cyrilzakka/clinical-trials huggingface dataset:
Massive Individualized N-of-1 Experiments (MINEs)

The project will enroll up to 10,000 adult volunteers in individualized experiments (N-of-1 trials) designed to assess the individual-level effects of any of five interventions on three outcomes. The five interventions are: gratitude journaling, mindfulness meditation, random acts of kindness, physical activity, and laughter therapy. The three outcomes are stress, cognitive focus, and happiness. Each participant will engage in the selected activity in 3 day intervals, separated at random by 3 day intervals of usual activity, for a total of six 3-day periods (18 days).

N-of-1 trials (single patient crossover experiments) are a uniquely powerful technique for estimating treatment effects in the individual. N-of-1 trials have been offered to hundreds or perhaps thousands of patients worldwide, but never at scale. HackYourHealth is a tool that supports the conduct of simple N-of-1 self-experiments to test if healthy activities that work in general (i.e., mindfulness meditation, physical activity, gratitude journaling, random acts of kindness, and laughter therapy), improve psychological well-being (stress, focus, happiness) in specific individuals. The tool supplies the experimental design, facilitates data analysis, and channels feedback to participants. The tool is flexible enough to support Massive Individualized N-of-1 Experiments (MINEs) at scale. Working with WNYC Radio in New York City, we will recruit and run 18-day N-of-1 trials up to 10,000 individuals. The purpose of this study is to conduct a formative evaluation of HackYourHealth in terms of its perceived usefulness and to explore heterogeneity in intervention response across the sample. We anticipate that the results will: 1) identify useful behavioral interventions for individual participants; 2) help to estimate generalizable treatment effects for the interventions of interest; 3) assess heterogeneity of treatment effects across subgroups; and 4) elucidate the user experience with N-of-1 trials. When complete, the study will support additional proposals designed to assess the utility of MINEs as applied to additional conditions and treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Living anywhere in the United States
* Using a smartphone
* Having regular access to internet on their phone
* Able to read and write in English

Exclusion Criteria:

There are no exclusion criteria, except that patients with pre-existing cardiovascular disease will be cautioned not to engage in new types of physical activity without consulting a physician.
Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases

This study will combine virtual reality (VR) technology with machine learning to focus on functional movement. Patients' symptoms will be evaluated, and exercise instruction with real-time feedback will be provided. The goals of this research are to: (1) develop a waist digital sensor for real-time monitoring as an evaluation tool, (2) apply a real-time monitoring system in conjunction with virtual reality for telerehabilitation, and (3) develop the standard model.

The remote assessment and training in this study can assist patients obtaining physical therapy care at home. It is suitable for patients who avoid going to the hospital due to the epidemic, and solve the problem of long-term treatment. The outcomes will provide DLSD patients tele-rehabilitation platform and system, help medical personnel to treat patients more effectively in the future, and reduce the burden of medical costs on close ones.

Eligibility Criteria:
Inclusion Criteria:

1. able to stand and walk for 5 minutes independently
2. aged between 50 and 80 years
3. received a diagnosis of DLSD based on imaging

Exclusion Criteria:

1. neurological disorder such as stroke or spinal cord injury
2. metabolic disease such as diabetes mellitus
3. vestibular disease such as Meniere's disease.
Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.

Primary Aim:

To determine the size of the RAS tracts as measured by MRI tractography. Specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. The RAS is involved in mediating arousal and consciousness. The size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. It is hypothesized that treatment will result in an increase in the size of these fiber tracts.

As a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. This will allow the clarification and understanding of the technical standards for MRI tractography related to the assessment of the reticular activating system.

Secondary Aim:

To determine and monitor changes in function following acquired brain injury as measured by the Disability Rating Scale (DRS) score. The DRS score will be obtained prior to initiating treatment and at termination of the study. It is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years - 65 years
* Nonpenetrating acquired brain injury (ABI)
* Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
* Consent from substitute decision maker

Exclusion Criteria:

* Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
* Anticipated neurosurgical intervention
* Medical instability including uncontrolled hypertension, fever, or infection
* Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
* Parkinson's disease
* History of heart failure or pre-existing peripheral oedema
* History of eczematoid dermatitis
* History of angle-closure glaucoma
* History of neuroleptic malignant syndrome
* Current treatment with Amantadine
* Impairment related to other neurologic disease other than ABI
* Allergy to Amantadine
* Pregnancy or lactation
* Impairment of renal function (creatinine clearance less than 60ml/min)
Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)

Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months

Exclusion Criteria:

* Symptomatic epilepsy due to malignant brain tumour or progressive brain disease.
* Confirmed diagnosis of a concomitant chronic disease
Reducing Mental Health in Informal Caregivers

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia

Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients.

Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia
* Informal caregivers can be family members or close friends
* Adults (18 to 89 years old) who read, write, and speak in English
* Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder

Exclusion Criteria:

* Formal caregivers (who are being paid to take care of the patient)
* Any informal caregivers with cognitive impairment is identified during the assessment.
Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder

Stress-related mental disorders are today the leading cause of long-term sick leave in Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called "Exhaustion disorder" (ED). Even though clinical guidelines recommend multi-professional rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment programs in clinical practice. This large-scale open clinical trial investigates whether MPR for ED seems to alleviate symptoms of ED and if it results in return-to-work.

This study is carried out at two specialized stress rehabilitation centers in Stockholm. All patients included in the clinics stress rehabilitation program are asked to participate in the study and are recruited consecutively from October 2017 throughout December 2018. An estimate of 400 patients will be included. The treatment program is a 24-week Multiprofessional standardized CBT-rehabilitation consisting of a nine-session CBT group treatment (stress management) followed by a seven-session group treatment in applied relaxation. Parallel to the group treatments patients receives nine sessions of individual CBT, three visits to an MD (for medication, follow-up, and sick-listing), two individual sessions to a physiotherapist and a three session-exercise group. Also, vocational measures are taken through rehabilitation meetings together with the patient's employer (if an employer exists). Primary treatment outcomes will be return-to-work (RTW) and symptoms of ED, anxiety, and depression. Secondary treatment outcomes will be quality of life, pathological worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms. Predictors of symptom development and RTW will be explored. Also, comorbidity of chronic pain, negative effects of psychotherapy and treatment credibility will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
* 18 - 64 years of age
* Considered suitable for multimodal rehabilitation in group
* Self-rating of \> 4,5 på SMBQ

Exclusion Criteria:

* Abuse of alcohol or drugs
* Moderate-high suicidal risk
* Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
* Untreated PTSD
Preschoolers Active at Child Care (PACT)

The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).

This was a matched pair cluster-randomized study in 10 child care centers. One classroom in each pair received either AP or OP, and their providers received a condition-specific 3-hour workshop. Pre- and post-intervention data were collected from classroom observation and accelerometers. Additional information about teachers' attitudes and practices was collected via pre-intervention survey.

Eligibility Criteria:
Inclusion Criteria:

* Teachers/Staff
* be a teacher/staff member in a participating childcare center
* Students
* be 3 - 5 years old
* be a full day student in the classroom where data collection was occurring

Exclusion Criteria:

-
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

For performing transnasal humidified rapid insufflation ventilatory exchange (THRIVE), jaw-thrust maneuver have to maintain to make sure the airway open and the CO2 clearance during apnoea. The objective of present study is to prove that nasopharyngeal airway facilitate THRIVE and no need jaw-thrust maneuver and maintain the similar PO2 and PCO2 during apnoea.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Undergoing surgery with general anaesthesia.
* Adult, \>18 years old.
* American Society of Anesthesiology classification I-II.

Exclusion Criteria:

* Coagulation disorders or a tendency of nose bleeding
* An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months
* Severe aortic stenosis or mitral stenosis;
* Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
* Acute myocardial infarction in the last 6 months;
* Acute arrhythmia (including both tachycardia and bradycardia) with hemodynamic instability;
* Diagnosed COPD or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
* Increased intracranial pressure;
* ASA \>II;
* Mouth, nose, or throat infection;
* Fever, defined as core body temperature \> 37.5°C;
* Pregnancy, breastfeeding or positive pregnancy test;
* Emergency procedure.
* Patient with known or suspected difficult airway
Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease

Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)

Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Treatment with Bilateral STN DBS
* Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context

Exclusion Criteria:

* DBS for non PD patients
* Unilateral DBS or other DBS targets
* Patients not evaluated with NFS
* Patients with incomplete preoperative evaluation
* Patients who refused the use of their data
Accolade® TMZF® Hip Stem Outcomes Study

The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.

