cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Findings of Thumb Muscles in 1st Carpometacarpal Osteoarthritis

Carpometacarpal (CMC) joint osteoarthritis is a disorder that is estimated to affect more than one-third of postmenopausal women, leading to decreased muscle strength, reduced joint range of motion, and pain.The pathogenesis of thumb CMC osteoarthritis involves complex interactions between biomechanical forces, genetic predisposition, hormonal changes, repetitive microtrauma, and aging. An important factor in the progression of carpometacarpal osteoarthritis is the loss of joint stability provided by the surrounding muscles (2). The common methods for diagnosing thumb CMC OA is plain radiographs and clinical examinations. However, radiographs are unable to assess the role of surrounding structures, including muscles and ligaments.

Ultrasound is a cost-effective, radiation-free, and easily applicable imaging method.

In this cross-sectional study, patients with various stages of 1st carpometacarpal (CMC) joint osteoarthritis (OA) were assessed using standard radiographs based on the Modified Eaton Litter classification. Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA will be included (Group 1). In the healthy control group, subjects will be matched based on age and hand dominance (Group 2). Demographic information including age, sex, height, weight, body mass index (BMI, kg/m²), dominant hand, and symptom duration (in months) will recorded. Pain levels will be assessed using the Visual Analogue Scale (VAS).The thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (FDI), abductor pollicis brevis (APB), and opponens pollicis (OPP)) was measured using musculoskeletal ultrasound. Muscle strength in both hands will be evaluated using grip strength measured with a dynamometer . Pressure pain threshold (PPT) for painful and non-painful finger joints will be assessed using a hand-held algometer

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women with clinical and/or radiological evidence of 1st CMC OA

Exclusion Criteria:

* De Quervain\&amp;#39;s tenosynovitis, flexor carpi radialis tendon pathology, and carpal tunnel syndrome, as well as those with hand trauma or hand surgery within the past year, had received steroid and local anesthetic injections into the 1st CMC joint within the last 3 months, or had connective tissue disorders, rheumatologic, or autoimmune diseases
Study of Alwextin® Cream in Treating Epidermolysis Bullosa

The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily.

Potential subjects came to the for a screening visit. Eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. Subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. Subjects returned every 4 weeks for a total of 12 weeks for repeat assessments.

Eligibility Criteria:
Inclusion Criteria:

* history of epidermolysis bullosa

Exclusion Criteria:

* use of any skin product containing allantoin for 30 days prior to enrollment
Mandibular Advancement Device for Obstructive Sleep Apnea

The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.

Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.

In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.

Eligibility Criteria:
Inclusion Criteria:

* AHI \> 5 on polysomnography
* sufficient set of teeth to hold a splint
* written informed consent

Exclusion Criteria:

* sleep apnea with severe cardiovascular disease
* other severe somatic or psychiatric disease
* periodontal disease
* significant occlusal dysfunction
* pregnant women
Trialling an Online UK Dementia Awareness for Caregivers Course

The purpose of this study is to investigate whether an online Dementia Awareness Course is feasible for delivery and acceptable to informal caregivers of people living with dementia in the UK. It will also explore the impact of the course on different caregiver outcomes.

All participants were given information on the study before providing informed consent. The participants were screened against eligibility criteria before being randomly allocated to either the treatment condition of attending the course, or the control condition of treatment as usual. Participants completed 5 outcome measures and a demographics questionnaire at baseline. The treatment group then attended a one-off half-day Dementia Awareness Course online, delivered by one trainee clinical psychologist. A month later, all participants completed the same 5 outcome measures and those who attended the course also attended a one-to-one half an hour online semi-structured interview.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified informal caregiver of a person living with dementia in the community.
* Residing in the U.K.
* Ability to engage in a course delivered in English
* Have access to an internet-connected device capable of videoconferencing (camera and microphone functioning)
* Available to attend pre-specified dates for DAC-UK delivery.

Exclusion Criteria:

* Person living with dementia residing in residential care
* Professional caregiver of people living with dementia.
Repaired Tetralogy of Fallot Italian Registry

The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

This is an observational prospective registry that will enroll patients presenting with repaired Tetralogy of Fallot (TOF) undergoing a cardiac magnetic resonance (CMR) imaging study in our recruiting CMR-Laboratories.

CMR imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the Late Gadolinium Enhancement (LGE), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. We will also assess the aortic valve for regurgitation and measurement of the aortic size.

At follow-up, any interventional or surgical procedures performed and symptoms or any major (Death) and cardiac (cardiac-related hospitalization) events will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Repaired - TOF

Exclusion Criteria:

* Age \< 10 years
* Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein
* Incomplete CMR exam
Polyethylene Glycol for Childhood Constipation

Background:

Aim:

Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.

