cyrilzakka/clinical-trials huggingface dataset:
Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

The investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of HCA from January 2009 to June 2011.

The investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. In addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011

Exclusion Criteria:

* none
SCHEDULE Follow Up Visit 5-7 yr

The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.

This protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month SCHEDULE (NCT01266148) study and the following 3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard immunosuppressive regimen including CsA, on renal and heart function. During the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).

Study code of SCHEDULE, the core study: CRAD001ANO02 (EudraCT No.: 2009-013074-41)

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit
* Patients who are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study
* Obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination.

Exclusion Criteria:

* Patients with a retransplanted heart since the original SCHEDULE study
Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency

Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* \>= 18 years of age
* CVI I or CVI II (without expanded trophic disturbances)
* Willing and able to give written informed consent in accordance to Good Clinical Practice and local legislation prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

* Decompensated cardiac insufficiency
* Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
* Peripheral arterial disease (ankle/arm pressure index \< 0.9)
* Current acute phlebitis or thrombosis
* Renal insufficiency (Serum creatinine \> 1.5 mg/dl)
* Liver disease (SGPT (ALAT) \> 3x upper limit of normal)
* Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
* Anamnestic indications of diabetic microangiopathy or polyneuropathy
* Drug and/or alcohol abuse
* Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
* Severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
* Immobility
* Avalvulie
* Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
* State after pulmonary embolism
* Recognized hypersensitivity to the trial drug ingredients
* Current florid venous ulcus
* Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

* Treatment with venous drugs within the last 4 weeks
* Changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days

Concomitant treatment/non-drug therapy exclusion criteria:

* Other venous drugs apart from the trial medication
* Compression bandages
* Venous surgery of the leg used for the fluxmetry
* Extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
* Major surgery requiring full anesthesia

Other exclusion criteria:

* Previously studied under this protocol
* Participation in another clinical trial within the previous 90 days or during the present study
* Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
* Patients in a bad general health state according to the investigator's judgment
Follow-up in Early and Locally Advanced Breast Cancer Patients

A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.

The objective of this study is to assess follow-up patterns and identify patients with increased levels of physical and/or psychosocial problems after treatment in early breast cancer and locally advanced breast cancer.

830 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.

Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 139 Quality of Life questions, at one single time point.

Statistical analysis includes descriptive statistic for socio-demographic and clinical data, overall and per treatment, age and risk group. Patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country.

Where available, normative data will be used to identify those QoL domains where there is a clinically relevant difference with the general population.

Multivariable model building will be used to build predictive models on the overall population to investigate determinants for the physical, sexual and emotional needs based on the identified PROM outcomes. Factor analysis will be undertaken to investigate the inter-correlations between physical, sexual and emotional needs in the overall population and in the relevant subgroups of interest.

The magnitude of the observed differences will be assessed by clinical important effect size rather than by statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Early Breast Cancer (EBC) and Locally Advanced Breast Cancer (LABC) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis.
* Disease-free without any evidence of relapse
* Age ≥ 18 years.
* Ability to understand and fill out questionnaires.
* Written informed consent.

Exclusion Criteria:

* Metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or DCIS.
* Other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia.
* Male breast cancer.
* Patients on maintenance therapy (other than endocrine therapy).
* Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
* Any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults

PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years
* No history of clinically-relevant atopic or dermatological disease
* Positive reaction to intradermal injection of histamine

Exclusion Criteria:

* Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
* Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C
* Intolerance to intradermal histamine injection.
* Subjects with dark skin (Part B only).
Internal Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.

OBJECTIVES:

Primary

* To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
* To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%).

Secondary

* To achieve adequate dosimetric coverage of the prostate comparable to current standards.
* To assess the effect of treatment on sexual function.

OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.

After completion of study treatment, patients are followed every 3 months for 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:

  * PSA 10-20 ng/mL
  * Gleason score ≥ 7
  * Stage ≥ T2b AND \< T3
* Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
* Prostate size \< 60 cc by MRI or CT imaging
* International Prostate Symptom Score Index ≤ 15

Exclusion criteria:

* Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)

  * Suspected extracapsular disease will not be considered an exclusion criteria
* PSA \> 20 ng/mL
* Presence of distant metastases

PATIENT CHARACTERISTICS:

* WBC ≥ 3,500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 1.5 mg/dL
* Liver function tests ≤ 1.5 times normal
* INR ≤ 2.5
* Able to complete quality of life questionnaires
* Able to give informed consent
* No active perineal infections
* No history of urethral stricture
* No prior history of pelvic malignancy
* No prior history of lymphoma disease, ulcerative colitis, or anal fissures
* No contraindications to general anesthesia
* No pacemaker

PRIOR CONCURRENT THERAPY:

* No prior transurethral resection of the prostate
* No prior pelvic radiotherapy
* No prior treatment for prostate cancer except for hormone therapy
Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma or ocular hypertension in both eyes
* Currently being treated with latanoprost 0.005% QD
* IOP greater than or equal to 18mm Hg on latanoprost 0.005%
* Best-corrected VA of 20/200 or better in each eye
* Visual field within 6 months of study entry

Exclusion Criteria:

* Secondary glaucoma
* Active intraocular inflammation or macular edema
* Intraocular surgery or laser surgery within the past 3 months
Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function

This study aims to assess the effect of nasal high flow oxygen therapy on regional function measured by volumetric computed tomography, in patients with chronic obstructive pulmonary disease.

Nasal high flow (NHF) is a non-invasive breathing therapy that is based on the delivery of heated and humidified air at flow rates that exceed peak inspiratory flow, via a large-caliber nasal cannula. It delivers a fraction of inspired oxygen (FiO2) from 21% to 100%, with a flow rate up to 60 L·min-1.

