cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)

This is a multicenter, randomized, controlled study in women who are having elective open abdominal surgery with general anesthesia and who are expected to need patient-controlled analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting in the first 24 hours after surgery. Participation in the study may last up to 3 months. The total duration of the study will be approximately 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia.
* Women whose postoperative hospitalization is expected to last at least 24 hours
* Women expected to require postoperative intravenous opioid PCA.
* Women whose surgery is expected to require at least 1 hour, but not more than 4 hours, of general anesthesia using the regimen defined in this protocol.
* Women of childbearing potential who have a negative pregnancy test or women who have been surgically sterilized or are postmenopausal.

Exclusion Criteria:

* Women with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease.
* Women with a known hypersensitivity to ondansetron (or any other 5-HT3 antagonist), to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
* Women who are scheduled to undergo certain types of surgery.
* Women who are breastfeeding.
* Women who have retching/vomiting or moderate or severe nausea in the 24 hours prior to surgery or suffer from chronic nausea and/or vomiting.
* Women with a body mass index (BMI) \>40.
* Women who have participated in a clinical trial of an investigational drug within 30 days prior to drug administration.
Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China

The primary objective of this study is to estimate the overall prevalence of IBS medically diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.

This is a multicentre, nationwide and cross-sectional study carried out in China, covering 30 sites and 3000 patients totally. As for the ratio of tertiary to secondary general hospitals is approximately 1:4 in China, 6 tertiary and 24 secondary hospitals will be randomly selected in this study.To adapt the representativeness of the data with the operational feasibility, 30 tertiary and 120 secondary hospitals will be randomly selected over the 6 geographic regions (north, northeast, east, south central, southwest and northwest). Among those, 1 tertiary and 4 secondary hospitals in each region will be further selected based on GI department setup, willingness to participate in the study, capability and primary investigator's consideration. Within participated hospitals, subjects will be enrolled consecutively from all the outpatients of GI department to minimize selection bias. 3000 subjects will be allocated to tertiary and secondary hospitals with a ratio of 1:1. In general, 250 subjects will be enrolled from tertiary hospitals and 250 subjects will be enrolled from secondary hospitals for each region. During the subject enrolment, the investigator will firstly explain the purpose of the study to consecutive GI patients and written informed consents will be obtained. Then qualified patients will be given a questionnaire and finish it during waiting time. After receiving questionnaires, IBS diagnosis will be made by investigators based on Rome III or Rome IV IBS diagnostic criteria. Subjects will be identified as medically diagnosed with IBS if they have been diagnosed by their clinicians. And subjects will be classified as IBS sufferers without medical diagnosis if they satisfy Rome III or Rome IV diagnostic criteria and have not received IBS diagnosis from physicians. For IBS patients, either medically diagnosed or diagnosed with IBS criteria, investigators will collect all the information on demographic features, disease characteristics and current treatment status. For non-IBS patients, only demographic information will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of subject informed consent
2. Consecutive female and/or male GI outpatients aged 18 years and over

Exclusion Criteria:

1. Subject with a cognitive condition and unable to finish the questionnaire
2. Subject has an acute or chronic non-GI condition; e.g., doesn't record a 'yes' response to the question, 'Do you have a gut problem?'
Migraine Inducing Effects and Changes in Brain Haemodynamics of PGI2

We hypothesised that intravenous infusion of PGI2 induced headache or migraine and cranial vasodilatation in migraineurs.


Eligibility Criteria:
Inclusion Criteria:

* migraine without aura and healthy apart from that
* age 18-55 years
* 50-100 kg
* Secure contraceptives

Exclusion Criteria:

* Tension Type Headache more than 3 time a month
* Other primary headaches
* Medication prior to the study (closer than 4 times plasma halflife)
* Migraine or headache 5 days prior to study.
* Hypertension (systolic BP \>150 mmHg and/or diastolic BP \>100 mmHg).
* Hypotension (systolic BP \<90 mmHg and/or diastolic BP \<50 mmHg).
* Heart-vessel disease of any kind incl cerebrovascular disease.
* Anamnestic or clinical signs of psychiatric disease or abuse.
* Anamnestic or clinical signs of disease of any kind relevant for participation in the study.
Postpartum Depression

Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women c-section (using general or regional anesthesia) aged between 18-45 years

Exclusion Criteria:

* age under 18 or above 45, history of smoking, a diagnosis with mental retardation, psychiatric patients, use of antipsychotics or antidepressants, patients with sleeping disorders, hormone replacement theraphy patients.
Modulation of Microbial Composition in Ileostomy Patients

To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology


Eligibility Criteria:
Inclusion Criteria:

* • Ileostomy installed at least 3 years prior to participation

  * Free of any complications originating from the colectomy procedure for at least 1 yr prior to participation, with the exception of possible skin irritation at the location of the stoma
  * BMI from 18 till 28 kg/m2
  * Age from 18 till 70 years
  * Available for entire study protocol.
  * For female: If of child bearing potential, female subjects must be using or complying with methods of contraception (such as oral birth control pills, intra-uterine device, double barrier methods (like condoms and spermicide, etc.)

Exclusion Criteria:

* • History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.

  * Subject with known lactose intolerance or with known or suspected allergy or hypersensitivity to any component of the study product(s) (milk protein for example) + sucrose + rhamnose
  * Severe gastrointestinal symptoms. In case of mild gastrointestinal symptoms, the principal investigator and the medically responsible MD will judge eligibility to participate.
  * Removal of more than 15 cm of the ileum during or at any moment after the colectomy procedure
  * Abdominal surgery interfering with gastrointestinal function, upon judgment of the principal investigator and the medically responsible MD
  * Use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (but except oral contraceptives), within 14 days prior to and during participation.
  * Consumption of any probiotic or prebiotic supplements or pre- and probiotics containing food products, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principal investigator), in the 4 weeks prior to the study and during study participation (E4 PreProbiotics).
  * Use of antibiotics in the 4 weeks prior to the start of study and during study participation
  * Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided'
  * History of any side effects towards intake of pro- or prebiotic supplements of any kind.
Joint Effort 2.0: a Mobile Application With University Students

The purpose of this study is to evaluate quantitatively and qualitatively a mobile application, Joint Effort, targeting safe cannabis use among consumers.

This randomized controlled trial is currently conducted on the Joint Effort mobile application.

This online randomized controlled trial with parallel groups is conducted in Quebec (Canada). Interested participants are invited to visit the study's website at www.etudejointeeffort.ca

The study's Website contains text explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (Joint Effort mobile application) or to a control group (brief normative feedback and standard information).

Four weeks and eight weeks after the baseline questionnaire, participants will complete the online questionnaires again.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35 years old
* Be a non-medical cannabis user and have used in the last month
* Understand, read and write French
* Own a smartphone (iPhone)

Exclusion Criteria:

* None
Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' elderly patients (aged ≥ 60 years) who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.

Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System
* Patients at least 60 years of age.

Exclusion Criteria:

* Patients under the age of 60 years old are excluded.
Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction

Chronic heart failure represents an extremely complex clinical syndrome, defined as the inability of the heart muscle to generate a volume adequate to the metabolic needs of peripheral tissues, or to do so only in the face of high filling pressures intracavity. Heart failure is one of the leading causes of mortality and morbidity in Western countries.

Despite advances in the therapeutic field, the prognosis of patients with heart failure of ischemic and non-ischaemic aetiology still remains unfavorable, with a mortality rate of 50% 5 years after the first hospitalization.Therefore, a deeper understanding of the pathophysiological mechanisms involved in heart failure and adverse ventricular remodeling is essential.

The study will be interventional, prospective, and single-center. Partecipants will be divided into three groups:

1. 30 partecipants admitted to our hospital with the diagnosis of STEMI-type ACS and ejection fraction ≤ 35% on echocardiographic evaluation
2. 30 partecipants with non-ischaemic dilated cardiomyopathy and ejection fraction ≤35% on echocardiographic evaluation
3. 15 partecipants diagnosed with STEMI-type ACS and ejection fraction \> 50% on echocardiographic evaluation
4. 15 controls with normal left ventricular contractile function. The study foresees a phase of patient recruitment, in which, in the hours immediately following the blood sampling, the isolation of the PBMCs, their incubation and cytofluorimetric analysis will be carried out and the conservation of the material to be analyzed subsequently by molecular biology and immunochemistry.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the Gemelli Polyclinic with acute coronary syndromes and heart disease;
* patients admitted to our polyclinic with the diagnosis of SCA type STEMI and ejection fraction ≤ 35% at echocardiographic evaluation;
* patients with non-ischemic dilated cardiomyopathy and ejection fraction ≤ 35% at echocardiographic evaluation;
* patients diagnosed with SCA type STEMI and ejection fraction \> 50% at echocardiographic evaluation;

Exclusion Criteria:

* evidence of inflammatory or infectious disease;
* malignancy, or immunological or hematologic disorders;
* treatment with anti-inflammatory drugs other than low-dose aspirin;
* age \> 85 years;
* recent surgery (within one month);
* advanced chronic kidney disease (eGFR MDRD-4 \<30 ml/min./1.73m2).
Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS

Outflow tract ventricular arrhythmia (OTVA) is the most common type of ventricular arrhythmia, and catheter ablation (CA) is the primary treatment option for patients experiencing symptoms. Accurately identifying the origin site of OTVA is essential for effective catheter ablation, minimizing procedural risks, and enhancing treatment success. However, most studies that developed algorithms or scoring systems for distinguishing OTVA origins excluded participants with structural heart disease and those with paced rhythms from their study groups. A recent prospective evaluation of a hybrid score (HS) that integrates both clinical and ECG data to predict OTVA-SOO, including patients with cardiac implantable electronic devices and those with structural heart disease in our study.

