cyrilzakka/clinical-trials huggingface dataset:
Information Recall on Informed Consent to Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke.

The aim of the study is to investigate the ability to recall information given during informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.

The purpose of this prospective multi-center study is to investigate whether patients with acute ischaemic stroke are able to recall information given before providing informed consent to intravenous thrombolysis after the end of treatment. Patients with acute ischaemic stroke will be compared to a group of relatives who witnessed the informed consent procedure of a relative with acute ischaemic stroke, stroke patients who were not treated with intravenous thrombolysis and patients without an ischaemic stroke but similiar risk factors (admitted to the Departement of Cardiology and Pneumology, Charité, Campus Benjamin Franklin, Berlin, Germany).

Eligibility Criteria:
Inclusion criteria (all):

* age ≥18 years
* able to give informed consent
* ability to understand and read German
* no prior i.v.-thrombolysis

Additional inclusion criteria - patients with acute ischaemic stroke:

* suspected ischaemic stroke (according to brain CT) or MRI-proven acute ischaemic stroke
* indication for intravenous thrombolysis

Additional inclusion criteria - relatives:

· relative (1st or 2nd dregree) of a patient with acute ischaemic stroke and present during the informed consent procedure

Additional inclusion criteria - stroke patients with a contraindication for thrombolysis:

* ischaemic stroke (according to brain MRI or CT)
* contraindication for intravenous thrombolysis

Additional inclusion criteria - non-stroke patients:

· present admission at the Department of Cardiology and Pneumology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany

Exclusion criteria (all groups):

* not able to give imformed consent or under legal supervision/guardianship
* participation in an interventional study
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.

This is a, prospective single center pilot study to investigate whether ctDNA detection can be improved by sampling the cancer draining vein vs. a peripheral vein (current practice). As a secondary endpoint, both ctDNA results will be compared with percutaneous biopsy (standard of care).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
* Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
* Must be able to provide a written informed consent

Exclusion Criteria:

* Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
* Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
* Patients with uncorrectable coagulopathy
* Platelet count \< 30,000/ul
* International Normalized (INR) \> 1.5
* Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
* No clear reachable target for percutaneous or trans-jugular biopsy
* Patient who cannot have a peripheral blood draw for ctDNA
Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection

The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

Gonococcal infections, including urethritis, cervicitis, epididymitis, and proctitis, are a significant cause of morbidity among sexually active men and women. The treatment of these sexually transmitted infections (STIs) has evolved over the years, mainly due to the emergence of antibiotic resistance. The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates. Ceftriaxone is highly effective against susceptible N. gonorrhoeae. Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. These doses of ceftriaxone are higher than previously recommended due to concerns regarding rising gonococcal minimum inhibitory concentrations (MICs) worldwide. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline (100 mg orally twice daily for seven days) was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Hypersensitivity to cephalosporins or penicillins
* significant renal failure or hepatic failure
Gender Influence on Torsadogenic Actions of Droperidol.

Postoperative nausea and vomiting (PONV) is a quite common complication affecting patients undergoing general anesthesia. There are a few pharmacological agents of well known effectiveness in reducing the risk of PONV. One of them is droperidol, which is a butyrophenone derivant. It has been widely used for the prevention and treatment of PONV due to its high effectiveness and low cost. Though, droperidol has a relevant side effect, that is a repolarization prolongation. This can lead to life-threatening cardiac arrhythmias: polymorphic ventricular tachycardia (torsades de pointes, TdP) that can degenerate into ventricular fibrillation and cardiac arrest. This was a reason why in 2001 the FDA issued a "black box" warning on droperidol. Ever since papers focused on this problem have described the influence of small doses of droperidol on TdP genesis as weak. This could be explained by the fact, that QT/QTc (corrected QT) interval prolongation, which represents prolonged cardiac repolarization on ECG, is not the sole determinant of a drug's potential to cause arrhythmia. Another electrocardiographical marker of torsadogenic action is increased transmural dispersion of repolarization (TDR). TDR represents differences in the repolarization between myocardial "layers" (like epicardium, endocardium, myocardium cells). It is believed that the induction of QT/QTc lengthening must coexist with TDR increase at the same time to promote torsadogenic changes.

It has been known, on the basis of research, that females have been more potent to torsadogenic actions of pharmacological agents than males. That could be related to estrogen influence on ECG parameters, which had been proven on animal model. It hasn't been investigated, whether gender is an important factor when considering droperidol's torsadogenic potential.

The aim of this study is to answer a hypothesis, that women are more potent to torsadogenic actions of droperidol in comparison with men.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 45 years old
* ASA (American Society of Anaesthesiologists) physical status 1 and 2

Exclusion Criteria:

* lack of informed consent
* ASA (American Society of Anaesthesiologists) physical status 3 and more
* admittance of repolarisation affecting drugs like: antiarrhythmics (Williams group I-IV), psychotropics, macrolides, antireflux drugs
* ischaemic heart disease
* cardiac failure NYHA (Hew York Heart Association) 1 and more
* congenital or acquired heart defects
* arrhythmias in anamnesis
* hormonal contraception,
* postmenopausal
* neoplasms
Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic arterial occlusive disease who presented with intermittent claudication

Exclusion Criteria:

