cyrilzakka/clinical-trials huggingface dataset:
Air Fluidized Therapy (AFT) in Patients With Suspected Deep Tissue Injury (sDTI)

Patients with a suspected Deep Tissue Injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the Clinitron® Rite HiteTM bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

Up to 15 centers will participate in this case series in acute care and long term acute care facilities. Patients who present with sDTI and consent for study will have the Clinitron® Rite HiteTM bed ordered and delivered within a 12 hour window to be able to participate. They will have their sDTI photographed, and an assessment of expected breakdown will be noted by the clinical team. The patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred.

Information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with sDTI on the supine aspect of their body
2. Patient does not require a pulmonary specialty bed for care
3. Patient is expected to be in the hospital for at least 3 days
4. Patient weighs between 30 and 350 Lbs.
5. Patient's height is less than 75 inches tall
6. Patient, or patient's representative, is willing and able to sign written informed consent
7. Patient is expected to survive hospitalization.

Exclusion Criteria:

1. Patient is less than 18 years of age
2. Patient has already participated in this study
Fast Track Total Hip Arthroplasty vs Standard Care

Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

The aim of this protocol is to compare standard care and fast track total hip arthroplasties. The fast track care consists of:

* preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
* antalgic protocol administered only orally
* early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position. The standard care consists of usual antalgic and physiotherapy post-operative care:
* Antalgic protocol consist in intravenous drugs
* the first physiotherapy session is the day after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
* BMI \< 32
* American Society of Anesthesiologists physical status classification system (ASA) \</= 2
* preoperative hemoglobin (HB) \>13 g/dl
* patients eligible for spinal anesthesia
* presence of a care-giver

Exclusion Criteria:

* psychiatric diseases
* preoperative use of crutches
* ASA \> 3
* preoperative HB \< 13 g/dl
Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients

The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.

We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

Eligibility Criteria:
Inclusion Criteria:

* All patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005
Genetic Epidemiology of Sarcoidosis

To determine if hereditary susceptibility predisposes African Americans to sarcoidosis and to identify sarcoidosis susceptibility genes in African Americans.

BACKGROUND:

Sarcoidosis is a multisystem, granulomatous inflammatory disease of unknown etiology. Hereditary susceptibility to sarcoidosis is suggested by reports of familial clustering and a higher prevalence in certain ethnic groups, particularly African-Americans. Over four hundred kindreds been reported in the medical literature and these investigators have recently described 101 families and shown that African Americans have a higher prevalence rate of familial sarcoidosis than Caucasians (19 percent vs. 5 percent). The reasons why sarcoidosis clusters in families or the role of genetic factors in this disease are not known.

DESIGN NARRATIVE:

The study was carried out in African American families ascertained through 400 African American sarcoidosis patients evaluated at the Henry Ford Health System. They were tested for association of sarcoidosis with markers for candidate genes using the affected family-based control method and tested for possible environmental risk factors and genetic mechanisms of disease transmission by performing a segregation analysis in African American families.

A strong association of one or more of the candidate genes with sarcoidosis or an indication of major gene segregation for the disease, provided the basis for future linkage studies. Investigating the hereditary susceptibility of sarcoidosis was best done in African Americans, because of the greater severity and occurrence of disease in this population. Once the reasons for familial aggregation of sarcoidosis are determined, the etiology of this disease will be better understood and it should be possible to design new approaches to prevention and treatment.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor

Eligibility Criteria:
No eligibility criteria
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail

This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed onychomycosis
* Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy
* Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions
* Positive potassium hydroxide mount preparation
* Positive fungal culture for a dermatophyte

Exclusion Criteria:

* Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance
Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease

The working hypotheses are as follows: #1 The processing of performance signals by automated lognormal segmentation and the extraction of the parameters of interest will make it possible to distinguish groups of patients from healthy elderly subjects. #2 The three instrumental approaches will not have the same degree of reliability as a predictive biomarker of clinical diagnosis established by consensus.

