cyrilzakka/clinical-trials huggingface dataset:
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.


Eligibility Criteria:
Inclusion Criteria:

* -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
* With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
* With fractures in the distal 1/3 of fibula (not-Maisonneuve)
* Enabling stability evaluation within 14 days after injury
* 18-75 years of age
* with pre-injury walking ability without aids

Exclusion Criteria:

* - With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs
* With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
* With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
* With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
* With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
* With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
* That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
* With previous history ipsilateral ankle fracture
* With previous history ipsilateral major ankle-/foot surgery
* Who live outside the hospital catchment areas not available to follow up
* With insufficient Norwegian or English language skills
* Non-compliant
Hospital Based Continuous Patient Monitoring System

In Ghana, and many other low and middle income countries in Africa, manual vital signs monitoring is the prevalent mode of vital signs monitoring because continuous bedside monitors are non-functional. This lack of continuous vital signs monitoring may result in missed opportunities to catch physiologic deterioration.

The investigators propose to develop a dashboard that is based on the Fitbit, a consumer wearable device that reliably measures heart rate, SPO2, and respiratory rate, as an alternative to bedside monitors in hospitals in Ghana.

Vital sign (VS) monitoring is a universal tool used to assess patients' basic physiologic status, primarily to detect physiologic deterioration indicative of clinically meaningful events. Physiologic deterioration occurs relatively commonly in trauma and postoperative patient populations. In most high-income countries (HIC), such patients are therefore monitored by automated, continuous, bedside VS systems, while, in many low-and middle-income countries (LMIC), manual, intermittent (from every 15 minutes to every 6 hours) VS monitoring is still widely employed.

The investigators propose to further refine and scale up a CONsumer-grade wearable monitoring System to improve Outcomes in Low resource settings (CONSOL) in Ghana. CONSOL is a CWD based platform, developed by the MPIs, that collects and displays in near real time, HR, skin temperature, RR, and SpO2, with snapshots of the past 1 minute, and 1, 4, and 24 hours, viewable on an iPad or smartphone. The investigators propose to evaluate the use of CONSOL for VS monitoring of (a) pediatric trauma patients in the Emergency Department (ED) and (b) pediatric postoperative appendicitis patients on a surgical unit, given higher risk of physiologic deterioration indicative of clinically meaningful events in these patient populations, and because pediatric patients are often more limited, than adults, in their ability to communicate about signs and symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients presenting with traumatic injury
* Pediatric patients postoperative status after an appendectomy

Exclusion Criteria:

* Pediatric patients missing their upper limbs,
* Pediatric patients who cannot wear a Fitbit on their wrist for known allergies to rubber or those with traumatic or medical conditions that prevent them from being able to comfortably wear a Fitbit on either hand
Postoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial

The purpose of this study is to determine if hip precautions, which are instructions that limit functional use of a hip replacement after surgery, affect the rate of dislocation in the first six weeks after primary total hip replacement surgery. The impact of hip precautions on a patient's return to activities of daily living and overall patient satisfaction will also be investigated. The overall cost effectiveness of hip precautions will be determined.

This study examines the necessity of postoperative hip precautions in patients after primary total hip arthroplasty via the posterior approach. Precautions are instructions that limit the functional use of the hip and are given for the first six weeks after surgery, with the goal of preventing an instability event resulting in dislocation. The hip precautions that will be investigated in this study are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary total hip arthroplasty via the posterior approach by participating attending surgeons at this institution
* Index diagnosis of noninflammatory arthritis
* Patients must be able to understand and comply with study procedures

Exclusion Criteria:

* Allergy or intolerance to the study materials
* History of previous surgeries on the affected joint other than arthroscopy; i.e. revision THA or open surgeries
Vitamin A Supplementation at Birth and Atopy in Childhood

INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation (NVAS) have been reported, and another four are underway to test whether NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of NVAS on atopy and wheezing was found (manuscript under review).

Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS is associated with a higher risk of atopy and wheezing. The investigators therefore aim to conduct a similar follow-up study of participants in the first NVAS trial conducted in Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is associated with an increased risk of atopy and wheezing and other allergic symptoms as well as growth.

METHODS

Study population:

From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns when they came for BCG vaccination. Provided parental consent, they received an oral supplement of 50,000 IU vitamin A or placebo.

Study design:

This study will be a follow-up study of the cohort of children randomised to NVAS (intervention) or placebo (current policy) together with BCG vaccine at birth.

Other exposures:

The investigators will also investigate the effect of receiving an additional dose of measles vaccine and the timing of DTP vaccine on the development of atopy.

Assessment of outcomes:

The investigators will visit all children at the last known address. Height, weight and mid upper arm circumference will be measured. BCG scar will be examined and vaccination card details recorded by the field assistant. Children will be excluded from skin prick testing (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine medication. SPT will be performed using aero-allergens, food allergens and positive histamine and negative saline control. The mother or guardian will be interviewed by a local assistant. Symptoms of eczema and asthma as well as food allergy will be assessed.

