cyrilzakka/clinical-trials huggingface dataset:
VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.

Eligibility Criteria:
Inclusion Criteria:

1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. remote metastasis
3. Child-Pugh C
4. combination with other hepatobiliary disease
5. suffer from other tumors concurrently or in last five years
Effects of Antiemetic Agents in Orthognathic Surgery Patients

In an effort to prevent or treat consistently high rates of PONV following maxillofacial operations, several medications, techniques and multimodal protocols have been studied. In the present study, the investigators hypothesized that combining metoclopramide with granisetron will improve PONV incidence when compared with granisetrone alone.

Despite advances in anesthetic techniques and antiemetic drugs that accompany increasing awareness of anesthesia providers, postoperative nausea and vomiting (PONV) remains one of the most common problems after general anesthesia. PONV is one of the major problems leading to patient dissatisfaction, prolonged stay in postoperative care unit and hospital, readmissions and thus it can increase health care costs. In the studies performed in PONV prone patients and high-risk surgeries, as compared with other antiemetic medications, "setrons" provided lower nausea and vomiting incidence postoperatively, but were unable to completely prevent this "big little" problem.The blood in the stomach has been indicated as one of the major causes of PONV following maxillofacial surgery thus, using metoclopramide may relieve the complaints by evacuating this irritant. After institutional ethic committee and National Medicines, 66 consecutive patients, classified as ASA I and II physical status and aged between 18 and 60 years were included in the study. Apfel's simplified PONV risk score including female sex, history of motion sickness or PONV, smoking status and predicted use of postoperative opioids was recorded.Procedures were performed under general anesthesia. Patients in Group G received 3 mg granisetron (Neoset, Deva, Istanbul) and the patients in group GM received 3 mg granisetron + 10 mg metoclopramide (Metpamid, Sifar İlaç, Istanbul) 30 minutes before the end of operation intravenously. A nursing staff collected the data concerning PONV, VAS, systolic, diastolic and mean arterial pressures, heart rate, peripheral arterial saturation, total doses of drugs used, overall bleeding score, infused fluid volume, VAS, surgical procedure, duration of surgery and rescue antiemetics for nausea if applied for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing orthognathic surgery
* ASA I and II physical status
* aged between 18 and 60 years
* must be volunteer to take study drugs

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Underwent to genioplasty
* Documented hypersensitivity to study drugs
* Gastroesophageal reflux or hiatal hernia
* Diabetes mellitus
* Renal insufficiency
* Pregnancy
* Electrolyte imbalance
* Neurological disease
* Mental retardation
* Prolonged QT interval.
Quantifying Disease Progression in LBSL

Leukoencephalopathy with brain stem involvement and lactate elevation (LBSL) is a genetic disorder caused by biallelic mutations in the DARS2 gene that encodes mitochondrial aspartyl tRNA synthase.(1, 2) It is characterized by typical abnormalities on MRI of the brain and spinal cord.(3) Clinically, the disorder is heterogeneous and can present in the neonatal period, later in childhood or even in adults.(3) In general it can be stated that the earlier presentations are characterized by rapid progression leading to severe disability and death. Presentation at a later age is typically characterized by a more benign disease course, although considerable disability is common. Clinically, the disease presents as a slowly progressive myelopathy with mainly involvement of the corticospinal tracts and the dorsal columns. Although the natural history has been studied in large cohorts, the rate of progression has not been systematically studied with clinimetric outcome scales or potential surrogate outcomes for spinal cord disease.


Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Age \> 16 years
* Definite diagnosis of LBSL confirmed by DARS2 mutation analysis.
* Able to understand Dutch or English and provide informed consent.
* No contra-indications for MRI of brain and spinal cord.

Subjects eligible to participate as healthy controls must meet all of the following criteria:

* Willing to visit the hospital
* 16 years or older
* Provision of written informed consent to participate in the study obtained from the participant

For the MRI controls:

- No contra-indications for MRI of the brain and spinal cord

A potential subject (patient or healthy control) who meets any of the following criteria will be excluded from participation in this study:

* Unable to visit the hospital for the follow-up visits
* Co-existing neurological disease that can cause pyramidal tract signs making interpretation of acquired data difficult (for instance, multiple sclerosis, stroke, etc)
Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients

Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
* Patients with ASA physical status classification I, II, III

Exclusion Criteria:

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
* Patients with morbid cardiac diseases
* Pregnancy
* Patients with previous history of lumbar spine surgery
Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural Haematoma

This study is aimed at improving reporting in Chronic Subdural Haematoma (CSDH) research studies, through development of a standardised Core Outcome Set (COS), a unified CSDH Definition and set of Data Elements (DE) for reporting.

