cyrilzakka/clinical-trials huggingface dataset:
Prediction of SSRI Treatment in Major Depression.

This project will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. The purpose of this research is to predict the success of the SSRI treatment and to categorize patients into sub-groups according to similar patterns of brain activation to personalize treatment.

Major depression is a mood disorder affecting 350 million people worldwide. The disorder is characterized by depressed mood, anhedonia, decreased quality of life, deficits in cognitive functions and even suicide thoughts. Treatment of depression is often a long process and includes taking different types and quantities of medications. Therefore, there is a need to predict the success of the SSRI treatment. Our research will examine the outcomes of the combined technologies: BNA (EEG), Eye-tracker, structural and functional MRI scans and neuropsychology tasks in patients with depression while receiving SSRI treatment. The purpose of the research is to track biomarkers and other measures, which will allow predicting the SSRI treatment's success within 4 weeks instead of 8 weeks. In addition, the investigators will attempt to categorize patients into different subgroups according to their brain activation and eye movements. This division into subgroups may contribute to the understanding of the mechanisms that account for the responsiveness to SSRI treatment and to the possibility of targeting patients with depression towards a particular treatment. From this research, the investigators aim to personalize the treatment of depression, make it more efficient and reduce the amount of time for the patient to reach an optimal responsiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18-65 years old
2. Male and female
3. Ability to comprehend and sign informed consent
4. DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)

Inclusion Criteria for patients with depression:

1. DSM-5 diagnosis
2. 0-2 failed treatments
3. Patients which will start SSRI treatment

Exclusion Criteria:

1. unconsciousness
2. Pregnancy or nursing
3. Cardiovascular instability
4. Metabolic instability (water, electrolytes, sugar)
5. Fever or evidence of microbiological pollutant
6. Deafness or blindness
7. Schizophrenia
8. Addiction disorders
9. Eating disorders
10. Bi-polar disorder
11. Cognitive deficits
12. Start a new psychotherapy during the research
13. Unable to enter the MRI scanner
Pulmonary Rehabilitation, Dyspnoea and Emotional Cognition in COPD

To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

The aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea emotional component and on emotional cognition. It will add a better understanding of the mechanisms of pulmonary rehabilitation on dyspnoea.

Patients with COPD will be included before starting a pulmonary rehabilitation and be evaluated with questionnaires (including the Multidimensional Dyspnea Profile, and quality of life questionnaires), emotional cognition (at rest and right after an endurance test, using some short movies sequences and pictures of faces expressing some well defined emotions) and smile production analysis.

After having followed a pulmonary rehabilitation, the same evaluation will be realised and results will be compared before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France.
* Age of 40 at least.

Exclusion Criteria:

* Facial paralysis
* Neuromuscular disease
* Contraindication for pulmonary rehabilitation
* Severe depression syndrom or psychiatric disease
* Drug use
* Impaired vision
* Higher functions disorders (Mini Mental Score Examination \< 26)
* Severe obesity (BMI\>40kg/m²)
Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation

The patients affected by severe chronic respiratory failure can develop hypercapnic decompensation leading to coma and death in a few hours. At present, the main treatment is noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation impossibility, invasive mechanical ventilation is proposed to patients, which is an aggressive therapy. Regularly, the patients undergo this aggressive therapy without having expressed their opinion. Indeed, a great majority of these patients with severe respiratory insufficiency did not anticipate directives in case of respiratory decompensation (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still uncertain but certainly alters quality of life (discomfort, loss of autonomy...). After complete, clear, loyal and adapted information, a majority of patient do not wish to go on these aggressive therapies. At the time of the decompensation, the patients are incapable to express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover device, such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the patient to improve his state of consciousness and so to find the conditions of spontaneous ventilation required for the noninvasive ventilation. The DECAP CO2 device can be used to stop quickly the hypercapnic narcosis and to collect the wills of the patient on the choice of possible aggressive therapies. It is in this last condition that we wish to estimate the DECAP CO2 device.

