cyrilzakka/clinical-trials huggingface dataset:
Personalized Music Therapy and Agitation in Dementia

Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).

This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
* moderate stage of dementia, a score of \<20 on MMSE;
* Age 60 to 90 inclusive;
* Preserved hearing (hearing aids are permissible);
* Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.

Exclusion Criteria:

* auditory deficits requiring correction beyond hearing aids.
* no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
* recent acute event eg. MI, fractures, or major infection (not UTI)
* patients receiving standing orders of medication for personal care
Steppin' Up: Positive Youth Development Program

As an antidote to juvenile aggression and violence, which has increased in recent years, group mentoring offers a viable alternative to intensive one-on-one mentoring. However, no group-mentoring programs have been evaluated.

The purpose of this study is to assess the efficacy of a school-based, group-mentoring intervention designed to prevent aggressive and deviant behavior among early adolescents.

Study participants will be incoming 6th grade students from two inner-city Baltimore middle schools and their parents. Approximately 1,400 students and their parents are expected to participate. All 6th grade students in these schools are eligible for the study.

Weekly student group-mentoring sessions are the principal component of this study. These groups will be held during the school day and will be designed to increase social skills and encourage academic engagement, restraint, and problem-solving. A master's level professional will direct and conduct these intervention activities, which will employ the use of field trips, cooperative games, discussion of real-life situations, and role playing.

Students will also complete a 1-hour written survey each fall and spring from grades 6-8 about the program and about attitudes and behaviors related to school involvement and staying healthy and safe. Study staff will contact participants' teachers and review their past and current school records, including attendance, grades, and disciplinary information.

Parents may be asked to participate in group meetings and will complete in-person or telephone interviews (about 20 minutes each) about similar information over a 3-year period (6th grade to 8th grade).

Group mentoring offers a potentially viable alternative to intensive one-on-one mentoring. However, no group mentoring programs have been evaluated. The purpose of this study is to assess the efficacy of a school-based, group-mentoring intervention designed to prevent aggressive and deviant behavior among early adolescents. Two successive cohorts of incoming 6th grade students from two inner-city Baltimore middle schools and their parents will be randomized to comparison group or intervention group consisting of weekly group-mentoring sessions for youth and persuasive communication and small-group media-development projects for parents.

Eligibility Criteria:
* INCLUSION CRITERIA:

The population of interest for the randomized trial is 6th-grade students and their parents in two participating Baltimore middle schools. Participating schools are urban, inner-city schools located in neighborhoods with low SES and high rates of unemployment and crime.
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity

Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
* Mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the Fugl-Meyer scale).

Exclusion Criteria:

* Cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the Mini Mental State Examination scale)
* Severe attention deficits or hemispatial neglect (as measured by the Mesulam Cancellation test and the Line Bisection test);
* Severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the Modified Ashworth scale) that would prevent safe performance of home-based exercises;
* Proprioceptive deficits that impair their ability to process feedback (as measured using the Fugl-Meyer Assessment-upper extremity; sensory section).
* Implantable medical devices that are not compliant with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for Bluetooth compatibility. We will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. If not, they will be excluded from the study.
* Participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...).
* Recent (\< 3 months) Botox injection in the upper-extremity or plan to undergo injections during the study timeline.
Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects

The therapeutic use of ALA in schizophrenia has recently been investigated in human populations. A case series explored the effiacy of ALA as a novel agent to treat antipsychotic-induced obesity, at a dose of 1200 mg/d (range between 600 and 1800 mg/d); reporting the key effect to be a reduction in body weight and BMI after a 12-week treatment. In a pilot open-label trial, 100 mg/d of ALA was administrated as a general adjuvant to antipsychotics therapy, with no significant improvement in BMI, abdominal circumference, blood count, or liver enzymes. Finally, another study investigated the effects of 500 mg/d of ALA on plasma adiponectin levels, fasting glucose, and aspartate aminotransferase activity, with no significant effect on the metabolic parameters. Based on this background, ALA may be a potentially interesting therapeutic agent to improve the metabolic effects of atypical antipsychotics. The purpose of this study was to assess: (1) the efficacy of ALA on metabolic factors and (2) its safety and potential therapeutic effects in a sample of schizophrenic patients in stable therapy with atypical antipsychotics.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 criteria for schizophrenia,
* aged between 18 and 60 years old
* in stable atypical antipsychotic monotherapy (clozapine, olanzapine, quetiapine, or risperidone) for least 3 months.