A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is a candidate for a primary total hip replacement.
2. Patient has primary diagnosis of osteoarthritis (OA).
3. Male and non-pregnant female patients ages 18 to 90.
4. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
5. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.

Exclusion Criteria:

1. Patient has an active infection within the affected hip joint.
2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. Patient who is morbidly obese, Body Mass Index (BMI) \> 40.
4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
7. Patient is a prisoner.
Tolerance of Cereals for Atopic Children

In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.

In the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. To feed a baby who has a food allergy, we want a food with low allergenic ingredients.

For this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease.

It allows a smooth transition into and through the weaning period. The ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. It has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms.

In this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test. We are also testing the same product containing an additional ingredient with a potential effect in allergy management.

Such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.

Eligibility Criteria:
Inclusion Criteria:

* Infant aged from 4 to 40 months at the time of enrolment
* With atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test
* Infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment
* Having obtained his/her signed legal representative's informed consent

Exclusion Criteria:

* Infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment
* Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
* Infant whose parents / caregivers cannot be expected to comply with treatment.
* Infant currently participating in another interventional clinical trial
Mindfulness as an add-on Intervention in Treatment for Problem Gambling in Clinical Settings in Sweden

This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. The study will primarily aim to decrease gambling behaviour compared to the control condition which receives the intervention later, after two months, and secondarily to decrease symptoms of depressive and anxiety symptoms. In addition, patients who have undergone the mindfulness intervention will be offered participation in a qualitative interview study aiming to deepen the understanding of feasibility and challenges of a mindfulness add-on intervention against gambling problems.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in any kind of treatment for problem gambling at a regional health care unit for problem gambling or at any municipal social service unit for problem gambling, and who provides informed consent

Exclusion Criteria:

* Inability to provide informed consent due to language difficulties or due to severe mental health problems, or because of mental health problems requiring urgent psychiatric management (such as suicidal, homicidal, delirious or psychotic behavior)
Multicomponent Program for the Integrated Management of Chronic Pain and Depression in Primary Care

This study evaluates whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care

Chronic musculoskeletal pain and depression are extremely common and relevant pathological conditions, and frequently presented as comorbid processes multiplying the impact on health, worsening the prognosis and complicating the care. The integrated management of both disorders is an opportunity to achieve better clinical outcomes.

AIM: To determinate whether the implementation of an integrated clinical program for chronic musculoskeletal pain and depression behave better clinical outcomes than the usual approach in primary care

METHODS

Design: Cluster randomized clinical trials with two arms:

1. Intervention: Integrated program for depression/chronic pain, and
2. control usual care.

Settings: Primary Care Centers in Tarragona, Spain. Patients: Adults with moderate/severe musculoskeletal pain (Brief Pain Inventory/pain intensity scale \> 4 points), with more than three months of evolution and current diagnostic criteria for major depression episode (DSM-IV).

Sample: A total sample of 330 patients (165 control arm and 165 intervention arm) divided into 42 clusters of 8 patients. Cluster composition: patients registered with the same doctor.

Intervention: Structured program with integrated management for depression/ pain with three main components:

1. Optimized care of major depression,
2. Case Management, and
3. Group psychoeducational intervention.

Measurements: "Blind" interviews at 0, 3, 6 and 12 months.

Main outcomes:

* Depressive symptoms (Hopkins Symptom Checklist-20): Severity, response rate and remission rate.
* Pain symptoms (Brief Pain Inventory). Intensity and interference, response rate.
* Disability by psychological problems (Sheehan Disability Inventory)
* Quality of life related to health (EuroQol-5D).

Eligibility Criteria:
Inclusion Criteria:

* Registered patient of a participant doctor
* Chronic musculoskeletal pain moderate to severe (BPI\>4), with more than 3 months of duration despite having received analgesic treatment
* Meeting the diagnostic criteria for major depression (DSM IV) at the time of recruitment.

Exclusion Criteria:

* Patients with mental, physical, language limitation or concurrent illness that prevents understanding/participation in the assessments of the study.
* Patients with serious or terminal illness.
* Patients whit psychotic disorder, bipolar disorder or dependence disorder.
* Pregnant or lactating patient
* Patients diagnosed of fibromyalgia or somatization disorder
* Patient in a process of claim for a work disability
* Intervention for a joint prothesis planned forn next 12 months.