cyrilzakka/clinical-trials huggingface dataset:
Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses

Since the beginning of lung screening program in the different countries around the world by chest CT scan, numerous lung nodules and masses of unknown etiology are diagnosed.

Usually, the pathological diagnosis is obtained by bronchoscopy. However, peripheral bronchi cannot be seen after the fifth bronchial division as the diameter of the broncoscope is greated than the diameter of the bronchi. Therefore, the Iriscope was developed. It consists in a thin catheter with a mini-camera at its distal extremity.

The aime of this study is to evaluate the diagnostic yield of bronchoscopy guided by Iriscope in the setting of peripheral lung nodules and masses supect of malignancy, to compare the Iriscope to endobronchial radial ultrasonography (which is a validated technique to guide bronchoscopy in the setting of peripheral lung nodules and masses) and to evaluate the added value on the diagnostic yield by combining these 2 techniques.


Eligibility Criteria:
Inclusion Criteria:

* Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters

Exclusion Criteria:

* Any contraindication to general anesthesia
* Coagulopathy
Performance of WOUNDCHEK Bacterial Status

The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.

The clinician treating the wound will be allowed to use the test result in treatment decisions. The pretest treatment plan will be documented on the Case Report Form (CRF) prior to performing the WCBS test. After receiving the test result the clinician will document the post-test treatment plan. The healing outcome at 12 weeks following the test will be recorded on the CRF. The study will evaluate the healing outcomes compared to when test results are not used to assist in treatment decisions with study success defined as a higher healing rate and/or mean wound size reduction for WCBS positive wounds than obtained in the study PROT-2023-001. Also, the healing rate of wounds with a negative test result will be compared to the pretest rate to ensure that clinicians do not neglect and under treat this cohort with success criteria being that the WCBS negative wound healing rate is not worse than the pre-test healing rate. Additionally, the study will establish whether there are any device related Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs).

Eligibility Criteria:
Inclusion Criteria:

1. Subject has presented to the participating study site with a VLU, DFU and / or a PU that is suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show more than two of the NERDS signs of infection.
2. Subject is 18 years of age or older.
3. The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area.
4. Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements.

Exclusion Criteria:

1. Subject does not meet inclusion criteria.
2. Target wound contains a malignancy.
3. Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
4. Subject is confirmed to be positive for HIV or hepatitis

   .
5. Subject is unable or unwilling to provide informed consent.
6. A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.
Development and Feasibility Testing of DM-BOOST Intervention.

DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support.

In DM-BOOST, the Principal investigator will deploy a mixed-methods, patient-centered approach to intervention development and initiate a multiphase optimization strategy (MOST) to learn how to maximize patient engagement and support of self-management training. In this pilot, study team will complete the first phase (Preparation), and initiate feasibility piloting of the second phase (Optimization). Completion of optimization and MOST's final phase (Evaluation), will occur in a subsequent project.

In the preparation phase, Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes (Aim 1). Next, Principal investigator will selectively recruit patients of identified persona types as consultants, elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention (Aim 2). Study team will then conduct a feasibility pilot (Aim 3) to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent, complete optimization trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18+)
* Cognitively able to consent (Aims 2 and 3)
* Diagnosed with type 2 diabetes (Aims 1-3)
* Receive primary care at UMMHC in past 12 months at time of initial analysis (Aims 1-3)
* English speaking (Aims 2 and 3)
* Have access to patient portal or a smart phone (Aim 3)

Exclusion Criteria:

* Adults unable to consent (lacking cognitive capacity) (Aims 2 and 3)
* Individuals who are not yet adults (infants, children, teenagers) (Aims 1-3)
* Pregnant women (Aims 1-3)
* Prisoners (Aims 1-3)
* Non-English speaking (Aims 2 and 3)
Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography

ABSTRACT

INTRODUCTION

Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.

MATERIALS AND METHODS

The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively.


Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

- Diagnosis of primary osteoarthritis

Exclusion Criteria:

* Diagnosis of secondary osteoarthritis
* Uncontrolled diabetes
* Uncontrolled hypertension
Determination of Voiding Patterns of Children With Vesicoureteral Reflux

Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR.

We hope to determine the statistical difference between the flow rate and volume of urination in children with VUR compared to those without.

Eligibility Criteria:
Inclusion Criteria:

* Children with or without vesicoureteral reflux (history of VUR)
* Toilet trained and can void on command

Exclusion Criteria:

* Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.


Eligibility Criteria:
Inclusion criteria:

* Ambulatory patients \>18 years
* Proof of breast cancer or prostate cancer
* Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
* Negative pregnancy test
* ECOG performance status of 0,1 or 2

Exclusion criteria:

* Patients with abnormal renal function
* Patients with clinically symptomatic brain metastases
* Known hypersensitivity on zoledronic acid or other bisphosphonates
* Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
* No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
* Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:

  * Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
  * Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
  * No co-infection with hepatitis B or human immunodeficiency virus (HIV)

Exclusion Criteria:

* History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
* History of neurological disease
* History of severe psychiatric disease
* Decompensated diabetes
* History of immunologically mediated disease
* History of severe cardiac disease
* History or evidence of severe chronic pulmonary disease
* Inadequate hematologic function
* Pregnant or breastfeeding women
* Male partners of pregnant women
Empathy, Psychopathy and Autism: Behavioural Associations and the Role of an Oxytocin Receptor Polymorphism in a Non-clinical Adult Population

This is an investigation into the associations between psychopathic traits, autistic traits and empathy (cognitive and affective) in the general population as measured using three self report questionnaires and one behavioural task. Participants will also be genotyped for OXTR rs53576 to assess whether this mutation associates with any of the behavioural traits investigated.

