cyrilzakka/clinical-trials huggingface dataset:
An Open-randomized, Balanced, Crossover Bioequivalence Study to Compare One MR Tablet of 60 mg Gliclazide and Two MR Tablets of 30 mg Gliclazide in Healthy Subjects

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR tablets of gliclazide after single oral administration at the same doses to healthy subjects.

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different MR tablets of gliclazide after single oral administration at the same doses to healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be enrolled into the study according to the following criteria:

1. Subjects must be male at the age of 20-40 years old in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:

   Ear body temperature between 35.0-37.5 °C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm. Fasting blood glucose, \< 100 mg/dL.
3. Body weight must be greater than 50 kg and within -20 to +20% of ideal body weight.
4. Able to sign informed consent prior to study.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

Subjects meet any of the following criteria during pre-study examination evaluation will be excluded from entry into or continuation in the study:

1. Use of any prescription medication within 14 days prior to dosing.
2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
3. Significant illness within 2 weeks prior to dosing.
4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
5. Donate or loss more than 500 mL of blood within 3 months prior to dosing.
6. Presence of cardiovascular disease.
7. Presence of gastrointestinal disease.
8. Presence of asthma or lung disease.
9. Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile such as GOT, GPT,gama-GT, alkaline phosphatase, serum bilirubin, HBsAg, or Anti-HCV.
10. Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
11. Presence of neurological disease.
12. Presence of psychiatrical disease.
13. Subject is known for HIV infected.
14. A known hypersensitivity to gliclazide or its analogs.
15. History of drug or alcohol abuse within 12 months prior to dosing.
16. Permanent confinement to an institution.
17. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and must sign an approved Informed Consent Form
* Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
* Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
* Willing to stop wearing habitual contact lenses for the duration of study participation
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
* Routinely sleeps in habitual contact lenses
* Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
* Other protocol-defined exclusion criteria may apply
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris

To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
* Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
* Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.
* Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
* Subjects with a baseline irritation score of 3 = severe (marked, intense).
IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

* Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
* Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
* Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
* Measurable disease according to the RECIST criteria.
* Prior radiotherapy authorized except for irradiation concerning measurable disease.
* Age \>18 and \< 70 years.
* PS \< 2.
* Normal hepatic function : serum bilirubin \< 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) \< 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be \< 5 x ULN.
* Creatinine clearance \> 60 mL/min.
* Granulocyte count \> 1,5 giga/L, platelet count \> 100 giga/L.
* Life expectancy \> 12 weeks.
* Written (signed) informed consent for use of tumors samples.
* Written (signed) informed consent to participate in the sudy.

Exclusion Criteria:

* Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
* PS \> 1.
* Prior chemotherapy other than cisplatin-gemcitabine.
* Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
* No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
* Concomitant radiotherapy except for localized bone irradiation.
* Symptomatic brain metastases.
* Superior vena cava syndrome.
* Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
* Pre-existing interstitial lung disease.
* Any inflammatory changes of the surface of the eyes.
* Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
* Grade \> or = 2 peripheral neuropathy.
* Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
* Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
* Inability to comply with follow-up procedures.
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
* Subjects' age is over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are able and willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor with a maximal diameter \> 5 centimeters.
* Subjects' ECOG Performance Status Scale is \> 3.
* Subject has a tumor of Keratoacanthoma histology.
* Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
* Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination

AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders enrolled in school,
* Children aged between 6 and 7 years,
* having cavity with access to ART hand instruments,
* cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
* proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

Exclusion Criteria:

* Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
* Children out of the age range,
Epidemiology and Risk Factors for Injuries in Beach Tennis Players

Beach tennis, a fast-growing sport since its creation in Italy in the 1970s, has rapidly gained in popularity, particularly in La Réunion sisland since 2000. However, despite its development, studies on beach tennis-specific injuries are rare, based on cross-sectional studies and therefore limited by temporal or memory bias. The need for prospective research is crucial if we are to gain a better understanding of the epidemiology of injuries and improve prevention and medical management.

The aim will be to determine the risk of injury among beach tennis players within a one-year national prospective cohort.


Eligibility Criteria:
Inclusion Criteria:

* Player declaring that they train regularly in beach tennis (at least once a week)
* At least 18 years old at the time of inclusion
* Male or female
* Able to read and understand French
* Whether or not registered within a club
* Not opposed to the research

Exclusion Criteria:

* Protected adults (guardianship or curatorship) or those under court protection
Pharmacokinetics of Ch14.18 in Younger Patients With High-Risk Neuroblastoma

This research trial is studying how Ch14.18 acts in the body of younger patients with high-risk neuroblastoma. Studying samples of blood from patients with cancer receiving Ch14.18 may help doctors learn more about how this drug is used by the body to develop better ways to give the drug to potentially improve its effectiveness and lessen its side effects.

PRIMARY OBJECTIVES:

I. Describe the pharmacokinetics of ch14.18 (monoclonal antibody Ch14.18) in children with high-risk neuroblastoma.

II. Quantify the degree of inter-patient and intra-patient variability in the clearance of ch14.18, and correlate ch14.18 clearance with patient characteristics, the presence of human anti-chimeric antibody (HACA), tumor burden (assessed on scans), and plasma GD2 levels to identify sources of variability in the clearance.

III. Develop a pharmacokinetic model to describe the pharmacokinetic profile of ch14.18 and derive pharmacokinetic (PK) parameters.

SECONDARY OBJECTIVES:

I. Correlate plasma concentrations of ch14.18 with the severity of neuropathic pain, which is being quantified using an observational pain scale, and the total dose of morphine administered to control pain.

