cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children

Allergy to nuts (cashew, pistachio, walnut, exotic nuts) is a frequent allergy in children, with a prevalence of up to 4.9% of the population and a low resolution rate (9%). Among the nut allergies, cashew nut allergy is one of the most frequent in Northern Europe: in France 41% of children allergic to nuts are sensitized to cashew nuts. Moreover, cashew nut allergy is associated with severe reactions that can be lethal in both adults and children. These reactions may even be more severe than those observed with peanuts, with more frequent respiratory and cardiovascular impairment. We note reactions for even limited contacts (cutaneous or mucous) and low reactogenic thresholds. However, the only recommendation for management at present is avoidance. The stakes of oral immunotherapy protocols cashew would be similar to those for peanut immunotherapy: to limit reactions in case of accidental intake, increase the reactogenic threshold and thus improve the quality of life of allergic patients.

To date, only one study has focused on the efficacy and tolerance of cashew immunotherapy : the prospective NUT CRACKER study conducted on 50 children aged 4 years or older with cashew nut allergy between 2016 and 2019, reports a good efficacy of immunotherapy on increasing threshold for cashew nut but also for pistachio and walnut, when there was a cross-over allergy. While the tolerance was similar to other immunotherapy protocols for the other foods.

The objectives of part 2 of the CAJESITO study are (i) to evaluate the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew immunotherapy and (ii) to identify risk factors for severe risk factors for severe allergic reactions during oral cashew immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age with a known allergy to cashew nuts cashew nut allergy and followed in the pediatric allergology unit of Nancy University Hospital.
* Patients who have received oral cashew immunotherapy for at least 18 months at 28/02/2023

Exclusion Criteria:

* Patients who have received oral cashew immunotherapy for less than for less than 18 months.
* Patients lost to follow-up for more than 3 years (last visit in 2020 or earlier)
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise

This study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.

Hot flush (HF) is the most common symptom among menopausal syndrome and can significantly affect women's quality of life. Considering the risk of hormone therapy, the behavioral therapies have been proposed for the alternative treatment of HF. However, the exercise prescription for women with HF is controversial. Previous studies show the inconsistent effect of aerobic exercise on HF, and a moderate-to-high intensity exercise seems to aggravate HF frequency and severity. Recent studies have shown that static stretching exercise could improve HF in middle-aged women, but the related research is quite few, and the physiological mechanism as well as predictors for responders who can benefit from stretching exercise are still not clear. The knowledge of predictors for responders will provide clinicians and clients with HF symptoms to choose static stretching exercise as their treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-65 years old.
2. With hot flashes.
3. No current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months.
4. With ability to follow instructions of stretching exercise.

Exclusion Criteria:

1. SBP \>160 mmHg or DBP \>100 mmHg
2. Medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease.
3. Any medical condition limiting the ability to participate the exercise.
Observational Study of People with Complete Hand Amputation Using a Multi-grip Myoelectric Prosthesis a Following Using a Standard Myoelectric Prosthesis

Cases of unilateral or bilateral upper limb amputation result in functional and aesthetic disability and a marked deterioration in quality of life. Amputees may use no prostheses, or use a combination of cosmetic prostheses, body-powered prostheses, or myoelectric prostheses (MHP). Among MHP, there are standard MHPs with a single degree of freedom (DOF) and one grip type, and multi-grip myoelectric hand (MG-MHP) with multiple DOF.

Amputees who do not use a prosthesis or a cosmetic prosthesis appear to have more difficulties in their daily activities and a greater disability than those who use body powered or myoelectric prostheses. While theoretically a MG-MHP offers the potential for subjects to perform more natural movements than a standard MHP, clinical evidence substantiating the advantages of MG-MHP over standard MHP in daily life remains inconclusive.

It remains essential to compare the advantages of MG-MHPs versus standard MHPs regarding functionality in daily life, quality of life and overall satisfaction among subjects who agree to transition from their standard MHP to a MG-MHP. The primary objective of this study was to assess upper limb function (specifically, the upper limb function component of the Orthotics and Prosthetics Users' Survey (OPUS) questionnaire) provided by a specific MG-MHP, i-Limb®, compared to a standard MHP in subjects with complete hand amputation.

