cyrilzakka/clinical-trials huggingface dataset:
Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients

The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

Esophageal cancer ("EG cancer") affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective.

The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease.

The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-90 years
* Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer
* Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection

Exclusion Criteria:

* Pregnant females
* Without malignant esophageal disease
* Malignancy at a secondary site other than the esophagus
* Undergoing palliative treatment for esophageal cancer
* Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer
* Inability or unwillingness to provide written informed consent
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \> or = to 7.5% and \< or = to 10.0%
* Body mass index (BMI) \< or = to 45 kg/m2
* Non smoker for at least 6 months before Screening
* Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
* Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment

  * Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose
  * Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent
  * Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent
  * Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range
* No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes
* Forced expiratory volume in one second (FEV1) \> or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
* Forced vital capacity (FVC) \> or = to 70% NHANES III predicted
* Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) \> or = to NHANES III lower limit of normal (LLN)

Exclusion Criteria:

* History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
* Any clinically significant radiological findings on screening chest x-ray
* Use of medications for asthma, COPD, or any other chronic respiratory conditions
* Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
* Renal disease or renal dysfunction
* Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
* Previous or current use of amiodarone
* Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
* History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
* History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of \> 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
* Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
* Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)

Exclusion Criteria:

* New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction \< 30%;
* Hospitalized for heart failure within 5 years prior to Screening
* Major adverse cardiac event (MACE) within 3 months prior to Screening;
* HbA1c ≥10%, or fasting glucose
* Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
* Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization
VEST Device to Enhance Safein Vein Patency

Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. This study evaluates clinical outcomes of external stenting in real world routine practice.

Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients. All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial and/or venous grafts. One or more venous grafts were externally stented. Choice of conduits, use of cardiopulmonary bypass, and vein harvesting technique were performed according to the routine practice of each surgeon.

All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects.


Eligibility Criteria:
Inclusion Criteria:

* CABG with at least one VEST implant

Exclusion Criteria:

* none
The Playful Learning in Infancy Program

In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.

The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.

Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.


Eligibility Criteria:
Inclusion Criteria:

* Residence address in the Danish municipalities of Hvidovre or Billund
* Residence address with child or legal custody of the child
* Child is between 1-7 months old
* Understands Danish or English

Exclusion Criteria:

* Parental age under the age of 18 when the child is born
* Multiple pregnancy
Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System

The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.

The main question\[s\] it aims to answer are:

* Early mortality
* Safety outcomes throughout the study
* Device failure throughout the study
* Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.


Eligibility Criteria:
1. Male and female age ≥18 years
2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
5. The subject is able and willing to provide informed consent to participate in the study.
6. Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
7. In the opinion of the Investigator, life expectancy exceeds one year
8. The subject is not pregnant or planning to become pregnant.
9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
10. In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.

The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.

Laparoscopic SNNS:

1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
2. Sentinel node basin identification and dissection
3. Sentinel nodes picking in back table
4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.

Sample size: 100 cases

Study duration: 5 years( 2year enrollment, 3 year follow-up)

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80
* Informed consent
* No other malignancies
* cT1N0 stage gastric cancers \< 4cm
* no allergic history of isotope

Exclusion Criteria:

* Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
Effect of Very-low Calorie Diet and Synbiotic Supplementation in Gut Microbiota (Pronokal Method)

The present study aimed to investigate the changes produced in gut microbiota by a very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics is able to modulate gut microbiota diversity and composition and its association with gut permeability and inflammation

All participants followed a very-low-calorie ketogenic diet according to a commercial weight loss program (Pronokal method), which includes lifestyle and behavioural modification support. This method is based on high-biological-value protein preparations which contained 15 g protein, 4 g carbohydrates, 3 g fat and 50 mg docosahexaenoic acid, and provided 90-110 kcal. The study was divided in two phases. The first phase consists of a very-low-calorie ketogenic diet (600-800 kcal/day), low in carbohydrates and lipids. Throughout this ketogenic phase, supplements of vitamins and minerals such as K, Na, Mg, Ca and omega-3 fatty acids were provided. In this study the ketogenic step was maintained for 2 months. Then, the patients started a low-calorie diet (800-1500 kcal/day) which lasted two months.

During the first phase consisting of a very-low-calorie ketogenic diet, subjects were randomly divided into two groups, the treatment group who received synbiotic supplementation as capsules, a complex of B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber (synbiotic 1) and the control group who received a placebo. During the second phase consisting of a low-calorie diet, the treatment group received synbiotic supplementation as capsules consisting of B. animalis subsp. lactis and prebiotics fiber (synbiotic 2) (synbiotic1 + synbiotic 2 group), while the control group was divided into two groups: one continued receiving a placebo (control group) whilst the other group received synbiotic 2 (placebo + synbiotic2 group).

