating doses of steroids
* Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
* Pregnant or lactating women
* Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI
* Patients who have received prior treatment with a MEK inhibitor
* Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol.
* A history of clinically significant interstitial lung disease or pneumonitis
* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval \>480msec, treatment refractory hypertension, presence of a cardiac defibrillator
* History of central serous retinopathy or retinal vein occlusion
Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations

ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.

Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p \<0.05).


Eligibility Criteria:
Inclusion Criteria:

* Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
* teeth in need of restoration to be first or second molars or permanent premolars;
* at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
* the antagonist and adjacent tooth in contact;
* pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
* no history of hypersensitivity in the teeth to be restored;
* permanent dentition;
* good oral health and absence of periodontal disease;
* patients not to have suffered from systemic diseases or allergies;
* absence of deleterious habits, xerostomia, and bruxism.

Exclusion Criteria:

* Fewer than 20 teeth;
* history of existing tooth sensitivity;
* known allergy to resin-based materials or any of the other materials used in this study;
* pregnancy or breastfeeding;
* chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
* non-vital teeth;
* abutment teeth for fixed or removable prostheses.
Measure of Frailty in Perioperative Setting

Though most physicians believe they can identify frail patients, frailty is a poorly characterized and complex clinical syndrome. Frailty has been categorized four dimensions by de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood); and, 4) social (social contact and support). 1 However, the pathophysiology of frailty remains unclear. Two broad hypotheses have been proposed.

Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation and additive effect of multiple deficits, which occur across various domains. The more deficits a person has, the more likely that person is to be frail. Frailty in this paradigm is thus measured by identifying the number of positive factors/ deficits from a list. This is used to create a proportional index of deficits, expressed as the ratio of deficits present to the total number of deficits considered.

Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to correlate well with patient outcomes after surgery.

Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she identified various clinical features that define frailty as a clinical syndrome. This criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion, slowness, and low physical activity level. The Fried index is the most commonly used phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during preoperative visits. Measurement of these factors in a perioperative setting was further characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS).

Currently, there exists no gold standard for assessment of frailty, especially in the perioperative setting. In the absence of a well-accepted gold standard, a measurement of frailty which would predict adverse postoperative outcomes would be useful. However, no study has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery.

All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic main campus will be included in the this prospective observational cohort study. Frailty would be evaluated prospectively using HFS and components of MFI will be obtained from Cleveland Clinic Perioperative Health Documentation System registry (PHDS).


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18-100 years of age)
* patients presenting to the PACE clinic for non cardiac surgery

Exclusion Criteria:

* children (under 18 years of age)
* patients presenting to the PACE clinic for cardiac surgery
The Effects of Synaquell on Brain Function

The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.

Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater.
* Fluent English speakers.
* Medically cleared to play ice hockey.

Exclusion Criteria:

* An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
* Clinically documented hearing issues.
* In-ear hearing aid or cochlear implant.
* Implanted pacemaker or defibrillator.
* Metal or plastic implants in skull.
* Lack of verbal fluency in the English language.
* History of seizures.
* Allergy to rubbing alcohol or EEG gel.
* Unhealthy scalp.
The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)

The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen.

Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma. Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying this, a large randomized trial comparing survival in patients with primary breast DLBCL is required. However, the rarity of primary breast DLBCL makes large trial virtually difficult in single center or study group. Additionally, retrospective studies for evaluating the role of rituximab in primary breast DLBCL had bias according to the difference of treatment period between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival and patterns of progression in patients with primary breast DLBCL, the investigators performed this matched pair analysis following strict matching criteria in patients with primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma Working Party, treated with R-CHOP regimen.

Eligibility Criteria:
Inclusion Criteria:

* Stage I or II of primary breast DLBCL treated with R-CHOP
* Stage I or II of nodal DLBCL treated with R-CHOP

Definition of primary breast DLBCL - Isolated breast involvement with or without nodal disease, which include distant nodal disease as well as regional nodal disease

Definition of nodal DLBCL

- The disease was only limited to the lymph nodes or lymphoid organs

Exclusion Criteria:

* Primary breast DLBCL or nodal DLBCL treated without rituximab
* Secondary breast DLBCL
* Recurrent DLBCL
* Stage III or IV of nodal DLBCL with extranodal involvement as a dissemination process
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.