Exclusion Criteria:

* treatment with more than one atypical antipsychotic, current treatment with insulin/oral hypoglycaemic/lipid-lowering agents
* significant concomitant medical pathologies
* organic brain disorders
* history of alcohol or substance dependence (excluding nicotine)
* dementia
* mental retardation
* pregnancy/breastfeeding.
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals

Although knee pain is prevalent among community-dwelling older adults, little is known about how people in general handle their pain. We will conduct a survey to explore how knee pain affects people's lives and which treatments or self-management strategies they have chosen (or are being offered), and how these interact concerning pain reduction and maintenance of function.

Although knee pain is prevalent among community-dwelling older adults and frequently leads to consultation in primary care, little is known about how people in general manage their knee pain.

Treatments of knee osteoarthritis include a variety of non-pharmaceutical, medical, and surgical interventions with highly individual and inconsistent results and with the possible exception of a longer lasting weight reduction, none of the non-surgical treatments have been able to demonstrate long-lasting effect on pain or disability.

It is well recognised that patient participation in handling of disease creates better compliance and satisfaction with pharmacological treatment.

Another option for taking active part in self-management is the use of complementary and alternative medicine (CAM). despite their popularity and effect, there is currently no overview of the actual extent of CAMs used for knee pain and disability at a population level, and most CAMs remain to be studied scientifically for efficacy.

The incidence of knee OA shows a steep increase at age above 60 years. Furthermore, after this age an increasing prevalence of disablement to knee trouble is encountered. To prevent this development, measures must be sought to alter the course of knee OA.

By asking people about how knee pain affects their life, which treatments or self-management strategies they have chosen (or are being offered), and how these interact for the reduction of pain and maintenance of function, new knowledge will be gained about the preferences and perceived effectiveness of treatments at large. The information gained will enable the prioritising of research on interventions to be tested and will align this with the primary concerns and interests of the population. This will subsequently lead to better guidance of patients by the health care providers, and will aid decision makers in choosing feasible health care policies and strategies.

Eligibility Criteria:
Inclusion Criteria:

* Between 60-69 years of age
* Citizen in the Community of Frederiksberg

Exclusion Criteria:

• No formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply
Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I/II
* Periodontal diagnosis of clinical gingival health or gingivitis on intact/reduced periodontium per 2017 American Academy of Periodontology (AAP) classification
* No history of periodontitis.
* Class I malocclusion
* Crowding of 4 mm or less on mandibular anterior incisors
* Incisor mandibular plane angle between 90-100 degrees
* No extractions indicated as part of the orthodontic treatment plan
* Keratinized tissue of at least 3mm

Exclusion Criteria:

* Patients who are current smokers
* Pregnancy
* Uncontrolled diabetes or other metabolic systemic conditions
* Presence of open bite or deep bite
* Spacing
* Excessive retroclined mandibular incisors
* Any contraindication to treatment or the material used if in the experimental groups
Quality of Life Intervention for Patients Receiving Radiation Therapy for Advanced Cancer Treatment and Their Caregivers

