cyrilzakka/clinical-trials huggingface dataset:
Ethanol in the Prevention of Central Venous Catheter Infections

In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success \[1-10\].

Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.

Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.

Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).

Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* Signed informed consent
* central Venous catheter more than 48 hours placed

Exclusion Criteria:

* pregnancy
* denial Informed consent Form
* ethanol intolerance
* Liver cirrhosis
Molecular Modulation of the Growth Plate

The researchers are trying to identify molecular mechanisms that control growth plate mediated limb growth and identify agents that can be used to enhance or slow growth.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally immature children/adults undergoing surgical procedures where growth plate cartilage is removed as a normal part of their procedure; or patients undergoing surgical procedures where bone is removed as a normal part of their procedure.

Exclusion Criteria:

* Skeletally mature children/adults
Tau And Connectomics In TES Study

This pilot study aims to assess if participants that meet the criteria for a TES diagnosis have a specific tau deposition profile on PET scanning using the PET tau binding ligand - \[18F\] PI-2620. It is hoped this study will highlight potential diagnostic tests of TES diagnosis, the in-life correlate of CTE.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have full capacity to understand the purpose and risks of the study to provide informed consent.
* All participants must be between 40 to 70 years of age.
* Must meet the Traumatic Encephalopathy Syndrome criteria as defined by the National Institute of Neurological Disorders and Stroke Consensus Diagnostic Criteria for Traumatic Encephalopathy Syndrome, Katz. D, et. al. Neurology, 2021.
* Participants must demonstrate that they have a cognitive decline, evident by performance on neuropsychological testing.
* Standard of care blood screening within 12 months of consent to the study to exclude other medical conditions which may cause cognitive decline, such as heavy metal toxicology.
* A PET scan within 6 months of consent to the study that is not consistent with Alzheimer's disease.
* Participants must consent to undertake Positron Emission Tomography (PET) with intravenous \[18F\] PI-2620 PET tracer ligand.
* Participants must be able to lie still, on their back for up to 60 minutes for the scans.
* Participants must not have any metal in their bodies e.g. pacemakers, aneurysm clips which are contraindications of MRI.
* Participants must consent to the use of their medical records and medical history, including but not limited to pathology results, previous imaging results and neuropsychology results

Exclusion Criteria:

* Participants will be excluded if they do not meet all the inclusion criteria.
* Participants must not be diagnosed with or suspected to be suffering from any other neurodegenerative disease, or cerebral disease affecting cognition as identified by results of neuropsychological evaluation or neurologist consultation.
* Participants will be excluded if Staff at Macquarie Medical Imaging determine that the participant is not suitable for imaging, for any reason.
* Participants will be excluded if they have kidney and/or liver dysfunction as diagnosed by a doctor
Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

This is a controlled non randomized study that will compare a group of patients with BN that participate in the SBS group therapy with a group of BN patients who will be in wait list as a control condition.

Patients for this single center trial will be recruited from the outpatient facility of the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain).

After assessed for eligibility participants will be given a set of self -report questionnaires. After the questionnaires are completed participants will be allocated to wait list condition or to the treatment arm. Time between assessment and starting the SBS group will be a month or least. Participants will be administered the same questionnaires the following month after finishing the treatment or after 3 to 4 months after the first assessment for the control condition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic of Bulimia Nervosa

Exclusion Criteria:

* Not understanding Spanish or Catalan Language
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count \<30 G/L) who failed previous first-line treatment with corticosteroids.

After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

Eligibility Criteria:
Key Inclusion criteria

1. Male or female patients aged 18 years and older on the day of signing the informed consent.
2. A signed informed consent must be obtained prior to participation in the study.
3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
4. Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag

Key Exclusion criteria

1. ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
4. Patients with current or history of life-threatening bleeding
5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
7. Patients with hepatic impairment
8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
9. Nursing (breast feeding) or pregnant women

Other protocol-defined inclusion/exclusion criteria may apply.
To Achieve Blood Pressure Control With Retained Quality of Life

The purpose of the study is to get an understanding about what problems patients with hypertension are facing, how they manage these challenges, how they feel and what requirements they believe are important to have in their treatment. These factors will later act as a foundation and incentive for designing an intervention that may result in more patients achieving blood pressure control with maintained quality of life.

