cyrilzakka/clinical-trials huggingface dataset:
Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma

This is a phase II study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (HCC).

The purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in HCC. The primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.

Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of HCC.

This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. Dose titration will be done according to the severity of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed HCC, OR clinically diagnosed HCC
* Inoperable tumor(s) and no applicable curative therapy. Not amenable to loco-regional therapy
* Documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced HCC
* At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure
* ECOG performance status 0 or 1
* Life expectancy is at least 2 months
* Child-Pugh class A liver function.

Exclusion Criteria:

* Systemic therapy other than sorafenib as first-line therapy for advanced HCC
* History of HCC tumor rupture
* Presence of brain or leptomeningeal metastases
* Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding
* History of upper gastrointestinal bleeding within 1 year
* Major systemic diseases that the investigator considers inappropriate for participation
* Uncontrollable hypertension
* Proteinuria
* Current use or anticipated need for treatment with potent CYP3A4 inhibitor, CYP3A4 or CYP1A2 inducers
* Requirement of anticoagulant therapy with oral vitamin K antagonists
* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study
Quality of Life After Biliodigestive Anastomosis (BDA) or Stents to Treat Biliary Obstruction in Pancreas Cancer

To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs. endoscopical stenting for palliation of biliary obstruction due to locally unresectable or metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on older studies, but with new chemotherapeutic regimens available, the likelihood to experience stent complications has increased. Therefore, the issue as to which palliation should be favoured has to be reconsidered.

The aim of this multi-centre, prospective-randomised study was to compare the effectiveness of palliative applications on patients suffering from a local, advanced and/or hepatic, metastasising, non-resectable pancreas head carcinoma and jaundice.

Before randomisation, all patients are fitted with an endoscopically inserted biliary tract drainage endoscopically inserted. When postoperatively ascertained that the pancreas head carcinoma is non-resectable, the patient shall be electronically registered and randomly assigned to one of the palliative strategies. Group 1 will be fitted with a biliodigestive anastomosis. Group 2 will continue with the endoscopically inserted drainage. Regardless of which group they belong to, all patients will receive a palliative chemotherapy.

The primary parameter is the average quality of life over a period of 6 months post-operatively, to be analysed monthly using identical questionnaires. The comparison of the randomisation groups will be carried out using a co-variance analysis (ANCOVA) with the initial value, taken directly before the operation, to be used as co-variant.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice.
2. Performance-status of 50 or above on the Karnofsky-scale (see attachment).
3. Adequate bone marrow reserves: leukocyte level \> 3.5 x 10´/l, thrombocyte level level \> 100 x 10/l; Haemoglobin\> 80g/l.
4. Male or female patients, at least 18 years old.
5. Women of child bearing age must be sufficient protected against pregnancy (contraception) during and for 3 months after the end of the study.

Exclusion Criteria:

1. Adult patients with focal, advanced adenocarcinoma of the pancreas head and no jaundice; also no jaundice in their anamnesis and with no endoscopic retrograde cholangio-pancreaticography (ERCP)-induced intervention.
2. Pregnancy
3. Breast feeding
4. Contra-indication for gemcitabine
Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients

The purpose of this study is to determine if an intravenous lidocaine infusion (compared to placebo) intraoperatively will decrease time to return of bowel function postoperatively, decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory markers and shorten time to discharge after colorectal surgery.

Lidocaine is an amide local anesthetic that has analgesic and anti-inflammatory properties. Lidocaine infusion is a very useful pain medication that is underutilized to treat surgical, chronic, and cancer pain in children. The investigators propose to examine the perioperative use of lidocaine infusion in children undergoing colorectal surgery that involves an abdominal incision. The investigators plan to measure the following outcomes: length of stay in hospital following abdominal surgery, postoperative pain scores, cumulative morphine consumption, incidences of opioid adverse-effects: respiratory depression, sedation, nausea, vomiting, time to passage of flatus, time to first bowel movement and end-tidal Sevoflurane in operating room throughout surgery. The following laboratory values will be measured: serial lidocaine levels of pharmacokinetics and safety levels, Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA and genetic variants.

Eligibility Criteria:
Inclusion Criteria:

* male or female children 1-15 years of age
* ASA physical status 1-3
* scheduled for colorectal surgery with abdominal incision
* scheduled for complex urology surgical case

Exclusion Criteria:

* ASA physical status \> 3
* postoperative intubation planned ahead of surgery
* history of chronic use of opioid
* history of hepatic,renal, or cardiac failure
* history of organ transplant
* BMI \> 30
* history of cardiac arrhythmia
* history of long QT syndrome
* history of allergic reaction to lidocaine or similar agents
* history of seizure disorder
* patient without Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction
* family history or know patient susceptibility to malignant hyperthermia
Registry for Automated Mechanical VEntilation in Adults

The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.