Study design:

Randomized, open-label trial.

Randomized, double-blind, placebo controlled trial.

Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg.

In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age 1 - 18 age
* functional constipation according to the Rome III Criteria
* consent of parents or guardians of the child to participate and study

Exclusion Criteria:

* organic cause constipation (including surgeries within the lower GI tract)
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

* unresectable breast cancer
* ER negative primary tumor
Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications

In this observational, retro-prospective, and multicenter PMCF clinical investigation, Biodentine™, an active dentine substitute for professional dental use only, is evaluated at 10 years post-treatment, in its endodontic indications as followed:

* Repair of root or furcation perforations.
* Repair of root resorptions (internal and external).
* Root-end filling in endodontic surgery (retrograde filling).
* Apexification (tooth with open apex).
* Revitalization procedure by means of revascularization.

Evaluation is done through a 10-year post-treatment follow-up with collection of radiographic, clinical examination and safety data.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, adult or child with permanent study tooth (immature or mature)
* Study tooth treated with an endodontic microsurgery using Biodentine™: all microsurgery including root end-filling, external or internal root resorption repair, root and furcation perforation repair and apexification
* Study tooth treated at least 1 year and no more than 5.5 years before inclusion visit
* Availability of baseline radiographic image of the study tooth
* Patient affiliated to national health insurance
* Patient informed about the study and who confirms his/her consent to participate to the study

Exclusion Criteria:

* Patient treated with anti-cancer therapy in the 5 years prior to the treatment
* Uncontrolled systemic disease 1 month prior to the treatment
* Development of a cancer or a systemic disease just after the treatment
* Participation to an interventional clinical trial at the time of the treatment
The Effects of High-Intensity Exercise on Biological Age

The purpose of this graduate student research study is to determine if a high-intensity exercise program can slow or reverse biological (transcriptomic) aging and shed light on the underlying transcriptomic pathways involved.

24 males and 24 females will be randomly assigned to either the control group or the exercise group. Baseline measures will be obtained, including questionnaires (on stress, sleep, depression, activity level, and fitness), body composition measures, vital signs, and a blood draw. Control group participants will make no modifications to regular diet or exercise habits for 30 days. Exercise group participants will perform supervised high intensity exercise three times per week at the LLU department of physical therapy laboratory utilizing treadmills, stationary bicycles, and rowing machines. Results will be collected following conclusion of the 30-day study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Sex: Both Males and Females
2. Age: 40-65 years old
3. Physical Fitness: Below average scores on the Self report fitness questionnaire
4. Physical Activity: Low as measured by the International Physical Activity Questionnaire

Exclusion Criteria:

1. Prior (within the last 5 years) or current history of cardiovascular disease, stroke, unexplained weight loss, clinical depression, congestive heart failure, cancer, arrythmia, respiratory disease, or other serious medical conditions that would make exercise unsafe or prevent full participation in the exercise protocol.
2. Any self-reported significant increase or decrease in activity levels within the past thirty days.
3. Current use of the following medications: antibiotics, glucocorticoids, anticoagulants, narcotics, antiepileptic medications, antipsychotics, antidepressants, and hypoglycemic agents.
4. Current self-reported pregnancy
A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer

In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth. This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients have hypoxic tumours. The results will be compared to tissue samples removed during surgery and to the distribution of 18F-FDG.

Hypoxia or anoxia can be found in 50% of locally advanced breast carcinomas. Assessment of pre-treatment in viva and in vitro hypoxia could allow patient selection for more aggressive therapy or clinical trails focused on targeting hypoxia. We will use the PET radiotracer 18F-FAZA to monitor hypoxia in the protocol. We will study pathological characteristics on the final tumour restriction specimen and correlate prognostic and predictive factors with PET scan data. Tumour banking is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Female ≥ 18 years of age. If female of child bearing potential and if outside of the window of 10 days since the first day of the 0last menstrual period, patient will be required to have a negative pregnancy test.
2. Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy), T1-T4(T ≥ 1.5 cm)
3. FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment.
4. FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy.
5. Able and willing to follow instructions and comply with the protocol
6. Provide written informed consent prior to participation in the study.
7. ECOG performance score ≤ 2

Exclusion Criteria:

1. Previous malignancy or diagnosis less than ten (10) years ago. Skin Cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
2. Excisional biopsy of the primary breast tumour has been performed
3. Women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype
4. Primary breast carcinoma previously treated.
5. Women who are nursing or pregnant.
Isometric Contraction-Based Pain Modulation Versus Eccentric Strengthening in Treating Achilles Tendinopathy

Achilles tendinopathy is a common overuse injury that leads to pain and functional limitations. Traditional rehabilitation focuses on eccentric strengthening, which has been widely studied for its benefits in promoting tendon remodeling and improving strength. However, recent research suggests that isometric contractions may offer superior pain modulation effects, especially in the early stages of rehabilitation.

This study aims to compare the effectiveness of isometric contraction-based pain modulation versus eccentric strengthening in treating Achilles tendinopathy. Isometric exercises involve maintaining a static muscle contraction, which has been shown to reduce pain through neuromuscular mechanisms, potentially making it a valuable alternative or complement to eccentric loading.

Eligibility Criteria:
Inclusion Criteria:

* Clinically Diagnosed with Achilles Tendinopathy using MRI
* At least 3 months incidence period of Achilles Tendinopathy
* Must be able to attend all treatment sessions and follow-up assessments.
* Ability to walk independently without any assistive devices.

Exclusion Criteria:

* Severely restricted ROM of ankle
* Patients who underwent surgery for Achilles tendinopathy
* Patients who had undergone previous surgery of lower limb extremity
* Those using ankle orthosis
* Patients with systemic diseases affecting ankle (osteoarthritis, rheumatoid arthritis, and osteoporosis)
* Individuals with neurological disorders affecting the lower limbs.
* Systemic Conditions like diabetes, cardiovascular diseases.
Healthy Beginning Initiative

The purpose of this study is to determine if providing free laboratory test to pregnant women and their spouses at churches, in addition to laboratories or hospitals, will increase the number of pregnant women and their spouses who get screened for HIV, malaria, sickle cell trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep mothers healthy during pregnancy and lead to healthy babies. This research is taking place in 40 churches in Nigeria.

We are conducting a randomized trial to evaluate the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) delivered by lay health advisors (Intervention Group; IG), versus a Facility Based Approach (Control Group; CG) on the HIV testing rate and PMTCT completion among 2,700 pregnant women. Four dioceses with forty churches nested in the dioceses, will be randomly assigned to either the IG (N=2; n=20) or the CG (N=2; n=20). The HBI combines a family educational game show and an integrated on-site laboratory testing in the context of a baby shower. Monthly prayer sessions for pregnant women will be used for recruitment and a baby reception following infant baptisms will be used for follow up after delivery. The primary outcome is difference in testing rate among pregnant women in IG compared to CG. The secondary outcomes are HIV testing rate among male partners and PMTCT completion among HIV-infected pregnant women. Pregnant women will complete an investigator-administered questionnaire at the baby reception to collect information on HIV testing and PMTCT completion. Data will be confirmed with Health Facilities and on-site testing data. This proposal is a collaboration among Partners for Prevention, education, Training, Treatment and Research (PeTR-Global Solutions)/AIDSRelief (our PEPFAR-funded partner in Nigeria responsible for training, HIV testing, linkage to treatment and local oversight of the project); New York University School of Medicine (program evaluation and shares oversight with PI), Board of Regents, NSHE, obo University of Nevada, Reno (provide overall oversight, data management and evaluation of program effectiveness).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females 18 years and older;
* Male partners of pregnant females 18 years and older;
* Subjects must attend church at one of the participating diocese

Exclusion Criteria:

- Subjects will be excluded if they are not pregnant women or their male partners or are younger than 18 years old.
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas

The overall aim of this study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This study will compare the effectiveness of two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit youth from primary care clinics in Texas metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.


Eligibility Criteria:
Inclusion Criteria:

* be aged 18-24 at the time of enrollment
* not have received mental health services in the past 90 days, excluding medication and case management
* English-speaking
* screen positive for suicide risk

Exclusion Criteria:

* are actively suicidal
* have a developmental disability that would preclude them from participating in the study intervention
* who are impaired due to psychosis, mania, or substance use that would prevent them from providing consent.
* Participants will also be excluded at YST-III sites if they are unable to identify a minimum of one support person to participate in the intervention with them
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+

Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs

Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
* All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
* Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
* Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
* Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;

Exclusion Criteria:

* Moderate-severe corneal pathology;

  * Irregular astigmatism;
  * Subject desire monovision correction;
  * Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
  * History of glaucoma;
  * Severe dry eye disease;
  * History of uveitis;
  * History of ocular herpes simplex virus;
  * History of nystagmus;
  * Zonular laxity or dehiscence;
  * History psueudoexfoliation;
  * History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
  * Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
  * Pregnant or breastfeeding.
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged from 20 years to under 80 years on the day informed consent is obtained
* Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
* Subjects in whom protocol-specified observations and assessments are considered possible

Exclusion Criteria:

* Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
* Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
* Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years