cyrilzakka/clinical-trials huggingface dataset:
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures

Management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. It is recently done guided by the new four column theory of distal tibia. Several approaches were advocated to address and fix each column. Fixation of posterior column is still a wide debate among orthopedic surgeons. This study is conducted to compare outcomes between two modalities for the management of posterior column fracture in pilon fractures.

The aim of this work is to assess and compare results of anterior to posterior screws versus posterior buttress plate in management of posterior column fracture in pilon fracture as regards functional, radiological outcomes and possible complications.

Optimal treatment of comminuted pilon fractures requires precise anatomical reduction. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial. On the basis of the anatomical characteristics of the ankle joint a four-column classification to guide the treatment of comminuted pilon fractures was proposed. The four-column classification can be summarized as follows: lateral column( the distal fibula), posterior column( the posterior part of the intermalleolus line with the distal tibial shaft), anterior column (the anterior part of the intermalleolus line with the distal tibial shaft) and medial column(the medial one-third of the tibial plafond with the distal tibial shaft).

A posterolateral incision is typically used to reduce and fix the posterior malleolar fragment to the tibial metaphysis which can be also done through the anterior incision using anterior to posterior screws.

Eligibility Criteria:
Inclusion Criteria:

* Two, Three and four column pilon fracture

Exclusion Criteria:

* Pathological fractures.
* Pediatric age group with open physis.
Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 30 years old
* Written informed consent obtained
* Patient with Body mass index (BMI) ≥ 20
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
* COPD patient with GOLD stages C and D
* Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
* Patient with smoking history of at least 10 pack-years
* Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1
* Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

Exclusion Criteria:

* Pregnant or lactating females
* Patient with severe immunological diseases and/ or severe acute infectious diseases
* Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
* Patient with diagnosis of cancer (except basal cell carcinoma)
* Patient with a history of depression associated with suicidal ideation or behaviour
* Patient with moderate or severe hepatic impairment.
* Patient with lactose intolerance
* Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
* Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
* Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)
Ivermectin Versus Albendazole for Chronic Strongyloidiasis

A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.


Eligibility Criteria:
Inclusion Criteria:

* Patients with positive strongyloides larva in the stool

Exclusion Criteria:

* Pregnancy
* Lactating women
* Known allergy to any study drug
Effectiveness of the Teacher Module of the Prevention Program for Externalizing Problem Behaviour in Preschoolers

Investigating effectiveness of the cognitive-behavioral based teacher training under routine care conditions by comparison of a baseline-interval with no special intervention to a following interval of PEP for the kindergarten teachers only each focussing on one child (3-6 years old) that the teacher herself indicated as "needing special attention for externalising behaviour". Effects on child symptoms and teachers behavior and burden within intervention-period are expected to be stronger than those during waiting-period.

Findings of the PEP-efficacy-study based on a randomised controlled sampling ((ISRCTN CCT-NAPN-18918) using combined training-modules for parents and teachers showed positive effects on children's behaviour in the intervention-group. These effects in teacher's view were stronger than in the control-group but could not be proved to be statistically significant. Moreover after this first step of evaluation there remain unanswered questions concerning the stability of effects after transferring the program in routine care. Therefore the study is continued by an effectiveness-study.

Eligibility Criteria:
Inclusion Criteria:

* teacher's interest in participating in a specific further training
* Identification of a target child (externalizing problem behavior)by teacher
* possibility of participation in at least 4 assessments (pre1, pre2, post,1stFU)

Exclusion Criteria:
Footwear Among Medical Doctors

The footwear fashion among medical doctors has been static for decades with a high preference for clogs. However, other types of shoes have been introduced, including sneakers, sandals etc. In some subspecialties with a "need-for-speed", high-agility footwear may be prioritized, while other subspecialist may benefit from "easy-to-clean" shoes. Even comfortability may influence the choice of footwear.

We intend to investigate measures of footwear fashion among medical doctors working at Aarhus University Hospital, Denmark. Participants will be blinded.


Eligibility Criteria:
Inclusion Criteria:

* Medical Doctor working at Aarhus University Hospital, Denmark
* Wear shoes at work
* Presence at the randomly selected meetings for medical doctors, where trial personal will perform the footwear assessment.

