cyrilzakka/clinical-trials huggingface dataset:
The Diabetes Patient-Reported Outcome Measures Trial

The study aim to evaluate the use of Patient-Reported Outcome Measures in clinical diabetes consultations.

The psychological and emotional impact of living with diabetes is greatly underreported in clinical diabetes care, and diabetes distress is found to be associated with decreased glycemic control. Therefore, regular assessment of diabetes distress is recommended. The integration of assessments with Patient-Reported Outcome Measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient-clinician communication. The overall aim of the DiaPROM trial is to develop, test and evaluate the effectiveness of a structured empowerment-based intervention with the use of a PROM regarding diabetes distress as a tool for needs assessment and dialogue support in clinical diabetes consultations among adults with Type 1 Diabetes. The investigator's hypothesis is that the intervention primarily will reduce diabetes distress and secondarily improve overall well-being, improve the perceived competence for diabetes management, improve glycemic control, and improve satisfaction with the diabetes follow-up.

Eligibility Criteria:
1. Inclusion Criteria:

   * type 1 diabetes for more than one year
2. Exclusion Criteria:

   1. not being able to read and complete questionnaires on the computer because of

      * language problems
      * reading problems
      * cognitive problems
   2. pregnancy
   3. severe somatic and psychiatric co-morbidities
BREATHE Registry - I Brazilian Registry of Heart Failure

The purpose of this study is to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions.

Background: Several local registries seek to show an isolated clinical characteristics of patients hospitalized with heart failure (HF) in hospitals and communities in Brazil. Overall, the analysis of these data suggests that there are important differences in etiology, the factors of decompensation, treatment and prognosis of HF patients in different regions.

Objectives: To evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions. Other specific objectives include describing the in-hospital mortality after admission, to describe the content and the reason for re-admission, to assess adherence to evidence-based guidelines (recommended by guidelines), to measure indicators of quality of care and establish a national registry data to allow for comparison with international records of patients admitted with ADHF.

Methods: Observational cross (record) with longitudinal follow-up where patients admitted to public and private hospitals primarily defined in IC will be studied.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old,
* Boston Criteria \> 7,
* patients hospitalized \> 24 hours.

Exclusion Criteria:

* myocardial revascularization during last month,
* heart failure due to sepsis,
* acute coronary syndrome with ventricular dysfunction as reason for current hospitalization
Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.


Eligibility Criteria:
Inclusion Criteria:

* Adherence to gluten free diet without medical need
* Negative Celiac Disease related serology (while on gluten containing diet)
* Normal villous structure at duodenal biopsy (while on gluten containing diet)

Exclusion Criteria:

* Diagnosis of Celiac Disease
* Diagnosis of Wheat Allergy
* Diagnosis of organic gastrointestinal disease
* Severe concomitant disease
Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
* Patient signs and dates the informed consent document
* Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
* 85% e-diary compliance
* Total body weight between 99 and 265 lbs, inclusive

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
* Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
* History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
* Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
* Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
* Pregnant or nursing females
* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
* Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months or 5 half-lives, whichever is longer

  * Additional criteria apply, please contact the investigator for more information
Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.

Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.

In this study we will compare two well established methods of pain treatment:

1. continuous infusion of local anesthetics + opioids into the epidural space,
2. patient controlled analgesia with IV Morphine.

The study design is double blind.

Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.

Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age: 55 to 85 years
* Osteoarthritis
* Primary unilateral total knee replacement
* American Society of Anesthesiologists (ASA) I-III
* Successful spinal epidural anesthesia for surgery

Exclusion Criteria:

* Any cause for knee replacement other than osteoarthritis
* Total knee revision (re-do)
* Any contraindication for regional anesthesia
* Abnormal coagulation studies
* Thrombocytopenia less than 100,000/cc
* Chronic renal failure (creatinine \[cr\] \< 1.8)
* Neurological disease involving lower extremities
* Major surgery during the last 2 weeks pre-operatively
* Current or past drug or alcohol abuse
* Allergy to study medications
* Post-operative bleeding over 2000 cc/24 hours
* Postdural puncture headache after anesthesia performance
Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.

The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing vessel catheterization
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Prisoners, pregnant women, and children
Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit

Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is that a strategy to promote sleep in ICU patients will increase time in rapid eye movement (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the ICU.

Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff.

Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.

Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Received care in ICU for at least 3 days
* Received care in ICU no longer than 14 days
* Score of 3 to 5 on the Riker Sedation-Agitation Scale (SAS)
* Age \< 55 years
* Able to tolerate PO or have gastric access present (Nasogastric/Orogastric/PEG)

Exclusion Criteria:

* Pregnancy
* Incarceration
* Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
* Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
* Hemodynamic Instability
* Sepsis
* Multiple Organ Dysfunction
* Acute Renal Failure
* Known history of sleep disorder
* Known Psychiatric disorder
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

The primary goal of the RIGHT-PCI study is to determine the rate of PCI indications categorized as appropriate, possibly appropriate, or rarely appropriate in patients with CCS undergoing elective PCI based on criteria established in medical literature at a Cardiology reference university hospital. To achieve this objective, we plan to analyze approximately 2,500 consecutive angioplasties performed between 2017 and 2020.

