cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial

This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used.

The clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.

Imaging diagnostic aid tools that use AI and facilitate the identification of findings on chest x-rays can contribute to doctors' care routines and clinicians' and radiologists' reporting routines, as these tools can allow the organization of care queues according to priorities, in addition to identifying subtle findings on the image, thereby reducing errors in reading the RXT and benefiting patients with greater agility in care and a shorter time until diagnosis. However, for reliability, these tools must undergo rigorous validation processes in large populations before implementation.

Eligibility Criteria:
Inclusion Criteria:

* Non-reported chest X-rays (XRts) of individuals aged over 18 years.
* Individuals images with respiratory complaints.
* Chest X-rays taken during the presence of these respiratory symptoms or while being followed up for respiratory disease.
* Chest X-rays taken on any X-ray machine.
* Chest X-rays that include at least one frontal view of the chest.

Exclusion Criteria:

* Those whose chest X-ray was performed due to a history of trauma, pre-operative risk assessment, lung cancer screening, or exclusively for verifying the correct positioning of a peripheral intravenous catheter (PICC).
* Chest X-rays with technical quality below the minimum required for proper interpretation and diagnosis.
* Cases without at least one frontal view.
* X-rays printed on regular paper.
Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .

Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.

Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing general anesthesia for thyroid surgery.
* aged between 19 and 64 years
* American Society of Anesthesiologists physical status I and II

Exclusion Criteria:

* patients with malformation or tumor of the upper respiratory tract
* patients with risk of aspiration
* obese cases with a BMI \> 35
* patients in which tracheal intubation was difficult
* refusal to participate in research
Lithia Water Study: Effects of Lithia Water on BDNF and Oxidative Stress Markers in Healthy Male Participants

This study investigates the effects of daily use of lithia water on blood tests of neuronal oxidative stress, mood, and well-being. Lithia water is a type of pure spring water containing trace levels of lithium, which is a naturally occurring mineral. Neuronal oxidative stress is caused by normal chemical reactions in the human body that sometimes result in damage to brain cells. Participation in this study will last for 8 weeks and includes daily use of study water for drinking.

The primary objective of this pilot study is to test the hypothesis that, in healthy male participants, daily use of lithia water will improve neurogenesis and antioxidant capacity as measured by serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress markers. Secondary objectives will include examining self-reported changes in mood, cognition, and well-being.

There is some indication from epidemiological studies that areas with trace concentrations of lithium in drinking water have lower rates of suicide. This study will evaluate the effects of drinking EDJ (pronounced "edge") lithia spring water (which comes from a natural spring in the Rocky Mountains and contains trace amounts \[0.68 mg/litre\] of lithium) for 4 weeks, compared to drinking commercially available bottled water (which contains no lithium at all) for 4 weeks.

This pilot study has been designed as an 8-week randomized, counterbalanced, crossover study in 15 healthy male participants. Eligible participants will use lithia water or control water for daily ingestion for 4 weeks, then cross over to the other condition for another 4 weeks. At baseline and after each 4-week condition, participants will complete self-report questionnaires of mood, cognition and well-being, and blood samples will be assayed for BDNF and oxidative stress protein markers.

Eligibility Criteria:
Inclusion Criteria:

* Male participants aged 19-35 years. \[Note: women are excluded in this pilot study because the variable effects of female sex hormones on oxidative stress markers and neurogenesis\];
* No current, past or family history (in first-degree relatives) of a major psychiatric disorder or alcohol/substance abuse/dependence;
* Non-smokers \[because smoking is associated with increased oxidative stress\];
* No active medical condition (e.g., thyroid disease);
* No regular use of prescribed or over-the-counter medications or illicit substances;
* Negative urine drug-screening test; and
* Competency to give informed consent.

Exclusion Criteria:

* See above
Endoscopic Peroral Myotomy for Treatment of Achalasia

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s

70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.

Primary outcome:

-Eckhard symptom score 3 month after therapy.

Secondary outcomes:

Lower esophageal sphincter pressure at 3 month after therapy. Reflux symptoms at 3 month after therapy. For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.

