cyrilzakka/clinical-trials huggingface dataset:
Cohort Research on Wilson's Disease

Wilson's disease (WD) is an inherited disorder that causes abnormal copper accumulation in the brain and/or liver. Some people develop neurological or psychiatric symptoms whereas other develop liver disease. The reasons for this are unclear but genetic factors are likely to contribute. Current treatment, using copper-binding medications, is required lifelong. Some respond well but others suffer debilitating side-effects or deteriorate despite treatment, leading to disability or the need for liver transplantation.

In the first part of this study the main aim is to identify genetic factors that determine whether someone with a diagnosis of WD will develop neurological involvement or not. The investigators will invite 500 adults with WD across the UK to take part. Participants will be asked to complete an online questionnaire and provide a saliva sample for genetic testing using a collection kit sent via post. Identifying these genetic factors would significantly advance our understanding of the disease and may provide new targets for drug discovery or help guide more personalised approaches to treatment.

In the second part of this study the main aim is to develop new ways to monitor the effect of WD on the brain using tests. Copper levels in blood and urine, currently used to monitor the disease, are unreliable and do not necessarily reflect ongoing brain damage. The role of MRI scans, cerebrospinal fluid tests or other measures of brain damage, commonly used in other neurological disorders, is unclear. The investigators will therefore follow a group of 40 patients using clinical assessments and a combination of neurological tests, including novel imaging and laboratory techniques, over 24 months. Developing new approaches to monitoring the effect of WD on the brain will enable better prevention of neurological disability and be essential for demonstrating the effectiveness of new treatments, such as gene therapy, in clinical trials in the future.


Eligibility Criteria:
Inclusion Criteria (part 1 and part 2):

* Diagnosed with Wilson's disease
* Age 16 years or over
* Living in the UK

Exclusion Criteria (part 2):

* Participant has another medical or psychiatric illness that would interfere in completing assessments
* Participant is pregnant
Building Emotional Self-Awareness Teletherapy (BEST)

To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.

This Phase I proof of principle pilot study of the Building Emotional Self-awareness Teletherapy (BEST) intervention will use a quasi-experimental, non-randomized, one-group pretest-posttest design with a double pretest and a 3-month follow-up in approximately 40 participants with mTBI (\~20 civilians and \~20 service members). Study objectives are to explore the feasibility and early efficacy of BEST to improve psychological health outcomes in civilian and Service Member (SM) participants with mTBI who have alexithymia (poor emotional self-awareness) and emotion dysregulation. We anticipate BEST will have good feasibility and acceptability in both civilian and service member participants, and post-treatment assessments will show significant improvements in alexithymia, emotion regulation, resiliency, and affective symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Mild TBI (determined by Ohio State University TBI Identification Method)
* ≥18 years old
* U.S. resident (exclusion for California residents)
* ≥6 months post-TBI
* elevated alexithymia and emotion dysregulation (defined by \>.5 standard deviation above means on the TAS-20 and DERS)
* capacity to consent
* proficient English
* if on medications that influence affect, must be stable for at least 6 weeks
* access to a device capable of video conferencing and high speed internet.

Exclusion Criteria:

* Premorbid neurological disorder other than TBI (e.g., stroke), active or uncontrolled major psychiatric disorder and/ or disorder that would pose a safety concern (e.g., borderline personality disorder)
* degenerative neurologic condition
* visual, hearing, communication, or cognitive impairments that would impede participation
* unstable or anticipated medication changes that will influence mood/ affect during study participation
* active involvement in an intensive rehabilitation program
* individuals who recently started psychotherapy (e.g., \< 3 months ago)
* participant behaviors that cause concern for their ability to participate in accordance with the study requirements and protocol (e.g., unreliable correspondences, no-shows, no-replies to multiple contacts, habitual rescheduling, unable to complete study requirements in timely manner)
* concurrent participation in any other clinical trial that aims to improve mood/ behavioral functioning will be an exclusion criterion.
* participants will be excluded if at any point, they participated in TREAT (in-person clinical trial of BEST - NCT03414463)
Placental Assessment in Diabetic Mothers

Diabetes mellitus is one of the major heath problems

Maternal and fetal effects are edpected to be more than in diabetic mothers

Eligibility Criteria:
Inclusion Criteria:

* in control group A non diabetic pregnant women

Exclusion Criteria:

* Diabetic pregnant women

And the reverse in group B
The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults

to investigate the effect of stimulation intensity on motor performance in healthy adults.