This is a Swedish observational mixed-methods study to get an understanding about what problems patients with hypertension are facing. The information will act as a foundation for designing an intervention/interventions that may result in more patients achieving blood pressure control with maintained quality of life. Patients, who have well/not well controlled blood pressure, are to fill in questionnaires about their view on ability to perform self-care and their perceived quality of life. Individual interviews will also be made about for what reasons they do or do not change lifestyle as well as take their drugs to treat their hypertension. In focus group interviews the patients are to be asked about what they want and expect in the encounter with health care personnel, what other things outside the health care area would be helpful for the patient and how age, gender, cultural and psychosocial aspects affect the ability to achieve blood pressure control. The developed future interventions will be evaluated in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with hypertension since 9 months
* being able to read and speak Swedish

Exclusion Criteria:

-
Introducing a New EEG Based Index for Monitoring Recall Under Sedation

This is a single centre prospective observational study that will investigate a new EEG based index in recognizing recall of anesthesia in sedated patients.

Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies (such as BIS and others) were developed in order to identify this condition during anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However, these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the awake patient. Due to the very low prevalence of awareness under general anesthesia it is difficult to validate or invalidate the effectiveness of these monitors directly. Nevertheless, sedation often involves much greater prevalence of awareness, which permits to evaluate identification of recalled awareness with much humbler sample size.

The current available depth of anesthesia EEG based monitors are not effective in sedated patients since they are susceptible to muscle activity effect, which is present under sedation.

Based on the current literature in the field of electrophysiology the investigators have developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the anesthetic level. It is based on a comparison of anterior brain activity levels to posterior brain activity levels in response to anesthetic medication. The novelty of the index is stem from the fact that it is based on analyzing EEG data from only 4 electrodes covering the frontal and posterior brain activity. The investigators have shown in a proof of concept study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle activity thus is the only index that can identify recall in sedated patients.


Eligibility Criteria:
Inclusion Criteria:

Research group:

1. Patients old 18-80 years
2. ASA I-III criteria
3. Patients undergoing sedation for lithotripsy

   Control groups -
4. Control general anesthesia group - Patients ASA I-III criteria, undergoing general anesthesia for general surgery
5. Control awake group - Awake healthy volunteers,

Exclusion Criteria:

Lack of informed consent, Age \> 80 years, Age \< 18 years pregnant women patients who do not comply with ASA I-III criteria.
Concept Mapping: as a Tool for Problem Based Learning

This study delves into the utilization of concept mapping as a strategic tool within problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive awareness, and self-directed learning abilities. Concept mapping, a visual representation of knowledge structures, is explored as a means to cultivate and refine students' problem-solving capabilities, preparing them for challenges in various domains.

This study delves into the utilization of concept mapping as a strategic tool within problem-based learning (PBL) to enhance students' problem-solving skills, metacognitive awareness, and self-directed learning abilities. Concept mapping, a visual representation of knowledge structures, is explored as a means to cultivate and refine students' problem-solving capabilities, preparing them for challenges in various domains. Additionally, the research investigates how concept mapping within a PBL context promotes metacognitive awareness, helping students become more conscious of their learning strategies and enabling them to identify gaps in understanding. Moreover, the study explores the role of concept mapping in empowering self-directed learning, fostering autonomy and a deeper sense of ownership over students' educational journeys. The insights gained from this research not only inform instructional design practices, providing evidence-based strategies for enhancing problem-based learning through concept mapping but also contribute to the broader educational research discourse, offering valuable perspectives on effective teaching and learning strategies.

Eligibility Criteria:
Inclusion Criteria:

* from 2 -4th academic year
* accept to participate in this study

Exclusion Criteria:

* first academic year
* psychological or mental disorder
Plyometric Exercises Versus Isometric Exercises With Theraband Elastic Band in Water Polo Players

Introduction: The improvement of strength affects muscle volume, dynamic stability and sports performance in water polo athletes. Plyometric exercises can improve biomechanics, performance and the most explosive actions during sports. The work done with elastic bands will increase the effectiveness and the resistance on the isometric exercises developed.

Objectives: To evaluate the effectiveness of plyometric exercises in the increase of quadriceps muscle strength, volume and stability dynamic in female athletic of water polo players from 18 to 25 years old.

Study Design: A randomized, multicentric, single-blind clinical study with a follow-up period.