II. Develop a limited sampling strategy that will accurately quantify the area under the curve (AUC) of ch14.18.

III. Simulate alternative dosing strategies with the pharmacokinetic model in order to reduce variability and simplify drug administration.

OUTLINE:

Patients undergo blood sample collection at baseline and during and after course 1, 3, or 5 of treatment for pharmacokinetic analysis. Some patients undergo blood sample collection at baseline and during and after two treatment courses (1 and 3, 1 and 5, or 3 and 5).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high-risk neuroblastoma
* Enrolled on the COG protocol ANBL0032 or ANBL0931 and eligible to receive ch14.18 according to the criteria on these primary treatment protocols
* Parental informed consent and verbal assent of the subject when appropriate

Exclusion Criteria:

* Prior testing demonstrating the presence of HACA
* Anaphylactic reaction to ch14.18 on a prior treatment cycle
Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy

The two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.

Pregnant women and adolescents (n=24) will be recruited when entering prenatal care. They will be invited to participate in a longitudinal study comparing the relative contribution of the two major maternal iron sources, i.e. maternal dietary iron intake and maternal red blood cell iron recycling, to fetal iron accretion during pregnancy. At about 15 weeks of gestation, participants will consume an oral dose of a stable iron isotope (57Fe as ferrous sulfate) to enrich their red blood cells (RBCs) with 57Fe. Maternal blood samples will be collected at 4 times during pregnancy to monitor changes in blood 57Fe concentrations. In the third trimester of pregnancy, women will consume a dose of a different iron isotope (58Fe as ferrous sulfate) as dietary nonheme iron. Cord blood samples and placental tissue will be obtained at delivery to determine how much of the dietary iron (58Fe) and RBC iron (57Fe) was transferred to the fetus and how much of each isotope was retained in the placenta. Placenta tissue samples will also be used to assess placental expression of iron transporters in relation to the amount of each iron isotopes transferred to the fetus. Circulating iron status indicators and regulators will be measured in all maternal and cord blood samples to examine the effect of iron status on placental transfer of iron derived from the diet vs. RBC during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Non-smoker
* No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

* Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia)
* Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty

The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients. Such diaphragm-sparing nerve blocks for shoulder arthroplasty may provide a very good anesthetic alternative in lung diseased patients who are in need for total arthroplasty of the shoulder.

The investigators hypothesized that a combination of suprascapular nerve block and lateral sagittal infraclavicular block of the posterior and lateral cords would provide good postoperative analgesia for patients undergoing shoulder arthroplasty.

The primary aims of this study were to document numeric rating scale (NRS, 0-10) and use of morphine equivalents during the first 24 hours after surgery. Secondary aims were to determine the incidence of diaphragm paresis 30 minutes after the block and to quantify postoperative hand grip force at 1 hr.

Eligibility Criteria:
Inclusion Criteria:

* 18-78 years old,
* BMI 20-35 kg.m-2
* ASA physical status 1-3

Exclusion Criteria:

* unable to consent,
* pregnancy,
* pre-existing severe respiratory disease,
* use of anticoagulation drugs other than acetylsalicylic acid or dipyridamol,
* allergy to local anaesthetics,
* patients on regular opioids,
* atrioventricular block,
* peripheral neuropathy.
Oral Surgery in Patients Taking Direct Oral Anticoagulants

This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.

Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic (International Normalized Ratio) INR levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. Similar recommendations were given for the dental treatment of patients taking DOACs, but there is a lack of clinical studies. The aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their DOACs or VKA medications.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over 18 years
* Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (DOACs group)
* Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery (VKA group)
* Indication for oral surgical procedure
* Signed informed consent

Exclusion Criteria:

* Liver or renal disease
* Coagulopathy
* Pregnant or breastfeeding women
* Allergy to lidocaine
* Patients who stopped taking their anticoagulant medication
* Patients taking VKA with INR \<2.0 or \>3.5 on the day of the procedure
New Markers of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Sweat

The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland.

Sweat is a watery solution containing trace amounts of proteins and peptides that may contribute to the antimicrobial defense system of the skin barrier, playing a role in innate immune responses against potential pathogens. The peptide and metabolite composition of sweat has not been fully explored. Evidence suggests that the composition of the skin barrier could vary with diseases. The causes and consequences of the changes of sweat proteins and peptides in humans are unknown. This clinical trial will focus on multiomics analysis of sweat, mainly of the antimicrobial peptides that play a key role in the host-pathogen interaction. Antioxidants, anti-bacterial and anti-inflammatory compounds may contribute to the regulation of systemic inflammation and pathophysiological disorders. In cystic fibrosis, inflammatory responses are altered, exaggerated and persistent, even in the absence of infection. It is therefore relevant to study the influence of CFTR mutations on the profile of antimicrobial peptides expressed in sweat. The clinical study will potentially lead to the discovery of novel non-invasive biomarkers of the disease in sweat.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged of 18 years or more.
* The patients with cystic fibrosis must have a confirmed diagnosis, be clinically stable, have a Forced Expiratory Volume in one second (FEV1) ≥ 30 and an O2 saturation ≥ 92%. F508del homozygous will been tested.
* Heterozygosity (parents of patients) will be confirmed by the presence of a single F508del mutation.

Exclusion Criteria:

* Presence of an acute infection
* Pregnancy and lactation
* Subjects currently included in another clinical trial
* Subjects with forearm skin alterations
* Subjects with signs of dehydration
* Smokers