cyrilzakka/clinical-trials huggingface dataset:
Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™

In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI \> 18 and \< 30.0.
2. Females of childbearing potential who are sexually active must be willing to use two forms of contraceptive methods throughout the study and for 14days after the last study drug administration.
3. Minimum weight of 50 kg.
4. Good health, defined as not having history of any chronic illness and not requiring any regular medication/therapy.
5. Must swallow tablets on a regular basis.

Exclusion Criteria:

1. Evidence of Helicobacter pylori infection, presently, or within the last year.
2. Subjects with known hypersensitivity to cysteamine.
3. History, currently or within the past 3 months, of the following conditions:

   * Pancreatitis
   * Inflammatory bowel disease
   * Malabsorption
   * Severe liver disease
   * Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
   * Unstable diabetes mellitus
   * Any bleeding disorder.
   * Zollinger-Ellison syndrome
   * Malignant disease
4. Subjects whom may be pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
5. Use of an investigational drug within 30 days (or 90 days for biologics) prior to dosing.
6. Use of prescription medication within 14 days prior to the first dosing;
7. Use over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing.
8. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
9. Hemoglobin \<13.5 g/dL (males) and \<12.0 g/dL (females) and hematocrit \<41.0% (males) and \<36.0% (females) at screening.
10. Breast-feeding subject.
11. Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study.
12. Presence of fever (body temperature \>37.6°C) (e.g. a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.

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Study of XIAP Antisense for Advanced Cancers

This study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers.

This is a Phase I study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. The starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven diagnosis of advanced or metastatic cancer (including solid tumours and lymphoma)
* refractory to conventional treatment, or for which no conventional therapy exists with life expectancy of at least 12 weeks
* ECOG performance status of 0 or 1
* hematological and biochemical indices as specified within one week prior to treatment

Exclusion Criteria:

* known bleeding diathesis or concurrent treatment with anticoagulants
* primary brain tumours or brain metastases
* radiotherapy (except palliative), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C)
* all toxic manifestations of previous treatment must have resolved (excepting alopecia or certain Grade 1 toxicities)
* pregnant or lactating women
* major thoracic and/or abdominal surgery in the preceding 4 weeks
* high medical risks from non-malignant systemic disease including uncontrolled infection
* hepatitis B, C or Human Immunodeficiency Virus
* allergic history to antisense agents
Refeeding Syndrome in Cancer Patients

The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.

Refeeding syndrome is a clinical entity triggered by the introduction of calories in chronically undernourished patients. A number of organs may be affected due to imbalance of fluids and electrolytes. In the intensive care setting, there are no formal guidelines to recommend the appropriate treatment of this condition. The aim of this study is to evaluate the implementation of a nutritional protocol to address cancer patients admitted to the ICU with refeeding syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Initiation of any type of nutrition (enteral, parenteral or glucose solution of at least 10% concentration) in the ICU in the last 48 hours;
* Reduction of serum phosphorus to a level below 2.5mg/dL with a drop above 0.5mg/dL compared to a previous measurement;
* Caloric intake greater than 500kcal in the last 24 hours;
* Central venous access for electrolyte replacement;
* Signature of the informed consent form.

Exclusion Criteria:

* Use of enteral or parenteral nutrition before ICU admission;
* Prediction of ICU discharge in the following 2 days;
* End-stage renal disease;
* Admission for diabetic ketoacidosis or hyperosmolar hyperglycemic state;
* Recent treatment of hyperphosphatemia;
* Parathyroidectomy surgery;
* Participation in another study;
* Refusal to participate in the study.
The Overall Survival of Patients With Unresectable HCC in Real-life

Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China).

The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of unresectable hepatocellular carcinoma
* Able to comprehend and provide written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

* Patients not willing to participate and/or give their written informed consent.
Total Ankle Replacement: Clinical and Radiological Outcomes

This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.

The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics \[1-4\]. Therefore the data related to this study can be considered a reference in the literature.

Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.

The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* age ≥ 18 years at the time of surgery
* patients who underwent ankle replacement surgery from January 2011 to March 2026

Exclusion Criteria:

- age \< 18 years at the time of surgery
Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, funded by National Key R\&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.


Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 years old;
2. Diagnosis of acute ischemic stroke;
3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting;
5. The patient or the patient's legal representative is able and willing to sign the informed consent.

Exclusion criteria

1. Isolated cervical ICA or VA occlusion;
2. No evidence of LVO on DSA.
Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients

Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.

The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course.


Eligibility Criteria:
Inclusion Criteria:

* Children/young people aged between 6 and 18 years with newly diagnosed CM according to recognised diagnostic criteria
* Obtaining informed consent

Exclusion Criteria:

* Refusal to participate in the study.
Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

A monocentric Study to evaluate the french translation of Gothenburg Trismus Questionnaire (GTQ).

Trismus is defined as a limitation in the mouth/jaw-opening ability due to a reduced mandible mobility. Trismus can occur from benign jaw related conditions, often referred to as temporomandibular disorders (TMD). It can also result from local or metastatic tumor growth of head and neck (H\&N) tumors, and more importantly, as a debilitating side-effect to H\&N oncology treatment, especially radiotherapy

The Gothenburg Trismus Questionnaire (GTQ) is a Patient Reported Outcome, validated in English, portuguese and sweden language.

The aim of this study is to develop a new tool in french language and to evaluate the specific impact of trismus on quality of life .

Eligibility Criteria:
* Inclusion Criteria:

  * Patient treated for trismus
  * Age ≥ 18 years old
  * Read, write and understand the French language
* Exclusion Criteria:

  * Patient under guardianship, deprived of liberty, safeguard of justice
  * Refusal to participate in research
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea

The effect of CPAP on weight and fluid homeostasis will be assessed. Obstructive sleep apnea treatment-naive subjects will randomized to CPAP and control groups. Weight change, and changes in overnight urinary volume, intra and extracelullar volume, plasmatic B-type natriuretic peptide (BNP) and antidiuretic hormone (ADH) and urinary osmolality will be compared between groups.

There is a bidirectional relationship between Obstructive Sleep Apnea (OSA) and obesity. Although obesity can lead to OSA, patients with OSA are more likely to gain weight. The mechanisms that lead to weight gain during the treatment of OSA are not known. Some evidence supports the hypothesis that fluid accumulation could be a possible explanation for weight gain after treatment for OSA. The hypothesis is that one night of CPAP treatment promotes increased body weight and reduced diuresis in patients with OSA. Participants will be submitted to 2 consecutive nights of polysomnography (PSG). A baseline PSG will be performed during the first study visit. During the second study night, participants will be randomized into two groups, CPAP and control (repeat baseline PSG). Overnight urinary volume will be determined. Intra and extracellular water volume will be assessed using electrical bioimpedance before bedtime and just after the subject wakes up. Plasmatic BNP and ADH and urinary osmolality will also be determined during each morning following PSG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Obstructive Apnea Sleep
* Over 18 years of age
* No previous treatment with Continuous Positive Airway Pressure

Exclusion Criteria:

* Congestive heart failure
* Renal insufficiency
* Hepatic failure
* Urinary incontinency
* Diuretic therapy
Middle East MED-EL Observatory Study

In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure.

This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine.

The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are implanted or will be implanted with a MED-EL CI system.
* Signed written informed consent for data collection for registry purposes.

Exclusion Criteria:

* Lack of compliance with any inclusion criteria.
* Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
* Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.
Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium

The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery.

comparing the total dose of rocuronium between continuous infusion and intermittent injection

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged between 2 and 12, undergoing elective noncardiac surgery which requires general anesthesia but does not require intense block, and estimated time of surgery is between 2 and 5 hours

Exclusion Criteria:

* ASA class 3-6
* BMI \>= 30
* Previous history of hepatic failure, renal failure or neuromuscular disease
* Patients taking medicine which interacts with rocuronium bromide, before or during surgery: aminoglycosides, lincosamides, acylamino-penicillin antibiotics, tetracyclines, metronidazole (high dose), diuretics, MAO inhibitors, calcium channel blockers, corticosteroids, phenytoin, carbamazepine, or norepinephrine
* Previous history of allergic reaction (including anaphylactic reaction) and/or malignant hyperthermia during general anesthesia
* Patients taking medicines which contains magnesium
Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC

The purpose of this study is to test two on-line interventions for families of young children who have experienced moderate or severe traumatic brain injury (TBI). This project builds upon the investigators' previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention groups will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.

The investigators will conduct a multi-site randomized controlled trial (RCT) comparing the efficacy of 7-week Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury Express (I-InTERACT Express) and 24-week long web-based positive parenting skills programs Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury (I-InTERACT) to an internet resource group (IRC) involving access to internet resources and education about brain injury. The project builds upon the feasibility and efficacy findings from an ongoing randomized trial comparing the efficacy of a 24-week positive parenting skills program to access to internet resources. However, it differs in size and scope by including multiple sites, and by including an abbreviated parenting skills training arm in response to family feedback that the existing 24-week intervention was excessively long, resulting in adherence difficulties. The investigators anticipate that the improvements in parenting skills and psychological functioning will translate into improved parent-child relationships and reductions in child behavior problems. Over time, such improvements in child and parent functioning should contribute to academic and social success and more successful community integration.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe TBI that occurred within the last 24 months
* Overnight hospital stay
* English-speaking
* Parent must be willing to provide informed consent

Exclusion Criteria:

* Child does not live with parents or guardian
* Child or parent has history of hospitalization for psychiatric problem
* Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
* Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Scaffold in Emilia Romagna and in the MAGIC Network

The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.

Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.

The aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.

The investigators agreed in the following preferential/optimal indications:

* complete revascularization in patients with age \<65 years
* revascularization of long lesions (\>24 mm), especially located in left anterior descending
* spontaneous coronary dissection

The investigators agreed in the following strategy implantation:

* mandatory predilatation
* sizing 1:1
* to avoid vessel with reference vessel diameter \<2.8 mm and \>3.8 mm
* to avoid vessel with severe calcifications
* mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter

The study organization is based on:

DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.

CORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria

Eligibility Criteria:
Inclusion Criteria:

* subjects \>18 years
* sign of the patients informed consent
* implanation of at least one scaffold

Exclusion Criteria:

* inability to garantuee at least one year follow-up
* inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction

To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial obstruction attending emergency services


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic children 5-\<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Exclusion Criteria:

* Patients with severe acute bronchial obstruction determined by functional and clinical evidence
* Patients unable to use the inhaling device at time of treatment
* Patients who received a bronchodilator drug within the last 12 hours
* Patients who received inhaled steroids within the last 72 hours
* Patients who received systemic steroids within the last 7 days
* Patients with near fatal asthma history
* Patients with fever (\>38.5°C axillar temp)
* Patients with any clinical significance condition

Other protocol-defined inclusion/exclusion criteria may apply