cyrilzakka/clinical-trials huggingface dataset:
A Study of ARQ 197 in Combination With Erlotinib

This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent for study participation must be obtained
* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
* ECOG PS of 0 or 1
* Life expectancy of ≥3 months
* Poor metabolizers as defined by CYP2C19 genotype

Exclusion Criteria:

* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
* Surgery for cancer within 28 days prior to ARQ 197 dose
* Active double cancer
* Known symptomatic brain metastases
* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
* Pregnant or lactating
* Subjects who wish to have a child and who would not agree to use contraceptive measures
Safety and Efficacy of Fingolimod in MS Patients in China

To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China


Eligibility Criteria:
Inclusion Criteria:

-Patients must have relapsing remitting multiple sclerosis

Exclusion Criteria:

Patients with:

* History of chronic immune disease
* Certain cancers
* Uncontrolled diabetes
* Certain eye disorders -Negative for varicella
* zoster virus IgG antibodies
* Certain hepatic conditions
* Low white blood cell count
* On certain immunosuppressive medications or heart medications
* Certain heart conditions or certain lung conditions
* Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
* Other protocol defined inclusion/exclusion criteria may apply
Effectiveness of the RAUC Pathway in Reducing Unscheduled Hospitalizations After Emergency Digestive Surgery

The number of emergencies's visits (22 million visits in 2019 in France), the organization of emergencies and the sustainability of the current health system are threatened. In the CHUAP adult emergency department, 60,000 visits were recorded in 2022.

Unlike medical emergencies which have structured their care and research activities (heart, brain), and whose organization has demonstrated its general interest for society, digestive surgical emergencies, which involve complex patients (elderly people, comorbidities) , emergency situations and surgical procedures, have never been thought of globally in terms of personalized care and research pathways. Currently, patients treated in emergency are managed without a pre-established optimization program and without a dedicated pathway, where emergency constitutes a major risk factor for postoperative complications.

RAUCAMIENS evaluates a new care pathway implemented within the framework of the RHU RAUC : the implementation of the Enhanced rehabilitation after surgery (ERAS) and e-health devices for home monitoring, for patients treated in the emergency room for a digestive pathology. The purpose is to evaluate the effectiveness of the RAUC pathway in reducing the rate of unplanned hospitalization readmission after emergency digestive surgery 30 days postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Criterion linked to the protocol
* Patient consulted in emergency for a digestive pathology requiring surgery

Search criteria:

* Adult patient (≥ 18 years old)
* Able to give consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Criterion linked to the protocol:
* Patient leaving hospitalization to a convalescent center
* Patient requiring direct operating room (vital emergency or surgical revision)
* Patient presenting to the emergency room for a postoperative complication
* Patient directly admitted to intensive care

Search criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship, curatorship or deprived of liberty
A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI

The study aim is to evaluate a patient-centred intervention focusing on improved quality of life and wellbeing among individuals with obesity and risk factors for adverse outcome.

In Denmark, University Hospital of Southern Denmark in Esbjerg has initiated The South Danish Obesity Initiative (SDOI) to optimize the treatment of and the research in obesity. The hospital has for years, offered treatment to individuals with obesity, however, SDOI is an investigation program with the aim to identify people with undiagnosed obesity-related diseases by a systematic and stepwise approach, delivering an up-to-date treatment of diagnosed diseases and offering personalized lifestyle advice based on the finding in the investigation program. The SDOI program comprises collaboration between different medical departments at the hospital and furthermore, entails the establishment of a well-defined cohort as a basis for research. ACT is of interest in the construction of the personalized lifestyle advice in the SDOI program. However, there is limited research available on the effect of the behaviour therapy ACT as a basic method for a lifestyle program targeting overweight individuals who have been made aware of obesity related diseases and re-conditions. ACT might be a valuable tool to assist these individuals to increase their quality of life and thereby, ability to make lifestyle changes.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be eligible for inclusion if they are ≥18 years
* Body mass index above 30 kg/m2

Exclusion Criteria:

* Individuals referred for bariatric surgery will not be eligible for inclusion in the study
Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics

This pilot randomized controlled trial of the Vermont Family Based Approach (VFBA) tested the feasibility of the VFBA in primary care pediatrics and its effects on children's and parents' emotional and behavioral problems and health-related quality of life. The VFBA is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health. The VFBA group received the VFBA intervention, while the Control group received pediatric primary care as usual.

