cyrilzakka/clinical-trials huggingface dataset:
Cognitive Reappraisal in Adolescents With Major Depression

Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). CR is a particularly effective emotion regulation strategy that aims at reinterpreting emotional events to modify affective responses. Adolescents with MD apply this strategy less often than their healthy peers and show disturbances in brain activation patterns underlying CR.

In this study, MD adolescents will be randomly assigned to a group that receives a task-based training in CR or to a control training group. It will be examined whether the task-based CR training is superior to the control training with regard to improvements in negative affect, perceived stress in daily life and depressive symptoms. Moreover, during the four training sessions, the event-related potential "Late Positive Potential" (LPP) will be recorded to assess neurophysiological indices of CR processes and gaze fixations on emotional areas within negative pictures and affective responses to pictures will be collected to identify mechanisms underlying training effects.This study will provide first evidence for the efficacy of a short-time training that has previously shown to be effective in healthy individuals. Moreover, the study will identify neurobiological mechanisms that predict training effects. The results of this investigation will lay the ground for a clinical trial to investigate whether a CR training added to an established intervention improves treatment effects for adolescent MD.


Eligibility Criteria:
Inclusion Criteria:

* Female and male participants
* age range: 12-18 years
* current diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
* intelligence quotient (IQ) of ≥ 80

Exclusion Criteria:

* neurological disorders
* schizophrenic disorder
* pervasive developmental disorder
* bipolar disorder
* borderline personality disorder
* substance dependence disorder
* gender dysphoria.

Participants comorbid with psychiatric comorbidities other than those listed above are included if MD is the primary diagnosis.
State Dependence of Prefrontal Transcranial Magnetic Stimulation

The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The study will measure change in brain function with EEG.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65,
* healthy controls

Exclusion Criteria:

* Diagnosed psychiatric disorder
* Potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
* Potential contraindication to TMS (as identified by the TMS safety screener)
* Any previous adverse reaction to TMS or MRI
* Diagnosed epilepsy or previously experienced a seizure
* Diagnosed neurological condition, such as stroke or tinnitus
* Experienced a head trauma that was diagnosed as concussion
* Current use of, or recent withdrawal from, medications that can increase the risk of seizure
* Currently pregnant
* Any metal in the head (excluding mouth)
* Any implanted medical device
Non Invasive Detection of Lung and Breast Cancer by Odor Signature

The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology enables a high level of sensitivity and provides users with a quick lab response and a simple yes or no answer.

The aim of this study is to contribute and detect the patient at the earliest possible stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a promising approach towards future possible lung and breast cancer screening method.

Early detection of cancer can dramatically improve the survival chances. to date, there is no efficient diagnostic tool for detection of lung cancer in early stages. Regarding breast cancer, the common screening tool us mammography, which suffer from low sensitivity and high false positive. Thus, there is an urgent need for developing a screening tool for early stages lung and breast cancer.

The sense of smell depends on the ability of specialized sensory cells of the nose to perceive volatile compounds (VOCs). Diseases such as infections and malignancies can be associated with changes in host metabolism, accompanied by production of different VOCs, and thus a different odor. Several studies have shown that different cancers secrete different VOCs, thus produce different smell.

We have developed a system which uses biosensors that can scent the VOCs that lung and breast cancer cell produce, thus distinguish between healthy control and lung or breast cancer. These biosensors can detect low stages lung and breast cancer.

Patients will supply urine samples and exhaled breath samples using a kit that we will supply. The samples will be shipped to our lab, where they will be processed and the VOCs will be separated from the head space of the samples. The biosensors will be exposed to the VOCs samples and will report whether the specific sample id cancerous (lung or breast) or not.

The Data will be collected from all samples and statistical analysis will be calculated, in order to test the specificity and sensitivity of our biosensors to detect cancerous samples.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Lung Cancer patients
* Diagnosed Breast Cancer patients

Exclusion Criteria:

* Cancer patients who were treated using chemotherapy
* Cancer patients who were treated using radiation
* Cancer patients who were treated using biological treatments
* Cancer patients who were treated with chemotherapy
* Cancer patients who were treated with any anti- cancer therapies
* Cancer patients who use drugs that affect the immune system
Improving Pulmonary Hypertension Screening by Echocardiography

This study aims to assess the application of the novel IMPULSE algorithm for the detection of pulmonary hypertension (PH) in those with a low or intermediate probability of PH according to the British Society of Echocardiography (ESC) and European Society of Cardiology (ESC) guidelines.

This is a prospective, multi-centre cross-sectional study with a planned 18 month longitudinal component.

Participants will be recruited from patients referred for the first time for transthoracic echocardiography at the Royal United Hospitals Bath National Health Service (NHS) Foundation Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals, Royal Papworth Hospital, and Golden Jubilee Hospital.

The investigators will prospectively recruit patients without a diagnosis of Pulmonary Hypertension.

