cyrilzakka/clinical-trials huggingface dataset:
Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

This observational cohort study is aimed at determining changes in the cytokine expression profile as well as the urinary and vaginal microbiome of women undergoing midurethral sling placement for the treatment of stress urinary incontinence.

Primary Objectives:

This is a pilot study to evaluate how midurethral sling (MUS) placement for the treatment of stress urinary incontinence (SUI) affects the bladder microenvironment, specifically the local microbial community or "microbiome" of the bladder and the cytokine expression profile. The investigators also aim to correlate any changes in the microbiome or cytokine expression profile with patient-reported urinary symptoms preoperatively and postoperatively.

Specific Aim 1: Assess the change in the urinary and vaginal microbiome (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that the bladder environment will be disturbed by surgery involving the lower urinary tract and will show demonstrable changes in the urinary and vaginal microbiota.

Specific Aim 2: Characterize the cytokine profile of the bladder (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that MUS treatment will change the cytokine profile of the bladder and lead to alterations in the expression of pro-inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Planning to undergo retropubic midurethral sling placement

Exclusion Criteria:

* Prior surgery for stress urinary incontinence
* Untreated pelvic organ prolapse \> Stage II based on POP-Q assessment
* Concomitant surgery for prolapse
* Current use of anticholinergic medications
* Use of systemic or vaginal antibiotics in the last 2 months
* Active urinary tract infection
* History of recurrent UTI
* Pregnancy
* History of pelvic radiation or bladder cancer
Global CMR Registry

The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting imaging and reporting standards, assessing its diagnostic impact on patient care, and determining the cost-effectiveness of CMR imaging. It will be the largest collective body of evidence reflecting the current clinical applications in patient care, which healthcare payers and governing bodies alike can depend on when metrics such as testing appropriateness, common indications, and diagnostic effectiveness are called for. It will also be able to reflect any changes in patient impact from CMR over time as technical development evolves. Furthermore, it will allow an assessment of improvements in diagnostic and therapeutic thinking, risk stratification, and cost-effectiveness relevant to current patient management.

A global CMR registry can be a crucial infrastructure of our CMR community that has many benefits. First, it is the largest collective body of evidence reflecting the current clinical applications in patient care, which healthcare payers and governing bodies alike can depend on when metrics such as testing appropriateness, common indications, and diagnostic effectiveness are needed. Second, it reflects any change in patient impact from CMR over time as technical developments evolve. Third, it allows an assessment for improvement of diagnostic and therapeutic evaluation, risk stratification, and cost-effectiveness analysis relevant to patient management.

Some practical questions that a global CMR registry may be able ot address include:

1. Variations in CMR protocols within specific clinical indications
2. Variations in CMR post-processing, analysis, and reporting
3. Practice adherence to appropriateness criteria and guidelines
4. Clinical effectiveness of CMR over a long period of clinical application and/or technological advance
5. Differences in CMR utility across centers, regions, or countries

The data collection process will be a collective effort on part of specialized health professionals across various CMR sites worldwide. All of the data will be extracted from existing registries and databases. Health professionals in the U.S. and abroad will first upload patient data and images onto the registry/database that they currently use. Then if they choose to, they can transmit relevant patient de-identified data onto the global registry using a user-friendly web interface. CMR sites without a database will be invited to use CMR Cooperative or REDCAP. De-identified data (usually submitted in excel or CSV format) will be harmonized and uploaded to the registry website (www.gcmr-scmr.org), which is a firewall and password-protected database that resides at an IT vendor (Center for Systems Biology at Massachusetts General Hospital) in Boston, Massachusetts. The pooled data will be used for retrospective analysis/research approved by the GCMR steering committee and SCMR.

Eligibility Criteria:
Inclusion Criteria:

* Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria:

* Patients who are 90 years and older
Clinical Characteristics and Practice Patterns of Type 2 Diabetes Mellitus Patients Treated With OADs in Japan: Analysis of Medical and Health Care Database of the MDV

Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of RI of OADs, in particular Dipeptidyl-peptidase-4 inhibitors, in clinical practice in Japan. Therefore, we will investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical practice in Japan


Eligibility Criteria:
Inclusion criteria:

* Patients with T2DM (ICD code: E11 or E14).
* Patients must have their first prescription (defined as index date\*) for any study drugs between 01/01/2014 and 30/09/2016.
* Patients must have at least 6 months enrolment verified by the presence of any record except for the study drug prescriptions within the database (look back period) prior to the index date for each drug.

Exclusion criteria:

* Patients who were under 40 years at the time of diagnosis of diabetes.
* Patients with record of type 1 diabetes mellitus.
* Patients who prescribed the study drugs during 6 month prior to index date for each drug.
* Patients whose mean visit interval are more than 92 days
Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR

Primary objective:

To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group.

Secondary objectives:

To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for first total knee replacement surgery.

  * Age over 18.
  * Diagnosed with Osteoarthritis.
  * Consent to participate in the trial.