Methodology: 25 water polo players will be recruited and randomly assigned to the two study groups: experimental (plyometric exercises plus isometric exercises with elastic bands) and control (isometric exercises with elastic bands). The intervention will last for 8 weeks, with 3 weekly sessions, of 15 minutes each. The study variables will be: strength (measured with the RM test), muscle volume (using anthropometry), and dynamic stability (through the SEBT test). The analysis of normality will be carried out with the Shapiro Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).

Expected Results: It is expected to observe improvement in muscle strength and quadriceps volume, as well as dynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Swimmers with more than 2 years of sports practice
* Age range of 18 to 25 years
* Currently participate in national championships.

Exclusion Criteria:

* Have some type of musculoskeletal injuries at the time of the study
* Not signed the informed consent document.
Adaptability to Stress of Healthcare Workers in the 8th Arrondissement

Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes:

* Diet, nutrition and micronutrition
* Physical activity
* Sleep
* Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.


Eligibility Criteria:
Inclusion Criteria:

* People of legal age
* Health professionals and players from the CPTS Paris 8 association:

  * Pharmacist,
  * Doctor
  * Midwife
  * Physiotherapist,
  * Dentist,
  * Nurse,
  * Pharmacy assistant,
  * Dietician-nutritionist,
  * Speech therapist,
  * Chiropodist,
  * Adapted physical activity teacher,
  * Medical secretary,
  * Other health service staff (maintenance, reception, general services and IT staff).
* Persons having given their non-opposition to participate in the study.
* Persons affiliated to a social security scheme or beneficiaries of such a scheme (article L1121-11)

Exclusion Criteria:

* People already following a wellness programme.
* People undergoing treatment for stress prescribed by a doctor.
* People on sick leave or long-term leave who are no longer at work and who cannot be included in the study.
* People with a poor understanding of spoken and/or written French.
* Vulnerable persons in accordance with article L1121-6 of the CSP.
* Persons subject to a legal protection measure (guardianship, curatorship) or unable to express their consent/non-opposition in accordance with article L1121-8 of the CSP or under court protection in accordance with article L1122-2 of the CSP.
Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

People with multiple sclerosis (MS) have variable adherence to MS medications, making the full efficacy of disease modifying therapies unrealized and the assessment of true treatment failures challenging. Whereas some patients forget to take medications due to active lifestyles, others may have cognitive impairments that prevent them from organizing and planning their regular dosing schedules. An electronic pill cap ("Pillsy") has been developed to record pill taking, timing, and set reminders through a mobile app. Data on adherence can be captured and analyzed remotely for health care provider review.

The investigators will enroll 85 adult patients, 18 years old and above, with relapsing remitting multiple sclerosis (RRMS), at the Massachusetts General Hospital MS Clinics in a pilot study of Pillsy electronic pill bottles. People with RRMS who are taking (1) fingolimod, (2) dimethyl fumarate, (3) terifluonomide, (4) diroximel fumarate, or (5) siponimod will be eligible. Patients must possess any type of smartphone capable of downloading the Pillsy application to be eligible. Per the Pillsy manufacturer, the Pillsy application is available on iPhones connected to the Apple App Store and smartphones running the Android operating system that are connected to the Google Play Store. Participants will be asked to use the Pillsy bottle for 90 days each. Participants will be randomized 1:1 to two conditions: 1) active reminders and 2) passive adherence tracking. Patients in the active reminders group will receive daily alerts through the Pillsy bottle, the Pillsy app, and their phone to remind them to take their pill. Patients in the passive adherence tracking group will not receive reminders and will instead have usual adherence monitored by the electronic pill bottle.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide individual written consent
* Ability to understand sufficient levels of English to use the Pillsy app
* Ability to come to Massachusetts General Hospital for two study visits over a 90-day window OR ability to access Zoom for virtual study visits
* Possess a smartphone
* Willingness to follow the study protocol

Exclusion Criteria:

* Presence of an MS relapse requiring acute management and/or hospitalization
* Daily medication provided by allied health care workers
* Foreign travel preventing electronic remote monitoring
* Expectation of discontinuation of the oral disease modifying therapy (DMT) in the upcoming 90 days for any reason
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study

This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
* Any psychopharmacological medication should be stable since 1 month.
* Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.

Exclusion Criteria:

* Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
* Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,