cyrilzakka/clinical-trials huggingface dataset:
Disease Progression and Treatment-induced Alterations in Glioblastoma

Summary of scientific evidence and rationale of this project:

Integrative molecular-genetic approaches have provided important insights in the biology of glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity but comprises different molecular subtypes, which are associated with a distinct genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio- and chemotherapy as well as the recent introduction of novel antiangiogenic agents have resulted in increasing survival times and improved quality-of-life of glioblastoma patients. Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma patients is limited, leading in virtually all cases to tumor recurrence and death of the patients.

As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor recurrence (\< 10%), post-therapeutic samples are rare and no systematic, large-scale studies exist, which address post-therapeutic morphological and molecular alterations in glioblastoma tumor tissue. Yet, these data would help to improve the understanding of mechanisms involved in therapy-resistance and tumor progression, to develop new therapeutic approaches and could pave the way for personalized treatment strategies.

Objectives of the project:

The aim of this study is to analyze systematically morphological and molecular changes associated with glioblastoma progression and therapy-resistance in matched pre- and post-therapeutic glioblastoma samples.

The following primary aims will be addressed:

1. Morphological characterisation of changes in a large series of matched glioblastoma tissues pertaining to i. Vascularization and hypoxia-mediated factors ii. Tumor necrosis and chemoradiation-induced necrosis iii. Inflammatory response iv. Tumor cellularity and proliferation v. Tumor cell phenotype after treatment e.g. glial-mesenchymal transition
2. Molecular analyses

   i. Transcriptomic, DNA methylation and genomic profiling will be performed to detect changes in gene expression, methylation and copy number aberrations in post-therapeutic as compared to pre-therapeutic tumor tissue. ii. The relationship between the transcriptomic, DNA methylation and genomic profiles will be analyzed.
3. Exploratory analysis of associations between morphological and molecular changes in a screening set of 30 glioblastoma cases (with available fresh frozen tissues at first and second surgery) and subsequent validation of relevant findings in a larger glioblastoma cohort (150 cases with matched formalin-fixed paraffin-embedded tissues) by appropriate methods including immunohistochemistry, fluorescence-in-situ-hybridization, and sequencing.
4. Special attention will be paid to gender-specific patterns of therapy-related changes and tumor progression.

Eligibility Criteria:
Initial Experience With the AngioVac Venous Drainage Cannula

This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.

Exclusion Criteria:

* Patients treated with the AngioVac venous drainage system outside of those dates.
Modifications of Heart Murmurs and Cardiac Output During Fever

The combination of fever and auscultation of a heart murmur suggests the diagnosis of endocarditis. However, fever itself increases cardiac output and could therefore modify heart sounds. The aim of the FeMur study is to measure the modification of heart sounds during fever.

Heart sounds of 15 hospitalized febrile patients with a heart murmur will be recorded using an electronic stethoscope before and after resolution of fever. The records will be analyzed using a computerized application in order to quantify the intensity of heart murmurs.

Fever is an frequently observed during acute illnesses, particularly infectious diseases. The hemodynamic consequences of fever have been extensively studied. Fever leads to an acceleration of heart rate (approximately 8.5 bpm per degree celsius) and to a moderate drop in blood pressure. Cardiac output increases in the context of heat stress as a result of complex physiological adaptations, including heart rate and systolic function increase while preload and after load decrease.

However, there are no studies on the specific consequences of fever on heart sounds. The question is important since auscultation of a heart murmur in a febrile patient suggests the diagnosis of endocarditis. In endocarditis, the heart murmur, which is present in 85% of cases, is due to the mutilation of heart valves, which requires urgent diagnostic and therapeutic management. Suspicion of endocarditis requires emergency cardiac ultrasonography. However, the proportion of patients with actual endocarditis among patients with heart murmur and fever is low. This could arise from the fact that fever itself may increase or trigger a heart murmur. Indeed, any increase in cardiac output may generate audible turbulence when blood is pumped across a heart valve.

Functional or inorganic murmurs are murmurs triggered by changes in cardiac output or blood viscosity, as opposed to organic murmurs reflecting an anatomical abnormality in the heart. Certain characteristics of the murmur and the context of occurrence can guide the clinical toward one of these two situations, but distinguishing functional from organic murmurs is most often difficult.

The impact of fever on cardiac murmurs has not been experimentally demonstrated. This is the aim of the FeMur study.

For this purpose, heart sounds of 15 patients will be recorded during a febrile ilness and after resolution of fever using an electronic stethoscope and analyzed using a computer application. The average intensity of heart murmurs will be compared between the two periods in order to determine the impact of fever.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized febrile patients (body temperature \> 38.5°C)
* Aged 18 or older
* Agreement to participate to the study

Exclusion Criteria:

* Patients treated with beta-blockers, verapamil, or diltiazem
* Patients with atrial fibrillation
* Pregnancy or breastfeeding
* Patients with severe psychiatric disorder
* Patients with diminished heart sounds
A Two-Session Exposure Treatment and Parent Training for ARFID

This study aims to assess the acceptability, feasibility, and preliminary efficacy of a two-session, virtual parent-training exposure protocol for children ages 5-12 who experience picky eating consistent with an Avoidant-Restrictive Food Intake Disorder (ARFID) diagnosis.

