cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of EXG-5003

This is a First in Human, randomized, placebo-controlled Phase I/II trial to evaluate the safety and immunogenicity of the intradermal COVID-19 vaccine, EXG-5003 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Has provided written consent for participation
* Age between 20 and 55
* Has a negative nucleic acid-based test result for SARS-CoV-2
* Has a negative antibody test result for SARS-CoV-2

Exclusion Criteria:

* Signs and symptoms consistent with COVID-19 upon screening
* History of COVID-19
* Presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease
* Presence of diabetes mellitus
* Presence of active autoimmune disease
* Positive for HBc, HCV or HIV antibody
* History of anaphylactic shock
* History of epilepsy
* Presence of active malignancy
* Presence of lung disease (e.g., COPD, asthma)
* Positive urine pregnancy test within 24 hours
* Pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug
* If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug
* If male, not agreeable to contraception for 90 days after second administration of the trial drug
* Presence of clinically relevant electrocardiogram or vital sign abnormality at screening
* Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days
* Received any SARS-CoV-2 vaccine
* Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product
* Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties
* Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid
* Deemed ineligible for the study as determined by the principal investigator or a co-investigator
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference\>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
2. Age ≥ 18 years and ≤ 75 years
3. Performance status (WHO ≤ 2)
4. Renal, hepatic and cardiovascular functions allowing systemic treatment administration
5. Adapted stomatologic care
6. Signed informed consent form
7. Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

1. Both parotids totally included in the target volume
2. Stages T1 or T2 with positive node disease N1
3. Neoadjuvant chemotherapy
4. Exereses of primitive tumor and/or nodes
5. History of other cancer within 5 years (except for basocellular epithelioma and cervical)
6. Previous neck radiotherapy
7. Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
8. Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
9. Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
10. Patient already recruited in another biomedical research ( non interventional study is authorized)
11. Pregnant or breast feeding patients
12. Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
13. Patient is deemed incapable of giving informed consent
14. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis

The main objective of this study is to measure, in patients with MS or Chronic Inflammatory Arthritis (CIA), the correlation between two calcium intake assessment methods: A self assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a reference (gold standard) and based on data from CIQUAL \*.

\* CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.

The secondary objectives of this study are:

A. To estimate the average calcium intake and variability in a population of MS patients and the proportion of patients at risk for osteoporosis.

B. To estimate the average calcium intake and variability in a population of CIA patients and the proportion of patients at risk for osteoporosis.

C. To describe the dietary changes observed in MS or CIA patients .

D. To estimate the administration time of the QALCIMUM® self-questionnaire.

E. Estimate calcium intake means and variability in a population of patients with MS or CIA and the proportion of patients at risk of osteoporotic fracture

F. To assess the quality of life of patients with MS or CIA

G. To evaluate endogenous mean vitamin D production in a population of patients with MS or CIA

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient with confirmed diagnosis of multiple sclerosis or chronic inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis)

Exclusion Criteria:

* The patient is participating in another biomedical research study
* The patient has participated in another biomedical research study in the past 3 months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The subject is not able to complete a self-administered questionnaire
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)

The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage intake promotes fluid balance during exercise in the heat compared with water or placebo intake.

Exercise in the heat has large effects on cardiovascular strain, the ability to regulate core body temperature, and performance because of an increase in the reliance on body fluid distribution to the skin to maintain adequate sweat rates and heat dissipation. Carbohydrate-electrolyte beverage intake during exercise in the heat may improve fluid balance and subsequent physical performance.

The participants will be assigned each arm in a randomized, counterbalanced, cross-over fashion separated by at least 2 weeks. Participants will be placed in a heated environment for the duration of the exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-35 years
* Healthy (No uncontrolled disease)

Exclusion Criteria:

* No medications that influence fluid balance
* No uncontrolled disease
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus

The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
* Men or women who are \>18 years of age at time of consenting upon Visit 1
* HbA1c \>7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
* Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
* History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
* Treatment with systemic glucocorticoids other than replacement therapy
* Inhaled, local injected and topical use of glucocorticoids is allowed
The Effect of Screen to Move Program in Preschool Children

The aim of this study is to determine the effect of the developed program on screen usage time and physical activity for pre-school children.

