cyrilzakka/clinical-trials huggingface dataset:
Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept

The goal of this clinical trial is to identify reliable markers of apathy in elderly subjects with bipolar disorder, age between 70 and 85 years, in order to accurately identify subjects at high risk of progressing to dementia by measuring motor activity (actimetrics), recorded language and analysing brain changes (MRI).

Actimetry is the measurement and recording of body movements using an actimeter. This device is worn on the wrist and contains sensors capable of measuring and recording all movements, including those of very low intensity. An automated speech analysis using artificial intelligence is used to detect low-intensity anomalies, and we want to test whether individual differences correspond to individual differences in brain anatomy and function.

Researchers will compare elderly subjects with bipolar disorder and healthy volunteer, age between 70 and 85 years.

Participants will be asked to:

* Perform an MRI
* Complete 3 cognitive tests: verbal memory, verbal fluency and an emotional storytelling task, in which you will be asked to describe a memory orally using positive, negative and neutral emotions.
* wear an actimeter on your wrist for 4 days.


Eligibility Criteria:
Inclusion Criteria:

1. Population: Age between 70 and 85 years-old, living at home (Participants living in nursing homes are not included).
2. Condition: OABD type 1, type 2 and type 3 assessed by the DSM5 criteria
3. Stable: no MDE or hypomanic state within the last 6 months
4. Ambulatory setting only
5. General condition: Successful Gait speed test from the Short Physical Performance Battery (SPPB): beingable to walk 4 meters in 4 seconds (SPPB NIH Toolbox)44
6. Person affiliated to a social security regime
7. Patients who have given their free, informed and written consent to take part in the study

Exclusion Criteria:

1. Psychiatric conditions and or co-morbidities

   1. Unipolar depression
   2. Recurrent unipolar depression
   3. Substance use disorder according to DSM5 criteria. Benzodiaepine and/or z-drugs dependence are accepted.
2. Neurological and cerebral co-morbidities

   1. Major Cognitive Disorder: significant cognitive decline characterized by extensive cognitive tests or at least a standardized clinical evaluation AND at least loss of autonomy in complex instrumental daily living function, not related to delirium (DSM5 criteria)
   2. Medical history of known degenerative disorders: Alzheimer's disease, Lobar Degenerative Fronto-temporal disorders, Lewy Body disease, corticobasal degenerative disorder, Supranuclear Palsy, epilepsy.
   3. Medical history of known Parkinson's disease (according to the Movement Disorder Society (MDS)45 criteria)
   4. Medical history of known stroke
   5. Severe Parkinsonism (defined by MDS-Unified Parkinson's Disease Rating Scale46 \> 20)
3. MRI contra-indications: metallic implants, severe claustrophobia
4. Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
5. Hospitalized at inclusion
Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels

Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.

In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
* completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy

Exclusion Criteria:

* Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
* no additional allergen-specific immunotherapy with another product than Pollinex Quattro
Vascular Cognitive Decline and Dementia

The ENIGMA study is a single-centre prospective clinical observational study with the aim to investigate vascular contributions to cognitive decline and dementia. By studying MRI-defined capillary dysfunction and EV profiles, the ENIGMA study links novel imaging and basic research techniques to a clinical cohort of stroke patients. With this study we hope to enhance the understanding of the mechanisms behind post-stroke cognitive decline and dementia.

Post-stroke cognitive impairment (PSCI) is common. However, the underlying pathophysiology remains largely unknown. Understanding how microvascular changes relate to PSCI and finding markers that can predict PSCI, could be a first step towards better screening and management.

Cerebral capillary dysfunction is characterized by limited oxygen extraction from the brain capillaries due to age- and risk factor-related capillary flow heterogeneity. Capillary dysfunction is a pathophysiological feature of cerebral small vessel disease (cSVD) and may play an important role in the vascular mechanisms underlying PSCI. Extracellular vesicles (EVs) carry molecules between cells. EV profiles may change during acute stroke, in the chronic stroke phase, and according to the level of cSVD, and EV profiles may therefore act as disease biomarkers.

