cyrilzakka/clinical-trials huggingface dataset:
Effect of Citrate on the Coagulation System in Patients Receiving CRRT

The aim of this study is to evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury. This will form the basis for future studies where the investigators plan to focus on patients with premature circuit clotting despite optimal post-filtrate ionised calcium parameters.

Purpose of clinical trial:

To evaluate the effect of regional citrate anti-coagulation on different pathways of the coagulation system in critically ill patients with acute kidney injury.

Patient population:

critically ill patients with acute kidney injury requiring citrate-based continuous renal replacement therapy (CRRT)

Primary objective:

Changes from baseline in a number of measures of coagulability (platelet count; Prothrombin Time; Activated Partial Thromboplastin Time ratio; fibrinogen; d-dimers; Thrombin generation assay; Clot lysis; platelet function analysis 100) in both the blood within the patient's systemic circulation and the CRRT circuit over the course of 72 hours of regional anticoagulation with citrate.

Number of Subjects/Patients:

12 patients with complete data.

Trial Design:

Prospective non-interventional study.

Endpoints:

Change from baseline in a number of measures of coagulability.

Main Inclusion Criteria:

Adult intensive care patients undergoing CRRT with citrate regional anti-coagulation for AKI.

Eligibility Criteria:
Inclusion criteria:

* acute kidney injury treated with citrate based continuous renal replacement therapy (CRRT)
* age \>18 years.
* expected to require \>72 hours of CRRT.

Exclusion criteria:

* Known preexisting clotting tendency
* Known preexisting bleeding tendency
* Disseminated Intravascular Coagulation (DIC)
* Prior transfusion of any blood product in the 24 hours before enrolment
* Active bleeding (ie. needing blood transfusion) at time of enrolment
* Haemoglobin at time of enrolment \<75g/L
* Haematocrit at time of enrolment \>0.55
* Patient would refuse Red Blood Cell transfusion (for example Jehova's Witness).
* Platelet count at time of enrolment \<100x103/µL
* Treatment with any anticoagulant or antiplatelet agent at time of enrolment or within 7 days of enrolment with the exception of heparin or low molecular weight heparin for DVT prophylaxis.
* Intravenous heparin exposure within 4 hours of commencing citrate anticoagulation.
* Malnourished: BMI \<18.5kg/m2 or unplanned weight loss \>10% actual body weight (ABW) in preceding 6 months or BMI \<20kg/m2 and unplanned weight loss \>5% ABW in preceding 6 months.
* CRRT prescribed for an indication other than AKI (for example poisoning).
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for \>or= to 6 months
* Stable regimen of metformin for \> or = to 1000mg/day or maximum tolerated dose) and a secretagogue \< or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
* Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
* HbA1c \>or= to 7.5% and \< or= to 11.0%
* BMI \< or = to 40kg/m2.
* FEV1\> or = to 70%, Total Lung capacity and \> or =80% DLco \> or= to 70%

Exclusion Criteria:

* Treatment with any type of anti-diabetic therapy, other than metformin \& secretagogues within the preceding 12 weeks
* Serum creatinine \> 1.4mg/dL in female subjects and \>1.5mg/dL in male subjects
* History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
* Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors

This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.

The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.

The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.


Eligibility Criteria:
INCLUSION CRITERIA

BOTH GROUPS

* M/F
* Patient agrees to follow study protocol and is able to follow study procedures
* Patient signed, dated and understood consent form
* Patient has a social security scheme

CASE GROUP

* Patient is 18 or older
* Patient for whom a bladder cancer recently diagnosed, or backsliding/progression is heavily suspected after the initial fibroscopy
* Patient who hasn't started systemic/oral/radiotheurapeutic pelvic treatment for his/her tumor

CONTROL GROUP

* Patient between 18 and 45 y/o
* Patient not suspected of having any bladder cancer
* Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology
* Patient who hasn't been exposed to bladder carcinogens (tobacco, industrial carcinogen (ex: coal tar, tar/coal oils, coal pitch and burning coal soot), urinary bilharzia, chemotherapy exposition (cyclophosphamid)
* Patient that had a negative cytopathological exploration of the excretory urinary route OR/AND iconography (pelvic echography, pelvic scanner) OR/AND endoscopy with prior urinary sample
* Patient unscathed of any cancer that might interact with bladder cancer : uterine cancer, prostate cancer, rectal cancer, and metastasis from other cancer or non-urologic tumor invading the bladder

EXCLUSION CRITERIA BOTH GROUPS

* Non-treated current urinary infection
* Patient with another pelvic cancer
* Bladder cancer outside of urothelial carcinoma
* Associated carcinoma of the high urinary apparatus
* Patient that received renal transplantation (BK virus)
* Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer)
* Patient having a JJ catheter
* Refused to signed consent
* Pregnant, susceptible to be, or breast-feeding women
* Person Under guardianship
* Impossibility to submit to medical monitoring because of geographic, social, or mental issues

CASE GROUP • Under 18y/o

CONTROL GROUP

• Under 18y/o or above 45 y/o
Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy

Local intra-articular injection of anesthetics (LIA) is increasingly used during knee arthroscopy for pain relief. The LIA can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. As a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. Since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable.

Intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the LIA.

The aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. In addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.

2X30 patients which are planned for elective knee arthroscopy are randomised: Lidocaine-group and Placebo-group.

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics paracetamol \& diclofenac, the patient is administered either linisol 2% (1.5 mg/kg) or placebo NaCl 0.9% (0.075 ml/kg = equivalent volume). At the end of the procedure, linisol or placebo is readministered at the same dose. The surgeon and anesthesiologist are blinded for patient allocation.

Postoperative analgesic consumption, nausea and vomiting (PONV), general comfort and pain scores are recorded. Visual Analogue scores (VAS) for knee pain are assessed before surgery, 1-15 minutes after awakening, at the moment of discharge from the post-anesthesia care unit (PACU) and at hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients which are planned for elective knee arthroscopy
* ASA 1 and 2
* knee arthroscopy suitable for intra-articular injection of anesthetics

Exclusion Criteria:

* contra-indication for lidocaine, paracetamol or diclofenac
* known history of severe post-operative nausea or vomiting
* knee arthroscopy associated with anterior cruciate ligament reconstruction
A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥ 18 years at the time of providing informed consent
* Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
* Willing and able to adhere to all protocol requirements
* Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
* Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
* Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
* A clinically significant medical or psychiatric condition
* A confirmed or suspected immunosuppressive condition
* History of seizures
* History of Guillain-Barré Syndrome
* Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
* Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
* Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
* Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
* Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
* Currently receiving treatment with warfarin or other anticoagulants
* Evidence or history of substance or alcohol abuse within the 12 months before study entry
* Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
* Females who are pregnant or lactating
* Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation
The Influences of Malnutrition and Inflammation Complex Syndrome in Hemodialysis Patients

The purpose of this study is to explore the severity of malnutrition and inflammation in Taiwanese hemodialysis patients.

Cardiovascular disease is the major of cause of mortality of hemodialysis patients. In addition to diabetes and hypertension, malnutrition and chronic inflammation are well-known to be major risk factors of cardiovascular diseases in normal population. For detecting the malnutrition and chronic inflammation and understanding the exact influences to hemodialysis patients, we conduct this study. We will collect the biochemical parameters, inflammatory markers, lipid parameters, hematologic parameters, and genomic DNA of patients. Then we will prospectively record the hospitalization, cardiovascular events, complications of arteriovenous fistula/graft, and mortality. According to the above results, we try to explore the exact role of malnutrition and inflammation in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received hemodialysis therapy for more than three months

Exclusion Criteria:

* Having active infection diseases now
* Patients who have a malignancy
* Had cardiovascular events in recent three months
Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block Vs. Adductor Canal Block Alone

In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.

Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.

Eligibility Criteria:
Inclusion Criteria:

* Physical status: ASA 1 or 2
* Age group: 21-40 years.
* No sex predilection.
* Patients undergoing arthroscopic knee surgery under spinal anesthesia.

Exclusion Criteria:

* Patient refusal
* Physical status: ASA III or above.
* Patients with contraindications for spinal anesthesia.
* Patients with history of drug allergies to study drugs.
* Evidence of local infection at site of injection.
* Neuromuscular pathology (example: - Multiple Sclerosis)
Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

Purpose: The purpose of this study is to evaluate the efficacy and safety of treatment with trastuzumab (Herceptin) along with the three other chemotherapy drugs, paclitaxel, carboplatin and gemcitabine, in patients who have advanced urothelial cancer. This clinical trial will also collect information (alternative therapy, response rates, overall survival) from enrolled patients with HER2 negative tumors who are ineligible to receive study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either metastatic or locally recurrent and not curable by surgery or radiation therapy.
* All patients must have tissue from either the primary or metastatic site tested for HER2 status determination. Patients with Her-2 negative tumors are not eligible for treatment on this protocol.
* All patients must have a blood sample drawn for HER2 serologic testing.
* If the available tissue is from the primary tumor and is HER2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible ONLY if this demonstrates HER2 over-expression.
* Patients may not have received prior systemic chemotherapy for metastatic disease. Patients may have received adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol treatment.
* Patients may not have cardiac disease and must have adequate cardiac function (ejection fraction \> 50% or higher than the lower limit of institutional normal) as determined by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and no evidence of symptomatic coronary artery disease (baseline EKG must show no active ischemia). Patients must not have history of congestive heart failure.
* If patients have received prior radiation therapy, disease must be present outside of radiated fields and at least 4 weeks must have elapsed since discontinuation of that therapy.

