cyrilzakka/clinical-trials huggingface dataset:
Comparison of Central Venous Pressures (CVPs) Measured From Peripherally Inserted Central Catheters (PICC) and CICC in Liver Transplantation Recipients

Background: Central venous pressure (CVP) monitoring from the peripherally inserted central venous catheter (PICC) has not often been used because of the higher inherent resistance of the PICC due to its longer length and narrower lumen. The objective of this study was to assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver transplantation.

According to the protocol of LT in our hospital, a PICC is concomitantly inserted with the pulmonary artery catheter (PAC) and 9-Fr advanced venous access (AVA) catheter for the LT recipient at anesthetic induction. PAC and AVA catheter are usually removed on the second postoperative day, and instead the PICC is used for the postoperative infusion of prostaglandin E1 which is very irritable to small peripheral vein. So we fortunately had chance to measure the CVPs from both CICC and PICC simultaneously in the same patients.

Methods: We measured the CVPs from the CICC and the PICC simultaneously during each main surgical period of adult liver transplantation (preanhepatic, anhepatic, reperfusion, and neo-hepatic period). Data are presented as means ± standard deviation. Statistical analysis was performed using simple linear regression analysis to observe whether changes in the PICCP were paralleled by simultaneous changes in the CICCP. Bland-Altman analysis was used to determine the degree of agreement between the two devices. Analysis of variance was performed to study whether there were changes in the CVP agreement profiles in regard to the different time periods of LT. Differences were regarded as being statistically significant when p values were less than 0.05.

(This observational study has been completed already.)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who had been scheduled for elective liver transplant surgery
* Patients who had been placed with both PICC and CICC at anesthetic induction

Exclusion Criteria:

* Failure to insert PICC
Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.

Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. In particular, the traditional work-up for these pathologies includes endoscopy, magnetic resonance imaging (MRI) and computed tomography (CT). Furthermore, the integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting. In particular, PET is taking on an increasingly relevant role for the study of neuroendocrine tumors, also thanks to the introduction of increasingly accurate radiopharmaceuticals (targeted towards somatostatin receptors), thus opening the way to new possibilities for the diagnosis andcharacterization of these tumors, is in the staging and restaging phase .


Eligibility Criteria:
Inclusion Criteria:

* Adult patients affected by neuroendocrine tumors; Patients who have performed at least one PET study with 18F-FDG and/or 68Ga- DOTATOC for the staging or diagnosis of their pathology.

Exclusion Criteria:

* Patients \< 18 years old;
* Lack of availability of clinical data and PET imaging useful for analyses.
Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin may have different effect on the development of incident diabetes. In the West of Scotland Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. In this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects have early diabetes mellitus or prediabetes. Early diabetes mellitus or prediabetes are defined according to the following criteria; Subjects have two or more of the following three, or they have one of them at the initial test and the repeat test.

  1. hemoglobin A1C 5.7-9.0%
  2. fasting plasma glucose level 100mg/dL or more
  3. plasma glucose level 140mg/dL or more at 2 hours after 75g oral glucose tolerance test
* Subjects have one of the following three;

  1. Low-density lipoprotein cholesterol (LDL-cholesterol) 130mg/dL or more, and body mass index (BMI) \> 23 kg/m2,
  2. 10 year atherosclerotic cardiovascular disease (ASCVD) risk of 7.5% or more, which is assessed by the ASCVD-Risk-Estimator (Circulation.2014;129:S1-S45)
  3. In diabetic patients, LDL-cholesterol 100mg/dL or more

Exclusion Criteria:

* Hemoglobin A1C \> 9.0%
* History of statin use in three months
* Use of oral antidiabetic drugs except for metformin in three months
* History of malignant diseases (cancers)
* History of coronary artery diseases, heart failure, arrhythmia, valvular heart diseases, or cerebrovascular diseases
* Pregnant
* serum creatinine level \> 1.5 mg/dL
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels higher than 80 U/l
* Taking weight loss medications, corticosteroids, Angiotensin converting enzyme (ACE) inhibitors, or estrogen replacement therapy
* Chronic hepatitis B or chronic hepatitis C
HIV Pre-exposure Prophylaxis Implementation Hong Kong Study

While pre-exposure prophylaxis (PrEP) is widely recommended and a number of pilot studies are on-going worldwide, progress of its implementation in the real world setting has been slow, especially in Asia. This study aims to develop a service model for PrEP delivery and test its operability in the real world setting. In this implementation study, 400 individuals with high sexual risk of HIV infection who fulfil eligibility criteria would be recruited. Eligible participants would receive one year of daily tenofovir disoproxil fumarate 300mg / emtricitabine 200mg (TDF/FTC) for free. A client-initiated approach would be adopted, requiring participants to self-arrange for regular HIV/sexually transmitted infections (STI) testing. An online system would be developed to facilitate participants to plan for testing and consultation for accessing PrEP. Questionnaire at baseline and subsequent monthly follow-up would be administered to assess behaviour, monitor adverse effects and drug adherence, the latter coupled with the completion of an online diary. Testing of HIV and creatinine would be performed using point-of-care test or by phlebotomy during clinical visits. Blood samples would be collected for archiving. Around 40 participants would be invited to join an in-depth interview in the later part of the study to evaluate the service model. The main outcome measures are: PrEP service adherence, PrEP drug adherence, prevalence of drug intolerance, prevalence of unprotected sex in the study period, incidence of HIV and STI


