cyrilzakka/clinical-trials huggingface dataset:
Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects

Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with congestive heart failure NYHA I-II
* Stable clinical condition

Exclusion Criteria:

* Resting systolic blood pressure \< 100
* Resting heart rate \< 50
* Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients

The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study medication will also be assessed.

This is an open-label, multicenter, randomized, 3-arm trial to compare the pharmacokinetic profile and the safety profile between 3 dose groups. There are 2 periods in this study: a 10-week treatment period and an 8-week follow-up period. Patients will receive 6 injections of long acting injectable risperidone at one of the dose levels (25, 37.5 and 50 mg) every 2 weeks according to their randomly assigned treatment. Blood samples will be collected throughout the 10-week treatment and 8-week follow-up period to determine the changes in study drug concentration in the plasma. Safety will be assessed by monitoring of adverse events, subjective symptoms/objective findings, laboratory tests, physical examinations, electrocardiograms, injection site reactions, and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). Efficacy of the study drug will be assessed based on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Change (CGI-C) scales. The patients will receive injections of long acting injectable risperidone (either 25, 37.5, or 50 mg) in their muscle every 2 weeks for 10 weeks for a total of 6 injections.

Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with a DSM-IV diagnosis of schizophrenia
* A Positive and Negative Syndrome Scale (PANSS) total score between 60 (included) and 120 (excluded)
* In- or out-patients (change of institutionalization status during the trial period is allowed).

Exclusion Criteria:

* No DSM-IV diagnosis other than schizophrenia
* No convulsive disorders such as epilepsy
* No neuroleptic malignant syndrome or physical fatigue associated with dehydration, malnutrition
* No present illness or history of diabetes or risks of diabetes such as hyperglycemia and obesity
* No hemorrhagic diathesis.
AVACEN Hand Heating on Fasting Blood Glucose

A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes diagnosis, diabetes medication, blood pressure medication
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.


Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills the ASAS classification criteria of axial spondyloarthritis (except Crohn's disease criterion) for \> 3 months with age of onset \< 45 years of age
* Subject has Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) score greater than or equal to 4 at screening and baseline
* Subject has spinal pain score (BASDAI question #2) greater than or equal to 4 at screening and baseline
* Subject has had adequate therapeutic trial (at least 4 weeks) of greater than or equal to 2 non-steroidal anti-inflammatory drgs (NSAIDs) at the maximum recommended dose unless contraindicated or subject is intolerant
* For subjects receiving non-biologic DMARDS subject has received treatment for greater than or equal to 3 months with a stable doe for greater than or equal to 4 weeks prior to initiation of IM
* For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for equal to or greater than 4 weeks prior to initiation of IMP

Exclusion Criteria:

* Complete ankylosis (fusion) of the spine; Subject has a positive test for tuberculosis
* Subject has a planned surgical intervention between baeline and week 16
* Subject has an active infection or history of infections as follows (any active infection for which systemic anti-infectives were used within 28 day prior to the first MP dose
* A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose
* Recurrent or chronic infections or other active infection that, in the opinion ofthe investigator might cause this study to be detrimental to the subject)
* Subject has active Crohn's disease or a history of Crohn's disease
* Subject has active ulcerative colitis requiring daily use of immunosuppressive therapy
* Subject has had active fibromyalgia within the past 12 months
* Subject has a prior history of greater than 1 anti-TNF therapy for ankylosing spondylitis
* Subject has used commercially available or investigational biologic therapies for ankylosing spondylitis as follows

  * Anti-tumor necrosis factor (TNF) therapy as follows: within 1 month prior to IMP initiation for etanercept and within 2 months prior to IMP initiation for other anti-TNF agents.
  * Other experimental or commercially available biologic therapies for ankylosing spondylitis within 3 months prior to IMP initiation
  * Anti-IL17 biologics (eg, brodalumab, secukinumab, ixekizumab) or anti-IL12/IL23 biologic therapy (eg, ustekinumab, briakinumab) at any time
  * Rituximab at any time
ALDOA Expression in Bladder Urothelial Carcinoma

1. Study the immunohistochemical expression of ALDOA in bladder urothelial cancer.
2. Correlate between ALDOA expression in specimens and different cilnicopathological factors.
3. Correlate between ALDOA expression and urothelial cancer prognosis and survival.

Bladder cancer is the 7th most prevalent malignancy and the 13th cause of cancer related death worldwide1. In Egypt, it's the third most common tumor2.

The most common histologic subtype of bladder cancer is urothelial carcinoma3. Bladder cancer is divided according to absence or presence of muscle invasion into non-muscle invasive bladder cancer and muscle invasive bladder cancer 3.

Despite the advance in diagnosis and development of therapeutic options of urothelial cancer, the recurrence and progression rate remains high4.

The conventional histopathological evaluation of urothelial cancer is vital for diagnosis and prediction of patient's prognosis. However, it doesn't fully reflect the biological behavior of the tumor or the clinical outcome of the patient5.

