cyrilzakka/clinical-trials huggingface dataset:
Prone Positioning and Regional Ventilation in Mechanically Ventilated COVID-19 Patients

The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.

Patients with acute respiratory distress syndrome (ARDS) frequently develop atelectasis in dorsal lung regions because of gravity and the compression by the heart and the diaphragm. Since lung perfusion is predominantly distributed in lower lung regions, a reduction of ventilation in these areas results in further ventilation-perfusion mismatch, called shunt. The development of atelectatic lung regions necessitate the use of higher ventilation pressures, which in turn results in excessive transpulmonary pressures and ventilation-induced lung injury in the ventral regions. Therefore it is common to promote the prone position in patients with ARDS in order to improve ventilation-perfusion matching and thus, protect the ventral regions from hyperinflation. In patients with COVID-19-related ARDS, the value of such therapeutic strategy based on placing in prone position has not been completely elucidated. The aims of the study are to determine whether prone positioning improves dorsal regional ventilation when compared to supine position. Moreover, another aim is to assess the changes in intrapulmonary shunt following patient position changes.

Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling all the following criteria are eligible for the study:

* Mechanically ventilated
* Fit the Berlin Definition for moderate or severe acute respiratory distress syndrome (arterial oxygen partial pressure over inspiratory fraction of oxygen less than 200 mmHg)
* Infection with coronavirus confirmed
* Scheduled to undergo prone positioning

Exclusion Criteria:

* Patients with pacemakers, defibrillators or other electrically active implants
* Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
* Patients with chest tubes
* History of thoracic surgery or lung resection
Social Cognition in Longstanding Psychosis

In the current study, the investigators propose to measure the five domains of social cognition identified by the National Institute of Mental Health (NIMH) as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). The investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).

There is growing evidence that individuals with longstanding psychotic disorders suffer from deficits in social cognition (i.e., the cognitive skills needed to successfully navigate social interactions). However, to date, there have been few attempts to measure multiple components of social cognition within the same population of individuals with psychosis. Thus, the interrelationships between various aspects of social cognition remain unclear. In the current study, the investigators propose to measure the five domains of social cognition identified by NIMH as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). The investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a schizophrenia spectrum disorder or an affective disorder with psychotic features per the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR) criteria using the Structured Clinical Interview for the DSM-IV.
* Duration of psychotic symptoms greater than or equal to 5 years determined using the Symptom Onset in Schizophrenia Inventory
* Age 18-75
* No evidence of mental retardation.
* Able to provide informed consent as evidenced by passing the informed consent quiz with a score of 80% or greater.
* Fluent in English as assessed per self-report from participant

Exclusion Criteria:

* Unwilling or unable to complete study assessments (e.g., unable to read self-report questionnaires)
* Subject is currently pregnant per subject's report
A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
* Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
* Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria:

* patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
* patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
* patients with any seropositive result for hepatitis B or hepatitis C or HIV
* patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
Physical Activity, Air Pollution, and High Blood Pressure

The investigators are investigating the effects of traffic-related air pollution (TRAP) on the cardiovascular and pulmonary response to exercise in patients with hypertension using a real world randomized, crossover study design. Participants will be exposed to 2 conditions: a low TRAP environment and a high TRAP environment. Each exposure will consist of 30 min of moderate-intensity exercise. Cardiovascular and pulmonary health outcomes will be measured before, during, and up to 24 hours following exposures. A minimum washout period of 1 week will be used to minimize carryover effects.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 40-70 years of age
2. Previously diagnosed with elevated blood pressure or hypertension by a physician

Exclusion Criteria:

1. Current or ex-smokers (abstinent for less than one year)
2. Lives with an individual who currently smokes cigarettes, e-cigarettes (i.e., vaping), or cannabis
3. Hormone replacement therapy use
4. Currently on beta-blocker or angiotensin receptor blocker (ARB) therapy
5. Currently using over the counter drugs or supplements that may alter cardiovascular measures (as per the principal investigator's discretion)
6. Prior diagnosis of any other existing cardiovascular or pulmonary diseases and/or conditions (other than hypertension)
7. Musculoskeletal injury or lower limb limitation preventing safe engagement in moderate-intensity exercise
Integrated Suicide Supports for Youth

The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers in the clinic, and videos to encourage supportive communication and skills for teens and young adults to stay safe. The main question it aims to answer is whether the use of an app can increase youth suicide-related coping for youth with suicidal ideation, parent suicide prevention self-efficacy, and healthcare provider self-efficacy in suicide management. Researchers will compare usual care to usual care with the app. Participants, including adolescents, their caregivers and healthcare providers, will use the ISSP app (if assigned to that group) and complete three online surveys.

The current study aims to evaluate the Jaspr app relative to usual care among youth (ages 13-21 years) who indicate suicidal ideation in pediatric outpatient medical settings. The Jaspr app includes supported safety planning between the young person and the healthcare provider, as well as skills and support videos for youth and caregivers intended to increase coping and decrease distress with an opportunity to access these resources through an at home app. Adolescents, parents, and clinicians will participate in the project to assess the effectiveness of Jaspr augmenting usual care, compared to usual care alone. The study will use a pre-post design in which each clinic begins with a control period and then transitions to the addition of Jaspr following healthcare provider training on use of the app. Participants and their parents will receive study assessments at baseline, 1-month, and 2-month follow up timepoints, and healthcare providers complete a survey at baseline, the end of the control period, and the end of the intervention period. Study assessments with youth will ask about coping, suicidal ideation and severity, anxiety and depression, service utilization, functional impairment, access to lethal means, therapeutic alliance, and satisfaction with care and the app. Study assessments for parents will ask about their self-efficacy in managing their youth's suicidality, service utilization for the youth, and satisfaction with care. Healthcare providers will complete surveys assessing their self-efficacy in managing youth suicidality. Youth, their legal guardian, and healthcare providers each assent/consent to participate in the research procedures.

Eligibility Criteria:
Youth Inclusion Criteria:

* Age 13-21 years, Ask Suicide Questions (ASQ) screen score of 1-4 with no current plan or intent (Item 5 negative and as assessed by their clinical providers).

Youth Exclusion Criteria:

* Previously recruited to other affiliated Suicide Care Research Center study, no phone access, non-English speaking, or already has a suicide safety plan that is being overseen by a mental health specialist.

Note: One parent/caregiver per teen/young adult and health care providers in participating clinics will also be invited to be study participants
The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer

Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.

The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer diagnosis 2019-2022

Exclusion Criteria:

* No rectal cancer diagnosis 2019-2022
Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
* Age ≥ 18 years
* Patient information and written informed consent form signed
* Patient must be affiliated to a social security system

Exclusion Criteria:

* Patients whose health-cons indicates a blood sample 10mL
* Age \< 18 years
* Pregnant or breast feeding females
* Persons deprived of liberty or under supervision
A Compassionate Use Program to Provide Access to Sodium Thiosulfate

This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma.

Approximately 10 patients will be treated as part of this program as specified below:

Sodium Thiosulfate vials i.v. 80 mg/mL.

This Compassionate Use Program for STS will consist of 2 phases:

Screening:

Patients will only be able to participate in this CUP if they meet the eligibility criteria.

Treatment:

Any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice.

All serious adverse events (SAEs) will be reported. All related non-serious adverse events (AEs) will be reported where "related" means any event where a causal relationship between STS and the event is at least, a reasonable possibility. All non-serious AEs leading to dose modification or discontinuation will be reported. Pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.


Eligibility Criteria:
Inclusion Criteria:

I-1. Children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with STS and receive cisplatin.

I-2. A written informed consent was provided from all the patients and/or parents or legal guardians of children.

Exclusion Criteria:

E-1. Any previous participation in an STS clinical trial. E-2. Participation in another clinical study with an investigational product during the most recent chemotherapy course.

E-3. Patients with a known hypersensitivity to STS or any of the excipients of the product.

E-4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to STS treatment.

E-5. Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.

E-6. Breast feeding or pregnant women.
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.

Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤ 28 weeks of gestation
* Postnatal age \< 96 hours

Exclusion Criteria:

* Congenital malformations
* Chromosomal anomalies
* Terminal illness needing to limit or withhold support
Immediate and Delayed Implant Placement Using Socket Shield Technique and Autogenous Dentin Graft

One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with badly destructed or non-restorable maxillary anterior teeth when the Labial cortical plate is still intact, and the thickness was found to be \<2mm in CBCT.
* Patients with health status according to American Society of Anesthesiology (ASA) I and II.
* Patients who agree to participate in the study.

Exclusion Criteria:

* Patients presenting with any systemic pathology or health condition that would inhibit the osseointegration process of the implants.
* Perforated labial cortical plate seen in CBCT.
* Patients undergoing radiation therapy or history of radiation within the last two years.
* Drug or alcohol abuse
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living(ADL) and improvement of range of motion (ROM).


Eligibility Criteria:
Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic imaging (CT arthrogram or MRI)\* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W\>2cm and L\>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon. - Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff
Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.

Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; \>57 days).

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.

Eligibility Criteria:
Inclusion Criteria:

- patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015.

To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* BMI (body mass index) maximum 27 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
* FBG (fasting blood glucose) maximum 6.0 mmol/L
Yoga Therapy for Chronic Tension-Type Headache

Chronic tension headache represents a considerable social burden in terms of both costs to the health services and also the costs of lost productivity. Episodic tension-type headache can be treated with rest and analgesics, while chronic tension-type headache demands a more fundamental treatment.

Effectiveness of yoga therapy in the management of chronic tension type headache is limited. In this study, yoga therapy was used to explore its effect on chronic tension-type headache.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
* Aged 18-55 years;
* Having the ability of understanding and completing the headache dairy;
* Provide written informed consent.

Exclusion Criteria:

* No headache during the pervious 3 months;
* Taking any prophylactic medication during the previous one month;
* Secondary headache or any systematic cause
* Having serious conditions of the heart, liver, kidney or other organs;
* In pregnancy or lactation, or planning to be pregnant in 6 months;
* Drug and Substance abuse
* Diagnosed psychiatric condition
* Taking any other complementary and alternative medicines
* Practicing yoga of any kind in last three months
UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: a Phase 2 Trial

Glioblastoma (GBM) is a high grade glioma (brain tumor) that is treated with surgery or biopsy followed by radiotherapy (RT) given daily over 3 or 6 weeks with or without an oral chemotherapy. Radiation is targeted to the visible residual tumor on magnetic resonance imaging (MRI) images plus a large margin of 15 to 30 mm to account for possible cancer cells outside the visible tumor and for potential growth or shifts in tumor position throughout the prolonged RT course. Standard RT uses MRI to create a reference plan (with large margins) and treats that same volume every day. This exposes a large amount of healthy brain tissue to radiation leading to toxicity and reduced quality of life.

A new technology, the MR-Linac, combines an MRI scanner and a Linac (radiation delivery machine) into one unit. This allows for "adaptive" RT by obtaining an updated MRI scan each day just prior to treatment, adapting the RT plan to take into account any changes in the tumor or the patient's anatomy on that given day. This allows for a smaller (5 mm) margin on the visible tumor as its position can be tracked daily. The goal of this study is to use adaptive RT with small margins to demonstrate that the local control of the visible tumor is not compromised compared to the large volumes used with standard non-adaptive RT, while determining whether smaller margins lead to decreased radiation toxicity and therefore improved quality of life by minimizing radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Histopathologically confirmed malignant glioma of the brain, Grade 4 (GBM)
* Eligible for RT in 15 or 30 fractions with or without chemotherapy (temozolamide)
* Expected survival greater than 12 weeks
* WHO performance status less than or equal to 2
* Able to converse and answer questionnaires in English language
* Has a maximum final planning volume less than 150 cm3

Exclusion Criteria:

* Contraindications to MRI examination as per standard MRI screening policy
* Contraindication to Gadolinium-based contrast media
* Unable to lie flat in a supine position for 30 minutes
* Poor baseline kidney function with an eGFR \< 60 mL/min
* Unable to tolerate immobilization in a head thermoplastic mask
* Patients \>140 kg and/or a circumference \>60cm
* Previous cranial irradiation
* Infratentorial tumour extent, multifocal of leptomeningeal disease
* Unable to give informed consent