cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Two Formulations of Erythropoietin

A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.

Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.

It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .

Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.

Exclusion Criteria:

* Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently \<1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.

We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.

Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).

Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.
Non Interventional Post Marketing Programme in Neuroendocrine Tumours

The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").


Eligibility Criteria:
Inclusion Criteria:

* The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this Post Marketing Surveillance programme and any subsequent analysis.
* The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
* The patient must have a diagnosis of neuroendocrine tumours
* The patient must be at least 18 years of age
* For patients receiving or intending to receive Somatuline Autogel by home injection:

  * The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service.

Exclusion Criteria:

* The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
Diastolic Blood Pressure and Lipid Profile in Infants

The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.

The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD, since they have faster early growth rate and higher risk of overweight, type 2 diabetes, high blood pressure, and unfavorable blood lipid profile in adult age. Formula-fed preterm infants have higher serum C-reactive protein (CRP) concentration, higher serum low-density lipoprotein to high-density lipoprotein (LDL:HDL) ratio, and higher serum apolipoprotein B to apolipoprotein A1 (apoB:apoA1) ratio in adolescence as compared with preterm infants receiving banked breast milk.

Eligibility Criteria:
Inclusion Criteria:

1. Breastfed infants
2. Formula-fed infants
3. Raw milk fed infants
4. Mixed fed infants

   1. Breast milk plus raw milk
   2. Breast milk plus formula

Exclusion Criteria:

1. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).
Epidemiological Screening of Psychiatric Disorders Among School Aged Children and Adolescent in Assiut Governorate

Paediatric behavioural, developmental, and mental health issues are more common than childhood cancers, cardiac problems, and renal problems combined.

Behavioural problems have often been conceptualized along two broad spectrums: internalizing problems which are expressed in intrapersonal manifestation, such as anxiety, depression, and withdrawal; and externalizing problems which are demonstrated in interpersonal manifestation, such as hyperactivity and aggression The lack of attention to the mental health of children and adolescents may lead to mental disorders with lifelong consequences, undermines compliance with health regimens, and reduces the capacity of societies to be safe and productive. As, children and adolescent mental health problems often have serious long term debilitating effects . Early identification and treatment of these problems are in the best interest of children, adolescents, their families, and society as a whole . All three essential ways in which epidemiology can contribute to our understanding of children and adolescent mental health: community burden, measurement, and triage were of utmost importance. planning and conducting the survey.

In this study the researchers will present the first large-scale survey of child and adolescent psychiatric disorders at Assiut government For adequate planning of services, including evidence-based mental health prevention and intervention, a population-representative survey of children and adolescent estimating mental disorders was urgently needed


Eligibility Criteria:
Inclusion Criteria:

1. age of children (6-18 years)
2. both males and females.
3. have education in school at Assiut government.

Exclusion Criteria:

1- unwilling parent to recruited in the study.
Preventive Approach for the Management of the Main Geriatric Risks

Nowadays, EHPAD residents are polypathological (cognitive and psycho-behavioral pathologies, undernutrition, IC, diabetes, COPD, IR, etc.) and multi-medicated. From a medical point of view, this implies the need for regular monitoring and a high level of medical or even multidisciplinary expertise for the healthcare team. The objective of the GER-e-TEC ™ project is to provide these complex patients with telemedicine tools allowing protocolized and personalized, non-intrusive monitoring. The GER-e-TEC ™ project more specifically takes into account the significant issues in nursing homes of aging residents with the main geriatric syndromes (fall, undernutrition, cognitive-behavioral disorders, iatropathogeny, etc.) The objective of the work undertaken is to develop a codified preventive approach for the management of the main geriatric risks, in order to avoid the occurrence of an acute decompensation factor in the elderly.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥65 years old)
* Subject hospitalized between June 17, 2019 to November 13, 2019, in the UF 3723 department, of the Medical Clinic B of the University Hospitals of Strasbourg
* Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subject under guardianship or guardianship
* Subject under safeguard of justice
* Subject in palliative / end of life situation
* Subject in acute emergency situation
Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented COPD based on the following criteria:

   Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
2. Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
3. Male or female patients aged ≥ 40 years.
4. Patients should be treated according to GOLD guidelines before study start.
5. Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
6. Maintained on stable respiratory medications for 6 weeks prior to visit 1.
7. Written informed consent obtained.

Exclusion Criteria:

1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
2. Inability to carry out pulmonary function testing.
3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
4. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
5. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
6. Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
7. A history of thoracotomy with pulmonary resection.
8. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
9. History of alcohol or drug abuse.
10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
12. Patients treated with any non-permitted concomitant medication (see 7.2).
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression Osteogenesis.

The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from anterior vertical maxillary excess that requires surgical intervention

Exclusion Criteria:

* total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).


Eligibility Criteria:
Inclusion Criteria:

* Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054
* Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
* Is medically stable with no anticipated changes in chronic medications in the opinion of the Investigator
* Continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
* In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

Exclusion Criteria:

* Inadequate supervision by parent(s)/caregiver(s)
* History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma

The purpose of this study is to characterize the safety of QLS32015 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS32015 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.

Multiple myeloma (MM) is a malignant disease with abnormal proliferation of clonal plasma cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia, and kidney damage. QLS32015 is a humanized immunoglobulin gamma-1 (IgG1) type bispecific antibody targeting G protein-coupled receptor family C group 5-member D (GPRC5D) and cluster of differentiation 3 (CD3). The study consists 3 periods: screening phase, treatment phase and a post-treatment follow-up phase. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLS32015 administered to participants with relapsed or refractory multiple myeloma. Total duration of study is up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, regardless of gender.
* Subjects should be willing and able to comply with the study schedule and protocols.
* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
* Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.

Exclusion Criteria:

* Known hypersensitivity to any of the ingredients of this product.
* Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
* Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
Transverse Abdominal Plane Block for Caesarean

Cesarean sectionis a commonly performed major surgical procedure that results in significant postoperative pain. The objective of this study was to evaluate the effectiveness in the management of post-cesarean pain at the CHU Souro Sanou of Bobo-Dioulasso


Eligibility Criteria:
Inclusion Criteria:

* Adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia
* ASAI, ASAII

Exclusion Criteria:

* Lack of informed consent,
* Parturients with cognitive disorders,
* Parturients with notion of chronic pain,
* Allergy to local anesthetics,
* Morphine allergy
* Parturients not understanding pain assessment scores
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure

Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.

Ten patients will be invited to participate in the trial. After obtaining informed consent, the ten patients will be randomly assigned to one month of treatment with oral n-acetylcysteine 500mg or placebo twice daily for thirty days in addition to their regular therapy. At enrolment the patients will be educated and counselled about the trial and the intervention medication. Patients will also have a blood test (serum creatinine) that will allow the calculation of their renal function by use of the Cockroft Gault equation. Blood samples will also be frozen and stored. Patients will also undergo an ultrasound test of the function of their arm blood vessels. Both the blood test and the ultrasound test will be repeated at the completion of the thirty day trial period. Again the blood test sample will be frozen and stored. Subjects will then cross over to the other treatment arm for a further one month period, with the same testing at the end.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years inclusive;
* Patients with chronic heart failure NYHA II, III and IV and LVEF\<40%. Stable medications for 1 month. Not admitted to hospital in the past month.
* Chronic renal failure with GFR (as estimated by the Cockroft Gault equation) of \>30 ml/min and \<50 ml/min not on any form of dialysis.

Exclusion Criteria:

* Age \<18 and \>75 years;
* Myocardial infarction in the preceding six months;
* Acute decompensation of renal function or heart failure in the last 30 days;
* Allergy to n-acetylcysteine or glyceryl trinitrate;
* Contraindications to the use of glyceryl trinitrate as per the product information lodged with the PBS (Australia);
* On treatment with allopurinol, vitamin C or vitamin E or other antioxidant therapy at time of randomisation (statins are acceptable);
* Acute decompensation of another organ system in the last 30 days;
* Current pregnancy.
Ozone Application in Periodontal Treatment

This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. The main question it aims to answer is:

• Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities.

Participants will be applied NSPT consisting of supra and subgingival debridement.

* NSPT will be applied alone in one quadrant
* In addition to NSPT, ozone therapy procedures were performed using a device at contralateral sites.

Researchers will compare the sites with and without ozone therapy in addition to NSPT to see if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological changes


Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* no periodontal treatment within 6 months from the enrollment date
* no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date
* no smokers
* no pregnancy or lactation at the time of the stud
* no contraindication for periodontal treatment and ozone application

Exclusion Criteria:

* Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions

The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.


Eligibility Criteria:
Inclusion Criteria:

* Class I patients according to the American Society of Anesthesiology (ASA),
* Indication for third molars extraction,
* Similar degree of complexity, according to the classification of Pell and Gregory.

Exclusion Criteria:

* Patients with systemic conditions,
* Patients with known allergy to any component of the anesthetic solution.
Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify the percent saturation. There is also available evidence shows that tissue oximetry is sensitive and has a quicker response to physiological derangement, such as bradycardia, in preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target range. In this study, we will monitor 2 different tissue beds including cerebral and abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to investigate clinical implications for using this measure to drive therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Term infants (37-42 weeks of gestation)
2. Elective cesarean section after pregnancy

Exclusion Criteria:

1. Thick hair that makes good measurements difficult/impossible
2. Obvious malformations or syndrome
3. Complications in relation to the cesarean section