Statistical analysis:

Effect of randomisation group and other factors on outcomes will be analysed in multivariable regression models. All analyses will be adjusted for skin prick tester. All analyses will be conducted stratified by sex.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled at birth in NCT00168610

Exclusion Criteria:

* Children with history suggestive of anaphylaxis will be excluded from skin prick testing but included in the study population
Pharmacological Treatment In Osteoarthritis

The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

Osteoarthritis is the most common joint disease, most frequently involving the hands, resulting in pain, stiffness and loss of hand function. At present, there is no option to prevent the onset or the progression of hand osteoarthritis (OA). It is believed that inflammation plays an important role in the pathogenesis of OA and that anti-inflammatory drugs might be an effective treatment for OA. Anti-malarial agents like chloroquine and hydroxychloroquine are potential anti-inflammatory drugs and hydroxychloroquine has already proven to be an effective suppressor of inflammation in rheumatoid arthritis. Several previous studies with hydroxychloroquine in hand OA also showed a possible effect on pain and inflammation, but these studies were mostly retrospective with a small number of patients. This is the first prospective, randomised, placebo-controlled study to determine the effect of hydroxychloroquine in hand osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* Primary hand OA according to the ACR classification
* Heberden or Bouchard nodule or Kellgren-Lawrence grade 1, 2 or 3 changes in ≥ 2 symptomatic joints
* Pain in the dominant hand ≥ 12 months
* Use of an NSAID for ≥ 1 episode of pain
* Written informed consent

Exclusion Criteria:

* Secondary hand OA, e.g. haemochromatoses, rheumatoid arthritis, posttraumatic
* Kellgren-Lawrence grade 4 OA
* Use of hydroxychloroquine within 3 months before entering the study
* Use of NSAIDs or corticosteroids within 7 days before entering the study
* Retinopathy
* Myasthenia gravis
* Known allergy or hypersensitivity for hydroxychloroquine
Phase 3 Study of EBI-005 in Dry Eye Disease

This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.


Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
* Are ≥ 18 years of age;
* Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
* Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
* Have normal lid anatomy.
* If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion Criteria:

* Have signs of infection (i.e., fever or current treatment with antibiotics)
* Have been exposed to an investigational drug/device within the preceding 30 days
* Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
* Be unwilling to or unable to comply with the study
The Effect of Music Therapy on Preoperative Anxiety in Elective Surgery

Anxiety is a common phenomenon among patients who are undergoing surgery. It is a condition characterized by stress, nervousness, fear, unpleasant feeling, and higher activity of Autonomic Nervous System. The current studies demonstrated that listening to music, reduces anxiety levels.

Pre-operative anxiety is recognised as a potential and preventable risk factor for post-operative complications. It is estimated that between 25% to 80% of patients admitted to hospital for surgery experience pre-operative anxiety, and anxiety can negatively influence patient recovery.Physiologically pre-operative anxiety can lead to autonomic dysfunction and can modify inflammatory responses, platelet activity, and immunologic functioning. The Beck Anxiety Inventory(BAI), created by Aaron T. Beck is a 21 questions multiple choice self report inventory which measures the severity of an anxiety in adults and adolescents. It has been widely used in clinical research in mental health care mainly to measure general anxiety. The total score for all 21 symptoms can range between 0 and 63 points. A total score of 0 - 7 is interpreted as "Minimal" level of anxiety, 8 - 15 as "Mild"; 16 - 25 as "Moderate" and 26 - 63 as "Severe" level of anxiety.

This study aims to compare the alleviation of Pre-operative anxiety in patients undergoing surgery with or without music.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years scheduled for elective surgery
* American Society of Anaesthesiologists Physical Status I, II

Exclusion Criteria:

* Patient's refusal
* Patient's with known auditory disability
* Psychiatric disorder
* Altered mental status
* Patients routinely taking CNS depressant drugs (eg : Diazepam, Clonazepam)
The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan

Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual. Surveying this syndrome in a large population in Jordan aims at studying the risk factors, components and stages of the syndrome, thus helping early screening, diagnosing and treating disease and its risk factors.

Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual.

CRM syndrome reflects the intersection of cardiovascular disease with chronic kidney disease (CKD), and metabolic disease and risk factors (RF). A critical combination of these diseases and their risk factors in the same individual has a profound impact on quality of life and overall mortality. The clinical implications of the presence of CRM are significant, with premature morbidity and mortality, multiple organ-system disease, and high health care budgets mainly driven by the burden of cardiovascular disease (CVD).

There are high prevalence rates of all components of CRM and its RF on a global level and in the Middle East. Of note is the high prevalence of CV in the young, smoking, diabetes mellitus, obesity and dyslipidemia.

The current study will evaluate the prevalence of components and RF of CRM disease in a large population in North, central and South of Jordan.

In the Middle East, no systematic study has evaluated the definition of CRM, definition of its stages, and prevalence of its RF and its relation to the coexisting social determinants of health.

The study will provide new and contemporary knowledge on the definition, staging, and comprehensive approaches to care for patients with CRM, and subsequently exploring opportunities for prevention and care optimization by life style modification and pharmacotherapy.