The "Screen-to-Move-Program" (STEP), developed on the basis of Social Cognitive Theory (SCT), is aimed to reduce screen usage time and increase physical activity in pre-school children. In this study, it was aimed to increase children's physical activity and decrease screen usage times with a 6 session intervention program based on SCT, which includes children and parents. The effectiveness of the program will be evaluated with the pre-test, post-test and 3rd month follow-up test.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 36-60 months and their parents.
2. Children without any physical and mantel disability

Exclusion Criteria:

1.The data of parents who fill in the data collection forms incompletely will be excluded from the analysis
Fixation of Unstable Sacral Fractures by Transpedicular System

This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.

Pelvic ring disruptions are high-energy injuries with a significant impact on quality of life and higher levels of mortality. Unstable sacral fracture is an unusual injury, and even though many studies implicate the surgical intervention as the treatment of choice, the purposes of surgery on sacral fractures include pelvic ring reconstruction, lumbopelvic stability restoration, fracture healing, early mobilization, fracture displacement prevention and improving the neurological deficiency. More and more surgeons are advocating for surgical management in the treatment of sacral fractures, and open reduction internal fixation (ORIF) has demonstrated marked benefits over conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years old age.
* Both sexes.
* Unstable AO sacral fracture type B and type C.
* Patient fit for surgery and hemodynamic stable patient.
* Closed fracture.

Exclusion Criteria:

* AO sacral fracture type A.
* Bedridden before the trauma.
* Patient unfit for surgery.
* Open sacral fractures.
* Sacral fractures with massive morel-lavallee lesions.
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Elderly subjects with psychosis

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant

medical condition.

* Have an established diagnosis of dementia
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults

To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living men and women aged 18 to 60 years
* Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
* Subject owns a refrigerator and is willing to keep study product refrigerated at all times
* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects
* Consent to the study and willing to comply with study product and methods

Exclusion Criteria:

* Influenza vaccination in last 6 months, or any other vaccination in previous 15 days
* Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
* Chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, COPD, as determined by medical history and baseline physical examination)
* Chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin C)
* Use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics)
* Contraindication to dairy products or any other substance in the study product (eg, lactose intolerance)
* History of alcohol, drug, or medication abuse
* Pregnant or lactating female, or pregnancy planned during study period
* Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 3 months of screening
* Participation in another study with any investigational product within 3 months of screening
* Investigator believes that the participant may be uncooperative and/or noncompliant, and should therefore not participate in the study
Irritability in Children With ADHD and Emotion Dysregulation

Objective:

Emotion dysregulation is common among children with ADHD and associated with a broad range of adult psychopathology, which is similar to the longitudinal outcomes of childhood irritability. However, the profiles of irritability in children with ADHD and emotion dysregulation has been understudied. This study aimed to investigate the efficacy of methylphenidate and aripiprazole in the treatment of irritability in children with ADHD and emotion dysregulation. In addition, the clinical profiles and neuropsychological characteristics of irritability in children with ADHD were explored.

Methods:

A three-step, open-label, 10 week pilot study was conducted. Methylphenidate (4 weeks), aripiprazole (4 weeks), and the combination (2weeks) were examined in sequence as the treatment for irritability in children with ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile. The primary outcome was improvement of irritability as measured by Aberrant Behavior Checklist-irritability subscale (ABC-I). During the first step, the subjects received pharmacological treatment of methylphenidate with flexible dosage for 4 weeks. Those subjects who had suboptimal response to methylphenidate (reduction of ABC-I score \< 25%) entered the second step and the medication was switched to aripiprazole. After 4 weeks of treatment, those whose ABC-I scores reduced \< 25% entered the third step and received the treatment of combination of methylphenidate and aripiprazole for two weeks (3rd step).

