cyrilzakka/clinical-trials huggingface dataset:
Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML

Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Azacitidine (AZA), a listed hypomethylating agent in China in 2018, is the only approved demethylating drug in the treatment of AML, following the NCCN guidelines. In addition, lenalidomide(LEN) has been shown to rapidly enhance cytotoxic T- and natural killer (NK)-cell function and reduce relapse post-chemotherapy in patients with MM, also has substantial activity as a single agent in elderly patients with AML. Measurable residual disease (MRD) has been proven to be highly prognostic in quite a number clinical studies. This study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain AZA and LEN in elderly or unfit for intensive therapy patients with AML based on MRD monitoring.

In this study, elderly or unfit for intensive therapy AML patients who had achieved complete remission(CR) after remission-induction and consolidation chemotherapy were assigned to 3 Arms: (1) Maintenance therapy with AZA combined with LEN（AZA+LEN）: AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression; (2) Maintenance therapy with AZA only: AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression; (3) Observation or with supporting therapy. MRD will be assessed by flow cytometry and molecular techniques. The efficacy and safety of the 3 Arms will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute myeloid leukemia.Meet the criteria of the 2016 WHO classification system(APL were excluded), based on morphology, immunology, cytogenetics and molecular biology (MICM) diagnosis.
* Complete remission was evaluated according to 2020 NCCN guidelines after induction treatment.
* Patients with age≥ 60 years; or age\<60 years unfit for intensive chemotherapy.
* Volunteered to sign the informed consent.

Exclusion Criteria:

* Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring.
* Allergic to Azacytidine, Lenalidomide , or other drugs of this study
* Age over 80 years.
* Any other conditions considered by the study investigators that are not suitable for participating in this clinical trial.
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases

Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract

Exclusion Criteria:

* clinical contraindication to diagnostic laparoscopy
Improving Sleep for Healthy Hearts

This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).

For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.

Eligibility Criteria:
Inclusion Criteria:

* meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
* have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (\>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
* minimum age of 18 years old.

Exclusion Criteria:

* no daily access to a computer with an internet connection
* visual impairment preventing use of a computer
* inability to read English
* severe uncontrolled medical or psychiatric problems
* heart failure with reduced ejection fraction \<35%
* high depressive symptoms (PHQ \> 15)
* drowsy driving
* \>3 days per week use of hypnotic medications
* known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
* shift-workers
* prior exposure to CBT-I treatment
* dialysis patient
A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)

The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the feasibility of using SMS technology within normal clinical practice in The Netherlands.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* The subjects should be considered eligible for this trail according to the physician:

  1. Patients with a diagnose of schizophrenia or bipolar disorder with a recent manic episode
  2. Patients who are being treated with quetiapine and are on an effective dose according to the Core Data Sheet; for schizophrenia between 300 and 450 mg (maximum 750 mg) and bipolar disorder between 400 and 800 mg.
  3. Patients who consent to make the coded data available to AstraZeneca; provision of written informed consent
  4. Considered eligible for this study and able to understand and comply with the requirements of the study according to the physician
  5. In possession of a private mobile phone and capable of using this mobile phone to send SMS text messages

Exclusion Criteria:

* Subjects who, in the opinion of the Physician, pose an imminent risk of suicide or a danger to themselves or others are excluded from the trial.
The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section

The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at ≥39 weeks of gestation scheduled for elective cesarean section at the Department of Gynecology of Policlinico Umberto I (Sapienza University of Rome) who gave written informed consent.

Exclusion Criteria:

* Urgent/emergent surgery
* Patients with gastrointestinal disorders
* Complicated pregnancy (e.g., active infection, placental adhesive disorders, hypertensive disorders), which would potentially prolong their hospitalization
* Incomplete medical records.
Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas

Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).


Eligibility Criteria:
Inclusion criteria:

* Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
* ≥18 years of age at index date during study observation
* ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
* ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
* ≥2 months post-index date
* ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms)
* ≥12 months of continuous enrolment prior to index date

Exclusion criteria:

* Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
* Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
* Admission to nursing home in the 12 months prior to index date
Prognostic Awareness and Patient-Physician Communication in Malignant Glioma

The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.