Transthoracic echocardiographic (TTE) imaging will be performed in line with British Society of Echocardiography minimum dataset guidelines, and comprehensive right heart echocardiographic imaging and analysis will be performed following the British Society of Echocardiography recommendations for assessing right heart function, in addition to the IMPULSE algorithm;

A right ventricular free wall longitudinal strain value of less than -23%, or, right ventricular fractional area change (FAC) less than 35% in females/30% in males, in addition to a right ventricular isovolumetric relaxation time in excess of 73ms in patients with low/Intermediate probability of PH by current guidelines would categorise that patient as being IMPULSE positive.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained breathlessness
* Risk factors for Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH)
* Unexplained elevation of B-type natriuretic peptide (BNP/proBNP)
* Referred for catheterisation.

Exclusion Criteria:

* ESC / BSE echo high probability of PH
* Known or suspected congenital heart disease
* Patients unlikely to benefit from management of PH or its underlying causes.
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.


Eligibility Criteria:
Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip
Effects of Gastric Bypass Surgery on Bile Acid Homeostasis

The purpose of this study is to determine whether the bile acid circulation is changed after gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences how the bile acid and food is mixed in the gut and how this is associated with the changes in gut hormone release after the surgery.

Our hypothesis is that bile acid reabsorption from the gut is increased as animal models suggest so and bile acid blood concentration increases after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 65 years
* For patients: uncomplicated Roux-en-Y Gastric Bypass surgery more than 12 months before study initiation
* For controls: Age, BMI and gender matched with patient group

Exclusion Criteria:

* Previous removal of gall bladder or other abdominal surgeries except appendectomy (and gastric bypass surgery for patient group)
* Known liver disease or thyroid disease requiring antithyroid medication
* Chronic gastrointestinal symptoms
* Any chronic disease interfering with, or susceptive of interfering with appetite or gastrointestinal function
* Any medication interfering with, or susceptive of interfering with appetite or gastrointestinal function
* Smoking within the last month
* Alcohol consumption above 168 grams per week
* Currently pregnant or breast-feeding
* Anaemia with haemoglobin \<6,5 mmol/L (\<117 mg/dl)
* Loss or gain of more than 3 kg within the last 3 months
Circulating Cytokines as Predictors of Radiation Induced Pulmonary Toxicity

This study is being conducted by the University of Rochester Cancer Center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.


Eligibility Criteria:
Inclusion Criteria:

Patients receiving radiation therapy for lung cancer combined with surgery either pre or post RT to the chest for lung cancer not associated with atelectasis, pleural effusion.

Patients receiving HDR Brachytherapy for lung cancer.

Patients receiving concomitant radiation and interferon therapy for lung cancer.

Patients receiving concomitant chemotherapy and radiation for lung cancer. Prior drug therapy does not make patients ineligible.

Karnofsky ≥ 70 %.

There are no age restrictions.

Acceptable bone marrow function - WBC 2 3000/mm3, platelet count \> 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl.

Life expectancy \> 6 months.

Patients must sign informed consent meeting all federal and institutional guidelines.

Exclusion Criteria:

Patients not meeting eligibility criteria stated above
Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis

Dendritic cells (DC) paly a key role in the induction and chronicity of psoriasis by capturing the antigenes and activating the T cell repsonse. This activation requires their migration from the cutaneous sensitisation site to the lymph nodes. This migration requires an important intracellular metabolic activity, with a strong involvmenet of glucdic metabolism. This activity is linked with the systemic activity. This study aims to compare the migration and the phenotypic and metabolic caracteristics of blood and skin DCs in patients with or without psoriasis and with or without type 2 diabetes,


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* hospitalized in the Dermatology department of the CHU of Nice for moderate to severe psoriasis (defined by a PASI \> or = 10)
* covered by a social security scheme after obtaining a free
* Clinical diagnosis of plaque psoriasis by a dermatologist with or without type 2 diabetes (defined by glycated hemoglobin \>7%)
* For the control group: without psoriasis or other inflammatory dermatosis aged in the presence or not of type 2 diabetes (glycated hemoglobin \>7%).
* free and informed consent

Exclusion Criteria:

* Minor or incapable or unwilling to consent freely or in an informed manner Pregnant or nursing woman.
* Patient in a period of exclusion from other biomedical research
* Patient with generalized chronic inflammatory disease or other inflammatory dermatosis
* Patients on general corticosteroid, immunomodulator or immunosuppressant therapy in the month prior to local inclusion or treatment with corticosteroid therapy in the 15 days prior to inclusion, on anti- treatmentIL-23 or anti IL12/23 for less than 3 months or under anti-IL-17 or anti-TNF treatment for less than 1 month.
* Contraindication to cutaneous biospsis (known hemostasis disorder, taking anticoagulants, allergy to xylocaine, history of cheloid scars, congenital immune deficiency)
LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward

The purpose of this study is to document how often and how severe are the breathing difficulties that patients suffer, while recovering on a general ward following a serious operation