60 healthy subjects were randomly allocated to one of three groups: (a) 20-min of High-Definition transcranial direct current stimulation (HD-tDCS) with an intensity of 2 mA (HD-tDCS 2 mA); (2) 20-min of HD-tDCS with an intensity of 1.5 mA (HD-tDCS 1.5 mA); and (3) 20-min of sham HD-tDCS (HD-tDCS sham). The stimulation was administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). The anodal stimulation targeted the right Brodmann area 4 (primary motor cortex) based on HD-Targets brain modelling software (Soterix Medical, New York, NY).

Tests: The non-dominant left arm was tested. The subjects performed a sequential point-to-point movement task on the graphics tablet. Initially, the participants were required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they performed the pre-test which consisted of two blocks of 6 sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the appropriate stimulation, they performed 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants performed a post-test, which was also identical to the pre-test. The participants returned after 24 hours to perform a retention test, which was equivalent to the pre- and post-tests. Two outcome measures were used: movement time (s) and the reaction time (s) of the reaching movements.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 35
* right-hand dominant
* healthy according to self report

Exclusion Criteria:

* taking psychiatric medications
* a history of drug abuse or dependence
* psychiatric or neurological disorder
* a history of seizures
* metal implants in their head
* musculoskeletal deficits interfering with task performance (proper reaching performance in sitting)
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome

Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.

This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19).

Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included. Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue since positive test. Patients will be screened using the fatigue survey and cases with a moderate to severe score will be included.

Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality of life will be assessed using validated surveys. Surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of scores from baseline levels will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Any ethnicity
* Adequate cognitive function to be able to give informed consent
* Technologically competent to complete web forms and perform video calls with the PI
* Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment
* A fatigue score above 9 in the Chalder Fatigue scale upon enrollment
* Willing to fill out regular questionnaires
* Willing to use LDN and NAD patches

Exclusion Criteria:

* Clinically significant kidney, heart, Hepatic impairment as determined by clinical judgement
* Taking opioid analgesics, or undergoing treatment for opioid addiction
* Opioid dependence or withdrawal syndrome
* Known sensitivity to naltrexone
* Suspected or confirmed pregnancy or breastfeeding
* Known issues with using iontophoresis patches
* Active cancers
* Enrolled in another trial
* Current users of LDN or NAD+
Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents

The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites


Eligibility Criteria:
Inclusion Criteria:

* FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
* FQHC's that have family medicine and/or pediatric practices
* a total adolescent patient population at least 50% Latino
* be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
* Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
* Staff, aged 18 and over, employed at each FQHC (5 staff per practice)
* Implementation team members (i.e., administrative designee, health care providers, immunization navigators, and other staff), aged 18 and over, employed at each FQHC (4 members per practice)
* Parents (aged 18 and over) of patients ages 11-17 seeking care at each FQHC (25 per practice).

Exclusion Criteria:

-FQHCs that participated in the pilot study were excluded.
Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

An ultrasound-guided infraclavicular block performed with the costoclavicular (CC) approach and the lateral sagittal (LS) approach will be compared in patients scheduled for forearm and hand surgery.

The CC approach is a recently introduced infraclavicular approach that targets three cords (medial, lateral and posterior) located lateral to the axillary artery in the costoclavicular space. Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered but maintain a consistent anatomical relationship with each other.

Patients will be divided into two groups:

Group LS: Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)

Group CC: Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years to 65 years
* Patients scheduled for elective forearm and hand surgeries
* Patients with American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

* Patients not consenting/unwilling to participate
* Age \<18 years or \>65 years
* Patients with ASA 4
* Obesity (BMI \>30 kg/m2)
* Regional anesthesia contraindicated (thrombocytopenia, infection at injection site)
* Severe renal, cardiac, or hepatic disease
* History of hypersensitivity or allergy to local anesthetics
* History of opioid or steroid use for more than 4 weeks
* History of psychiatric disorders
* Analgesic treatment in the last 48 hours preoperatively
* Operations lasting less than 60 minutes and more than 180 minutes
* Patients who converted to general anesthesia
Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.

