cyrilzakka/clinical-trials huggingface dataset:
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates

in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time. Patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and visualized with the patient. The questions may seem impersonal (e.g. too general and not directly assessing their individual goals, motivations, aspirations), irrelevant (e.g., asking about symptoms of depression when a person is seeking musculoskeletal specialty care) and insensitive (e.g., asking about sensitive subjects at the outset thereby disengaging the individual), and redundant or awkward (e.g., presenting questions that seem very similar or administered in strange orders). Finally, PROMs may also confer some burden (e.g., long PROM questionnaires often used for research may be unnecessarily burdensome for patient care), and provide logistical challenges (e.g., difficulties in administering the tools at the right time points), adding to a poor patient experience.

The investigator sought to assess the impact of an enhanced and more personalized PROM strategy to overcome these barriers by providing i) a primer ahead of PROMs administration, ii) simple 3-part survey capturing capability, comfort, and calm, iii) a short distress and misconception survey, iv) goal setting question, v) summary sheet of PRO scores, and vi) a commitment intervention. Patients will subsequently be requested to complete the CollaboRATE survey, JSPPE survey, and questions about their experience in relation to the new format of surveys (only if they were in the intervention group) before receiving a text message reminder around 6-weeks followed by a set of deprioritization questions and the 3-part capability, comfort, and calm survey.

Eligibility Criteria:
Inclusion Criteria:

All new patients English and Spanish speakers

Exclusion criteria:

Cognitive deficiency precluding PROM completion Language other than English or Spanish
Brain Attack Surveillance in Corpus Christi--Cognitive (BASIC-Cognitive)

The Mexican American population in the U.S. is rapidly growing and aging. This project seeks to determine the prevalence and outcomes of cognitive impairment and dementia in Mexican Americans. It also seeks solutions to help patients with cognitive impairment and dementia and their caregivers get the resources they need.

Hispanic/Latinos will comprise more than 30% of the U.S. population by mid-century, and Mexican Americans account for the largest share of this growing segment of society. This proposal aims to use door-to-door surveillance in Nueces County, Texas, a non-immigrant, bi-ethnic community, to determine the prevalence and trajectory over time of cognitive impairment and dementia in Mexican Americans and non Hispanic whites. The study will elucidate the mechanisms that explain the hypothesized ethnic disparity in Alzheimer's disease and Alzheimer-related dementias by evaluating the roles of vascular disease risk factors, educational attainment and socio-economic status among others. This research will also delve deeply into the differences in informal caregiving for Mexican American and non Hispanic whites with cognitive impairment and dementia. Caregiver burden and mental and physical health of caregivers will be examined toward efforts to develop interventions that build resilience in caregivers. A novel ability of this population-based study is to examine community resources for both patients and caregivers, and how these provisions differ by ethnicity. Using a rigorous mixed methods approach the study will identify the gap between available resources and needs for those with cognitive impairment and dementia. In this way we will be well positioned to propose ethnic-specific testable interventions that promote mental and physical health for those with cognitive impairment and dementia, as well as for those family members who provide the care. This research will therefore lead to improved well-being, autonomy and outcomes among those with cognitive impairment and dementia and their caregivers. The investigative team members have conducted research in this community for 20 years and are experts in Mexican American culture and health, cognitive impairment and dementia, epidemiologic methods, community needs assessment and health behavior research. As the Mexican American population continues its tremendous growth and aging it is vitally important to better understand the prevalence and outcomes of cognitive impairment and dementia in this population, and to rapidly develop interventions that address the burden of these common conditions in Mexican American adults, families, and communities.

Eligibility Criteria:
Inclusion Criteria:

1. \>64 years of age
2. MoCA \< 26
3. Nueces County resident at least 6 months a year
4. English or Spanish speaking
5. Community dwelling or nursing home

Exclusion Criteria: none
Effectiveness Study of a Swedish Youth Mentoring Program

This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.


Eligibility Criteria:
Inclusion Criteria:

* a self-reported need of the youth for additional adult contacts

Exclusion Criteria:

* current or past regular use of illicit drugs
* repeated delinquent behaviour or single acts of violence against persons
* ongoing contacts with psychiatric care or social services
Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting

Assessment of possible predictors of occlusion of jailed side branches following main vessel coronary artery stenting and detection of clinical, electrocardiographic and echocardiographic changes following occlusion of jailed side branches postprocedural and at 3 months follow-up.