A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

Eligibility Criteria:
Inclusion Criteria:

* Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis
* persons of age \> 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
* Signed written informed consent.

Exclusion Criteria:

* Patients with previous surgery of the stomach or esophagus
* Patients with known coagulopathy
* Previous achalasia-treatment with surgery
* Patients with liver cirrhosis and/or esophageal varices
* Active esophagitis
* Eosinophilic esophagitis
* Barrett's esophagus
* Pregnancy
* Stricture of the esophagus
* Malignant or premalignant esophageal lesion
* Candida esophagitis
* Hiatal hernia \> 2cm
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis

Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* With clinical diagnosis of herpes labialis.
* who self report having six or more episodes of herpes labialis in the previous 12 months.

Exclusion Criteria:

* Pregnant or lactating females.
* Current or recurrent infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
* Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma.
* History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
* History of organ transplantation
* Negative HIV-positive status determined by history at screening or known history of any other immuno-suppressing disease.
* Severe comorbidities (diabetes mellitus requiring insulin, CHF (EF\<50% at baseline will be exclusionary) of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
* Subjects who have known hypersensitivity to Squaric acid or any of its components.
* History of recent alcohol or substance abuse (\< 1 year)
* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
* History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol
* History of non-compliance with other therapies.
C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).

The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.

New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)

Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.

Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.

The purposes of the study are:

1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility Criteria:
Inclusion Criteria:

* patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
* patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.

Exclusion Criteria:

* lack of histological diagnosis;
* not a candidate for erlotinib;
* pregnancy.
Assesment of the Change in Consumer Behaviours to Afford the Dietary Cost According to Food Security Status and Choice Motives

The aim of this study is to assement of the change in consumer behaviours during the food inflation period in order to afford the dietary cost according to food security status and food choice motives. The study was planned in four stages. 1) First stage is adapting the Single-item Food Choice Questionnaire to Turkish society and to make its validity and reliability in Turkish. 2) The Impact of Food Inflation on Consumer Behavioural Change (TIF-Con) scale will be developed. 3) Observational cross-sectional data collection including these surveys will be carried out. 4) The Cost of the Recommended Diet (CoRD) will be calculated by collecting data simultaneously with the fieldwork. Hypotheses will be tested in line with the findings obtained.

The reliability and validity of the Single-item Food Choice Questionnaire was planned in eight stages. 1) Translation into Target Language 2) Synthesis of translations 3) Back translation to Original Language 4) Expert assessment 5) Pilot study 6) Reporting 7) Testing 8) Retesting. The development of the Impact of Food Inflation on Consumer Behavioural Change (TIF-Con) scale was planned in eight stages too. 1) Generating an item pool 2) Determining the format for measurement 3) Initial item pool reviewed by experts 4) Pretesting 5) Optimizing scale length 6) Testing 7) Retesting 8) Reporting. A cross-sectional survey will be conducted by questioning food security and socioeconomic status, along with the developed TIF-Con and the adapted food choice questionnaire. This stage will be combined with the sixth stage of scale development in order to act economically. Simultaneously, the CoRD will be calculated with the collection of food prices with fieldwork and the recommendations of the offical Turkey's dietary guideline. The obtained results will be analyzing to assesment of the change in consumer behaviours during the food inflation period in order to afford the dietary cost according to food security status and food choice motives.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65
* Who volunteered to participate in the study
* Adult individuals who have access to the Internet and agreed to participate in the study
* Native language being Turkish
* Living in Turkey at least five years

Exclusion Criteria:

* Those with a disease that requires a specific diet
* Inability to use a computer, tablet or mobile phone
* Native language not being Turkish
* Those who have not lived in Turkey for at least five years
Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation

The goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF)

The main questions this study aims to answer are:

1. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease)
2. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia

To do this, we will measure troponin in patients with rapid AF and then carry out further investigations of the heart (electrocardiogram, echocardiogram, CT scan and cardiac MRI)


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and over
2. Primary presentation with symptoms related to atrial fibrillation
3. Atrial fibrillation with a ventricular rate \>100 bpm on a 12-lead electrocardiogram
4. Able to provide informed consent

Exclusion Criteria

1. Previous myocardial infarction
2. Previous coronary revascularisation procedure
3. Patients in renal failure (eGFR \<30ml/min/1.73m2) or major allergy to contrast media
4. Pregnancy or breast feeding
5. Deemed unsuitable for participation in the study by the attending clinician
6. Previous enrolment in the trial
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.


