cyrilzakka/clinical-trials huggingface dataset:
Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.

The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years old
* AML according to the World Health Organization (WHO) criteria (% of blasts ≥ 20% in bone marrow aspiration).
* All FAB subtypes.
* Any type of AML (de novo or secondary)
* All participants to clinical trials gave their written informed consent

Exclusion Criteria:

* Have an Eastern Cooperative Oncology Group (ECOG) score ≥2
* Active uncontrolled infection
Mechanism of Action of Transcranial Magnetic Stimulation

This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.

This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages of 18-80
2. DSM-IV diagnosis of Depressive Episode
3. Patients requiring TMS treatment as part of their psychiatric care

Exclusion Criteria:

1. Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
2. Substance use disorder (abuse or dependence) with active use within the last 3 months
3. Severe or unstable medical illness.
4. MRI contraindications as determined by MGH department of radiology.
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program

Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.

This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.

160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 50 years old
* Diagnosis of schizophrenia according to the DSM-IV-TR
* French speaker
* Unchanged psychotropic treatment during month preceding the inclusion
* Patients having given their consent lit to participate in the study
* Patients not having been part of therapeutic education program during six months preceding the inclusion
* Affiliated to the French social security

Exclusion Criteria:

* Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco
* History of neurobiological illness or trauma
* Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)
* Simultaneous participation on another program of cognitive remediation
* The ineffectiveness of neuroleptic treatment
Evaluation of an EEG Based Concussion System

This study will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. The system captures an electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual. The device is not FDA approved, but it is a non-significant risk device. The device is a non-invasive, non-interventional sensor. It will not replace the opinion of the physician in diagnosing a concussion.

This study will test the EEG based concussion system on 200 individuals, Participants will be made up of individuals who are seeking medical consultation at the Play Safe Concussion Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave, New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The doctors who see patients these locations will be involved in conducting this research. In addition to the standard-of-care clinical assessments, participants will also receive an evaluation from the concussion based system.

When a subject experiences a head trauma, the subject will be evaluated for a concussion by both the standard-of-care clinical assessments. The treating physician will provide all necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose and treat each patient and by the new concussion system. The researchers will also collect data from healthy, age-matched controls in order to collect a database of healthy responses to the technology.

To determine how accurate the new concussion system is at detecting concussions, the research team will compare the diagnostic results from the device to the diagnostic results of the doctor's assessments. The goal of this study is to develop a device that can give sound advice as to whether an individual should seek medical attention for a possible concussion following a head injury.


Eligibility Criteria:
Inclusion Criteria:

* Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
* Healthy Individuals with no recent history of head trauma

Exclusion Criteria:

* Known history of epilepsy or any other seizure disorder
* Legally blind
* Reduced capacity to consent if there is not a Legally Authorized Representative (LAR) present
Respiratory Infection Monitoring

This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential respiratory infections.

The advanced, bio-integrated wireless sensor (ADAM) that provides a comprehensive assessment of cardiopulmonary health. The technology employs advanced low-power operation, in-sensor analytics, and cloud integration. The sensor's novel soft mechanics allows for comfortable placement on the suprasternal notch, a location of unique anatomical importance, to collect both core vitals (heart rate, respiratory rate, temperature, and physical activity including sleep quality) and novel respiratory digital biomarkers (cough count, swallowing, throat clearing and respiratory effort). The investigators will deploy this system in a cohort of high-risk patients for respiratory infection in a home setting to predict for respiratory infections prior to clinical deterioration.

The investigators aim to capture data on 122 study subjects over the course of 52 weeks of continuous wear or the investigator's device to thoroughly characterize physiological data and diagnosis of respiratory infections. Data from standard of care appointments, diagnostic testing or imaging, or treatment will be collected from the patient medical record to validate device data.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Outpatient at start of the study
* Established clinical history of COPD
* Previous hospital or ICU admission for pneumonia or COPD
* Active corticosteroid prescription
* Willingness to participate in the study (long term continuous wear of the device)
* Ability to apply and remove devices and use a mobile application

Exclusion Criteria:

* Mental or neurodegenerative disease
* Including a current diagnosis of asthma, respiratory disorders (e.g. active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases); pneumonia or other RTIs not resolved ≤14 days or ≤7 days, respectively, prior to screening
* Skin condition or wound on suprasternal notch.
A Future-oriented Group Training for Suicidal Patients

The main goal of this study is to evaluate the effectiveness of a Future-oriented Group training aimed at reducing suicidality in adults. This will test the effectiveness by studying the effect on suicidal ideation and related outcomes, compared to Treatment As Usual. Participants will also be asked to evaluate the group training. The study is a multicentre randomized controlled trial conducted in out-patient Flemish mental healthcare facilities.


Eligibility Criteria:
Inclusion Criteria:

* Speak Dutch
* Be at least 18 years old
* Have access to internet
* Be suitable for group therapy
* Have mild to severe suicidal thoughts (BSS score of minimum 1)

Exclusion Criteria:

* Conditions expected to severely hinder group participation, comprehension of the training content or adherence
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects

The investigators will conduct a safety and immunogenicity study in health employees as detailed below:

* Examine adverse events of all employees after vaccination using adverse events form
* Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 \& 42 after vaccination (up to 500 people)
* Provide a detailed time course of the immune response to vaccination with a novel influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses in 50 volunteers
* Investigate the long lasting immunity induced by the vaccine
* Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.