The harmful effect of invasive mechanical ventilation can be prevented by intensive training of ICU physicians, respiratory therapists, and ICU nurses on the one hand, and by improvement of the technology installed in ventilators on the other hand. Advanced mechanical ventilation modes use new technologies to assist physiology, optimize gas exchange and minimize ventilator induced lung injury. Modes such as proportional assist ventilation and neuronally adjusted ventilatory assist deliver assisted ventilation proportional to the patient's effort, improving ventilator patient synchrony. The Adaptive Support Ventilation (ASV) mode automatically adjust tidal volume and respiratory rate based on patient's respiratory mechanics to protect from mechanical ventilator induced lung injury, hence deliver safe mechanical ventilation. The implementation of advanced closed-loop systems automates medical reasoning and has potential to improve patient ventilator interactions, the time spent on mechanical ventilation, staff workload and potentially outcome.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.

Exclusion Criteria:

Expected to be weaned from HFNO, NIV within 2 hours. Expected to be weaned and extubated from IMV without subsequent need of HFNO or NIV support within 2 hours.

Expected to be transferred to another non-participating ICU within 2 hours. Moribund subject: death expected within 2 hours.
Munich Study for Beer Related ECG Change Workup

The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

Both regular and acute excessive alcohol intake may deteriorate health. Possible sequelae include cardiac arrhythmias. For acute alcohol intake in particular it is insufficiently understood to what extent cardiac arrhythmias and other ECG changes occur, if the occurence depends on alcohol levels, and if there is a cut off value for occurence. Munich BREW aims to help clarifying these questions.

Participants of Munich BREW are identified and invited as visitors of the Munich Octoberfest and similar events. Participants need to be 18 years of age and over and need to declare theri will to participate. Following enrollment, participants will answer astudy questionnaire and will subsequently undergo recording of a 30 sec smart phone based ECG. Ultimately, the alcohol level is determined using a breath alcohol analyzer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* informed conset signature

Exclusion Criteria:

* Incapability of contracting according to German law (BGB §105, paragraph 2)
* contraindications against ECG recording or alcohol breath test
* denial of informed consent
Dermacyd Teen Care Tangerina Mix - Compatibility

The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
* Personal history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects

This study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese women or non-Japanese of child bearing potential using nonhormonal contraceptives.
* Japanese female subjects are defined as being born in Japan but living outside of Japan for less than 5 years.

Exclusion Criteria:

* Any significant disease.
* Positive urine drug screen, increased liver funtion tests, use of prescription drugs.
Stress Reduction & CVD Morbidity and Mortality in Blacks

To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks with hypertension.

BACKGROUND:

Life expectancy for Black Americans is about 10 percent less than for whites. The leading cause of excessive mortality in older Blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older Blacks. Conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life (QL) and low compliance rates, especially in elderly minority populations.

The present study is an extension of a pilot study on a comparable sample of 80 Black elderly. The previous study, which was the first of its kind, yielded results which indicated that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure, with TM producing the most significant improvements in blood pressure and in quality-of-life. Dr. Schneider hypothesized from this and related evidence that TM should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly Blacks, and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications.

DESIGN NARRATIVE:

Randomized. Over an 18-month period, 213 people were screened for inclusion in the study. Of these, 127 with initial diastolic blood pressure of 90 to 109 mm Hg, systolic blood pressure of 189 mm Hg or less, and final baseline blood pressure of 179/104 or less mm Hg were randomized to treatment. Of the 127 participants, 16 did not complete follow-up blood pressure measurements. Thus, 111 subjects completed the study. All subjects were pretested over a four session baseline period on clinic blood pressure, ambulatory blood pressure, cardiovascular and emotional reactivity, and quality-of-life measures. Subjects were then randomly assigned, 36 to TM, 37 to PMR, and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables. The primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly. The secondary outcomes were changes in self-monitored home blood pressure and compliance.

The study was extended through July, 2007 for an additional 5 years of followup of the cohort.

Eligibility Criteria:
Inner-city Blacks with mild hypertension
Micronutrient Supplement for Nurse Burnout

The purpose of this study is to confirm and quantify the ability of an 8-week intervention with a supplement containing magnesium citrate and vitamin B6 to reduce anxiety, stress, and burnout among nurses working full time in hospitals and urgent care centers during the COVID-19 Pandemic.

After being informed about the study and potential risks, all participants woh meet the eligibility criteria will provide written informed consent. They will then be randomized in a 1:1 ratio to either MagnéVie B6® or a placebo group. The assigned product will be consumed 3 times daily for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Woman aged 20-59
* Lives in the United States
* In good general health as evidenced by medical history
* Stress subscale score from the DASS \> =22
* Ability to take oral medication and be willing to commit to taking 3 tablets a day for 8 weeks.
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of MagnéVie B6® administration
* Employed full time as a nurse in a hospital, primary, or urgent care center that treats COVID-19 patients. Full time is defined as 35 hours or more each week.
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Current use of the following pharmaceuticals: bisphosphonates, calcium channel blockers, digoxin, aminoglycoside antibiotics, ketamine, levodopa/carbidopa, gabapentin, potassium sparing diuretics, quinolone antibiotics, skeletal muscle relaxants, sulfonylureas, tetracycline antibiotics, amiodarone, antihypertensives, or antiepileptic drugs (including phenytoin, valproic acid, carbamazepine, phenobarbital).
* Pregnancy, trying to conceive or breastfeeding
* Known allergic reactions to any components of the supplement including magnesium citrate anhydrous, pyridoxine hydrochloride, lactose anhydrous, magnesium stearate, hypromellose, macrogol 6000 titanium dioxide, or talc
* Positive COVID-19 test within 60 days of the study period
* COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
* Current diagnosis or lifetime history of a bleeding disorder, kidney disease, or neuromuscular disease
* Recent dramatic weight changes (10% change in body weight in the last 6 months)
* Existing usage of a magnesium or vitamin B6 supplement
Contribution of Psychological Autopsy to the Understanding of Suicidal Behaviors in French Overseas Territories

