cyrilzakka/clinical-trials huggingface dataset:
Negative Pressure Vs. Compression in Venous Ulcers

This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.

Venous ulcers are characterised by a cyclical pattern of healing and recurrence, with recurrence rates between 45 and 70% at one year. Venous leg ulceration has been identified as a common source of morbidity and reduced quality of life, especially in the elderly population. Non-healing ulcers place the patient at a much higher risk for lower extremity amputation.

Compression therapy is currently recognised as the main treatment for venous leg ulcers. External compression is applied as a therapy for venous leg ulcers, in an attempt to reverse the increased hydrostatic pressure in the veins.

The application of negative pressure to successfully treat and aid in the healing of open wounds has been studied extensively for decades, demonstrating favourable clinical results. However, there is a lack of evidence in the literature regarding the use of VAC in venous ulcers.

The combination of negative pressure therapy and compression therapy is theorized to provide the benefits of both individual therapies. As such, the utilization of the Bridge VAC under a compression dressing is expected to expedite the healing of venous ulcers.

The investigators aim to randomise patients with venous ulcers to either be managed using conventional compression dressings or combined bridge vacuum assisted closure with compression dressings.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more
* Provide written informed consent
* Venous ulcer present, greater than 10cm2 in surface area
* A C6 grading in the CEAP classification

Exclusion Criteria:

Pregnant (confirmed by β-HCG analysis). Female patients of childbearing potential are advised to adhere to an appropriate form of contraception, and those unwilling to follow contraceptive advice are excluded from the study

* Involvement in another clinical trial in the previous six months
* Legal incapacity
* Patient is bed-ridden or immobile
* Ulcer smaller than 10cm2 in surface area
* Ischaemic ulcer/s present
* Diabetic ulcer/s present
* Malignant ulceration/s present
* Ulcer exposing bone or tendon
* Osteomyelitis
* Pseudomonas infection
* Presence of gangrene
* Deep venous thrombosis (DVT) present
* Connective tissue disease present
* Presence of any illness that could limit long-term compliance (e.g. epilepsy)
Aerobic Exercise Training in Patients With Chronic Hepatitis B and Hepatic Steatosis

This study is a randomised, controlled, unblinded, clinical intervention trial consisting of 12 weeks of aerobic exercise training. Thirty persons with chronic hepatitis B (CHB) and hepatic steatosis are randomised to either aerobic exercise training (intervention group, n=15) or no intervention (control group, n=15). The study will investigate the effects of the exercise intervention on the liver and the hypothesis is that the exercise group will reduce the fat-fraction of the liver after the intervention.

Primary aim: To investigate whether regular aerobic exercise training will decrease the fat-fraction of the liver in persons with CHB and hepatic steatosis shown by magnetic resonance imaging (MRI) by use of Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation (IDEAL-IQ).

Secondary aim: To investigate the effects of aerobic exercise training on hepatokine secretion in persons with CHB and hepatic steatosis. Also, to investigate if regular physical exercise will improve lipid- and glucose metabolism, liver status, markers of inflammation, body composition, and blood pressure.

Study participants will undergo pre and post the interventioon: Clinical examination with ECG, blood pressure measurements, blood sampling, oral glucose tolerance test, a hormone infusion of somatostatin and glucagon, -increasing the glucagon/insulin ratio mimicking an acute exercise bout, measuring the effect on circulating hepatokines and cytokines, fibroscan, VO2-max test, DXA scan, AX3 activity monitoring, nail fold capillaryscopy, IQOLA SF-36 and IPAQ-SF questionnaire, 24H food intake registration, MRI scan of the liver and optional liver biopsy. 6 and 12 months follow-up is planned.

The exercise intervention will be randomised 1:1 with no stratification: The training program includes three weekly supervised training sessions of 40 minutes/session over 12 weeks. Participants are instructed not to change their lifestyles during the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B defined by HBsAg positive \>6 months
* Positive HBV-DNA
* Age \>30
* Hepatic steatosis diagnosed by Controlled Attenuated Parameter (CAP) \>250 assessed by Transient Elastography or by ultrasound defined hepatic steatosis

Exclusion Criteria:

* HIV, HCV, HDV-co infection
* Primary biliary cholangitis
* Wilsons Disease
* Autoimmune hepatitis
* Hepatocellular carcinoma
* Antiviral medication
* Steatogenic medication (systemic corticosteroids, amiodarone, tamoxifen, valproic acid, and methotrexate)
* Average alcohol intake \>30 g for men and \>20 g for women pr. day
* Contraindications for MRI scan
* Coronary artery disease contraindicating HIIT
* Unable to understand and read written information for participants written consent
* Pregnancy
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.

Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.


Eligibility Criteria:
Inclusion Criteria:

* malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
* palliative treatment of malignant disease: UICC stage \>1
* impaired nutritional state: weight loss \> 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
* informed written consent

Exclusion Criteria:

* age \< 18 years
* pregnancy
* exclusive enteral or parenteral nutrition
* taking of eicosapentanoic acid in form of fish oil capsules
* contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
* terminal stage of disease with a life expectancy \< 3 months
* missing or withdrawn consent
* simultaneous participation in another trial
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities
* Positive drug screen, excessive alcohol and tobacco use
Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: a Pilot Study

This is a pilot study of early postpartum initiation of the injectable progestin contraception, depo medroxyprogesterone acetate (DMPA), among 40 postpartum people. The study aims to assess the feasibility to conduct a larger trial evaluating the effects of early postpartum initiation DMPA on lactation and infant growth outcomes in Nepal.

The primary objective of this study is to pilot the procedures necessary to demonstrate feasibility for a larger randomized trial evaluating the effects of early postpartum initiation of DMPA on time to lactogenesis (transition to mature milk), lactation continuation, and infant growth and development.

The investigators will conduct a pilot study among 40 birthing people who deliver a singleton, healthy, term infant; intend to feed their infant human milk (breastfeed) exclusively for at least 6 months; and plan to use DMPA for postpartum contraception. Participants will be administered DMPA within 48 hours after birth and will be followed for 12 weeks postpartum. Time to lactogenesis, the proportion of participants exclusive feed their infant human milk at 12 weeks, any lactation and infant growth through 12 weeks will be measured. We will analyze time to onset of lactogenesis the proportion of participants exclusively feeding human milk at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Currently live in Nepal
* Had a vaginal or cesarean delivery of a singleton full-term infant within the past 48 hours
* Not yet undergone lactogenesis
* Desire to use DMPA as a method of postpartum contraception

Exclusion Criteria:

* Desire a repeat pregnancy in less than 6 months
* Do not intend to exclusively feed infant own human milk for 6 months
* Do not have access to a telephone
* Any medical contraindication to DMPA
* Any contraindication to human milk feeding for their infant
* History of breast surgery (augmentation or reduction)
* Infant with a major congenital anomaly (will be excluded due to unique challenges with feeding in these populations)
A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens

The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.

Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (\>180-250 mg/dL), very high(\> 250 mg/dL), low(54-70 mg/dL) and very low(\<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 13 and 21 years.
* Patients with Type 1 diabetes for at least 6 months
* Defined as either a c peptide \<1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty
* Patients who currently receive insulin injections with a CGM.
* English speaking.
* Have access to a smart phone. on an insulin to carbohydrate ratio

Exclusion Criteria:

* Individuals less than 13
* Non-English speaking.
* No access to a smart phone.
* Intellectual disability that would impact their ability to utilize the technology
* Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)
Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.

The purpose of this study is to determine the effects of premature birth on cardiac function, cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration studies.

Eligibility Criteria:
Inclusion Criteria:

* National Lung Project Cohort only- birth weight \<1500g and a gestational age \<36 weeks
* Adults born preterm (Non-National Lung Project) only- gestational age ≤32 weeks OR birth weight ≤ 3lbs 5oz
* Healthy Controls only- No personal history of known cardiovascular or pulmonary disease

Exclusion Criteria:

* Metabolic Disorders that would affect Fludeoxyglucose uptake
* Contraindications to positron emission tomography and/or magnetic resonance imaging
* Pregnancy, if a female of child-bearing potential
* A personal history of Type I or Type II diabetes
Prediction of Progression of Retinal Ischemia in Diabetes

Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability.

PREDICTION is a longitudinal prospective clinical study in DMT2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. Investigating the retinal vascular network (vessel density metrics with Optical Coherence Tomography Angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for DR worsening.