The therapy is used for a variety of disease conditions including chronic obstructive pulmonary disease (COPD). Patients with COPD frequently manifest flow limitation during resting tidal breathing, through dynamic compression of the airways, which is attributed to a loss of parenchymal tethering of the airways. In patients with severe COPD and respiratory failure, improved oxygenation and ventilation may reduce mortality. There are limited clinical data available in adult applications of NHF and on the effectiveness of NHF in patients with stable moderate or severe COPD.

The mechanisms through which NHF affects the respiratory system are still being investigated. Two of the proposed mechanisms of action of NHF therapy are the generation of 3-5 cmH20 positive airway pressure during expiration and washout of the nasopharyngeal dead space. Positive airway pressure has been shown to improve oxygenation, ventilation-perfusion matching and respiratory rates, while nasopharyngeal washout reduces the anatomical dead space and thereby improves alveolar ventilation.

Our working hypothesis is that positive nasopharyngeal pressure generated by NHF particularly during expiration can help maintain small peripheral airways patent, thereby reducing the amount of gas trapping.

Gas trapping can be quantified based on densitometric analysis of registered computerized tomography images obtained at high and low lung volumes.

Eligibility Criteria:
Inclusion Criteria:

* Stable, moderate to severe COPD, defined as follows:

Moderate: FEV1/FVC \< 0.7 or lower limit of normal, and 30 \< FEV1 ≤ 60 percent predicted; Severe: FEV1/FVC \< 0.7 or lower limit of normal, and FEV1 ≤ 30 percent predicted

* Indication for CT imaging as part of routine workup.
* Written informed consent signed

Exclusion Criteria:

* Acute disease condition such as infection, respiratory or cardiac failure
* Persons referred to in Articles L1151-5 to L1151-8 and L1122-1-2 of the French Public Health Code: Declared pregnant, parturient or lactating, persons deprived of their liberty by judicial or administrative decision, minors, adults who are legally protected or unable to express consent, etc.
* Evolving neoplastic disease
* Patient without social security health care coverage
* Subject in an exclusion period from another study
* Any contraindication to NHF such as nasal or upper airway bleeding, secretion, tumor, recent surgery; cervical, nasal or skull fracture.
the Use of Magnesium Sulfate for Prevention of Postspinal Shivering

Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia.

Aim:

to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-45 years old
* Both genders
* ASA I, II

Exclusion Criteria:

* Patients with hemodynamic instability
* cardiopulmonary
* renal , liver disease
* hypo or hyperthyroidism
* cerebrovascular insufficiency
* coagulation defects
* those with psychiatric disorder
* patients receiving vasoactive drugs or beta blockers
* BMI \> 35
* allergic to study drug
* height \<160 cm or \>190 cm
* basal body temperature \>38°C or \<36°C
* those who received blood transfusion or \>2000 mL fluid intra-operatively
* surgery duration \> 3 hours
Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease

The study searched for answers to two questions:

1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.

2. Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy proven non-alcoholic fatty liver disease

Exclusion Criteria:

* Taking any drugs
* \>20 gr/day alcohol consumption
* chronic metabolic diseases
* morbid obesity
Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD). The study will compare the outcomes of LVAD patients with low sodium levels who take Tolvaptan to those who do not take Tolvaptan. Tolvaptan is FDA approved for use in the study population and is commonly used to treat low sodium levels in heart failure and LVAD patients. It is not known if taking Tolvaptan or not taking Tolvaptan is better at improving outcomes in newly implanted LVAD patients with low sodium levels. By doing this study, the Principal Investigator (PI) hopes to learn which is better at improving outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with American College of Cardiology (ACC) and the American Heart Association (AHA) Stage D heart failure and plan to undergo LVAD implantation
* Age greater than or equal to 18 years old

Exclusion Criteria:

* No plan for LVAD implantation
* Age less than 18 years old
The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes

Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar levels in people with type 2 diabetes.

This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic acid for 12 weeks, or lipoic acid followed by placebo.

A blood test for overall diabetes control will be taken at the start and end of each 12 week period, and the change in control will be compared for lipoic acid vs placebo.

This is a randomized, double-blinded, placebo-controlled crossover trial of lipoic acid for glycaemic control in type 2 diabetes.

The trial has 3 phases, each lasting 12 weeks. During phases 1 and 3, subjects take lipoic acid or placebo tablets, the order to be determined by randomization. Phase 2 is a 12-week washout period. The intervention is lipoic acid 200mg daily for 1 week, 400mg daily for the second week, and 600mg daily for weeks 3-12. Equivalent numbers of placebo tablets will be taken during the placebo phase.

The principal outcome measure is change in HbA1c between the start and end of lipoic acid supplementation, by comparison with the same change with placebo.

The secondary outcome measure is change in urine albumin:creatinine ratio over the same periods.

Assessments for safety will include standard adverse events reporting, repeated laboratory measurements throughout the study (blood count, renal and liver function) and hypoglycaemia frequency.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age \> 18 years
* Capable of giving informed consent
* Treated with oral antidiabetic agents (not insulin)
* HbA1c 7.0 - 8.5% at last measurement (must be within 6 months of study)
* Most recent HbA1c within 1% of all measurements within preceding year
* Prepared to self-test blood glucose on a regular basis
* Prepared to use contraception during study if of child-bearing potential

Exclusion Criteria:

* Unstable cardiac disease (NYHA class III or IV heart failure, or unstable angina or myocardial infarction within last three months)
* Significant renal or hepatic impairment (creatinine\>170 micromol/L, alanine transaminase or alkaline phosphatase \> 3x upper limit of normal)
* Other medical condition or treatment likely to affect glycaemic control
* Previous history of significant hypoglycaemia
* Pregnancy
* Involvement in other clinical trial in last three months
* Known or suspected sensitivity to trial products