Under hypoxic conditions, cancer cells produce ATP by glycolysis, which provide energy for tumor proliferation and dissemination6,7. Glycolytic enzymes are abnormally activated in cancer cells8,9. Thus, several studies have identified glycolytic enzymes or related metabolic pathways as potential drug targets. One of the typical glycolytic enzymes is Aldolase A (ALDOA) 6 which is the most abundant glycolytic enzyme detected in tumors10.

Several studies have identified ALDOA as an oncogene in different types of malignancy 6,8,10-12. The oncogenic potential of ALDOA contributed to its ability to stimulate DNA synthesis and accelerate S phase in tumor cell cycle6-8.

In addition, studies have shown that ALDOA promotes tumor cell invasion by negative regulation of E-cadherin and by activation of MAPK, AKT and EGFR signaling pathways7,11,13.

Thus, increased expression of ALDOA in tumor predicts a bad prognosis and poor survival of patients13-15.

Eligibility Criteria:
Inclusion Criteria:

* All cases diagnosed as bladder urothelial cancer with known follow-up data and presence of muscle proper detected in the specimens.

Exclusion Criteria:

1. Subtypes of bladder cancer other than urothelial carcinoma subtype.
2. Cases of urothelial carcinoma without known follow up data.
3. Cases of urothelial carcinoma without muscle proper detected in the specimen.
Influence of FSH/LH Ratio in Controlled Ovarian Stimulation

The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF cycles in Cruces University Hospital.
* Signed IVF and cryopreservation informed consent.
* Age \>35 and \<40 years.
* FSH levels \<10 mIU/ml.

Exclusion Criteria:

* When inclusion criteria are not fulfilled
Targeted Forceps Biopsy for Colorectal Tumors

This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal neoplasms of the size larger than 2 cm

Exclusion Criteria:

* Patients who deny the participation in the study
A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C

The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c), given intravenously to patients with chronic hepatitis due to infection with the genotype 1 version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of virus circulating in the patients' blood.

Hepatitis C virus (HCV) chronically infects 1% to 3% of the world's population, including about 3.9 million infected patients in the United States, with an estimated 36,000 new cases in the US each year. 70-85% of infected individuals develop a chronic infection complicated by chronic liver disease during the next 20 to 30 years, which is the tenth leading cause of death in the US. HCV is implicated in the development of hepato-cellular carcinoma. Chronic HCV hepatitis is the most frequent reason for liver transplantation. HCV genotype 1 is the most common genetic variant of HCV causing HCV hepatitis in the US. It responds less well to conventional anti-HCV treatment than the other HCV genotypes, so that 60% of genotype 1 patients fail conventional therapy due to the virus's resistance to treatment and/or due to toxic side effects of the therapy.

Extracellular levels of ascorbic acid (vitamin c) attainable only by high-dose, intravenous administration, are reported to have in vitro and in vivo anti-cancer and anti-viral effects in humans and animals. Ascorbic acid briefly generates extracellular hydrogen peroxide, an oxidative stress specifically toxic to cancer cells and cells infected with viruses, including HCV, but not to normal cells. High-dose, intravenous ascorbic acid has been given to large numbers of patients, particularly cancer patients, with anecdotal reports of good safety and occasional benefit. Given the foregoing, the investigators propose that there is sufficient rationale for a careful pilot study of the safety and anti-viral efficacy of infused ascorbic acid in HCV genotype 1 hepatitis.

Eligibility Criteria:
Inclusion Criteria:

* hepatitis C, genotype 1
* failed treatment with interferon-alpha and ribavirin
* abstain from alcohol consumption for the duration of the study

Exclusion Criteria:

* cirrhosis
* decompensated liver disease
* glucose6phosphate dehydrogenase deficiency
* AST or ALT more than 5 times upper limit of normal
* platelets less than 125,000
* diabetes mellitus
* alcohol and/or drug abuse within 1 year of screening
CRP Monitoring After ICR in CD Patients

Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease.

Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.

In colorectal surgery, inflammatory markers (CRP, PCT) are used systematically in the postoperative period as an early predictor of postoperative complications and in particular the prediction of anastomotic leaks and intra-abdominal septic complications.

Indeed, the occurrence of an anastomotic leak (5 to 15% of cases) involves the introduction of antibiotics, the carrying out of invasive procedures which can go as far as reoperation (and the establishment of ostomy) and always increases the length of stay and the cost of hospitalization. It is therefore essential to benefit from the most sensitive and specific tools to detect this serious and sometimes lethal complication at an early stage.

Numerous studies have evaluated and demonstrated the value of monitoring the CRP in the early postoperative period to detect the occurrence of an anastomotic leak. However, the majority of these studies presented heterogeneous populations for two reasons: all types of colorectal surgery interventions were included (right colectomy, transverse colectomy, left colectomy and anterior resection of the rectum) and multiple surgical indications were taken into account (colorectal cancer, inflammatory bowel disease, colonic diverticulosis).

In addition, a 2015 study comparing the postoperative monitoring of markers of inflammation after ileocolic resection of patients with, on the one hand, Crohn's disease and, on the other, colon cancer showed a greater inflammatory reaction in patients with Crohn's disease (in particular on POD1, 4, 5 and 6) without identifying a threshold value. This increased inflammatory response can be explained by a greater inflammatory state than in the general population: bacterial translocation due to an alteration of the mucosal barrier aggravated by immunodeficiency.

It thus appears that the cut-off values usually used (170-175 mg/l on POD3 and 125mg/l on POD4) are probably not suitable for the postoperative monitoring of these patients and for prediction of intra-abdominal septic complications.

No study to date has identified a threshold value of postoperative CRP that can predict the occurrence of postoperative anastomotic fistula and intra-abdominal septic complications after ileocecal resection for Crohn's disease.

Eligibility Criteria:
Inclusion criteria:

* Patients who underwent an ileocolic resection for Crohn disease
* Patient ≥18 years old

Exclusion Criteria:

- Patient who reject the study protocol
Balanced Solution Versus Saline in Intensive Care Study

A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients

Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.

Eligibility Criteria:
Inclusion Criteria (all three):

1. Need for plasma expansion, and the clinician considers that Plasma-Lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion.
2. Patients not expected to be discharged on the day after their admission.
3. At least one of the following risk factors for acute renal injury:

   1. Age ≥ 65 years
   2. Hypotension (mean arterial pressure \[MAP\] \< 65 mmHg or systolic blood pressure \[SBP\] \< 90 mmHg) or use of vasopressors
   3. Sepsis
   4. Use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) \> 12 hours
   5. Oliguria (\< 0.5 mL/kg/hour for ≥ 3 hours)
   6. Serum creatinine ≥ 1.2 mg/dL for women or ≥ 1.4 mg/dL for men
   7. Liver cirrhosis or acute liver failure

Exclusion Criteria (any of the below):

1. Age \< 18 years
2. Acute renal failure treated with renal replacement therapy (RRT) or expected to require RRT within the next 6 hours
3. Severe hyponatremia (serum sodium ≤ 120 mmol/L)
4. Severe hypernatremia (serum sodium ≥ 160 mmol/L)
5. Death considered imminent and inevitable within 24 hours
6. Patients with suspected or confirmed brain death
7. Patients under exclusive palliative care
8. Patients previously enrolled in the BaSICS study
A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal cancer
* Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
* Progression on or following treatment for metastatic colorectal cancer
* Progression within 12 months of adjuvant chemotherapy for colorectal cancer

Exclusion Criteria:

* Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
* Previous adjuvant therapy with irinotecan within 12 months of randomization
* More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.


Eligibility Criteria:
Inclusion Criteria:

Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

* Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
* Patient \>18 years
* Patient who understands the trial requirements and the treatment procedures and provides written informed consent

Exclusion Criteria:

Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
HOPE Against Cancer Recurrence in HCC

Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received.

Machine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion.

The objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recurrence is improved when the liver is perfused before implantation.

The study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.


Eligibility Criteria:
Inclusion Criteria:

* Adult recipients (\>18y), listed for liver transplantation with documented HCC (Liver Imaging Reporting and Data System (LIRADS) 5 lesion in magnetic resonance imaging or computer tomography of the liver or biopsy proven),
* within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and the number of tumours at the time point of liver transplantation,
* written informed consent for the trial. This also includes patients beyond the up to seven criteria after successful downsizing of the HCC

Exclusion Criteria:

* Donation after circulatory death (DCD) liver grafts
* Combined liver transplants
* Partial liver transplants
* Combined or mixed hepatocellular cholangiocarcinoma (cHCC-CCC) or pure cholangiocarcinoma or other malignancies in histopathology of the liver explant
* Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors
* Post-transplant treatment with mTOR inhibitors
* Acute and unexpected medical contraindications
* Pregnancy
* Cold storage time of \> 10 hours (both study arms)
Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension

The aim of this study was to investigate the efficacy and safety of low dose amlodipine alone, or combined with low dose terazosin in male patients with both lower urinary tract symptoms and hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Men 50 years or older
2. with LUTS \[defined as International Prostate Symptom Score (IPSS) \>= 10\].
3. Stage 1 or 2 essential hypertension (SBP \>= 140 mm Hg and \< 180 mm Hg and/or DBP \>= 90 mm Hg and \< 110 mm Hg)

Exclusion Criteria:

1. A history of postural hypotension
2. Secondary hypertension
3. Prostate cancer
4. Prostate surgery or other intervention
5. Use of any agents to influence the LUTS symptoms in the last 4 weeks
6. Other severe diseases