cyrilzakka/clinical-trials huggingface dataset:
Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients

The study aims to test the Mindful Construal Diary (MCD- a mindful eating intervention) initially developed by Mantzios and Wilson. The diary aims to facilitate weight-loss, while also promoting a present centred awareness to current food consumption. There has yet to be any research testing the MCD in clinical populations.

(BSP = Bariatric surgery patients) The MCD is an intervention that consists of 10 questions an individual must consider prior to eating, and revisit while eating. Mindfulness refers to being consciously aware in the present moment and being accepting to emotions, and in practice, ME can be defined as an awareness to thoughts, feelings and emotions related to current food consumption (e.g., portion size, feelings of hunger/satiety, and healthfulness of food). Being underpinned by both concepts, the MCD intervention prompts individuals to consider aspects of their meal by generating a more focused perspective to the experience of eating. Current applications of mindfulness in health-related settings are promising, benefits include long-term weight-loss, and decreases in symptoms associated with physical and psychiatric disorders. Although the MCD is similarly associated with weight-loss, existing literature on its utility within the bariatric surgery population is scant. Furthermore, as weight regain is often observed post-surgery, it is important to explore how the MCD can help BSP overcome this obstacles. Furthermore, as the MCD is yet to be applied to BSP, this research will also establish whether the MCD is effective in promoting mindfulness, ME and subsequent weight-loss in this population. The potential benefits of this research are broad, as it can help establish a novel approach to effective weight-loss in BSP, and equip health care practitioners with a cost-effective weight-loss intervention. This research will employ a mixed-method design, where participants will be asked to maintain use of the MCD when eating for a three month period, and at their usual care visit complete questionnaires and an interview. Participants will be recruited from Heartland Hospital's Bariatric Clinic.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* Bariatric surgery patients cared for at Heartlands Hospital
* English speakers (reading and writing)
* Post bariatric surgery

Exclusion Criteria:

* Under the age of 18 years old
* A lack of capacity
* Not cared for at Heartlands Hospital
* Non-english speakers (reading and writing inc)
* Special communication needs
* Severe mental health illness
Restoration of Atrioventricular Synchrony Trial

The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and chronically using echocardiographic and functional measurements.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with:
* QRS width \< 120 msec
* Left ventricular ejection fraction (LVEF) \< 35% (no more than 180 days prior to enrollment)
* NYHA functional class II/III
* Optimal pharmacological heart failure therapy
* PR interval \>/= 230 msec
* Ability to tolerate protocol required programming
* Access to a telephone line compatible with the LATITUDE® Communicator
* Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol

Exclusion Criteria:

* Previously placed pacemaker, ICD, or CRT device
* Inability or refusal to sign the Informed Consent Form
* Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months
* Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
* Inability or refusal to comply with the follow-up schedule
* Have a neuromuscular, orthopedic, or other noncardiac condition that prevents subject from normal unsupported walking for the six minute hall walk test
* Have surgically uncorrected primary valvular heart disease
* Second or third degree atrioventricular block (AVB)
* Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies
* Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future
* Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group
* Women who are pregnant or plan to become pregnant
Impact of Computerized Reminders on Blood Pressure Documentation and Control

Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.\[21-23\] However, to our knowledge, there have been no studies examining the relationship of physician adherence to JNC guidelines to racial disparities in outcomes from HTN; nor have there been published studies examining the use of interventions such as computerized decision support tools or case-management to improve JNC adherence with the goal of reducing racial differences in blood pressure control. The aims of this study are: 1) To determine if physician's prescribing practices for HTN medications adhere to JNC guidelines for drug therapy.

2) To determine if there are variations in adherence to JNC guidelines based on patient race.

3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To determine if the use of computerized medical reminders improves adherence to JNC guidelines.


Eligibility Criteria:
Inclusion Criteria:

We examined data obtained from the electronic medical record review of patients older than 20 years with a diagnosis of hypertension, with at least one hypertension-related outpatient visit to one of fourteen general medicine clinics in community health centers, community-based practices, and hospital-based practices affiliated with a large urban academic medical center during the one-year period prior to the beginning of the intervention trial.