The subjects participating in the study were patients equipped with MHP, coming to the center for a MG-MHPs hand test. If the prescription for the MG-MHPs hand was validated, the patient was then followed in the study for 8 to 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old
* Patient with a unilateral acquired or congenital complete amputation
* Patient using a standard myoelectric hand prosthesis for at least 4 weeks
* Patient who has an indication of a Multi-Grip Myoelectric Hand Prosthesis , according to a multidisciplinary team

Exclusion Criteria:

* Pregnant women
* Patient under guardianship
* Patient with multiple amputations
Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome

The investigators hypothesized that ticagrelor may enhance endothelial healing after DES implantation by increasing adenosine concentrations by the inhibition of adenosine uptake into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal thickness) 3 months after DES implantation by optical coherence tomography (OCT)


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 20 years old
* Patients who are hospitalized and expected to undergo PCI for acute coronary syndrome, including acute myocardial infarction and unstable angina.

Exclusion Criteria:

* Age \> 80 years
* Cardiogenic shock or unstable patients
* Increased risk of bleeding, anemia, thrombocytopenia
* A need for oral anticoagulation therapy
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
The Effects of Intrauterine Infusion of hCG at the Time of Embryo Transfer

The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.

Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.

On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.

1. control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
2. study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes

The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.

Eligibility Criteria:
Inclusion Criteria:

1. infertile women aged 18-43 years
2. indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer

Exclusion Criteria:

1. Azoospermic male partner
2. Failure to retrieve oocyte after controlled ovarian hyperstimulation
3. No embryo retrieved for transfer
4. Endometrial preparation failure
Thoracic Tumours Register

Observational, multicenter study in patients with lung cancer and other thoracic tumors.

The GECP, in its commitment to improve the treatment and prognosis of patients with lung cancer and other thoracic tumors, has marked the individualization of treatment according to the expression of markers predictive of response to chemotherapeutic agents and molecular inhibitors of cell proliferation as one of its primary objectives. This could significantly improve the prognosis of patients with lung cancer, and will lead to a radical change in routine clinical practice. The aim of the register is to explore all data available of all patients treated because of thoracic tumours.

Observational, multicenter study in patients with lung cancer and other thoracic tumors. In a prospective and retrospective way, information will be obtained from the clinical history of each patient.

In Europe, patients with lung cancer have a poor prognosis, and there has been only limited improvement between 1999 and 2007. Potential advantages of the centralization of care and the discussion of treatment strategies in multidisciplinary teams, as suggested in other studies,13 require further research. However, the priorities should be to prevent lung cancer by implementing anti-smoking policies and controlling asbestos exposure throughout Europe, such as was recommended by the World Health Organization (WHO) in 2008.14 Other priorities are to reduce levels of residential radon in risk areas, and early diagnosis to improve the results of surgery, which is still the main curative treatment.

The variability in the diagnostic process, treatment and advocacy, as well as the anticipated increase in associated mortality in Spain in coming years, has stimulated the creation of an epidemiological, observational, multicenter study of cases of lung cancer and other thoracic tumors diagnosed and treated by medical personnel, including both thoracic surgeons and medical oncologists. Data from this study will be collected retrospectively and prospectively, so as to enable an extensive study of the epidemiological and therapeutic factors related to the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thoracic disease, treated with an active treatment or not treated (only palliative care)

Exclusion Criteria:

* Patients with other type of tumours
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult

the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。

This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects.

After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups.

Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group .

After completion of dosing, follow-up will be at least 150 days.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult subjects
2. Signed informed consent

Exclusion Criteria:

1. Signs and symptoms of upper respiratory tract infection prior to randomization
2. Prior use of RSV vaccine or RSV antibody-based medications
3. history of malignant tumor
Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma

In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
* Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment

Exclusion Criteria:

* History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
* Administered a radioisotope within 5 physical half-lives prior to study enrollment
* Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
* Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)
The Preventive Effect of 2-years Use of Hydroxyapatite Containing Toothpastes in Children.