* Recent myocardial infarction
* Severe valvular heart disease
* After organ transplantation
* Cardiomyopthy( EF\< 25%)
* Liver failure
* Coagulopathy
* HIV
* Pregnancy
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
* Evaluable disease or disease measurable per RECIST 1.1
* Life expectancy \>= 12 weeks
* Adequate hematologic and end organ function
* Consent to provide archival tissue

Exclusion Criteria:

* History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment
* History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
* Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment
* History of glaucoma
* Intraocular pressure \> 21 mmHg as measured by tonometry
* Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
* History of retinal vein occlusion (RVO), neurosensory retinal detachment, or neovascular macular degeneration
* Allergy or hypersensitivity to components of the GDC-0994 formulation
* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
* Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
* Prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer
* Current severe, uncontrolled systemic disease
* History of clinically significant cardiac dysfunction
* Pregnancy, lactation, or breastfeeding
* Active autoimmune disease
* Inability or unwillingness to swallow pills
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
* Any condition requiring warfarin or thrombolytic anticoagulants
* Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 46 subjects were randomly divided into Hydrolysed Red Ginseng extract 10ml or placebo group. The investigators measured Ocular Surface Disease Index, tear break-up time, Visual analog scale, Schirmer's test, meibomian gland test and Fluorescein staining.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 19years
* Ocular Surface Disease Index score is 13 scores and more at a screening
* Tear Break-Up Time is 10 seconds less or those who have positive in ocular staining test at a screening
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have clinically significant acute or chronic ophthalmologic, cardiovascular system, endocrine, immune, respiratory, liver biliary system, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Those who couldn't control diabetes at screening
* Those with acute eye infections or inflammation within 1 month before screening
* Those who have ophthalmic surgery within 3 months before screening
* Those who use contact lens 1 month before screening
* Those who take a medication or health function food that affects your promotion of dry eye within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by showing the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breastfeeding
* Those who don't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in the study because of Laboratory test results, etc.
Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients

This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers tested include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation
* Willing to give informed consent

Exclusion Criteria:

* Patients with co-existing renal diseases
Ultrasound Guided Central Vein Catheterization and Complications

There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

Exclusion Criteria:

* Refuse
* hematologic disorder
* Anatomical abnormalities of central vein structure
Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment

To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.

Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.

Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.

174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.

The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.

The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee replacement
* Successful spinal placement
* ≥18 years old

Exclusion Criteria:

* Failed spinal anesthesia
* Chronic opiate users
* Liver disease patients
* Allergy/hypersensitivity to acetaminophen
* Patients with baseline dementia
* Patients weighing less than 50kg, history of alcohol dependence, renal impairment, opiate allergy, and pregnancy.
Restrictive Fluid Management In Liver Transplantation (REFIL)

Hypothesis: A Canadian multicentre clinical trial is feasible. Study Design: Multicenter internal pilot parallel arm randomized controlled trial

Study population: Patients with end-stage liver disease undergoing a liver transplantation not meeting any exclusion criteria.

Primary endpoint: The primary feasibility endpoint is an overall recruitment rate ≥ 4 patients/month across all three participating sites.

Secondary endpoint: The secondary feasibility endpoints are a protocol adherence \> 90%, a 30-day (or hospital discharge) and 6-month outcome measurement \> 90%, and a mean difference in total intraoperative volume received (crystalloids and colloids combined) \> 1000 ml between groups.

Study intervention: Low splanchnic blood volume restrictive fluid management strategy (intervention). A phlebotomy, performed prior to dissection and transfused back after graft reperfusion, combined with a hemodynamic goal-directed restrictive fluid management strategy

Optimized cardiac-output liberal fluid management strategy (control) A hemodynamic goal-directed liberal fluid management strategy that optimizes cardiac output throughout surgery

MAIN OBJECTIVE The main objective of the REFIL-1 pilot study is to establish the feasibility (recruitment, adherence, outcome measurement) of conducting a Canadian multicentre randomized controlled trial comparing an intraoperative low-splanchnic blood volume restrictive fluid management strategy to a cardiac output optimised liberal fluid management strategy in adult LT for ESLD. The hypothesis is that a Canadian multicentre clinical trial is feasible.

SECONDARY OBJECTIVES The overarching objective of the ReFIL (Restrictive Fluid management In Liver transplantation) research program, which will be answered in a future large-scale trial, regards the efficacy of the proposed interventional strategy to improve postoperative outcomes in LT.

TERTIARY OBJECTIVES Our tertiary objective is to measure the cost-effectiveness of the proposed intervention based on the composite outcome of any severe postoperative complications and graft loss.

DESIGN AND STUDY POPULATION This study a multicentre internal pilot parallel arm randomized trial comparing two intraoperative hemodynamic and splanchnic blood volume management strategies in LT recipients.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient ≥ 18 years of age undergoing liver transplantation for ESLD.

Exclusion Criteria:

* Patients undergoing LT for an indication other than ESLD such as acute liver failure, liver cancer without ESLD, retransplantation, amyloid neuropathy or any other indication not associated with ESLD.
* Patients undergoing a combined liver and lung or liver and heart transplantation.
* Patients with any of the following conditions:
* severe chronic renal failure (GFR \< 15 ml/minute/1.73 m2 \[CKD-EPI equation\] or already on RRT);
* severe anemia (hemoglobin level \< 80 g/L);76,93,109
* hemodynamic instability (norepinephrine equivalent \> 10 ug/min).