cyrilzakka/clinical-trials huggingface dataset:
Children Food Neophobia - a Playful Intervention at a Kindergarten

The aim of this project is to investigate the efficacy of taste exposure-plus small reward in acceptance and consumption of vegetables among preschool children at school. In this context, interventions were attended at school in order to capture the influence of this environments towards consumption of vegetables among preschool children. For this, the methodology applied will be a repeated exposure protocol by introducing small rewards to encourage children to taste an unfamiliar or dislike food. Child intake (weight or number of pieces) and liking (hedonic scale) will be assessed at baseline sessions and exposure sessions. Moreover, child's neophobia will be evaluated and additional determinants of child neophobia, such as child's eating behaviour

Food neophobia, understood as the rejection of novel foods, is considered one of the biggest barriers to the consumption of fruits and vegetables in preschool children. Some factors like food preferences, gender, genetic characteristics, psychological factors and family factors are also crucial for the acceptance of vegetable in childhood. Some strategies used to modify food preferences of children are repeated exposure and the use of rewards. The aim of this project is to investigate the efficacy of taste exposure-plus small reward in acceptance and consumption of vegetables among preschool children at school. In this context, interventions were attended at school to capture the influence of this environment towards consumption of vegetables among preschool children.

For this, the methodology applied will be a repeated exposure protocol by introducing small rewards to encourage children to taste an unfamiliar or dislike food. Child intake (weight or number of pieces) and liking (hedonic scale) will be assessed at baseline sessions and exposure sessions. Moreover, child's neophobia will be evaluated and additional determinants of child neophobia, such as child's eating behaviour. Quantitative data analysis will be performed by software IBM-SPSS Statistics®. In conducting this research is expected to achieve techniques to overcome neophobia in preschool children and promote vegetable consumption in school and at home. The results may contribute to improve food quality in childhood and consequently in adulthood.

Eligibility Criteria:
Inclusion Criteria:

* children attending an educational institution

Exclusion Criteria:

* children with cognitive impairment
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR

Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with AML according to the 2022 WHO diagnostic criteria;
* Age 60-75 years;
* Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L);
* Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy;
* Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN;
* Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \> 8 weeks;
* Voluntarily signed the informed consent form and can understand and comply with the study's requirements.

Exclusion Criteria:

* Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening;
* Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
* Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication;
* Pregnant or breastfeeding women;
* Unable to understand, comply with the study protocol, or unable to sign the informed consent form.
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist

The purpose of this study is to measure the gastrointestinal emptying time using the wireless motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with migraine who are taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP) antagonist called galcanezumab or erenumab.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
* Have a frequency of less than 15 monthly headache days of which up to 14 can be migraine headache days.
* Participants can be on no more than 1 other migraine preventive treatment (except for tricyclic antidepressants and verapamil which are not allowed) as long as: that participant has had a stable dose of the oral migraine preventive treatment for a minimum of 2 months or participants have received onabotulinumtoxinA for a minimum of 2 cycles prior to screening

Exclusion Criteria:

* Participants with a history of gastric bezoars, swallowing disorders, severe dysphagia to food or pills, suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
* History of any abdominal surgery within the past 3 months or GI surgery with the exception of cholecystectomy, appendectomy, or Nissen fundoplication
* History of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, or diverticulitis
* Participants with type 1 or type 2 diabetes
* Participants with cardiac pacemakers or other implanted or portable electromechanical device
* Participants with a body mass index of ≥40 kilograms per square meter (kg/m²)
* Women who are pregnant or nursing
* Participants currently on mAb CGRP antagonists or have received a mAb CGRP antagonist within the past 6 months prior to visit 1
* Participants who have received an oral CGRP antagonist (gepant) in the last 14 days prior to Visit 1
RCT Comparing ESPB Solutions in Breast Surgery

The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 75 years of age at screening
2. Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center

Exclusion Criteria:

1. Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)
2. Pregnant women
3. Pregnant minors
4. Woman of childbearing potential who are unwilling or unable to complete a pregnancy test
5. Minors i.e., individuals who are not yet adults (neonates, children, teenagers)
6. Wards of the state
7. Non-viable neonates
8. Neonates of uncertain viability
9. Prisoners
10. Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication
Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications

This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. The investigators record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively."