Recurrent and/or metastatic HNSCC patients will be treated with combination of metformin and pembrolizumab. Patients will be randomized into arms 1 and 2, to either receive Metformin prior to pembrolizumab or to begin Metformin after pembrolizumab treatment begins. The patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent or metastatic non-cutaneous HNSCC for which there are no surgical or radiation curative options.
* Patients may have received up to 3 prior lines of therapy for metastatic or recurrent disease.
* ECOG performance status ≤2

Exclusion Criteria:

* Patients with nasopharyngeal HNSCC will be excluded
* Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study.
* Patients who have not recovered from adverse events due to prior anti-cancer therapy
* Patients who have previously received PD-1 or PD-L1 inhibitors for metastatic/recurrent disease
* Patients currently receiving metformin or who have received metformin in the last 6 months
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls

Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls


Eligibility Criteria:
Inclusion criteria:

1. T2DM patients and healthy controls aged =18 to \<70 at Visit 1.
2. Patients diagnosed with T2DM according to the American Diabetes Association criteria prior to informed consent who are drug-naïve
3. T2DM patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study.
4. T2DM patients with HbA1c between \>7 and \<10.0% (\>53 mmol/mol and \<86 mmol/mol) at Visit

Exclusion criteria:

1. Patients with type 1 diabetes mellitus.
2. Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast.
3. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 3; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease (history of claudication), or pulmonary disease as determined by investigator.
4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?

Not significantly increased survival in T/T


Eligibility Criteria:
Inclusion Criteria:

* NSCLC with spinal metastasis

Exclusion Criteria:

* brain metastasis and expected survival \< 3 months
Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.

Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation.
* Symptom duration of less than 14 days

Exclusion Criteria:

* \>14 days of symptoms
* confirmed bacterial infection
* Hospital acquired infection (\>3days in hospital)
Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

Anthroposophic therapeutic speech is a complementary method that indirectly influences breathing and uses specific vowels, consonants, syllables and metres depending on the indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic speech in patients with asthma regarding clinical and physiological parameters, asthma control and quality of life.

Background

Breathing retraining techniques receive increased attention in the management of asthma, since the evidence for safety and usefulness of such procedures is growing. Physiotherapist-guided breathing programs, such as the Papworth method and the Buteyko method, are most systematically investigated and hence yield the best evidence of effectiveness.

Active breathing modulation techniques are frequently assigned to complementary and alternative medicine CAM, comprising of a variety of systems and modalities other than the politically dominant healthcare system.

However, patients may take a different perspective, since the prevalence of CAM use in the treatment of asthma is at a level of 20-30% among adults and 50 - 60% for children, even if rigorous estimates are being applied.

Anthroposophic therapeutic speech applies sounds and syllabic rhythm, e.g. the hexameter, for improving articulation, breathing and cardiorespiratory interaction. The method has been used for many years as a breathing retraining method for asthma in all settings. This study is the first to systematically investigate the effects of ATS in asthma patients in a real-life outpatient setting.

Objective

The following hypotheses are tested: i) anthroposophic therapeutic speech improves relevant parameters of pulmonary function in patients with asthma. ii) anthroposophic therapeutic speech reduces the use of as-needed medication in patients with asthma. iii) anthroposophic therapeutic speech improves asthma control and quality of life in patients with asthma.

Methods

The study is a randomised, controlled, multicentre, 2-period cross-over clinical trial conducted at 3 centres in Switzerland and Germany. Participants are randomly assigned in a 1:1 allocation ratio to either firstly receive 11 speech therapy sessions or to wait (control), followed by a cross-over to the other group.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 12 years
* Asthma ≥ 1 year
* Inhaling β2 agonist ≥ once weekly

Exclusion Criteria

* Not willing to perform therapy actively
* Insufficient general condition for active therapy
* COPD
* Coronary heart disease
* Oral corticosteroids
* Pregnancy
Robotic Bariatric Database (RBD) Collaborative

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality.