The mains objectives of our project are to coordinate the monitoring of suicides and to identify common or specific suicide risk factors in four overseas DROM-COM (French Polynesia, La Reunion, French Guiana and Martinique) by comparing to a site in mainland France (Amiens). A mixed approach (quantitative and qualitative) will be used, based on semi-directed interviews of the psychological autopsy type.

Epidemiological studies on suicide are rare in Overseas France. Nevertheless, studies conducted independently in New Caledonia (NC) and French Guiana were able to highlight a high prevalence of suicides in minority indigenous populations (Kanaks and Amerindians). These data therefore suggest a socio-cultural variability of suicides within the different territories. Psychological autopsies (used in NC) are an innovative approach that has already proven worldwilde its effectiveness in researching socio-cultural factors and prevalence of mental disorders in suicide subjects (Inserm). However, the qualitative analysis of psychological autopsies, even if it is very complete, is limited to known factors of suicide risk. Given the ethnic specificities of suicidal behavior and the socio-cultural richness of each overseas territory, an exploratory anthropologic approach will make it possible to complete identification of risk factors for suicide or combinations of these specific factors (profiles).

Our project will improve the data collection of suicide cases with the implementation of a network in each site (Public Health Department, Emergency units, Coroner offices, GP, associations, families...). Then interview with proxies of subjects deceased by suicide will allow psychological autopsy (questionnaires SCID to detect mental disorders, Life Trajectories, to detect life events and their burden, Anthropologic for socio-cultural aspects and Psycholinguistic analysis).

The total duration of the project will be 24 months with the recruitment of a maximum of 30 cases per site. Duration of the inclusion period will be 23 months, duration of follow-up per participant 1 month. The follow-up interview will be carried out one month after the inclusion interview. It will make it possible to establish a post-vention of suicide among the bereaved and an evaluation of the impact of the psychological autopsy interviews and the life trajectories of the bereaved.

Eligibility Criteria:
Inclusion Criteria:

* Persons close of the deceased
* Persons who knew about his/her childhood
* Age 18 or over
* Interviewed for the study between 2 and 11 months after the suicide

Exclusion Criteria:

* People with neuropsychiatric disorders that may affect the quality of the information collected, cognitive (memory and expression) and judgmental functions
* People who refuses to participate
* Persons referred to articles L.1121-6, L.1121-7, L. 1121-8 L.1121-1-2 of the French Public Health Code.
Genetic Susceptibility Factors for Candidemia.

This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Informed consent.
* Positive blood culture with isolation of Candida sp.

Exclusion Criteria:

* No informed consent.
* Patient younger than 18.
* No insurance coverage.
Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.

Patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (PVI) for paroxysmal and persistent atrial fibrillation (AF) get incrementally less benefit with redo-PVI. This implies non-pulmonary vein (PV) triggers, which are more challenging to locate. The autonomic nervous system is implicated in the multifactorial pathogenesis of AF but few studies have attempted neural targeting as a therapeutic intervention. We have demonstrated that stimulation of specific left atrial ganglionated plexi (GPs) triggers both AF and atrial ectopy and importantly stimulation of these sites may not induce AV block, the 'conventional' marker used to locate GPs. Having shown that these ectopy-triggering GP (ET-GP) sites are anatomically stable and can be rendered inactive by either ablation at the site or by ablation between the site and the adjacent PV, a single centre study suggests that ET-GP ablation can prevent recurrent AF in some patients.

Eligibility Criteria:
Inclusion Criteria:

* Males or females eighteen (18) to eighty five (85) years old
* Paroxysmal atrial fibrillation
* Previous pulmonary vein isolation
* Suitable candidate for catheter ablation
* Signed informed consent

Exclusion Criteria:

* Contraindication to catheter ablation
* Presence of a cardiac thrombus
* Valvular disease that is grade moderate or greater
* Any form of cardiomyopathy
* On amiodarone therapy
* Patients who lack capacity
* Active gastrointestinal bleeding
* Active infection or fever
* Renal failure (Creatinine \>200µmol/L)
* Life expectancy shorter than the duration of the trial
* Bleeding or clotting disorders or inability to receive heparin
* Pregnant