cyrilzakka/clinical-trials huggingface dataset:
Interprofessional Training to Improve Diabetes Care: The ReSPECT Trial

The investigators' study focuses on improving the care of diabetes, a complex chronic illness, by providing important insights into interprofessional training and its potential role in fostering the necessary interdisciplinary management needed for chronic conditions and in addressing the gap between best practice and actual care provided.

The complexity of diabetes management challenges the acute care-oriented healthcare system. Some experts suggest part of the problem is that the healthcare system fosters a separate silos decision making model. While there is increasing recognition that quality diabetes care is best provided in an interdisciplinary manner, interprofessional training models are limited, as is understanding of the links between interprofessional training, actual practice, and patient outcomes. Advancing our understanding of interprofessional training models is critical because most of the complications associated with diabetes (e.g., amputations, renal failure, strokes) can be prevented or delayed with proper management. The investigators' objective is to better understand the processes and mechanisms by which interprofessional training impacts on chronic care management (practice patterns) and the ways it translates into improved patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

CLINICIANS

* All clinicians in all of Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study (all PCPs have patients with DM in their panel of patients).

PATIENTS

* All diabetic patients who are seen in Ohio's CBOCs (except for the Georgetown CBOC) will be eligible for the study.

Exclusion Criteria:

CLINICIANS

* Any clinician who does not have diabetic patients on their panel, who aren't apart of Ohio's CBOC's, or see patients at the Georgetown CBOC will not be eligible to participate.

PATIENTS

* Patients who don't have a diagnosis of diabetes, who aren't seen at one of Ohio's CBOC's, or is seen for their medical care at the Georgetown CBOC will not be eligible to participate.
Clinical Performance of NIPT in Multiple Gestation Pregnancies

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.


Eligibility Criteria:
Inclusion Criteria:

* subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
* subject was 18 or older at the time of NIPT

Exclusion Criteria:

* none
A Personalised Approach Utilising the Frailty Index to Empower Consumers

Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.

Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided. It is expected that engagement with patients and clinicians in regards to frailty will address expectations and subsequently support the ability of patients/consumers and clinicians to make informed decisions that minimise risks and maximise benefits in regards to surveillance colonoscopies.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 65 years of age
* Ability to understand the study instructions and answering questionnaires

Exclusion Criteria:

* Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.
* Lack of informed consent
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 years-of-age or older.
* Stable, heterosexual relationship for at least 6 months.
* A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

* Any underlying cardiovascular condition, including unstable angina pectoris
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
* Uncontrolled atrial fibrillation / flutter at screening
* History of congenital QT prolongation
* History of surgical prostatectomy due to prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
* Presence of penile anatomical abnormalities
* Spinal cord injury
* Resting or postural hypotension or hypertension
* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
* Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
* Subjects who have been confirmed with phenylketonuria (PKU).
* Use of any treatment for ED within 7 days of Visit 1.
Evaluation of a New Catheter Material for Intermittent Catheterization

The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.

Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Males, aged 18 years and over
* Maintained urethra sensibility
* Practice intermittent self-catheterization at least 2 times daily
* Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
* Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
* Experience of using LoFric catheter within the last 12 months prior to study entry
* Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

* Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
* Known urethral stricture at enrolment as judged by investigator
* Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrolment or randomisation of treatment in the present study
Evaluation of Patient Reported Outcomes (PRO) After Total Knee Arthroplasty (TKA) Under Spinal Anesthesia

The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition.
* Patient with chronic knee pain who is indicated for total hip or knee replacement surgery
* Patient is at least 50 years of age
* Patient is willing to participate in pre- and postoperative surveys

Exclusion Criteria:

* Failure to complete pre-operative surveys.
* Revision Total Knee Arthroplasty
* Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy
* Contralateral Total Knee Arthroplasty
* Prior tibial plateau fracture
* Ligamentous Insufficiency
* History of fibromyalgia, chronic fatigue syndrome
'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment

This pilot study examines the feasibility and potential effects on upper limb (UL) motor function using a wearable device integrated with a telerehabilitation function in the home setting with chronic stroke survivors.

The study seeks to address the question:

- Is wearable device intervention more effective in promoting arm recovery in stroke survivors than conventional therapy for home-based training? We hypothesize that using a multimodal feedback system in the wearable device can provide more effective training to improve the hemiplegic UL function of chronic stroke survivors than conventional therapy.

This is a single-blinded randomized crossover pilot trial. Twelve participants will be randomly assigned into two groups: the experimental (wristwatch) and the control (conventional therapy) groups. Participants in the experimental group will undergo a 4-week wearable device treatment followed by a 4-week conventional training.

Participants in the control group will complete conventional therapy and then wearable device treatment. There will be a 3-week washout period between treatments. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, after a 3-week washout period for pre-intervention, and post-intervention after crossover by research assistants blinded to group allocation.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* unilateral hemispherical involvement
* diagnosis of stroke with onset ≥ three months
* hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version (FTHUE-HK) ≥ score of 3 (maximum of 7) (Fong et al., 2004).
* no complaint of excessive pain and swelling over the hemiplegic arm
* able to provide informed consent to participate.

Exclusion Criteria:

* participating in another similar form of experimental study during the same period
* having a history of botulinum toxin injection in the past three months
* having other significant upper limb impairment, i.e. fixed contractures, frozen shoulder, and severe arthritis
* having a diagnosis which would interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment.
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Between 14 and 18 years of age
* Tanner stage 4 or 5 (mature adult stage of puberty)
* Normal weight (BMI ≥ 5th percentile \& \< 85th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c \> 5.7%)
* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes

Exclusion Criteria:

* Currently pregnant
* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
* Allergies or intolerance to milk, soy, or palm oil
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures

The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.

The primary hypothesis is, that immediate training leads to earlier and faster recovery.

Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.

Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.

Eligibility Criteria:
Inclusion Criteria:

* Over 50 years of age
* Distal radius fracture suitable for volar locking plate osteosynthesis
* Inhabitants in Region Sjaelland

Exclusion Criteria:

* Dementia
* Abuse of drugs, medication or alcohol
* Open fractures
* Multitrauma or other injures on same extremity
* Earlier wrist fracture
* Delay of osteosynthesis of more than 14 days
Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant

RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.

PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.

OBJECTIVES:

Primary

* To ascertain the safety of donor natural killer (NK) cells, generated from peripheral blood hematopoietic stem cells, when given as a single intravenous infusion in patients who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
* To determine the maximum tolerated dose of donor NK cells when given as a single infusion.

Secondary

* To determine the effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor BMT.

OUTLINE: Patients receive donor natural killer cells as a single infusion over 1 hour.

Cohorts of 3-6 patients receive escalating doses of natural killer cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience grade III toxicities or acute graft-vs-host disease.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
* No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* AST \< 3 times upper limit of normal
* Creatinine \< 2.0 mg/dL
* Ejection fraction \> 40% on MUGA scan

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.

This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.

We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.

Eligibility Criteria:
Inclusion Criteria

* Patients over 65 years of age
* Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
* Patients are able to understand the study and express opinions clearly
* Patients are willing to participate in this study and provide informed consents

Exclusion Criteria

* Patients with inflammatory joint disease
* Patients with neurosensory system disease (such as stroke or parkinsonism)
* Patients have intellectual impairment, or dementia.
Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata

It is a study of translational research with mechanistically objectives and including biological samples of patients with chronic inflammatory disorders

This study was a single-center prospective study to collect blood and skin tissue at the time of consultation with a patient with non-segmental vitiligo, psoriasis, atopic dermatitis or alopecia areata, in order to better understand and compare blood and skin immune response in chronic inflammatory skin disorders: psoriasis, alopecia areata, atopic dermatitis and vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years;
* Patients with non-segmental vitiligo;
* Patients with plaque psoriasis;
* Patients with atopic dermatitis;
* Patients with alopecia areata sclerosis;
* written consent, free, informed and signed by the patient and the investigator (before any examination required by the study);
* Subject affiliated or beneficiary of a social security system.

Exclusion Criteria:

* Patients with segmental vitiligo
* Patients under local treatment (topical corticosteroid-Calcineurin inhibitor) for less than two weeks.
* Patients on therapy, systemic treatments: acitretin, methotrexate, cyclosporine, Apremilast, infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, dupilumab) for less than 4 weeks.
* Pregnant or breastfeeding women
* Patient (e) under guardianship
* Patient (e) Non-affiliated (e) a social protection
Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.

All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

Eligibility Criteria:
Inclusion Criteria:

* Primary Ovarian cancer
* Epithelial histotype
* Stage III-IV disease

Exclusion Criteria:

* Anesthesiological contraindication to primary cytoreduction
* Extension of disease contraindicating primary cytoreduction
Clinical Explorative Optical Breast Investigations

This study evaluates diffuse reflectance spectroscopy and photoacoustic imaging for differentiating healthy, benign, and malignant breast tissue by identifying their optical profiles.

Breast cancer is the most prevalent cancers among women worldwide. Current diagnostic modalities have notable limitations. Mammography exposes patients to harmful ionising radiation whilst MRI often requires intravenous contrast agents. Additionally, diagnosing breast cancer frequently relies on invasive biopsies, which can cause patient discomfort.

This study investigates the potential use of two optical modalities, diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI), as non-invasive diagnostic tools for breast tissue analysis. Advantages include use of non-ionising radiation, contrast-free imaging, and the ability to assess tissue properties in detail.

DRS is a non-image based hand-held modality that utilises white light to generate optical signals. PAI is a hybrid biomedical imaging modality that combines traditional ultrasound with optical imaging. The latter generates a functional image that can potentially assess oxygenation levels which is known to be different in healthy vs cancerous tissue.

The study will focus on analysing three types of human breast tissues: healthy tissue, benign lesions (such as fibroadenomas), and malignant lesions (invasive breast carcinomas). By identifying the unique optical signatures of each tissue type, the research aims to evaluate the feasibility of these optical techniques as complementary tool to traditional imaging methods for diagnosing or monitoring breast cancer in the future.

Eligibility Criteria:
Inclusion Criteria:

* solitary malignant or benign biopsy verified tumour \> 1 cm
* understands written and oral Swedish

Exclusion Criteria:

* previous breast surgery
* has received neoadjuvant chemotherapy
* skin burns in on the chest