The study design includes a Delphi survey process from two main stakeholder groups: Health-Care Professionals or Researchers (HCPR) and Patients or carers. HCPR, patients and carers will all be invited to complete the survey on the COS, only the HCPR survey will include questions on definition and DE. Results of the Delphi Survey will be discussed at a final consensus meeting before results are confirmed and published.

Chronic subdural haematoma (CSDH) is a collection of blood and fluid surrounded by membranes that accumulates on the brain surface over weeks to months. It predominately affects older people and often has a delayed association with a preceding head trauma.

There has been significant growth in the number of CSDH publications in recent years mirroring progress in potential management options but there is wide variation in how and when patient outcome is measured amongst studies. Much could be gained by agreeing a minimum set of standardized outcomes that should be measured and reported in all CSDH studies, known as a Core Outcome Set (COS).

The overall study design includes a Delphi survey process.This is a process whereby all outcomes and data elements from the CSDH literature and expert opinion are presented to a large group of patients, carers and HCPR via a survey. Each survey participant has the opportunity to rank the elements and outcomes in levels of importance to them, and the survey is then repeated including presentation of the results from the first round, in order to attempt to gain agreement between participants on what is important. All elements are then reviewed at a final "consensus" meeting

Eligibility Criteria:
Inclusion Criteria:

All invited participants who provide consent to take part in 2 rounds of survey
Lapatinib Resistance in Patients With Breast Cancer

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.

PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

OBJECTIVES:

* To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
* To investigate ErbB2 copy number changes and expression levels.
* To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.

OUTLINE: Previously collected tumor tissue samples\* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.

NOTE: \*Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed invasive breast cancer

  * ErbB2-positive disease
* Has received or is currently receiving lapatinib ditosylate

  * Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
* Must have tumor tissue samples available for research studies
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant\*
* Coagulation profile normal\*
* Platelet count \> 100,000/mm³\* NOTE: \*For patients requiring a post-treatment biopsy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
* No concurrent anticoagulants, including warfarin or low-molecular weight heparin\*
* No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents\* NOTE: \*For patients requiring a post-treatment biopsy
COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS

The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain. The study involves completing 16 weekly 3-question surveys either online or by phone. The new catheters are FDA-approved and will be provided for FREE. No medications will be given.

The purpose of this study is to see if a redesign of the catheter to remove the extended tip of the conventional urinary catheter will reduce problems with catheter blockage or catheter-associated discomfort. By eliminating the extended tip, the bladder wall will no longer be subject to the tip rubbing on the bladder wall. This could lead to fewer problems with blockages and less irritation and trauma to the bladder lining. A reduction in trauma to the bladder wall could reduce pain, bladder inflammation/irritation and the risk of urinary tract infections.

Eligibility Criteria:
Inclusion Criteria:

* Indwelling suprapubic Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.
* Catheter associated discomfort or difficulty with mucous plugging of the catheter.

Exclusion Criteria:

* Inability to provide informed consent
* No catheter associated discomfort or problems with mucous plugging
Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Patients with dyschesia
* Prescription of rehabilitation for dyschesia

Exclusion Criteria:

* Rectal diseases
* Pain killers
* Pregnant women
* Breast feeding patients
* Non-compliant patients
The Cohort Study for Asthma in China

The study is to establish a standardized asthma cohort study, build an information network platform system and a biospecimen bank for asthma cohort, establish clear follow-up standards and norms, observe the asthma outcomes and identify biomarkers to predict asthma outcomes.