Postoperative pulmonary complications (PPCs) are often underestimated yet remain a leading cause of perioperative morbidity and mortality. These complications encompass postoperative hypoxia, atelectasis, bronchospasm, pulmonary infections, infiltrations, aspiration pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, and pulmonary edema. They are prevalent and associated with significant costs, prolonging hospital stays, ventilation duration, and ICU admissions, while also increasing mortality and morbidity risks.

Perioperative mechanical ventilation stands as a primary risk factor for the development of postoperative pulmonary complications. Approximately one in four patients with normal lungs will develop some form of lung injury following mechanical ventilation, although much of this damage can be mitigated through the use of appropriate ventilation strategies. A range of pulmonary complications induced by mechanical ventilation is known as ventilator-induced lung injury (VILI).

A growing understanding of the injury mechanism aids researchers in identifying risk factors for lung injury, including tidal volume, respiratory rate, pressures, and flow. Mechanical power, which combines tidal volume, respiratory rate, and airway pressure, has been identified as a potential contributor to VILI. The greater the power, the higher the likelihood of lung injury occurring.

Mechanical power represents the total energy expended over a specific period and is typically expressed in joules per minute (J/min). The equation for mechanical power can help estimate the contribution of different causes of VILI and their variations. This equation can be easily applied in the software of each ventilator. Recent studies have investigated threshold values for mechanical power in relation to ventilator-associated lung injury using the simplified formula found for mechanical power

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Patients undergoing elective major abdominal surgery
* Patients with ASA (American Society of Anesthesiologists) physical status classification I-IV
* Patients capable of providing voluntary consent

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant individuals
* Those who decline to participate in the study
* Patients requiring reoperation due to surgical complications
* Organ transplant recipients
* Patients who were intubated preoperatively
* Day surgery patients
HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Exclusion Criteria:

* Participants previously treated with adalimumab
A Multiple Ascending-Dose Study of RG7625 in Healthy Volunteers

This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week of RG7625 dosing in healthy male and female volunteers. Each participant will receive a single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each participant will also receive intradermal administration of 4 recall antigens at Screening and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity (DTH).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females 18 to 60 years of age, inclusive
* Body mass index 18.0 to 30.0 kilograms per meter-squared (kg/m\^2), inclusive

Exclusion Criteria:

* Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results, or a history of any other clinically significant disorders
* Any major illness within the one month preceding the Screening visit, or any febrile illness within the two weeks preceding the Screening visit
* Any significant allergic reaction to drugs
* Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
* Women who are pregnant or lactating or of childbearing potential
* Clinically significant abnormal electrocardiogram (ECG) or other risk factors for QT prolongation
* Use of prescribed or over-the-counter medication
* Inability or unwillingness to comply with study requirements
Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care

The aim of this project is to develop a model for return to work (RTW) for patients sick listed due to stress related mental disorders, which takes into account each patient's specific situation; includes the workplace, and is well adapted to the Swedish primary care setting.

In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and private primary care centers will be offered a one-day training about work and workability for patients with stress related mental disorders. Also, the participants will be trained in a specific method that includes the patient's employer early in the rehabilitation process

The project has a quasi-experimental and longitudinal design. The intervention will be conducted on 15 different primary care centers, which will be matched with a comparison group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18 months after sick-listing. The hypothesis is that patients who are sick-listed at primary care centers that completely or partially implemented the specific method on average will return earlier to work than patients sick-listed at primary care centers that did not implement the method.