This study will use video technology in conjunction with in-person participation. This is a pilot project, where all enrolled participants will receive the multidisciplinary intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend an in-person group session, and participants (patients and caregivers) from Mayo Clinic Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use of video conferencing. The goals are to examine feasibility (percent of eligible patients and caregivers who enroll), attrition, and adherence (attend at least four of the six sessions), to determine any differences between the two formats, and to examine potential QOL differences as a result of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age.
* Ability to attend all treatment sessions and follow-up.
* Ability to provide written informed consent.
* Ability to participate in all aspects of the study.
* Initial diagnosis of cancer must have been 12 months prior to study entry.
* Intermediate to poor prognosis, defined as an expected 5-year survival of 0%-50% in the judgment of the physicians entering the patient on the study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.
* 1 week of planned cancer treatment (radiation or chemotherapy) at Mayo Clinic.
* Has a caregiver also willing to participate.
* Willingness to get e-mail/text reminder to complete the follow-up survey or complete the follow-up survey with a study coordinator by phone.

Exclusion Criteria:

* Expected survival of \<6 months.
* Active substance abuse (alcohol or drug).
* Participation in other psycho-social research trials.
* Active untreated thought disorder (bipolar illness, schizophrenia, etc.).
* Untreated suicidal intent or plan.
* In need of psychiatric hospitalization.
* Recurrent disease after disease-free interval of \>6 months.
* Previous cancer 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer).
* Use of Proton Beam Radiation.
Observation of Intraosseous Vascular Access in the Emergency Department

The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.

Exclusion Criteria:

* Fracture in target bone, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in target bone
* Infection in target area
* IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
Diffusion MRI in Appendicitis

In this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. Investigators believe that Diffusion-weighted magnetic resonance imaging is a valuable method in the diagnosis of acute appendicitis and in making the decision of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected acute appendicitis and scanned by diffusion weighted magnetic resonance imaging

Exclusion Criteria:

* Patients evaluated by CT
* younger than 18 years
Duloxetine Versus Placebo in Chronic Low Back Pain

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female outpatients 18 years of age with chronic low back pain
* Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

* Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
* Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
* Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
* Have acute liver injury (such as hepatitis) or severe cirrhosis
* Have had previous exposure to duloxetine
* Have a body mass index (BMI) over 40
* Have a major depressive disorder
* Require daily narcotics
* Have suicidal risk
* Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:

* the number and intensity of adhesions,
* whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
* rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
* whether there is any difference between treatment groups regarding patient functional recovery.

Data to be analyzed includes:

Age, gender, traumatic injuries, trauma alert level, procedure information, length of hospital stay, length of ICU stay, interval between admission and initial operation, interval between operations, whether operation took place during the day or night, duration of operation in minutes, number of surgeons present during the operation, description of the initial operation, justification for using damage control approach, complications noted, injuries missed or delayed in diagnosis, Acute Physiology and Chronic Health Evaluation II (APACHE II) calculations at various time points, Simplified Acute Physiology Score (SAPS II) calculations at various time points, Glasgow Coma Score (GCS) calculations at various time points, changes in GCS at over time, Injury Severity Score (ISS) at various time points, Abbreviated Injury Scale (AIS) at various time points, Penetrating Abdominal Trauma Index score (if applicable) at various time points, complete blood count (CBC) results at various time points, blood chemistry results at various time points, blood gas results at various time points, subject randomization information, number of operations, adhesion scores (Zuhlke and Yaacobi) for each operative procedure, contamination score for each operative procedure, diagnosis and description of sub-procedures for each operative procedure, wound characteristics from the start and end of all operative procedures (e.g. length and width of the fascia and skin), type of abdominal coverage or closure, discharge destination (e.g. home, short term rehabilitation facility, etc.), Functional Outcome Measure score, Glasgow Outcome Score (GOS) at various time points, number and interval of post discharge follow-up visits, wound characteristics since discharge at several time points and complications/complaints noted since discharge at several time points.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients undergoing DC/OA management for traumatic injury
* Age 18+
* Life expectancy longer than 48 hours

Exclusion Criteria:

* Prisoners
* Pregnant patients
* Younger than 18 years of age