cyrilzakka/clinical-trials huggingface dataset:
Effects of Population Compared to Purposive Sampling for Consensus in an Online Delphi Study

This study will be nested as a randomized controlled trial within an online Delphi and will assess the effects of the population sampling compared to purposive sampling for consensus in an online Delphi.

The Delphi method of engaging panels of experts from specific interest areas has been widely utilized in the for the development of research reporting guidelines, core outcome sets, clinical medicine, nursing practice, medical education and healthcare services. An assessment completed by Atkins and colleagues in 2005 report that a small panel of similarly trained experts can develop reliable criteria that inform judgment and support effective decision-making. Despite the wide applicability of the Delphi methodology, it is not known how the number of participants or their similarity as a stakeholder group influences results in an online Delphi.Purposeful sampling will be used with a randomized sample taken from each stakeholder group for analysis and this analysis will be presented alongside the full analysis and the results compared.

The Protocol Lab for Online Trials-Delphi (PLOT-D), which will use an online 3-round Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.

Eligibility Criteria:
Inclusion Criteria:

* Protocol lab online trials Delphi (PLOT-D) Participant

Exclusion Criteria:

* None if meets inclusion criteria
Intestinal Microbiome and Chronic Inflammatory Bowel Disease

The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)

IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.

Eligibility Criteria:
Inclusion Criteria:

* IBD

Exclusion Criteria:

* patient refusal to participate
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.

Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS.

The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.

Eligibility Criteria:
Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle.

Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight \> 300 lbs.
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)

120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion Criteria:

* insulin allergy
Neurofunctional Study of Preterm Infants' Brain Activity

During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. In preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (KMC), are actively promoted. Studies carried out with electroencephalography showed that preterm infants who participated in KMC interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. It has also been observed that KMC carried out in preterm infant with gestational age \<33 weeks promotes adequate development of the primary motor cortex during adolescence.

Recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. After few days of life, the infant's brain picks up messages from the human context and interacts with them. For example, a study using near-infrared spectroscopy (NIRS) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. Similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. The aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) KMC and 2) listening to their mother's voice, using optical topography, a multichannel NIRS system.


Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth ≤32 weeks
* absence of brain injury and neurological problems
* newborn-mother pairs in KMC
* adherence to research by parents.

Exclusion Criteria:

* contraindications to KMC and NIRS, according to internal protocol
A Bioavailability Study on Dronabinol

This study is a two part study

This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.

Exclusion Criteria:

* Smokers
MyT1DHero: an mHealth Intervention for Type 1 Diabetes

The overall objective of the proposed research is to improve HbA1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of T1D. The investigators will test the efficacy of the MyT1DHero app against an attention control group. This will allow investigators to better understand the health and psychosocial improvements being made through the app.

This research seeks to realize the potential and test the efficacy of MyT1DHero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. The investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. The investigators further seek to decrease family conflict among children with T1D and their parents. In a 12-month RCT, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study will be 10-15 years old, and will have been living with T1D for \<1 year or \>5 years at the start of the study. The primary outcome will be a change in the participants' HbA1C from baseline levels at the start of the study, to levels measured after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* The adolescents must:

  1. have a T1D diagnosis according to the ADA practice guidelines,
  2. be 10 to 15 years old,
  3. have had a diagnosis of T1D for at least six months,
  4. have an HbA1c \> 7,
  5. have had at least two outpatient visits in the past two years,
  6. be treated at Spectrum for diabetes,
  7. be fluent in English,
  8. have a parent/guardian willing to participate,
  9. have and be allowed to use a mobile phone for the study, and
  10. have permission from their care team to participate.

The parent/guardian must:

1. have an adolescent with T1D who is 10 to 15 years old,
2. be fluent in English, and
3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria:

* For the adolescents include:

  1. significant medical conditions other than T1D,
  2. being treated for thyroid disorders, celiac disease, or eating disorders, and
  3. being in foster care.

Exclusion criteria for both the adolescents and parents/guardians include:

(a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.
Comparative Aesthetic Analysis Between Titanium and Ceramic Implants

Objective: The aim of this randomized clinical trial was to compare ceramic and titanium implants with respect to the esthetic and clinical parameters, and patient reported outcome measures (PROMs).

Material and methods: Thirty patients received thirty implants (8-12 mm in length, 3.3 mm diameter and a tissue level design) to replace the absence of a single tooth in the anterior maxilla. Patients were randomly allocated to receive a ceramic or a titanium implant. Esthetic and clinical parameters and PROMs were evaluated 18 months after surgery.

The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design, comparing ceramic (test group) and titanium (control group) implants, for the replacement of a single-tooth in the anterior maxilla.

All patients were randomized and assigned to each of the study groups through a computer-generated randomization.

Surgical and restorative procedures In the test group, a Tissue Level Ceramic monotype implant was placed (Straumann PURE Ceramic implants®; Institut Straumann, Basel, Switzerland) and in the control group a Tissue Level SLA Titanium implant (Straumann Standard Plus Narrow Neck CrossFit®; Institut Straumann, Basel, Switzerland). The length of the implants was 8, 10 and 12 mm.

The primary outcome was the Implant Crown Aesthetic Index (ICAI). It consists of nine sections: mesiodistal dimension of the crown, position of the incisal edge of the crown, labial convexity of the crown, color and translucency of the crown, crown surface, position of the gingival margin of the peri-implant mucosa, position of the interdental papilla, contour of the vestibular mucosa and color and surface of the vestibular mucosa. These sections were compared with the adjacent and contralateral tooth as a reference and assigned the following score: 0, excellent; 1 or 2 satisfactory; 3 or 4 moderate; 5 or more bad.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal and systemically healthy patients \> 18 years of age, with good plaque control (\< 25%).
* Patients with a missing tooth in the anterior maxilla (from 13 to 23) with the presence of adjacent natural dentition mesially and distally (single gap). A minimum of 4 months of healing after tooth extraction was required before implant insertion.
* Presence of ≥ 2mm of keratinized tissue.
* Simultaneous bone regeneration was allowed during surgery.

Exclusion Criteria:

* Intake any medication or presence of any systemic disease that could affect bone metabolism.
* Pregnancy, or lactating women.
* Active periodontal disease
* Smoking \>10 cig/day
Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is:

1. Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?

Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2)
* Patients that are eligible for operative treatment of clavicle fractures.

Generally accepted indications include:

* Displacement of one or more shaft width
* Shortening of more than 1cm in length
* High demand patients (physical activity)

Exclusion Criteria:

* Delayed presentation (\> 14 days)
* Initial operative treatment at non-participating hospitals
* Open fractures
* Pathological fractures
* Re-fractures of clavicle
* Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs)
* Cognitive impairment or language barrier precluding answering questionnaires
* Unable to complete follow-up (e.g. different residential area/tourists)
Exploring Biological Linkage Between Circadian Disruption and Cancer Progression

The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.

The biological markers that are assumed to bridge this association are measured and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70
* Breast cancer patients who are getting chemotherapy for the first time in life
* Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy.
* Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

* Patients already have received chemotherapy
* Patient had another cancer (except thyroid cancer) within 5 years
* Patient with severe medical condition
* Patient had taken psychiatric medication more than 1 month in life
* Patient worked the night shift for more than 1 month in 6 months
EEG-based Brain-computer Interface Database for Motor Rehabilitation

The human brain, as a processing center, controls bodily, cognitive, emotional and social functions, enabling perception, signal analysis and decision making. However, these functions can be affected by acquired brain injury (ABI), resulting from traumatic (blows to the head) or non-traumatic factors (tumors, strokes, infections, among others). Annually, about 55 million new cases of ABI are reported, with sequelae that can affect the quality of life of patients and their families. This scenario has driven research into tools to mitigate and recover lost capabilities. The Center for Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS) of the Faculty of Engineering of the National University of Entre Ríos in Argentina has developed neuromuscular and sensory rehabilitation systems, with a focus on the innovation of motor rehabilitation tools using EEG-based brain-computer interfaces (BCI). These BCIs stand out for their economy and versatility, showing significant effects in the rehabilitation of motor functions. Challenges in BCI include signal complexity, artifacts, and inter-person variability, making it difficult to estimate user intent and extending calibration time. To mitigate these problems, strategies based on Deep Learning and dictionary learning have been proposed, which allow for sparse representations of data, being robust to noise and missing data, but with challenges in classification. The study proposes to develop a database of electroencephalographic signals applicable in the development of new algorithms for processing and feature extraction of this type of signals, contributing to the development of technology that supports rehabilitation processes.


Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to fully understand the purpose and scope of the experiment and to comply with the experiment instructions.
* Ability to easily distinguish visually the figures in the study.
* Ability to perform tasks that demand sustained concentration.

Exclusion Criteria:

* History of neurological diseases.
* Suffering from any type of musculoskeletal disorder that limits the motor skills necessary for the experiment.
* Having a significant hearing loss that prevents him/her from hearing the study instructions.
* Pregnancy.
* Lack of cooperation.
Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia

The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.

Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl.

Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA.

The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists I or II,
* 18-72 months of age,
* scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia

Exclusion Criteria:

* developmental delay
* psychological and neurologic disorder
* sedatives medication
* an abnormal airway
* reactive airway disease
* extreme agitation and uncooperation
* previous history of anesthesia
Data Collection After Intensity IOL Implantations

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1. Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus point on the retina, MIOLs are designed to help patients to see at varying distances using different points of focus2. MIOLs used in clinical practice were either refractive initially, or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with different optical powers in different parts of the lens, while diffractive MIOLs use diffractive steps on the lens to distribute light rays into two or more principal foci. Irrespective of the design type, however, all MIOLs involve some form of optical compromise and a process of neuroadaptation for the patient.

Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology. Intensity SL lenses provide clear vision at all distances - from near to far - thus offering the best chance of true spectacle independence.

Despite the promising results obtained with the latest generation of MIOLs, many surgeons remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced contrast sensitivity and night vision problems are all known complications of multifocal implants and have served to hamper wider acceptance of these IOLs4.

Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18
* Patient who underwent bilateral implantations with Hanita Lenses Intensity IOL

Exclusion Criteria:

* Patients who don't have any follow up visits after implantation
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population

The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
* Good health with the exception of psoriasis or atopic dermatitis

Exclusion Criteria:

* Any disease affecting the HPA-axis
* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period