Exclusion Criteria:

Patients without documented hypertension-related primary care visits or less than 20 years of age
Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
* Patient is able and willing to administer eye drops.
* Patient is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

* Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.
* Known sensitivity to any of the ingredients in the study medications.
* Abnormal eyelid function.
* History of herpetic keratitis.
* History of non-compliance with using prescribed medication.
* Current or planned pregnancy within the study duration.
* Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.
* Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma

Background and objective

The introduction of a proteasome inhibitor bortezomib has significantly improved response rates and overall survival in patients with multiple myeloma (MM), and it has soon become the cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However, the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which becomes an obstacle during treatment with bortezomib, either alone or in combination. Until now, there are no consistent findings regarding the risk factors that may cause BiPN. There is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk factors of BiPN using retrospective analysis in a large cohort with longer observation period as well as the relations between BiPN and gene polymorphisms, and to compare different routes in the incidence of BiPN.

Methods

This is a retrospective cohort study with a sample size of about 400 MM patients treated ever with at least one full cycle of bortezomib in the institution. All the patients enrolled need to be adults (≧20 years ) with measurable M-component in either blood or urine. The investigators will perform a retrospective chart review to collect clinical data, including anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also plan to perform genotyping for the possible genetic factors associated with development of BiPN.

Expected contributions

The successful collaboration between clinical hematologist-oncologist and biopharmaceutical researcher would result in the concrete evidence of efficacy and safety of bortezomib in Taiwanese patients with MM. The findings in this large cohort study will unveil the risk factors of BiPN, including the administration routes and ethnicity. As results, the investigators would be able to provide the precision medicine-based bortezomib treatment strategy to MM patients in Taiwan.


Eligibility Criteria:
Inclusion criteria

1. Age \>20 years
2. Diagnosed with MM
3. Bortezomib new users (2006/4/1-2016/6/30)

Exclusion criteria

1. Varying on IV and SC administration
2. Receive bortezomib at other hospitals
Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study

Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants with a high incidence and significant impact on resource utilization and long-term outcome. Systemic corticosteroids have been shown to be effective in the prevention of BPD through their potent anti-inflammatory effects but there are serious concerns on their potential detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids administered to ventilated infants are thought to be safer due to their topical effect but have not been shown to improve outcomes including BPD. To date, there have been few studies evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot trial to examine the impact of inhaled budesonide on non-ventilated infants.

The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a small cohort of preterm infants.

This will be a single-center randomized double-blind controlled pilot trial. We will recruit a total of 50 infants born at less than 30 weeks gestation who are on continuous positive airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later. Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7 weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD, re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse outcomes.

The prevention of BPD would have a significant positive impact on patient quality of life and medical resource utilization and costs. The study hypothesis is that inhaled budesonide on non-ventilated infants with early signs of BPD will reduce the 'days on supplemental oxygen' indicating a positive effect for the prevention of BPD. The result of this pilot study might also justify and support to proceed to a large confirmatory study to evaluate an effect of the intervention on BPD, in which the estimate of the impact on BPD gained in this pilot trial may be used to calculate a sample size.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous breathing preterm Infants on day 14 to day 42 of age
* Born at \< 30 0/7 weeks gestational age
* Requiring FiO2 ≥ 25% on CPAP including biphasic CPAP or high flow nasal canula

Exclusion Criteria:

* Presence of chromosomal defects or major congenital anomalies
* Presence of severe infections including sepsis, meningitis, pneumonia, systemic fungal infections
* History of administration of systemic corticosteroids for pulmonary problems, not including that for hypotension
Type 2 Continuous Glucose Monitoring Academy

The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):

* The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
* The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics.
* The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.

Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.


Eligibility Criteria:
Inclusion Criteria:

1. Current age of 13-24 years;
2. T2D diagnosis;
3. Able to speak, read, and write English or Spanish

Exclusion Criteria:

a. Known history of medical adhesive allergies;
Dual-Diagnosis and Compulsory Treatment

The Norwegian Social and Welfare Act of 1992, opened for compulsory commitment of patients with serious alcohol and drug problems to inpatient care. Clinical research of compulsory committed dual diagnosed patients is to date unavailable and is demanded by the health authorities of Norway. Because there has been limited examination/screening and no post-treatment research efforts on this group of patients, the investigators have limited knowledge of the treatment as well as the patient group. Do compulsory treated patients differ from those voluntarily admitted? Does this type of treatment influence the patients' motivation to change their behaviour, and does the treatment effort lead to positive outcome effects in the long run?

