cyrilzakka/clinical-trials huggingface dataset:
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials

This study aims to gather insights into the perceptions of legal representatives regarding the recruitment process for clinical trials in the intensive care setting when the patients cannot decide for themselves. With this information, effective strategies will be developed to increase involvement and the feeling of ownership of LARs of (potential) participants in clinical trials and thus enhance and facilitate patient recruitment for clinical trials. The single-arm study design does not include a choice of comparator, as the focus of this trial is to explore the perceptions of the participants at first hand without comparing different cohorts or strategies.

The evidence for specific therapies and treatment strategies, particularly for critically ill patients, remains limited. A significant difficulty for the planning, initiation and implementation of clinical trials in these patients is the urgency of the necessary medical measures, which leaves patients and their relatives, as well as the treating clinicians, little time and opportunities to present necessary studies and to inform the patients or their legal guardians about them. Critically ill patients are a particularly vulnerable group of patients. The measures required as part of a study can mean additional efforts for these patients over and above the burden of the disease and the necessary diagnostic and therapeutic measures, which are only justified if special duties of care are observed. In addition to an ethical assessment of the study, this also includes providing comprehensive information to patients or their legal representatives.

In this study, the process of informing and educating patients or their legal representatives will be examined in more detail. The aim of the study is to gain a better understanding of this process, in particular the perceptions and views of the persons to be informed, and specifically to investigate which aspects are particularly important to patients and their legal representatives in an information and education discussion and what information they need in order to be able to consider participating in a study or what reasons exist that would prevent them from giving their consent. The overall aim of this study is to improve the information and education process.

For some years now, the involvement of patients and relatives in individual aspects of the planning and conduct of clinical trials has been increasingly demanded and promoted. For example, large public funders often require the involvement of patient and/or family representatives at an early stage in the planning of trials. The objectives of this study are based on these expectations.

Eligibility Criteria:
Inclusion Criteria:

* The study will include LARs of adult patients aged 18 years or older who are admitted to the Freiburg University Medical Center in Germany.

Exclusion Criteria:

* LARs who have expressed their unwillingness to participate in the study or have objected to the measures implemented in the study will not be included.
Turmeric Gel as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol, when used as non-vital Pulpotomy medicaments.

It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).

Eligibility Criteria:
Inclusion Criteria:

1. Cooperation of patients and consent of parents.
2. Patients with ASA classification I and II (mild to moderate systemic disease).
3. Non-traumatic extensively carious hence restorable primary molars.
4. No history of antibiotic use for 2 weeks.
5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.
2. Radiographic evidence of pulpal floor opening into the furcation area.
3. More than half of the roots resorbed.
NeoAMR Observational Study in Neonatal Sepsis

Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).

1. NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally.
2. NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.

Eligibility Criteria:
Inclusion Criteria:

* In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions

  * Age \<60 days of age
  * Clinical suspicion of a new episode of sepsis (as defined below)\*\* together with planned treatment with IV antibiotics OR new episode of confirmed bacterial meningitis\^ OR new episode of infection in which a Carbapenem-resistant organism (CRO) is isolated from blood culture OR new episode of infection in which a candida species is isolated from blood culture
  * Informed consent from parent / guardian
  * Willingness to provide location information and to be contacted at 28 days from start of antibiotic treatment

Exclusion Criteria:

* • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached

  * Enrollment in any interventional trial
  * A serious, non-infective co-morbidity (other than prematurity), anticipated to cause death within 72 hours
PROSPECTIVE EVALUATION OF HEARTFOCUS

The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion.

Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views

This prospective multicentric international pivotal trial will evaluate the ability of the Heartfocus software to support novices for the acquisition of 10 reference views of cardiac ultrasound. The 10 reference views are the following:

Parasternal long axis, Parasternal short axis at the aortic valve, Parasternal short axis at the mitral valve Parasternal short axis at the papillary muscles Apical 5-chamber, Apical 4-chamber, Apical 3-chamber, Apical 2-chamber, Subcostal 4-chamber, Subcostal inferior vena cava.

Patients included in the study will be adult patients scheduled for an echocardiogram at one of the two investigating centers. Ultrasound exams will be limited to the acquisition 10 reference views.

