cyrilzakka/clinical-trials huggingface dataset:
Retaining Donors and Increasing Donation Frequency

To retain individuals as blood donors once they have entered the voluntary blood donation system and to increase the frequency of their donations.

BACKGROUND:

The study continued research previously funded as part of a National Research and Demonstration Center (NRDC) in Transfusion Medicine.

DESIGN NARRATIVE:

There were six components to the study. The first identified significant factors influencing regular blood donations by individuals with different donation histories - first-time, second-time, committed (frequent), and lapsed donors. The second component developed and assessed the validity of behavioral models to increase donor retention and to predict whether first and second time donors would contribute again. The third developed donor-retention interventions, especially for the first and second time donors. The fourth component identified homogeneous subgroups among first, second and committed donors who might be receptive to different types of intervention strategies to increase the frequency of their donations. The fifth component evaluated the success of cost-effectiveness of the new interventions compared to existing blood center maintenance strategies. The sixth identified whether or not donors had a limit or ceiling on how often they donated per year.

The investigators drew on two related social psychological theories to combine cognitive and behavioral approaches to blood donor retention and to use the findings to construct a multiattribute model of donor decision-making. A behavioral decision model was used to predict donor behavior prospectively and to target and direct the design of interventions to increase donor retention and the frequency of donations.

Approximately 33 percent of the total project supported the subproject on retaining donors.

Eligibility Criteria:
No eligibility criteria
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.

The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses.

The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged 50 or over on the day of inclusion, presenting a
* bilateral cataract for which posterior chamber IOL implantation
* has been planned.
* Fit within the available IOL diopter range.
* Have had no previous refractive surgery.
* Regular corneal astigmatism \< 1 dioptre by an automatic
* keratometer (regularity measured by topographer).
* Availability, willingness, and sufficient cognitive awareness to
* comply with examination procedures.
* Ability to attend all study follow-ups.
* Signed informed consent.

Exclusion Criteria:

* Ocular surface disease potentially affecting study results
* Subjects suffering from diagnosed degenerative visual disorders
* Pre-existing ocular pathology
* Acute or chronic disease or illness that would increase risk or confound study results
* Axial lengths and keratometry such as the IOL spherical power is
* not in the range of 14 to 28 D
* Instability of keratometry or biometry measurements
* Amblyopia
* History of ocular trauma or any prior ocular surgery including refractive procedures
* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss

This observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. This study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 - 80 years of age.
* Living in the United States.
* Consented from the Inspire online platform patient community for COSMOS-DIGITAL.
* Self-Reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity:
* Semaglutide (wegovy)
* Tirzepatide (zepbound)

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial.
* Self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel.
* Self-reported fear of blood.
* Self-reported circulatory conditions causing difficulty in drawing capillary blood.
* Known history of bleeding diathesis or any coagulation disorder.
* History of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.
Prevalence of Presenting Diseases for Elderly Patients Admitted to Emergency Department

The number of elderly patients admitted to the Emergency Department (ED) is dramatically increasing.

The number of elderly patients admitted to the Emergency Department (ED) is dramatically increasing. Most emergency physicians have not been trained in specific geriatric approaches, and many report being less comfortable when dealing with older patients. Aim of this study is the investigation the most common conditions affecting older patients in the ED.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients who visited the Emergency Department

Exclusion Criteria:

* Patients below 65 years of age
* Patients with missing data in medical records
Training With Whole Body Vibration Device in Patients With PAH

Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.

Study Design: Open Monocentric prospective randomized observational trial Study arms: Treatment group (4-weeks wbv training) planned 20 patients Control group: planned 20 patients Endpoint (-s): Changes in muscle power, changes in 6-Minute Walk Distance (6MWD), changes in QoL changes in peak VO2 (bike exercise test)

Major study procedures:

Blood samples, vital parameters, questionnaires, echocardiography, lung function test, blood gas analysis, bike exercise test, 6-Minute Walk test, ECG, Chair rising test, power plate measurement, walk across test

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-90 years
* Signed informed consent
* Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
* Invasively confirmed PAH
* 6MWT ≥ 50 m
* Stable specific therapy for at least 2 months
* Ability to perform bike test
* Ability to perform wbv training
* NYHA/WHO-FC II-III

Exclusion Criteria:

* any other PAH/PH than idiopathic, hereditary or associated with systemic scleroderma
* Rehabilitation or other training concept performed within 2 months before inclusion
* pregnancy
* acute thrombosis
* newly implanted Hip or Knee
* recent bone fracture
* Disability to confirm consent
* NYHA/WHO-FC IV
Use of Varenicline for 4-weeks Prior to Quitting

Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.