Two population groups (presbyopes and astigmats) will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document;
* Adapted, current soft contact lens wearer with either:

  1. A spectacle add between +0.50 and +2.50 (inclusive) \[Presbyopes group\]
  2. A spherical correction of an astigmatism up to 20% of the amount of the sphere \[Astigmats group\];
* Contact lens prescription in the power range specified in the protocol;
* Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
* Willing to wear study lenses up to 12 hours and attend all study visits;
* Can be successfully fitted with study lenses;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Use of artificial tears and rewetting drops during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
* Participation in any clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.
Spinal Morphine in Robotic Assisted Radical Prostatectomy

This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy

This study is a randomized controlled trial. It will randomize 160 patients who are scheduled for Robot-Assisted Radical Prostatectomy. The intervention group will receive a single spinal injection of a bupivacaine (12,5 mg)/morphine(300 mcg) mixture. Controlgroup will receive a subcutaneous injection of lidocaïne for placebo purposes and an intravenous loading dose of morphine at the end of surgery.

Both groups will receive general anesthesia during surgery in a standardized fashion.

After the surgery, both groups will receive a Patient-Controlled Analgesia pump for post-operative pain control.

Primary outcome is patient satisfaction as measured by the Quality-of-Recovery-15 questionnaire. This questionnaire will be taken at baseline, day 2 and 1 week after surgery.

Secundary outcomes are morphine use per PCA, duration of hospital stay, side-effects and ease of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Robot-Assisted Radical Prostatectomy

Exclusion Criteria:

* Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders)
* Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol)
* Conversion to an open procedure
* Post-operative ICU-admission
Patient Centred Communication Intervention

The most frequent consequence of a stroke is a communication impairment. When patients cannot articulate their needs, frustration and agitation are frequent responses, often resulting in poor optimization of post-stroke function. Staff's lack of knowledge of communication strategies exacerbates the problem. A key component of patient-centred care is the ability of staff to communicate in such a way that allows them to understand the patient's needs. Members of our team developed the patient-centred communication intervention (PCCI) targeting registered and unregulated staff caring for complex continuing care (CCC) patients with communication impairments post stroke. The purpose of the study is to examine if the PCCI results in improved patients' quality of life and in improved staff attitudes and skills in caring for patients with communication impairments.


Eligibility Criteria:
Patients:

Inclusion Criteria

* diagnosis of stroke related to cerebral infarct
* presence of a communication impairment
* ability to speak and understand English before the stroke
* ability to consent

Exclusion Criteria:

* global aphasia or severe Wernicke's aphasia

Staff:

Inclusion Criteria

* directly involved in providing care
* employed full or part-time
* ability to consent
* ability to speak and write English
* work with patients who have communication impairments

Exclusion Criteria

* unwilling to provide informed consent
Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule

This study will look at how the \[18\]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. \[18\]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
3. Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
4. Ability to lie still for PET scanning
5. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Age less than 18.
2. Active carcinoma with known metastatic disease.
3. Size of primary lesion less than 1 cm or greater than 3 cm
4. Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
5. Inability to lie still for PET scanning
6. Cannot provide written informed consent
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study

The Fondazione per la Ricerca Ospedale di Bergamo (FROM) decided to propose and promote the completion of ERNEST registry: the aim of the project is to obtain up-to-date estimates of clinical outcome of these patients in primary and secondary Myelofibrosis that have been included in the 'original' ERNEST study. The last was conducted between 2012 and beginning of 2015 including 1292 patients with Myelofibrosis, but it was interrupted in 2015 because of bankruptcy of the previous sponsor.

Follow-up of patients already been registered in the ERNEST registry resulting alive and/or in active surveillance at November 2014 (Blood 2014 124:1849) will be updated retrospectively until December 2020. Data collection will be centralized at Fondazione per la Ricerca Ospedale di Bergamo (FROM), and performed by a web-based and Electronic Data Capture (EDC) system through ad hoc electronic case report forms (e-CRFs). The e-CRFs system will be pre-filled with pre-existing data collected from cases already entered in the registry. Information on therapies received and outcome events occurred (in term of death, evolution to acute leukemia, secondary cancer and cardiovascular complications) until December 2020 will be recorded by authorized participating investigators.

Eligibility Criteria:
Inclusion Criteria:

* previous registration in the ERNEST registry (2012 - 2014)
* diagnosis of MF performed between January 2001 and 2012 December
* Signed informed consent to continue participation in the registry

Exclusion Criteria:

None
PsA Digital Phenotyping and Inflammation Drivers Study

The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:

* In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?
* In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?

Participants will be requested to:

* Install app on their phone
* Use a smartwatch
* Complete questionnaires
* Collect biological material


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PsA
* Age 18 years or older and competent
* Using a smartphone
* Agree to use smartwatch
* Good command of the local language

Exclusion Criteria:

* Less than 18 years of age
* Incapacitated