The primary aim is to acquire new and in depth descriptive knowledge about the compulsory treated group of patients according to: Drug dependence, psychiatric and somatic co-morbidity and socio-demographic characteristics, and investigate whether the treatment yields the intended outcomes in terms of improved substance abuse measures.

A second aim is to compare the group with a corresponding group of voluntarily admitted patients within the same wards. A follow-up interview focusing on motivational issues within 6 months post treatment to evaluate the long-term results of the treatment is planned.

A quasi-experimental, prospective case-control study will be conducted. Compulsory committed patients in five counties during a two year period, will be compared to a group of voluntarily admitted patients. The groups will be compared regarding 1) description and screening 2) motivation to change and 3) outcome results after 6 months.

Both official authorities as well as clinical practitioners would benefit from valid Norwegian results and knowledge within this field to form further policies and evidence based best practice for this vulnerable group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with alcohol and substance use disorders
* Estimated premorbid IQ of 70 or higher

Exclusion Criteria:

* Active drug or alcohol abuse
SonoVue Guided Prostate Biopsy

This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.


Eligibility Criteria:
Inclusion Criteria:

* Male patient, age ≥ 40 years old
* Optimization part only: Diagnosis of prostate cancer
* Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
* Written Informed Consent and willing to comply with protocol requirements

Exclusion Criteria:

* Documented acute prostatitis or urinary tract infections
* Known allergy to sulphur hexafluoride micro bubbles
* Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
* evolving or ongoing myocardial infarction
* typical angina at rest within the previous 7 days
* significant worsening of cardiac symptoms within the previous 7 days
* recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
* acute cardiac failure, class III/IV cardiac failure
* severe cardiac rhythm disorders
* right-to-left shunts
* Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
* Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
* Determined by the Investigator that the patient is clinically unsuitable for the study
* Participation in a concurrent clinical trial or in another trial within the past 30 days
* Repeated participation in this trial (the patient should not be enrolled twice in the present study)
Brain Network Disruptions Related to Traumatic Coma

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

So far, the gold standard for neuroprognostication of severe traumatic brain injury (TBI) or anoxic encephalopathy is the bedside behavioural evaluation. Nevertheless, the predictive value of such an exclusive clinical approach has been consistently reported as limited and insufficient in this challenging clinical setting. Recent theoretical and experimental data converge towards the idea of the critical implication of long-range brain connection in consciousness access and maintain. Nevertheless, previous studies have focused on the specific analysis of some targeted connections (regions of interest), and have used exclusively a single approach in neuroimaging (structural or functional imaging), with no interest in the neuro-inflammatory and neurodegenerative mechanisms likely associated with these disconnection phenomena. So, cerebral disconnection characterization at the level of the whole brain, at different stages of pathological abolition of consciousness must be made, on an anatomical, functional and metabolic scale. This descriptive study represents a first step in the identification of relevant multimodal imaging biomarkers. This will then lead to a larger study to identify the prognostic impact of these different biomarkers obtained in the acute phase of patient management.

Eligibility Criteria:
Inclusion criteria for patients:

* Male or female / age between 18 to 75 years.
* Coma of traumatic or anoxic aetiology (GCS \< 10).
* Early (\< 1 month after TBI) and after the complete withdrawal of sedative agents.
* Written agreement for participation (legal responsible).

Inclusion criteria for controls:

* Male or female / age between 18 to 75 years, paired with patients (gender and age).
* Written agreement for participation

Exclusion criteria:

* Patients without public insurance regime.
* Pregnancy.
* Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand).

Exclusion criteria for controls:

- pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)
Pharmacokinetic Modeling of Methadone

The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.


Eligibility Criteria:
Inclusion Criteria:

* Major patients on methadone on the same dosage for at least 7 days.
* Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
* 24 hours monitoring is possible and accepted

Exclusion Criteria:

* Patients that cannot be sampled because of weakened veins
* Unable to received information about the study
* Exclusion period determined by previous study
* Adult protected by law or patient under guardianship
* Not affiliated to french social security system
* Not able to give written inform consent
* Pregnant or breastfeeding woman
* Underaged patients (under 18 years old)
* Patient under court protection