cyrilzakka/clinical-trials huggingface dataset:
Effect of Drinking Fermented Milk on Immune Response

This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.

This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B between study group and control group. The study group receives influenza vaccine and drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor and investigators are blinded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 45 years old
* healthy and having normal vital signs
* no history of uncontrolled systemic or autoimmune diseases
* no signs or symptoms of respiratory infection
* normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar
* no history of influenza vaccine during the past 6 months
* able to continuously take the intervention daily for 6 weeks
* able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection
* accepted to receive influenza vaccine shot
* able to refrain from receiving other vaccine during the trial
* able to refrain from traveling to endemic area of influenza
* able to communicate in Thai and sign their written inform consent

Exclusion Criteria:

* under pregnancy or expected to be pregnant
* lactose or milk protein intolerances
* daily intake of probiotic product for one month prior to recruitment
* chronic alcoholism
* GI disturbance e.g. stomachache, frequent diarrhea or constipation
* history of GI surgery
* ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids
McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.


Eligibility Criteria:
Inclusion Criteria:

• Requiring orotracheal intubation

Exclusion Criteria:

* Contraindication to orotracheal intubation
* Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)
* Minor (\<18 )
* Pregnant, parturient , or breast-feeding woman
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Lack of informed consent
* Concomitant inclusion in a trial whose primary endpoint focuses on intubation procedure
Droperidol and Cardiac Repolarization

For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. It is known that droperidol prolongs time of repolarisation, but there wasn't any data confirming its impact on transmural dispersion of repolarisation. Only estimation both of those actions in one time allows to define for sure arrhythmogenic role of droperidol.

The aim of this study was to answer the questions:

6. Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?

1. Does droperidol cause increase of transmural dispersion of repolarisation?
2. Does possible torsadogenic acting of droperidol depend on dose of drug?
3. Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* sex: males
* ASA score I or II

Exclusion Criteria:

* treatment with drugs influencing cardiac repolarization
* coronary artery disease
* heart insufficiency NYHA\>1
* serum electrolyte disturbances
* hypersensitivity to droperidol and/or ondansetron
Urinary Calculi After Bladder Augmentation in Children

The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:

* location of the calculi (kidney or bladder)
* type of bladder augmentation with higher rate of urinary calculi and why
* Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)

Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 18 years old, with urinary calculi, after bladder augmentation

Exclusion Criteria:

* Patients older than 18 years old, with urinary calculi, after bladder augmentation
Effects of Local Treatment With and Without Sensorimotor and Balance Exercises in Neck Pain

The sensorimotor disturbance and postural instability have been demonstrated to be associated with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed.

The sensorimotor (joint position sense and oculomotor control) and postural stability (balance) disturbances have been demonstrated to be associated with neck pain. Specific therapeutic exercise directed to neuromuscular impairments and manual therapy for the cervical spine are effective interventions for improving dizziness symptoms, neck impairments, functional ability and quality of life. However, the effects of these interventions on the actual impairment of joint position sense and balance remain uncertain. Adaptive changes in the sensorimotor and postural control systems may need to be specifically addressed. Currently, it is not known whether the clinician has to train every impairment or can choose between sensorimotor training and balance training in the rehabilitation of neck pain. Different training approaches may have specific influences on the different outcomes and their outcomes will be important to inform the optimal and efficient management of persons with chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

* insidious neck pain for at least 3 months
* an average neck pain intensity over the past week ≥ 30 mm on a 100 mm visual analog scale (VAS)
* a score of neck pain and disability ≥ 10/ 100 on the Neck Disability Index-Thai version
* an absolute error of cervical joint position error \> 4.5°
* an inability to stand in tandem stance with eyes closed for 30 seconds
* cervical segmental joint dysfunction (pain provoked \>2/10 with abnormal tissue resistance)

Exclusion Criteria:

* a previous history of neck and head injury or surgery
* known or suspected vestibular pathology
* vertigo or dizziness caused by underlying pathology in the ear, brain, or sensory nerve pathways (e.g. benign paroxysmal positional vertigo and BPPV)
* vascular disorders (e.g. a migraine and hypertension)
* any musculoskeletal or neurological conditions that could affect a balance
* inflammatory joint disease
* systemic conditions
* cognitive impairment
* taking four or more medications
* received physiotherapy treatment for their neck disorder in the past 12 months
Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers

The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).

The secondary objectives are:

to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively


Eligibility Criteria:
Inclusion criteria:

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests.
2. Age 21 to 50 years.

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. History or evidence of relevant psychiatric disorders or neurological disorders
5. History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts)
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
8. Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
10. Smoker (more than 10 cigarettes daily)
Herpes Simplex Reactivation in Adult Critical Care Patients

Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown.

Normally primary HSV infection is asymptomatic but can under certain circumstances cause manifestations such as encephalitis and bronchopneumonitis. Bruynseels showed that HSV was detectable in the throat of two percent of healthy volunteers and three percent of patients not admitted to the ICU, this provides a broad "recruitment-base" for either latent or lytic HSV infection in the ICU. Viral dissemination to the bloodstream is seen in neonates , immunocompromised patients, but also in patients with primary herpetic gingivostomatitis. Patients testing polymerase chain reaction (PCR) positive for herpes simplex DNA in blood, have a higher rate of systemic symptoms than those testing PCR negative for herpes simplex. Additionally it is known that HSV suppression in HIV patients has beneficial effects. PCR, now being available for more than a decade, has been shown to provide a more sensitive method for the detection of HSV than culture, but viral detection does not per se translate to viral disease thus the impact of disseminated HSV infection in ICU patients remains unclear.