Eligibility Criteria:
Inclusion Criteria:

* Can communicate in written and spoken English or Chinese
* Is normally resident in Hong Kong
* Has tested HIV antibody negative in the past 3 months
* Has more than 1 episode of unprotected sex (especially anal sex) in the preceding 6 months
* Has any one of the following experiences in the past 6 months: chemsex engagement, group sex, multiple sex partners, STI diagnosis, having sex partner(s) with HIV+ve status
* Is inclined to engage in high risk sexual activities

Exclusion Criteria:

* Chronic HBV infection (HBsAg +ve)
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \< 60mL/min/1.73m2
* Having any form of mental illnesses
* Inability or refusal to give consent
* Prisoners or any institutionalised persons
* Pregnant or planning to get pregnant (for female)
* Injection drug user
Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2

This study assess the ways in which e-cigarette product characteristics, such as flavors and nicotine salts, impact user experience to inform potential regulations.

There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile.

Eligibility Criteria:
Inclusion Criteria:

Vapers/E-cigarette Users - Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

- Regular use of cigarettes containing nicotine

Exclusion Criteria:

* Pregnant or planning to become pregnant
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients

The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are well-controlled by the treatment with prednisone
* Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain

Exclusion Criteria:

* Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
* Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
* Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
* Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
* Pancreatitis or diabetes
* Serum creatinine≦1.5mg/dL
Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté)

Observational study about patients treated for a metastasis breast cancer who live far from their comprehensive cancer center and followed by telemedicine, connected wtaches and patient-reported symptom monitoring.

Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls.

If nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Women more than 18 years old
* Treated for an advanced metastasis breast cancer
* Who live far from their comprehensive cancer center in the Landes department

Exclusion Criteria:

* Women who are not able to understand the study because of psychiatric disease
EMERALD TRIAL Open Label Extension Study

EMERALD OLE trial is an open-label extension of the EMERALD trial. Long term tolerability and safety of the MediCabilis CBD oil has not been extensively studied. EMERALD OLE aims to establish data on the prolonged used of the study drug product.

All participants who completed the EMERALD trial will be offered to enter EMERALD OLE. Participants will be taking the active drug MediCabilis CBD oil for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ALS/MND, either definite or probable according to the El Escorial revised criteria
* Can provide written informed consent
* Able and willing to comply with all study requirement
* Male or female, 25-80 years old
* Randomised into the EMERALD trial

Exclusion Criteria:

* Participants who are bedridden
* History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
* Heavy consumption of alcohol or use of illicit drug
* Hypersensitivity to cannabinoids or any of the excipients
* Any of the following: eGFR \<30 mL/min/1.73m2, ejection fraction \<35%, or AST and ALT \>5 X ULN
* Unwillingness of a female participant of child-bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
* Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
* Received any investigational drug or medical device within 30 days prior randomisation except MediCabilis CBD Oil
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
* Inability to cooperate with the study procedures
* Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
* Close affiliation with the study team, e.g. close relative of the investigator
PAVmed CarpX Device Clinical Study

To study the safety and feasibility of the CarpX device to divide and release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome (CTS).

This is a prospective, single center, single arm, study of the CarpX device for treatment of carpel tunnel syndrome. Patients will be followed for up to 30 days post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years old
* Patient is scheduled to undergo carpal tunnel release surgery
* Patient has failed to respond to conservative treatment of CTS
* CTS confirmed by strong clinical signs and positive Nerve Conduction Velocity (NCV) test
* Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures Patient is willing and able to complete follow-up requirements

Exclusion Criteria:

* Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand that is unrelated to carpal tunnel syndrome.
* Patient with stiff wrist, suspected space occupying lesions or other anatomic abnormalities of the forearm, wrist or hand or other concerns related to patient anatomy such as small wrist and/or thin skin
* Prior invasive treatment of the hand or wrist for disease processes such as De Quervain's syndrome, arthritic wrist etc. on the intended treatment side
* Previous trauma/fracture or other anatomic abnormalities of the forearm, wrist or hand on the intended treatment side
* Patient has an ipsilateral injury or other conditions affecting hand function
* Patient has acute CTS resulting from an injury (e.g., fracture)
* Patient has had previous CTR surgery on the affected hand
* Patient has severe chronic median nerve neuropathy shown by the EMG and NCS that shows denervation of the thenar muscle
* Active local or systemic infection
* Known allergy to any device component
* Known severe allergy to contrast reagent that cannot be managed with premedication
* Any significant medical condition(s) that would place patient at excessive risk for surgery such as: known bleeding disorder including thrombocytopenia (platelet count \< 80,000), thrombasthenia, hemophilia or Von Willebrand's disease, unstable cardiac disease, renal failure or uncontrolled diabetes
* Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating
* Women who are pregnant
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction

Obesity and its adverse cardiometabolic consequences are major public health problems. Several features of obesity contribute to the associated cardiovascular risk and are potential targets for intervention. These include insulin resistance and beta cell dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic health in individuals who are obese and insulin resistant.

Obesity is a risk factor for nearly all cardiovascular (CV) disease including coronary artery disease, hypertension, and heart failure. Increased CV risk in obese individuals appears to depend largely on the degree of metabolic dysregulation and metabolic risk factors (glucose intolerance, dyslipidemia, etc.). Notably, interventions that improve insulin sensitivity and cardiorespiratory fitness can reduce CV risk in obese individuals, even in the absence of weight loss.

The cyclic guanylate monophosphate pathway (cGMP) is involved in energy homeostasis and systemic metabolism. Multiple lines of evidence suggest that increasing cGMP activity is beneficial from a metabolic standpoint. Tadalafil is a clinically-available drug that inhibits the enzyme that breaks down cGMP.

The study investigators hypothesize that chronic PDE5 inhibition in obese, insulin-resistant adults will improve cardiometabolic health.

Aim 1: To examine the effect of PDE5 inhibition on energy expenditure. Aim 2: To examine the effect of PDE5 inhibition on insulin sensitivity and secretion.

Aim 3: To examine the effect of PDE5 inhibition on cGMP tone and circulating mediators of cardiometabolic risk.

Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 21-50)
* Obesity (BMI ≥ 30 kg/m2)
* Prediabetes on oral glucose tolerance test.

Exclusion Criteria:

* Age \<21 or \> 50
* BMI \< 30 kg/m2
* Systolic blood pressure (SBP) \< 100, \> 150 mmHg
* Current anti-hypertensive medication use, including diuretics
* Current use of organic nitrates
* Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
* History of reaction to PDE-5 inhibitors
* Known HIV infection
* Use of medications that strongly alter CYP3A4 activity
* History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
* Known non-arteritic ischemic optic retinopathy (NAIOR)
* History of hearing loss
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
* Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
* Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study
* History of priapism
* Use in excess of four alcoholic drinks daily
* History of diabetes mellitus or use of anti-diabetic medications
* Known anemia (men, Hct \< 38% and women, Hct \<36%)
* Menopause
* Inability to exercise on a bicycle
* Weight \> 300 pounds
Improving Cognition in Schizophrenia Using Non-invasive Brain Stimulation

This is a double-blind sham-controlled study to evaluate the effects of the combination of non-invasive brain stimulation, i.e. transcranial direct current stimulation (tDCS), with brief cognitive training (CT) on cognition in patients with schizophrenia. All participants will practice the same cognitive training tasks and will be randomised to either real tDCS or sham stimulation. Patients with schizophrenia will undergo the study interventions while maintaining their standard treatment with antipsychotic medications.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Treatment with stable doses of antipsychotic medications. For the purpose of this study stability is defined as a not more than 50% change in the dose of their antipsychotic medication 3 months preceding the screening visit.
* Age between 18 and 55 years
* Written and witnessed informed consent
* Participants must read and write in English at a level sufficient to understand and complete study-related procedures

Exclusion Criteria:

DSM-IV diagnosis of alcohol or drug dependence in the 6 months, current treatment with benzodiazepines or hypnotics

* Current or past skin disease
* History of a neurological disorder or a systemic illness with known neurological complications; including epilepsy
* History of seizures
* Head injury, accompanied with loss of consciousness or/and required hospitalization
* Unwillingness or inability to follow or comply with the procedures outlined in the protocol
the Impact of Noise on Requirements of Anesthetics During General Anesthesia

The investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. Study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. Desflurane requirements are adjusted using neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are randomized to receive hearing protections or not.

All patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. Placement of epidural catheters takes place before induction of general anesthesia. Thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery.

Following induction of general anesthesia and tracheal Intubation, intraoperative hypnosis is maintained using desflurane.

Eligibility Criteria:
Inclusion Criteria:

* full contractual capability
* written informed consent
* abdominal surgery in combined general/epidural anesthesia
* position during surgery: supine
* clinically normal hearing

Exclusion Criteria:

* history of psychiatric disease
* history of intraoperative awareness
* clinically impaired Hearing
* contraindication for placing an epidural catheter