The ENIGMA study aims to investigate capillary dysfunction and EV profiles as predictors of cognitive function one year after acute ischemic stroke (AIS) and transient ischemic attack (TIA). Consecutive patients with AIS and TIA are included and followed for one year with follow-up visits at three and 12 months. An MRI is performed at 24 hours and 12 months after admission. EV profiles will be characterised from blood samples drawn at 24 hours and three months after admission. Cognitive function is assessed three and 12 months after AIS and TIA using the Repeatable Battery for the Assessment of Neuropsychological Status and the Montreal Cognitive Assessment (MoCA).

The study has two main objectives: 1) to study associations between capillary dysfunction and PSCI and 2) to assess associations between EV profiles and PSCI.

Eligibility Criteria:
Inclusion Criteria:

* AIS or TIA with a clinically relevant diffusion restriction identified on MRI DWI-sequence on admission
* Admittance within 24 hours from symptom onset
* Age ≥ 60

Exclusion Criteria:

* Dependency in activities of daily living (mRS score \> 2)
* Known dementia, neurodegenerative disease, or other significant brain disease
* Concomitant life-threatening disease
* Contraindications to undergo MRI
* Allergy or intolerance to MRI contrast agents
* eGFR \< 30
* Unable to give written informed consent
* Deemed unfit for follow-up
Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Arthroscopic repair of infra and / or supraspinatus tendon of the rotator cuff with or without associated procedure on the biceps, the acromion-clavicular joint or acromion
* Informed consent

Exclusion Criteria:

* Allergy to local anesthetics (ropivacaine, bupivacaine, xylocaine)
* Previous surgery on the involved shoulder
* Severe or morbid obesity (BMI\> 35)
* Psychiatric disorders (impossible self-assessment of the pain)
* Patient unfit physically, mentally or legally to give informed consent
* Patient refusal
* Pregnant or lactating women
Efficacy of Attachment-based Compassion Therapy in Population With Chronic Medical Illness (CUIDA-TEC)

Compassion-Based Interventions are increasingly relevant as a potentially beneficial way to support people with chronic medical conditions and improve different outcomes related with the management of the disease. Online interventions The purpose of this study is to evaluate the effectiveness of the internet version of the attachment-based compassion therapy for improving quality of life in a population with chronic medical illness.

Our participants will be randomized to one of the following two conditions: 1) the Internet version of the attachment-based compassion therapy, and 2) Waiting list (WL) control group.

The corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, and a three- and six-month follow-up.

This study will use the internet version of attachment-based compassion therapy (iABCT) for improving the quality of life in a population with chronic medical illness.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. ability to understand and read Spanish;
3. access to a computer with the Internet; and
4. fulfill criteria for diagnosis of one of the following chronic medical conditions: diabetes, inflammatory bowel disease, fibromyalgia, low-back chronic pain, migraines, and other conditions.

Exclusion Criteria:

1. Terminal disease;
2. severe psychiatric disorders comorbidities (schizophrenia, substance dependence, bipolar disorder, psychotic illness) or severe neurologic or medical condition; and
3. receiving psychological treatment or mindfulness training at the time of recruitment.
The Changes of ETT Cuff Pressures After Head and Neck Positions Placed for Adenotonsillectomy and Tonsillectomy in Children

The main purpose of this study was to assess the effect of each of position (neck extension by under-shoulder pillow and Crowe-Davis retractor use) during adenoidectomy and adenotonsillectomy on the intracuff pressure of ETTs in children.

The cuff of the endotracheal tube seals the extraluminal airway to facilitate positive-pressure ventilation and reduce subglottic secretion aspiration. As increase or decrease of ETT intracuff pressures can lead to many morbidities. A total of 140 patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation, were included in the study . A standardized general anesthetic was given and cuffed endotracheal tubes by the assistance of video laryngoscope were placed in all patients. The pilot balloon of each endotracheal tube was connected to the pressure transducer and standard invasive pressure monitoring was set to measure intracuff pressure values continuously. The first intracuff pressure value was adjusted to 18.4mmHg (25cm H2O) at supine and neutral neck position. The patients then were given appropriate position for the surgery. These positions were neck extension and placement of mouth gag These positions were neutral position, extension by under-shoulder pillow and placement of the mouth gag. The intracuff pressures were measured and noted after each position, at every 5th minute while the operation and before the extubating. If intracuff pressure deviated from the targeted value of 20-30cm H2O at any time, it was set to 25cm H2O again.

