cyrilzakka/clinical-trials huggingface dataset:
Norepinephrine to Prevent Hypotension in Ceasrean Delivery

This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.

Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.

All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.

Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.

10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.

Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.

The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.

Eligibility Criteria:
Inclusion Criteria:

* ASA I \& II
* Non laboring
* Normotensive
* Elective cesarean delivery under spinal anesthesia.
* Baseline systolic blood pressure 90-140 mm Hg

Exclusion Criteria:

* Known fetal abnormality.
* Preexisting or pregnancy-induced hypertension.
* Known cardiovascular or cerebrovascular disease.
* Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.
* Weight \<50 or \>100 kg, height \<140 or \>180 cm.
* Inability or refusal to give informed consent
Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males or females greater than or equal to 18 years of age
* Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
* Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
* If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion Criteria:

* History of stroke or transient ischemic attack (TIA) within the last one year
* History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
* Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose \<160 mg/dl may enroll
* Patients with hemodynamically significant cardiac valvular disease
* Patients with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication
Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients

aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.

Eligibility Criteria:
Inclusion Criteria:

* undergoing radiotherapy session

Exclusion Criteria:

* family refusal
* chronic nausea and vomiting
* apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases
* cardiac disease
* kidney failure
* liver failure
* anticipated difficult airway
* metabolic diseases
* neurological or muscular diseases.
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)


Eligibility Criteria:
Inclusion Criteria:

* Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
* Patient is unable to be treated by endovascular or surgical means

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has had a previous surgery within 30 days of the study procedure
* Patient has a planned surgical or interventional procedure within 30 days after the study procedure
* Patient has a life expectancy of less than 1 year
* Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
* Additional restrictions as specified in the protocol
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
* No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

Exclusion Criteria:

* Prior myelodysplastic disorder, or treatment-related leukemia.
* Prior myeloproliferative disease.
* Acute promyelocytic leukemia (APL).
* Prior chemotherapy for a malignant or nonmalignant disorder.
EnSite Precision Observational Study

This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study.

This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration, lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the success of complex ablation procedures. Utilization of this system in the treatment of complex ablation procedures and its impact on patient outcomes is not well characterized. This clinical study is designed to collect a broad range of usage scenarios, therefore this clinical study has limited patient selection criteria and data collection is focused on EnSite Precision™ Cardiac Mapping System usage and patient outcomes.

The data collected from the procedure (performed per Instructions For Use (IFU) and per standard practice of the physician) as well as the 12 month follow up period enables the Sponsor to review the system's standard practice usage. This information will be added to the current knowledge and understanding of treatment options for patients with arrhythmias, which can assist the Sponsor to provide future recommendations for best practices to improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use
* Over 18 years of age
* Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule

Exclusion Criteria:

* Patients who are only presenting with:

  * Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
  * Atrioventricular Reentrant Tachycardia (AVRT)
* Planned cryoablation procedure
* Implanted with a neurostimulator
* Contraindication to anticoagulation
* Known presence of cardiac thrombus
* Recent (\<3 months) myocardial infarction or unstable angina or coronary artery by-pass
* Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study
* Pregnant or nursing
* Individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence
STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure

The primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone.

STARBRITE will test the hypothesis that a defined fluid management strategy, tailored to specific symptoms and physiological targets, will improve morbidity and mortality in the advanced heart failure population. Individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function. Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients. In addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings.

In this study, patients will be randomized to two strategies of outpatient fluid management: 1) the Congestion Score Strategy and, 2) the BNP Strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted with NYHA class III/IV symptoms of heart failure
2. Left ventricular ejection fraction ≤35%
3. Will have received at least one dose of intravenous diuretics during the current hospitalization
4. Prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions
5. Able to return for follow-up care at the Brigham and Women's Hospital Cardiomyopathy Clinic or the Duke Heart Failure Management Program
6. Has regular access to a telephone
7. ≥18 years of age

Exclusion Criteria:

1. Moderate to severe valvular stenosis
2. Admitted with acute coronary syndrome
3. Creatinine \>3.5
4. Renal failure on hemodialysis
5. Pregnant or lactating
A Clinical Evaluation of Omron Digital Blood Pressure Monitor

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.


Eligibility Criteria:
Inclusion Criteria:

* Upper arm circumference: 17-50cm

Exclusion Criteria:

* Patients who has arrhythmia.
* When body motion is observed during measurement.
* Korotkoff sound is poor quality.
* Patient's arm circumference is outside cuff range.
* Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.
* Patients stated they did not wish to continue with the study and it is stopped before completion.
Markers of Liver Apoptosis After Anesthesia With Sevoflurane or Propofol

Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. In the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.

Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. The type of anesthesia will be determined in a random way using a computer generated table.

All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the propofol group patients anaesthesia will be induced and maintained with propofol.

Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively.

Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60 values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) levels will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer

Exclusion Criteria:

* Drug intake which may affect liver function
* Severe cardiovascular or respiratory disease
* Hepatic or renal dysfunction
* Pregnancy
* Alcohol and drug abuse
* Body Mass Index (BMI) \> 35
Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy

The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.

The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.

Eligibility Criteria:
Inclusion Criteria patients:

* Women
* Older than 18 years
* Speaking, understanding and writing Dutch fluently
* Mentally competent
* Recently underwent a operation for breast cancer (invasive or in situ)
* Takes AET for maximum two months
* Consultation planned within 4-5 month
* Home access of a computer with internet connection

Exclusion Criteria patients:

* Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
* Metastatic disease

Inclusion Criteria health care professionals:

* Contact with patient(s) included in the trial

Exclusion Criteria health care professionals:

* Included in panels
* Member of the research team
Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects from chemotherapy agents. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing cancer care providers with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide treatment decisions and improve patient outcomes.

This is a non-randomized implementation study, which means that all participants in this study will undergo genotyping for a pharmacogenetic test. The investigators will primarily measure the feasibility of using this test to guide cancer care.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide informed consent
2. Male or female, aged 18 years or older at the time of study initiation
3. Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated
4. Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures
5. Life expectancy of at least 6 months

Exclusion Criteria:

1. Prior treatment with irinotecan
2. DPYD or UGT1A1 genotype already known
3. Severe renal or hepatic impairment (or unacceptable laboratory values), including:

   * Neutrophil count of \<1.5 x 109/L, platelet count of \<100 x 109/L
   * Hepatic function as defined by serum bilirubin \>1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \>2.5 x ULN, or in case of liver metastases ALT and AST\>5 x ULN
   * Renal function as defined by serum creatinine \>1.5 x ULN, or creatinine clearance \<60 ml/min (by Cockcroft-Gault Equation)
4. Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study
5. Treating physician does not want subject to participate
A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, aged ≥ 18 years.
* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC
* Progressive disease on or after prior treatment with EGFR-TKIs.
* Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.
* At least 1 target lesion according to RECIST 1.1.
* ECOG PS score: 0-1.
* Estimated life expectancy\> 12 weeks.
* Men or women should be using adequate contraceptive measures throughout the study.
* Women must have the evidence of non-childbearing potential.
* Signed and dated Informed Consent Form.

Exclusion Criteria:

* Subjects with known oncogenic driver genes other than EGFR.
* Subjects with mixed cell histologic or with phenotypic transformation.
* Treatment with any of the following:

  1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
  2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.
  3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose
  4. Uncontrolled pleural effusion or ascites or pericardial effusion.
  5. Major surgery within 4 weeks before the first dose.
  6. CNS metastases with symptomatic or active progression.
* Subjects who have any grade ≥2 residual toxicities from prior therapies.
* Subjects who have history of other primary malignancies.
* Inadequate bone marrow reserve or hepatic and renal functions.
* Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.
* Hypersensitivity to any ingredient of HS-10504.
* Moderate to severe pulmonary diseases.
* Prior history of significant neurological or mental disorders.
* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function

The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.

percentage of change on HCV RNA titer and liver function (GPT).

Eligibility Criteria:
Inclusion Criteria:

* 40 \< GPT \<200 HCV carrier Age: 18-65 yrs old

Exclusion Criteria:

* Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of type 2 diabetes mellitus (T2DM).
* HbA1c at baseline: ≥7.5 % to 8.5 %.
* BMI between ≥26 and ≤35 kg/ m2.
* Established Diabetic neuropathy diagnosed by nerve conduction study (NCS).

Exclusion Criteria:

* Patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas.
* Patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with HbA1c measurement.
* Thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin\>1.5mg), or renal excretion ≤90ml/min.
* Patients on medications which can result in a change of weight (orlistat, metformin, clozapine, gabapentin) and patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, non-selective β-blockers, thiazides, etc.)
* Treatment with any diabetes medications other than glimepiride prior to intervention.
* Clinically significant cardiac abnormalities (diagnosed clinically, history, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation.
* Patients with morbid obesity (BMI ≥ 40 kg/ m2).
* History or current diagnosis of major depressive disorders or other psychiatric disorders.
* Pregnant and breastfeeding women.
* Patients with any inflammatory diseases.
* Patients on cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, etc.).
* Patients with Low vitamin B12 levels according to suggested normal values for T2DM patients over 60 years old (\<400 pmol/L).