Nuevo Leã³n, Monterrey, Mexico

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety.

A double-blind, randomized, controlled clinical study will be conducted in patients with GAD. The development of the phytopharmaceutical will be carried out at the Southern Biomedical Research Center, belonging to the Mexican Institute of Social Security. The preparation of the plant material, extraction, concentration, standardization of the vegetable drug, the design and production of the experimental drug as well as the control treatment will be carried out in this site. The clinical trial will be developed with outpatient from the Primary Care Family Medicine Unit of the Regional General Hospital No. 1 of the Mexican Institute of Social Security in Cuernavaca, Morelos, Mexico. SUBJECTS. Patients of both sexes aged 18 years and older who present Generalized Anxiety disorder (GAD) and who meet the selection criteria. Experimental group Patients with a clinical diagnosis of GAD (with a score of 18 points or more on the Hamilton anxiety scale) that will be included in the experimental group and will be assigned the treatment consisting of hard gelatin capsules with a pharmaceutical formulation prepared with a standardized extract (in its content of Galphimine-B, G-B) of G. glauca, which will be administered once a day. Control group Patients with a clinical diagnosis of GAD (with a score of 18 points or more on the Hamilton anxiety scale) that will be included in the control group and will be assigned the treatment consisting of hard gelatin capsules with the drug Alprazolam (1 mg ), which will be administered once a day. GENERAL DESCRIPTION OF THE STUDY The project will be promoted through posters that will be placed in strategic areas of the Medical Unit. In addition, brochures will be distributed with information about anxiety and the requirements to enter the project. There will also be support staff, Who will be in charge of giving conferences related with GAD in the waiting Hospital rooms. Once a person is identified who is a candidate to be included in the study, an invitation will be made to go to the clinical research office for evaluation. In the research office, a trained physician, will practice the candidates a medical history and physical examination. The above, with the purpose of corroborating the diagnosis of GAD through the application of the Hamilton Anxiety Scale. This fully validated instrument will serve to make the clinical diagnosis of the condition. If the questionnaire applied to the candidate gives us a total score of 18 points or more, the patient will be considered a candidate to enter the study. In order to be admitted, the patient, in addition must to have a clinical diagnosis of GAD, must meet the selection criteria established in this study. Once the patient complies with these two aspects will be given the necessary information about the study and about their participation in it. Patient must also sign a letter of informed consent, this letter will contain information about the characteristics of the study, benefits to the population, commitment that the patient acquires when participating, commitments that the researcher acquires when the patient is included and the rights that the participant acquires. Each of the participants will be randomly assigned the corresponding medication (which can be experimental or control) through a procedure based on a table of random numbers. The dosage of medications will be every 24 hours, administered orally in the morning. The indication will be given that the medication is taken together with the food. The duration of the administration of the medication will be for ten weeks. In addition, each of the patients will be provided oral and written instructions on the form and times to take the medication, as well as the possible adverse effects and hygienic-dietetic measures that must be taken. The patient will be following weekly, but may go to receive care at the time you require it. At each appointment, the state of health and the evolution of the condition will be evaluated, and the overall improvement scale will also be applied. At each appointment, patient will be given a control card (to each patient) where he will write down the days the medication was taken and whether or not there were any adverse effects during that administration period. In this way, adherence to treatment and tolerability will be evaluated. The values of the Hamilton anxiety scale and the global improvement scale will be used to define the effectiveness, the therapeutic success or failure. The final assessment of efficacy, tolerability, attachment and therapeutic success will be made during the last appointment. A summary will be sent to the family doctor of each of the participants and their discharge from the study. SAMPLE SIZE The size of the sample was calculated according to the formula for comparison of two proportions, taking as background the efficacy that the species showed in previous clinical studies on generalized anxiety. The procedure yielded a total of 105 patients. 