To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Eligible for or have undergone robotic bariatric surgery per the treating physician
* Undergone robotic bariatric surgery between January 2018 and December 2019

Exclusion Criteria:

* Do not meet the Study Inclusion Criteria l
Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock

The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic instability, systemic inflammatory response syndrome and multiorgan failure has been extensively investigated, but there is no consensus on the trigger mechanisms of tissue injury at the molecular level.

Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are unable to act at the "beginning of the cascade", because of the lack of a model explaining the molecular basis of shock induced tissue injury and ensuing organ damage.

The present observational study is aimed at identifying the molecular triggers of acute heart failure (HF) induced by shock and to identify inflammatory mediators and markers that are activated in shock, with a particular emphasis on the role of uncontrolled proteolytic activity.


Eligibility Criteria:
Inclusion Criteria:

* For patients in septic shock, Severity: SOFA score \> 5
* For patients in cardiogenic shock, Severity: SOFA score \> 5
* First blood sample available within 16 hours from admission to the ICU.
* Only community medical acquired septic shock. We include patients with shock symptoms and shock diagnosis occurring within the first 48 hours from hospital admission
* Informed Consent available

Exclusion Criteria:

* Risk of rapidly fatal illness and death within 24 hours
* Patients already enrolled in other interventional studies
* N \> 4 units of red blood cells transfused
* Patients treated with plasma or whole blood
* Active hematological malignancy
* Metastatic cancer
* Immunodepression, including transplant patients: HIV+, constitutive immune system deficiency, immunosuppressive therapy, systemic corticosteroids (aerosols allowed)
* Patients with pre-existing end stage renal disease needing renal replacement therapy (RRT). The introduction of continuous veno-venous hemofiltration (CVVH), from the day of admission onward is allowed.
* Cardiac surgery patients
* Cirrhosis Child C
Early Support in Primary Care for People Starting Treatment for Cancer

This is a feasibility, randomised controlled trial (RCT) of a person-centred care planning intervention involving patients recently diagnosed with a poor prognosis cancer who are starting a palliative oncology treatment in a Scottish regional cancer centre.

This study will evaluate the feasibility and acceptability of an early 'palliative care' intervention consisting of anticipatory care planning coordinated in primary care that is systematically triggered when patients with poor prognosis gastrointestinal cancers start palliative oncology treatment.

Patients will be identified and invited to participate during their assessment and treatment planning by the cancer care clinicians. A screening log will record eligible cases. Patients who consent will be randomised to receive a letter about the benefits of early anticipatory care planning to take to their preferred general practitioner to help trigger earlier support by their primary care team. Control patients receive usual care. All study patients will be asked to complete 3 questionnaires (EuroQol EQ-5D-5L (full title of tool), ICECAP Supportive Care Measure (full title of tool), and CollaboRATE (full title of tool) for shared decision-making) at baseline, 6, 12, 24 and 48 weeks. A purposive sub-sample of patients, family carer and general practitioner (GP) triads will be invited for interview at around 6 and 20 weeks to explore their experiences of trial participation, their illness and care. Health service use will be recorded including hospital admissions, oncology treatment, palliative care referral, time and place of death or survivorship.

Eligibility Criteria:
Inclusion Criteria:

* People with advanced, inoperable oesophageal, gastric or pancreatic cancers
* People being offered palliative chemotherapy and/or radiotherapy

Exclusion Criteria:

* People too ill to participate or give informed consent.
* Patient who are not fit for oncology treatment or who opt for best supportive care.
* People with other life-limiting conditions likely to cause death within 6 months.
* People with moderate to severe cognitive impairment that precludes completions of questionnaires or participation in interviews.
* People unable to give informed consent or communicate by telephone with the researcher.