cyrilzakka/clinical-trials huggingface dataset:
The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM

This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).

This study was conducted to examine the effects of Information, Motivation and Behavioral Skills (IMB) model-based diabetes education and motivational interviewing on care outcomes in adults with Type 2 diabetes. The study is a single-blind, randomized controlled trial with pre-test, post-test and follow-up test measurements from experimental research designs. The study was carried out in the Endocrinology and Metabolic Diseases Polyclinic, and the data were collected between June 2021 and February 2022. The sample of the study (intervention group=30, control group=30) consisted of 60 individuals with type 2 diabetes. Study data were collected with Adult Diabetes Information Scale, Health Belief Model Scale, Diabetes Self-Efficacy Scale, Diabetes Self-Management Scale and metabolic control parameters follow-up form. IMB model-based diabetes education and motivational interview program were applied to the individuals in the experimental group for three months. Initially, diabetes education was given in small groups in four sessions, then Motivational Interviews were held individually every two weeks for a total of five sessions via WhatsApp.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 30-64
* Receiving insulin therapy
* BMI value of 25 and above
* HbA1c of 7 and above
* At least primary school graduate and can speak Turkish
* No communication barrier (speech, vision or hearing problem)
* Having a smart phone and internet access
* Individuals who agree to participate in the research.

Exclusion Criteria:

* Those who have retinopathy at a level that may hinder the sense of sight.
* Those with neuropathy at a level that prevents them from doing their daily physical activities
* Diagnosed with kidney failure
* Using an insulin pump
* Pregnant
* Those with a diagnosis of cancer
Characterization of the Efficacy of Furosemide Depending on Albumin Function

During this prospective, uncontrolled and non-interventional observational study, the influence of albumin function on the efficacy of furosemide will be investigated. The aim of the study is to provide information on the efficacy of furosemide depending on albumin function.

In patients with intravenous furosemide administration, an additional 15 ml of blood is taken for the analysis of specific parameters as part of the blood sampling necessary for the treatment of the patient.

The effect of furosemide is assessed on the basis of the patient's urine excretion. For this purpose, fluid intake and excretion are balanced over 6 hours. The blood sample is taken at the beginning of the balancing period.

In addition, the albumin concentration, ABiC, as well as the total and free concentration of furosemide in the collected urine are determined.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Attending intensive care physician intends to prescribe IV furosemide to increase urine output
* Arterial (central venous if applicable) and urinary catheter in situ

Exclusion Criteria:

* Attending intensive care physician intends to prescribe further doses of diuretic medication (including furosemide infusion) within the 6 hours required for fluid collection
* Patients who received intravenous or oral diuretics (including mannitol) in the 6 hours prior to study enrolment
* Patients who have received other medications (e.g. fludrocortisone) known to affect renal sodium or water excretion in the 24 hours prior to study entry
* Patients with uncontrolled hyperglycaemia (plasma glucose \>10mmol/L).
* Patients who were receiving renal replacement therapy prior to the start of the study
* Patients with obstructive uropathy, macroscopic haematuria or intra-abdominal hypertension (\>20mmHg)
* Age \< 18 years
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.


Eligibility Criteria:
Inclusion Criteria:

* Present to Emergency Department (ED) primary for management of Low Back Pain (LBP), defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
* Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
* Patient is to be discharged home.
* Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly.
* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
* Pain duration \<2 weeks (336 hours).
* Prior to the acute attack of LBP, back pain must occur less frequently than once per month.
* Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
* Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant
* Any analgesic medication use on a daily or near-daily basis
* Allergic to or intolerant of investigational medications
* Open wounds or skin breakdown of the lower back
* Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR \<60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
A Prospective and Retrospective Cohort Study in Patients With Chronic Forms of Acid Sphingomyelinase Deficiency (ASMD)

Primary Objective:

* To describe the clinical features and their severity at the time of diagnosis and their evolution over time in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD
* To describe Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) at enrollment and their evolution over time; disease severity at the time of diagnosis and its evolution over time

Secondary Objectives:

* To describe abnormal values in laboratory parameters and all values of specific clinical and imaging assessments at the time of diagnosis and their evolution over time
* To study the use and applicability towards validation of a newly developed ASMD disease severity scoring system
* To study the use and applicability towards validation of a newly developed ASMD PRO tool
* To describe ASMD-related disease burden among patients with ASMD, caregivers, and healthcare resource utilization
* To describe the association between patient demographics (eg, age, gender, race, Ashkenazi ancestry) and genotype with selected clinical features in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD

Estimated average of study duration (for each patient) is 2 years

Eligibility Criteria:
Inclusion criteria :

* Patients with confirmed diagnosis of chronic forms of ASMD based on 1) a clinical diagnosis consistent with chronic visceral ASMD (ie, NPD B) or chronic neurovisceral ASMD (ie, NPD B variant or intermediate NPD A/B) and 2) deficient enzymatic activity (as measured in peripheral leukocytes, cultured fibroblasts, lymphocytes, or DBS) or presence of 2 pathogenic SMPD1 mutations,
* The patient (or patient's legal guardian) must provide signed informed consent.