This is a prospective, 2-center, 2-phase pilot study of post-surgical adult patients on the hospital ward at high risk of developing respiratory and cardiovascular events. Phase I, 70 patients will be 1:1 randomly allocated to Capnostream 20p monitoring system or to PM1000N-RR pulse oximeter monitoring system and the alarms of both devices will be silenced and the screen information blinded, to establish a baseline for the incidence of respiratory events. Phase II, 140 patients will be 1:1 randomly allocated to Capnostream 20p or to PM1000N-RR monitoring but the screen information will be visible at the bedside and through the Vital Sync™ remote patient monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* Non-cardiac post-surgical patients at high risk of developing respiratory and cardiovascular events (High or intermediate risk for postoperative pulmonary complications).
* Adult age (≥18 year old).
* Patient is able and willing to give informed consent.

Exclusion Criteria:

* Expected ward length of stay ≤24 hours.
* Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
* Ventilated or intubated patients.
* Patient is unwilling or unable to comply fully with study procedures due to any disease condition which can raise doubt about compliance
* Patient is a member of a vulnerable population regardless of authorized representative support.
* Patient is participating in another potentially confounding drug or device clinical study.
Effect of tDCS on Brain Organization and Motor Recovery

Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome.

Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated.

The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* ≤ 4 weeks after stroke onset
* Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
* Capable of participating during treatment sessions of 30-60 minutes
* Informed consent obtained

Exclusion Criteria:

* Incapacity to understand study information or task instructions during trial.
* New additional stroke during rehabilitation
* Reduced vigilance or delirium
* Severe language deficits
* Preexisting affection of an upper limb
* Severe spasticity or dystonia
* Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
* Pregnancy
* Pacemaker
* Skull breach
* History of seizures or epilepsy
* Metallic object in the brain
* Other contraindication to non-invasive brain stimulation
A Method to Determine the Size of Laryngeal Mask Airway (LMA)

After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I/II
* scheduled for genitourinary operation
* LMA was indicated for anesthesia

Exclusion Criteria:

* surgery lasting more than 3 h
* overweight or underweight patients
* gastroesophageal reflux
* risk of aspiration
* airway infection in the last six weeks
* decreased pulmonary or chest wall compliance.
Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome

The objective of this study is to determine if nerve glide exercises in patients with cubital tunnel syndrome can improve pain, paraesthesias and reduce the need for future surgery. Cubital tunnel syndrome is a common form of peripheral neuropathy caused by compression of the ulnar nerve at the elbow. Surgical intervention is typically reserved for those with severe symptoms, but many cases can be treated with non-operative measures. This study will look at the efficacy of nerve glide exercises in the management of cubital tunnel syndrome. 70 subjects with cubital tunnel syndrome will be enrolled and randomized into groups receiving either standard conservative measures or standard measures in addition to nerve glide exercises. Outcomes will be measured 6 months after initiation of treatment with questionnaires on clinical symptoms and function to see if there is a difference between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cubital tunnel syndrome on physical exam

Exclusion Criteria:

* Patients with diagnosed or self-reported cognitive dysfunction
* Patients who are unable to understand or follow commands
* Any patient that the investigators feel unsafe or cannot comply with all study related procedures
* Patients who had previous ulnar nerve release at the elbow
* Patients with documented cervical spine pathology
* Patients with clinical signs of other nerve pathology
* Patients with palpable subluxation of the ulnar nerve at the elbow
Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.

The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Primiparous women.
* Birth after 22 weeks and neonatal weight \> 501g.

Exclusion Criteria:

* Multiparity.
* Birth before 22 weeks or neonatal weight \< 500g.
Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Primary Objective:

- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine

Secondary Objectives:

* To assess the non inferiority on the same way as the main criteria:
* at Day 28 before corrected cure rate
* at Day 14 and Day 42 before and after corrected cure rate
* To compare the two groups of treatment in terms of:
* Efficacy:

  * Proportion of aparasitaemic patients at 24, 48 an 72 hours
  * Proportion of afebrile patients at 24, 48 and 72 hours
  * Percentage of gametocyte carriers during follow-up
  * Evolution of the mean of gametocytes during the 42 days of follow-up
  * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
* Clinical and biological tolerability:

  * Proportion of any adverse event
  * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
  * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

Each patient will be followed for a period of 42 days

Eligibility Criteria:
Inclusion criteria:

* Adults and children over 6 months old and bodyweight \> 5 kg
* Able to be treated by oral route
* Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
* Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
* Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.

Exclusion criteria:

* Known project of leaving the investigator site area during the follow-up period (42 days)
* Hypersensitivity to one of the investigational medicinal products or to any of the excipients
* Intake of an antimalarial treatment in the previous 30 days
* History of hepatic and (or) haematological impairment during treatment with amodiaquine
* Blurred vision suggesting a retinopathy
* Presence of at least one danger sign of malaria
* Pregnant or breast-feeding women
* Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study
* Known severe concomitant or underlying disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.