cyrilzakka/clinical-trials huggingface dataset:
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults

Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.

Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor
* From 3 to 40 years
* Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal.

Exclusion Criteria:

* Toxicity or liver, medullar, renal insufficiency that advise against participation
* Pregnant or breast feeding women
* Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma
* Immunosuppressive treatment
* Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection
A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss

The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.


Eligibility Criteria:
Inclusion Criteria:

1. 19 Years and older
2. Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
3. Participants who are willing to undergo the treatment of dorsal hand to correct volume loss

Exclusion Criteria:

1. Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
2. Active inflammation or infection on the dorsal hands
3. Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
4. Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization)
5. Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
6. Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization)
7. Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)
Developmental Origins of Attention Deficit Hyperactivity Disorder

This is a study evaluating the relationship between prenatal nutrition and neural development in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd trimester of pregnancy will have infants with more advanced neural development as compared to infants born to mothers receiving standard-of-care treatment.

Pregnant women with ADHD will be recruited from the patient population at Oregon Health \& Science University (OHSU). They will be recruited during their 1st or 2nd trimester. After consent, baseline measures will be collected including height, weight, body composition measurements using calipers, 24-hour dietary recalls, and blood and urine samples. Women will also complete questionnaires regarding ADHD symptoms, stress, depression, and lifestyle. Women will be given a one-week food diary to fill out at home, which will be mailed in upon completion. Upon receipt of the food diary, women will be randomized into either a nutrition intervention group or a standard-of-care group. Women who are randomized to the intervention group will receive individual nutritional counseling every 2 weeks during their 3rd trimester of pregnancy. Before delivery, the baseline measures described above will again be collected. At delivery, placenta and cord blood samples will be taken. After birth, the infant will undergo an MRI between 2 and 5 weeks of age. The scan is completed while the baby sleeps, and special ear protection is worn to limit sleep disruption from the noise of the MRI. When the infant is 3 months old, mothers will complete questionnaires about infant feeding, sleep and behavior.

Eligibility Criteria:
Inclusion Criteria:

* Women in general good health
* 18 years of age or older
* Confirmed pregnancy and currently between 8 and 24 weeks pregnant
* With symptoms of inattention or impulsivity

Exclusion Criteria:

* Obstetrician confirmed high-risk pregnancy
* Current drug/alcohol addiction
* Current smoker
* Unwilling/unable to discontinue psychiatric medication during pregnancy
* Comorbid schizophrenia, bipolar, or major depressive disorder
Comparison of Synchrony Between 4 NIV Ventilators

Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2 ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients admitted in the intensive care unit for respiratory failure and treated with NIV.


Eligibility Criteria:
Inclusion Criteria:

* respiratory failure

Exclusion Criteria:

* Severe hypoxemia requiring an FiO2 \> 0.6
* Hemodynamic instability : defined as a variation of \> 20% in mean arterial pressure (MAP) and heart rate (HR) during the previous 2 hours; the need for high doses of catecholamines (namely \> 0.5 mcg/kg/min) and/or the need of major volume resuscitation (more than 2 liters of fluids in 2 hours)
* Impaired consciousness or absence of patient cooperation;
* Facial or laryngeal lesions contraindicating the use of NIV;
* Poor short term prognosis.
* Age \< 18 years old
Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applied

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied
Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients

The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity called ''Senior Fitness Test''. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.

The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity (PA) called ''Senior Fitness Test''. There are four methods to measure physical activity: 1. Self-Report Questionnaires 2.Self-Report Activity Diaries/Logs 3.Direct Observation 4. Devices (Accelerometers, pedometers, arm band, Heart-Rate Monitors). Accelerometers can measure PA accurately and have ability capture large amounts of data. Accelerometers measure acceleration (activity counts:AC) in real time and detect movement in up to three orthogonal planes (anteroposterior, mediolateral, and vertical) These counts are then translated into a metric of interest, which can be biological (e.g. energy expenditure) or PA patterns (e.g. stationary). There are pros and cons of measurement methods of physical activity. Strengths of accelerometers include minute-by-minute on-line monitoring, capturing intensity level. Accumulated AC provide an accurate estimate of the duration and intensity of body movement at the waist and were summed across the whole day to assess total PA volume. However, accelerometers are expensive and require technical expertise, specialized hardware, software, and individual programming. Self-report PA measurement methods are able to measure large numbers of participants at low cost. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with first ever, unilateral stroke
2. Patients with stroke who can walk independently or with an assistive device
3. Being at between the ages of 40-80

Exclusion Criteria:

1. Illiteracy
2. Having severely impaired mental function and being unable to complete questionnaires
3. Presence of neglect, demantia, apraxia
4. Having uncontrolled hypertension, cardiopulmonary disease
Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder

In this randomized controlled clinical trial, 326 patients with ADHD will be investigated regarding the effectiveness of a digital therapeutic for improved ADHD symptomatology, the unguided online intervention attexis. Inclusion criteria are: male, female or non-binary, age 18-65, diagnosis of ADHD, elevated levels of ADHD symptoms (score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1), stable treatment for at least 30 days at time of inclusion, sufficient German skills, and consent to participation. Exclusion criteria are: Diagnosis of any other severe psychiatric disorder and plans to change treatment in the upcoming three months. Patients will be randomized and allocated to either an intervention group, receiving access to attexis in addition to TAU, or a control group, receiving access to TAU only. Primary endpoint will be self-rated ADHD symptomatology, assessed via the ASRS v1.1, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, self-esteem, work and social functioning, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* women, men, non-binary
* age 18-65 years
* diagnosis of ADHD (assessed via DIVA)
* ADHD severity score (cut-off): score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1
* stable treatment (psychotherapy, medication, no treatment, ...) for at least 30 days at the time of inclusion
* consent to participation
* sufficient knowledge of the German language

Exclusion Criteria:

* diagnosis of another severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, Borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)
* plans to change treatment (psychotherapy, medication, ...) in the upcoming three months after inclusion
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Drug-naïve Obsessive-compulsive Disorder(OCD)

This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG).

The purpose of this study is to examine the efficacy of tDCS over orbitofrontal cortex (OFC) in treatment of drug-naïve OCD patients. 60 drug-naïve OCD patients will be randomized into two groups (i.e. active or sham stimulation). tDCS stimulation will be performed once a day, five times a week, for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and TMS-EEG.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-50 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16, discontinued medication for at least 8 weeks before tDCS stimulation.
* \>or＝9 years education

Exclusion Criteria:

* Any axis I psychiatric disorder comorbidity
* The inability to receive tDCS because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery.
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
* Any current significant medical condition.
* serious suicide risk
MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events

This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.


Eligibility Criteria:
For patients with intracerebral hemorrhage

Inclusion Criteria:

* Patient participating in the PRO-SVD cohort
* Symptomatic intracranial hemorrhage
* Written informed consent provided by patient or next-of-kin
* No contraindications against MRI

Exclusion Criteria:

* Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
* Patients unlikely to attend 1-year follow-up

For healthy controls

Inclusion Criteria:

* Clinically healthy person ≥ 55 years
* Written informed consent provided by the healthy control
* No contraindications against MRI

Exclusion Criteria:

* Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)
* Pre-existing dementia, cognitive decline or disorder of the central nervous system.
Epidemiologic Study Evaluating Infections in Elderly Patients

The purpose of this observational study is to assess the prevalence and demographic and clinical characteristics of infections in elderly people admitted to Internal Medicine wards in Spain, as well as the etiology and resistance pattern for the main causal agents, and outcome.


Eligibility Criteria:
Inclusion criteria:

* Patients \> 65 years of age that are hospitalized in an Internal Medicine ward and have an active infection (skin and soft tissue, intra-abdominal, or respiratory infections) from the community that needs antibiotic treatment
* Patients must have at least one sample processed for microbiological diagnosis

Exclusion criteria:

* COPD exacerbation
* Urinary tract infections
* Hospital acquired infections
* Other infections not in inclusion criteria
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.

A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian \& European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* NIHSS between 4-20
* Time from symptom onset between 8 and 24 hours

Exclusion Criteria:

* Hemorrhagic stroke
* Certain types of heart disease
* Kidney disease
* Other conditions the doctor will assess
Biofilm Formation on Different Endotracheal Tube Materials

Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.

Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.

Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.

Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.

It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.

In this study the investigators will compare microbiology and EM images in that same manner.

Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.

Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.

ICU patients needing mechanical ventilation will be intubated with the three different devices with different surfaces characteristics.

The tubes are: A - standard Poly vinyl chloride (PVC) tube; B - PVC with a silicon coating; C - PVC with a special metal film coating

Eligibility Criteria:
Inclusion Criteria:

* Patients needing invasive mechanical ventilation through an endotracheal tube

Exclusion Criteria:

* Anticipated need for mechanical ventilation less than 24 hours
The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion

The actual recommendations for infants aged 3 to 12 months presented with first episode of Febrile Convulsions highly recommend performing lumbar puncture in order to rule out Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. The purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of Bacterial Meningitis among infants admitted with the First episode of Febrile Convulsions.

Demographic data, including ethnic origin, age an gender will be recorded. The type of Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also recorded. Another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and the final diagnosis including the cause of fever.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions during the period 1/1/2000 until 31/12/2010

Exclusion Criteria:

* infants with previous neurological diseases, or
* recent neurological disease that are not included in the characteristics of Febrile Convulsion
Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care \[SoC\] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).


Eligibility Criteria:
Principal inclusion criteria :

* Subjects with histologically- or cytologically-documented NSCLC
* Locally advanced, unresectable (Stage III) NSCLC
* World Health Organisation (WHO) performance status 0-1
* At least one measurable lesion, not previously irradiated
* Must have a life expectancy of at least 12 weeks at randomization

Principal exclusion criteria :

* Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
* Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness
* History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
* Mixed small cell and NSCLC histology
* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
* Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
* Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.