Eligibility Criteria:
Inclusion Criteria:

* Younger than 18 years
* American Society of Anesthesiologists (ASA) physical status I- II
* Elective tonsillectomy/ adenotonsillectomy under general anesthesia

Exclusion Criteria:

* Older than 18 years
* American Society of Anesthesiologists (ASA) physical status \|\>II
* Nasotracheal intubation
* Peroperative tracheotomy requirements
* Respiratory tract infection.
Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia

This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.


Eligibility Criteria:
Inclusion criteria:

* Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
* Require inpatient hospitalization.
* Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.

Exclusion criteria:

* Subject is in their first episode of schizophrenia.
* Subject has other psychotic disorders or bipolar disorder.
* Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
* Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
* Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
* Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
* Subject poses a current serious suicidal or homicidal risk.
* Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
* Subject has recently or is currently participating in another clinical study.
* Subject is stabilized on their current schizophrenia treatment.
* Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
* Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
* Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model

The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.


Eligibility Criteria:
Inclusion Criteria:

* Positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

The accuracy of stress single photon emission computed tomography (SPECT) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress SPECT. These patients will undergo SPECT imaging both with conventional methodology and the GE Hawkeye system. The conventional study will be interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. The primary study hypothesis is that AC will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (MI). Clinical data and noninvasive test results (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to MI (true-positive).


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT

Exclusion criteria:

* Prior PTCA or CABG
* Left bundle branch block (LBBB) or paced ventricular rhythm
* Clinically significant valvular heart disease
* Hypertrophic or idiopathic dilated cardiomyopathy
* Atrial fibrillation or frequent atrial or ventricular ectopy (defined as \>20% ectopic beats
* History of MI
* ECG evidence of MI
* Chest circumference \>55 inches
Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)

Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival.

The present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.

Early intolerance to the newly transplanted lung starts at the time of transplantation and results in PGD driven by an intense inflammatory response. Cytokines play a critical role as signaling molecules that initiate, amplify, and maintain inflammatory responses both locally and systemically. The use of cytokine filtration devices to target middle- and low-molecular weight molecules has been shown to reduce levels of a diverse number of cytokines. These results have been demonstrated in the in vitro reduction of pathogen-associated molecular pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine adsorption has been used successfully in clinical applications to both heart and kidney transplantation.

The present study is a randomized controlled study which aims to collect preliminary data on the efficacy of a medical device through the comparison of patients undergoing LTx with and without cytokine adsorption.

Eligibility Criteria:
Inclusion Criteria:

• Eligibility to undergo double lung transplantation at either trial site

Exclusion Criteria:

1. Age \<18 years
2. Previous organ transplantation
3. Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:

   1. Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.
   2. Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.
4. Non-consent
Assessing Psychotherapy Outcome With Feedback

This study is a comparison of client outcomes in two different types of psychotherapy treatment. In one condition clients will receive treatment-as-usual (TAU); the therapy that they would normally receive. In the other condition clients will receive treatment-as-usual but in addition their therapist will have access to empirical feedback on client progress. Clients in the feedback condition will fill out weekly online questionnaires, and their therapists will have access to a website that feeds back the results of these questionnaires. The purpose of the study is to understand the impact of providing such feedback to therapists. Participating therapists at 4 sites will offer all of their clients the opportunity to participate, and participating clients will be randomly assigned to either condition. This should result in a representative sample of client seeking treatment at these 4 Chicago-area clinics.


Eligibility Criteria:
Inclusion Criteria:

* Client seeks therapy at one of the 4 participating sites
* For Individual therapy: client must consent and complete pre-test battery before the first therapy session
* For couple therapy: both clients must consent and complete pre-test battery before the first therapy session
* For family therapy: at least one client must consent and complete pre-test battery before the first therapy session
* Clients must be 12 years of age or older
* Clients must be able to read (English or Spanish) at a 6th grade level

Exclusion Criteria:

* Clients under 12 years of age
* Clients incapable of reading at a 6th grade level
* Clients who are blind, or are have sufficiently impaired sight as to be unable to read the questions on the web portal