The investigators would like to investigate the incidence of HSV reactivation in blood and tracheal secretions critically ill patients and its impact on clinical course.

Eligibility Criteria:
Inclusion Criteria:

* Admission to ICU
* Expected length of stay (LOS) \>72 hours
* Intubated \<24 hours prior to inclusion
* Informed consent by patient, relative or guardian

Exclusion Criteria:

* Ongoing antiviral treatment/prophylaxis
* Expected LOS \<72 hours
* Intubation \>24 hours prior to inclusion
* Withdrawal of informed consent
Effect of Sodium Alendronate on the Final Implant Stability.

evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials

compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique

Eligibility Criteria:
Inclusion Criteria:

* Patients with seeking implant drive prosthesis after socket has been preserved by either technique.
* Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to implant surgery.
* Patient seeking immediate implant placement.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly
* followed. Referred only for implant placement or unable to attend a 5-year follow-up
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam

This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A (midazolam).


Eligibility Criteria:
Main Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Healthy male and female subjects of non-childbearing potential aged 18 to 60 years, inclusive.
3. Body mass index ≥ 18.0 and ≤ 30.0 kg/m2.
4. Subjects as well as their partners, must agree to contraception requirements. Male subjects must refrain from donating sperm.

Main Exclusion Criteria:

1. Have known allergies to any components of the linaprazan glurate formulation, to clarithromycin/midazolam or to any drugs of a similar class including excipients associated with any of the drugs.
2. Use of CYP3A4 inhibitors, antacids, PPIs or any medication that changes gastric pH.
3. Use of any prescribed or non-prescribed CYP3A4-inducing medication or other metabolic enzyme inducers.
4. History of any clinically significant disease or disorder defined in the protocol.
Laparoscopic Appendectomy by Multi-port vs Single Port.

Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.


Eligibility Criteria:
Inclusion Criteria:

* age: 14-60
* American Society of Anesthesiologists (ASA) score: I-III
* absence of non-correctable coagulopathy (international normalized ratio \>1,5, or platelet count \<90 × 109/l).
* diagnosis: acute appendicitis with surgical indication

Exclusion Criteria:

* Complicated appendicitis after exploration or previously diagnosed (CT)
* Psychical inability
* Pregnancy
Creatine Supplementation and Bone Mass

Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* osteopenia and osteoporosis
* women older than 60 years old

Exclusion Criteria:

* cardiovascular diseases or muscular disturbances precluding exercise training
* drugs affecting bone metabolism
Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis

Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.

The development of new targeted therapies for alcoholic hepatitis (AH) is one of the more urgent needs in clinical hepatology. To reach this goal, large multidisciplinary networks are required. The proposed initiative "Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis" (InTeam) will coordinate a multidisciplinary group composed of clinicians, physician-scientists, basic scientists and bioinformatics experts. The overarching hypothesis of InTeam is that the most rational way to provide a useful framework for future clinical trials in (AH) consists of the (i) determination of key drivers of the disease process, (ii) classification of molecular profiles and subtypes of AH, and (iii) identification of "druggable" targets based on both key drivers and molecular classification. Moreover, mouse models for AH are lacking making it impossible to evaluate promising targets in preclinical mouse studies in a meaningful manner. For this purpose, InTeam will integrate data obtained from molecular pathology studies in human AH and functional studies of key pathways in animal models. The proposed InTeam consortium includes three research projects, ten clinical centers, a Human Biorepository and a Mouse Models Core. The Human Biorepository Core will generate the to-date largest collection of samples from patients with AH from 10 academic liver centers and a comprehensive database that will serve as a basis for the proposed translational studies and be a valuable asset for the broader scientific community. The Mouse Models core will conduct murine studies after establishing and evaluating mouse models of AH based on the pathophysiology and molecular drivers of human AH determined by this consortium.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 ≥ and ≤ 70 years of age.
* Active alcohol abuse within the past 3 months.
* Has an Aspartate Aminotransferase (AST) \> Alanine Aminotransferase (ALT).
* Elevated Total Bilirubin level \> 3.0.
* Absence of autoimmune liver disease (ANA\>1/320).
* Absence of hepatitis B infection.
* A liver biopsy, and/or a clinical picture consistent with alcoholic hepatitis.
* The "Start Date" (is the date of the liver biopsy or ≤ to 1 week \[72 hours is preferred\] from the time of admission).

Exclusion Criteria:

* Hepatocellular carcinoma.
* Complete portal vein thrombosis.
* Advanced or terminal extrahepatic diseases.
* Lack of consent to participate in the study.
* Pregnancy.
* Received more than 3 days of treatment with (prednisolone or pentoxifyllin) prior to start date.

Control patients
COVID-19 Booster Incentives

The goal of this work is to understand whether small financial incentives and messaging can increase the take-up of COVID-19 boosters among patients empaneled at a county public health system. The motivation for this work is the relatively low take-up of COVID-19 boosters. In California, where our experiment is based, only 59% of the population has been boosted, with only 13% receiving the recommended bivalent booster (State of California, 2022).


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 and above
2. At least one COVID-19 vaccination (primary series or monovalent booster) but no vaccination dose within the past 2-months.
3. Active phone number or email

Exclusion Criteria:

1. Opt-out of health system messaging
Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System

The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.

After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.

Parameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.

Patients will be followed up the next day for local side effects and their need for analgesic medication.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* confirmed diagnosis of periodontitis
* presence of minimum 20 teeth
* absence of decay
* preserved tooth vitality
* good systematic health

Exclusion Criteria:

* allergy to articaine with 1: 100,000 epinephrine
* pregnancy
* lactation
* medication uptake that affects the periodontal supporting tissues
* acute pain, swelling, presence of gingival lesions