The strength of this study is to compares three refined parametric approaches drawn from functions mediated by very different neuromuscular programs (visually guided voluntary movement control to perform trajectories with the hand or arm versus vocal control) among two groups of patients and a healthy group. Its weakness lies in the lack of multimodal methods to accurately confirm clinical diagnosis and the predictive reliability of patient performance. These modalities are too costly to be included in this project. However, different oculovisual measurement standards such as optical coherence tomography, hyperspectral imaging (OPTINA Diagnostics Inc.), and eye tracking will be used at the School of Optometry, University of Montreal. There is indeed a remodeling of the retina and oculomotor changes in Parkinson's Disease (PD) and these non-invasive techniques, which have been accepted for several years, will be used in patients in support of their clinical diagnosis compared to normal subjects.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Parkinsonism including idiopathic Parkinson's disease or a related syndrome;
* Have motor symptoms of Parkinsonism for 6 years or less;
* Be a healthy volunteer subject in good general health with no prior neurological history;
* Age between 50-75 years old;
* If applicable, be able to safely leave home in the morning without having taken antiparkinsonian medication for the past 12 hours.

Exclusion Criteria:

* Major neurocognitive disorders;
* History of other neurological conditions, such as ischemic or hemorrhagic stroke, paralysis of a limb, traumatic brain injury, epilepsy, orofacial dystonia, essential tremor;
* History of oromandibular or laryngeal procedures;
* Uncorrected deafness;
* Any contraindication to pupillary dilation.
BRAVE Study: Designing and Evaluating Technologies to Promote Adolescent Mental Health

The BRAVE study is a randomized controlled trial carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,330 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,030 to participate in the 9-month study. Teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and promote cultural pride and resilience; or 8 weeks of Science Technology Engineering and Math (STEM) text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine; and then received the other set of messages. Retention in the study was high, with 87% of participants completing both BRAVE and STEM intervention arms.

There are approximately 2.1 million self-identified American Indian and Alaska Native (AI/AN or Native) youth under the age of 24 living in the United States. Like many teens, AI/AN youth report frequent technology use and poor mental health outcomes, including trauma, stress, anxiety, depression, and suicidality.

To support Native youth, the Northwest Portland Area Indian Health Board (NPAIHB) launched We R Native in 2012, a holistic health resource for Native youth, by Native youth (www.weRnative.org).

While this broad reach and utilization is promising, more focused research is needed to better understand the acceptability and usability of the mental health messages delivered by We R Native, and systematic research is needed to determine whether We R Native's messages actually improve mental health and resilience, teach mental health skills (like coping skills, mindfulness, help-seeking, and use of suicide prevention chat-lines, etc.), and promote healthy social norms - all protective factors against suicide and substance abuse.

Housed at the Colorado School of Public Health, the mission of the mHealth Impact Lab is to facilitate the rapid and rigorous development, implementation, and evaluation of mobile and digital technology for health promotion and disease prevention that address inequalities in health outcomes.

The research teams tested whether We R Native's BRAVE messages improved self-efficacy and behaviors related to mental health, resilience, and cultural pride; as well as the relative impact of user engagement.

The BRAVE study will improve the relevance, efficacy, and utilization of mental health resources delivered through We R Native' messaging channels - reaching a high-risk, underserved population - and will create new mechanisms to monitor and evaluate the impact of mHealth interventions. Both teams are committed to sharing resultant data collection tools and processes with those working in the field.

Eligibility Criteria:
Inclusion Criteria:

* The study included self-identified American Indian and Alaska Native youth
* Age 15-24 years old

Exclusion Criteria:

-Participants were required to have a cell phone with text message capabilities
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically demonstrated NSCLC
* Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
* Inoperable patients treated by exclusive radiotherapy
* A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
* FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
* Written informed consent
* Accessibility to follow-up
* Age \> 18 years

Exclusion Criteria:

* Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
* Stage IV NSCLC
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
* Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
* Pregnancy and lactating woman
* Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre
Behavioral Activation Teletherapy to Increase Physical Activity

This is a pilot study of acceptability, feasibility, and preliminary efficacy of a brief, 10-session Behavioral Activation intervention delivered via teletherapy to increase physical activity and treat depressive symptoms.

