cyrilzakka/clinical-trials huggingface dataset:
Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation

The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation.

Atrial fibrillation is a common arrhythmia in clinical practice. Catheter ablation can be used when the cause of atrial fibrillation is in the pulmonary veins. However, the procedure takes 2 to 4 hours, and patients complain of considerable discomfort. Remimazolam has the advantage of having no drug interaction with CYP3A4 and shorter elimination half-life, duration of action, and shorter recovery time than midazolam, a previously used drug. In addition, compared to dexmedetomidine, side effects such as bradycardia and hypotension are expected to be less. In addition, even if unexpected deep sedation is induced, complete reversal using flumazenil is possible, so the risk of re-sedation could be low.

In other words, when remimazolam is used instead of a drug previously used as a sedative in atrial fibrillation patients undergoing catheter ablation, effects such as rapid action and recovery, reduced complications, improved safety, and improved patient satisfaction can be expected. Therefore, this study was designed to confirm the hypothesis that administration of remimazolam would improve satisfaction in patients undergoing catheter ablation compared to dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-79 years, gender not limited
* Patients undergoing catheter ablation for atrial fibrillation who require monitored anesthetic care (MAC).
* Patients with an American Society of Anesthesiologists (ASA) physical status classification 1,2,3.

Exclusion Criteria:

* Patients with an American Society of Anesthesiologists (ASA) physical status classification \>3.
* Patients with a history of psychiatric disorders
* Patients with myocardial infarction or stroke within the past year
* Patients with a history of major vascular surgery or cardiac surgery within the past year
* Patients with reduced liver function, chronic kidney disease (stage 3 or higher)
* Patients diagnosed with heart failure with a left ventricular ejection fraction \<40%
* Patients who need vasopressor or oxygen therapy due to unstable vital signs before procedure.
* Patients with fever (\>38°) or severe uncontrolled high blood pressure
* Patients with a history of drug hypersensitivity during previous anesthesia
* Patients who are unable to communicate and have cognitive impairment
* Patients with a history of drug or alcohol addiction
* Patients with a history of obstructive sleep apnea
Protocol PERCAF 2018

In this multicentric controlled study, we aims to evaluate effect of caffeine on mental performances during a sleep deprivation protocol. Genetic polymorphisms are considered as a covariable.

Coffee is the most consumed arousing substance in the world. Caffeine is used as a natural countermeasure to maintain the performance of sleep deprived subjects. However, the effectiveness of caffeine is characterized by a large individual variability, also observed on side effects. This variability could notably be related to polymorphisms of the adenosine receptor 2a gene (ADORA2A) and Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine whose increase is observed during sleep deprivation.

This study, under conditions of total sleep deprivation in the laboratory (40 hours of continuous awakening), examine the cross-influence of two polymorphisms (ADORA2A: rs5751876 and TNF-alpha: rs1800629) on the sensitivity to caffeine and on the degradation of attentional performances. Physical performance, mental performance, immuno-inflammatory responses and the occurrence indesirable effects will be evaluate.

This work aims to understand the mechanisms that contribute to increasing individual vulnerability and promoting protective countermeasures. The purpose of this project is to improve the recommendations concerning the daily use of caffeine and during periods of prolonged awakening, particularly in the military environment.

Eligibility Criteria:
Inclusion Criteria:

* healthy subject

Exclusion Criteria:

* Treatment
* History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
* Nonvoluntary
* Pregnancy
Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment

We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colorectal cancer 2008-2016 in Sweden

Exclusion Criteria:

* None
Osteopathic Procedure on Pain in Palliative Care

The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.


