cyrilzakka/clinical-trials huggingface dataset:
Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

The proportion of women with breast cancer treated by chemotherapy (CT) is increasing. CT-induced nausea and vomiting negatively impact patient quality of life.

The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-HT3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant CT with FAC50, FEC100 or TAC in patients with non-metastatic breast cancer.

Secondary objectives are to test:

* the persistence of Cocculine® efficacy over the 2nd and 3rd CT courses
* the contribution of Cocculine® to the global management of nausea and vomiting during adjuvant CT
* patient compliance with Cocculine® dose.

Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically proven non metastatic breast cancer
* No previous chemotherapy
* Treatment planning including 6 adjuvant CT courses with the first 3 being necessarily of the FAC50, FEC100 or TAC type
* Age\>= 18 years
* ECOG performance status (PS) \<= 2 (WHO scale)
* Patient able to read and understand French
* Written, voluntary, informed consent

Exclusion Criteria:

* Previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer)
* Previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years)
* Contraindication to corticosteroids or 5-HT3 receptor antagonists
* Treatment with Cocculine® or any other anti-emetic drug in the 15 days before inclusion
* Pregnant or lactating women
* Follow-up impossible for social, geographical, familial or psychological reasons
* Patients who cannot be contacted by phone
Effective Maneuver for Post-laparoscopic Shoulder Pain

The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopy for benign gynecologic diseases
* patients aged 19-65 years
* patients with american society of anesthesiology physical status I-II
* patients obtaining written informed consent

Exclusion Criteria:

* patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
* patients with past history of pneumothorax or any pulmonary surgical history
* patients with any shoulder surgery histories
* patients who required to conversion to open surgery from laparoscopic surgery
* patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
* patients with inability to understand or express 10 point visual analogue scale
* pregnant women
Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics

It is controversial whether or not patients whose Renin Angiotensin System is blocked for the treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.

The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System causes altered dose response under general anaesthesia in a dose dependant manner. The investigators wish to look for altered responses across the usual anaesthetic dosing range as measured by blood pressure and heart responses.

There has been mixed results in retrospective studies examining the effects of renin angiotensin blockade for the treatment of cardiovascular disease and post operative outcomes. Studies done in high risk patients have shown increased risk of death if patients are exposed to angiotensin converting enzyme inhibitors and angiotensin blocking agents.

The hypothesis is that patients exposed to medications that block the renin angiotensin system have altered dose response (a type of adverse drug reaction) to inhaled anaesthetic agents in a dose dependant manner as measured by cardiovascular response, specifically systemic vascular resistance index.

This is a pilot study of hypertensive patients undergoing anaesthesia and composite head and neck surgery. The patients will be separated into three groups: Angiotensin converting enzyme inhibitor exposed, Angiotensin Receptor Blocking Agent exposed, and any other treated hypertension. Following separation into groups based upon preoperative medication exposures each group will be randomized to determine the order in which two types of inhaled anaesthetics are administered. Each subject will be randomized to receive either Sevoflurane/air/oxygen first or Sevoflurane/50 per cent nitrous oxide/oxygen second or vice versa. The dose of the anaesthetic will be adjusted across the dosing range from 0.8 MAC (minimum alveolar concentration) to 1.6 MAC in steps of 0.2 MAC.

Each subject will have hemodynamic parameters measured at each dose of anaesthetic at each MAC. Five measurements of hemodynamic parameters will be recorded to minimize the effects of surgery on each measurement. The hemodynamic variables will be measured using a Flotrak and Vigeleo monitor and the quantities to be measured are: heart rate, blood pressure, systemic vascular resistance, systemic vascular resistance index, cardiac output, cardiac index, central venous pressure, stroke volume variation.

The subjects are offered the opportunity to donate DNA for future study of hypertension.

Eligibility Criteria:
Inclusion Criteria:

* age over 40
* composite head and neck tumor resection
* treated hypertension
* hypertension medications taken on morning of surgery (except diuretics)

Exclusion Criteria:

* patient refusal
* age less than 40 or over 80 years
* combined surgical procedures
* emergency surgery
* Left ventricular ejection fraction less than 50 per cent
* calculated creatinine clearance less than 60 mL per minute
Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE

Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.

This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18)
* Informed consent
* CHC Child-Pugh stage A or B, BCLC stage B
* Referred for chemoembolization of a non-surgery-candidate CHC
* Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT\<5N, albumine\>2,5g/dl)

Exclusion Criteria:

* Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
* Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
* extra hepatic metastasis
* Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
* Waiting list for liver transplant
* Complete portal venous thrombosis or flow inversion
* Pregnancy or breast feeding
* Protected major (Guardianship)
* Patient in situation of exclusion (determined by a previous or ongoing study)
* Subject incapacity to understand informed consent
The INFO-II Trial: Nurses Knowledge About and Attitude Towards Clinical Trials

The purpose of this study is to examine (a) nurses' knowledge about and attitude towards clinical research, and (b) the effect of written and oral information on nurses' knowledge about and attitude towards clinical research.

