cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Didanosine in Children Treated for HIV

The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children treated by a ARV combination including ddI

The didanosine is one of the reverse transcriptase inhibitors. This drug is efficient against the viral replication of the HIV. Licensing for the children was obtained in June, 1992. The main problem of the didanosine is its poor bioavailability: although gastro-resistant capsules were developed, its bioavailability remains dependent on alimentation. Taking a meal 1-2 hours before the administration of ddI leads to a reduction of 50% of its bioavailability as well for the child as for the adult. It is therefore recommended to take ddI during fasting period. This regimen in some cases can decrease therapeutic observance. A pharmacokinetic study of ddI will be conducted during the meal with 240 mg/m2/day during fasting period compare to 400 mg/m2/day during the meal. 26 patients, aged more than 6 years old, will be included and randomised in 2 groups. The first group will take the standard dose of ddI during 28 days during fasting period (phase A), then the high dose during the meal during 28 days (phase B). The second group will take first the phase B and secondly the phase A. Patients will be sequentially evaluated both after the first and the second period of treatment for pharmacokinetics and biological analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children treated by the didanosine capsules more than 3 months
* viral load \< 50 copies/ml
* written informed consent
* Normal renal function

Exclusion Criteria:

* Lack of observance
* Any treatments which can interact with ddI
* No written informed consent
* Weight \> 60 kg
Preventing Behavior and Health Problems in Foster Teens

The primary goal of this study is to test the efficacy of two levels of the KEEP intervention with adolescents and their foster and kin parents in the San Diego Child Welfare System.

The cost of child welfare services in the U.S. has been estimated at $20 billion per year. During the past decade, the number of teenagers in foster care has nearly doubled. Numerous studies have documented that these adolescents are at high-risk for developing serious problems, including substance use, participation in health-risking sexual behaviors, involvement in the juvenile justice system, serious educational problems and school drop-out, failed placements/foster care "drift" and homelessness. Yet, there is little research on the characteristics of interventions that can be used to guide the improvement of services for this vulnerable population of youngsters. The proposed study extends our previous research with adolescents referred for serious behavioral and emotional problems and research with elementary-aged children in foster care to a test of the efficacy of a preventive intervention for adolescents placed with foster and kin care providers in the San Diego County Child Welfare System. Two hundred and forty adolescents and their foster/kin care providers will participate (i.e., 60 in a foster/kin parent training only condition, 60 in a parent training plus youth skill training condition, and 120 in a casework "as usual" control condition). In addition to testing the efficacy of the two levels of intervention, the investigators propose to examine the effects of the intervention on a set of youth behavioral and health-related outcomes. Parenting mediators to be tested include positive parenting, parental supervision, and non-harsh discipline. Youth mediators are social competence, commitment to school, and knowledge about norms related to health-risking behaviors including substance use and high-risk sexual behavior. In addition, theoretical hypotheses about the effects of early risk/adversity factors to youth outcomes will be examined, and an economic analysis will be conducted to examine the relative benefits and costs associated with the two levels of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Any child between ages 12 and 16 years in relative or non-relative foster care

Exclusion Criteria:

* Only medically fragile children
Knowledge Attitude and Practice Regarding Bloodstream Bacterial Infections and Antibiotics Usage Among Doctors.

This study is designed to use a questionnaire to assess doctors' knowledge, attitudes, and practices regarding bloodstream bacterial infections and antibiotic use in Tawam and Al Ain tertiary Hospitals (both hospitals have the same medical team) in Al Ain City, UAE.

Background: Bloodstream bacterial infection is a serious medical problem and one of the leading causes of death worldwide among all age groups. Appropriate and early antibiotic use has been associated with better outcomes based on many clinical trials. On the other hand, misuse and abuse of antibiotics have been linked to long hospital stays, significant morbidity and mortality, increased medical costs and rising antimicrobial resistance (AMR). Statistics in hospitals involved in the study, showed increased antibiotic consumption compared to previous years and other regional healthcare facilities. Rates of AMR in the UAE have increased significantly in the last decade, based on the 2022 annual report.

Aims and objectives This study will assess knowledge, attitude and practice regarding bloodstream bacterial infections and antibiotics use among doctors. It is a questionnaire-based cross-sectional descriptive study that will be conducted at Tawam and Al Ain Hospitals (tertiary hospital, both hospitals have the same medical team).

The investigators want to explore the degree of knowledge and attitude, assess the appropriate usage of antibiotics among doctors in different subspecialties, assess any possible barriers, and find solutions such as medical education for this challenging medical problem.

Eligibility Criteria:
Inclusion Criteria:

All physicians with valid medical licenses working in Tawam and Al Ain tertiary hospitals

Exclusion Criteria:

Infectious diseases physicians and Microbiologists
Vitamin D Status Fluctuations Over One Academic Year in Students

The main objective of the study is to assess changes in the concentration of vitamin D metabolite in serum throughout the academic year and to examine its relationship with the occurrence of inflammation indicators, dietary habits, nutritional status, severity of depressive states, and cognitive abilities in a group of students. An additional objective will be to assess the relationship between the genotype in the CYP2R1 gene and the concentration of 25(OH) vitamin D.


Eligibility Criteria:
Inclusion Criteria:

* no chronic diseases
* student status
* age 18-30 years

Exclusion Criteria:

* chronic diseases (related to malabsorption, kidney and liver diseases)
* not active student status
* age \<18 and \>30 years
Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China

The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data from patients of four hospital. The trends in the axial length and corneal curvature will be observed.

The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data between 2012 and 2023. There were four clinical centers involved in this study. The study was approved by the Medical Ethics Committee of Zhongnan Hospital, Wuhan University, Yichang center hospital, Jingzhou center hospital , Yichang center hospital and Xiaogan center hospital, and conformed to the tenets of the Declaration of Helsinki. We divided the participants into ten groups of 10 years each based on their year of birth (called birth decade) and observed the trends in the axial length and corneal curvature in different groups.

Eligibility Criteria:
Inclusion Criteria:

- Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October 2023. Only patients who would cooperate with examinations to ensure stable and repeatable data (AL was measured 5 times or more, CC was measured 3 times or more, and the coefficient of variation of the measured results were≤15%a coefficient of variation ≤15% was considered low variation) were selected.

Exclusion Criteria:

- Severe systemic disease, corneal diseases, severe dry eyes, serious fundus disease, noticeable lesions of the refractive stroma, inability to cooperate, or poor measurement quality (coefficient of variation\> 15%) were the exclusion criteria.
Electronic Monitoring and Improvement of Adherence to DOACs in Polymedicated Stroke Patients

Primary objective of the MAAESTRO trial is to evaluate the impact of an educational and reminder-based intervention on the adherence of stroke patients to DOACs. Secondary objectives are to evaluate the association between non-adherence and clinical events, to identify predictors of non-adherence and to compare objective measures of adherence with self-reporting.

Key methodological instrument for this study will be the "Time4Med" pillbox with Smart/ Reminder Card. The study includes 3 visits (baseline visit 0, follow-up visit 1 and end-of-study visit 2) with a total follow-up of 9 months.

After an initial 3-month observational phase with electronic monitoring of adherence using the "Smart Card", all patients will receive counselling based on their electronically recorded drug intake data, as well as a multicompartment pillbox. Patients will be then randomised to one of two groups in a crossover design, so that in the subsequent 6-month interventional phase one group will use a (reminder-delivering) "Reminder Card" for the first 3 months and the "Smart Card" for the last 3 months, while the second group will use the cards in reverse order.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF)
* Adult patients (≥ 18 years)
* Hospitalization for acute ischaemic stroke (including TIA with positive neuroimaging)
* DOAC treatment for atrial fibrillation or embolic stroke of undetermined source
* Patients receiving polypharmacy, defined as at least 3 drugs (including DOAC treatment)
* Patients self-administering their medication
* Patients already using a pillbox or willing to use one

Exclusion Criteria:

* Patients not able or unwilling to sign ICF
* Medication administration by caregiver - Filling of the pillbox by a pharmacy, relatives or other caregivers does not exclude the patients, provided that they self-administer their medication
* Patients who are, in the opinion of the investigator, unlikely to adhere to the study schedule or are unsuitable for any other reason
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections

The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.

This is a prospective, non-randomized, single center, feasibility trial. All consecutive patients that fulfil the inclusion/exclusion criteria will be informed about the possibility to be included in the present clinical investigation. Only subjects that have signed the study informed consent will be included in the study. The Trident System v1.0 will be used only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before the final resection of the surgical specimen. Patients will be prospectively followed at 30 days post-surgery. Data will be collected prospectively from the medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:

  * Colon cancer OR
  * Sigmoid diverticular disease OR
  * Rectal cancer
* All genders
* Age \> 18 years old
* Ability to understand the information related to the study protocol

Exclusion Criteria:

* Pregnancy or breastfeeding
* Contraindications to anaesthesia
* Inability to provide a written informed consent
* Inclusion in a different ongoing clinical trial
* Emergency procedure
* Abdomino-perineal resection
* Hartmann procedure
* Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.

Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) \[1\]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) \[2\]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence \[3,4\]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy \[5\]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy \[6\]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE \[7\]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).

Eligibility Criteria:
Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy

Exclusion Criteria:

* Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
* Previous DVT or venous thromboembolism
* Administration of LMWH or unfractionated heparin before randomization
* Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
* Thrombocytopenia (platelets \<100 x 109L)
* Severe chronic kidney disease (estimated glomerular filtration rate \<30 ml/minute)
* Pregnant women
Physical Capacity and Activity in Children With Congenital Heart Disease

Congenital malformations correspond to defects in organ morphogenesis identifiable at birth or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital Heart Disease corresponds, in particular, to structural defects of the heart or major blood vessels thereof may or may not be associated with other types of syndromes.The resolution is usually surgical.

Also, these patients present a decrease in physical fitness, psychological imbalance, lower quality of life and risk significant morbidity and mortality from respiratory infections among other problems.

This can have severe consequences for health in the medium and long term. The habits acquired during childhood and adolescence are determinant for the adult life, being relevant levels of activity and physical condition, especially in children with pathologies.

In this way, it is vital to know from childhood parameters that indicate the baseline state of these patients according to the levels of physical activity, exercise capacity, nutritional status and quality of life. These will be key indicators to take into account in the future, to adapt rehabilitation plans that will reduce the effects of their condition.

The objective of this protocol is To characterize the levels of Activity, and Physical Capacity of children with congenital heart disease regularly treated at the Cardiovascular Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and sex.


Eligibility Criteria:
Inclusion Criteria:

* Children with Tetralogy of Fallot corrected
* Age from 6 to 15 years
* Assistants to periodic control at HLCM Cardiovascular Center

Exclusion Criteria:

* Morbid obesity
* Musculoskeletal disorders that impede physical activity
* Neurological comorbidity
* Respiratory comorbidity in the last 30 days.
* Pacemaker users
Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH

The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth.

This trial includes three arms of treatment :

* arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor)
* arm B (IMP2Control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth.

The randomization 1:1 (block design), generated by the computer.

Primary outcomes: assessment of total blood loss expressed in mL:

* immediately after delivery
* two hours after delivery

The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth.

The measurement two hours after delivery will be performed by weighing of the adsorbent material \[ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin\]. The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.

Eligibility Criteria:
Inclusion Criteria:

* Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI \> 35 ), anemia (Hb \< 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight.
* Subjects full capacity and the willingness to give written informed consent .

Exclusion Criteria:

* Subjects with preterm pregnancy (\<37 weeks ) or with prolonged pregnancy ( \> 42 weeks )
* Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1.Protocol Study, vers.2.0 of 07/05/2016)
* multiple pregnancy
* History of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia )
* Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation
* Intrauterine fetal Death
* Epilepsy
* Autoimmune disease Tab1 medical history :
* Placental abruption during pregnancy
* Placenta previa
* Hypertension / preeclampsia
* Previous PPH
* Polyhydramnios
* Obesity ( BMI \> 35 )
* Anemia ( \< 7 g / dL )
Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults

Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.

Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.

This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults aged 18-65 years
* Iron deficiency, defined as low serum iron \<50 µg/dL, ferritin \<20 ng/mL, and TIBC \>400 µg/dL.
* Able and willing to provide informed consent
* Willing to comply with oral supplementation and study follow-up

Exclusion Criteria:

* Severe anemia, defined as hemoglobin (Hb) \<8 g/dL, requiring urgent intervention
* Known malabsorption syndromes (e.g., celiac disease, IBD)
* Active bleeding or blood transfusion within the past 3 months
* Pregnancy or lactation
* Use of iron supplements within the past 4 weeks
* Known allergy or intolerance to oral iron formulations