cyrilzakka/clinical-trials huggingface dataset:
Cancer of the Upper Aero-digestive Tract and Socio-professional Future

The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

Socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer.

A series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. Medical data will be collected via the CRF.

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis ≥ 18 to ≤ 55 years
* Employed at the entry into the care pathway
* Presenting an upper aero-digestive tract cancer (excluding nasal cavities), stage I, II and III, under a first anti-tumor treatment (surgery, radiotherapy, or chemotherapy)
* Patient mastering the French language
* Affiliated to the social security system
* Consent signed by the patient before the implementation of any specific study procedure

Exclusion Criteria:

* Having been treated for another cancer before (except skin cancer and / or prostate)
* Metastatic disease from the outset
* Patient unable to submit to a regular follow-up
* Presenting psychiatric disorders
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study.

Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies.

The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes \[Polman, 2008\]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models.

Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).


Eligibility Criteria:
Key inclusion Criteria:

* Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
* A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
* An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
* Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
* Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.

Key exclusion Criteria:

* A manifestation of another type of MS than RRMS
* History of chronic disease of the immune system other than MS
* Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
* Active infections
VitalScan MCG Rule-out Multi-centre Pivotal Study - UK

The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.

Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. \<\< 2% false negative rate) in patients presenting to an emergency setting with chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
* 18+ year old male or female
* Patient is willing and able to give written informed consent

Exclusion Criteria:

* ST-segment Elevation MI (STEMI)
* Clear non-ischaemic cause for symptoms (e.g. trauma)
* Haemodynamic instability on admission (e.g. BP\>220mmHg systolic \& \>110mmHg diastolic, \<80mmHg systolic \& \<40mmHg diastolic, HR\>160bpm)
* Ventricular tachycardia or fibrillation that cannot be treated effectively
* Atrial fibrillation
* Thoracic metal implants
* Pacemaker or internal defibrillator
* Pregnancy (if after 20-week period)\* or lactation
* Patient unable to lie down (i.e. supine position) or stay still on the examination bed
* Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English-speaking relative/translator not available)
* Patient unable to comply with the requirements of the protocol
A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia

The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA.

The tertiary objectives are to evaluate the effect of deferiprone on:

1. cardiac function,
2. quality of life, and
3. functional status.

This is a multi-centre, open-label, non-randomized, single treatment, safety and efficacy study. All subjects who completed the LA29-0207 study are eligible for participation. Participants will receive deferiprone oral solution at the same dose (20 or 40 mg/kg/day) that they were assigned for LA29-0207. The duration of treatment will be 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who completed the ApoPharma study LA29-0207
2. Female subjects of childbearing potential must have a negative pregnancy test.
3. Male subjects must confirm that he and/or his female partner will use an effective method of contraception for the length of the trial and for 30 days following completion of the study or early termination.
4. Signed and witnessed written informed consent/assent, obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedules.

Exclusion Criteria:

1. Serum Ferritin and Hemoglobin (Hb) levels are below the reference range for age and sex-matched controls.
2. Unable to complete T25FW AND with a score \> 5 minutes in the 9HPT. Subjects who can complete T25FW or with a score ≤ 5 minutes in the 9HPT will be allowed to enrol).
3. Doubling of score on 9HPT or T25FW compared to their study baseline results in LA29-0207.
4. History or evidence of neutropenia/agranulocytosis defined by a confirmed absolute neutrophil count (ANC) \< 1.5 x 109/L or thrombocytopenia defined by a platelet count \<150 x 109/L.
5. Occurrence of SAEs or any other AEs during the LA29-0207 study, which in the opinion of the investigator cause the patient's participation in the extension study to be inappropriate.
6. Unable to comply with requirements of the protocol.
7. Pregnant, breastfeeding or planning to become pregnant during the study period.
8. QTc interval \>450ms.
9. Have been on antioxidants prior to start of study treatment.
Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy.

The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small-cell lung cancer (SCLC)
* Limited disease (stage II-III)
* Stage I if ineligible for surgery
* Eastern Cooperative Oncology Group (ECOG) Performance 0-2
* Measureable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Adequate organ function defined as: (a) Serum serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN); (b) Total serum bilirubin ≤ 1.5 x ULN; (c) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; (d) Platelets ≥ 100 x 109/L; (e) Creatinine \< 100 µmol/L and calculated creatinine-clearance \> 50 ml/min. If calculated creatinine-clearance is \< 50 ml/min, an ethylene diamine tetra-acetic acid (EDTA) clearance should be performed.
* Pulmonary function: Forced Expiratory Volume in One Second (FEV1) \> 1 l or 30 % of predicted value and diffusing capacity of the lungs for carbon monoxide (DLCO) \> 30 % of predicted value
* All fertile patients should use safe contraception
* Written informed consent

Exclusion Criteria:

* prior systemic therapy for small-cell lung cancer
* Previous radiotherapy to the thorax
* malignant cells in pericardial or pleural fluid (at least one sample should be analysed if pleural fluid is present
* serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
* conditions - medical, social, psychological - which could prevent adequate information and follow-up
* clinically active cancer other than SCLC. Hormonal therapy for prostate cancer or breast cancer and basocellular carcinoma of the skin is allowed
* pregnancy, lactation
Electrocardiogram Variations in the Prediction of Development of Atrial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of adults, with its prevalence increasing with age \[1\]. It is associated with increased morbidity and mortality.

Most patients who develop AF have architectural and anisotropic micro changes in the atrial myocardium. These cause heterogeneous and discontinuous changes in the patterns of impulse propagation, heterogeneous atrial activation and shortening of atrial refractory period \[2, 3\].

Since 1911 the standard EKG \[4\] (approximately 15 seconds of recording and bandwidth 0.05 to 150 Hz) is the most used tool for the evaluation of patients with arrhythmias, due to its low cost and high availability. Various electrocardiographic patterns are known predictors of AF as evidenced by direct visual inspection. For example, prolongation of P wave duration during sinus rhythm would correlate with structural changes such as increasing the size of the left atrium (the increase in left atrial pressure) or a decrease in driving time \[5\]. These changes favor the development of reentry circuits responsible for the development and maintenance of AF.

The registration of the electrocardiographic activity provides much more information than evidenced by direct visual inspection. Biosignal processing of these specific techniques to detect potential delays caused by abnormal conduction of the myocardium that favor re-entry mechanisms \[6-10\]. For this purpose prolonged ECG with 1000 Hz sampling frequency. Knowledge about the prediction of the development of AF with the standard ECG is not obvious on visual inspection is limited.

Many of these structural changes and anisotropic, occur slowly over time and may be evidenced by direct variations between 2 ECG from the same individual \[11\]. Little is known about whether differences in morphology, axis, scope or duration of P wave related to these structural changes may predict the development of AF.

Our main purpose is to evaluate the prognostic performance of a set of parameters as evidenced by direct inspection of the ECG, and ECG changes from 2 to predict the FA development. The design of this tool could allow future generation of software capable of identifying and reporting these variations, most useful prognostic risk in patients with AF.

Retrospective cohort of patients 18 years or older with 2 EKG with sinusal rithm between 2004 - 2011.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years Health Plan members of the Italian Hospital of Buenos Aires with at least 2 ECG separated .

Exclusion Criteria:

1. Patients with sinus rhythm different.
2. Patients with a history of congenital heart disease (tetralogy of fallot, CIA)
3. Patients with implanted defibrillator or pacemaker.
4. Patients with a history of cardiac surgery or performing heart surgery from the last ECG and the development of AF.
5. Patients with a history of radiofrequency ablation for treatment of arrhythmias.
An Explorative RVA of the Motor Development of Children With DCD <2y

This study compares motor development in three groups of infants (controls, DCD, DCD+ASD) before the age of 2 years using retrospective video analysis of infants in home video contexts.


Eligibility Criteria:
CONTROLS:

Inclusion Criteria:

* Availability of video material of the child before the age of 2.
* No indication of DCD (as measured by M-ABC-2 Pc\>16 and DCD-Q)
* No indication of ASD (as measured by SRS-2 T-score ≤60 )

Exclusion Criteria:

* Medical diagnosis possibly influencing motor development (DCD, ASD, ADHD, CP, ect)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)

DCD GROUP:

Inclusion criteria:

* Availability of video material of the child before the age of 2.
* Formal diagnosis of DCD provided by multidisciplinary team in Flanders
* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)

Exclusion Criteria:

* Other medical diagnosis possibly influencing motor development (ASD, ADHD, CP, ect)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)

DCD+ASD GROUP:

Inclusion criteria:

* Availability of video material of the child before the age of 2.
* Formal diagnosis of DCD and ASD provided by multidisciplinary team in Flanders
* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
* Indication of ASD (as measured by SRS-2 T-score \>60 )

Exclusion Criteria:

* Other medical diagnosis possibly influencing motor development (ADHD, CP, ect.)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

Spontaneous myogenic oscillations will be studied under general anesthesia using finger photoplethysmography. This pilot study will explore potential physiological conditions that will effect the amplitude and/or frequency of myogenic oscillations.