Patients will receive 2 additional limited exams, which consist of the acquisition of ultrasound clips for each of the 10 references views:

one by a novice, nurses having received a dedicated training of 2 days, with an ultrasound probe and the HeartFocus software with the guidance system, one by an expert (experienced sonographer/cardiologist) with the same ultrasound probe and the HeartFocus software without the guidance system.

A total of 8 novices will perform the acquisition on 30 patients each. In total 240 patients will be included in the study, half in each investigator center. The exams (240 acquired by novices, 240 by experts) will be analyzed by cardiologists to assess their quality. The endpoints are described below.

Eligibility Criteria:
Inclusion Criteria:

Patient (male or female) over 18 years old, Patient having an echocardiography examination scheduled in one of the two investigation centers.

Patient who has given his non-objection to participate in the research

Exclusion Criteria:

Patient subject to a measure of legal protection (safeguard of justice, guardianship or curatorship), Patient deprived of liberty by judicial or administrative decision, Patient being unable to give his non-objection, Pregnant or breastfeeding women, Patient with cardiac anatomy that does not allow reference electrocardiographic sections to be made (situs inversus, single ventricle, congenital anomalies, etc), Patient having benefited from prior echocardiographic exams whose reports mention poor or weak echogenicity, Patient having known chest deformity that has already been mentioned in previous reports or has been the subject of investigations (pectum excavatum), Patient who has undergone total or partial pneumectomy
Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh. A barium swallow test with x-rays will be performed to look for recurrence of hiatal hernia. If the participants are symptomatic, additional medical therapy will be provided as deemed appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent paraesophageal hernia repair at UNMC.
* Greater than 19 years of age
* Not pregnant

Exclusion Criteria:

* Children and adolescents
* Pregnant and breast-feeding patients
* Vulnerable subjects such as decisionally impaired persons
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary

This is a Hungarian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

Secondary Objective:

* To identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To asses the impact of adherence on Insulin-like Growth Factor-1 (IGF-1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to the Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in an interventional clinical study
Living Memory Home-4-Dementia Care Pairs

The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories.

The main aims of this study are:

* To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
* To explore the potential for LMH-4-DCP to reduce feelings of pre-loss grief and enhancing relationship quality in dementia family caregivers and their care-recipients ('Care-Pairs')

Care pair participants will be asked to log-in to LMH-4-DCP and complete study activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.

The goal of this randomized controlled trial is to evaluate the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) web application, a dyadic online psychosocial reminiscence platform, to reduce feelings of pre-loss grief and improve relationship quality in individuals with dementia and their family caregivers ('Care Pairs').

The main aims of this study are:

* To evaluate the feasibility and acceptability of the LMH-4-DCP platform.
* To explore the influence of the LMH-4-DCP intervention on reducing feelings of pre-loss grief and enhancing relationship quality in the care pair

Caregiver participants randomized to the intervention condition will be asked to log-in to LMH-4-DCP and complete reminiscence activities three times per week for two weeks. Researchers will compare the intervention group to an attention control condition, which includes LMH-4-DCP use without reminiscence-specific features, to see if LMH-4-DCP's use is associated with reduced feelings of caregiver pre-loss grief and improved care pair relationship quality at follow-up.

Eligibility Criteria:
Inclusion Criteria:

Family Caregivers:

* be a primary source of care for a family member in the early to moderate stages of dementia
* 18 years of age or older
* English-speaking
* able to use the internet and has internet access
* residing in the United States

Exclusion Criteria:

Caregiver exclusion criteria:

* is not the primary family caregiver of the PwD
* under the age of 18-years-old
* exhibits cognitive impairment (by scoring 3 or more on the SPMSQ)
* does not speak English as a primary language.

PwD exclusion criteria:

* severe cognitive impairment detected by the clinical or study staff using validated, brief screening tools (e.g., a score of 8 errors or more on the SPMSQ)
* does not demonstrate capacity to consent (e.g., a score of 9 or fewer errors on the University of California-San Diego Brief Assessment of Capacity to consent
* PwD is living in a long-term care facility
* does not speak English as a primary language
* is under the age of 18 years old.
Topical Pharyngeal Anesthesia With Articaine for Gastroscopy

Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists' satisfaction.