The presented study aimed to assess the effectiveness of the previously described hybrid algorithm in predicting OTVA-SOO in a patient population characterized by a wide basal QRS due to intraventricular conduction defects or paced rhythms.

The Hybrid Score The Hybrid Score (HS), involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions apply for transitions up to V6. A score ≤ 1 suggests an RVOT origin, whereas ≥ 2 suggests an LVOT origin.

ECGs were recorded with a standard configuration at a 25 mm/s sweep speed.

Premature Ventricular Contraction (PVC) Ablation Activation mapping of spontaneous OTVAs was conducted. The procedure aimed to abolish spontaneous OTVAs, with the site of ablation marking the site of origin (SOO).

Collected data

* Patient Information and Consent (procedure must be done within 60 days of consent)
* Demographics (age, gender, etc.)
* Vital signs (length, weight, etc.)
* Medical history, including cardiovascular risk factors, cardiomyopathy and drugs
* ECG data
* Echocardiographic data (left ventricular ejection fraction and left ventricular end-diastolic diameter)
* Procedure data (number of radiofrequency applications, site of effective ablation, total radiofrequency time, total fluoro time, points mapping, procedure time)
* Adverse Events


Eligibility Criteria:
Inclusion Criteria:

* ventricular arrhythmia with a morphology indicating an outflow tract origin and a wide basal QRS complex
* a QRS width greater than 110 ms was considered wide
* willing and capable of providing written informed consent to the study

Exclusion Criteria:

* catether ablation procedure was unsuccessful
* infrequent arrhythmia requiring ablation guided by pacemapping.
First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects

The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.

This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40 enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.
* Male subjects
* Subject is healthy as determined by medical evaluation
* Subject provided written informed consent
* Subject is willing to comply with all requirements and restrictions according to the study protocol.

Exclusion Criteria:

* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
* Any acquired or congenital immune deficiency.
* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
* Any acquired or congenital immune deficiency.
* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
* Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.
* Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
* Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.
* Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.
* Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.
* Positive drug or alcohol screen at screening and admission.
* Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.
* Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last pharmacokinetic (PK) blood sample time point.
* Legal incapacity or limited legal capacity, or incarceration.
* Inability to understand or communicate reliably with the Investigator.
RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy

This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.

Myotonic dystrophy type 1 (DM1, Steinert disease) is a multisystem disorder that affects, beside muscle, several other organs, including the heart.

Cardiac involvement represents a major problem in the clinical management of patients, so that cardiac complications represent one of the primary causes of premature death in DM1. In particular there is a high incidence of sudden death, ranging from 2 to 30% of cases, so far principally related to the development of conduction blocks. However, literature reports of sudden death in patients implanted with pacemakers, as well as of spontaneous ventricular tachycardia would suggest a potential etiologic role also for ventricular arrhythmias. The lack of clinical research studies conducted on a large number of patients does not make available definite data regarding the etiology and the epidemiology of arrhythmic events in DM1. For the same reasons, other considerable topics, such as prognostic stratification of the arrhythmic risk and clinical management of life-threatening arrhythmias in DM1 patients, are still undefined.

To clarify these issues, the investigators propose a clinical research study performed on a large cohort of DM1 patients enrolled through a multicenter collaboration that also involves 5 cardiological-neurological Italian centres.

Aims of this study are:

* To estimate the incidence of arrhythmias and to characterize the brady-tachyarrhythmic mechanisms underlying the occurrence of cardiac sudden death in DM1;
* To verify by statistical analysis the reliability of data obtained from both non invasive and invasive diagnostic procedures as indexes useful for estimating the arrhythmic risk in DM1;
* To identify more adequate therapeutic guidelines in order to prevent the occurrence of life-threatening arrhythmias.

The protocol of study includes:

1. Clinical-genetic evaluation;
2. Non invasive and invasive diagnostic cardiac procedures;
3. The use of devices for diagnostic and therapeutic follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient affected by myotonic dystrophy type I (MD1).
* Patient willing to provide a signed informed consent.

Exclusion Criteria:

* Age \< 18 years old or \>70 years old.
* Ischemic cardiomyopathy
* Cardiomyopathy due to chronic excess of alcohol consumption (\>100 g\\day)
* Congenital heart disease
* Acquired valvular heart disease
* Metabolic cardiomyopathy: thyrotoxicosis, hypothyroidism, adrenal cortical insufficiency, pheochromocytoma, acromegaly
* Familiar storage and infiltrative diseases (hemochromatosis, glycogen storage, Hurler's syndrome, Niemann-Pick disease; primary, secondary, familial and hereditary cardiac amyloidoses)
* Systemic diseases (connective tissue disorder; sarcoidosis)
* Peripartum cardiomyopathy