cyrilzakka/clinical-trials huggingface dataset:
Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management

The objective of this application is to develop and evaluate Spanish-language hearing education materials for adults. Our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials.

There are documented disparities in hearing healthcare use between Hispanic/Latino adults and non-Hispanic/Latino Whites, despite similar hearing loss prevalence rates. It has been suggested that a lack of culturally competent interventions contributes to poor healthcare delivery and outcomes for those with limited English proficiency. The objective of this application is to develop and evaluate Spanish-language hearing education materials for adults. Our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials. The rationale for the proposed research is that findings will contribute to the development and testing of novel interventions aimed at increasing hearing healthcare access and utilization in vulnerable populations in a subsequent R01 application.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will include community-dwelling, Spanish-speaking (monolingual or bilingual) adults over age 50 who self-identify as Hispanic/Latino
2. Clinically-significant hearing loss defined as either greater than 25 decibels hearing leve (dB HL) thresholds at 2 or more frequencies from 250 - 8000 hertz (Hz) and/or significant self-reported hearing difficulties as defined by a score of greater than 8 on the Hearing Handicap Inventory - Screening measure for adults/elderly.

Exclusion Criteria:

* Individuals who are not fluent Spanish-speakers or who do not self-identify as Hispanic/Latino are not eligible to participate in this study.
The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy

The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate in Danish
* Allergic reactions toward drugs used in the trial
* Pregnancy
* Abuse of alcohol/drugs
* Daily opioid intake
* Infection at injection site
* Can not be mobilised to 5 meters of walk; pre-surgery
Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care

Purpose: Assessing nociception and sedation in mechanically ventilated patients in the ICU is challenging, with few reliable methods available for continuous monitoring. Measurable cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal EEG, and frontal EMG, might provide a medium for sedation and nociception monitoring. The hypothesis of this explorative study is that the aforementioned variables correlate with the level of sedation, as described by the Richmond Agitation-Sedation score (RASS).

Methods: Thirty adult postoperative ICU patients on mechanical ventilation and receiving intravenous sedation, excluding patients with primary neurological disorders, head injury, or need for continuous neuromuscular blockage. Continuous measurements of bispectral index (BIS), EMG power (EMG), EMG-derived Responsiveness Index (RI), averaged blood pressure variability (ARV), and Surgical Pleth Index (SPI) were tested against repeated RASS measurements, and separately against responsiveness to painful stimuli at varying RASS levels.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years old)
* Postoperative ICU admission (planned and un-planned admissions), on mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line
* receiving intravenous sedation by continuous infusion (propofol, midazolam).

Exclusion Criteria:

primary neurological disorders (including stroke, cardiac arrest with probable hypoxic brain injury, intracranial hemorrhage, and head injury with reduced level of consciousness prior to intubation), the continuous use of neuromuscular blocking agents during monitoring, confirmed meningitis or encephalitis, or a short data collection time (less than 12 hours).
Dose Escalation of HSP990 in Japan/Korea

This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced solid tumors (advanced cancer)
2. Patient's disease must be evaluable using the RECIST criteria
3. Patients must be 18 or older in Korea or 20 or older in Japan
4. Patients must be relatively healthy as measured by their performance status
5. Patients must have acceptable laboratory values as measured by blood tests
6. Patients must be able to swallow capsules
7. Patients must understand the study and give written permission to enter study

Exclusion Criteria:

1. Patients cannot have brain tumors
2. Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine
3. Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood
4. Patients must have recovered from all previous anti-cancer therapy
5. Patients must have finished taking their previous anti-cancer therapy before entering study
6. Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.)
7. Patients must have relatively good heart function

Other protocol-defined inclusion/exclusion criteria may apply
French National Observatory of Aortic Syndromes

The study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to different risk profiles. The aim of the Observatory is to provide a photograph "size" of practices in France at present, both in the larger centers than in smaller and optimize diagnostic and therapeutic currently available by the activation pathways of rational management.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age (e) over 18 years old
* Patients with a AAS duly authenticated by further tests
* Patients who consented to participate in the study