Clinical profiles of irritability were evaluated with the Affective Reactivity Index (ARI), the Strengths and Difficulties Questionnaire, the Social Adjustment Inventory for Children and Adolescents, and the Autism Behavior Checklist-Taiwan Version. The neurophysiological characteristics of the subjects were assessed by three Cantab subtests: Emotion Recognition Task, One Touch Stockings of Cambridge, and Spatial Working Memory. The aforementioned measurements were administered at baseline and at the end of each step.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 to 18 who have ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile.

Exclusion Criteria:

* Patients who are not willing to participate in the study after detailed explanation.
* Patients who have intellectual disability or could not follow the investigator's instructions.
* Patients who have severe neurological or mental illness like epileptic disorder, schizophrenia, bipolar disorder, or uncontrolled suicide risk.
* Patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, or severe congenital heart disease.
* Patients who are allergic to methylphenidate or aripiprazole.
Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy

Previous surgery and obesity has disputed as an unfavorable factor during Total Laparoscopic Hysterectomy. The aim of the investigator's study was to assess the effects of previous abdominal surgery and obesity on intra-operative and post-operative outcomes of TLH.

Abstract:

Objective: To assess the effects of previous abdominal surgery and obesity on the intra-operative and post-operative outcomes of total laparoscopic hysterectomy (TLH).

Method: In this retrospective cohort study, women who underwent TLH for benign conditions between January 2011 and December 2016 in tertiary academic center were included. Patients were grouped according to previous abdominal surgery. The study group consisted of patients who had at least one previous abdominal surgery and the control group consisted of patients with no previous abdominal surgery. In a further analysis, a subgroup of obese patients with BMI (body mass index) ≥30 kg/m2 was evaluated. For this analysis, the obese patients who underwent TLH were picked up and the results were compared to the results of obese patients who underwent total abdominal hysterectomy (TAH) during the same time period. The main outcome parameters were duration of hospital stay and major complication rate.

Eligibility Criteria:
Inclusion Criteria:

* all women who underwent TLH for benign conditions during study period
* all obese ≥30 kg/m2 women who underwent TAH for benign conditions during study period

Exclusion Criteria:

* No
PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn

The purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs).

Persistent pulmonary hypertension of the newborn (PPHN) occurs when the pulmonary vascular resistance fails to decrease at birth during the transition to postnatal life. The affected infants have severe hypoxemia, a 10% risk of mortality, and among survivors, a 30% incidence of long term neurodevelopmental and hearing deficits. The etiology of PPHN in the majority of affected infants remains unknown. Although constriction of fetal ductus arteriosus in response to maternal intake of non-steroidal anti-inflammatory drugs (NSAID) has been implicated in PPHN case reports, our laboratory was the first to provide objective evidence for such an association. Nearly 87% of infants with PPHN were exposed to NSAID in utero. Yet 25% of control infants also were exposed without developing PPHN. The basis for the biological susceptibility of some neonates to in utero NSAID exposure remains poorly understood. The hypothesis of this proposal is that PTGS1 genetic variation is associated with increased susceptibility to ductal constriction from in utero NSAID exposure and an increased risk of PPHN. This hypothesis will be tested through the following specific aims: Determine the incidence of PTGS1 sequence variants in PPHN patients versus matched controls. PTGS1 sequence will include all 11 exons, a minimum of 100 bp of exon flanking sequences, and 1 kbp of upstream regulatory information. Cycle sequencing will be performed followed by analysis using capillary electrophoresis. Differences in the frequency of sequence variants will be determined using Fisher's exact test. The study will also quantify NSAID exposure in meconium samples using a previously established GC/MS assay and correlate exposure levels to both the incidence of PPHN and the presence or absence of PTGS1 sequence variants using regression analysis. Benefits include the ability to predict risk for PPHN based on PTGS1 sequence and avoidance of such risk in the future, thereby reducing patient morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN and normal, healthy infants born greater than or equal to 34 weeks gestational age.

Exclusion Criteria:

* Patients will be excluded if they are diagnosed with lethal congenital anomalies
* structural congenital heart disease except presence of patent ductus arteriosus (PDA) or patent foramen ovale
* structural gastrointestinal tract abnormality that could interfere with meconium passage
* congenital anomalies such as diaphragmatic hernia, Potter's syndrome, or pulmonary hypoplasia