Exclusion criteria:

Patients suspected or diagnosed with infantile onset ASMD (ie, NPD A, with progressive developmental delay, or presence of any combination of R498L, L304P, and P333fs\*52 genotypes, if available),

* Patients having received or receiving an investigational drug,
* Patients receiving any ASMD specific ERT,
* Patients with poor general condition that would not be able to undergo study assessments as per investigator's clinical judgment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.

It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET™ device than with conventional surgical procedures.

This is prospective, comparative clinical evaluation to investigate whether there is a reduction in the skin-to-skin time of the first surgical debridement with VERSAJET™, compared to conventional debridement techniques. Skin-to-skin time is defined as the time of incision to the end time of debridement (wound ready for dressing application). Conventional debridement is defined as scalpel plus pulse lavage.

The purpose of this comparison is to demonstrate the resource savings which VERSAJET™ may provide in terms of operating room (OR) and personnel time, in addition to the potential to reduce the procedure, and possibly anaesthetic, time for the patient. It is envisaged that this information, combined with the costs associated with the procedure, will also provide valuable economic data to help justify the use of VERSAJET™ from a financial perspective and support the future commercial success of the device.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age.
* Males and females (provided they are not pregnant or, if of reproductive age, are using contraception).
* Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot.
* Patients undergoing surgical debridement of their reference ulcer in the operating room (OR).
* Patients undergoing their first surgical debridement of the reference ulcer.
* Patients suitable for debridement of their reference ulcer with both VERSAJET™ and conventional debridement techniques.
* Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation.

Exclusion Criteria:

* Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour).
* Patients with haemophilia
* Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study.
* Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV).
* Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing.
* Patients with a known history of poor compliance with medical treatment.
* Patients who have participated in this evaluation previously or are currently participating in another clinical study.
Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital.

The efficacy of the product was assessed at the end of the study; clinical examination by the dentist.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand and provide informed consent
* general good health male and female adults, were 20 years or older
* no pregnant woman
* had six caines-free maxillary anterior teeth without restorations on the labial surfaces

Exclusion Criteria:

* had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)
* evidence of fracture or major cracks on tooth
* were pregnant or nursing
* had tooth sensitivity
* smokers
* had teeth shade A1, A2
Nut Supplementation to Mitigate Post-stroke Cognitive Decline

Stroke is a strong risk factor for dementia, with up to 80% of individuals having lower cognitive function 5 years after a stroke event. However, having a stroke does not need to result in declining cognition if effective strategies to reduce the risk of post stroke dementia are identified. Diets containing nuts can reduce the risk of both dementia and stroke but have not been tested in stroke survivors. Therefore, this pilot study aims to determine whether eating nuts regularly reduces post-stroke cognitive decline and dementia. The NUT-me pilot study will supplement the diet of stroke survivors with a mix of nuts containing walnuts, hazelnuts, almonds and Brazil nuts for 3 months and assess the effects on cognition and health markers. The researchers predict that regular nut consumption will contribute to preserving post-stroke cognitive function in comparison to patients who do not consume nuts. The results of this novel pilot study will be used to guide a larger trial and provide a simple dietary strategy that stroke survivors can adopt to reduce post-stroke cognitive decline.

This study will investigate the efficacy and feasibility of supplementing the habitual diet of stroke survivors with a supply of mixed nuts containing Brazil nut, walnuts, hazelnuts, and almonds to reduce post-stroke cognitive decline. The overall aim of this project will be achieved through the following objectives:

* Examine the feasibility through the assessment of compliance with the intervention and participants' perception of the study
* Investigate the efficacy of the intervention on cognitive decline, body composition and health outcomes (blood pressure, fasting glucose and insulin, and blood lipids) The investigators hypothesise that the inclusion of nuts is a simple dietary strategy that will slow post-stroke cognitive decline and that supplementation with nuts will improve body composition and health biomarkers of stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Ischaemic stroke (first or recurrent stroke) in the last 6 months
* Able to attend 4 study visits over 3 months
* Motivation and willingness to participate in the study protocol
* No prior neurological or psychiatric disease, including dementia
* Can give informed consent and participate in cognitive testing

Exclusion Criteria:

* be \< 18 years;
* have allergy to nuts
* have premorbid modified Rankin scale (mRS)≥4, denoting no severe disability
* incapable of giving consent
* have problems with mastication that preclude nut intake
* have habitual consumption of tree nuts (\>2 servings/wk) in the previous 2 months
* have habitual consumption of alpha-linolenic acid supplements (fish oil, flaxseed oil, and/or soy lecithin)
* have dementia or psychiatric disease
* do not speak English
Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes mellitus
2. Diabetes duration ≥ 5 years
3. Aged between 45-75 years-old
4. ETDRS level \< 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20 or 35 with presence of at least one microaneurysm in Field 2 between the superior and inferior arcades (50% of enrolled patients) in the Study Eye as determined by the Reading Centre.
5. Informed Consent

Exclusion Criteria:

1. Previous laser photocoagulation
2. Other diseases which may induce retinal degeneration (e.g. glaucoma)
3. Subject with a refractive error ≥ ± 5 diopter
4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.
5. Renal failure (creatinine \> 1.4 mg/dl)
6. HbA1C \> 10 % in the previous 6 months and at Screening
7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months
8. Subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
9. Pregnancy or nursing
10. Hypersensitivity to the active substances to be tested or to any of the excipients
11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)
Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
* Pathologically-proven diagnosis of prostate adenocarcinoma
* PSA 10-20ng/mL or
* Gleason =7 or
* Clinical stage T2b/c
* Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
* Age ≥18
* KPS≥70
* Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
* International Prostate Symptom Score ≤15

Exclusion Criteria:

* Prior prostate surgery (including TURP)
* Prior history of chronic prostatitis or urethral stricture
* Inflammatory bowel disease
* Prior history of pelvic radiotherapy
* Unable to give informed consent
* Metastatic disease.
Family Planning in Inflammatory Bowel Disease

This study explores the lived experiences of family planning for women with inflammatory bowel disease (IBD) and their partners during the reproductive stages of pre-conception, pregnancy and the postnatal period through qualitative interviews. Insights from existing literature alongside findings from interviews and focus groups with patients and healthcare providers to develop an intervention to address the issues and support needs as identified by study participants.

This study will be conducted in 3 phases:

Phase 1: Literature review (0-9 months). The research literature on pregnancy outcomes and factors affecting family planning decisions of women and men diagnosed with IBD will be systematically searched and reviewed. The findings will be used to prepare a topic guide to be used in the interviews with women and their partners.

Phase 2: Interview study (10-20 months). A topic guide prepared in Phase 1 will provide a structure for in-depth interviews to explore the experience of family planning by women diagnosed with inflammatory bowel disease (IBD) and their partners. Detailed face-to-face interviews will be voice recorded and transcribed verbatim. Each interview may last approximately 45-60 minutes, giving participants sufficient time to share their experience. A total of 24-30 women diagnosed with IBD will be interviewed, where possible selecting 8-10 women at different family planning stages (pre-pregnancy, pregnancy and post-delivery). 3-4 women's partners for in each group, to explore partner's perspective of the pregnancy or pre-conception experience.

Phase 3: Intervention development with focus group interview (21-24 months). The Phase 2 findings will be used to prepare a draft of the intervention to address the issues and support needs as identified by study participants. A group of patients (3-4) and healthcare practitioners (3-4) will be recruited to take part in a joint discussion (focus group interview) on intervention acceptability, and the comments will be used to further develop the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with IBD at different family planning stages (pre-pregnancy, pregnancy and post-partum).
* Women diagnosed with IBD's partners.
* Health practitioners involved with women diagnoses with IBD and on-going care (phase 3 only).

Exclusion Criteria:

* Does not consent
Hospital Discharge Following Bariatric Surgery by Telepresence Robot

This is a non-inferiority randomized controlled trial aimed to compare the effectiveness and feasibility of performing the ward round using a telepresence robot vs. a face-to-face ward round to discharge patients after bariatric surgery.

This study is aimed to analyze the effectiveness and feasibility of performing the ward round using a telepresence robot (PadBot U, Inbot Technology Ltd, China), compared to the face-to-face ward round, for hospital discharge after bariatric surgery. Patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy will be randomized to one of two groups: intervention group - who will be evaluated and discharged, on postoperative day (POD) 2, during ward rounds with the assistant team present, but the telepresent surgeon via robot; and control group - who will be evaluated and discharged, on POD 2, during ward rounds with the whole team physically present.

The study main hypothesis is that the ward rounds with the surgeon telepresent by a robot are not inferior to the face to face ward rounds, to evaluate and discharge patients after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

Exclusion Criteria:

* complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.