cyrilzakka/clinical-trials huggingface dataset:
Visualizations to Improve Pain Communication Between Patients, Interpreters, and Providers

The purpose of this study is to pilot test a pain assessment information visualization (InfoViz) tool to facilitate communication about pain severity, location, and quality to increase mutual understanding between patients with limited English proficiency (LEP), interpreters, and providers during pain assessment. 40 participants will be enrolled and can expect to be on study for up to 4 weeks.

The purpose of this study is to pilot test a pain assessment information visualization (InfoViz) tool to facilitate communication about pain severity, location, and quality to increase mutual understanding between patients with limited English proficiency (LEP), interpreters, and providers during pain assessment.

The investigators focus on the LEP Hmong because pain is particularly problematic for this group. The Hmong describe pain using visual metaphors that are inconsistent with providers' knowledge and interpreters struggle to translate metaphors accurately between patients and providers. The goals of the study are (1) to examine the feasibility of implementing the pain InfoViz tool, (2) to explore congruency of patient-interpreter-provider triads' mutual understanding (MU) of pain severity, location, and quality, and (3) to evaluate outcome measures selected to capture satisfaction with communication, pain relief, and pain interference with life and explore variables identified in the InfoViz tool conceptual framework (MU of pain assessment information, satisfaction with communication, pain diagnosis and treatment).

The investigators will first collect data from 20 participants under the usual care control condition (i.e., interpreters verbally interpreting and communicating pain descriptions), followed by data collection from another 20 participants under the intervention condition (i.e., interpreters using verbal descriptions and the InfoViz tool).

The investigators believe that the pain assessment InfoViz tool will increase mutual understanding of pain severity, location, and quality between patients, interpreters, and providers, and consequently lead to increased satisfaction with communication, greater pain relief and reduced pain interference with daily life through better-informed diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and up
* Hmong patients that indicate they do not speak English well (LEP)
* self reported pain

Exclusion Criteria:

* indicate that they speak English well

Interpreter Inclusion Criteria:

* 13 years old or greater
* self-identify as interpreting for a Hmong individual in the health care setting

Interpreter Exclusion Criteria:

* telephone interpreters as they are unable to view and use the InfoViz tool
Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield.

In pleural infection, It is suggested that the bacteria being diagnostically targeted, might more likely be residing on the pleural surface with a better blood supply and nutrition rather than being planktonic in the acidic, glucose deficient pleural fluid. The investigators thus hypothesize that an agitation of the pleural fluid prior to sample aspiration would aid in achieving a better cellular representation of the pleural space. This could have the effect of washing bacterial cells off the pleural surface as well as moving sedimented cells in the aspirated sample. This study aims to investigate whether an increase in the microbiological yield for infected pleural fluid could be achieved by a pre-aspiration agitation of the pleural fluid which would have a positive effect on management and eventual patient outcomes. Adult participants with pleural infection will undergo thoracentesis via both the standard and agitated fluid techniques guided by thoracic ultrasound. Microbiological yields will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old
2. Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose \< 40 mg/dL or pH \<7.2 with lower respiratory infection or pus on aspiration
3. At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

Exclusion Criteria:

1. Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
2. Hemodynamic instability
3. Uncorrected coagulopathy
4. Transudative or exudative lymphocytic pleural effusion on biochemical analysis
COMPuter-assisted Self-training to Improve EXecutive Function

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Eligibility Criteria:
Inclusion Criteria:

* A diagnose of stroke, cardiac arrest or Parkinson's disease.
* Aged 18 years or older.
* Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards
* Computer and internet access at home.
* Providing informed consent.

Inclusion criteria specific for stroke

* Inclusion within 6 months post-stroke
* Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
* Initial stroke severity \>/= NIHSS 3.

Inclusion criteria specific for cardiac arrest

• Inclusion within 6 months post ictus.