Eligibility Criteria:
Inclusion Criteria:

* Major patient (age\> 18) male or female
* Patient hospitalized or admitted to a day hospital that can be followed
* EVA between 40/100 and 60/100
* Signed informed consent

Exclusion Criteria:

* Patients requiring a modification of analgesic molecule during the study.
* Clinical stability of the patient estimated during the duration of the study.
Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:

* Treatment A: 500 mg nicotinic acid
* Treatment B: Placebo


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50 and 90 kg with a body mass index between 19 and \<30 kg/m2
* No clinically relevant findings in the medical history, laboratory examinations and physical examination, especially with regard to cardiovascular system, liver function test, bilirubin values and the skin
* No clinical relevant pathological findings in electrocardiogram (ECG)
* Normal blood pressure (BP, syst. 100 to 140 mmHg, diast. 60 to 90 mmHg) and pulse rate (between 50 and 90 beats/min) in sitting position
* Voluntarily signed informed consent after full explanation of the study to the participant

Exclusion Criteria:

* Treatment with any other investigational product in the last 60 days before the day of randomization into the study
* Regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants
* Treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics)
* Any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
* History of hypersensitivity to the investigational product
* History or presence of abnormalities of the vascular bed
* History or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement
* History of allergy or hypersensitivity to other drugs or to food constituents
* History of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study
* Blood donation of \>400 ml in the 60 days before the day of randomization into the study
* Smoking
* Positive result in urine screen for drugs of abuse or in alcohol breath test
* Known or suspected to be drug-dependent, including consumption of \>30 g alcohol per day
* Pregnancy or lactation
Probiotic After Acute Colonic Diverticulitis

The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis.

The main question it aims to answer are:

* Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score?
* Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma?
* Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic?
* Is there any correlation between microbiota modification and symptoms during follow-up?
* Is there any impact on fecal calprotectin values before and during probiotic therapy?
* Is there any modification of evacuation before and during follow-up?
* Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up?
* The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
* Symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma;
* Patients with diverticulosis;
* Asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
* Asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma.

Exclusion Criteria:

* Ongoing acute diverticulitis at radiologic assessment
* Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment;
* Lactulose-lactitol use within four weeks before enrolment;
* Presence of chronic inflammatory bowel diseases;
* Presence of Segmental Colitis Associated with Diverticulitis (SCAD);
* Presence of ischemic colitis;
* Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases;
* Patients with severe renal failure;
* Presence of suspected/actual pregnancy;
* Presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment;
* Presence of COVID-19 infection;
* Patients unable to give informed consent.
Real Life AI in Polyp Detection

The objective of this study is to compare the polyp detection rate (PDR) of endoscopists unaware of a commercially available artificial intelligence (AI) device for polyp detection during colonoscopy and the PDR of endoscopists with the aid of such a device. Moreover, an extensive characterization of the performance of this device will be done.

Recently, there have been remarkable breakthroughs in the introduction of deep learning techniques, especially convolutional neural networks (CNNs), in assisting clinical diagnosis in different medical fields. One of these artificial intelligence (AI) devices to diagnose colon polyps during colonoscopy was launched in October 2019. Its intended use is to work as an adjunct to the endoscopist during a colonoscopy with the purpose of highlighting regions with visual characteristics consistent with different types of mucosal abnormalities.

It is essential to know whether deep learning algorithms can really help endoscopists during colonoscopies. Several studies have already addressed this issue with different approaches and results. However, one common drawback of these type of Machine vs Human retrospective studies is endoscopist bias. It is usually generated because of human natural competitive spirit against machine or human relaxation because of AI-reliance. This can have an effect in the overall results.

The investigators perfomed colonoscopies with the use of a commercially available AI system to detect colonic polyps and recorded them during clinical routine. Additionally from March 2019 - May 2019, 120 colonoscopy videos were performed and captured prospectively without the use of AI.

In this study, the investigators plan to retrospectively compare those two video sets regarding the polyp detection rate, withdrawal time and polyp identification characteristics of the AI system.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopies for Polyp detection

Exclusion Criteria:

* Colonoscopies for Inflammatory Bowel Disease (IBD).
* Colonoscopies for work up of an active bleeding
Immediate ART in Subjects with Opportunistic Diseases

The aim of this study is to compare the clinical response and mortality rate by an opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy.

Immediate ART (iART) is defined as starting antiretroviral therapy in the first 48 hours after the hospitalization.

Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of infectious disease specialist.