Eligibility Criteria:
Inclusion Criteria:

* Smokers seeking treatment
* Aged 18 and over
* Consenting to take part in the trial

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage renal disease
* Used varenicline in the past 6 months
* Unable to fill in questionnaires in English
* Current psychiatric illness
* Current serious illness including uncontrolled hypertension and recent cardiac event
* Sensitivity to varenicline currently enrolled in other research projects.
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.

The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 10 to below 18 years at screening visit
* Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
* Have HbA1c \>6.5% to ≤11% at screening
* Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region.

Exclusion Criteria:

* Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
* After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
* Had chronic or acute pancreatitis any time prior to study entry
* Female participants who are pregnant or breast feeding or intending to become pregnant.
* Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Labor Induction After Cesarean Section: Outcome, Hormonal Trends

Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section.

Design- Participants were randomized to undergo induction of labour by breast stimulation or intracervical balloon compared to spontaneous labour (controls).

Setting- A single tertiary hospital Population- women at term, with previous caesarean section

Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including the two groups catheter balloon and breast stimulation and controls in spontaneous labor. Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical outcomes were documented in the two induction groups.

Eligibility Criteria:
Inclusion Criteria

* uncomplicated pregnancy
* 37-42 weeks of pregnancy
* singleton pregnancy
* cephalic presentation
* previous one low transverse cesarean section
* indicated induction of labour

Exclusion Criteria

* fetal anomaly
* past uterine rupture
* previous preterm cesarean section
* multiple pregnancy
* polyhydramnios
* any contraindication for vaginal delivery or catheter balloon insertion
Testing the Feasibility of the DASH Cloud Intervention Using Amazon Alexa

The DASH diet is a proven behavioral strategy to reduce blood pressure, however, national adherence rates are poor. Using digital health tools may help to improve adoption of the DASH diet. Digital health approaches capitalize on the ubiquitous utilization of mobile technologies and have broad dissemination potential. There have been few efforts to test a DASH intervention via digital, and none using voice-activated technologies (e.g, Amazon Alexa). This proposal will enroll up to 20 participants to leverage a commercial diet tracking application, an existing intervention technology platform and the Amazon Echo Dot to test the feasibility of using DASH Cloud, a digital health intervention, with the Amazon Alexa personal assistant.

Digital health approaches are promising intervention channels for improving DASH diet adherence. Almost all Americans own a mobile phone and 97% of mobile phone owners use text messaging. Digital health approaches can capitalize on the ubiquity of mobile technologies and allow investigators to reach affected populations with highly personalized content at low cost. Despite this ubiquity, interventions using text messaging for hypertension self-management primarily rely on reminders for tracking and medication adherence without diet and physical activity behaviors or feedback. As such, they are less effective. Investigators will establish the feasibility of a novel digital health-based approach for disseminating the DASH diet using the Amazon Alexa personal assistant. The data from this pilot feasibility trial will set the foundation for a larger, fully-powered R01 grant to examine whether DASH Cloud using Alexa can improve health outcomes. The primary aim of this proposal is to test the feasibility of the DASH Cloud intervention using Amazon Alexa.

Eligibility Criteria:
Inclusion Criteria:

* Over 21 years old;
* BMI \>18.5 kg/m2;
* Current use of a smartphone with an updated operating system
* Data plan
* Willingness to be texted daily or weekly
* Wifi network at home
* An active email account
* Spoken and written English fluency.

Exclusion Criteria:

* CVD event in prior 6 months
* Active malignancy
* Active psychosis or recent psychiatric institutionalization
* Current pregnancy or lactation
* Current participation in a similar trial.
Evaluation of Partial Versus Complete Pulpotomy in Carious Immature Molars Permanent Teeth Using Bioceramic Material

One of our major concerns and daily challenges is the management of carious immature permanent teeth, also known as young permanent teeth while preserving the vitality of the dental. Preserving radicular pulp tissue in these teeth allows continuing apical maturation and apical closure.