This is a single center observational prospective longitudinal cohort study to establish a standardized asthma cohort, consisting of 400 patients with asthma. Baseline data including lung function test, chest CT, induced sputum, etc. was collected and the patients were followed up for 2 or more years. Subjects who met the 2023 GINA diagnostic criteria for asthma and were able to participate in the study according to the protocol and sign the informed consent were included. No additional investigational drugs will be applied to the patients. Blood samples are transported to designated laboratories for safekeeping and biomarker testing. We aimed to explore the mechanism of biomarkers involved in asthma pathogenesis and identify treatable traits related to disease outcome. Full analysis set will be used for all analyses. Missing data will be analyzed as it is. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure. Working group will do the data cleaning and data analyzing.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Meet the 2023 edition of GINA asthma diagnostic criteria
* Subjects must sign informed consent prior to study participation, participate in the study according to the protocol and follow up for 2 years

Exclusion Criteria:

* Suffering from other massive lung tissue destructive diseases such as severe bronchiectasis and tuberculosis
* Severe pleural disease and/or sternal and rib lesions
* Serious uncontrolled disease of other system
* Thoracic or abdominal surgery in the past 3 months
* Eye surgery in the past three months
* Retina detachment
* Myocardial infarction within the last 3 months
* Hospitalized for heart disease within the past 3 months
* Ongoing anti-tuberculosis treatment
* Pregnancy or breast feeding
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30 million North Americans and Europeans by 2050. Atrial fibrillation is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. Many studies have investigated the efficacy of different drugs in converting atrial fibrillation to sinus rhythm. There are numerous randomized controlled trials that have tested the efficacy of agents against placebo and some trials that directly compared the efficacy of two or more different drugs. The class III antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent vernakalant has been approved by the European Commission for the rapid conversion of recent onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes is different between vernakalant and ibutilide in patients with recent-onset atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of atrial fibrillation since no longer than 48 hours
* Age 18 - 90 years

Exclusion Criteria:

* Need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure \< 100 mmHg, dyspnea, loss of consciousness, unstable angina)
* Moderate to severe heart failure (NYHA III/IV) and patients with previously documented left ventricular ejection fraction (LVEF) ≤ 35%
* History or signs of acute coronary syndromes (acute myocardial infarction, unstable angina) within the last 30 days
* Resting ventricular rate \< 80 beats per minute without pace maker back-up
* QT interval of \> 440 milliseconds
* Wolff-Parkinson-White (WPW) syndrome
* History of Torsade de pointes arrhythmias or other polymorphic ventricular tachycardias
* Signs of thyreotoxicosis
* Sick Sinus Syndrome or atrioventricular block greater than first degree
* Severe valvular heart disease, clinically meaningful hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
* Serious disorders of the hepatic, renal (Creatinine \> 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders
* Abnormal serum electrolytes despite adequate therapy (especially potassium \<3.5 mmol/l or \> 5.5 mmol/l)
* Intravenous use of other Class I or III antiarrythmic drugs within 4 hours of study drug application
* Pregnancy (a β-HCG test will be performed in all female subjects apart from women \> 50 years and with amenorrhea for at least 12 month (absence of other causes of amenorrhoea)
* Known hypersensitivity to study medication
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis

Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
* Written informed consent
* \>20 and \<80 years of age

Exclusion Criteria:

* Misuse of alcohol in the preceding 6 months,
* Episodes of hepatic decompensation leading to in-patient admissions during the previous month
* History or clinical signs of overt HE or severe sleep-wake disturbances
* On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
* History of significant head injury
* Neurological/psychiatric comorbidity needing medical treatment
* Taking neuroactive medication/medication known to affect sleep
* Travel across more than two time zones in the preceding 3 months
* Shift work in the preceding 5 years
* Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).
PET-TC in Thyroid Evaluation

The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.

It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.

The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.

The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.

Eligibility Criteria:
Inclusion Criteria:

For the retrospective part:

* Patients aged \>18 years,
* Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
* Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
* Obtaining informed consent

For the prospective part:

* Patients aged \>18 years,
* Finding hypercaptant findings of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice.
* Patients scheduled for agesult to be no more than 12 months.
* Obtaining informed consent

Exclusion Criteria:

* Nothing
Multimodal MRI in Multiple Sclerosis (MS): Reliability and Follow Up

To determine wether multimodal MRI (conventinal T1 and T2 sequences, diffusion, magnetization transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early remmittent MS after treatment with interferon.


Eligibility Criteria:
Inclusion Criteria:

* MS patients according to Poser's criteria
* Remitting evolution (less than two years of evolution)
* Aged 18-50
* Immunomodulatory treatment indicated

Exclusion Criteria:

* Unable to perform MRI
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training

The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* traumatic brain injury at least 6 months prior to study

Exclusion Criteria:

* currently receiving outpatient therapy
* medically unstable
* body weight \> 150 kgs