A randomised (1:1:1), evaluator-blinded educational trial on written and oral information versus oral information alone versus no information on nurses' knowledge about and attitude towards clinical research in a university hospital in Copenhagen, Denmark. The investigators planned to randomise 213 nurses (approximately 71 to each intervention group) based on a minimal relevant difference of 1.6 points on the knowledge scale, a standard deviation of 3.1 points, a beta (type II error) risk of 0.20, and an alpha of 0.025. At entry and two weeks later, the nurses should complete two validated questionnaires, which indicated their knowledge on a 0-17 point scale and their attitude on a 0-156 point scale. Predictors of the entry knowledge and attitude and changes in knowledge and attitude after interventions were planned to be identified through adjusted ANOVA. The effects of the active interventions were compared with the control and adjusted for multiple comparisons. Interventions: Written and oral information: The nurses in this group are offered the written information consisted of a booklet which described basic aspects of clinical research including aim, background, formalities, ethics, informed consent, randomisation, blinding, placebo, drug development, and financial aspects. The booklet was developed with the assistance of nurses, physicians, psychologists, researchers, and communication experts. The booklet was adjusted after repeated pilot tests among laymen and employees at our research institution. The booklet was 12 A4 pages long and took about 15 minutes to read. In the INFO I trial, the booklet had a significant effect on outpatients' knowledge about and attitude towards clinical research. The oral information consisted of group sessions which focused on active feedback. Each session was lead by one of the authors who first went through the topics described in the booklet. The review of the topics was followed by a plenary discussion. The sessions lasted 15 to 40 minutes, depending on the interest of the nurses. Written information: The nurses in this group are offered the written information consisted of the same booklet as above, but without oral information. No information: The nurses in this group are offered no booklet or oral information.

Eligibility Criteria:
Inclusion Criteria:

* Graduated nurse
* Signed informed consent

Exclusion Criteria:

* Participant in another trial similar to the present trial
Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III

Exclusion Criteria:

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
* Patients with morbid cardiac diseases
* Pregnancy
* Patients with previous history of lumbar spinal surgery
* Patients with anatomical abnormality of lumbar spine
A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

Postoperative adverse events may be associated with substantial morbidity and mortality. However, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. In 2004, the Clavien-Dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations.

Despite the appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. In a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by Dindo et al. Especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.


Eligibility Criteria:
Inclusion Criteria:

* All patients with unexpected events within the study period, treated at the department of pediatric surgery (preterms - 17 years of age), Hannover Medical School

Exclusion Criteria:

* None;
Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss

The goal of this clinical trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are:

1. How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise.
2. How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.

Hearing loss is a leading cause of disability globally. Undertreated hearing loss has been associated with several deleterious sequelae, including social isolation, decreased quality of life, and cognitive decline. For a large portion of individuals with hearing loss, hearing aids remain the intervention of choice for improving communication, decreasing social isolation, and enhancing quality of life. Yet, less than 20% of hearing aid candidates choose to use them2. This is partly due to a perceived lack of benefit from hearing aids. Individuals who use hearing aids continue to report difficulty with speech perception in noisy environments with multiple speakers, such as parties, restaurants, and other complex auditory settings.

The investigators have developed a neural network that runs on-device to achieve real-time target speech hearing in realistic multi-talker environments. Using our neural network, the wearer can focus on speech from a target speaker by learning their unique speech cues while ignoring all interfering speech and noise in complex acoustic environments. The wearer is additionally able to use distance to separate sounds from the environment from target sounds to be amplified. Finally the wearer is also able to specificy categories of sound that will be amplified in environment.

This study will prospectively study a hearing aid implementing these algorithms on individuals with hearing loss. Participants will be randomized to utilizing one of two commercial hearing aids vs the experimental device. Participants will participate in listening tests in which they must identify the words spoken by a specific voice in multi-talker babble noise. The investigators will measure performance with the primary and secondary outcome measures listed elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Minimum Age of 18 yo
* Bilateral sensorineural hearing loss amenable to hearing aids
* Able to give informed consent
* Native English speaker
* Able to wear a standard pair of hearing aids

Exclusion Criteria:

* Unable to participate in informed consent
* Use of a cochlear implant
* Hearing loss not amenable to hearing aid use
* Conductive hearing loss
Postbariatric EArly Discharge Controlled by Healthdot

This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult (equal or above 18)
* Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
* Willing and able to sign informed consent form
* Able to understand instructions
* In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
* An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.

Exclusion Criteria:

* Patients of psychiatric wards, inmates of prisons, or other state institutions
* Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
* Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
* Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
* Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
* Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
* Expected participation less than 8 days
* Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
* Patients with antibiotic resitant infections (e.g. MRSA)
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.

To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Written informed consent from patient or guardian

Exclusion Criteria:

* Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
* Patients with a history of cerebrovascular disorders within the past 52 week
* Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
* Pregnant women, nursing mothers or possibly pregnant women
Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

The purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers

This research is a dietary intervention study designed to evaluate the effect of progressive changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also be compared to the DNA strand breaks. In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia. Similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* willing to limit food and beverage intake to that provided by the study
* willing to discontinue consumption of alcoholic beverages during the study
* willing to stop zinc supplementation 4 weeks prior to start of the study
* has an operative understanding of English
* no plans to move from the area during the study period

Exclusion Criteria:

* Chronic or acute metabolic disease
* smoker or user of nicotine products
* history of alcohol abuse, or use of illicit drugs.
* Is underweight or overweight, body mass index (BMI) \< 18 or \> 30 kg/m2.