Eligibility Criteria:
Inclusion Criteria:

Patient Inclusion Criteria

* Age greater than or equal to 18
* Diagnosis of any WHO grade III or IV glioma
* Admitted to the inpatient Neurology service
* Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English

Caregiver Inclusion Criteria

* Age greater than or equal to 18
* Identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her physical or emotional assistance.
* The patient has himself or herself agreed to participate in this study

Exclusion Criteria:

Patient Exclusion Criteria

* A patient will be excluded if the Glasgow Coma Scale is less than 15. The patient must be oriented to self, age, place, and year, and month.
* Aphasia precluding comprehension and verbalization of consent to participate
* Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.

Caregiver Exclusion Criteria

* No eligible caregivers who can complete the brief assessment in person or via telephone will be excluded
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.

A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
* Clinical diagnosis of COPD for more than 1 year at Visit 1
* FEV1 ≥ 30 to \< 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC \< 70%
* Reversible airway obstruction

Exclusion Criteria:

* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
* An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
* Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
* Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
* Long-term oxygen therapy, as judged by the Investigator
Titratable Dosing in Moderate to Severe Asthmatics

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
* Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.
NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.

NKTR-102 (Topoisomerase I Inhibitor Polymer Conjugate) is a polyethylene glycol (PEG) conjugate of irinotecan. Irinotecan is a topoisomerase I inhibitor approved worldwide. In the US, irinotecan is indicated as a component of first-line therapy in combination with 5 fluorouracil (5 FU) and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Second-line therapy for colorectal cancer typically involves cetuximab and irinotecan. However, growing evidence indicates that cetuximab (or other EGFR inhibitors) is not appropriate therapy for patients with mutant KRAS. For these patients, irinotecan may be appropriate as a single agent, and a new therapy that could improve upon efficacy and safety would provide an important option for the treatment of advanced colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* metastatic colorectal cancer
* tumor with k-ras mutation

Exclusion Criteria:

* More than 1 prior regimen for treatment of metastatic disease
Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology

This study is designed to gain a better understanding of the mechanisms leading to muscle wasting and metabolic abnormalities in skeletal muscle of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-80 years
* Diagnosis of metastatic cancer with cachexia (≥5% drop in body mass in less than 12 months), metastatic cancer without cachexia (\<5% drop in body mass in 12 months) or no history of cancer but similar in age and sex as other groups.

Exclusion Criteria:

* Current use of vitamin D analogs
* Fasting plasma glucose ≥126 mg/dL
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (Bilirubin \> 17mmol/L, AST\>144IU/L, or ALT\>165IU/L)
* Contraindications to MRI (e.g., pacemaker, ferrous materials within body).
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal insufficiency/failure (serum creatinine \> 1.5mg/dl)
* Oral warfarin group medications or history of blood clotting disorders.
* People who have taken Bevacizumab
* Platelet count \<100,000 per uL
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled thyroid disorders
* Debilitating chronic disease (at the discretion of the investigators)
* Previous injury/trauma/surgery to the region being measured without full recovery
* Pain in the area to be assessed
* Any medical condition affecting the ability to execute a maximal muscle contraction
* The presence of infections, highly communicable diseases (AIDS, active tuberculosis, veneral disease, hepatitis) or metastatic bone disease that may interfere with safely executing maximal effort.
* Significant neurological or musculoskeletal disorders or disease that may interfere with safely executing maximal contraction
* Any congenital, developmental, or other bone disease or previous surgeries that may interfere with successful testing
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency

13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.

The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic pancreatitis who meet at least one of the following criteria:

   * Adult men or women \>18 years of age.
   * Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
   * Abnormal secretin pancreatic function test with a peak bicarbonate concentration \<80 mEq/L
   * Presence of pathogenomic pancreatic calcifications
   * Pathology proven chronic pancreatitis on surgical specimens
2. Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
3. Patients who can fast for at least 8 hours
4. Able to perform the testing and procedures required for the study, as judged by the investigator
5. Willing and able to provide written informed consent

Exclusion Criteria:

* Failure to obtain consent
* Patients with liver cirrhosis
* Any co-morbid condition with expected survival \< 1 year
* History of extensive bowel resection, multiple abdominal surgeries
* Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
* Uncontrolled diabetes
* Patients currently receiving total parenteral nutrition (TPN)
* Recipients of an organ transplant
* Patients who have consumed \>20cc of alcohol or have taken acetaminophen in the past 24 hours
* History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
* Patients taking drugs that can interfere with 13C di-peptide metabolization
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention

A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

There are two major objectives:

* To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
* To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing TAVR intervention
* agreement given

Exclusion Criteria:

* severe thrombopenia ( \<40.10\^9/L)