Coronary bifurcation lesion (CBL) involves coronary artery stenosis adjacent to and/or including the origin of a significant side branch (SB) 1. Treatment of bifurcation lesions constitute about 15% of coronary interventions and are consequently of major clinical interest 2. Even in the modern era of per-cutaneous coronary intervention(PCI) with stent implantation, treatment of bifurcations is hampered by a higher event rate and requires longer procedure time, more radiation exposure, and higher volumes of contrast material compared with non-bifurcation lesions 3 .

Occlusion of large side branches (SBs) may result in significant adverse clinical events 4. Occlusion of jailed sizable septal and right ventricular (RV) side branches (non-classic bifurcations) is often overlooked following left anterior descending (LAD) and right coronary artery (RCA) main vessel stenting, respectively. Most of the operators decline intervening in these side branches on contrary to classic bifurcations as diagonals and obtuse marginal branches, for example. Whether or not intervening with these occluded jailed side branches have clinical implications or even sub clinical left ventricular (LV) dysfunction was not previously elucidated and warrants studying.

Left ventricular function is an important predictor of outcome in patients with coronary artery disease (CAD). Extensive myocardial ischemia can cause decreased LV contractility and function 5. Conventional echocardiography enables us to identify significant left ventricular dysfunction but not sub-clinical dysfunction \[10\]. Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deterioration of contractility 6 .

In this study, investigators tried to explore the possible predictors and outcomes following occlusion of jailed side branches after main vessel coronary artery stenting, in both classic and non-classic bifurcations, and whether intervening via various techniques would have clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to cathlab for elective PCI along one year duration
* patients who have significant main vessel lesion subtending large, sizable (≥2mm) side branches (Medina 1,0,0 / 1,1,0 / 0,1,0)

Exclusion Criteria:

* acute myocardial infarction
* previous CABG
* LV EF\<50%
* baseline SWMA in the territory of the vessel to be stented
* totally occluded main vessel.
* small (\<2mm) side branch
* any ostial, mid or distal significant side branch disease at baseline.
* true bifurcation lesions (Medina 1,0,1 / 1,1,1 / 0,1,1) with upfront 2-stent strategy.
* advanced renal impairement
Influencing Factors for Physical Activity in People With Head and Neck Cancer

The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.

Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:

* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
* What motivates people with advanced head and neck cancer to be physically active?
* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?

The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

see attached study protocol

Eligibility Criteria:
Inclusion criteria for people with head and neck cancer:

* minimal age 18
* diagnosis of a primary head and neck squamous cell carcinoma within the last 24 months
* oral, pharyngeal, or laryngeal cancer stage III or IV
* completed surgery and/or radio(chemo)therapy in curative intent

Exclusion criteria for people with head and neck cancer:

* not having the physical, mental, and cognitive ability to understand, follow and hold a conversation in (Swiss-)German
* treatment in palliative intent
* recurrence of the head and neck tumour (local or distant)

Inclusion criteria for significant others of people with head and neck cancer:

* minimal age 18
* being a significant other (partner, spouse, close family member or friend) of an individual with a head and neck cancer with the above-mentioned criteria
* having the permission of the individual affected by head and neck cancer to talk about their experiences

Exclusion criteria for significant others of people with head and neck cancer:

- not having the physical, mental, and cognitive ability to understand, follow and take part in a group discussion in (Swiss-)German
Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement

The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary knee arthritis, in need of a total knee arthroplasty.
* The ability to read, speak, and understand English
* The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer
* 18 years of age or older

Exclusion Criteria:

* Revision total knee arthroplasty
* Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery
* Patients with active cancer or receiving palliative care
Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria:

* Patient refusal to participate to the data collection
* Pregnant woman
* Patients age is less than 18 years old
* The planned intervention is a revision of a previous intervention on the studied hip joint
* Previous metal implant, except for pure titanium or titanium alloys
* Exposure to cobalt and chromium that could influence serum metal ions levels
* Planned bilateral intervention
* Patient residing outside France
* Patient not implanted with a Pinnacle(R) ULTAMET(TM)
Effects of Induced Inspiratory Muscle Fatigue on Functional Mobility of Older Adults

The aim of study was to evaluate the effects of inspiratory induced muscle fatigue on functional mobility of older adults. Though, limited literature exists regarding inspiratory muscle fatigue and its consequences on functional activities of daily living and balance. Yet, it is not clear how improvement in inspiratory muscle strength is related with improvement in functional mobility.

Respiratory muscle fatigue was first described in 1977. Inspiratory muscle relaxation rates are known to slow following induction of fatigue. Inspiratory muscle fatigue was induced by threshold loading at 80 percent of (Maximum Inspiratory Pressure) Pimax until the subjects were unable to generate the target pressure. Inspiratory muscle fatigue (IMF) is proposed to negotiation exercise performance, probably via a respiratory muscle metaboreflex that impairs blood flow to working muscles, thereby accelerating the progress of fatigue in these muscles. Respiratory muscle fatigue revealed that a maximal inspiratory load of 50% could quickly fatigue both the inspiration and expiration muscles. Increased inspiratory muscle work may induce fatigue of the respiratory muscles, as well as of the non-respiratory muscles by central alterations at spinal and supraspinal level. Also there is an association between respiratory muscle dysfunction and physical performance in older adults. The abnormalities of respiratory movements may be dependable clinical signs of inspiratory muscle fatigue, mostly when accompanied by tachypnea and hypercapnia. Fatigue is distinguished from weakness, a decrease in force generation that is static and not reversible by rest, though muscle weakness may be a susceptibility to muscle fatigue. This study will contribute to determine the effects of respiratory muscle fatigue on balance and functional mobility with healthy older adults. To further understand this relationship, a battery of tests (considered as gold standard) will be performed after induced inspiratory muscles fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Adults with age 60+ years
* Both male and female participants
* Patients with Forced Expiratory Volume 1/Forced Volume Capacity ratio greater than 80%

Exclusion Criteria:

* Smokers
* Subjects with a history of cardiovascular, respiratory, or neuromuscular
* Diseases that can impede test or alter the maximum inspiratory pressure.
* Subjects with cognitive impairment.
* Subjects with low back and musculoskeletal disorders.
* Previous experience in respiratory muscle training.
Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* Men or women
* Ear surgery
* Written consent given

Exclusion Criteria:

* Paracetamol hypersensibility
* Tropisetron hypersensibility
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Subjects currently working at the Local Health Authority of the province of Bergamo

Exclusion Criteria:

* Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis

The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).

The objectives of this study are:

* To assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin.
* To also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx.
* Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage.
* All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture.
* Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device \[IUD\]). The patient must agree to continue with the same method throughout the study.

Exclusion Criteria:

* Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months
* Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days
* Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks)
* Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days
* Patients who are long-term (\> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%)
* Patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic
* Impaired hepatic or renal function (creatinine clearance \[CCL\] \<20 ml/min)
* Severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy.
* Requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents.
* Treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.
A Study of ONO-1110 in Patients With Major Depressive Disorder

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive Disorder


Eligibility Criteria:
Inclusion Criteria:

1. Japanese (sex not specified)
2. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
3. Participants diagnosed with major depressive disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
4. Outpatients
5. Participants whose current depressive episode has lasted for at least 2 months but no more than 12 months
6. Participants with a HAM-D17 (Hamilton depression rating scale 17 items) total score of 18 or higher and a CGI-S (Clinical global impression-Improvement) score of 4 or higher

Exclusion Criteria:

1. Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:

   * Participants with a comorbid psychiatric disorder other than major depressive disorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I.(Mini-international neuropsychiatric interview))
   * Participants with major depressive disorder with mixed features, psychotic features, or catatonia as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
   * Participants with a current or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
   * Participants with neurodevelopmental disorders or personality disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
   * Participants with a current or past history of clinically significant neurological disorders (including epilepsy)
   * Participants with neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)
2. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different antidepressants, each administered at an adequate dose for at least 6 weeks, during the current or past depressive episode.
3. Participants who have used adjunctive treatments such as lithium, triiodothyronine/thyroxine, lamotrigine, valproate, carbamazepine, or atypical antipsychotics, or who have used combination therapy with antidepressants for the current depressive episode.