After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study:

* Noninvasive ventilation alone
* Noninvasive ventilation associated with the DECAP CO2 device

Eligibility Criteria:
Inclusion Criteria:

Adult patient suffering from severe chronic respiratory failure

* Chronic obstructive pulmonary disease : stage III
* Hypercapnic respiratory decomposition
* No anticipated directive with the treating physician, pulmonologist or his family.
* Challenged for invasive ventilation by critical care doctor, emergency doctor or pulmonologist ; due to the respiratory pathology severity or other (age, comorbidity)
* Not challenged for a noninvasive ventilation
* Failure of the noninvasive ventilation in intensive care unit (pH decrease due to hypercapnia after 2 hours of noninvasive ventilation

Obtaining of the consent of the patient or the reliable person or the close relation

Exclusion Criteria:

* - Patients who made anticipated directives (decision of the patient to have no tracheotomy, intubation, noninvasive ventilation)
* Contraindication to heparin (active bleeding, Heparin-induced thrombocytopenia)
* Patients \< 18 years and \> 90 years
* Patients already included in another therapeutic trial
* Pregnant woman or breast feeding
* Legal incapacity
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
* At least one lesion that can be accurately measured in at least one dimension;
* Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
* Age 18 and older;
* ECOG performance status 0-2;
* Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
* Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
* Any other investigational agents;
* Known brain metastases;
* Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
* Pregnancy.
Evaluating the Impact of Personalized Move Goals on Physical Activity

The purpose of this study is to evaluate the impact of personalized move goals in the Welltory mobile app on daily step count among adults from 30 to 65 years old. The study also aims to assess how personalized move goals impact workout quality and frequency.

The Welltory app sends users messages with move goals to help people move smarter. Adapted daily based on each user's historical data and overall wellbeing, Welltory's move goals gradually increase physical activity levels, motivating sedentary people to move more without demanding drastic lifestyle changes.

This randomized controlled study will assess if messages with personalized move goals in the Welltory mobile app help increase physical activity among adults.

Participants include individuals aged 30-65 who use iPhones, wear an Apple Watch, and lead sedentary lifestyles (their median daily step count does not exceed 6,000). Participants are selected among active Wellotry mobile app users who had previously not received any messages with move goals.

All participants are randomly assigned to 3 groups:

* Participants in group 1 receive daily messages with personalized move goals in the Welltory mobile app. Personalized move goals are computed based on each participant's historical physical activity data and their daily wellbeing.
* Participants in group 2 receive daily messages with a static move goal of 10,000 steps per day in the Welltory mobile app.
* Participants in group 3 use the Welltory mobile app but don't receive any messages with move goals.

For all participants, steps and workouts are automatically registered by their Apple Watch wearable devices and the Welltory mobile app. Additionally, participants regularly measure their body weight and manually record it in the Welltory mobile app.

This study's duration spans a total of 24 weeks for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Using an iPhone smartphone
* Using an Apple Watch
* Willing to use the Welltory app every day for 6 months
* Median daily step count is less than 6,000 in the month before the beginning of this study

Exclusion Criteria:

* Already participating in another physical activity study
* Known medical conditions or physical problems that require special attention in an exercise program
* Pregnant/gave birth in the past 6 month
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 to 85 years, inclusive
2. Serum potassium value 5.1 to \<6.5 mmol/L
3. Chronic kidney disease with eGFR ≥20 to \<60 mL/min/1.73m2
4. Able to understand and comply with the protocol
5. Willing and able to sign informed consent

Exclusion Criteria:

1. Pseudo-hyperkalemia signs and symptoms
2. Treatment with potassium-lowering drugs within 7 days prior to enrollment/randomization
3. Treatment with glucocorticoids
4. Uncontrolled Type 2 diabetes, defined as most recent historical HbA1c \> 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
5. Diabetic ketoacidosis
6. Severe heart failure, defined as NYHA (New York Heart Association) Class IV or hospitalization to treat heart failure in previous 3 months
7. History of bowel obstruction, severe gastrointestinal disorders, or major gastrointestinal surgery (e.g., large bowel resection)
8. Females who are pregnant, lactating, or not willing to use appropriate contraception
Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment

The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.

Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?

Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS.


Eligibility Criteria:
Inclusion Criteria:

* 1. over 18 years old
* 2. Ultrasound-confirmed pregnancy
* 3. infected (past or present) or non-infected with Covid19

Exclusion Criteria:

* 1. presents alcohol abuse during pregnancy
* 2. other concomitant causes of risk of demonstrated neurodevelopmental disorders
* 3. presents drug abuse except tobacco during pregnancy
* 4. under 18 years of age
An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy

One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose.

Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly. Effective treatment is strongly expected in such relapsed patients in Japan. This is a open label multiple center study to evaluate the effectiveness and safety of bortezomib. This study is an extension or re-treatment study for patients who were administered with bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the previous study will be administered into a vein as a bolus twice weekly followed by a 10-day rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study will be administered in 3-week cycle.