Eligibility Criteria:
Inclusion Criteria:

* body mass index ≥ 30 kg/m2
* stable body weight in the previous 3 months

Exclusion Criteria:

* Diabetes mellitus
* Obesity induced by endocrine disorders or by drugs
* Gastrointestinal disorders
* Use of antibiotics, probiotic or prebiotic agent which could modify microbiota in the previous 3 months
* Severe depression or any other psychiatric disease
* Abuse of narcotics or alcohol
* Severe hepatic insufficiency
* Any type of renal insufficiency or gout episodes
* Neoplasia
* Previous events of cardiovascular or cerebrovascular disease
* Renal lithiasis
* Uncontrolled hypertension and hydroelectrolytic alterations
* Females with child-bearing potential, who were pregnant, breast-feeding, intending to become pregnant
Epidural Neostigmine for Labor Pain

The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.

This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnancy
* Term pregnancy ( \> 37 weeks)
* Primiparous or multiparous
* Induction or spontaneous labor greater or = 18 years of age
* Cervical exam on entry \</=5 cm

Exclusion Criteria:

* Weight \> 115 kg
* Non-English speaking
* IV analgesics within 60 minutes prior to epidural being administered
* Allergy to local anesthetics or neostigmine
Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE

It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal protective equipment (PPE) have increased. In those cases, existing methods such as auscultation and chest uprising have to be limited. Quantitative waveform capnography is recommended as the gold standard for confirming correct endotracheal tube placement in the 2010 American HeartAssociation (AHA) Guidelines for Cardiopulmonary resuscitation (CPR) and Emergency Cardiovascular Care (ECC), but it has some well-known limitations in cardiac arrest patients.

Ultrasonography is a non-invasive, real-time diagnostic tool commonly used during resuscitation. Especially, tracheal ultrasonography can be performed in real-time when the tube is passed through the trachea or esophagus. Previous prospective studies revealed that tracheal ultrasonography could feasibly and rapidly confirm tracheal intubation during emergency intubation.

There have already been several studies comparing the accuracy of tracheal ultrasound and capnography, but there was no study comparing the two tools under the constraints of PPE that is essential in pandemic situations as in this study. This study aimed to determine the accuracy of tracheal ultrasonography in assessing endotracheal tube position during CPR with PPE.

When patients in cardiopulmonary arrest enter a emergency room (ER) or patients staying in a ER have a cardiopulmonary arrest, participants perform intubation and CPR. When it is judged as a high-risk group with a high probability of droplet infection, all participants in resuscitation team should wear personal protective equipment. Tracheal ultrasound and end-tidal carbon dioxide are used to confirm the placement of tube. The gold standard is the direct visualization using laryngoscope. The time it takes to confirm the placement of tube is also measured.

Eligibility Criteria:
Inclusion Criteria:

* 1. cardiopulmonary arrest patients receiving emergency intubation and CPR
* 2. patients judged to need to wear PPE according to the judgement of the clinician

Exclusion Criteria:

* 1. sign for "do not resuscitate (DNR)"
* 2. patients unable to perform tracheal ultrasound due to trauma of the site
* 3. patients unable to perform tracheal ultrasound due to oropharynx cancer
* 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
* 5. patients not used tracheal ultrasound for checking tube placement
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

Primary Objectives:

To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).

Secondary Objectives:

* To evaluate safety and treatment related mortality after CD8 depleted DLI.
* To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
* To evaluate the incidence and timing of pancytopenia following DLI.
* To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
* To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
* To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.


Eligibility Criteria:
* Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (\>20% donor cell within three months of study entry)
* Expected survival \>4 weeks
* CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation

  1. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
  2. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate \>10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
* CML patients with accelerated phase or blast crisis following allogeneic transplantation
* Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:

  1. MM- patients with a rising M-protein is detectable at 180 days post-transplant
  2. NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
  3. CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
* Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
* Patient's original donor must be available for lymphocyte donation
* There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (\<16 mg/d) without evidence of active GVHD are also eligible.
* Patients must have a Zubrod PS\<2 (see appendix 7), Cr\<2.5, bilirubin \<3, and transaminases (SGPT, SGOT) \<4x normal
* Patient must be able to sign informed consent
Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis

The costs to a rural emergency medical services (EMS) system of a change from a traditional cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The purpose of this study is to use current EMS data to calculate the costs to a rural EMS system associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected cyanide exposure.


Eligibility Criteria:
Inclusion Criteria:

* Included in Maine EMS database
* House Fire Victim
* Poisoning

Exclusion Criteria:

* No potential cyanide exposure
* Incomplete data available