Sample size was calculated using formula, of difference in proportions formula using a beta of 0.1, alpha of 0.05 and an expected difference in mortality of 20%, The sample size is 225 subjects in each group. Informed consent will be obtained. Patients will be allocated to each group (iART or cART) after randomization stratified by the CD4+ T cell count (less or more than 50 cells/mm3).

Plasma viral load and CD4+ T cell count will be measured at study entry and at weeks 2, 4, 12, 24 and 48 after ART initiation. Clinical outcomes will be: mortality at 4, 12, 24, and 48 weeks, length of hospitalization (measured in days), clinical and microbiological cure of the opportunistic disease, incidence and severity of immune reconstitution of inflammatory syndrome (IRIS), and adverse drug reactions and interactions.

Once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy of iART; if differences in the mortality are observed, the study will be terminated.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Time from admission to study entry: less than 48 hours
* Confirmed HIV diagnosis or high probability of HIV infection based on a positive HIV rapid test
* Having an opportunistic disease
* Subjects must be naïve to ART or have failed their first or second ART regimen or must have abandoned ART for more than 3 months

Exclusion Criteria:

* Meningitis due to Cryptococcus spp. or for M. tuberculosis
* Pregnancy
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed diagnosis of COVID-19 \<= 14 days prior to randomization
* The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:

  1. Bilateral chest radiograph infiltrates.
  2. PaO2:FiO2 ratio of less than 200.
  3. Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
* Absence of moribund state that would indicate imminent demise and poor chance of survival.

Exclusion Criteria:

* Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
* Breastfeeding mothers
* Patients on ECMO
* Receiving concurrent treatment with an investigational agent in a clinical trial.
* Exception: Use of COVID-19 convalescent plasma is permitted.
* More than 72hrs on mechanical ventilation before randomization
* Receiving concurrent investigational vaccine
Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression

The purpose of this study is to determine if 20mg BID of Rabeprazole is effective in controlling GERD in patients with concomitant bronchial asthma and to assess improvement in asthma after reflux control.

Gastroesophageal Reflux Disease has been considered as having a role in the course of asthma, as shown by the improvement of symptoms with adequate acid suppression therapy. It is important to consider and establish the presence of GERD in patients with asthma specially, those who fail to respond to conventional asthma management. It is believed that two mechanisms may play a role in the association between Bronchial Asthma and GERD, most commonly microaspiration of acid causing bronchoconstriction, the second being increased vagal tone.

Establishing an adequate and timely diagnosis and confirming or excluding a relationship between the two entities in asthmatic patients is the first step towards effective patient management. The next important consideration is establishing the correct acid suppression therapy and monitoring response to therapy with objective testing such as Pulmonary Function Testing (PFT) and esophageal pH testing. Since there is not a real "normal" or physiologic reflux measure for patients with extresophageal manifestations as seen in patients with "classic" reflux where a total time of exposure to acid (pH \< 4) less than 5% is considered normal, in these patients it will be necessary to establish a more strict pH control than in those with classic GERD. Achieving complete acid control in this population is expected to require higher doses of medication than those used in patients with classic reflux and no extraesophageal manifestations. Thus we have developed this study in which we will assess the response to 20 mg BID dosing of Rabeprazole measured by pH monitoring and then follow improvement in Pulmonary Function Testing ( objective measure),as well as symptomatic response.

Eligibility Criteria:
Inclusion Criteria:

* Moderate Persistent or moderate severe bronchial asthma as determined by the study pulmonologist
* Gastroesophageal Reflux disease

Exclusion Criteria:

* History of hypersensitivity to rabeprazole or its metabolites
A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants

The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.

Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical history, vital signs, and physical examination.
* Participants of Japanese, Chinese, and Non-Asian ethnicities
* Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²). For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m²
* Have venous access sufficient to allow for blood sampling
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have a current or recent acute, active infection
* Had any surgical procedure within 12 weeks prior to study
* Are immunocompromised
* Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values
* Are currently enrolled in a clinical study involving any experimental antibody or biologic therapy within the previous 6 months, or any other experimental therapy within 30 days before the first dose of the study intervention or during the study