Eligibility Criteria:
Inclusion Criteria:

* All patients within the age range who underwent elective PCI defined as a procedure indicated in an outpatient scenario or an inpatient in a non-acute setting when the Heart Team was called to evaluate the patient and agreed with the indication for PCI

Exclusion Criteria:

* History of acute coronary syndrome \< 30 days of the referral for PCI
The STOP-HPV Trial 1: Communication Intervention

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.

As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention. Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates. MOs are office visits during which a patient is eligible for a vaccine, but does not receive it. Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy). This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates. This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.

Eligibility Criteria:
Practice Inclusion Criteria:

* The practice provides HPV vaccination services to adolescents.
* The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
* The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
* The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

* The practice plans to change EHR systems in the next three years.
* The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
* Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).
CogniFit Computerized Cognitive Training in Primary School Students in Hong Kong

This study aims to address these gaps by conducting a comprehensive evaluation of the effects of CogniFit training in children. The primary objective of this study is to evaluate the effectiveness of CogniFit training on executive functions among primary school students in Hong Kong.

Specific objectives include:

1. To assess the effectiveness of CogniFit training on improving executive functions, such as working memory, attention, and inhibitory control in children compared to a waitlist control group.
2. To assess the effectiveness of CogniFit training on improving executive functions, such as working memory, attention, and inhibitory control in children compared to an active control group that will receive Cogmed training.

Participants will be randomly assigned to one of three groups: 1) the CogniFit training group; 2) the Cogmed Group, and 3) the wailist controlled group.

Participants in the two computerized cognitive training groups (CogniFit/Cogmed Group) will receive training in the first phase of intervention, while the waitlist control group will CogniFit trainings in the second phase of intervention.

Participants who receive the computerized cognitive training will complete 24 sessions of training, 15-20 minutes each, conducted three times per week spanning 8 weeks. These programs comprise a range of game-like exercises targeting various cognitive skills, including working memory, attention, and inhibitory control, with automatic level advancement after each exercise.

To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow up). The assessment will take around 1 hour and it will be conducted at participants' schools. Also, parents will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 time points.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6- 12
* Studying in Grade 1 to 6 in mainstream primary schools in Hong Kong

Exclusion Criteria:

* Inability to answer the first five questions in Raven's Progressive Matrices
* Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities
* Current participation in a computerized cognitive treatment
Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)

Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients.

Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.

Eligibility Criteria:
Inclusion Criteria:

* Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid

Exclusion Criteria:

* Previous treatment with platelet inhibitor
* NOAC or Vitamin K-antagonist treatment
* Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack
Supporting Decisions With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals

Decisions are part of the daily life. On the neuronal level, activity in the dorsolateral prefrontal cortex (dlPFC) is important during complex decisions (e.g., whether something is emotional for a person or not). We apply transcranial direct current stimulation (tDCS) with the aim to increase dlPFC activity and thereby modulate decisions towards emotional content.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Non-smokers
* Right-handedness
* Native German speakers or comparable level of fluency
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Neurological or psychiatric condition (other than diagnosed cognitive impairment)
* Past head injuries
* Magnetizable implants
* History of seizures
* Current or life-time alcohol or drug abuse
* Skin diseases
* tES in the 3 months preceding or during the present study
* Caffeine 3 hours prior to training
The Impact of the Anaesthetic Technique Employed on the Quality of Recovery in Patients Undergoing Hysterectomy Surgery.

The objective of this study is to evaluate the results of different anesthesia methods (general anesthesia with epidural catheter application and spinal anesthesia with epidural catheter application) applied in elective hysterectomy surgeries performed in our hospital. The aim is to compare the advantages of both methods.

The study was designed as a prospective observational study. The researchers participating in the study were not involved in administering any medications to the patients. A review of the patient records will result in the creation of two differentiated groups according to the anesthesia method administered: Group 1 will include patients who underwent general anesthesia with an epidural catheter, while Group 2 will include patients who underwent spinal anesthesia with an epidural catheter. The quality of recovery score will be evaluated using a 15-question scale both preoperatively and postoperatively. The researchers will evaluate quality of recovery using the 15-item Quality of Recovery scale (QoR-15).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective hysterectomy
* Patients with The American Society of Anaesthesiologists (ASA) physical status class1-2-3
* Those who are literate enough to answer the compilation quality of recovery score (QoR-15) questionnaire

Exclusion Criteria:

* Patients with contraindications for neuraxial anesthesia
* Patients with The American Society of Anaesthesiologists (ASA) physical status score above 3
* The presence of another malignant neoplasm, other than the indication for hysterectomy,
* Patients with substance abuse disorders, including alcohol and drug addiction
* Patients who do not consent to or desire to be included in the study.