15% will be added to the sample size to compensate for possible losses, which leaves us with a final sample size of 122 patients. DATA ANALYSIS. The results will be analyzed through descriptive statistics with frequencies and percentages. The X2 test will be used for the analysis of differences in proportions and ANOVA for mean differences, as well as Tukey's test for the difference between groups. Values of p less than 0.05 will be used to define differences between statistically significant groups ETHICAL ASPECTS Project research was evaluated and approved by the National Scientific National Committee. The species G. glauca has been used for many years in traditional Mexican medicine to treat some mental disorders. A pharmaceutical formulation, elaborated with the extract obtained from G. Glauca has been used in clinical projects to evaluate its efficacy and tolerability in patients with anxiety disorder. The administration time has been four weeks with a daily dose of a standardized product in 0.374 mg of G-B per dose. No significant adverse effects have been identified. Because it is a phytopharmaceutical that has shown good tolerability, the risk of adverse effects is low. In developing this project, the aim is to have a novel alterative treatment that expresses a different mechanism of action, and that shows efficacy and tolerability in the treatment of GAD, but also that the effect obtained is comparable or better than that of a drug, elaborated with Alprazolam, which is the benzodiazepine of first choice and with specific indication for the treatment of this condition. According to the Regulation of the General Law of Health in Research, there is no risk in the patients who will participate in the present project. The project will only include adults; will not include women with pregnancy or lactation or another sector vulnerable to research. The research procedures are in accordance with the ethical rules of investigation, the Regulation of the General Law of Health in the field of health research and the Declaration of Helsinki and its amendments. All information obtained by conducting this study will be handled in a scientific and confidential manner. The clinical files will be kept under guard and the management of the information for the analysis of results will be done exclusively with the assigned folio number. No patient will be included if it is not widely known in which it will consist of their participation, the background of the medication, time that will last the study, dose that will be administered and frequency of the same, laboratory studies to which you will be subjected in addition to informing you that you have the freedom to withdraw from the study at the time you want. The patient will receive extensive and clear information about the protocol, the content of the letter of informed consent will be read, will be given space for the formulation of questions or concerns. ASPECTS OF SECURITY The patients included in the study will be evaluated clinically in each of the appointments. In addition, at the beginning of the study and at the end of the administration period, laboratory tests will be performed to assess liver and kidney function. Medical surveillance with the search for adverse events will be included in each of the visits. In case of identifying any adverse effect, it will be monitored until its disappearance and the measures described below will be applied according to the event's rating. An adverse event will be considered as any unpleasant, unintentional harmful medical occurrence that a patient submits to the administration of a pharmaceutical product, which may or may not have a causal relationship to the treatment. The intensity of the adverse events refers to the maximum intensity with which the patient and / or the investigator qualify the adverse events that the patient presents. 1. Mild: The adverse effect is presented, but it is easily tolerated and does not require treatment 2. Moderate: the adverse effect is enough to interfere with normal activities 3. Severe: The adverse effect incapacitates the subject 4. Serious: Any adverse effect that results in the death of the patient, endangers life, requires hospitalization, causes disability or persistent or significant disability, causes a congenital anomaly or cancer, requiring surgical intervention to prevent permanent sequel or develop drug dependence or abuse Overdose is defined as the exposure without a specific therapeutic goal to an amount of medication of at least twice the maximum daily dose reported in the study protocol. In all cases in which a severe adverse effect is identified, the treatment will be suspended and the patient will be removed from the study. In addition to the above, the patient will be referred for care in the specialized medical area and will be monitored until the resolution of the adverse effect. In the event of a serious adverse effect, the treatment will be suspended, the patient will be removed from the study and the blind code of the patient will be opened. In those cases in which there is a mild or moderate adverse effect, it will be reported in the patient's clinical file, it will be attended immediately and surveillance will be maintained until its complete remission. In these cases, the treatment will not be suspended, and the patient will remain within the investigation.

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

Primary objectives This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives: Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology. Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives Key secondary objectives of Part 1: - To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis - To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH Other secondary objectives of both Part 1 and Part 2: - To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period) - To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period) - To assess the effect of lanifibranor on liver tests - To assess the effect of lanifibranor on glycaemic parameters - To assess the effect of lanifibranor on lipid parameters - To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography. - To assess the effect of lanifibranor on health-related quality of life - To assess the safety of lanifibranor - To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease

Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis

In order to identify possible participants, the project will be promoted in the outpatient waiting rooms for family medicine and specialties of the General Hospital of Zone # 1 of the Mexican Institute of Social Security (IMSS) in Cuernavaca, Morelos. People interested in participating will be asked to go to the clinical research office so that the supporting physician will perform a medical history in addition to a physical examination, in this way the clinical diagnosis of knee osteoarthritis will be made and it will be defined if the patient meets the clinical criteria necessary to be included in the study. Once it is determined that the patient is a possible candidate and the diagnostic, treatment and follow-up procedures can be continued, the patient will need to sign an informed consent letter, duly completed and authorized by the Ethics Committee. Otherwise, if patient decide not to participate, an interconsultation with the corresponding family doctor will be given. To make the radiological diagnosis, the patient will be submitted to X-ray office, in order to take a front to back and lateral knee (s) radiograph. Once the diagnosis is corroborated, the participants will prepare a file that will contain a questionnaire with questions related to sociodemographic, personal, family and condition history, in addition, treatment will be assigned with the corresponding folio number upon admission. Each of the patients will be given oral and written instructions on how the treatment should be administered and the hygienic measures that must be followed during their participation in the study. The first administration of the treatment will be in the research office, in order to teach the participant how to do it; later, instructions about how the medication should be administered three times a day in the affected knee (s), for four weeks will be given. Patients will be cited every week for four weeks where their evolution will be assessed; in each of the appointments. Patients will undergo a complete evaluation of their condition, there will be a format in which each of the data that is collected will be recorded, either at the interrogation or on the physical examination. The patients will be summoned every week in order to evaluate the evolution of the disease, and consequently the therapeutic efficacy by means of the Visual Analogue Scale of pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function, a scale used to evaluate function of the knee. The presence of adverse effects (Therapeutic tolerability) and the adherence to the treatment (based on the days of administration) will be evaluated. A concentrate related to tolerability and adherence to treatment will be filled in each of the patients.

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose. Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period. Subjects receive the following: • Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later OR • Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).

PRECAMA: Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women

Breast cancer (BC) has become a major public health problem in Latin America (LA), as it is the most common form of cancer among women. In Women are more likely to develop BC at younger age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty years, the mortality from BC in LA has also been increasing very rapidly, and is currently the leading cause of cancer mortality among LA women. The large number of incident BC cases among premenopausal women, which is only partly explained by the population age-structure, is therefore of major concern. Little is known on specific risk factors for premenopausal BC in general, and in LA in particular, and risk factors related to diet, obesity and low physical activity play a role on incidence and mortality. Estrogen receptor (ER) and/or Progesterone receptor (PR) expression in breast tumors may differ according to risk factors and to molecular pathological characteristics. There is a lack of specific knowledge on tumor molecular and pathological characteristics of BC in premenopausal women, particularly in lower resource countries where the hormone-dependence status is poorly documented. This has major consequences on cancer treatment and survival. To improve our understanding of determinants of BC incidence and mortality in young Latin America women and support preventive actions, we implemented an international, population-based multi-center case-control study in LA: the PRECAMA study (Molecular Subtypes of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter population-based case-control study). PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major aims of the project are the following: 1. To develop a multi-centric population-based case-control study on BC in premenopausal women in several countries in LA with structured collection of individual, clinical, pathological information and biological specimens, according to strictly controlled protocols 2. To characterize, in these populations, the subtypes of premenopausal BC on the basis of their molecular and pathological phenotypes 3. To improve the identification of specific endogenous/exogenous factors, and disentangle the interplay of these different factors with regard to breast tumor subtypes. 4. Provide advanced training, induce a structuring effect on the BC research community in LA and influence the public health agenda regarding the management of BC. Standardized methods and questionnaires have been developed and implemented as well as standard operating procedures for laboratory activities. Incident primary invasive cases aged 20-45 years are recruited from major cancer hospitals in four large Latin American cities (Mexico City, San Jose, Medellin, and Santiago) prior to any treatments. Controls for the study are selected from the population residing in the same cities for at least 3 years and matched to cases on age (+/- 5 years) and health care institution. For each subject, complete questionnaire data on socio-demographic factors, health history, reproductive history, use of hormones, early risk factors, body silhouette at different ages, physical activity, diet, occupation, environmental risk factors, ethnicity, and family history of cancer are collected. Validated and standardized food frequency questionnaires are administered to gather information on diet. Anthropometry (body weight, standing and sitting height, waist and hip circumferences) are measured according to standardized protocols. Blood and urine samples are also collected for biomarker analyses. For all cases, highly standardized immunohistochemical and molecular analyses are performed to identify BC subtypes. The results of our study will be of utmost importance to understand the etiology of breast cancer in Latin America countries in epidemiological transition, and would provide important information on the role of modifiable exposures on the disease which may provide important support for breast cancer prevention.

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus