cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

This was a randomised, double-blind, placebo-controlled, single dose, dose escalation study with 4 dosing cohorts. Within each cohort, 45 evaluable subjects were planned (36 subjects receiving M01ZH09, 9 receiving placebo).

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects aged 18 to 50 years inclusive, who are able and willing to give informed consent, following a detailed explanation of participation in protocol
* available for the duration of the study and available for scheduled and potential additional visits

Exclusion Criteria:

* women who are pregnant, breast-feeding or of childbearing potential and unwilling to use a reliable method of contraception throughout the study period
* history of anaphylactic shock following vaccination by any route have phenylketonuria
* hypersensitivity to any component of the vaccine or are hypersensitive to two of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole
* received antibiotic medication within 14 days prior to dosing
* received any vaccine within 4 weeks prior to dosing or plan to receive a vaccine within 4 weeks after dosing
* received any vaccine against Salmonella typhi (licensed or investigational) or ever suffered from typhoid fever
* subjects who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27
* known or suspected history of liver or active gall bladder disease, ongoing gastro-intestinal disease or abnormality
* commercial food handlers or health care workers with direct contact with high risk patients or who have household contacts with immuno-compromised individuals, pregnant women or children less than 2 years of age
* subjects who have a clinically significant amount of protein or haemoglobin in their urine or abnormality of their haematology or serum biochemistry parameters
* impairment of immune function or those receiving or have received cytotoxic drugs in the 6 months prior to study entry
* subjects who use antacids, proton pump inhibitors or H2 blockers on a regular basis or have consumed proton pump inhibitors or H2 blockers within 24 hours prior to dosing
* acute infections (including fever of 37.5 degrees Celsius or greater) on the day of dosing.
* subjects with chronic disease (e.g Crohn's disease, inflammatory bowel disease, diabetes) who cannot withstand a 3 hour fast
* substance abuse or a history of substance abuse that might interfere with participation in the study
* body mass index (BMI) is less than 19 or greater than 34 kg per m2
* clinically significant medical condition that precludes participation in the study
* subjects who have participated in an interventional clinical trial within 60 days of dosing
The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.

Cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. The etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state.

Most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. The high incidence of postoperative AF in these patients suggests a possible embolic cause for some strokes. As such, some postoperative strokes may be preventable.

Previous studies report incident AF in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (CABG) and valve surgery.

In patients with non-operative AF, the risk of ischemic stroke is markedly reduced by adequate OAC. However, the management of postoperative AF is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. The risk of bleeding poses a significant limitation to the use of OAC, which consequently increases focus on left atrial appendage (LAA) closure, as the LAA is a predilection site for thrombus formation during AF.

Based on previous studies, ≥90% of AF-related left atrial thrombi are located in the left atrial appendage (LAA), and therefore, LAA occlusion is a tempting method for AF-related stroke prevention.

Current recommendations regarding surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years scheduled for first-time planned open-heart surgery.

Exclusion Criteria:

Pediatric population \>18 years. Emergent open heart surgery. Patients with current endocarditis. Where follow-up is not possible. The patient refused to sign the informed consent to participate in the research.
Investigation of Clofarabine in Acute Leukemias

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
* Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
* No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
* Adequate liver function (bilirubin \</= 2 mg%) and renal function (creatinine \</= 2 mg%).
* Pregnant and lactating females not eligible.
* Zubrod performance status 0-2
* Adequate cardiac status
* No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.
Toward a Real-time Access to Sleepers' Mental Content

Sleep is crucial for global cognitive functioning, but its exact functions and mechanisms are still poorly understood. Cognitive studies of sleep typically rely on linking electrophysiological changes measured during sleep with behavioral and neural changes collected in tasks performed during wakefulness. What concomitantly happens in the mind of sleeping subjects is often ignored, certainly because it is virtually inaccessible. Yet, major advances in the understanding of human behaviors have resulted from an integrated approach that combines both neural and cognitive measures of their ongoing mental processes. The goal of this study is to provide real-time measures of the cognitive processes occurring within sleep.