Diagnosis and treatment of carious immature permanent molars are considered a challenging aspect of daily clinical routine, where constant irritation of the pulp without treatment leads to irreversible pulpitis and necrosis, which impedes the natural root development and its complete formation ; leading at the end to a decision of extracting the tooth .Therefore; when treating immature permanent teeth, the main goal is to preserve the vitality of the pulp to guarantee natural root development.

Pulpotomy is a commonly employed treatment for this procedure involving either the removal of only the outer layer of damaged and hyperemic tissue in exposed pulps (partial pulpotomy or Cvek pulpotomy); which is a procedure staged between pulp capping and complete pulpotomy.

Complete pulpotomy is the total removal of coronal pulp tissue and the placement of a wound dressing on the canal orifice. Followed by the placement of a biocompatible material to promote healing and regeneration of the remaining vital pulp tissue.

In many studies, MTA showed high success rates in treatment of carious immature permanent molars. However, MTA is expensive and has poor handling characteristics, a long setting time and no predictable antimicrobial activity.

Recently, new bioceramics have emerged as promising materials, showing good potential for vital pulp therapy in immature permanent teeth due to their biocompatibility and favorable clinical outcomes.

Both MTA and bioceramics have almost similar compositions, but bioceramics materials contain titanium oxide and calcium phosphate, in addition to the absence of aluminum in its composition. Besides, bioceramics can release a high percentage of calcium ions early while maintaining this high percentage for 28 days, in contrast to the mineral trioxide, which showed a lower ability to release calcium ions more slowly.

Therefore, this study will be conducted to compare the effectiveness bioceramic material in partial and complete pulpotomy of immature permanent molars.

comparing the effectiveness of bioceramic material in partial and complete pulpotomy in carious immature permanent molars.

Eligibility Criteria:
Inclusion Criteria:

1. Children with vital immature mandibular first permanent molars; with clinical carious exposure of the pulp and presence of bleeding upon exposure.
2. Age ranges from 6-10 years.
3. No history of spontaneous pain.
4. Absence of sinus tract, sinus swelling.
5. The posterior teeth could be restored.

Exclusion Criteria:

1-History of spontaneous pain, or pain that wakes up the child at night. 2-Teeth with closed apex. 3-Teeth with furcation, prominent radiolucency in the periapical region. 4-Teeth with excessive mobility. 5-Non-restorable molars.

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Clinical Outcomes in Patients With Infection by Resistant Microorganism

The goal of this individual patient data meta-analysis is to estimate the attributed and the associated health burden related to bloodstream infections, pneumonia, skin and soft tissue infections, surgical site infections and urinary tract infections, caused by target drug-resistant pathogens, in high income countries.

The main question\[s\] it aims to answer are:

* Are common infections caused by drug-resistant pathogens associated with an increased health burden, when compared with individuals with the same infection caused by a susceptible strain (attributed burden)?
* Are common infections caused by drug-resistant pathogens associated with an increase health burden, when compared with individuals without the infection under study (associated burden)?


Eligibility Criteria:
Inclusion Criteria:

* Individuals of all ages
* Individuals with hospital acquired, community acquired, or healthcare associated infections
* Individuals treated at hospital level, community, or long-term care facilities
* Individuals with the targeted pathogen, resistance phenotype, and infection site combinations under study

Exclusion Criteria:

* Individuals with infections in the following systems: central nervous system, genital system, pelvic infections and head and neck infections
* Individuals with the following specific primary infections: endocarditis, upper respiratory tract infections, lung abscess
* Individuals with bacterial infections not included in the table of pathogens of interest, polymicrobial infections except for intraabdominal infections, fungal infections, parasitic infections, viral infections, mycobacterial infections, sexually transmitted diseases, and zoonotic infections
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune persistence group.


Eligibility Criteria:
Inclusion Criteria:

* 7\~17 years old at the time of screening
* Volunteers and their legal guardians or delegates have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete 180 days of study follow-up
* Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial

Exclusion Criteria:

* Fever on the day of vaccination, axillary temperature \>37.0°C
* Have a moderate or severe acute illness/infection
* Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
* Current meningitis or history of meningitis
* Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
* History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
* Previous severe allergic reactions due to drugs or vaccines
* Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
* Any meningococcal vaccine in the last 1 year
* Any other vaccine within 14 days
* Participation in other studies involving interventional studies within 28 days (\<28 days) prior to study entry and/or during study participation
* Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable