cyrilzakka/clinical-trials huggingface dataset:
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period

The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.

The prevalence of atopy at Taiwan increased 8 times in past 20 years and also increased all over the world. In our previous study, maternal atopic history rather than paternal one is the major factor to effect infant eczema and IgE titers. This may be related to maternal inheritance and environments during pregnancy. Kalliomaki et al. (Lancet, vol.357, p1076-9, 2001) presented that Lactobacillus GG used 2-4 weeks prenatally to mothers and 6 months postnatally to infants was effective in prevention of early atopic disease in children at high risk.

We designed a double-blind randomized placebo-controlled study to evaluate whether cord blood IgE and childhood atopic disease decreased after allowing allergic mothers intake of Lactobacillus GG in second trimester, followed by infant intake of Lactobacillus GG for 6 months after birth.

Materials and Methods:

1. Inclusion criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE \> 100 kU/l and positive specific IgE.
2. Case number: 100 cases were collected in both control and study groups.
3. Study design: In a double blind randomized placebo-controlled study, eligible cases are allowed to take Lactobacillus GG or placebo daily from gestational age of 24 weeks until delivery in both groups.

   In study group, Lactobacillus GG is given prenatally from gestational age of 24 weeks to delivery for mothers and 6 months postnatally for infants.

   In control group, placebo starch is given prenatally from gestational age of 24 weeks for mothers to delivery and 6 months postnatally for infants.
4. Schedule of follow-up: Infant/child clinical symptoms and sign are evaluated and IgE and specific IgE are tested in bloods from umbilical cords, infants in 1, 3 and 5 year old.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE \> 100 kU/l and positive specific IgE

Exclusion Criteria:

* Multiple pregnancy
Inducing Systemic Immunity and Regressions in Metastatic Melanoma

In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.

Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Multiple cutaneous or subcutaneous metastases of melanoma

Exclusion Criteria:

* Visceral metastases on admission.
* No current chemotherapy or immunotherapy.
* Note study performed between 1978 and 2002 before current therapies were available.
Effect of Isoflurane on Tissue Doppler Imaging of Mitral Annulus During Cardiac Surgery

The purpose of this study is to determine Isoflurane's dose-dependent effect on left ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery patients.

Isoflurane is widely used in cardiac surgery patients due to its beneficial effects, but many studies have shown that isoflurane reduces myocardial contractility in a dose-dependent manner, and compromises left ventricular (LV) function.

Tissue Doppler imaging (TDI) of mitral annular velocity during the cardiac cycle has been introduced as a reliable method for analysis of systolic and diastolic LV long-axis function. Efficacy of systolic and diastolic TDI profiles, including systole (S'), early early relaxation (E')and atrial contraction (A') have been suggested to be useful in predicting the impact of isoflurane on LV systolic and diastolic function.

The investigators hypothesized that isoflurane, even at a clinical dosage, would affects intraoperative LV systolic function in a dose-dependent manner and thus produce significant changes int the TDI profiles of systolic mitral annular velocity (S').

So the investigators planned to study the changes in S' of lateral mitral annulus at the clinical isoflurane dosage during remifentanil based anesthesia for cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* low ejection fraction \< 50% in preoperative transthoracic echocardiography
* atrial fibrillation
* pacemaker
* pericardial and infiltrative myocardial disease
* mitral annular calcification, surgical rings, prosthetic mitral valves
* lateral left ventricular regional wall motion abnormality
* esophageal spasm, stricture, laceration, perforation, and diverticulum diaphragmatic hernia
* history of extensive radiation to mediastinum
* upper gastrointestinal bleeding
Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.

Tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. Therefore, accurate diagnosis of tinnitus is so difficult.

So, Investigators measure auditory ERP through autonomously developed system to make a objective diagnosis tinnitus. Moreover, patients undergo continuous resting EEG measurement.