The aim of this RCT was to verify the caries preventive efficacy of toothpastes containing biomimetic hydroxyapatite (H.A.) complex in children compared to traditional fluoridated toothpastes. In total 610 children of two age groups (4-5 years and 6-7 years at baseline) were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (H.A.F.) (1000 and 1450 ppm F-) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two traditional fluoridated toothpastes (1000 and 1450 ppm F-) without other active components were administered randomly to two groups with younger children (Gyoung) and to two groups with older children those containing1450 ppm F (GOLD) during 24 months. A standardized questionnaire was administered to parents/caregivers to gain information regarding caries risk factors. Caries evaluation was performed at school using ICDAS, scoring lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores 5-6).


Eligibility Criteria:
Inclusion Criteria:

* Written declaration of informed consent signed by parents/guardians;
* Age between 4-5 years and 6-7 years; Good general health, as assessed by the examiners;
* Agreement of not to use any oral hygiene products except for the toothpastes provided for the duration of the study.

Exclusion Criteria:

* Ongoing oral or dental treatment except for emergency treatment;
* Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx;
* Allergy to one of the components of the test products or the standard toothpaste;
* Participation in another clinical trial either currently or within the last 30 days;
* Antibiotic therapy within the past 3 months.
Talk Therapy by Phone to Promote Treatment for Alcohol Problems

A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.


Eligibility Criteria:
Inclusion Criteria:

* age 18-plus;
* score ≥ 16 on AUDIT;
* within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA: \>3 standard drinks on any occasion or \>7 drinks per week (women); \>4 drinks on any occasion or \>14 drinks per week (men).

Exclusion Criteria:

* unable to communicate with the researcher in English;
* unable to comprehend the nature of the study;
* history of alcohol-related care;
* alcohol withdrawal necessitating medical evaluation;
* residency outside of The Greater Rochester Area.
Safety and Immunogenicity of a Melan-A VLP Vaccine in Early Stage Melanoma Patients

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Able and willing to complete all protocol requirements
* Age: 18 years and older
* Histological confirmed stage II melanoma
* HLA-A\*0201 haplotype
* Expected survival of at least 6 months
* ECOG performance status of 0 or 1
* Full recovery from surgery
* Adequate organ and bone marrow functions
* Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
* Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.

Exclusion Criteria:

* Pregnant or nursing
* Use of an investigational drug within 30 days before enrolment
* Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
* Major surgery within 4 weeks prior to enrollment.
* Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).
* Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
* Serum tests positive for HIV, HBV, HCV.
* Active autoimmune diseases or severe allergies.
* Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
* Blood donation or loss of \> 500mL within 8 weeks prior to inclusion.
* Abuse of alcohol or other recreational drugs.
* Previous vaccination with a Melan-A analog peptide.
The Effects of Minocycline in Humans

To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.

We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.

This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.

Eligibility Criteria:
Inclusion Criteria:

* Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine dependence according to DSM-IV criteria;
* No cocaine use for the past 30 days;
* No other current dependence or abuse of other drugs of abuse or alcohol (except cocaine and tobacco);
* No current medical problems and normal ECG;
* For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
* history of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
* Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
* Liver function tests (ALT or AST) greater than 3 times normal.
* Allergy to minocycline or other tetracyclines.
InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.

The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.

Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to or after birth
2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
4. Age ≥ 1 hour AND ≤ 6 hours
5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
6. Require CPAP
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
8. If subject is \>346/7 weeks' gestation a chest radiograph is required

Exclusion Criteria:

Exclusion criteria are ANY of the following:

1. Surfactant administration prior to randomization
2. Mechanical ventilation prior to randomization
3. Major congenital anomaly (suspected or confirmed)
4. Abnormality of the airway (suspected or confirmed)
5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
6. Apgar score \< 3 at 5 minutes of age
7. Umbilical cord gas pH \<7.0 or BD \> 10
8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk