cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).
* Has documented baseline mean platelet count of \<30 x 10\^9/L before randomization
* Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.
* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
* Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).
* Has documented prior response defined as 1 platelet count of ≥50 × 109/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin

Exclusion Criteria:

* Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.
* Secondary ITP
* Nonimmune thrombocytopenia
* Autoimmune hemolytic anemia
* ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.
Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients

Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.

Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. The success of this therapeutic strategy is based on several factors, including the medication adherence. Whatever the method used, adherence evaluation is not sufficient, around 66% of the treated patients. Nevertheless, studies analysing the predictive factors of medication adherence in RA are rare.

RA patients are also educated about the infectious risk related to RA and treatments, and the importance of vaccination. These recommendations are not always respected by the patients, without knowing the exact factors leading to this decision. Furthermore, a lot of patients take personal initiatives without the agreement and the help of their practitioner, like diets or special feeding behaviors. Lastly, plenty of patients affected bv chronic diseases claim and use electronic health tools without any real evidence of the efficacy of such device.

The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.

Eligibility Criteria:
Inclusion Criteria:

* patient aged over 18 years old,
* affected by RA according to ACR/EULAR 2010 criteria,
* francophone,
* and informed about the aims of the study.

Exclusion Criteria:

* guardianship patient,
* patient who refuses to participate.
The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia

The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).

This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.

The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.

At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Adult cancer patients (\>18)
* Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
* Patients that will experience PPE grade 1 or above
* Willing to participate
* Ability to complete the psychometric assessments.
* A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG

Exclusion Criteria:

* Patients with hypersensitivity to Vitamin B.
* Patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results
* Patients on oral Pyridoxine or nicotine patches
* Patients with a previous history of PPE
* Patients whose chemotherapy was discontinued for more than a week
Enhanced vs Conventional Recovery After Breast Surgery

the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.

Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway

Eligibility Criteria:
Inclusion Criteria:

* • Age: 20-60 years.

  * Adequate cognitive state (able to understand and collaborate)
  * American society of anesthesia (ASA) I, II

Exclusion Criteria:

* Patients who are:

  * Uncooperative.
  * Having allergy to any of the study drugs.
  * Known abuse of alcohol or medication.
  * Having Local infection at the site of injection or systemic infection.
  * Pregnancy.
  * With coagulation disorders.
  * Any complicated patients
A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System Versus Bulk Filled Resin-based Composite

The aim of the present study is to evaluate the clinical performance of EQUİA restoration material in Class II cavities comparing with a resin-based composite / dentin bonding system.

35 patients at 12-year-old, who have a matched pair of permanent molars with an approximal and /or occlusal carious lesion of similar size will be included.

split -mouth design for the two restorative materials will be used. After removing the carious each patient will receive two restorations following the taking impressions to determine the cavity size.

One of the two materials will be Equia (GC Europe N.V., Leuven , Belgium), a high viscosity glass ionomer cement and the second material used will be Tetric EvoCeram Bulk Fill composite (IvoClar Vivadent), along with a dentin bonding system (AdheSe One F, Ivoclar Vivadent, Lichtenstein).

The dentist will randomly select the restorative material to be placed. The dentist will mix and handle the materials, in accordance with the manufacturers' instructions.

The clinician will use a matrix to maintain tight adaptation of the restorations.

The clinician will take impressions after the first setting reactions of the materials are done to determine the wear of the restorative materials.

Two blinded examiners who were not involved in the placement of the restorations will evaluate the restorations at six, 12 and 24 months.

Impressions will be repeated at 12 and 24 months intervals. The examiners will use the U.S Public Health Service (USPHS) Ryge criteria to evaluate the restorations.

Wear analysis will be performed with a 3 dimensional laser scanning device (Laserscan 3D, Willytec, Germany) by scanning the cast models.

The data will be analyzed using statistical software (SPSS 13.0, SPSS, Chicago). Cumulative survival rates will be estimated using the Kaplan-Meier method and long-rank-test.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has occlusal carious lesions in their mandibular molar teeth

Exclusion Criteria:

* Patients with extremely poor oral hygiene, severe or chronic periodontitis, or heavy bruxism habits were excluded from the study
Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre

HIV patients are likely to suffer from opportunistic infections, in absence of highly active retroviral therapy. This happens due to lack of awareness of HIV status among patients or unresponsive to anti retroviral drugs. This study is for the prevalence of AIDS defining OIs among treatment naive HIV patients.

Oppotunistic infections (OIs) happen in persons with weakened immune system. HIV patients, who remain untreated due to lack of knowledge of existing HIV infections, often get OIs. HIV patients with AIDS defining OIs fall into stage 3 of HIV illness. Prevalence of OIs in resource poor settings are tuberculosis (pulmonary and extra pulmonary), toxoplasmosis, cryptococcosis, and oesophageal candidiasis. There are a few data to show AIDS defining OIs in treatment naïve HIV patients. Incidence of OIs among HIV patients in United States, and Canada between 2000 to 2019 was 9%. Leading OIs were peumocystis Jiroveci, oesophageal candidiasis and disseminated MAC or M. kansassi.

Minimal diagnoses at poor settings can be made by observation of symptoms, use of microscope, imaging and diagnostic therapy.

Eligibility Criteria:
Inclusion Criteria:

• HAART naïve HIV patient

Exclusion Criteria:

* Patients died during screening
* Transferred in HIV patients
Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates. All 28 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
2. Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.

Exclusion Criteria:

1. History or presence of significant:

   • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

   In addition, history or presence of:
   * Hypersensitivity or idiosyncratic reaction to topiramate
   * Nephrolithiasis or gout
   * Alcoholism or drug abuse within the past year
2. Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
3. Subjects who had any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
4. Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
5. Subjects who, through completion of the study, would have donated in excess of:

   * 500 mL of blood in 14 days, or
   * 500-750 mL of blood in 14 days (unless approved by the Principal Investigator),
   * 1000 mL of blood in 90 days,
   * 1250 mL of blood in 120 days,
   * 1500 mL of blood in 180 days,
   * 2000 mL of blood in 270 days,
   * 2500 mL of blood in 1 year,
6. Subjects who had participated in another clinical trial within 28 days of study start.
Cardiovascular Assessment Before and After Limb Amputation

Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.


Eligibility Criteria:
Inclusion Criteria:

* all vascular or diabetic patients before leg amputation

Exclusion Criteria:

* traumatic amputation
* sepsis patient
* urgent surgery
Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months

The goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China.

The main questions it aims to answer are:

How does iron-deficiency anemia affect children's neurobehavioral development, including motor skills, language ability, and social behavior? How does anemia influence growth and nutrition, such as weight, height, and body mass index (BMI) in children?

Participants will:

Undergo blood tests (including hemoglobin levels, serum ferritin, and serum iron) to assess anemia status.

Be assessed using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6" to measure motor, cognitive, language, and social development.

Provide general health information, such as birth history, feeding methods, and parental details, through interviews with trained surveyors.

Researchers will compare children with and without iron-deficiency anemia to determine differences in neurobehavioral outcomes and development levels. The findings aim to provide evidence for early interventions to prevent the negative impacts of anemia and support children's healthy development.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 24 months at the time of enrollment
* Diagnosed with iron-deficiency anemia (for the exposure group) or confirmed
* non-anemic status (for the control group) based on blood test results
* Resident in the study area for at least 6 months prior to enrollment
* Availability of parental or guardian consent to participate in the study and willingness to follow study protocols
* Completion of all baseline assessments, including neurodevelopmental and physical growth evaluations

Exclusion Criteria:

* Presence of congenital or chronic illnesses that could affect
* neurodevelopment, such as Down syndrome or cerebral palsy.
* History of severe infections or trauma within 3 months prior to enrollment that
* could influence neurodevelopmental outcomes
* Current use of medications or treatments that may interfere with iron metabolism (e.g., iron supplementation or blood transfusions in the last 6 months)
* Premature birth (before 37 weeks of gestation) or low birth weight (\< 2,500 grams)
* Parental refusal to provide consent or non-compliance with study procedures.
Prospective Registry of Acute Coronary Syndromes in Ferrara

The ARYOSTO has been designed to describe the clinical epidemiology and the current management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors will evaluate the medical and interventional management of ACS patients admitted to hospitals in the area of Ferrara and receiving coronary artery angiography and percutaneous coronary intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria di Ferrara, Cona (FE), Italy)

The Cardiovascular Institute of the University Hospital of Ferrara is the hub center of the area of Ferrara (400.000 residents). The cath-lab of the University Hospital of Ferrara is the hub center of the network for the management of patients with ACS. This finding guarantees a very high number of patients with ACS admitted to University Hospital of Ferrara (more than 1500 by year). In the cath-lab are performed more than 2000 coronary artery angiography by year and more than 1100 PCI by year. The staff of the cardiology unit has a great experience in the management of studies (investigator-driven, randomized controlled trials, with or without sponsor) enrolling patients with ACS and treated with PCI. All consecutive patients with ACS admitted to hospitals of the Ferrara area will be included in the registry. All data will be related to long-term clinical outcome.

METHODS:

Prospective collection of following data:

* baseline characteristics including cardiovascular (CV) risk factors, CV history and comorbidities (see below)
* clinical management (CV drugs, imaging exams, diagnostic exams, time to cath-lab access)
* biomarkers evaluating inflammation, endothelial, platelet, thrombotic function and activation
* procedural details including coronary disease description, intervention modality, stent, coronary imaging, CV drugs during intervention, procedural complications and management, access site
* in-hospital adverse events
* medical treatment at discharge and during the follow-up
* clinical follow-up (1, 2, 3, 4 5 years)

PRE-SPECIFIED SUBSTUDY

The Authors will focus the attention in specific subset of patients:

* patients with diabetes
* patients with chronic obstructive pulmonary disease
* patients with chronic kidney disease
* patients with rheumatologic disordes
* patients with malignancy In these subsets of patients the Authors will collect a more detailed description of symptoms, clinical presentation, disease management and relationship between comorbidity and ACS.

Similarly, a specifc substudy of the registry will be focused on the characterization of coronary artery disease and of atherosclerotic plaque morphology in patients with comorbidities (diabetes, COPD, CKD, malignancy) as compared to patients without comorbidities.

Finally, the Authors will evaluate the quality of life of ACS patients in the area of Ferrara applying at 1, 2, 3, 4 and 5 years the following questionnaires: EQ-5D and SF-12 v2

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* hospital admission for acute coronary syndromes
* resident in the Ferrara area

Exclusion Criteria:

* none
Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine

Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.


Eligibility Criteria:
Inclusion Criteria:

* being healthy and ≥ 18 and ≤ 49 years of age
* willing and able to give informed consent

Exclusion Criteria:

* having participated in an influenza H5 vaccine trial in the past
* known to be allergic to any constituent of the vaccine
* serious adverse reactions to previous (influenza) vaccination
* currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study
* using medication that influences the immune system
A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers

The purpose of the study is to learn about the use of \[13C\]pyruvate as an imaging agent for MRI scans. In past studies, researchers have seen that \[13C\]pyruvate can improve imaging with MRI scans. However, they would like to know more about how the imaging agent is distributed in healthy organs and tissues. This study will provide additional information about the use of \[13C\]pyruvate as an imaging agent for MRI scans, and it will show us how the substance is metabolized (changed into energy) in the organs and tissues of healthy volunteers. For (n=5) volunteers undergoing brain imaging we will compare the standard injection at 5mL/second with a slower infusion (0.1-1mL/second) to achieve a 60 second infusion time, to approach quasi steady-state metabolism and improve SNR.


Eligibility Criteria:
Inclusion Criteria:

Fifty healthy volunteers will be included.

* Age between 18-80
* Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \<2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test.

Exclusion Criteria:

* Breast-feeding
* History of metabolic (e.g. diabetes) and renal functional disorders.
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
* Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).
* Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 and 18 years must weigh \>60 kg
* Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
* Not a candidate, as determined by the Investigator, for suitable alternative therapy
* After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment

Exclusion Criteria:

* Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
* Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
* Evidence of significant liver disease: ALT \>3 × ULN or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis

The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.


Eligibility Criteria:
Inclusion Criteria:

* all records with sepsis in emergence department of hospitals

Exclusion Criteria:

* subjects with major missing data