cyrilzakka/clinical-trials huggingface dataset:
Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* exclusion from resection-anastomosis surgery after multidisciplinary evaluation,
* Cotton Meyer \> grade II,
* follow-up of at least 3 years after endoscopic surgery,
* no previous tracheal surgery.

Exclusion Criteria:

* age \> 80,
* stent intolerance which requires removal in the first year after endoscopic treatment,
* performance status \> 2,
* end-stage chronic pulmonary disease,
* life-threatening stenosis that needs urgent endoscopic treatments,
* any neoplastic stenosis of the airways,
* dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).
A Study of 18F-AV-45 in Healthy Volunteers

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.


Eligibility Criteria:
Inclusion Criteria:

* Able to lie still on the imaging table for periods up to 1 hour

Exclusion Criteria:

* Radiation exposure for experimental purposes within the last year
* Claustrophobic or otherwise unable to tolerate the imaging procedure
* Medical condition or surgical history that would confound evaluation
* Current clinically significant cardiovascular disease
* Received an investigational medication within the last 30 days
Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

This open label, single centre, proof of concept pilot imaging trial will evaluate technique for the diagnosis of invasive Aspergillus infection. It aims to demonstrate uptake of the gallium-siderophore tracer at sites of known proven/probable invasive aspergillus app infection. It will also assess the safety and tolerability of this technique.

10 patients within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis will be recruited to this study over a period of 12-24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided written informed consent
2. Aged 18 years or older at written informed consent
3. Within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis as per EORTC criteria
4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter
5. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up

Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Iron infusion within one week prior to scan
Study of Tumor RNA Disruption Assay™ (RDA)

The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management.

When administering neoadjuvant chemotherapy, the current practice of monitoring response to treatment is by measuring the size of the breast tumor after each cycle of chemotherapy. The drawback to this method is, it will take several weeks before we can actually measure a significant change in size; and the initial response to chemotherapy is often evident as a softening of the tumor without an apparent decrease of the tumor size. Finding a reliable way to identify early response to chemotherapy would be helpful to enable matching of chemotherapy to an individual's need.

In a previous trial of breast cancer treated with neoadjuvant chemotherapy, researchers have identified that the pCR to a full treatment of chemotherapy could be predicted by the change in RNA pattern obtained from a biopsy of the tumor half way through the chemotherapy course. \[Parissenti et al. 2010\] The purpose of this study is to determine if we can predict the pCR to neoadjuvant chemotherapy by examining the pattern of RNA disruption (RNA Disruption Assay or RDA score) from breast biopsy tissue obtained 7 to 14 days after the first, second and third cycle of chemotherapy. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management. For example, if RDA score can identify non-responders earlier, we can switch to other chemotherapy agents and reduce the exposure to the unnecessary side-effects of ineffective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female,18 years or older;
* Able to read and write in English:
* With palpable cancer \> 2cm (T2, T3) on clinical examination or clinical diagnosis of locally advanced breast cancer (LABC) (T3 or T4; or N2 or N3, according to TNM cancer staging including inflammatory breast cancer);
* Must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
* Scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
* Agree to have FNAB after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional FNAB after the first cycle of the new chemotherapy.

Exclusion Criteria:

* Subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
* Subjects who are pregnant or breast feeding;
* Subjects with Stage IV breast cancer;
* Psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section

HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for cesarean section will be affected by the genetics of the woman's mu-opioid receptor

Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most receive a dose of preservative free morphine with the spinal anesthetic. Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.

The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at the 40th amino acid of the protein, with asparagine and asparate being present in different people. The less common variant (aspartate), present in 25-30% of the overall American population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in many studies to affect opioid analgesia.

This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150 micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other genes that may affect pain and analgesic responses. The primary outcome will be the amount of intravenous morphine patients self-administer in the 24 hours postsurgery.

The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.

It is anticipated that there will be an interim data analysis at 150 evaluable subjects for assessment of the dose response to morphine in the overall population; then a final analysis at 300 subjects for the genetic effect assessment.


Eligibility Criteria:
Inclusion Criteria:

* healthy women undergoing elective cesarean

Exclusion Criteria:

* cardiovascular disease
* analgesic medications
* complications of pregnancy
Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER

The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).