To enhance the health of our communities, we need approaches to healthcare delivery that focus on the entire family, recognize the central role of emotional and behavioral health in relation to all health, use evidence-based health promotion in addition to evidence based treatment of existing problems, and intervene early in children's life.

The VFBA is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health.

The study was a pilot RCT of the VFBA in a primary care pediatrics clinic. The goals of the study were to test whether the VFBA would (1) be feasible in primary care pediatrics and (2) would lead to improved emotional and behavioral health and health-related quality of life or children and parents. Families were recruited at the pediatric clinic and randomized to the VFBA or Control conditions.

The VFBA group received family-based assessment of emotional and behavioral health and family functioning, family wellness coaching, and a menu of cost-free wellness activities, such as parent and child violin instruction, yoga and mindfulness training, and nutrition counseling. Where indicated by results of family-based assessment, families in the VFBA group also received family-based, evidence-based psychotherapy and psychiatric care. Families in the Control group received pediatric primary care, as usual.

Eligibility Criteria:
Inclusion Criteria:

* Families with a 3 - 15 year-old child who receives his/her primary care at the University of Vermont Pediatric Primary Care Clinic

Exclusion Criteria:

* Families with a target child in the legal custody of the State of Vermont
* Families where the parents' proficiency in English is not sufficient to participate in the protocol without an interpreter
Effects of Sugary Drinks Counter-marketing Messages

This study aims to examine consumer responses to traditional and counter-marketing messages discouraging sugary drink consumption, including effects on intentions to consume sugary drinks and perceived weight stigma. Because prior research has suggested that counter-marketing may be especially effective among younger populations, the investigators will examine effects overall and by age group (young adults \[ages 18-29 years\] vs. middle and older adults \[ages 30+ years\]).

In this online randomized clinical trial, participants will be randomized to one of three arms: 1) Control (neutral) messages, 2) Traditional health messages, and 3) Counter-marketing messages. In each arm, participants will view four messages developed for their randomly assigned arm and answer questions about the messages and their behavioral intentions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* Less than 18 years old
Assessing Cervical Sensorimotor Control With VR in Chronic Neck Pain

To develop a cervical SMC VR assessment system incorporating different SMC tests and to compare cervical SMC performance using this self-developed VR assessment system in individuals with and without CNP


Eligibility Criteria:
Inclusion Criteria:

1. For patients with chronic neck pain:

   * Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra,
   * Neck pain persisting for 3 months and above,
   * Average pain intensity of last pain episode was between 2 and 8 based on the numerical rating scale (NRS)
2. Healthy asymptomatic adults:

   * Do not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months

Exclusion Criteria:

* acute or the first onset of neck pain
* previous fracture or surgery of the spine
* diagnosed cardiopulmonary diseases, for example, chronic obstructive pulmonary disease, pulmonary tuberculosis, asthma, chronic bronchitis, pulmonary emphysema
* diagnosed gastrointestinal and abdominal conditions which may interfere daily activities within the past 6 months
* medical conditions that may affect balance and study procedures (e.g. neurological diseases, vestibular disorders, malignant tumors)
* metabolic diseases such as anemia and diabetes
* smoking, plan to pregnant or in pregnancy
* psychological disorders (affect questionnaire responses)
* unable to walk independently
* Corrected visual abnormalities or individuals unable to wear contact lenses for vision correction due to the potential interference of wearing VR head-mounted display with glasses
Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With NMD

This study aims to evaluate perceived clinical and psychosocial experiences of patients and their families during the Covid-19 pandemic. it is important to understand the implications of the pandemic for this population, particularly given its likely protracted course, and resultant limitations to daily activities and clinical care. This will help clinicians plan support and adaptations to the services they provide in the medium to long term.