Exclusion Criteria:

* Refusal of consent for study participation and ancillary studies
* AAS occurring in the aftermath of a traumatic thoracic
* Diagnosis AAS aside in favor of an alternative diagnosis
A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers

The primary objective of this study is to determine the 5-day tolerability of one commercially available prebiotic food ingredient, FOS, in healthy human subjects with and without diet control.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to give written informed consent;
2. Be male or female of any race, between 18 and 65 years of age;
3. Have a BMI \> 20 \& \< 27 kg/m2;
4. Be willing to follow a controlled low fiber diet for a period of 11 days;

Exclusion Criteria:

1. Are less than 18 and greater than 65 years of age;
2. Are hypersensitive to any of the components of FOS;
3. Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days;
4. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study;
5. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgment, entry to the study;
6. Subject is a smoker;
7. Subject has a history of drug and/or alcohol abuse at the time of enrollment;
8. Taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
10. Subjects may not be receiving treatment involving experimental drugs;
11. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study;
Symptom Monitoring and Menopausal Symptoms

A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women.

One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.


Eligibility Criteria:
Inclusion criteria:

* Women
* Aged 18+
* Reporting at least 2 menopausal hot flushes per day
* Self-reported peri- or post-menopausal status.

Exclusion criteria:

* Male
* Under age 18
* Reported fewer than 2 hot flushes per day
* Does not self-report peri- or post-menopausal status.
Slide Tracheoplasty Versus Tracheal Resection Anastomosis in Acquired Tracheal Stenosis

Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* All patients with grade III, IV acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex.

  * Patient with symptomatic high grade II acquired laryngotracheal stenosis after failure of endoscopic interventions.
  * Clinical indications for surgical intervention (Symptoms of airway obstruction).
  * Feasible for surgical intervention.

Exclusion Criteria:

* congenital tracheal stenosis

  * Malignant stenosis.
  * Severe comorbidities that contraindicate the surgery.
  * Patients refusing to sign the consent.
Early Non-invasive Ventilation and Progressive High Flow Oxygen Therapy Through Tracheostomy Tube Weaning Protocol in Tracheostomized Patients with Prolonged Mechanical Ventilation

The aim of our study was to assess the feasibility of an early NIV and progressive HFOT through tracheostomy tube weaning protocol implemented by tracheostomized patients with PMV referred to a specialized weaning unit of a rehabilitation hospital.

The most common indications for tracheostomy are acute respiratory failure with demonstrate or expected prolonged duration of mechanical ventilation (MV),failure to wean from MV.MV is associated with several complications. Placement of a long-term airway (tracheostomy) is also associated with short and long term risks. As more patients with multiple co-morbidities undergo tracheostomy and develop difficulty with weaning, new innovative concepts are urgently needed for their management. Surprisingly, there is very little data dealing with tracheostomized patients in weaning from mechanical ventilation and subsequent tracheostomy tube decannulation.

PMV patients were not able to sustain completely unsupported breathing ,since their load/capacity balance was impaired. Spontaneous breathing trial is not suitable for PMV patients.

For these reasons, PMV patients are often transferred to specialized weaning units with multidisciplinary teams ,which offer advanced weaning protocols and physiotherapists. The role of non-invasive ventilation(NIV) in MV patients with tracheostomy tube to facilitate both weaning off from the ventilator and removal of the tracheostomy tube has a solid physiological rationale, but most clinical evidence is derived from limited observational studies. And mainly focus on patients with chronic obstructive pulmonary disease(COPD) .Besides most NIV delivered through the facial interface while the tracheostomy tube is capped. This was difficult to tolerate for patients with poor lung function and upper airway obstruction. Then delayed NIV transfer. High flow oxygen therapy(HFOT)allows a more accurate FiO2.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* After tracheotomy;
* Patients who met the definition of long-term mechanical ventilation (requiring invasive mechanical ventilation for more than 6 hours per day for more than 21 consecutive days);
* willing to participate in this study and signed the informed consent.