Exclusion Criteria:

* Medical student
* Nurse or other health care profession
* Unidentifiable gender and/or educational level
Evaluation of 3D Printed Myoelectric Prosthetic Devices in Children With Upper Congenital Limb Deficiency

This will be a prospective study over a 14-month duration with clinical evaluations throughout. Limitless Solutions will provide prosthetics and training system for study subjects that qualify for enrollment.

Prosthetics for children are costly and those families who do get them often find that children don't use them for very long for a variety of reasons, including weight and ease of use. Limitless Solutions has developed technology to create personalized bionics for people with disabilities at an affordable cost. This will be a prospective study over a 14-month duration with clinical evaluations throughout. Limitless Solutions will provide prosthetics and training system for study subjects free of charge. During each visit, the study team will include an occupational therapist, a prosthetist, a study coordinator, and a research volunteer along with Limitless support staff and a supervising physician. Subject will complete quality of life questionnaires throughout their participation.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 7 to 17
* Congenital/infant upper limb deficiency specifically transhumeral and transradial limb deficiency as identified by Limbitless Solutions.

Exclusion Criteria:

* Non-English-speaking children and families.
* Any shoulder or wrist disarticulation will be excluded.
RCT for Innovating Stress-related eHealth

The Randomized Control Trial for Innovating Stress-related eHealth (RISE) Study tests the hypotheses that a highly promising digital therapeutic (RISE Guide) targeting anxiety sensitivity (AS) will be acceptable to women sexual assault survivors; reduce survivors' anxiety sensitivity, and, in turn, posttraumatic stress.

If successful, RISE Guide could be provided at no cost to all women who present to US emergency departments for emergency care after sexual assault.

The RISE Study plans to recruit up to 60 women (natal and self-identifying) who present for Sexual Assault Nurse Examiner (SANE) care within 72 hours of experiencing sexual assault. Willing participants will complete enrollment procedures (i.e., consent forms and initial survey) during this same, initial SANE care visit.

All enrolled participants will complete 4/day ecological momentary assessments (EMAs; day 1 through day 49) and complete a follow-up assessment at week 1. More information on EMA and week 1 assessment content is available in the "Outcome Measurements" section of this listing.

Following their week 1 survey, all participants will be randomized into either the active (RISE Guide) or control (Breathe2Relax app) condition. Participants will receive a link to their assigned intervention. Participants in the active condition will additionally begin receiving ecological momentary interventions (EMIs) at the end of their ecological momentary assessments, which consist of personalized feedback based on symptoms reported during EMAs.

All participants will receive an Empatica wristband in the mail. Participants will wear the wristband week 1 through week 7 and press a button on the wristband's interface whenever they experience internal (e.g. thought) or external (e.g. seeing the assailant in public) trauma reminders. The wristband will collect continuous data on participants' heart rate, temperature, and perspiration, which will be used as measurements of stress reactivity.

All participants will complete further follow-up assessments at week 7, month 6, and month 12.\* More information on each follow-up assessment's content is available in the "Outcome Measurements" section of this listing.

\*The month 12 follow-up assessment was removed via an IRB modification approved on December 14, 2022. Participants enrolled after December 14, 2022 will not complete this timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Women sexual assault survivors presenting for emergency care \<72 hours post-assault at one of our study locations.
* English speakers
* 18+ years of age
* Able to provide informed consent
* Have a smartphone with continuous service \>1 year

Exclusion Criteria:

* Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening).
* Prisoner
* Currently pregnant
* Lives with assailant and plans to continue to do so
* Admitted patient
* No mailing address
* Previously enrolled
* No SANE examination
Incentives for Influenza Vaccination

In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and over
* Empaneled patients or non-empaneled patients with a primary care visit in past 18 months with valid insurance
* Due for an annual flu shot according to the electronic medical record
* Active phone number or email
* Do not have "Do not contact" flag

Exclusion Criteria:

* Under age 18
* Received an annual flu shot based on medical record
A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)

This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX) given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1 pharmacokinetics results before continuing to Part 2. The same participants participated in Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma concentration 12 hours after administration (C 12 hrs) would not differ significantly from raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after raltegravir.


Eligibility Criteria:
Inclusion Criteria:

* On a stable raltegravir dose as part of a stable antiretroviral regimen for ≥1 month before the study
* If female, is not pregnant or breast feeding
* Body mass index ≤32 kg/m\^2

Exclusion Criteria:

* Mentally or physically incapacitated, has significant emotional problems, or history of clinically significant psychiatric disorder within ≤10 years
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease (excluding HIV)
* History of gastric bypass surgery
* History of cancer, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥10 years before the study
* History of chronic diarrhea within ≤3 months before the study
* History of significant multiple and/or severe allergies (food, drug, latex), or had an anaphylactic reaction or significant intolerability to drugs or food
* Had major surgery or donated or lost ≥1 unit of blood (500 mL) ≤4 weeks before the study
* Participated in another investigational trial ≤4 weeks before the study
* Taking rifampin or is unable to refrain from the use of 1) any proton pump inhibitor from 2 weeks before and throughout the study, or 2) any histamine H2-blockers, antacids, calcium supplements, or multivitamins from 2 weeks before and throughout the study
* Consumes \>3 glasses of alcoholic beverages per day
* Consumes excessive amounts of caffeine beverages (coffee, tea, cola, energy drinks, or other caffeinated drinks) per day
* Currently uses or has a history of drug abuse within ≤6 months before the study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients

In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024.

The investigators will therefore compare the risk of IE before vs after march 2024.

Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves.

These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade.

In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases.

These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical valve replacement patients.

In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS).

Thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of IE in patients undergoing.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical valve replacement

Exclusion Criteria:

* None
Nocturnal Hypertension and Non-Dipping Blood Pressure

The purpose of this study is to determine if high salt diet contributes to high nighttime blood pressure. The investigators will determine if high compared to low salt diet increases 24-hour blood pressure levels. The investigators will also determine if high salt diet affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also determine how high salt diet affects the activity of certain genes related to control of blood pressure. A total of 60 participants will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* Nocturnal hypertension

Exclusion Criteria:

* Stage 2 clinic hypertension
* History of congestive heart failure
* Chronic kidney disease,
* Diabetes with insulin use
* History of a cardiovascular event
* Pregnant or nursing
* Current use of continuous positive airway pressure
* Shift work
* A known circadian rhythm disorder
The Effects of Guarding on the Outcomes of the Six Minute Walk Test

This study was designed to determine if walking with a healthy individual during the 6 minute walk test significantly influenced the outcome of the test.

Introduction: The American Thoracic Society recommends not walking with the patient or client during the Six Minute Walk Test (6MWT). However, this recommendation raises safety concerns for individuals at increased risk of falls. Given the recommendations and concerns, the effects of guarding during the 6MWT has not been investigated. Purpose: The purpose of this study was to determine if guarding during the 6MWT affected gait speed and distance walked. Methods: Participants were randomized into a 'guarded first' vs 'guarded second' condition. Data were analyzed using a one-sample t-test, Pearson Correlation Coefficients, Intraclass Correlation Coefficients (ICC), and Bland Altman plots to assess differences and relationships for gait speed and distance walked between the guarded and unguarded trials.

Eligibility Criteria:
Inclusion Criteria:

Young Group

* Between 18 and 50 years of age
* Independent with ambulation such that no physical assistance was required during the 6MWT
* No pertinent acute or chronic medical conditions.

Older adult group

* 50 years of age or older Ambulatory without requiring physical assistance Intact cognition as determined by achieving a score of 24 on the Mini Mental Status Exam
* Stable balance by scoring a minimum of 18cm (7 inches) on the Functional Reach Test

Exclusion Criteria:

* All Participants:
* Unstable angina
* History of myocardial infarction 30 days prior to the study
* Resting heart rate greater than 120 beats per minute
* Resting systolic blood pressure greater than 180 mmHg
* Resting diastolic blood pressure greater than 100 mmHg
* Symptoms were reported or observed that were consistent with low blood pressure
* Recent injury, surgery or medical procedure.
* Older Participants:
* Functional Reach Test (\<18cm or 7 inches)
* Mini Mental Exam (score \< 24).
System Accuracy of 14 Blood Glucose Monitoring Systems

The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015