As above

Eligibility Criteria:
Inclusion Criteria:

Adult group

* Patient over 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
* Able and willing to provide informed consent

Paediatric group

* Parent of a patient under 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
* Able and willing to provide informed consent

Exclusion Criteria:

* Unwilling for telephone questionnaire to be audio-recorded
Biomarkers for Hunter Syndrome

International, multicenter, observational, longitudinal study to establish Hunter Syndrom biomarker/s and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

Mucopolysaccharides are long chains of sugar carbohydrates, found within the cells that help build bone, cartilage, tendons, cornea, skin, and connective tissue. Glycosaminoglycans (GAGs) are also found in the fluids that lubricate joints. Mucopolysaccharidosis (MPS) are part of the Lysosomal Storage Disorder (LSD) family, a group of more than 40 genetic diseases, and occur when a particular enzyme exists in a small quantity or is missing altogether. The effect is the accumulation of GAGs in the cells, blood, and connective tissues, resulting in permanent and progressive cellular damage which affects appearance, physical abilities, organ and system functioning and, in most cases, mental development.

MPS2 (also called Hunter syndrome) is a hereditary, progressive, multisystemic disorder, caused by mutations in the IDS gene coding for the enzyme iduronate sulfatase (Ids). It is the only type of mucopolysaccharidosis that is X-linked, therefore, if mothers are carriers, there is a 50 percent chance for males to be born with the disease.

MPS2 has a wide range of symptoms that vary in severity, which can be managed with enzyme replacement therapy (ERT). ERT is unable to cross the blood-brain barrier, therefore it addresses strictly extra-neurological manifestations. On this note, further efforts are being made to develop novel therapies, in the attempt to stop the disease progression and to offer a better quality of life to the patients.

As MPS2 is very rare and many medical professionals only see a few or no patients in their lifelong practice, genetic testing is crucial for diagnosis. This study thrives to identify, validate, and monitor potential biomarker/s for MPS2 in genetically confirmed samples.

Eligibility Criteria:
INCLUSION CRITERIA:

* Male individuals
* Informed consent is obtained from the participant's parent/legal guardian
* The participant is aged between 2 months and 50 years of age
* The diagnosis of MPS II is genetically confirmed by CENTOGENE

EXCLUSION CRITERIA:

* Females
* Informed consent is not provided by the participant's parent/legal guardian
* The participant is younger than 2 months or older than 50 years of age
* The diagnosis of MPS II is not genetically confirmed by CENTOGENE
Impacts of Alcohol Warning Labels: An Online Experiment

The goal of this experiment is to examine responses to alcohol warning messages about 10 different topics among US adult alcohol consumers. The main questions this experiment aims to answer are:

Which warning topics make alcohol consumers in the US want to drink less alcohol? Which warning topics remind alcohol consumers in the US of alcohol's harms? Which warning topics help alcohol consumers in the US learn something new? There will be a total of 20 alcohol messages, 2 messages for each of the 10 topics. For each topic, participants will be randomly assigned to 1 of the 2 messages so that they view a total of 10 alcohol messages. All 10 messages will be shown in random order. Participants will rate each message on how much it makes them want to drink less alcohol, reminds them that drinking can be harmful, and teaches them something new.

This study aims to determine which topics in alcohol warning labels are most effective at making US adults who consume alcohol want to drink less alcohol, which topics best remind consumers of alcohol's harms, and which topics are most likely to teach consumers something new. The survey research company NORC at the University of Chicago will recruit a sample of 1,000 US adults ages 21+ who consumed alcohol at least one time per week during the past 4 weeks.