Eligibility Criteria:
Inclusion Criteria:

Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study

Exclusion Criteria:

* Persons with a history of anaphylaxis or serious reactions to any vaccine
* Person with known hypersensitivity to any of the vaccine components
* Persons who have had a temperature \>38oC during the previous 72 hours
* Persons who have had an acute respiratory infection during the last 7 days
* Suspected non-compliance
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspiratory pressure.

We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by decrease in tidal volume. This is due to a reduction in respiratory system compliance and increase in airway resistance.

Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration of episodes of hypoxemia when compared to conventional mechanical ventilation during routine clinical conditions and over longer periods of time.

The objective of the study is to evaluate the effects of Volume Guarantee on the duration, severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants who present with frequent hypoxemia episodes in comparison to conventional ventilation over two periods of 24 hours each and under routine clinical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Born at less than 32 weeks of gestational age.
* Requiring mechanical ventilation on a mandatory ventilator rate greater than or equal to 20 per minute and receiving a mean tidal volume of at least 4 ml/kg.
* Presenting with 4 or more episodes of hypoxemia, defined as oxygen saturation less than 75%, in the 8 hours prior to the study.

Exclusion Criteria:

* Major congenital anomalies.
* Hemodynamic instability requiring inotropes within 72 hours prior to the study
* Culture proven sepsis within 72 hours prior to the study.
* Diagnosis of pulmonary interstitial emphysema or pneumothorax within the 72 hours prior to the study.
Mechanisms of Diabetes Control After Weight Loss Surgery

Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.


Eligibility Criteria:
Inclusion Criteria:

* morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.

Exclusion Criteria:

* any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
* diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
* HbA1C \> 8%
Therapeutic Plasma Exchange to Alleviate Hyperinflammatory Condition During Severe Covid-19 Infections

Severe Covid-19 (Coronavirus Disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-IFN (Interferon) auto-antibodies, inducing acute respiratory distress syndrom (ARDS). Therapeutic plasma exchange (TPE) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series.

The study aims to remove cytokines during cytokine storm and anti-IFN auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. To that aim, the study investigates to compare a treatment using TPE plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Hospitalized for COVID-19 confirmed by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) or scanner
* Patients with PaO2/FiO2 between 100 and 200 mmHg requiring non invasive ventilation or high flow oxygen
* At least two biological results suggesting a cytokine storm or hyperinflammatory condition state among : C-reactive protéine (CRP)\>50mg/L, Procalcitonin (PCT)\>1µg/L, Fibrinogen\>5g/L, D-dimer \>1000ng/mL, Ferritin \> 800ng/mL during the last 72 hours.
* Treatment with corticosteroids (at least 2 intakes of dexamethasone 6 mg or equivalent with another form of corticosteroids)
* Patient affiliated to a social security or similar scheme
* Information and written consent from the patient or if not possible from a confident person

Exclusion Criteria:

* Ventilated intubated patients
* Patient with advanced cancer and without curative possibility
* Bacterial or viral (HIV) infection explaining the worsening (the main reason)
* Body Mass Index \> 40
* Impossibility to put a central venous catheter according to investigator's judgement
* Severe hemodynamic instability with mean arterial pressure \< 65 mmHg (whatever the noradrenaline dosage used)
* Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
* Inclusion in another study that could interact with the Covidep study (investigator's judgement)
* Patient under legal protection measure
* Pregnant or breastfeeding women
* In case of allergy to amotosalen (psoralens) or AI-FFP (Amotosalen Inactivated Fresh Frozen Plasma) , use Se-FFP (Secured Fresh Frozen Plasma)
Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.

Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid.

This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock
* NE-dose \> 0.1 microg/kg/min
* CI \> 3.0 l/min/m2

Exclusion Criteria:

* Age \< 18, unable to obtain informed consent from relatives
* Untreated hypertension
* Pregnancy
* Pathology in the rectum or stomach
* Limitation of therapy
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations

To investigate the frequency and clinical significance of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary peritoneal cancer).

In this study, investigators plan to clarify the frequency of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

And investigators will also investigate whether HRD-positive ovarian cancer patients show the clinical characteristics of highly platinum-sensitivity and good prognosis, comparing to HRD-negative ovarian cancer patients.

In addition, it is planned to investigate any association between Progression Free Survival (PFS) / Platinum-Sensitivity and germline mutation in Breast Cancer Susceptibility Gene (BRCA1/2 gene) in ovarian cancer patients who can provide the patients' gBRCA1/2 gene information for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who can approve informed consent and sign it. Patients who show their will to participate in this study and can sign the informed consent forms by themselves.
2. Patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery.
3. Patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens)
4. Patients who are 20 years old and over at the enrollment.
5. Patients with ECOG Performance status (PS): 0-2.

Exclusion Criteria:

1. Patients with active concomitant malignancy\* except breast cancer.

   \*Includes synchronous multiple cancer and metachronous multiple cancer with less than 5 years of disease free survival. However, excludes skin basal cell carcinoma, skin squamous cell carcinoma, and any other curable lesions with local therapy such as carcinoma in situ or intramucosal carcinoma.
2. Patients who are diagnosed as any other acute/chronic, physically/mentally severe diseases and judged by the primary physician as inappropriate to enroll this study because of safety reasons or any influence to study outcomes.
3. Any other cases that are inappropriate to enroll this study, judged by study principal investigator.