Acute exacerbation of COPD (AECOPD)are usual and frequent cause of admission in emergency room (ER). No validated clinical or biological predictor of evolution are available.

The main objective is to determine the prognosis value of Mr proADM in addition to the clinical risk stratification for AE COPD patients in ER.

Patients presenting with a AECOPD diagnosis in ER will have a blood sample collected and freezed at their admission. Mr proADM will be assessed at the end of the study. Clinicians in charge of patients will not have the result during the management of their patients. This study implies no change in the patients' management.

Data related to the patients'demographic,current exacerbation and basic COPD characteristics will be collected.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 40 years old
* Acute exacerbation of COPD

Exclusion Criteria:

* Medico social conditions not allowing home discharge
* Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer
* Pneumonia on chest ray
* acute respiratory distress requiring immediate ICU transfer
Burn Micronutrient Repletion Pilot Study

Burn injury patients undergo a series of metabolic changes that, if untreated, could lead to reduced health outcomes. Nutrition is thought to play a vital role in post-burn recovery. The research team developed a novel vitamin and mineral supplementation protocol based on current scientific literature. The study will test the hypothesis that the novel vitamin and mineral supplement regimen will improve adult patient recovery from burn injury.

Burn injury patients undergo a series of metabolic events that, if untreated, could lead to severe physical impairment and even death. Antioxidants minimize free radical damage by neutralizing the chemical reaction as well as promoting cellular repair. Currently there is no consistent protocol for micronutrient repletion in adult burn patients. The aim of this study is to evaluate the effectiveness of the current vitamin regimen in comparison to the novel vitamin and mineral supplementation protocol developed by the research team. Dosages for oral and intravenous supplementation are based on current literature. The combination of intravenous and enteral treatment is important due to gastrointestinal mucosal swelling related to post-burn fluid resuscitation. Measurable health outcomes will include rate of infection, length of hospital stay, mortality rate, hospital cost, number of days in intensive care unit, number of ventilator-dependent days and wound healing. The investigators hypothesize that use of the novel vitamin and mineral supplement regimen will improve adult burn patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* patients who present at the burn unit with TBSA \> 1%

Exclusion Criteria:

* less than 19 years old
* chronic renal failure
* chronic liver failure
* pregnancy or lactation
* patients who require parenteral nutrition
Cilostazol and Endothelial Progenitor Cell

To assess impact of adjunctive cilostazol on endothelial progenitor cell (EPC) mobilization in patients with acute myocardial infarction (To reveal the role of cilostazol in up-regulation of EPC count)

Primary endpoint: % Change of EPC count

Secondary endpoints:

1. Changes of ADP/AA/collagen-induced PFT
2. Changes of lipid profile and high sensitivity-C-reactive protein
3. Change of TEG measurements
4. Change of PWV
5. Predictors of EPC count (baseline and 1-month)
6. ischemic (CV death, MI \& stroke) and bleeding events (BARC)

Eligibility Criteria:
Inclusion Criteria:

* naïve AMI
* undergoing successful coronary stent implantation

Exclusion Criteria:

* high-risk patients for thrombotic event;
* a history of active bleeding or bleeding diatheses;
* contraindication to antiplatelet therapy;
* hemodynamic or electrical instability;
* oral anticoagulation therapy;
* left ventricular ejection fraction \< 30%;
* leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3;
* AST or ALT \> 3 times the respective the upper limit;
* serum creatinine level \> 3.5 mg/dL;
* stroke within 3 months;
* pregnancy;
* non-cardiac disease with a life expectancy \< 1 year;
* any patients not tolerable or suitable for coronary intervention; and
* inability to follow the protocol
Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens

A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™ Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases from all major organ systems. Pathologist will read and diagnose cases on a conventional light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized read order. College of American Pathologists (CAP) cancer protocol checklists will be used to capture diagnostic reporting.

Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth (GT) diagnosis for both modalities.