Participants will complete a within-subjects online randomized experiment in which they view and rate messages shown on alcohol containers. Participants will rate each message on perceived message effectiveness (primary outcome), reminding of alcohol's harms (secondary outcome), and learning something new (secondary outcome). These tasks will be repeated for 10 messages, each with a different topic. There will be 9 warning topics (i.e., topics about alcohol's harms) and 1 control topic (i.e., neutral topic not about alcohol's harms). In this within-subjects experiment, the survey will present the topics in random order and participants will view 1 of 2 messages for each topic.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* Reside in the United States
* Able to complete a survey in English
* Consumed alcohol at least once per week during the past 4 weeks

Exclusion Criteria:

* Under the age of 21
* Reside outside of the United States
* Unable to complete a survey in English
* Consumed alcohol less than once per week during the past 4 weeks
Simple Cognitive Task After Trauma EKUT RCT

This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game "Tetris") on intrusive memories ("flashbacks") and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event will be randomly allocated to either the simple cognitive task intervention or control. Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories and less severe related clinical symptoms than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation and training aspects in a hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.

This is a Randomised Controlled Trial informed by prior feasibility and pilot work (ClinicalTrials.gov ID: NCT03509792). The primary outcome is the number of intrusive memories of the traumatic event (week 5). The intervention is delivered in emergency departments of Swedish hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Experienced or witnessed a traumatic event resulting in admission to the emergency department
* Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD) in that ("The person was exposed to actual or threatened death, serious injury, or sexual violence" by "Directly experiencing the traumatic event(s)" or "Witnessing, in person, the event(s) as it occurred to others")
* Can be seen in the emergency department ca. 6 hours after the traumatic event (day 1)
* Report memory of the accident
* Fluent in spoken and written Swedish
* Alert and orientated
* Have sufficient physical mobility to use their smartphone
* Willing and able to provide informed consent and complete study procedures
* Willing and able to be contacted following discharge to complete follow-up assessments
* Have access to an internet enabled smartphone

Exclusion Criteria:

* Loss of consciousness of \> 5 minutes
* Current intoxication
* Report a history of severe mental illness
* Current substance abuse or neurological condition
* Currently suicidal
* Other medical reasons (on advice by medical staff)
The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes

The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).

A prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an Android smartphone application and Study Watch.

This sub-study is only open to sites participating in the RECOVER clinical study.

All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study.

Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study.

Subjects who opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study.

Eligibility Criteria:
Inclusion Criteria:

All Subjects

1. Current consented subject in the RECOVER clinical trial;
2. Adult (i.e. ≥ 18 years of age, unless a resident of any U.S. state where the age of majority is 19, in which case must be ≥ 19 years of age);
3. Able and willing to provide written informed consent for this sub-study;
4. Able and willing to comply with all study procedures;
5. Able to read and speak English.

Phone Application

1. Have a personal Google user account or be willing to create and own a personal Google user account;
2. Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;
3. Agrees to download and maintain the phone application onto personal Android smartphone for the duration of the sub-study;

Study Watch

1. Willing to comply with Study Watch wearing and recharging requirements

Exclusion Criteria:

All Subjects

1. Any condition or situation the Principal Investigator determines as inappropriate for study inclusion

Phone Application

No additional exclusion criteria for phone application

Study Watch

1. Subjects with known severe allergy to nickel or metal jewelry
The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health

The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).

The primary outcome envisioned consists of 2 goals.

1. In this study, the first objective is to determine whether the microbiota and biogenic molecules found in sea air are also found in the nasal swabs of the participants. In this way, the investigators will gain an understanding of which sea air components are inhaled by humans and how this changes over time.
2. Second, the investigators want to get an idea of whether these inhaled sea air components have an effect on certain pathways in the human body. In the in vitro study with cell lines, effects were already seen of sea air exposure on certain pathways in the body. Now the second goal of this study, is to see if changes in immunity biomarkers (IL-6, TNF-alpha, IL-10) are seen in vivo in humans. The Investigators will do this by taking VAMS blood samples from the participants.

Eligibility Criteria:
Inclusion Criteria:

* health participants between 18 and 50 years old

Exclusion Criteria:

* people with a medical condition
* people younger than 18 and older than 50
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia who are drug-free with regard to their antipsychotic medication
* In clinical remission and free from acute exacerbation of their psychosis
* In good health

Exclusion Criteria:

* Clinically significant medical conditions considered inappropriate for trial participation