To prompt real-time access to the sleeping mind, investigators will use auditory stimulation in people with unique sleep peculiarities: sleepwalkers whose overt behaviours may enable to objectively visualize ongoing cognitive processes during non-REM (NREM) sleep.

Investigators aim to offer a quantifiable, real-time measure of memory processing during NREM sleep by using memory-related cues to influence which behaviours sleepwalkers will exhibit. Because sleepwalking is characterized by complex behaviors emerging from NREM sleep, it could provide an observable window into mental activity in NREM sleep. While neuronal memory reactivations have largely been demonstrated in sleeping rodents, evidence for the existence of such reactivations in humans is at best indirect. Here, investigators will use targeted memory reactivation (TMR), a tool that allows to control which individual memories are reactivated on a trial by trial basis. TMR consists in associating sensory cues with a specific learning, then re-applying these cues during subsequent sleep to trigger the reactivation of the corresponding learning. Sleepwalkers will be trained on a modified version of the serial reaction time task: sleepwalkers will perform as fast and accurately as possible a sequence of gestures in response to auditory cues. Investigators goals are to: i) show that playing the auditory cues during NREM sleep triggers a behavioral replay of the learned 'choreography' in sleepwalkers, ii) quantify, with a gesture recognition algorithm, how the sleep gestures differ from the wake ones (speed, accuracy, sequence fidelity), and iii) test whether this evoked replay is accompanied by a congruent dream.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35 y.o
* Written consent
* Affiliated to social security
* Sleepwalking (group patients only)

Exclusion Criteria:

* Psychiatric or neurologic disorder
* Sleep disorder except sleepwalking for the patient group
* Surdity
* Pain or physical disability affecting the upper limbs
* Consumption of drugs altering sleep structure
* Subjects under legal protection
Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients

To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

The aim of this study is;

To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:

1. The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
2. To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

Eligibility Criteria:
Inclusion Criteria:

1. Under regular HD for at least 6 months
2. Clinically stable condition as outpatients.
3. Treatment naïve patients with serum positive for HCV GT4 with HCV RNA \> 1000 IU/ml by PCR.
4. White blood cell count \> 2500/mm\^3.
5. Platelet count \> 7500/mm\^3.
6. Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score \>3 \[including 3/4 or 3-4\] ).

Exclusion Criteria:

1. Confirmed pregnancy.
2. HCV-HIV co infection.
3. HBV-HCV co infection.
4. Uncontrolled hyper or hypothyroidism.
5. For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal
6. Patients on peritoneal dialysis.
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.

Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (\<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven rectal adenocarcinoma
* Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT
* Resectable tumor, or considered as potentially resectable after CRT
* No distant metastases
* Patient eligible for surgery
* Patient aged from 18 to 75 years
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2.
* No heart failure or coronary heart disease symptoms (even controlled).
* No peripheral neuropathy \> grade 1
* No prior radiotherapy of the pelvis for any reason and no previous CT
* No major comorbidity that may preclude the delivery of treatment and no active infection (HIV or chronic hepatitis B or C).
* Adequate contraception in fertile patients.
* Adequate hematologic function
* Adequate hepatic function
* Signed written informed consent

Exclusion Criteria:

* Metastatic disease
* Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles
* Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
* Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
* Medical history of angina pectoris or myocardial infarction
* Progressive active infection or any other severe medical condition that could jeopardize treatment administration
* Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma
* Patient included in another clinical trial testing an investigational agent.
* Pregnant or breast-feeding woman.
* Persons deprived of liberty or under guardianship or incapable of giving consent
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.


Eligibility Criteria:
Main inclusion Criteria:

* Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
* ECOG Performance Status of 0 - 1
* Bidimensionally measurable disease or evaluable disease
* Adequate organ function

Main exclusion Criteria:

* Have greater than Grade 1 neuropathy - motor/sensory
* Significant history of cardiac disease
* Pleural effusion
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer

For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

1. histologically proven adenocarcinoma
2. 75 years old or younger
3. forced expiratory volume in one second ≥ 50 %
4. arterial oxygen pressure in room air ≥ 70 mmHg
5. clinically T2/T3/T4 with ≤3 cm esophageal invasion
6. written consent

Exclusion Criteria:

1. Carcinoma in the remnant stomach
2. Borrmann type 4 (linitis plastica)
3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
4. history of left thoracotomy, or left pleural adhesion
5. past history of myocardial infarction or positive results of exercise ECG
6. liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
ILIT: Follow-up of Rhinitis Quality of Life

Re-evaluation of patients treated with intralymphatic immunotherapy (ILIT) in terms of quality of life and therapeutic efficacy and comparison with subcutaneous immunotherapy (SCIT) 15 years post immunotherapy

In Switzerland, around 20% of the population suffers from hay fever. The allergy usually begins in childhood and can worsen or improve as the child grows. The quality of life of those affected suffers greatly. Since the allergens are seasonally found in the air, patients cannot really avoid the source of the allergy. On the one hand, allergic rhinitis can be treated pharmacologically. On the other hand allergen-specific immunotherapy (AIT) (=desensitization), can be considered. AIT can greatly reduce the symptoms and restore the patient's quality of life. It is the only treatment method that can offer long-term therapeutic success without the need for regular medication.

Subcutaneous immunotherapy (SCIT) is the traditional method in which the allergen is administered subcutaneously over a period of three to four years with alternating treatment intervals. The chances of success are good, but the drop-out rate is comparatively high due to the long treatment period (at least 3 and up to 5 years). In contrast, intralymphatic immunotherapy (ILIT) requires only three sessions over a period of three to four months. The allergen is administered by ultrasound directly into a lymph node. The results are equally good (compared to SCIT), but the treatment time is much shorter.

In the following project, the quality of life of the people who participated in the first ever ILIT study (ClinicalTrials.gov Identifier: NCT00470457) will be evaluated. The aim is to have a meaningful result on the duration of the therapeutic effect, as judged by the patients themselves.

To develop a meaningful result, a questionnaire was designed for patients to fill out at baseline (prior to pollen season). This shold allow assessmen of how each individual's quality of life has evolved since treatment. The study subjects will also receive a standardised (European) questionnaire. This questionnaire refers to the quality of life and symptoms of the last seven days and is filled out at baseline (prior to season) and in season (Mai-June). The data will be analysed and presented to the scientific and clinical audience as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

* Receiving ILIT or SCIT treatment at the USZ.
* Indication: hay fever (type I sensitisation to grass pollen)
* Adult male and female patients
* Written/digital informed consent of the participating person
* Complete return of both questionnaires

Exclusion Criteria:

* Discontinuation of immunotherapy
* Incomplete data set
* Pathological barrier (e.g. dementia)
* Language barrier (not understanding the German language)
Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.

Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.

Eligibility Criteria:
Inclusion Criteria:

* Known or suspected Crohn Disease
* Undergoing colonoscopy and CT enterography

Exclusion Criteria:

* Contraindication to MR
Pain Post Abdominal Laparoscopy Prevention With Arcoxia

To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary acceptance to participate in the study and signed the informed consent form
* Age older than 18 years old and younger than 70 years
* Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery

Exclusion Criteria:

* Age less than 18 years or older than 70 years.
* Laparoscopic procedures for diagnostic purposes.
* Current use of anticoagulants.
* Known hypersensitivity to etoricoxib or its components.
* History of a CABG or MI (less than 1 year)
* History of unstable angina (over the past six months).
* Current inflammatory bowel disease.
* Uncontrolled hypertension or heart failure
* Renal dysfunction/impairment (creatinine clearance \< 30ml/min)
* Cirrhosis or severe hepatic dysfunction
* Any degree of dehydration (mild to severe)