Eligibility Criteria:
IInclusion Criteria:

* Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
* Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

* Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
* Subject has active cystic acne.
* Subject has acne conglobata.
* Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke

Stroke has been considered one of the main causes of long-term disability in the adult population, and is no longer considered a disease of the elderly, since 2/3 of all strokes occur among people under 70 years of age. According to the Ministry of Health, stroke is responsible for 40% of early retirements, being one of the most important causes of mortality in Brazil. The electroencephalogram (EEG) has been shown to be a very useful tool in the study of functional status and for the diagnosis of brain damage and disorders. It is considered a simple, non-invasive test with high temporal resolution, being a method widely used in laboratories to non-invasively monitor brain activity.

Stroke has been considered one of the main causes of long-term disability in the adult population, and is no longer considered a disease of the elderly, since 2/3 of all strokes occur among people under 70 years of age. According to the Ministry of Health, stroke is responsible for 40% of early retirements, being one of the most important causes of mortality in Brazil. Stroke usually causes long-term deficits such as asymmetrical muscle weakness between limbs, impaired proprioceptive ability, sensory loss, vision problems, and spasticity. In addition, these sensorimotor deficits interfere with various functions of the lower limbs, including balance, postural control, and gait ability, affecting their quality of life. The electroencephalogram (EEG) has been shown to be a very useful tool in the study of functional status and for the diagnosis of brain damage and disorders. It is considered a simple, non-invasive test with high temporal resolution, being a method widely used in laboratories to non-invasively monitor brain activity. Microstates reflect short periods (\~100 ms) of nearly stable brain states evolving over time, resulting from the synchronous and coordinated activity of brain networks. The aim of this study is to observe whether EEG microstates have correlations with clinical characteristics of people with stroke.

Eligibility Criteria:
Inclusion Criteria:

* people over 18 years of age, regardless of sex and with a stroke confirmed by computed tomography or magnetic resonance imaging.

Exclusion Criteria:

* have other associated neurological pathology
Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

Transcranial light therapy, or transcranial photobiomodulation (tPBM), is a treatment that stimulates the brain by applying near-infrared light to the forehead. Transcranial light therapy has been found to promote brain metabolism, which may help improve executive function in people with bipolar disorder. The research team proposes a novel approach to treating bipolar disorder by using transcranial light therapy.

This study involves a virtual screening visit, 7 in-office visits, and a virtual check-in call with a clinician. Participation will last approximately 3 weeks in total.

Participants will attend a baseline visit during which they will complete mood questionnaires and a gambling task. Participants will then receive five treatments of transcranial light therapy over one week. The first and last of these treatments will be administered while the participant is in an MRI scanner. At the first visit, participants will also receive a "sham" tPBM treatment, meaning that the device will simulate real treatment, but will not actually apply the near-infrared light. The check-in call will occur approximately 2-3 days after the final treatment visit. This will be a brief call with a study clinician to check-in on the participant's mental and physical health. The follow up visit will occur approximately one week after the final visit. Subjects will be asked to complete mood questionnaires and/or gambling tasks during the first and fifth treatment visits, as well as at the follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 65
* Diagnosis of bipolar disorder
* Currently experiencing symptoms of impulsivity
* Vision normal or corrected to normal with contacts

Exclusion Criteria:

* Currently in depressive, manic, or mixed episode
* Currently psychotic
* Judged to be at serious and imminent suicidal risk
* Currently in alcohol or substance use disorder (meeting criteria in the past 3 months)
* Unstable medical conditions
* Inability to consent or to complete study procedures
* Failure to meet standard MRI safety requirements (e.g. claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals)
* Changes in medications or use of augmentative devices and other interventions in the 2 weeks prior to the study
* Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
* Current pregnancy.