In this study investigators examined the efficacy of rTMS treatment for tinnitus and check into changes in brain connectivity or auditory task with ERP, continuous resting EEG before and after rTMS. And develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic tinnitus
* Chronic subjective tinnitus for more than 6 months
* Subject is naive regarding rTMS
* Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
* Stable enough to complete this study per the opinion of the Study Physician
* No restrictions, provided the dosages have been in place for at least 3 months
* A three month washout from any other tinnitus treatment or management program is required prior to entering this study.

Exclusion Criteria:

* Objective tinnitus or tinnitus with treatable cause
* Presence of intracranial or intraocular ferromagnetic materiel or particles
* Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
* Personal history of central nervous system disorder, head injury, stroke or seizures
* Familial history of epilepsy
* Concomitant medication with antidepressants and antipsychotics
* Pregnant women
* Others known contraindications to rTMS or brain MRI
Retrospective Review of Amino Acid Formula Use at a Children's Center

This is a retrospective review of data documented in medical records.

This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Consuming or with a history of consuming an amino acid-based formula

Exclusion Criteria:

* Medical records lacking information on consumption of an amino acid-based formula
Allogeneic Cord Blood for Neurological Diseases in Adults

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.

Neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. Cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. The investigators clinical research aims to determine the safety and efficacy of allogeneic Umbilical Cord Blood for adult patients with neurological diseases such as stroke and spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke (onset \< 24 months), or
* Spinal cord injury (onset \< 24 months)

Exclusion Criteria:

* Raised intracranial pressure
* Malignant cancer
* Renal failure
* Severe pulmonary dysfunction
Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.

The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups.

* Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant
* Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.

Eligibility Criteria:
Inclusion Criteria:

* 20-60 years old
* Those who will undergo elective laparoscopic cholecystectomy surgery
* Those in ASA I-II physical status
* Those who gave consent to participate in the study

Exclusion Criteria:

* Those outside the age range of 20-60
* Those outside of ASA I-II physical status
* Serious heart, lung, liver disease
* Kidney failure
* Bleeding diathesis
* Those who develop complications during the procedure
* Those with fever, active infection
* Those who are allergic to the drugs to be used
* Those who refused to participate in the study
* Those with hypothermic and acid-base disorders
* Electrolyte disturbances such as hypokalemia, hypocalcemia
* Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
* Pregnant
* Those with bleeding
* BMI 30 and above
Study Phase III Comparison of Superiority, Open With Blind Appraiser, to Evaluate the Efficacy and Safety of Barium Sulphate 66.7% With V (OPTI-BAR) Compared to Proceedings in Inert Radiological Examinations for the Diagnosis of Diseases for Image the Tratogastrointstinal

Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as a contrast X-ray (X-ray).


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 who need x-rays gastrointestinal tract with contrast;
* Healthy patient, ambulatory;
* Willingness to comply with the requirements of the study after signing an informed consent and (hit).

Exclusion Criteria:

* Pregnant or lactating women;
* Patients allergic to barium sulfate, latex rubber or simethicone;
* Patients who have asthma, eczema, cystic fibrosis, heart disease, high blood pressure, rectal cancer, colostomy, obstruction in the stomach or intestines, pseudotumor cerebri, blocking stomach or intestinal disease, Hirsch or pseudotumor cerebri;
* Patients who have recently undergone a rectal biopsy or surgery or a recent history of drilling into your esophagus, stomach or intestines; Patients who have already participated in another clinical protocol in the last six months;
* Other clinical criteria that in the opinion of the study investigator could compromise the welfare of the patient or interfere with the results expected from the study.
Treatment of Hyperlactatemia in Acute Circulatory Failure Based on Analysis of CO2: a Prospective Randomized Superiority Study (The LACTEL Study)

The management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. Lactate is a marker of tissue hypoperfusion commonly used in the ICU. In principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type A), decreased lactate uptake (type B), or a combination of both mechanisms. It is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. A classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). In clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type A and type B). From work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous CO2 gradient (pCO2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, SVO2....). Furthermore, when we relate pCO2gap to the arteriovenous O2 difference (pCO2gap /C(a-v)O2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type A) and those related to the underlying disease.