Potential subjects aged 5 to 12 years with picky eating symptoms consistent with an ARFID diagnosis, as determined by the Pica, ARFID, Rumination Disorder Interview, a semi-structured diagnostic interview, will be recruited via social media and local doctor's offices. Eligible subjects will complete informed consent and an intake session. Participants will then be randomized to an immediate treatment group, in which they will begin treatment the following week, or a 4-week waitlist condition, in which they will wait four weeks to begin treatment. All participants will have the opportunity to receive the treatment, ARFID Parent Training Program or "ARFID-PTP." ARFID-PTP was adapted from a seven-session parent-training for extremely picky eating behaviors to examine the efficacy of a two-session, virtual protocol on increasing food intake and decreasing selective eating. The two virtual treatment sessions will include psychoeducation, parent-training skills, and exposure protocol. There will be 5 major assessment time points: intake, end of treatment, 4-weeks post-treatment, 3-months post-treatment, and 6-months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 5-12
* Child meets criteria for ARFID using the Pica, ARFID, Rumination Disorder Interview
* Established care with a primary care provider
* Not engaging in other medication or psychotherapy for ARFID during this treatment trial
* Fluently speak and read English

Exclusion Criteria:

* Child or parent experiencing suicidal thoughts
* Child or parent experiencing psychotic symptoms
* Child has a cognitive functioning disability
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk.

The secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved).

HCM is a genetic disease, usually autosomal dominant, with a prevalence of about 1/500 in the general population. HCM represents a major cause of SCD in the young, and is the first cause of SCD in athletes less than 35 years of age. The only efficient prevention of SCD, apart from exercise restriction, is ICD.

Given this dreadful potential outcome of HCM, the identification of patients that should receive an ICD is of paramount importance. However, the indications for ICD are controversial and very different guidelines are currently available, coming from the American society of Cardiology, the French Haute Autorité de Santé and from the European society of Cardiology. In addition, these guidelines are all based on retrospective studies and have major limitations. The situation faces a critical need of improvement. Thus, this study has been designed with the objective to propose a revision of international recommendations for defibrillator implantation in HCM patients.

This prospective multicenter non-interventional single-arm study is planned to be conducted in 40 sites with a collection of clinical and biological data, carried out as required for the usual management and care of patients. No investigation will be performed specifically for this study except for an additional blood sample collection at baseline during routine outpatient care and annual interview during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions
* Aged ≥ 16 years
* Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention)
* Affiliation to a social security insurance

Exclusion Criteria:

* Specific etiologies such as amyloidosis
* Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
Efficacy Evaluation of a Novel Diagnostic Assay Which is the Basis for Seaforia Diagnostic System

Evaluation of specificity and sensitivity of Seaforia- an vitro diagnostic system for evaluating semen quality.

Quantities assessment of semen quality as defined by:

Semen volume, semen pH, leukocytes concentration, sperm cells concentration, motile sperm cell concentration, total motile sperm cells threshold and sperm cells morphology

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* 20\<Age\<45
* Male

Exclusion Criteria:

None
Effect Tunnel in Oral Medicine

Evaluate whether there are differences in knowledge between practitioners and students regarding the tunnel effect, to validate the benefit of teaching it in oral medicine. Main objective: to evaluate the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels. Secondary objectives: evaluate the nature of the means they propose in order to counter the effects of this cognitive bias.


Eligibility Criteria:
Inclusion Criteria: - Externs in the 6th year, interns and teachers working within the Riquier Institute of Oral Medicine at Nice University Hospital, and private dental surgeons.

Exclusion Criteria: - dental student under 6th year
The Effect of COVID-19 Patients' Serum Phosphate Level on Mortality in ICU

The investigators aimed to investigate the relationship between phosphate level and mortality using the 4C Mortality Score in COVID-19 patients who were followed up in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Participants hospitalized in the intensive care unit diagnosed with COVID-19 will incluse in the study

Exclusion Criteria:

* there is no exclusion criteria
Retrospective Study on Data Aiming to Establish a Prediction Score for Return Home at the Time of Admission to a Multidisciplinary Medical Department (SCORDOM

The goal of this observational study is to define clinical, biological and socio-cultural criteria, from the very first days of hospitalization on the multidisciplinary medicine department, to guide the patient's discharge from hospital (return to home when discharged from hospital).

The data collected will be those contained in the medical records of patients over 60 years of age who were admitted to the multidisciplinary medical department between October 2021 and February 2022 and between October 2022 and February 2023.

