cyrilzakka/clinical-trials huggingface dataset:
Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60

This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.

The fundamental questions that this study aims to answer are as follows:

Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?

Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged ≥ 60 years

Exclusion Criteria:

* History of lumbar spine surgery
* Cancer
* Spinal infection
* Severe degenerative scoliosis
* Chronic kidney failure
* Liver cirrhosis
* Bilateral hip arthroplasty
Natural Experiment: "Gentle Nudge" Intervention, Eliminating Phone Call Requirement

Back pain costs the U.S. over $100 billion annually, and much of this spending is wasteful due to the overuse of advanced diagnostic imaging. Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Real-time electronic clinical decision support (CDS) at the point of care has been increasingly emphasized as an important strategy to improve the value of back pain management; however, studies suggest that CDS at best only modestly influences practice patterns. The aim is to implement a behavioral economic-based intervention in the ED to promote the use of CDS system.

Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Few studies have rigorously investigated the causes of CDS' limited influence on care as well as interventions to enhance CDS' impact on reducing low value imaging. The implementation of CDS to reduce low value MRI and CT imaging studies for back pain at a large safety net health system was monitored. The CDS systems was integrated into the electronic health record system. Clinicians answered several questions and select from a list of basic imaging indications and CDS provides an American College of Radiology Appropriateness Criteria score. Appropriate scores ranged from 7-9, borderline scores ranging from 4-6, and inappropriate scores ranging from 1-3 (clinicians are encouraged to cancel inappropriate orders).

Electronic order data on imaging studies was pulled using CPT billable data and imaging studies were categorized as appropriate, canceled, changed, and unscored orders. Early observation of CDS implementation revealed that LAC+USC Medical Center (one of 16 sites) had high percentages of unscored orders. At this intervention site, a "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice) was provided where clinicians ordering medium or high scoring studies could bypass the usual mandatory phone call to radiology. This natural experiment was evaluated using a quasi-experimental difference-in-differences (DinD) analysis to measure whether high scores increased and unscored studies decreased at the intervention site vs. 15 control sites over time. Generalized linear regression models were used that accounted for clustering by practice site and adjusting for patient and clinician characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Lower Back Pain receiving treatment at Los Angeles Department of Health Services Facility (LAC-DHS)
* Adults whose physicians order Imaging Studies (CT SCANs and MRIs)

Exclusion Criteria:

* Non-LAC-DHS patients
* Patient without Lower Back Pain
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease

The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures
* Patients of any race
* On outpatient treatment
* History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twice a week, for about four to eight weeks)
* Diagnosis of erosive esophagitis (grade A to D, according to Los Angeles Classification)
* In good health condition, except GERD symptoms
* Able to follow the protocol directions and to complete daily the questionnaire ReQuest™ throughout the study

Exclusion Criteria:

* Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret's esophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
* Previous history of surgery to reduce acid secretion, or other upper gastrointestinal tract surgeries (excepting polypectomy and cholecystectomy)
* At initial endoscopy presenting complicated disorders due to erosive esophagitis: obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophageal varices, achalasia and hiatal hernia
* Pregnant women or during nursing period
* Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
* Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior to start of the study
* H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of the study
* Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) for more than 3 consecutive days a week, within the last 28 days prior to start of study, with exception of regular intake of acetyl salicylic acid in dosages of up to 163 mg/day.
Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's Disease

Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson Disease (PD)
* Aged ≥18 years
* Individuals with the capacity to provide informed consent

Exclusion Criteria:

* Individuals with PD living in institutional care or in hospital
* Drug, infection or toxin induced parkinsonism
* Individuals with diabetes
* B12 injection users
* Currently taking antibiotics
* Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics)
* Any other medical, cognitive or psychosocial issue, or co-enrolment in another study, that could interfere or disrupt adherence to the study requirements
* An allergy to any of the ingredients in the functional and/or control drinks
* Consuming a fermented food and/or probiotic yogurts on a daily basis
Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients

Comparison of aqueous and plasma glucose level in diabetic patients

High glucose concentrations in aqueous humor are thought to be related of diabetic ocular injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic glycation, oxidative stress and activation of polyol pathway. However, glucose concentrations in aqueous humor of diabetic patients was only examined in a few patients in the past.

This study will compare glucose concentration in blood plasma and aqueous humor in diabetic patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also be examined. Correlation between these parameters will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

- Diabetic patients planed for elective cataract surgery

Exclusion Criteria:

* s/p traumatic eye injury
* past or current uveitis
* patients using prescription eye drops except lubricants
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand

A procedure called silicone metacarpophalangeal joint arthroplasty (SMPA) is sometimes used to treat knuckle deformity in the hands of rheumatoid arthritis (RA) patients. The purpose of this study is to compare the health outcomes of RA patients who choose to undergo SMPA surgery to RA patients who do not undergo surgery.

The purpose of this study is to provide a better understanding of the effectiveness of SMPA, a procedure to correct knuckle deformity in the hands of rheumatoid arthritis patients. This study will examine whether rheumatoid arthritis patients who undergo SMPA will have better outcomes than those patients who do not have this surgery.

RA affects 2.1 million Americans and costs the United States an estimated $8.7 billion annually in medical costs and wages. RA is a progressive disease, and approximately 25% of RA patients experience hand deformities associated with the destruction of the metacarpophalangeal (MCP) joints. For the past 30 years, SMPA has been performed on such patients to correct metacarpophalangeal joint deformity in the rheumatoid hand. SMPA can provide pain relief, restoration of function, and aesthetic improvement to the patient. However, because data are limited on its efficacy, SMPA remains a controversial procedure. Hand surgeons and rheumatologists frequently disagree about the indications for this procedure and its value to their patients. In addition, most published studies have been hampered by inadequate consideration of research design, small sample size, and inconsistent outcome measures. The purpose of this study is to measure short- and long-term outcomes following SMPA. The study will also define indications of the surgery for specific patient groups and disease severity. The experiences of both surgery and rheumatology services will be used to jointly evaluate this surgical procedure.

This study is a multicenter, international outcomes study to evaluate RA patients with severe MCP joint problems. Patients will choose to be enrolled into a surgical group undergoing SMPA or a nonsurgical group. Patients will be evaluated at Month 6 and annually until the third year. Patient evaluations will be based on the Michigan Hand Outcomes Questionnaire, the Arthritis Impact Measurement Scales questionnaire, and standard, objective hand function tests.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis based on the diagnostic criteria of the American Rheumatology Association
* Able to complete questionnaires in English
* Sum of average metacarpophalangeal joint ulnar drift AND average metacarpophalangeal joint extensor lag of 50 degrees or greater

Exclusion Criteria:

* Severe medical condition precluding surgery
* Concomitant extensor tendon ruptures and metacarpophalangeal joint disease
* Other joint injury of the hand (e.g., swan-neck deformity, boutonniere deformity) requiring surgery
* Previous metacarpophalangeal joint replacement on their study hand
* Disease modifying antirheumatic drugs (DMARDs) within the 3 months prior to study entry
Virtual Reality as a Tool for Rehabilitation on Elderly People

Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after two physical activities, being one of an activity guided by interactive video game (Xbox) and another on the treadmill. The participants will perform the activities in two different days, the order will be obtained by randomization.


Eligibility Criteria:
Inclusion Criteria:

* Participate in this study elderly
* Of both sexes,
* Over 60 years,
* without cardiac and respiratory diseases
* Who accept to participate in the research, giving your consent by signing the informed consent

Exclusion Criteria:

* Those who oppose the signing of the informed consent
* Submit proposals and activities intolerance who can't understand or accomplish correctly the procedures due to physical and or mental limitations.
Developing and Evaluating Effectiveness of a Reinstatement Tutorial

This study will compare a computerized tutorial to a brochure in terms of their education impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. The goal of this study is to determine if this new computerized tutorial decreases the harm of gambling experienced by gamblers who are reinstated. For example, are they less likely to relapsing to problematic levels of gambling.

Voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. Currently there are over 10000 people in the program. Although some self-exclusion programs place a permanent ban on the individual, others offer the possibility of reinstatement after a period of time. Many problem gamblers actually do change their minds about self-exclusion and wish to return to gambling. Centre for Addiction and Mental Health (CAMH), in cooperation with Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. The goal of this study is to evaluate an the intervention to determine its impact on problem gamblers who is reinstated from relapsing to problematic levels of gambling. The content for the tutorial will be informed by CAMH, will be developed for land based gambling, and also adapted for online gambling as well.

Eligibility Criteria:
Inclusion Criteria:

* people currently in the voluntary self-exclusion program who wish to be reinstated (allowed back into the casino to gamble).

Exclusion Criteria:

* people who are not currently in the voluntary self-exclusion program
Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients

Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti mullerian hormone is recent marker for ovarian reserve. The investigators are searching ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma patient who are operated for their cysts.

long term results of the postoperative follow up for the endometrioma patients

Eligibility Criteria:
Inclusion Criteria:

* Ultrasonographical symptomatic and benign cysts which has surgery indication.

Exclusion Criteria:

* Over 42 years old, systemic endocrine disorder, history of ovarian surgery
Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness/Implementation Hybrid Study

Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria.

Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in Nigeria:

1. HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing.

   Objectives: To determine the effectiveness of the intervention to:
   * identify youth living with HIV, particularly YMSM and
   * link those who test HIV-positive to HIV care
   * pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.
2. HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.

Objectives: To determine the effectiveness of the intervention on

* viral suppression and
* adherence to ART
* success of implementation in the target populations

Eligibility Criteria:
Inclusion Criteria:

HIV Case Finding Intervention:

* Aged 15 to 24
* Male birth sex of any current gender identity
* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative

HIV Treatment Intervention:

* Aged 15 to 24
* HIV seropositive
* Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic
* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English
* Intention to remain a CRPS patient during follow-up

Exclusion Criteria:

* Unable to provide consent
* No parental permission if aged 15 and not emancipated
18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Adults with age equal or above 18
* Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
* if woman being of childbearing potential, woman taking contraceptive measures
* Patient able to understand benefits and risks of protocol
* Subject affiliated to French health insurance (Social Security)
* Informed consent form signed

Exclusion Criteria:

* Patients not fulfilling inclusion criteria
* Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
* Chemotherapy within 2 the months preceding the TEP-CT
* Acute pancreatitis within 2 the months preceding the TEP-CT
* Pregnant women or breast-feeding women refusing to temporary stop it
* Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
* Patients with claustrophobia
* Patients not accepted under the anesthesia point of view
Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:

Does the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.

Participants will:

Undergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).

Complete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older.
* At least two teeth affected by dentinal hypersensitivity.
* Good standard of home oral hygiene.

Exclusion Criteria:

* Use of pain relievers.
* Ongoing orthodontic treatment.
* Non-vital teeth or teeth with restorative materials.
* Pregnant or breastfeeding women.