Also, several studies have demonstrated a strong ability of the pCO2gap and the pCO2gap/CavO2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. As a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these CO2-derived indexes.

The hypothesis of this study is that the use of an algorithm based on CO2gap and the CO2gap/CavO2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Oral, free and informed consent obtained from a trusted person (health care proxy) or a close relative or consent in an emergency situation
* Adult patient managed in intensive care for whom the physician has decided on hemodynamic management because of signs of acute circulatory failure (systolic blood pressure \< 90 mmHg, mean arterial pressure \< 65 mmHg, or the need for infusion of vasopressors, skin mottling, diuresis \< 0.5 mL/kg/h for a duration ≥ 2 hours, skin recoloring time \> 3 sec
* Arterial lactate level ≥ 3 mmol L-1

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person subject to a measure of legal protection (curatorship, guardianship)
* Person subject to limited judicial protection
* Pregnancy or breastfeeding
OBT Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI

The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

1. Informed consent will be obtained from all patients prior to enrollment.
2. The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
3. This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
4. All patients will undergo AFP and US if they do not have results within the past three months.
5. If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
6. For all patients, a case report form will be completed.
7. All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
8. If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
9. All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
10. If available, all additional MRI/CT/US results will be recorded within the patient's CRF.

Eligibility Criteria:
Inclusion Criteria:

1. Any patients with chronic liver disease at risk for HCC.
2. Age ≥ 18 years.
3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.

Exclusion Criteria:

1. Any patients with chronic liver disease at risk for HCC.
2. Age ≥ 18 years.
3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
5. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
6. Women who are pregnant or breast feeding.
7. Patient taking drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
8. Patient, based on the opinion of the investigator, should not be enrolled into this study.
9. Patient unable or unwilling to sign informed consent.
10. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Influence of a Lifestyle Intervention in Preschool Children on Physiological and Psychological Parameters

Childhood obesity and low fitness tracks into adulthood and carries significant co-morbidities. The investigators test the hypothesis that a multidisciplinary multilevel lifestyle intervention in preschool children in the French and German speaking part of Switzerland during one school-year results in a smaller increase in body mass index (BMI) and a larger increase in aerobic fitness.

We will assess the effect of this multidisciplinary intervention in a multicenter cluster randomized controlled trial including a total of 40 kindergarten classes in the French (canton Vaud) and in the German (canton St. Gallen) speaking part of Switzerland. Health promoters, trained in physical education, will receive further postgraduate training (in nutrition, education, psychology) and will then in reward teach several kindergarten teachers hands-on. These trained health promoters will intervene on the level of the kindergarten teacher, the parents, the local community and also on the level of the children following a professional pre-specified curriculum in the kindergarten that focuses primarily on physical activity, healthy nutrition, media use and sleep duration. The curriculum also includes information evenings, workshops and fun weekly homework packages. Special attention will be paid to establish a curriculum that reaches also socio-cultural high risk groups living in Switzerland. Measurements will be performed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy kindergarten children

Exclusion Criteria:

* Children with severe chronic disease (restricting physical activity)
The Neural Representation of Self in Depression Patients

To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Negative self-bias was found to serve as the core cognitive mechanism of depression disorder. However, there was no evidence to show the reason lead to negative bias. In the current study, investigators hypothesized that the blurring self representation was the neural correlates in depression disorder.

To test investigators' hypothesis, investigators adopted the self-referential task and fMRI to investigate the neural representation of self in depression patients, and compared with healthy control.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be clinical diagnosis of major depression disorder.
* Healthy control participants should be age-matched with depression group, and should have no history of neurological or psychiatric diagnoses

Exclusion Criteria:

* Patients who also have bipolar disorder, schizophrenia, anxiety disorder
* Healthy controls who have history of mental disorders
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b

The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years or older
2. HIV positive
3. Evidence of uncontrolled virus (e.g., \> 20 copies/ml) within the past 12 months as verified by medical record
4. Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)

Exclusion Criteria:

1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
2. Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
3. Opinion of the PI that the participant would be at risk for harm to self or others
4. Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.