Exclusion Criteria:

* - Rheumatic diseases.
* Neurological diseases involving lower limbs.
* Prior knee surgery in operated knee.
* Secreting surgical wound.
* Skin diseases.
* Incontinence.
* Incapable of signing informed consent.
* Patients living outside Jerusalem
Evaluation of Purse-String Closure Vs Second Intention

To compare healing time, scar size, aesthetic outcome, and complication rates following second intention healing or purse string closure of surgical wounds on the trunk or extremities. This study, will allow surgeons to make informed decisions on whether purse string closure is superior to that of second intention healing and thus worth considering or inferior and not worth performing.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow-up visits
* Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the trunk and extremities (including the shin, hands, and feet)

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow-up
* Pregnant women
* Wounds less than 8 mm in length
* Wounds on the head, neck or digits
* Patients in which primary linear closure is recommended
A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA

This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.

The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation.

The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia.

The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

Eligibility Criteria:
Inclusion Criteria:

* Patient is of legal age and skeletally mature
* Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk
* The patient will be available for follow up throughout the duration of the study.

Exclusion Criteria:

* Patient is unable to have an MRI scan due to the following conditions:

  * Cardiac pacemaker
  * Surgical clips in head (aneurysm clips)
  * Some artificial heart valves
  * Electronic inner ear implants
  * Metal fragments in eyes
  * Electronic stimulators
  * Implanted pumps
* Patient has active infection or sepsis (treated or untreated)
* Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
* Patient is female of child-bearing age and not taking contraceptive precautions.
* Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).
* Patient has known moderate to severe renal insufficiency.
* Patient has a known or suspected metal sensitivity.
* Patient is immunosuppressed or receiving high doses of corticosteroids.
* Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
* Patient has BMI \>40.
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis

Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic plaque type psoriasis having body surface area involvement of \> 20%
* Patients of either sex
* Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
* Age range 18-65 years

Exclusion Criteria:

* Females of child bearing potential
* H/O hypersensitivity to acitretin
* Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase \>1.5 times the upper limit of normal)
* Impaired renal function (serum creatinine \>1.5mg% in males and \>1.4 mg% in females)
* Hyperlipidemia
* BMI \>30 kg /m2
* H/O excessive alcohol use
* Diabetes mellitus
* Congestive heart failure
* Ischemic heart disease
Azithromycin Reduction to Reach Elimination of Trachoma B

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Eligibility Criteria:
Inclusion Criteria:

* Provision of appropriate informed consent
* Stated willingness to comply with all study procedures
* Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Exclusion Criteria:

* Does not consent to participation
* Unwilling to comply with all study procedures
* Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Personalized Physical Back Training Program to Improve Physical Functioning in People with Non-specific Low Back Pain: a Feasibility Study

The aim of our clinical trial (2024-01285) is to determine how an individualized physical back training program affects physical functioning and back pain. The results will help identify the most effective treatments for low back pain. This feasibility study (2024-01284) aims to conduct a test run of the clinical trial. The main questions are:

* Do all procedures run smoothly?
* Does the back training program improve physical functioning?
* Does the back training program reduce back pain?

Participants will:

* Follow a back training program for 4 weeks.
* Attend group exercise sessions (30 minutes per week)
* Perform exercises at home (3x10 minutes per week).
* Fill out a daily questionnaire on pain and exercise adherence.


Eligibility Criteria:
Inclusion Criteria: Individuals who

* have access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers),
* report NSLBP for at least 6 weeks (e.g., no upper limit of pain duration),
* report activity limiting NSLBP (i.e., at least one activity with a PSFS Score of ≤ 5/10 on a scale from 0 = unable to perform due to NSLBP to 10 = able to perform at the same level as before NSLBP),
* identify NSLBP as their primary musculoskeletal complaint,
* are between 18 and 65 years of age,
* understand the German language,
* are willing to participate in the study (i.e., adhere to a 4-week intervention),
* and provide written informed consent.

Exclusion Criteria: Individuals who ...

* have been diagnosed with specific LBP (e.g., fractures, carcinoma, anomalies, nerve root affection with neurological signs such as sensitivity or reflex loss, muscle weakness, or radicular pain below the knee),
* report red flags associated with any serious pathology or specific LBP (e.g., major trauma of the back, unintended weight loss, saddle anaesthesia, changes in bowel or bladder function associated with LBP, progressive lower extremity neurologic deficits, fever),
* are less than 12 months post-surgery following any surgery on the lower back,
* are on a waiting list for any surgery on the lower back,
* are pregnant or have given birth within the last 12 months,
* are planning to become pregnant in the next 12 months,
* have diagnosed peripheral and/or central neurological disease,
* have diagnosed psychological and/or psychiatric condition,
* have diagnosed chronic toxic substances abuse (i.e., drugs, alcohol),
* take specific medication (i.e., neuroleptics, sedatives, anti-epileptics, antidepressants),
* are not allowed to exercise during the intervention period (e.g., on medical advice, due to a health-related condition),
* or are expecting to be absent more than 2 weeks during the training intervention period.
Early Virtual Intervention for Infants With CP Following HIE Diagnosis

This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
2. Received therapeutic hypothermia
3. Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life
4. Greater than or equal to 34 weeks gestation
5. Patients are followed by the Neonatal Follow-Up Clinic at SickKids
6. Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age

Exclusion Criteria:

1. Known or high suspicion of a genetic syndrome
2. Residence post-discharge will not be with biological parents
3. Limited fluency in English
4. No internet access
Biomarker for Duchenne Muscular Dystrophy

International, multicenter, observational, longitudinal study to identify biomarker/s for Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.