Alongside studying if the intervention has an effect on the patients' RTW over time, the investigators aim to investigate the mechanisms explaining the effects and the individual and organizational level (primary care units) circumstances necessary for these mechanisms to be triggered. To gain deeper knowledge about mechanisms and context, the investigators will conduct interviews with the treatment staff and collect registry data about the primary care units.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of International Classification of Diseases (ICD)10 F43
* Has an employment
* Good command in spoken and written Swedish

Exclusion Criteria:

* Participants must not have been on long term sick-leave (\>60 days) during the last three years, regardless of causative diagnosis.
Online HIV Prevention Vignette Evaluation

This is an evaluation of the effect that an online live action, dramatic vignette about four gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch the vignette and participate in the evaluation study. The primary hypothesis is that men will be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to inform their sex partners of their HIV status after watching the vignette. The secondary hypothesis is that men will be more likely to follow through on these intentions in the three months following the intervention than they were in the three months before viewing the vignette. This is a one group pre-posttest intervention in which each man serves as his own control.

* Men over 18 years of age will be recruited for the study through a banner posted on the exit page of manhunt.net an internet gay hook-up site. Those clicking on the banner will go to the evaluation website (www.hivbigdeal.org)
* asked to read the consent and click agreement.
* asked to complete a relatively brief questionnaire about their sexual behavior, HIV testing and HIV disclosure in the preceding three months
* watch the 8 minute dramatic vignette
* complete a brief questionnaire that elicits their response to the video and their HIV testing and disclosure intentions.
* if they agree to provide the study with their e-mail address, participants will be re-contacted in three months and asked to complete a second behavioral survey online that asks about sexual behavior, HIV testing and HIV disclosure in the three months since watching the vignette.Behavior before and after watching the vignette will be compared.
* The entire study will be conducted online.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Gay/bisexual men
* Age \> 18

Exclusion Criteria:

* Women
* Men under 18
* Men who do not have sex with other men
Intravascular Injection Rates During Lumbar Medial Branch Block

The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block.

In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, the investigators postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, the investigators used the real time fluoroscopy after injection of contrast medium.

The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block

Eligibility Criteria:
Inclusion Criteria:

* facet joint arthropathy

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality
QT-Prolongation in Lung Transplantation

Experimental intervention: electrocardiography. Control intervention: none

Duration of intervention per patient/subject:

5 min, observation 6 months

Key inclusion criteria:

* outpatients after lung transplantation (single, double or combined)
* outpatients on the wait list for lung transplantation

Key exclusion criteria:

• no informed consent

Primary endpoint:

• prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

Key secondary endpoint(s):

* prevalence of any QTc-interval prolongation (\>440 msec ) after lung transplantation
* prevalence of PQ prolongation (200 msec sec or above) after lung transplantation
* prevalence of QRS prolongation (120 msec or above) after lung transplantation
* prevalence of QTc-prolonging drugs in drug regimen before and after lung transplantation
* influence of long-term neo-macrolide (e.g. azithromycin) on QTc interval after lung transplantation
* intra-individual difference of QTc interval before and after lung transplantation
* incidence of any QTc-interval prolongation(\>440 msec ) after lung transplantation
* incidence of any QTc-interval prolongation (\>440 msec or increase by 50msec or above) after initiation of new QTc prolonging drugs (especially neo-macrolides)
* reversal of QTc-interval prolongation (440 msec or lower or decrease by 50msec or above) after stopping any QTc prolonging drug
* Assessment of safety:
* Incidence of new onset heart rhythm disorder during 6 months of follow-up

Eligibility Criteria:
Inclusion Criteria:

* outpatients after lung transplantation (single, double or combined)
* outpatients on the wait list for lung transplantation

Exclusion Criteria:

* no informed consent
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian males aged between 18 and 45 years (inclusive) at Screening
* A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
* Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
* Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1

Exclusion Criteria:

* Receipt of any investigational agent or drug within four months before Screening
* A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
* Hypersensitivity and/or allergy to drugs
* Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
* A history of chronic or recurrent infections or current active infection
* A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
* A history or presence of malignancy
* Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
* A history of smoking at any time within one year before Screening