Following the FDA issued guidance document, "Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable"- 2006, the specimens are surgical pathology samples from leftover human specimens from clinical cases, archived and previously signed-out across the majority of surgical pathology subspecialties

Eligibility Criteria:
Inclusion Criteria:

• All surgical pathology samples from pre-identified list provided by FDA

Exclusion Criteria:

* Gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis)
* Immunofluorescence specimens
* Fluid-based specimens
* Intraoperative consultation specimens only (frozen preparation)
* Specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in Omnyx user manuals).
* Specimens for which any slide (other than a blank) that should be in the case part cannot be located
Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")

Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.

Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c\> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for 6 months.

The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.

The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c\> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.

The present study will be carried out under the usual conditions of clinical practice.

No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.

The people with diabetes 1 included in the study have a profile of "expert patient" having completed their diabetological education program at basic and advanced level (count of rations, calculations of ratios and sensitivity indexes) in such a way that the application will only be an aid in your daily decision making (mathematical calculations of ratios, IS, and recommended insulin doses, which you usually have to do "by hand").

Eligibility Criteria:
Inclusion Criteria:

* Patients with DM1 over 1 year evolution.
* Age ≥18 and \<65 years.
* HbA1c prior to the inclusion of the study\> 7%.
* Intensive insulin treatment with MDI in basal-bolus regimen.
* Patients with basic digital skills and with 3G mobile phone and NFC technology.
* Patients who have given their informed consent in writing.

Exclusion Criteria:

* Treatment with subcutaneous insulin infusor (ISCI)
* Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
* Pregnancy or pregnancy planning.
* Diabetes mellitus type 2.
* Severe psychological alterations.
* Absence of collaboration (informed consent).
* Patients who are participating in other clinical studies.
Tween Sleep Patterns, Appetite Control, and Environment

The goal of this study is to learn about how children's sleep is related to their eating behaviors the next day, and to learn about factors that relate to eating behaviors and sleep health that are specific to preadolescent children living in rural communities.

The aims of this study are to a) describe the prevalence and characteristics of eating in the absence of hunger (EAH) in rural preadolescent children using a novel methodology, ecological momentary assessment (EMA); b) to examine the within-person temporal relationship between daily changes in sleep health (i.e., duration and quality) and EAH; and c) examine associations between family, child, and environmental characteristics, sleep, and eating behaviors in rural preadolescent children. Parent-child dyads will participate in the study via remote data collection methods including Zoom interviews, online surveys, EMA survey completed by smartphone, and actigraphy.

Eligibility Criteria:
Child Inclusion Criteria:

1. Age 8 to 12 years
2. Primary residence is in a rural ZIP code in the United States, as defined by Health Resources \& Services Administration
3. BMI for age ≥ 85th percentile OR BMI ≥ 15th percentile plus at least one biological parent with BMI ≥ 25 kg/m2
4. Able to read and answer questions in English

Parent Inclusion criteria:

1. Parent or caregiver of an eligible child
2. Age 18 years or older
3. Able to read and answer questions in English

Exclusion Criteria:

1. Any medical condition that significantly impacts eating, sleep, growth, or ability to operate the mEMA smartphone platform (e.g., eating disorder, Type I diabetes, blindness) (Child participants only)
2. Unable to connect to a Zoom session via internet or cell-phone data from home
3. Unable to receive and sign for package with study supplies
Registry Measuring the Impact of Adding RNA Expression Testing on Referral Decisions in Early Stage Lung Cancer Patients and Assessing the Disease-free Survival With Long-term Follow-up

This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment decisions of Surgeons when added to standard clinical-pathological parameters in patients with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early stage non-small cell lung adenocarcinoma
* Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
* Resection of tumor within previous 2 months of enrollment
* ECOG performance of 0-2
* A minimum life expectancy of six months

Exclusion Criteria:

* Pre-operative radiation or chemotherapy for NSCLC
* Post-operative radiation or chemotherapy for NSCLC
* Enrollment in a separate clinical trial restricting treatment options
* Unable to provide informed consent
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria

  * CR 1 with poor risk features
  * CR 2, or higher order CR
* Acute lymphoblastic leukemia (ALL) with one of the following criteria

  * CR 1 with poor risk features
  * CR 2, or higher order CR
* Myelodysplasia, RAEB I
* Donor has been identified
* Age ≤ 65 years.
* Performance Status 0-1.

Exclusion Criteria:

* Patients relapsing \<6 months after autologous SCT are not eligible.
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
* Non-pregnant and non-nursing