There are different aspects that explain the interaction between the components of CRM. (A) The bidirectional association between the heart failure and the kidneys (cardiorenal syndrome) in addition to the risk of CAD in patients with CKD, (B) adipose tissue link to atherosclerosis mediated by inflammation, insulin resistance and endothelial dysfunction, and risk for DM (C) DM link to CVD, heart failure and kidney dysfunction., and many other links as well.

Screening for CRM is an important pillar in promoting health in every community. The CRM staging system facilitates identifying individuals at progressive levels of severity starting from the preclinical phase to delay or avoid the onset of clinical CVD and CKD. To appropriately find individuals at stage 0 (i.e., asymptomatic stage) it is important to undertake active screening within the population.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 years and above).
* Willing to sign an informed consent.

Exclusion Criteria:

* None.
Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy

Objectives. To study the short-term neurophysiological and clinical outcome of botulinum toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring uninjected muscles in children with cerebral palsy.

Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales were assessed and video gait was analyzed at all three time points.

Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side decreased significantly from pre-injection values at T10 (p\<0.05) and T30 (p\<0.002). Assessment at both time points after injections also showed that ankle spasticity had diminished (p\<0.05), equinus foot excursion increased (p\<0.05), and functional gait improved (p\<0.05).

Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy therefore needs individualizing according to the child's clinical features.


Eligibility Criteria:
Inclusion Criteria:

* spasticity refractory to oral medication
* patients able to walk independently or with aid
* no contraindications to BoNT-A treatment such as fixed contracture,aminoglycoside therapy and myasthenia gravis and no other neuromuscular diseases
* no orthopedic surgery before
* normal or mildly declined cognition
* previous treatment at least six months before the study

Exclusion Criteria:

* all contraindications to BoNT-A treatment
Impact of Anti-Tumor Necrosis Factor (TNF) Antibodies on the T-lymphocyte and Macrophage Cooperation in Crohn Disease

The aim of this research is to study Crohn disease patients before and after anti-TNF, the cooperation between lamina propria T-lymphocytes and macrophages, through the expression of co-signalisation molecules and their ligands, the production of cytokines participating in this cooperation, and the potential role of regulatory T lymphocytes.

Crohn disease is an inflammatory disease and its frequency has been increasing over the last 25 years. The physiopathology involves a failure in the negative regulatory mechanisms of the inflammatory responses in the intestines, along with an excessive production of TNF-α by T-lymphocytes and macrophages of the lamina propria.

Anti-TNF-α antibodies usually give good therapeutic results, in particular in patients who are resistent or dependant on steroids. Nevertheless, in Crohn disease, the destructive T-lymphocytes - macrophage interactions, their inhibition by anti-TNFα, and the impact of these antibodies on cellular signaling remain largely unknown.

Two groups of 10 patients with active Crohn disease, with or without azathioprine, and requiring the start of anti-TNF treatment are included in this study. Rectosigmoïdal biopsies and blood tests will be done before starting the treatment and after 10 weeks of treatment. Surface antigens, cytokines and cellular molecules and the number of apoptotic cells will be analyzed by FACS, and the quantification of RNA will be analyzed by RT-PCR.

This will therefore enable us to study, before and after anti-TNF-α, in patients treated or not with azathioprine, on intestinal and blood lymphocytes, the production of cytokines involved in the lymphocyte-macrophage interaction, and the potential role of regulatory T cells.

Eligibility Criteria:
Inclusion Criteria:

* patient older than 18
* social security
* active Crohn disease defined by a CDAI \> 250
* sigmoïdal and/or rectal lesions
* requiring treatment by infliximab
* having never received any anti-TNF treatment
* a negative pregnancy test for women
* prescription of efficient contraception for women, having started at least a month before beginning the study, and throughout the duration of the study
* acceptance to participate in this research and having signed the consent form
* not participating in any other study

Exclusion Criteria:

* consent withdrawal
* the halt of infliximab treatment
Evaluation of the Effectiveness of Spa Treatment in Swieradow Zdroj With Special Regard to the Action of Radon Waters

Observation conducted during the 21 days of treatment in the health resort of Swieradow-Zdroj. In a treatment of applied therapy: radon therapeutic baths and inhalations, kinesiotherapy. Study group with degenerative joints and disc disease participating in therapy. The control group was selected by the spa workers, also suffering from a degenerative disease of the movement organs not using the spa's treatment base. In both of these groups, appropriate pre- and post-treatment studies were performed.

The observation was conducted during 21 days of medicinal stays in the health resort of Swieradow-Zdroj. The treatment included a comprehensive therapy: radon therapeutic baths and inhalations, kinesiotherapy.

The study group consisted of patients with degenerative joints and disc disease participating in therapy. On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS scale.

The control group was selected by the spa workers, also suffering from a degenerative disease of the movement organs not using the spa's treatment base. In this group also made the same study.

Eligibility Criteria:
Inclusion Criteria:

* the presence of degenerative joints and/or disc disease;
* age range 40-60 years;
* the written consent to participate in research;
* no impediment to comprehensive treatment at the spa.

Exclusion Criteria:

* the lack of consent to participate in research;
* the age under 40 and over 60 years;
* the presence of diseases constituting a contraindication to therapy (compatible with the standard list of indications and contraindications to spa therapy);
* the presence of metabolic diseases.