Inclusion criteria specific for Parkinson's disease

* Clinical diagnosis of PD.
* Anti-parkinsonian medical treatment (dopaminergic or other).

Exclusion Criteria:

* Informed consent not provided
* Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator
* Not able to participate according to investigator

Exclusion criteria specific for stroke

* Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)
* Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.

Exclusion criteria specific for cardiac arrest • None

Exclusion criteria specific for PD

• Diagnosis of PD Dementia according to the MDS PD Dementia criteria
MTX Hold During Covid-19 Booster

To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 19 years of age at time of consent
* Have a diagnosis of RA per ACR criteria
* Require methotrexate for RA treatment
* Subject to a Covid-19 booster vaccination
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

* Pregnant or lactating females
* Previous anaphylactic response to the vaccine components
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD

This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices. Half of the patients without history of bleeding will receive fish oil while the other half will not. Half of the patients with history of bleeding will receive fish oil while the other half will not. Markers of angiogenesis and inflammation, as well as changes in the microbiome will be assessed in each group.

A potential mechanism of bleeding in patients with continuous-flow left ventricular assist devices (CF-LVAD) is dysfunctional angiogenesis. Angiogenesis is a complicated process controlled by several markers. Previous studies have shown that elevated Angiopoietin-2 and TNF-alpha are associated with bleeding events in CF-LVAD patients.

Fish oil has anti-inflammatory and potentially anti-angiogenic properties. A retrospective study of CF-LVAD patients on high-dose fish oil showed a marked decrease in gastrointestinal bleeding rates in these patients. Additionally, these patients had lower levels of circulating Angiopoietin-2. Fish oil is known to have an effect on the microbiome, and the aforementioned effects may be seen in changes of the microbiota.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has signed consent
2. Age \> 18 years
3. Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant

Exclusion Criteria:

1. Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial issues that might impair compliance with the study.
2. Patients already taking fish oil.
The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial

This study is prospective randomized trial study. "O" type tracheal intubation tube is anatomically consistent and will able to increase the success rate of first intubation without any other external help.

This study is divided into two groups. : control vs. "O" shape endotracheal tube.

The investigator was studied 238 consecutive the American Society of Anesthesiologists' physical grades I and II adult patients scheduled to undergo general anesthesia requiring tracheal intubation for elective surgery. Exclusion criteria included a gross anatomical abnormality, before surgery of the head, neck and cervical spine, previously difficult tracheal intubation, loose teeth, or those requiring a rapid sequence or awake intubation, moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests. Anesthesia was induced with remifentanyl 3ng/kg, propopol 1-2 mg/kg or TIVA 2% fresopol 4ug/dL, remifentanyl 3ng/dL and rocuronium 0.8 mg/kg to facilitate tracheal intubation. Laryngoscopy was performed after the loss of the fourth twitch in the train-of-four in response to ulnar nerve stimulation. All laryngoscopies using a #4 Macintosh blade were performed with the patient placed in the sniffing position. Tracheal intubation was performed without assistance (ex. External laryngeal manipulation, Used stylet). A single experienced anesthesiologist, blinded to each group, performed all of the direct laryngoscopies and classified the laryngoscopic view according to the modified Cormack and Lehane grade, measured number of attempts, intubation time and blood pressure and heart rate before/ after intubation.

Eligibility Criteria:
Inclusion Criteria:

* Consented to participate in the study
* Aged 19 years or older
* The American Society of Anesthesiologists' physical grades I and II
* Undergo elective surgery under general anesthesia

Exclusion Criteria:

* Do not agree to participate in research
* Previously difficult tracheal intubation
* Rapid induction of anesthesia
* Previous c-spine disc or had surgery
* Teeth are severely shaken or poor
* Moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests
Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia

Colistin (polymyxin E) is considered a last resort antimicrobial for treatment of infections with multidrug- resistant bacteria, classified by WHO as 'highest prioritized, critically important for human medicine'. WHO suggests to ban or highly restrict its use in animals. In Indonesia, colistin resistance in human Escherichia coli isolates is poorly characterized as it requires specific non-routine tests. Presence of colistin resistance in E. coli in poultry resulted in a ban for livestock in Indonesia in 2020. However, colistin is still suspected to be routinely used in humans in multiple settings but the reasons for these practices are poorly understood. The ban on colistin use in livestock offers a unique opportunity to assess the impact of this intervention on colistin resistance in humans and animals, and how a One Health perspective can strengthen this intervention. This project aims to: i) determine phenotypic and genotypic colistin resistance in E. coli from humans and poultry in Indonesia; ii) assess the impact of the colistin ban on resistance in E. coli in animals and humans; iii) estimate the transmission of colistin resistance between animals and humans; iv) study colistin use and perceptions at the community level; and v) expand the initial colistin ban in the animal production sector into an integrative multi-sectorial One Health intervention, which will be designed and implemented using a community participatory approach. This project will provide a strong scientific basis to AMR policies in Indonesia, with great significance across Southeast Asia.


Eligibility Criteria:
Inclusion Criteria:

* All individuals with age \>= 18 years old, that are willing to participate

Exclusion Criteria:

* Vomiting and/or diarrhea
Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)

Worldwide, refugees and asylum seekers suffer at high rates from trauma- and stress-related mental health problems. The investigators thus developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a 9-week, mindfulness- and compassion-based, trauma-sensitive and socio-culturally adapted, group intervention for refugees and asylum seekers. The overarching aims of the study were to, first, test whether MBTR-R is an efficacious and safe mental health intervention for traumatized refugees and asylum seekers with respect to stress- and trauma-related mental health outcomes; and, second, to test theorized mechanisms of action of MBTR-R. Accordingly, the investigators conducted a randomized waitlist-controlled trial among a community sample of female and male Eritrean asylum seekers in an urban post-displacement setting in the Middle East (Israel).

Broadly, the investigators aimed to assess whether MBTR-R is an efficacious and safe mental health intervention for traumatized asylum seekers. Aim I: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to improved stress-and trauma-related mental health outcomes, including lower levels and rates of posttraumatic stress, depression, anxiety, and improved subjective well-being at post-intervention and 5-week follow-up. Aim II: The investigators aimed to test, whether relative to the waitlist-control condition, MBTR-R was safe and thus not associated with participant-level clinically significant deterioration in any of the monitored primary mental health outcomes at post-intervention or at follow-up. In the event of adverse responding, the investigators planned to test whether key demographic factors or pre-existing vulnerability factors at pre-intervention that may predict participant-level deterioration or adverse responding to the intervention - so as to identify candidate contraindications for MBTR-R. Aim III: The investigators predicted that, relative to a waitlist control condition, MBTR-R will lead to changes in psycho-behavioral processes targeted by the intervention and implicated in vulnerability at pre-intervention, from pre-to-post intervention, measured in controlled behavioral and cognitive-experimental lab tasks or experience sampling measures, including measures of (a) self-compassion and self-criticism, (b) self-referential processing of fear, (c) avoidance, (d) emotional reactivity to trauma-related information and autobiographical memory, (e) impaired executive functions of trauma-related information processing in working memory. Aim IV: The investigators aimed to test whether, among the MBTR-R group, pre-to-post-intervention change and pre-intervention to follow-up change in mental health outcomes (Aim I) will be predicted or mediated by pre-to-post intervention change in the targeted psycho-behavioral processes.

Eligibility Criteria:
Inclusion Criteria:

* Eritrean refugee or asylum seeker living in Israel

Exclusion Criteria:

* active suicidality
* current psychotic symptoms
* current mental health treatment (e.g. psychotherapy, participation in psycho-social support group)
Auditory Functions in Patients With Multiple Sclerosis

The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.

The results of DPOAE and CSF will be correlated to identify statistically significant correlation.