Eligibility Criteria:
Inclusion Criteria:

* Complete 6 cycles treatment in preceding phase I/II study
* response (CR, PR, MR or NC) was obtained in 6 cycles treatment during the preceding phase I/II study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
* Patients who did not have Grade \>=3 non-hematologic toxicity or Grade 4 hematologic toxicity during the preceding phase I/II study or extension treatment of this study
* Investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.

Exclusion Criteria:

* Patient is known to be HBs antigen positive, HCV antibody positive or HIV antibody positive (check is required for patients who received blood product during phase I/II study)
* Patients who receive G-CSF product or blood transfusion within 7 days before the start of treatment
* Disease progress was observed during the phase I/II or this study when patients receive recommended dose
* Patients who suffer Grade \>=2 peripheral neuropathy or Grade \>=2 neuropathic pain
* Patient has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
Neurofeedback in Patients With Frontal Brain Lesions

In this randomized double-blind controlled study we would like to test the benefit of neurofeedback for the recovery of patients with frontal brain injury during an early stage of neurorehabilitation.

Aim of the study: Patients with a frontal brain lesion often suffer from deficits in brain functions like attention, concentration, planning, impulse control and emotional stability. In this study the investigators would like to test, whether neurofeedback as a non-medication option can help to improve these cognitive functions. Neurofeedback is a method for optimization and stabilization of the brain activity. The brain continuously gets computer-based information about its state. This information is used by the brain for self-regulation. Because neurofeedback is a process based on learning, the positive effects can be integrated into the daily life and seem to persist also after the training stopped. From the literature, several studies have shown promising results of neurofeedback therapy in patients with brain injuries, but no study so far fulfills the scientific criteria which proves a benefit. Methods: The selection of potential study participants is made by the senior or chief physician. Totally, we include 20 patients with a newly acquired frontal brain lesion. 10 patients receive normal neurofeedback training and 10 patients receive a placebo-neurofeedback in a randomized, double blinded manner. In total, 20 neurofeedback sessions are conducted. At the beginning, after 10 sessions and at the end of the intervention time, a neuropsychological assessment is performed to test the main cognitive functions of the frontal brain. Data analysis: The performance in the neuropsychological testing is the primary outcome. We expect that all participants will gain performance during the course of the study due to natural brain recovery, so that we will focus on the difference of the improvements between the two groups (neurofeedback and placebo-group).

Eligibility Criteria:
Inclusion criteria:

* Middle to severe frontal or frontotemporal brain injury due to accident, bleeding or ischemia, assessed by the Initial Glascow-Coma-Scale from 3 to 12.
* Time between the injury and inclusion into the study should be 1-6 months
* The participants must be able to perform simple neuropsychologic tests including sufficient vigilance and motor function for pressing a button.
* There is no age limitation. The patients who are hospitalized in the REHAB for a initial rehabilitation have a minimum age of 18 years.
* signed consent form

Exclusion criteria:

* therapy-resistant symptomatic epilepsy
* severe cognitive deficits, which do not allow understanding of the required neuropsychological tests, e.g. sensory aphasia.
* preexisting dementia
* progressive cerebral diseases e.g. multiple sclerosis, brain tumor
* schizophrenia
Comparison of the Effect of Two Types of Fixed Retainers on the Health of the Gums

Different types of retainers have been used to assure the stability of orthodontic treatment. The aim of this study is clinical and radiographic comparison and evaluation of two common types of lingual fixed retainers on the health of periodontium.

The participants in this study will be examined both clinically and radiographically just after the completion of orthodontic treatment and after a 6-month-period.

The results of the study will be analyzed with Mann-whitney and independent t-test.


Eligibility Criteria:
Inclusion Criteria:

1. The patient who have completed orthodontic treatment
2. The patients should be healthy with no systemic disease at the time
3. In clinical examination no apparent periodontal disease or inflammation should be present
4. Patients who have complete permanent dentition (3rd molar eruption is not required)
Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.

Study design:

• Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 30 weeks
* 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210)
* Health Assessment Questionnaire (HAQ) evaluation
* Disease Activity Score (DAS28) evaluation
* Clinical Disease Activity Index (CDAI) evaluation
* American College of Rheumatology criteria (ACR) evaluation
* Visual Activity Schedule(VAS) evaluation
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
3. Patients with at least 6 swollen joints
4. Patients with partial response in treatment with methotrexate for 2 months

Exclusion Criteria:

1. Pregnancy and Lactation
2. Patients with uncontrolled hypertension
3. Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
4. Non-steroidal anti-inflammatory drug in the last 4 weeks
5. Any pathology or past medical condition that can interfere with this protocol
6. Patients with immunodeficiency and/or immunosuppressive disease;
7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.