cyrilzakka/clinical-trials huggingface dataset:
Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)

The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.


Eligibility Criteria:
INCLUSION CRITERIA :

* Inclusion criteria for register :
* Adults ≥ 18 years of age.
* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
* Patients not hospitalized at the time of sudden death.
* Inclusion criteria for DNA bank :
* Case subjects :
* Adults ≥ 18 years of age.
* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
* Patients not hospitalized at the time of sudden death.
* Patients supported clinically by an emergency ambulance service.
* Control subjects :
* Adults ≥ 18 years of age.
* Adults hospitalized in an cardiac intensive care unit.

EXCLUSION CRITERIA :

* Exclusion criteria for register :
* Violent death : criminal, suicidal or accidental.
* Exclusion criteria for DNA bank :
* Case subjects :
* Violent death : criminal, suicidal or accidental.
* Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.
* In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :
* Adult subject to legal protection measure,
* Pregnant woman,
* Parturient,
* Breastfeeding mother,
* Person deprived of liberty,
* Person hospitalised without his consent,
* Person admitted to a medical or socially facility.
* Control subjects :
* History of sudden death,
* Documented history of ventricular fibrillation,
* History of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.

A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age of consent per local regulations at the time of screening
* Unresectable or metastatic hepatocellular carcinoma
* ECOG Performance Status ≤ 2
* Life expectancy of ≥ 3 months;

Exclusion Criteria:

* Child-Pugh Score for Cirrhosis Mortality \> 7 points
* Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic, targeted or experimental therapy
* Prior local treatment for HCC less than 4 weeks prior to initiating study treatment
* Active second malignancy
* Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment
* Thrombotic or embolic events within 6 months prior to initiating study treatment
* Ongoing pancreatitis
* Uncontrolled or refractory ascites
* Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis
* Hepatic encephalopathy \> Grade 1
* Active brain metastases with exceptions
* Poorly controlled diabetes mellitus
* Active coronary artery disease
* Uncontrolled hypertension
Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease

The proposed research study is a cross-sectional study enrolling young children with sickle cell disease between 5 and 12 years of age. They will be screened as outpatients for consent to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of bronchodilator response will be assessed at each session. To estimate presence of pulmonary hypertension, echocardiography will be performed at the time of PFT measures.

Study Design:

1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established patients within the Duke Pediatric Sickle Cell Clinic.
2. Perform a chart review of all enrolled subjects to obtain specific details regarding birth history, nutritional status (weight, height), family history, sickle cell genotype, parental smoking history, recent laboratory parameters, parental smoking history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle cell complications and prescribed medications.
3. Perform spirometry and plethysmography with the administration of albuterol.
4. Before or after completion the PFT session, the patient will have echocardiography in the PFT lab area
5. Using medical record information, determine number of hospitalizations for any pulmonary symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing, hypoxia, cough, chest pain). In addition, we will track any respiratory or cardiac symptoms or therapies for each subject 6 years after enrollment up to age 18 years using the registry.
6. As standard of care, refer any child identified as having lung disease or pulmonary hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment and ongoing care.


Eligibility Criteria:
Inclusion Criteria:

* children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta plus thalassemia, HbS beta zero thalassemia, and HbS OArab)
* established patients within the Duke Pediatric Sickle Cell Clinic.
* Subjects must have been full-term at birth
* any race or gender

Exclusion Criteria:

* significant chromosomal/congenital anomalies
* hemodynamically significant congenital heart disease (arrhythmia requiring medication, defects with chronic hypoxia, single ventricle physiology, heart failure)
* any child within 3 weeks of a respiratory tract infection, an asthma attack, an episode of ACS or of a vaso-occlusive or hemolytic crisis.
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL


Eligibility Criteria:
Inclusion Criteria:

* Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
* Is CD20 positive (by immunohistochemistry or FACS)
* Is Cyclin D positive (by immunohistochemistry or FACS)
* Has received prior chemotherapy (required minimum of 1 prior therapies)
* Has received prior treatment with Rituxan
* Has an ECOG Performance Status (PS) 0-2
* Is greater than or equal to 18 years of age
* Has appropriate laboratory values (please refer to protocol for specific laboratory values)
* If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
* Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
* If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form

Exclusion Criteria:

* Has other lymphomas not classified as MCL
* Has had prior treatment with Gemzar and/or Novantrone
* A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
* Has a history of hypersensitivity to murine-cell derived therapeutics
* Has a LVEF indicative of a cardiac condition (LVEF \< 50%)
* Is receiving concurrent immunotherapy
* Has evidence of CNS involvement
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
* Is a pregnant or nursing woman
* Is unable to comply with requirements of study
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.

High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a

Eligibility Criteria:
Inclusion Criteria

* ALL high risk or low risk or lymphoblastic lymphoma
* age 15-55 years old
* informed consent signed

Exclusion Criteria:

* patients previously treated with a chemotherapy or alpha-interferon
* ALL 3 (burkitt like)
A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

To evaluate the efficacy and safety of KPS-0373 in patients with SCD.


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.