Case-Control study

Tools for patients' selection and inclusion in the study

STEP one

* Full medical records detailed for neurological diseases
* Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
* Lumbar puncture
* Blood test
* Questionnaire for screening hearing disorders
* App for screening hearing loss

STEP two

* Pure Tone Auditory test + Tympanometry and Stapedial Reflex
* Speech Perception test
* In case of tinnitus: tinnitus questionnaire and acuphenometry
* DPOAEs
* ABR

STEP three in case of Hearing impairment

- MRI Tractography

Eligibility Criteria:
Inclusion Criteria

* age \>18 and \<50,
* no history of hearing loss,
* no psychiatric condition
* no familial history of otosclerosis/deafness/genetic hearing loss
* patients with PD and/or MS.

Exclusion Criteria

* Conductive hearing loss
* stroke \< 2 years
* cardiovascular disease non under control
* diabetes
* hypotensive disorders
* alcohol abuse
* recreational drug consumption
* epilepsy
Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation

The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery


Eligibility Criteria:
Inclusion Criteria:

• Patients undergoing VATS with OLV ≥2 hours

Exclusion Criteria:

* ASA (American Society of Anesthesiologists Physical Status Classiﬁcation) score ≥ 4
* severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
* preoperative hemoglobin less than 10 g ml-1
* hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),
Evaluating the Clinical Efficacy and Safety of Colflex

This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.


Eligibility Criteria:
Inclusion Criteria:

* availability to give written consent
* age 18-60, men and women (who are not pregnant or nursing)
* people in good health
* able to follow protocol
* must be experiencing a sore throat or cold at least once a year

Exclusion Criteria:

* smokers
* liver and kidney disease
* inflammatory bowel disease
* pancreatitis
* gallbladder or biliary disease
* neurolgical/psychological disease
* bleeding disorders
* platelet abnormatilies
* gastrointestinal disorders that could interfere with fat absorption
* serum triglycerides \> 500 mg/dL and/or total cholesterol \> 300 mg/dL
* hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 Hg
* BMI \>30
* consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
* reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
* reported use of experimental medication within 1 month prior to the trial
Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child mortality as it could reach the most vulnerable children in a community and reduce severity of not only diarrhea but also of associated infections. It might also potentially reduce antibiotic use.

We conducted a pilot study prior to conducting a community based controlled effectiveness trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, reduces visits to health care providers, antibiotic and other drug use, and increases ORS use during diarrhea.

The pilot study was conducted in a primary health centre (population \~33000) in Faridabad district of the state of Haryana in India. Formative research identified perceptions of caregivers regarding childhood diarrhea, causation and management, care seeking sources and caregivers expectations from healthcare providers. Caregivers in households with children under 5 years old were interviewed in a cross sectional survey to ascertain family characteristics, ORS prescription and use rates, drug prescription rates by healthcare providers and other variables of interest.

In partnership with the local government, channels for distribution of zinc and ORS packets were defined. The channels included physicians (at PHC and private practitioners), auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs)of the Integrated Child Development Services (ICDS) scheme. Recommendations were developed and translated into local vernacular. A poster, which incorporated the recommendations and pictures of zinc strip and ORS packets, was designed. These posters were put up at different places in the study area. All channels were trained and provided with the supplies of zinc strips and ORS packets except the private practitioners who received only zinc strips and advised caregivers to take ORS packets from government channels. Effectiveness of this pilot program was assessed through 2 cross sectional surveys, 3 and 6 months post training.

The cross sectional surveys revealed that the prescription of syrups, tablets, powders and injections during diarrhea and cost of treatment decreased significantly. Prescription and use of ORS increased markedly. Zinc tablets were prescribed and used in about half the episodes 6 months after start of intervention. It was feasible to train various government and community channels to promote zinc as treatment of acute diarrhea through the primary health care system.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

* Illness requiring hospitalization (referral)