This is a single center, nonrandomized, nonblinded, interventional clinical pilot research study that plans to enroll 40 patients.

Study will be conducted while subjects are under general anesthesia.

Myogenic oscillations will be measured using finger photoplethysmography. Changes in the amplitude and/or frequency of these oscillations will be analyzed in response to the interventions. Arterial blood pressure will be recorded to verify the efficacy of the interventions.

Six different interventions that will either lower or increase blood pressure will be applied to the subjects. Each subject will receive 1 or 2 of the six interventions. Each of the 6 interventions will be applied to 8 subject.

The interventions that the subject will not be randomized. They will be determined by the subjects blood pressure immediately before the intervention to guarantee that the blood pressure manipulations are within a safe range.

Data will be analyzed offline using Matlab.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 yrs of age
2. Undergoing surgery in Moffitt-Long operating rooms
3. Receiving general anesthesia
4. Will have an intra-arterial catheter for clinical purposes
5. Able to consent in english

Exclusion Criteria:

1. Under 18 years of age
2. unable to provide informed consent
3. Pregnancy
Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.


Eligibility Criteria:
Inclusion Criteria:

* Male and female,age 18-65 years
* Has type 2 diabetes mellitus
* BMI 20 to 29kg/m2
* Willingness to adhere to the protocol requirement

Exclusion Criteria:

* Patients with type1 diabetes mellitus
* Received any antidiabetic drug within run-in or during screening
* Hepatic diseases
* Kidney diseases
* Clinical abnormal finding in EVG,labs and physical exams
* Women of child-bearing potential
Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test

This project aims to investigate the sensitivity and specificity of the rapid antigen test compared to RT-PCR test performed on samples from the nasopharynx and the anterior nasal cavity and the oropharynx, respectively.

The purpose of the study is to investigate the sensitivity and specificity of correct SARS-CoV-2 test results of nasopharyngeal swabs and swabs swabs from the anterior part of the nose examined by rapid antigen test (Standard Q COVID-19 Ag - test, SD Biosensor INC.) compared with swabs from the oropharynx examined by RT-PCR test among citizens who have booked an appointment for a COVID-19 test in one of Testcenter Denmark's test centers in the Capital Region.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* A booked appointment for a COVID-19 test at one of Testcenter Denmark's test centers in the Capital Region

Exclusion Criteria:

* Previously tested positive for COVID-19
* Non-fluent in Danish
Early Rheumatoid Arthritis COR Intervention

The primary aim of our present study is to evaluate the effect of a targeted, intensified, multidimensional intervention compared to conventional treatment of modifiable risk factors for CVD in patients with early RA. The primary endpoint, a composite of death from cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be assessed after 5years' follow-up.

The study is a prospective randomised open, blinded endpoint trial with balanced randomisation (1:1) conducted in seven outpatient clinics in Denmark. Follow-up visits for patients in the intervention group are scheduled to occur at baseline and then after 2, 4 and 12 weeks and thereafter every third month for 5 years after randomisation. The control group will be monitored for RA disease activity and comorbidity after 2, 4 weeks, 12 weeks and thereafter following national guidelines for RA. Prevention of CVD risk factors in the control group will be treated in general practice according to national guidelines for diabetes (2011), hypertension (2009) and CVD (2013).

Eligibility Criteria:
Inclusion Criteria:

* RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL \> 2.5mmol/l.

Exclusion Criteria:

* Pregnancy
* Lactation
* Ongoing/previous DMARD therapy
* Ongoing/previous steorid therapy
* Contraindication to any of the trial drugs
* Current infection with parvovirus B19, hepatitis B, hepatitis C or human immune deficiency virus. Previous report of hospitalisation for myocardial ischaemia defined as follows: a) non-fatal myocardial infarction (MI) defined according to national and international guidelines. b) Acute coronary syndrome (ACS) including acute ischaemic symptoms with possible biomarker changes or elctrocardiographic changes that to not meet the criteria for MI, c) angina pectoris, d) revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.

The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who need a surgery
* Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
* Old patient under age 12
* Patient whose parents agreed to participate

Exclusion Criteria:

* Patient with psychomotor limitations
* Patient that had already been hospitalised for a surgery