Patients with Mild to Severe NPDR (ETDRS DRSS 43-53) often progress to PDR and/or CI-DME (ETDRS Report). However, it is unclear which patients in this group are likely to progress. Previous studies have shown that diabetic macular ischemia (DMI) is a risk factor for progression of DR. This study aims to correlate baseline OCTA metrics with visual function and identify risk factors for progression from NPDR to PDR and/or CI-DME.

Eligibility Criteria:
Inclusion Criteria:

* DM type 2 according to 1985 WHO criteria.
* Age between 35 and 80 years.
* BCVA ≥ 75 letters (20 /32).
* Refraction with a spherical equivalent less than 5 Diopters.
* NPDR levels 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP).

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations.
* HBA1C ≥ 12%
* Any eye surgery within a period of 6-months before the inclusion visit date.
* Other retinal vascular disease.
* Previous laser or intravitreal injection treatment.
* Dilatation of the pupil \< 5 mm.
TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study

TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application (APP) to help patient manage their diabetes and hypertension and other chronic conditions by assisting them in setting goals and connecting them to their healthcare team.

This pilot study is a program evaluation that will employ developmental evaluation techniques to collect qualitative and quantitative data that will be handled, using a sequential explanatory mixed methods approach.Developmental evaluation is particularly useful for pre-formative development of potential scalable interventions. Developmental evaluation tracks and attempts to make sense of what emerges under conditions of complexity, documenting and interpreting the dynamics, interactions, and interdependencies that occur as innovations unfold. It will be helpful to explicitly understand: 1) what important decisions occur during the TAPESTRY-CM intervention development process and; 2) what data have validated those decisions about how the intervention will be structured and delivered. This understanding will provide a basis for describing key decisions and their rationale to our community and to other communities so that they make more informed adaptations to their local context.

TAPESTRY-CM has applied the principles of participatory design by engaging community stakeholders to co-create and refine TAPESTRY-CM interventions in the early phases of the project.

The use of mixed methods was purposefully chosen for this developmental evaluation. Answering a set of related research questions which included the collecting, analyzing and interpreting of qualitative and quantitative data increases the depth of understanding of results, provides stronger evidence for patterns or themes if data converge, can neutralize or cancel out some of the disadvantages of each method alone, and explicitly recognizes that social phenomena are complex such that varied methods are helpful to best understand these complexities.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 55 at the start of the study
* Patients with both diabetes and hypertension
* Patients with access to a computer and the internet

Exclusion Criteria:

* Patient is palliative or receiving end-of-life care
* Patient is deceased
* Has explicitly stated that they do not want to be part of a research project
* Patient resides in long-term care
* Patient has indicated that they do not want to receive a home visit from trained community volunteers.
* Patient or family member does not speak English
* Patient will be out of the country for more than 50% of trial duration
* Patients without access to a computer with the internet
Clinical Evaluation of Ceramage Inlays Cemented with Beautilink Self-Adhesive Resin Cement Versus Rely X Resin Cement in Carious Posterior Teeth

Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.

The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.

Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.


Eligibility Criteria:
Inclusion Criteria:

* Posterior vital tooth with a large carious lesion (ICDAS 4/5)
* Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
* Vital, periodontally sound and with positive reaction to cold stimulus.
* Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.

Exclusion Criteria:

* Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
* Non-vital teeth, Fractured or cracked teeth.
* Endodontically treated teeth.
* Periodontally affected teeth.
Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.

The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.

The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).

Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.


Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo to diagnostic or interventional procedures

Exclusion Criteria:

* Previous coronary artery by-pass
* Acute myocardial infarction with ST segment elevation myocardial infarction
* Cardiogenic shock
* Ischemic Allen Test
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study

The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 years
* BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
* Interested in being enrolled in a weight loss program
* Available to comply with study protocol and sign informed consent

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant within the study period.
* Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
* Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
* Subjects with renal impairment
* Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
* Subjects with autoimmune diseases and/or chronic use of corticosteroids.
* Use of weight loss medications/other nutritional supplements
* Subjects with psychiatric or neurological illness
* Subjects sensitive to any component of supplements
* Subjects with surgery or hospitalization in the last 30 days
* Subjects prescribed with 5 or more drugs
* Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
* Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
* Subjects with history of drug, alcohol or other substances abuse.
* Eating behavior disorders
* Pacemaker carrier
* Urinary incontinence
* Vegetarians or vegans
* Subjects underwent bariatric surgery
* Type 1 or type 2 diabetes mellitus
* Altered blood clotting
* Severe heart failure