Eligibility Criteria:
Inclusion Criteria:

A. Subjects who are asymptomatic and scheduled to undergo routine screening mammography

OR

B. Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities

AND

C. Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D)

Exclusion Criteria:

1. Male by birth.
2. Individual is less than 30 and greater than 70 years old.
3. Contraindication to bilateral mammography or MRI
4. Subjects who are unable to read, understand and execute the informed consent procedure.
5. Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
6. Subjects who have significant existing breast trauma.
7. Subjects who have undergone lumpectomy/mastectomy.
8. Subjects who have undergone breast reduction or breast augmentation.
9. Subjects who have undergone any other type of breast surgery, excluding surgical biopsy.
10. Subjects who have large breast scar / Breast deformation
11. Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6 month period prior to their intended enrollment into the study.
12. Subjects who have a temperature \> 100° F (37.8C) degrees on the day of the MIRA imaging
13. Subjects who are pregnant or lactating
14. Subjects with known Raynaud's Disease
15. Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
16. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices
17. Subject with kidney failure
18. Subject with known allergy to gadolinium
19. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
20. Inmates (45 CFR 46.306) or mentally disabled individuals
21. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy)
22. Subjects currently participating in another investigational clinical study
23. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
Assessment of KAN-101 in Celiac Disease (ACeD)

A safety study of KAN-101 in patients with celiac disease. The study has two parts:

1. Part A - first in human study in which patients receive a single dose of KAN-101
2. Part B - patients will receive three doses of either KAN-101 or placebo

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).

An overview of the two parts and proposed dose groups is given below:

1. Part A (SAD): Patients will receive a single dose of KAN-101.
2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Eligibility Criteria:
Key Inclusion Criteria:

1. Adults aged 18 to 70 years inclusive
2. Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
3. Has HLA-DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygotes or heterozygotes)
4. Has followed a GFD for \> 12 months immediately prior to study entry
5. Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
6. Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
7. Capable of understanding and complying with protocol requirements
8. Patient understands and has signed the informed consent form

Key Exclusion Criteria:

1. Refractory celiac disease
2. Selective IgA deficiency
3. Positive for HLA-DQ8 (DQA1\*03, DQB1\*0302)
4. Previous treatment with tolerance-inducing therapies for celiac disease
5. Known wheat allergy
6. Part B only: History of hyperacute or prolonged symptoms following gluten exposure
7. Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
8. History of dermatitis herpetiformis
9. Pregnant or breastfeeding
Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias.

Specifically the investigational questions are:

1. Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy?
2. Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy?
3. Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy?
4. Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy?
5. Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?

Myocardial deformation parameters of the left heart chambers are of particular clinical importance because of their possible association with the severity of HCM and the presence of arrhythmias. However,current literature appears conflicting.

This is a prospective cohort study aiming to examine the echocardiographic parameters of myocardial deformation, estimated by the "speckle tracking" method, and their correlation with clinical presentation and symptomatology, other imaging parameters, exercise capacity, arrhythmias (ventricular or supraventricular) and risk factors for sudden death in patients with hypertrophic cardiomyopathy.

Although, similar efforts have been made in international literature, they are scarce and their results contradictory. The present study is the first to be performed in a Greek population, a fact that is particularly important given the genetic heterogeneity of the disease.

Eligibility Criteria:
Inclusion Criteria:

-Patients with diagnosed hypertrophic cardiomyopathy

Exclusion Criteria:

* Concomitant severe valvular heart disease
* Prior myocardial infarction
* History of atrial fibrillation
Exploration of Neural Bases in Social Cognition

An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.

Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p\<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p\<0.05).

Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.

Social cognition neural basis. Impairment of the "social brain" in schizophrenia

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 18 to 60 years old
* who have signed a consent and, if there is one, whose legal representant has signed a consent

  1)For healthy subjects:
* without any psychiatric affection (Mini International Neuropsychiatric Interview)

  2)For patients
* meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder

Exclusion Criteria:

* pregnant woman
* neurological affection
* medical objection to Magnetic Resonance Imagery (MRI)
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 2 HCV-infection
* Male or female, age ≥ 20 years
* Body weight ≥ 40 kg
* HCV RNA ≥ 10,000 IU/mL at screening

Exclusion Criteria:

* Current or prior history of clinically significant illness other than HCV
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China

The primary objective of this study is to estimate the distributions of HCV viral/human genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the time the study is conducted.

A sample of 1000 Han ethnic Chinese male or female who are ≥ 18 years old with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study is to estimate the distributions of HCV Viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (ITPA) gene, and IL28B. This study also collects other data including patients' demographic and clinical characteristics. There is no active antiviral treatments and no follow-up in this study.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* Han ethnic
* ≥ 18 years old
* recent confirmation of anti-HCV-antibody positive and HCV RNA positive 30 days prior to the recruitment
* antiviral or interferon treatment naive

Exclusion Criteria:

* \< 18 years old
* not Han ethnic
* treated by antiviral before this study
CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areata,receiving routine care from dermatology providers. Visit schedules for patients will be determined by the provider in accordance with routine clinical care, and any prescriptions provided to patients will adhere to product availability and local prescribing guidelines/regulations in the country where the participating registry site is located.

The objective of the registry is to create a cohort of adolescent subjects to evaluate the long-term real-world safety and effectiveness of routine clinical care of treatments for severe AA. Data collected through the registry may be used to address a range of research questions and use cases including, but not limited to: better characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of severe AA in adolescents, providing information to support characterization of adolescent growth and development and ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected may be used to generate real world evidence to inform clinical decision making by patients and treating providers.

This will be enabled through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this registry, an individual must meet all the following criteria:

1. Has ever been diagnosed with severe AA by a dermatologist or a qualified dermatology provider.
2. Is 12-17 years of age at the time of enrollment.
3. Is willing to provide consent/assent for participation in the registry.
4. Has been prescribed a new commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents in the context of routine clinical care that is consistent with local prescribing guidelines and/or regulations for the country where the site is located.

A new therapy is a medication that the subject has never taken before.

1. At the time of registry enrollment OR
2. Within 6 months prior to registry enrollment In the opinion of the treating provider, is deemed a candidate for treatment with a commercially available advanced therapy and/or conventional systemic therapy for the treatment of severe AA in adolescents but has not received nor is planning to initiate treatment at the time of registry enrollment.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

1. Is participating or planning to participate in a blinded clinical trial for any investigational medication.
2. Is unwilling or unable to provide standing height measurements.