cyrilzakka/clinical-trials huggingface dataset:
A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain

In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.

30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.

Eligibility Criteria:
Inclusion Criteria:

* Sacroiliac joint pain
* Age \> 18

Exclusion Criteria:

* No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower participants blood sugar levels. Participants will get Rybelsus® as prescribed to them by their study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor...


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Effectiveness Evaluation of a Dengue Self-monitoring System

The goal of this clinical trial is to compare the effectiveness of a dengue self-monitoring system with standard care in reducing treatment delay among dengue patients receiving outpatient care. The main question it aims to answer are:

• Is a dengue self-monitoring system effective in reducing treatment delay in dengue patients? Participants will use the dengue monitoring system in addition to the standard care they are receiving for outpatient follow up for dengue.

Researchers will compare them with dengue patients receiving the usual standard care to see if the dengue monitoring system reduces delay in treatment seeking in patients.

Dengue Self-Monitoring System (DeSMoS) was developed to guide patients about warning signs and advise them to visit a doctor appropriately before their scheduled follow up on the next day, apart from motivating them to comply to the daily follow up visits at the clinic. DeSMoS is hypothesised to effectively reduce delay in treatment seeking in dengue patients.

The main aim of this system is to get dengue patients to key-in their symptoms regularly via the app when they are at home. Reminders will appear on the phone to remind them to key in the symptoms thrice daily.

The system is designed as a supportive tool for outpatient dengue management. It is not meant to replace to usual standard care for dengue care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above
* Newly diagnosed with dengue fever
* Have a smartphone
* Receiving outpatient follow up for dengue

Exclusion Criteria:

* Hearing and speech impairment
* Cognitive impairment
The Men on the Move Study

The Men on the Move Study is a randomized, controlled, feasibility study designed to address the health problem of physical inactivity in older men.

Men on the Move is a randomized, controlled, feasibility study to provide preliminary evidence of feasibility and efficacy for promoting mobility through the uptake of physical activity among men aged 65 years and older who are physically inactive. Specifically, Men on the Move will evaluate the effects of a choice-based physical activity model paired with an active transportation model. The choice-based physical activity model encourages older men to use existing community-based resources to create and implement actions plans for physical activity. It also provides ongoing face-to-face and telephone-based support from trained activity coaches. The active transportation model provides transit passes and active travel planning to promote use of transit and walking to destinations of interest. The feasibility of delivering the intervention will be assessed. Accelerometry and travel diaries will be used to measure the effects of the intervention on physical activity.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age and older;
2. identify as a man;
3. English speaking; and
4. demonstrate readiness for physical activity (by the PAR-Q+ questionnaire or a letter of recommendation from their physician)

Exclusion Criteria:

1. participated in any strength training in the past 3 months;
2. participated in any aerobic exercise class in the past 3 months;
3. live in a nursing home or assisted living facility; or
4. have plans to be out of town for more than 7 days during the 12-week intervention period.
The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery

The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.

The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.

Eligibility Criteria:
Inclusion Criteria:

* Military healthcare beneficiaries between the age of 18 and 50 years.
* Must intend to remain on station at location of surgery for 6 months from date of surgery.
* Meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension.

Exclusion Criteria:

* Concomitant ligamentous repair/reconstruction
* Known pregnancy
* Any medical condition for which aerobic exercise is contraindicated
* Additional back, hip, or knee surgery in the previous 12 months
* History of vascular or cardiac impairment
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group.

The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Presence on waiting list for planned spinal (instrumented vertebral arthrodesis) and urological (radical prostatectomy) surgeries
* Understanding of the Italian language (in fact, it is believed that the percentage of non
* Italian mother-tongue patients is minimal and therefore not impacting the study)
* Ability to access computer tools -

Exclusion Criteria:

* Age \< 18 years
* Inability to self-determine
* Urgency/emergency of intervention
Trial of Screening for ALOA-IgG AtheroAbzyme Test

This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients
* High Risk patients or Asymptomatic myocardial Ischemic patients
* Acute Coronary Syndrome patients

Exclusion Criteria:

* None
Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy

The purpose of the research is to characterize the effect of labetalol, atenolol, and nifedipine on maternal hemodynamics early in pregnancy. Patients will be given medication based on their hemodynamics and asked to return for a repeat measurement.

When a patient presents to the Maternal Hypertension Center at Cabell Huntington Hospital, she will receive a non-invasive hemodynamic assessment via the NICaS system as per usual protocol. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. In typical practice, the vasodilator nifedipine is initiated for increased systemic vascular resistance and elevated cardiac output is treated with beta blockade (via either atenolol or labetalol). The medication to be given to each subject will be based on their hemodynamics. Specifically, nifedipine will be given for a mean arterial pressure \>100 and a beta blocker will be given for a cardiac output \>8 l/min. The patients will be asked to return in one week for repeat ICG measurement.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to Maternal Hypertension Center at Cabell Huntington Hospital
* English speaking
* 18-45 years old.
* Willing to provide informed consent
* Gestational age prior to 15 weeks gestation

Exclusion Criteria:

* Non-English speaking patients, patients
* \<18 years old or \>45 years old
* Not willing or able to provide consent
* Gestational age \>15 weeks
Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU

Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Understanding the physiology of ARDS has led to improved ventilatory management, which must be protective to ensure adequate oxygenation and CO2 clearance. Prone position (PP) is a technique that can reduce mortality in patients with severe ARDS. PP results in a more homogeneous distribution of pulmonary stress and strain, helping to protect the lung against ventilator-induced lung injury (VILI). It also increases the PaO2/FiO2 (P/F) ratio, improves the pulmonary ventilation-perfusion ratio, decreases PaCO2 and promotes ventilation of the dorsal lung regions. This technique should be offered to all patients with severe ARDS for 16 consecutive hours, to improve survival and weaning success from mechanical ventilation. However, PP has adverse effects. A meta-analysis showed an increased risk of pressure sores, possibly linked to generalized acute inflammation associated with significant cytokine discharge and diffuse lesions of the vascular endothelium. PP also increased the risk of obstruction and displacement of the endotracheal tube. Final positioning in PP, (i.e., the position imposed on the patient for the duration of the PP session) varies from one ICU to another, and is rarely described in scientific articles. There are two main variants:

1. prone , with arms alongside the body
2. prone, swimmer's position

The aim of our study is to show that the "swimmer" PP reduces the occurrence of stage 3 or higher pressure sores, compared with the "arms alongside the body" PP (standard care) at Day 28 post inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Intubated patient on invasive mechanical ventilation with moderate to severe acute respiratory distress syndrome according to the BERLIN classification with a P/F ratio \< 150, requiring prone position.
* Express consent of the patient or representative or in the absence of this, emergency inclusion procedure
* Health insurance coverage

Exclusion Criteria:

* Patient with 2 (or more) Prone position sessions
* Patient in whom one of the two positions could not be achieved: (Joint limitation; Neck size that would prevent head rotation; Orthopaedic spinal or segmental trauma; BMI greater than 45)
* Presence of stage 2 or higher pressure ulcers on the anterior parts of the body at screening
* Presence of extracorporeal membrane oxygenation (ECMO)
* Patient already included in the study
* Pregnant or breastfeeding woman
* Patient under legal protection
Moletest Clinical Study in Scotland

To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign


Eligibility Criteria:
Inclusion Criteria:

All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion Criteria:

There is no exclsion criteria
Apioc Toric/Spherical Single Vision Contact Lens

The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must provide written informed consent.
2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
3. At least 18 years of age and no more than 35 years of age.
4. ≤ 4.00 D of corneal astigmatism.
5. ≤ 4.00 D of refractive astigmatism.
6. Refractive error range +20.00 DS to -20.00 DS
7. Flat and steep keratometry readings within 40 to 50D.
8. Clear, healthy corneas with no irregular astigmatism.
9. Normal, healthy conjunctiva in both eyes.
10. Free of active ocular disease. Refractive error is permitted.
11. Be a current or former (within the last 12 months) contact lens wearer.
12. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

1. Irregular corneal astigmatism.
2. Presbyopia
3. Corneal scarring unless off line-of-site and well healed.
4. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
5. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
6. Systemic disease that would interfere with contact lens wear.
7. Currently pregnant or lactating (by self-report).
8. History of strabismus or eye movement disorder.
9. Active allergies that may inhibit contact lens wear.
10. Upper eyelid margin at or above the superior limbus.
11. History of ocular or lid surgery.
Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia

This proposal tests the efficacy of a phone-based tobacco cessation intervention for people living with HIV (PLWH) in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources. The previously tested SMS-platform to be used in this study is uniquely positioned to be scaled in low- and middle-income countries worldwide, in which case rigorous research showing even modest success in reducing the prevalence of tobacco consumption among PLWH could confer substantial health and economic benefits.

While there is substantial evidence supporting interventions to help tobacco users in the general population quit, little is available relevant to the challenges facing HIV+ tobacco users, especially those living in low-income African countries. This study approaches this gap with the first randomized control trial (RCT) to test the efficacy of a tailored short message service (SMS) based tobacco use cessation intervention on prolonged tobacco use abstinence at 6 months post program initiation in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) among PLWH in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Females who are pregnant, planning to get pregnant, or breastfeeding
* \<18 years (underage of consent)
* Visitor, not receiving continuous care at study site
* Not a current daily tobacco user
* Any physical, cognitive, or psychological disabilities that would prevent them from participating in the study
* Illiterate in English and/or local languages
* Does not consent
Vitamin D in HIV-Infected Patients on HAART

This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive men and women age 18 and older.
* HIV-1 RNA documented to be \< 200 copies/mL on their current ART regimen, with supporting viral load documentation in the 24 weeks prior to study entry.
* Subjects must receive primary HIV care at the UCLA CARE center.
* Subjects must be undergoing screening for vitamin D deficiency by their primary care provider at the time of study entry, or have undergone vitamin D screening in the 90 days prior to consent without yet initiating vitamin D supplementation (for insufficient subjects).
* Ability and willingness of subject to provide informed consent

Exclusion Criteria:

* Use of vitamin D supplementation (not including 400 IU daily, the amount in a standard multivitamin) at the time of screening.
* HIV-infected subjects not on ART.
* HIV-infected subjects not suppressed on their current ART regimen (HIV-1 RNA \> 200 copies/mL in the 6 months prior to screening).
Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma

The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in DLBCL.

In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in DLBCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed DLBCL
* treated using an anthracycline-containing regimen with or without rituximab
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.