In clinical populations with psychopathy or autism, associations with different forms of empathy have been found. An increase in autistic traits has been found to be associated with a decrease in cognitive empathy traits but no difference in affective empathy traits, while an increase in psychopathic traits has been found to be associated with a decrease in both cognitive and affective empathy traits. The current investigation is to establish whether this previously observed relationship between cognitive empathy, affective empathy, psychopathic traits and autistic traits found in clinical populations is also found in a non-clinical population. This will be assessed by three self report questionnaires and one behavioural task (as described in 'Outcome Measures'). This investigation will also assess the potential link between of all of the traits measured and a specific SNP on the Oxytocin Receptor Gene (OXTR rs53576) to establish whether this mutation is associated with any of these behaviours.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at time of participation
* Proficient English reading comprehension

Exclusion Criteria:

* Current or previous diagnosis of a psychopathy, autism or related conditions.
* Not proficient in English reading comprehension
Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis

Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic Lateral Sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

* Signed written-informed consent.
* Subjects over 18 years of age, and less than 70 years old.
* Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria.
* Subjects having experienced their first ALS symptoms within 18 months before recruitment/consent.
* FVC \> 70%
* Subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study.

Exclusion Criteria:

* Subjects with a clinically significant preexisting lung disease not attributable to ALS.
* Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
* Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
* Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
* Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
* Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team
* A history of frequent adverse reactions (serious or otherwise) to blood products.
* Hypersensitivity to albumin or allergies to any of the components of Albutein.
* Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants
* Plasma creatinine \> 2mg/dl.
* Present a history of heart disease including ischemic heart disease or congestive heart failure.
* Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
* Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)
Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity

This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.

Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed.

The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability.

therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.

Eligibility Criteria:
Inclusion Criteria:

1. more than 18 years old.
2. systemically and periodontally healthy patients.
3. need of single implant placement between two maxillary teeth.
4. need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
5. more than 3 month after extraction.
6. full mouth plaque index lesser than 20%.
7. sufficient mesiodistal and buccolingual space.
8. At least 10 millimetres mesiodistal dimension in tuberosity.
9. sufficient implant primary stability.
10. at least 6 mm crestal ridge width.

Exclusion Criteria:

1. History of periodontitis and radiotherapy.
2. Need of horizontal ridge augmentation.
3. Previous soft tissue augmentation.
4. Heavy smoker( more than 10 cigarette per day)
5. Local or systemic conditions that would interfere with routine periodontal therapy.
Iowa WISEWOMAN Project

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* NBCCEDP

Exclusion Criteria:

-
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.


Eligibility Criteria:
Inclusion criteria:

* Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
* Male or female, being 18 years of age or older
* Written informed consent for study participation

Exclusion criteria:

* Persistent symptoms of VTE
* PE requiring urgent intervention
* Use of vena cava filter
* Contraindications to anticoagulant therapy
* Allergy to study medications
* Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
* Severe renal impairment
* Patients considered unsuitable for inclusion
Health2016: Monitoring Chronic Disease and Risk Factors in the General Population

Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.

A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status). Trends in these parameters over time will be assessed.

Eligibility Criteria:
Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark

Exclusion Criteria:

* pregnancy
Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care

The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness

This study will be on music use as musicotherapy "receptive " or " passive ", using hearing aid for listening in order to relax and reduce the anxiety and pain state of the patient. This care will be focused on the acute stress and pain during the dental care.

Another major secondary purpose will consist to explore the anxiolytic effect of the musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary cortisol ratio and electro-dermal intensity (RED).

Eligibility Criteria:
Inclusion Criteria:

* Majors aged between 18 and 55 years, with an appropriate hearing and able to use Music-Care© (selection of the playlist via internet access),
* Needing treatment in odontology - periodontal surgery (coronary elongation or sanitation surgery or muco-gingival surgery) or implantary surgery (placement of an unit implant or two implant in the same localization),
* Oral and dated consent,
* Agreeing to be contacted via phone at J+1 and to fill follow-up study documents,
* Profiting of social security or CMU.

Exclusion Criteria:

* Patients with a long-term taking of anxiolytic or analgesic,
* Regular consumer of soft drug (cannabis) or hard drug (opioid),
* Patient with medical history of psychiatry (mental harm), hearing problem, cognitive and behavioural impairment (claustrophobia), sensory disabilities,
* Patient with problems of hemostasis,
* Majors under trusteeship or guardianship,
* Pregnant women or lactating,
* Minors,
* Protected person, deprived of freedom or under justice safeguard,
* Profiting of a medical help from government (AME),
* Not contactable after care,
* Patient with hepatic impairment,
* Patient with dry mouth,
* Patient relevant a suboptimal hearing incompatible with musicotherapy or inability to use Music-care®.