This study also aims at developing and validating a predictive score of orientation at the end of hospitalisation.

Participants are patients previously hospitalized. They will be informed about the study by post and will be able to object to the use of his or her data.


Eligibility Criteria:
Inclusion Criteria:

For the development of the score:

1. All patients over 60 years of age admitted to the multidisciplinary medical department in the investigating center between October 2021 and February 2022.
2. Patients for whom data of interest to this study are available in medical records.

For score validation :

1. All patients aged over 60 admitted to the multidisciplinary medicine department of the investigating center between October 2022 and February 2023.
2. Patients for whom data of interest to this study are available in medical records.

Exclusion Criteria:

1. Patients transferred from an intensive care or continuing care unit
2. Patients in palliative care
3. Patients residing in an EHPAD (establishment for the elderly) or nursing home prior to hospitalization
4. Patients without a minimum blood test on admission (blood test less than 48 hours old)
5. Patients whose reason for hospitalization is due to COVID
6. Patients who have objected to the use of their personal data
A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

* Documentation of IDH1R132 mutation of tumor
* ECOG performance status ≤ 2
* Clinically fit for standard of care medication per protocol.

Exclusion Criteria:

* Prior treatment for AML or MDS
* Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
* Acute Promyelocytic Leukemia
* Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply
Carbetocin at Elective Cesarean Delivery Part 4

PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.

The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the investigators study, the investigators are going to compare those two doses of carbetocin to determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective cesarean delivery. This study will be a randomized, double - blind, non inferiority study.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean delivery under spinal anesthesia.
* Written informed consent to participate in this study.
* Term pregnancy

Exclusion Criteria:

* Refusal to give written informed consent.
* Allergy or hypersensitivity to carbetocin or oxytocin.
* Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
* Hepatic, renal, and vascular disease.
Randomized Trial of Parent Training for Young Children With Autism

The purpose of this 24 week study is to determine whether a new Parent Training program is effective in reducing disruptive behaviors in young children with pervasive developmental disorders.

Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD also have behavior problems, including defiance of rules, aggression, and tantrums. The purpose of this study is to evaluate a new Parent Training program designed to decrease these behavior problems and improve daily living skills.

Following confirmation of eligibility, participants will be randomly assigned to receive either Parent Training or a Psychoeducational Program. The Parent Training program involves specific suggestions about how to deal with behavior problems. The Psychoeducational program covers specific issues related to autism and parenting, including an co-occurring medical conditions and treatment options.

Parents will attend up to 13 one-on-one sessions with a trained therapist over a 24-week period. Participation in the study also involves 2 home visits and 6 monthly assessment visits. The purpose of the assessment visits is to evaluate the child's response to treatment. Evaluations will also be conducted at 3 and 6 months after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
* Between ages 3 yrs 0 months and 6 yrs 11 months.
* No planned changes in the intensity of current treatment(s)
* Medication free or on stable medication

Exclusion Criteria:

* Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
* Participation in a structured parent training program in the past 2 years
* Developmental age \< 18 months (IQ \< 35)
Increase Protein Intake in Elderly

The objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home).

Prevalence rates of protein-energy malnutrition in elderly are high. In order to prevent loss of muscle mass and remain physically independent, it is utmost important for elderly to maintain their body protein mass. A sufficient protein supply according to their needs is therefore highly important. Especially for frail elderly, it is not easy to realize an increased protein intake by simply eating more. It is hypothesized that protein enriched food products that fit in a habitual diet (dairy and bread), result in a higher protein intake compared to regular products.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the department of internal medicine of VU university medical center or to the rehabilitation department of "Herstelhotel Dekkerswald"
* signed informed consent
* age of 55 or more
* rehabilitating from a hospital stay with the aim to return back home (rehabilitation home only)
* likely to remain admitted at least 3 weeks (rehabilitation home only).

Exclusion Criteria:

* not speaking Dutch language
* allergy for milk, soy or gluten
* a medical condition that is considered by the treating physician as a contra indication for receiving protein enriched food products
* a diet that does not allow the use of normal bread or dairy products (e.g. fluid diet, strong sodium restricted diet)
* not able to eat or feed themselves
* receiving tube feeding or parenteral nutrition
* suffering from a terminal illness
Rapid Movement Therapy for Stroke Rehabilitation

Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.


Eligibility Criteria:
Inclusion Criteria:

1. have single stroke with onset \>1 year,
2. have unilateral paresis,
3. are 50 years of age or older,
4. able to stand without aid for at least 15min,
5. have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
6. have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)\< 52/56,
7. have a minimum Snellen visual acuity of 20/40 with/without spectacles,
8. have a minimum Mini-Mental-Status-Examination score of 22/30, and
9. have to be able to follow the training procedures.

Exclusion Criteria:

1. enrolled in other rehabilitation program in the study duration,
2. have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
3. have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure \>160mmHg/100mmHg), or
4. have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.