cyrilzakka/clinical-trials huggingface dataset:
REducing the Risk of COgnitive DEcline ad Dementia in Patients With Subjective Cognitive Decline Through an Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: the SCD-ReCODED Study

Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Self-perceived decline in cognition compared to five years ago
* Lack of objective cognitive impairment.

Exclusion Criteria:

* Clinically significant depression and anxiety;
* Psychiatric disorders;
* Unstable medical conditions.
* Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
* Dizziness or epilepsy history;
The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment

In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.

This is a single arm before-after study with a historic control cohort to evaluate the effect of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose

Exclusion Criteria:

* Prior treatment with a paclitaxel-based regimen;
* Inability to orally ingest cetirizine
Study of a Polymorphism in Patients With Prostate Cancer

RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA.

PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.

OBJECTIVES:

Primary

* Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer.

Secondary

* Determine the incidence of this polymorphism in African-American patients with prostate cancer.

OUTLINE: This is a retrospective, multicenter study.

DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern.

PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer OR healthy participant
* Patient enrolled on an IRB-approved clinical trial at the National Cancer Institute or Northwestern University, including, but not limited to, any of the following:

  * NCI-99-C-0052
  * NCI-95-C-0178
  * NCI-00-C-003
  * NCI-00-C-0080

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men

This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation program on carotid intima-media thickness and major adverse cardiovascular events in 197 African American men and women at risk for atherosclerotic CVD. After baseline testing, participants were randomly assigned to either a stress reduction program (Transcendental Meditation) or a standard health education program. Follow up was conducted over one year and 12 years.

This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation (TM) program carotid intima-media thickness and major adverse cardiovascular events (MACE) in 197 African American men and women at high risk for ASCVD. This trial compared the efficacy of the TM program to health education over one year on cIMT. Eligible participants were randomly allocated to either the TM program or health education (HE). The primary outcome was carotid intima-media thickness (IMT) assessed by B-mode ultrasonography at baseline and 12 months. Secondary outcomes were blood pressure, lipids, lifestyle, psychosocial stress and MACE. Fatal and nonfatal clinical events were assessed over one year, and mortality after 12 years.

Eligibility Criteria:
Inclusion Criteria:

race/ethnicity: African American, self-identified, age: no upper limit, gender: male or female, minimum carotid artery intima medial thickness (IMT) of at least .72 mm for men and .65 mm for women or long-term history of diabetes, myocardial infarction, coronary artery revascularization or coronary angiography indicating at least one vessel with 50% stenosis.

Exclusion Criteria:

myocardial infarction, unstable angina, CABG, percutaneous transluminal coronary angioplasty (PTCA), or stroke within the previous three months, carotid artery endarterectomy, arrhythmia - atrial fibrillation, second or third degree AV block, congestive heart failure - class III or IV or ejection fraction less than 30 %, clinically significant valvular heart disease, clinically significant hepatic or renal failure, major psychiatric disorders, current alcohol or other drug abuse dependency disorder, non-cardiac life-threatening illness, and participating in a formal stress management program

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PEL-1235_REN-0176-I (Pelicon)

Aim of this study is to investigate whether in patients following kidney transplantation (\>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* signed written informed consent
* male or female patient ≥ 18years of age
* Patient has received a kidney transplantation at least 6 months prior to inclusion into the study
* No acute rejection episodes for at least 3 months
* PRG through level and dosing stable for at least 1 month
* Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study

Exclusion Criteria:

* Acute rejection episodes within the last 3 months prior to study entry
* Unstable PRG trough level or dose change in the month before study entry
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
* Treatment with another investigational product during this study or during the last 30 days prior to study start
A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident

This research study is designed to investigate the effects of a simple cognitive task (a memory reactivation cue following by playing the computer game "Tetris") on flashbacks and other post-traumatic stress symptoms after a road traffic accident. Patients presenting to a hospital emergency department soon after a road traffic accident will be randomly allocated to either the simple cognitive task intervention or usual care. Participants will be followed up at one week and one month. It is predicted that participants given the simple cognitive task intervention will develop fewer flashbacks and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Experienced or witnessed a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
* Met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criterion A1 for Post-Traumatic Stress Disorder (PTSD) ("experienced, witnessed, or confronted with actual or threatened death or serious injury)
* Can be seen in the emergency department within 6 hours of leaving the scene of the accident
* Report memory of the accident
* Fluent in written and spoken English
* Alert and orientated, Glasgow Coma Scale score (GCS) = 15
* Have sufficient physical mobility to play a computer game on the intervention platform (a Nintendo DS) at the point of taking informed consent
* Willing and able to provide informed consent and complete study procedures
* Willing and able to be contacted following discharge to complete follow-up assessments

Exclusion Criteria:

* Loss of consciousness of \> 5 minutes
* Current intoxication
* Report a history of severe mental illness
* Current substance abuse or neurological condition
* Currently suicidal
Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.