Topical Pharyngeal anesthesia (TPA) is widely used as an adjunct to sedation during upper endoscopy. TPA improves patient tolerance and the ease of endoscopy.1 Methemoglobinemia and anaphylactic reactions are serious complications of such topical anaesthetic agents, as lidocaine, tetracaine, and benzocaine. Articaine is as a unique amide local anaesthetic that possesses both an amide and an ester linkage and this is of clinical significance in minimizing the risk of overdose (toxic reaction). In routine dental procedures, articaine is a superior anaesthetic to lidocaine. Also, in comparison to lidocaine articaine acts faster and its duration of action is shorter what may be an advantage in such relatively fast procedures as gastroscopy. Articaine have not been previously evaluated in pharyngeal anesthesia for upper endoscopy. The aim of this randomised double-blind placebo controlled study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists'satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* allergy to articaine, propofol, alfentanil
Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets

The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release tablet and to test for bioequivalence of the new versus the commercial product in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
* Body Mass Index (BMI) of approximately 18.5 to 30.0 kg/m2, and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
* Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* History of hypersensitivity to acetylsalicylic acid (ASA), naproxen sodium, acetaminophen, other non-steroidal anti-inflammatory drugs (NSAIDs), and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product
* Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease, or malignancies
* Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
* Females who are pregnant or lactating
* Consumption of xanthine-containing food and beverages within 24 h before investigational medicinal product (IMP) administration during Treatment Periods 1 and 2; or not willing to abstain from any xanthine containing food and beverages during the study
Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings

Endometriosis is classically defined as the presence of endometrial glands and stroma outside the uterine cavity and its musculature.

The definition of deep endometriosis is based on anatomic assumptions that may prove erroneous.

In fact, the term '' deep endometriosis '' should be reserved for lesions in the retroperitoneal tissue. For practical purposes, several reports included in the so-called deep endometriosis the infiltrative forms that involve vital structures such as the bowel, ureters, and bladder, as well as forms such as many rectovaginal lesions. For the term ''deep'' to apply, there should be ectopic endometrial tissue penetrating the peritoneum more than 5 mm in depth.

The ectopic endometrium responds to hormonal stimulation with various degrees of cyclic hemorrhage which result in suggestive symptoms and appearances.

A common symptom is infertility. Pelvic pain is a frequent complaint among patients with endometriosis. Such pain generally manifests as secondary dysmenorrhea, worsening primary dysmenorrhea, dyspareunia, or even noncyclic lower abdominal pain and backaches. The pain may be site-specific when endometriosis is found in unusual locations outside the pelvis.

Diagnosis Physical examination and laparoscopic exploration may not allow diagnosis or prediction of the extension of deep pelvic endometriosis, especially in pelvic retroperitoneal sites.

Transvaginal sonography is recommended for diagnosis of endometriomas and endometriosis of the bladder but its value for assessment of superficial peritoneal lesions, ovarian foci, and deep pelvic endometriosis is uncertain.

MR imaging is now commonly used for diagnosis of endometriosis and provides a tremendous advantage over other methods of investigation, owing to the possibility of making a complete survey of the anterior and posterior compartments of the pelvis at one time.

MRI is becoming a mainstay of preoperative diagnosis, in particular for diagnosis deep infiltrating endometriosis.

A prospective study including 30 Female patients of reproductive who were previously clinically diagnosed to have endometriotic lesions. these will be sent to our department to identify the extent of the lesions and clarify the exact location for proper treatment.

All patients were evaluated with ultrasound and MRI. the sensitivity, specificity and diagnostic accuracy for both examination were calculated.

Transvaginal ultrasound and MRI will be done in our Radiology department to all patients after signing an informed consent to be enrolled in the study.

All our imaging results were finally compared to the laparoscopic results which are our gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Female patients who have symptoms consistent with endometriosis such as pelvic pain, dysmenorrhea, deep dyspareunia, and infertility

Exclusion Criteria:

* The common contraindication to MRI, peacemaker, metallic foreign bodies, and claustrophobia