cyrilzakka/clinical-trials huggingface dataset:
Barriers and Facilitators of Key Stakeholders to Implement Remote Monitoring Technologies: a Mixed-methods Analysis

Advancements in digital technologies alongside the global pandemic of COVID-19 have accelerated the adoption of novel healthcare pathways worldwide, with healthcare delivery transitioning beyond the traditional face-to-face model. Telemedicine has gained long over- due exposure during a complicated crisis; as the number of cases continue to grow with second waves predicted, digital modalities have become critical in moderating exposure risk to healthcare staff, reducing community spread, and delivering quality healthcare remotely for exposed or infected individuals.

Remote monitoring solutions are being established internationally to allow individuals to continue living at home rather than in expensive hospital facilities using non-invasive digital technologies (such as wearable sensors) to collect health data, support health provider assessment and clinical decision making.

With the advances in technology miniaturisation, sensors have become increasingly portable, unobtrusive, lightweight, and waterproof, offering an emerging solution to continuous remote monitoring of vital signs. It is predicated that continuous monitoring allows for early recognition of clinical deterioration, and through digital alerting, offers an opportunity for earlier clinical intervention, improving patient care and patient outcomes.

Within the United Kingdom (UK), widespread digital transformations are facilitated by NHS digital, a non-departmental public body created by statute, delivering large health informatics programmes. As such, this study aims to investigate key stakeholder perspectives on an organisational level of implementing remote monitoring solutions, given the pandemic, in the National Health Service (NHS), identifying factors that could affect successful execution and adoption.


Eligibility Criteria:
Inclusion Criteria:

* A mixed methods approach will be implemented: semi-structured interviews will be conducted with high level stake holders from industry, academia, and healthcare providers who have played an instrumental role with prior experience of implementing digital solutions.

Exclusion Criteria:

* not able to provide informed consent
Pharmacogenetic Treatments for Alcoholism

Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication.

This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.

This study is a 24 week clinical trial. During the 24 weeks participants will receive either ondansetron or placebo. Participants will also receive Brief Behavioral Compliance enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e., African-Americans and European-Americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs. TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group assignment will be achieved using a block randomization procedure that balances the treatment groups on PHDD, age, and gender.

Eligibility Criteria:
Inclusion Criteria:

* Males and females who have given written informed consent
* Between the ages of 18 and 65 years and weighing within 30% of ideal body weight. Also, patients must weigh at least 40 kg and no more than 155 kg.
* Good physical health as determined by a complete physical examination, an electrocardiogram (EKG) within normal limits, and laboratory screening tests within acceptable parameters.
* Current DSM-IV diagnosis of alcohol dependence
* AUDIT score of ≥8
* Currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for men in the last 30 days, and have met this criteria prior to randomization
* Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months.
* Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
* Expressed a wish to reduce or stop drinking
* Willingness to participate in behavioral treatments for alcoholism

Exclusion Criteria:

* Please contact site for additional information
Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 to 50 years
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
* Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
* A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria:

* Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
* Asthma requiring treatment other than beta-2 inhaled agonists.
* Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.
Online Mindful Self-Compassion Training for Medical Students: an Exploratory Feasibility Study

The goal of this clinical trial is to develop and investigate a compassion-based intervention (Self-Compassion for Healthcare Communities (SCHC) course) in medical students. The main objectives are:

1. Explore the feasibility of trial processes including recruitment, adherence, retention, and follow-up
2. Explore the experiences of medical students with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
3. Determine potential effects on burnout, compassion fatigue, compassion satisfaction, self-compassion, compassion for others, empathy, mindfulness, perceived stress, and emotional regulation.

Participants will be asked to take part in a 6-week online Self-Compassion for Healthcare Communities course and report changes in levels of burnout, compassion fatigue, compassion satisfaction, self-compassion, compassion for others, empathy, mindfulness, perceived stress, and emotional regulation from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement.


Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in first or second-year of the MD or MD/PhD program at the University of Toronto,
2. Over 18 years of age,
3. Able to speak, read, and write in English,
4. Willing to take part in the SCHC course for up to the full 6-week duration,
5. Willing to complete all study related questionnaires

Exclusion Criteria:

1. Those already having completed a mindful self-compassion course or Mindfulness based-intervention (Mindfulness-based stress reduction or Mindfulness-based cognitive therapy) within the past 12 months.
The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family

Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.


Eligibility Criteria:
Inclusion Criteria:

The patients will be:

* over the age of 65 and under 80
* with a colorectal cancer operated between 65 and 80 years with a documented histological diagnosis, dating from 2 to 5 years.
* be able to provide informed consent and appoint a caregiver who would be willing to participate in the study.

The spouse and / or children and / or parents will be eligible:

if he is at least 18 years old, if he can be considered a caregiver of the index patient for whom a diagnosis of CRC has been made.

Exclusion Criteria:

* Patients with a diagnosis of colorectal cancer before the age of 65 or after the age of 80 from 2 to 5 years old.

Near a deceased patient or under 18 years old.
Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Children of both gender
* Aged from 2 to 5 years
* With fever \>37.5 C (99.5 F)
* Will be presented with symptoms and signs of uncomplicated community acquired pneumonia

Exclusion Criteria:

* Children requiring ICU care (having cyanosis SpO2 \< 85% requiring intubation within first day of admission or in state of shock)
* Children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency
* Children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation
* Children already on antibiotics
* Presence of any complication of community acquired pneumonia
* Patients having symptoms of multi-organ involvement/sepsis
* Hypersensitivity to Amoxicillin or Ceftriaxone
* Other co-existing infections like dengue, malaria, or measles
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies

EXALT-2 is a prospective, randomized, three arm study for treatment decision guided either by either comprehensive genomic profiling, next generation drug screening or physician's choice


Eligibility Criteria:
Inclusion Criteria:

* patient is suffering from aggressive haematological disease AND has undergone at least two lines of previous therapies AND/OR has undergone at least one previous therapy and no standard treatment is available in the specific disease setting and disease specific guidelines recommend treatment in studies.
* duration of last response is less than 6 months defined as first day of last treatment to date of relapse, the response duration has to be available with dates (dd/mm/yyyy) for initiation of and relapse to previous treatment.
* best response to previous treatment has to be available.
* The patient is able to give written informed consent and wishes to undergo further therapy
* further therapy is medically feasible
* tumor cell-containing samples can be obtained

Exclusion Criteria:

* current participation in another experimental clinical trial
* performance status does not allow participation (ECOG ˃ 1)
* pregnancy, tested at screening
* patient suffers from classical or nodular, lymphocyte predominant Hodgkins lymphoma.
* other malignoma, diagnosed \<1a before inclusion (except localized squamous cell carcinoma of the skin, surgically curable melanoma of the skin, basal cell carcinoma of the skin)
Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders

The term or definition of Autism Spectrum Disorder (ASD) defines a pervasive neurodevelopmental disorder in which deficits in communication and social interaction, altered sensorimotor behaviours, repetitive, restricted and stereotyped interests and activities are observed.

One of the disorders most frequently associated with ASD, and which most affects the quality of life of the child and his or her family, is sleep disorders; it is estimated that between 50 and 80 percent of children with ASD present this alteration and generally continue to suffer from it in adolescence and adulthood; It has also been observed that there is a correlation between sleep problems and an increase in aggressive behaviour, social and emotional deficits and deficits in activities of daily living, which severely affects the child and his or her close family environment; they become emotionally destabilised in a notorious way, and this has a negative impact on their work and productive environment.

The microcurrents generated by the non-invasive neuromodulation device introduce, by means of a non-invasive technique (surface electrodes), electrical energy to normalise the nervous stimulus. This makes it an excellent complementary treatment to the activity of rehabilitation treatment. Its effects are achieved by establishing several input nerve pathways corresponding to the body's dermis, through which the signals are intellectualised in time-space. These signals are the basis for achieving normalisation of the nerve impulse by means of microcurrents.

The main objective will be to test the influence of surface neuromodulation applied NESA on sleep disturbances in children with Autism Spectrum Disorders and how this is related to disruptive behaviours and quality of life in the family environment.

It is estimated to take 8 months from the design, management and development of the project, and does not have sources of funding.

Eligibility Criteria:
Inclusion Criteria:

* Children with a diagnosis of Autistic Spectrum Disorder, attending school in the City of San Juan de Dios in Las Palmas de Gran Canaria.
* Children with symptoms related to sleep disturbances.
* Children who present episodes of disruptive behaviour.
* Children who may present sensory alterations or cognitive deficits.
* Children whose parents sign the informed consent form.

Exclusion Criteria:

* Present some of the contraindications for treatment with NESA XSIGNAL®: pacemakers, internal haemorrhages, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity.
* If parents do not sign the informed consent form.
* Presence of uncontrolled convulsions.
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.

A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. RVHD diagnosed by echocardiography at any time prior to enrollment
2. Age ≥18
3. Increased risk of stroke by any of the following

   1. CHA2DS2-VASc score ≥ 2 OR
   2. Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
   3. Left atrial spontaneous echo contrast OR
   4. Left atrial thrombus
4. Heart Rhythm

   1. AF or Flutter and unsuitable for VKA therapy. (AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram). OR
   2. In the absence of AF or Flutter, patients would be eligible in the presence of any one of the following:

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   1. Left atrial enlargement ≥5.5 cm OR
   2. Left atrial spontaneous echo contrast OR
   3. Left atrial thrombus OR
   4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter monitoring

Exclusion Criteria:

1. Refusal to give informed consent
2. Actively involved in any study that would compromise the protocol of INVICTUS Trial
3. Severe co-morbid condition with life expectancy \< 1 year
4. Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
5. Likely to have valve replacement surgery within 6 months
6. Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.
7. Contraindication to the study medication of the trial

   * Allergy to rivaroxaban
   * Allergy to VKAs ( non-inferiority trial)
   * Allergy to aspirin ( superiority trial)
8. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) \<15 ml/min
9. Serious bleeding in the past six months or at high risk for bleeding
10. Moderate to severe hepatic impairment
11. Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
12. Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
13. Received an investigational drug in the past 30 days
14. Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
15. Women who are pregnant and/or breastfeeding
16. Women of child bearing age who do not use an effective form of birth control.
Music Therapy in Alzheimer's Disease

The primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with AD or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the Neuropsychiatric Inventory (NPI).

The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

A technique of receptive music therapy to induce relaxation has been developed in the university hospital of Montpellier: the "U" sequence. The musical sequence lasts 20 minutes and is made up of several phases that progressively induce a relaxed state in the patient. This effect is obtained by modulating the rhythm of the music, the orchestral formation, frequencies and volume. The phase of maximum relaxation is followed by a stimulating phase. These musical sequences have been specially designed by the music publishers Music Care©.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either sex aged 65 years and over, living in an institution for the dependent elderly for at least 3 months
* Subjects with Alzheimer-type dementia (DSM-IV and National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria)or related symptoms
* If treated, Treated for at least 6 months with a stable dose of cholinesterase inhibitor or memantine
* Mini-Mental State Examination (MMSE) score between 5 and 20
* Patients with disruptive behaviour (at least one disruptive item on the NPI: oppositional behaviour/aggressiveness/agitation, aberrant motor behaviour, with a severity score grater than or equal to 4) and treated with at least one neuroleptic whose dose which could not be decreased because of persistence of the behavioural problems for at least 15 days.

Exclusion Criteria:

* Decompensated physical disease
* Inability to give informed consent
* Lack of health insurance coverage
* Non-corrected hearing impairment
* treatment ongoing with two or more neuroleptics
Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function

Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS.

To assess the effects on arterial function and structure and hemostatic parameters using an levonorgestrel intrauterine device (IUS-LNG) in women with obesity

A randomized controlled clinical trial.

Setting: Academic hospital.

88 women between 18 and 40 years of age with obesity (BMI between 20 and 40 kg/m2)randomized to use IUS-LNG or Copper-IUD for 12 months

Exclusion criteria: category 3 and 4 Medical Eligibility Criteria for IUD-Cu and IUS-LNG - WHO-2010, pregnancy, lactation, concomitant drugs, smoking.

Main Outcome Measures: Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers of cardiovascular disease and hemostatic parameters will be also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive

Exclusion Criteria:

* any clinical conditions corresponding to category 3 or 4 of the World Health Organization medical eligibility criteria for IUD-LNG or IUD-CU use smoking
* alcoholism
* illicit drug use
* any systemic disease (systemic arterial hypertension, DM, immune system diseases or thyroid diseases) except PCOS
* current or previous (up to two months before the study) use of oral, vaginal, monthly injectable or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant or intrauterine device)
* twelve weeks or less since childbirth
* currently breastfeeding or had stopped breastfeeding within two months of the screening visit
* chronic and/or acute inflammatory processes
* use of drugs known to interfere with inflammatory markers or with CVD risk (anti-androgens, hypoglycemic drugs, anti-inflammatory drugs or statins)