Exclusion Criteria:

* The expected survival time less than 3 months;
* Participated in another clinical study related to weaning;
* death or discharge within 2 weeks after referral;
* Unable to cooperate with the study for any reason or considered not suitable for inclusion in the trial by the investigators;
Multicomponent Intervention to Reduce Sexual Risk and Substance Use

The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Identify as a transgender woman (assigned male at birth and currently identify as female)
* Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days
* Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30
* Provide contact information
* Reside in the NYC metropolitan area
* Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff)
* Provide informed consent

Exclusion Criteria:

* Unstable, serious psychiatric symptoms
* Current suicidal/homicidal ideation
* Evidence of gross cognitive impairment
* Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)

Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center.

Exclusion Criteria:

* Inability to provide informed consent and comply with study-related procedures
Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk

Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a rational economic model of behavior. Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by BE principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors.

Main objective: to assess whether the implementation of two strategies based on behavioral economics, that include the use of a financial incentive scheme and specific framing to beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and follow-up of people with moderate and high cardiovascular risk in the public health network, compared to the usual strategy.

Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or control will be assigned to 9 health centers in total (3 CHC per arm).

Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be selected, which will be randomized: 3 centers to the control, 3 centers to framing intervention with messages and 3 centers to the intervention with incentives.

A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular risk ≥ 10% will participate in this study.

Follow up: 3 month


Eligibility Criteria:
Inclusion Criteria:

* Subjects that only have public health coverage.
* Residence in the area of influence of the health centers of the study.
* Have a mobile phone for personal use.
* 10 year cardiovascular risk ≥ 10%

Exclusion Criteria:

* Pregnant women.
* Immobilized people.
* Persons who do not give their informed consent.
* People planning to move in the next 3 months
Coronary Drug Project

To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.

BACKGROUND:

Correlation of high levels of serum cholesterol with an increased incidence and prevalence of coronary heart disease (CHD) was demonstrated--prior to the inception of the Coronary Drug Project--repeatedly in prospective and cross-sectional epidemiological surveys (e.g., the Tecumseh Study, the Framingham Heart Disease Study). These findings led to the question of whether long-term lowering of serum lipids in individuals both with and without CHD would have a beneficial effect on morbidity and mortality.

The Coronary Drug Project was designed to answer the question of secondary prevention. In 1961, Dr. Robert Wilkins (Boston University School of Medicine) chaired an ad hoc committee which determined the desirability and feasibility of the conduct of this study. Following National Heart Advisory Council (NHAC) support, a study Policy Board, Steering Committee, and Coordinating Center were established and a detailed protocol was written.

In 1964, NHAC approved the project and the NHI recommendation for implementation; the study was begun in 1965. Supported by the grant mechanism, the trial involved 53 participating clinics, a coordinating center, central laboratory, ECG center, drug procurement and distribution center, and NHI medical liaison office, and a policy board, steering committee, and 12 other committees (e.g., a data and safety monitoring committee).

The first patient was randomly allocated to treatment in March 1966 and the last in October 1969. Each patient reported to the clinic every 4 months for a follow-up visit.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. A total of 8,341 patients were randomly assigned to six treatment groups consisting of 2.5 mg/day of conjugated estrogens, 5.0 mg/day of conjugated estrogens, 1.8 gm/day of clofibrate, 6.0 mg/day of dextrothyroxine sodium, 3.0 gm/day of niacin, or 3.8 gm/day of lactose placebo.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Men, ages 30-64. Three months beyond most recent myocardial infarction.
Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome

Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS.


Eligibility Criteria:
Inclusion Criteria:

* APS patients who fulfilled the revised criteria for APS

Exclusion Criteria:

* Patients less than 18 years old
* Solid and hematological malignancies
* Other autoimmune diseases
* Cirrhosis
Effects of Connective Tissue Massage in Women With Overactive Bladder

The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* having overactive bladder
* being volunteer

Exclusion Criteria:

* being in the period of pregnancy or breastfeeding,
* having an accompanying neurological disease, presence of a mental issue that would prevent cooperation in examinations and/or implementations, history of acute infectionor presence of a malignce