This is a one-site, two-phase study that will use an initial group of individuals between the ages of 18 and 64 who have moderate to severe depressive symptoms and exercise less than 90 minutes a week. In both phases, participants will complete a total of 8 behavioral activation teletherapy sessions used to increase physical activity, followed by two biweekly booster sessions, for a total of 10 sessions. Participants will also complete weekly assessments remotely for both phases of the study. The screening visit and final intervention session will be in-person, and all other visits will be via telehealth. Participants will have the option to come to the clinic if they prefer.

In the initial phase (n = 15), participants who completed the intervention will have the option to participate in a focus group, and participants who partially completed the intervention will have the option to participate in a semi-structured interview. The total duration of phase one is 14 weeks. This initial phase will allow the researchers to refine and optimize the intervention to be delivered in the second phase.

In the second/pilot phase (n = 50), participants will complete a one-month and a two-month follow-up after the 10 intervention sessions. The total duration for phase two is 22 weeks.

Participants for both phases of the study will wear a Fitbit during the duration of their study participation, in order to record step count.

Eligibility Criteria:
Inclusion Criteria:

* Be18-64 years old;
* Able and willing to provide informed consent;
* Have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10;
* Insufficient moderate-to-vigorous physical activity (\< 90 minutes a week);
* Demonstrated interest in increasing physical activity;
* Have a smartphone.

Exclusion Criteria:

* Have any current, past, or lifetime manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder;
* Be currently experiencing active suicidal ideation (i.e. with suicidal thoughts, plan, and intent) or at a high risk for suicide during the course of the study, as designated by the PI;
* Have a medical condition that prohibits physical activity; be medically prohibited to exercise by primary care physician (PCP), OB-GYN (obstetrician-gynecologist) or study MD.
* Be in current, active psychotherapy
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol.
2. Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)\] during the study and up to 30 days after the last dose of the study drug..
3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-302E study.

Exclusion Criteria:

1. Premature discontinuation from the MS-LAQ-302 study, for any reason.
2. Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding.
3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E study.
4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Effects of Individualized Cognitive Training on Cognition in Heart Failure

The SYNAPSE trial is designed to study the effects of an individualized home-based cognitive training program on cognitive functions in heart-failure patients.

The purpose of the SYNAPSE study is to evaluate the effects of an individualized home-based training program aimed to improve cognitive functions and well-being in heart failure patients. Heart failure is characterized by the inability of the heart to pump blood efficiently through the body. Nearly half of patients with heart failure present with cognitive deficits. Memory and executive functions that allow us to perform complex tasks are mainly affected. These cognitive deficits are linked to an increased risk of hospitalization and mortality, in addition to decreasing patients' well-being and ability to care for themselves. Although rehabilitation programs that include physical activity and counseling help reduce heart and brain health risks, these programs are unpopular. Among the few who enroll, between 24% and 50% drop out before the completion of the program. Offering alternative options such as cognitive training would help to reach this proportion of patients. The literature has shown that cognitive training is effective in preventing or reducing cognitive deficits in older adults with or without cognitive loss. Although still understudied in patients with heart failure, a better understanding of the association between heart failure and changes in cognition would allow better adaptation of patient care to their situations and needs.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 50 or older
* Have access to Internet
* Have access to a computer or a tablet;
* Have the ability to perform cognitive training;
* Have the ability to read, understand and consent to the informed consent form;
* Have chronic heart failure on tolerated therapy for at least two months;
* Without limitation of physical activity to severe limitation of physical activity (i.e. NYHA class I, class II, class III OR class IV).

Exclusion Criteria:

* Acute cardiovascular event 1 month before randomization;
* Cardiovascular procedure scheduled within 3 months;
* Uncontrolled diabetes or untreated thyroid dysfunction;
* Current or recent malignancy with a life expectancy of less than 1 year;
* Neurological disease;
* Chronic hemodialysis or peritoneal dialysis.
Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan

The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for diagnosis, treatment, and prevention of dental caries.

We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used the same questionnaire as used in the DPBRN Study, "Assessment of Caries Diagnosis and Caries Treatment".

Eligibility Criteria:
Inclusion Criteria:

* This study queried dentists working in outpatient dental practices who have affiliated with JDPBRN to investigate research questions and to share experiences and expertise (n = 282).

Exclusion Criteria:

* Dentist who doesn't perform some measure of restorative dentistry at their practice.