Duchenne Muscular Dystrophy (DMD) is a devastating inherited neuromuscular disorder that affects 1 in 3300 live male births (females can be mildly affected carriers). DMD causes progressive weakness and loss of muscle mass, with symptoms usually appearing in early childhood. DMD arises from mutations in the DMD gene that codes for dystrophin.

The DMD gene is located on the short arm of chromosome X (locus Xp21) and codes for dystrophin, containing 3685 amino acid residues. 60-65% of DMD mutations are large dele-tions, 10-30% are nonsense and frame-shift mutations, 5-15% are duplications, and 2% are intronic or 5'- and 3'-UTR alterations.Dystrophin aggregates as a homotetramer in the skeletal muscles or associates with actin and Dystrophin-Associated Glycoproteins (DAGs), forming a stable complex that interacts with laminin in the extracellular matrix. Dystrophin is considered a key structural element in the muscle fiber, whose primary function is to stabilize plasma mem-brane, while the DAGs maintain the sarcolemmal stability by mediating the complex interactions of the muscle membrane and extracellular environment. The low levels of dystrophin lead to cellular instability and progressive leakage of intracellular components, explaining the characteristically high levels of creatine phosphokinase (CPK) in the blood of DMD patients.

Biomarkers serve as measurable indicators of normal biological or pathological processes. They are typically directly linked to genetic variants in specific genes and can predict, diagnose, monitor, and assess the severity of a disease. It is the goal of this study to identify, validate, and monitor biochemical markers from DMD affected participants.

Eligibility Criteria:
INCLUSION CRITERIA

* Informed consent is obtained from the parent/ legal guardian
* The participant is aged between 2 months and 50 years
* The diagnosis of DMD is genetically confirmed by CENTOGENE

EXCLUSION CRITERIA

* Informed consent is not obtained from the parent/ legal guardian.
* The participant is younger than 2 months or older than 50 years
* The diagnosis of DMD is not genetically confirmed by CENTOGENE
The Programmed Intermittent Epidural Bolus Adrenaline Study

This study evaluates the use of intermittent epidural boluses compared to continuous infusion in maintaining epidural pain relief in labor.

The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in both groups.

Labor is often painful for the woman going through it, and thus many women choose to have pain relief by an epidural catheter.

This is done by placing a thin plastic catheter in the epidural space in the lower back of the patient, and injecting a medicine solution usually consisting of local anesthesia and opioids.

To ensure an effective pain relief through the labor process, additional medicine solution is injected through the catheter. Traditionally, this is done by a continuous infusion, often with the addition of patient controlled boluses.

In this study the investigators investigate if maintaining the pain relief through programmed hourly intermittent boluses is more effective than continuous infusion. This is done in other studies with promising results, but the difference in this study is the addition of adrenaline to the medicine solution in order to make it more effective.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in labor requesting epidural analgesia
* ASA group 1 and 2
* 0 or 1 previous births
* Must be at least 18 years of age.
* Singleton pregnancy
* Active labor
* Signed informed consent and expected cooperation of the patient

Exclusion Criteria:

* Poor communication skills in norwegian or english
* Adverse reactions to local anesthetics or synthetic opioids
* Body height below 150 cm
* Gestational age below 37 weeks, 0 days
* Any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc)
* Pre-eclampsia
* Sound reason by the investigator to suspect patient non-compliance (e.g. with use of PCEA)
Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy

This study will test the use of video ophthalmoscope to provide information about intracranial pressure without the use of invasive methods, anesthesia or contact with the eye.

The monitoring of intracranial pressure (ICP) is crucial in head injuries and pathologies such as brain edema, arachnoid cyst, craniosynostosis or, in very-low-birthweight infants, post-hemorrhagic hydrocephalus. Some current methods of ICP are invasive and, in the case of lumbar puncture, require anesthesia, which can distort the measurement by 5-10 mmHg. The golden clinical standard is direct measurement using a surgically-implanted intraventricular drain connected to an external pressure transducer ("ICP probe"). However, this method carries risks such as hemorrhage, malfunction, obstruction or infection . The risk in pediatric patients is up to 5% and in adults the risk of fatal hemorrhage is 4-5% in patients with subdural and intraparenchymal monitoring devices. Due to these risks and the financial burden on patients, there have been attempts to develop tools for non-invasive ICP estimation. This study will test the use of a video ophthalmoscope that will calculate the relative waveform of intracranial pressure and provide information about intracranial compliance without the use of anesthesia, invasive methods or contact with the eye.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to sit still and fix their eyes on a target in the VO objective.
* ICP participants must have an inserted ICP probe for clinical purposes.

Exclusion Criteria:

* Diagnosis of glaucoma, retinopathy or head tremor.