Exclusion Criteria:

* Pregnant or lactating women may not participate.
* HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
Testing a Resilience Intervention for Individuals Aging With Multiple Sclerosis (MS)

This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week telephone-delivered program to promote resilience and happiness for individuals living with MS.


Eligibility Criteria:
Inclusion Criteria:

* 45 years of age
* Diagnosis of multiple sclerosis
* regular access to the phone and internet
* willing to join a moderated group on MSConnection.org

Exclusion Criteria:

* under 45 years of age
* no diagnosis of multiple sclerosis
* no access to the phone or internet
* unwilling to join moderated group on MSConnection
A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years of age
* Voluntarily signed an informed consent
* Confirmed NSCLC and Stage IIIB or IV disease.
* At least a ≥15 pack year smoking history and must have been an active smoker within 20 years of diagnosis.
* Must have archival NSCLC tissue available to provide for analysis or have a lesion that is accessible for biopsy
* Must have experienced disease progression during or after receiving at least 1 prior platinum-containing chemotherapy regimen.
* Must have received no more than 2 prior chemotherapy regimens
* Measurable disease by RECIST 1.1 criteria.
* ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).
* Women of child-bearing potential (WCBP), all sexually active male patients, and partners of patients must agree to use adequate methods of birth control.

Exclusion Criteria:

* Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment
* Known hypersensitivity to drugs formulated with polysorbate-80.
* Not recovered from any toxicities related to prior treatment
* Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer
* Inadequate hematologic function
* Inadequate hepatic function
* Inadequate renal function
* Symptomatic keratitis or keratoconjunctivitis.
* Uncontrolled systemic fungal, bacterial, viral or other infection
* Patients with clinically active brain metastases
* Patients with clinically stable brain metastases (previously treated or untreated) are eligible.
* Sinus bradycardia (resting heart rate \<50 bpm).
* Significant cardiac disease
* Previous or current malignancies at other sites within the last 2 years
* Prior hepatic resections or hepatic-directed therapy
* Known HIV-positive patients receiving combination antiretroviral therapy.
* Women who are pregnant or lactating.
Phase I Compare OS in Post-CyberKnife Radiosurgery Tx in 1-3 VS 4 or More Brain Metastases

The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals. The importance of this new knowledge will be to determine the treatment efficacy of CK RS with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to support either the continuation or modification of the CK RS treatment of patients with brain metastases.

This is registry-based cohort study of patients with brain metastases treated at Stanford University Medical Center (SUMC) with CyberKnife radiosurgery (CK RS). It has two components: (1) a retrospective follow-up of patients treated since 2006, and (2) the accrual of a new cohort of patients treated over a 5-year period from January 15, 2013 to December 31, 2017 and followed for at least one year thereafter. The primary aim of this study is to estimate the effect of the number of brain tumor metastases on survival after adjusting for known risk factors for mortality.

Eligibility Criteria:
Inclusion Criteria:

1. the presence of a tumor metastasis or tumor metastases to the brain as manifested by the neurological examination and visibility of the metastatic lesion(s) on MRI and CT scans
2. a Karnofsky performance status (KPS) score of greater than or equal to 60.

Exclusion Criteria:

The exclusion criteria are the converse of the above, i.e. patients without a brain tumor metastasis or brain tumor metastases or a KPS of less than 60.
Vitamin D for Improving Metabolic Control and Depressive Symptoms

This study will examine whether weekly vitamin D supplementation in women with significant depressive symptoms and diabetes will exhibit improved mood and metabolic control. If supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method for treatment. Women will be targeted since they have greater depression and worse metabolic control than men with diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 and older
2. medically stable type 2 diabetes with HBA1c \<9%.
3. significantly elevated depressive symptoms as measured by a score greater than or equal to 14 using the Center for Epidemiologic Studies Depression Tool (CES-D.

Exclusion Criteria:

1. vitamin D levels of 32 ng/dl or greater
2. malabsorption problems (e.g., crohn's disease, celiac sprue)
3. hypercalcemia-level greater than 10.5 mg/dl
4. Severe complications of diabetes (amputation, blindness, or renal problems) 5) Women with low thyroid function

6) active suicidal ideation, a history of bipolar depression, psychotic disorders, and current alcohol or substance disorders. Active treatment for depression (e.g., antidepressant therapy) will not be exclusion criteria 7) Any serious chronic illness that may impact on their health-related quality of life and treatment effect 8) Women who are pregnant 9) Women who have had bariatric surgery.