Eligibility Criteria:
Inclusion Criteria:

Will be included in this study, patients:

* Having an indication of pancreatic surgery
* In scheduled surgery
* Agreeing to participate in the research (ie who signed the informed consent to research participation)
* \>18yo

Exclusion Criteria:

Will not be included in this study, patients:

* With emergency surgery
* Protected by law
* Under 18 years
* Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)
Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature.

The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for awake craniotomy

Exclusion Criteria:

* pregnancy
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 10 years old
* Myopia: between 0.50 D and 4.00 D in both eyes
* Astigmatism: \<1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
* Anisometropia: ≤ 1.50 D
* Symmetrical corneal topography with corneal toricity \<2.00 D in both eyes
* Agree for randomization

Exclusion Criteria:

* Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
* Any type of strabismus or amblyopia
* Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
* Rigid contact lenses (including orthokeratology lenses) experience
* Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
* Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
* Poor compliance for lens wear or follow-up
Efficacy of Hamstring Stretching According to the Neural or Muscle Tissue Involvement

Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.

Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.

Design: Cross sectional study. Methods: A randomised, blinded, assessor-blinded clinical trial was performed. According to the sample size calculation, a total of 35 subjects will be recruited from the International University of Catalonia. Each subject will undergo three hamstring stretching techniques on their dominant leg, Straight-leg-raise (SLR), Passive knee extension (PKE) and Maximun hip flexion (MHF) with an interval of one week on the dominant leg. Muscle elongation in each stretching modality will be assessed with the modified black saver sit and reach test and whether the technique generates a neural or musculoskeletal response when performing the structural differentiation manoeuvre.

Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.

Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.

Design: Cross sectional study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects over 18 years old who signed the informed consent.

Exclusion Criteria:

* The exclusion criteria were as follows: 1) injury in the thigh 6 months previously, 2) diagnosis of any orthopaedic problem or surgery in the lower limbs, 3) back pain or previous surgery in the spine or 4) systemic or neurological disorders.
Physician Coaching to Reduce Opioid-related Harms

This project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

This project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. The implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings.

The standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. A clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. The implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. This project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. If the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.The long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.

Eligibility Criteria:
Inclusion Criteria:

At each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. All clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants.

Exclusion Criteria:

* Residents will be excluded.
Fluid Requirement During Surgery PVI v Doppler

Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.

Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.

The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.

The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery
* Anaerobic Threshold \>11 ml O2/kg/min
* VE/VCO2 \<34 OR
* Low risk according to Consultant anaesthetist

Exclusion Criteria:

* Patients age less than 18
* Patient refused consent
* Patient unable to give consent
* Patient has had \<24hrs to consider the Patient information Sheet
* Contraindication to Doppler Probe being inserted
* Emergency Procedure
* Patient has a ASA Grade 5
* Patient is receiving dialysis treatment
* Patient has a known hypersensitivity to hydroxyethyl starch or gelatin solutions
* Patients with renal failure with oliguria or anuria - not related to hypovolaemia
* Patients with a previously diagnosed dysrhythmia
* Patients who weight \>100kg
D-Dimer Guided Oral Anticoagulant Treatment (OAT)

This clinical trial will investigate the hypothesis that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of deep venous thrombosis (DVT) using a prospective, randomized, and controlled design.

After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in \~2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, \~10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.

Eligibility Criteria:
Inclusion Criteria:

To be enrolled in this study, patients must:

* have an objectively confirmed first episode of unprovoked VTE or of VTE during a minor transient risk factor. Minor transient risk factors include 6 weeks of estrogen therapy, prolonged air travel (i.e., \> 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention
* be scheduled to receive oral anticoagulant treatment for at least 3 months
* be willing to be randomized
* be willing to participate for the full duration of the study

Exclusion Criteria:

* pregnancy or breast feeding
* contraindications against OAT (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke)
* age \< 18 years
* presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term OAT (i.e., antithrombin deficiency, hereditary PC deficiency)
* poor patient compliance