rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Argentine Registry of Lp(a)
Status: Recruiting

The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.

The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.

One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.

Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.

The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: Adult patients with validated Lp(a) values -  Exclusion Criteria: Associated pathologies that can increase the Lp(a) value in a non-specific manner  - - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients residing in Argentina - SamplingMethod: Probability Sample
Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
Status: Not yet recruiting

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy], and at least 3 prior lines of therapy (LOT). Documented disease progression during or after their last anti-myeloma regimen as per IMWG. Participants must have measurable disease during screening. Have measurable disease during screening. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.  Exclusion Criteria  Active or history of central nervous system involvement with MM. Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis. Other protocol-defined Inclusion/Exclusion criteria apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Low-Intensity Focused Ultrasound and the Complex Patient
Status: Not yet recruiting

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Males and females aged 18-65 years Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.  Exclusion Criteria:  Evidence of neuropathic pain Previous spine surgery Current substance use disorder other than OUD or tobacco use disorder Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder Chronic Pain Conditions other than chronic back pain Daily opiate use other than buprenorphine/methadone for OUD/pain control Pregnant or breastfeeding History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI) Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).
Status: Not yet recruiting

The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.

This study is seeking for participants who are:

Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.

The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult Patients newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or CP, AP, BP Ph+ CML with resistance or intolerance to prior therapy Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.  Exclusion Criteria:  - Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy who are administrated Bosulif according to the approval label in Korea. - SamplingMethod: Non-Probability Sample
The HIP Self-management Study
Status: Not yet recruiting

The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).

The main purpose of the study is:

To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS).

H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS.
H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.
To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.

Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.

Follow-up will be at 3-, 6- and 12-months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants between 18 and 70 years of age History of lateral hip pain > 3 months Pain ≥ 3 on a numeric rating scale the last 3 months Pain at palpation of the greater trochanter region  In addition, lateral hip pain on at least one of the following tests:  Single leg stance test: standing 30 seconds on the affected leg FADER: passive stretch/compression of gluteus medius/minimus FADER-R: static muscle test with resistance to internal hip rotation ADD: passive stretch to hip adduction in sidelying ADD-R: resisted hip abduction in sidelying FABER (Patrick's) test  A positive test is defined as a spontaneous reproduction of the participant's lateral hip pain. In participants with bilateral lateral hip pain, the worst hip will be included, and presence of bilateral pain will be documented.  Exclusion Criteria:  Significant pain from the lumbar spine, causing referred pain to the hip or clinical signs of lumbar radiculopathy Moderate or severe hip osteoarthritis (OA)/total hip replacement (Kellgren-Lawrence grade ≥2, if relevant, confirmed by hip x-rays. If the participants have taken a previous appropriate x-ray within the last 6 months, they will not require a second x-ray) History of trauma or surgery on the affected side Not able to fill in questionnaires in Norwegian language Pregnancy Post-partum pelvic pain (<12 months) Active cancer - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits
Status: Recruiting

This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parents with children aged 4-10, who experience difficulties with transitions. The program will be advertised that it was developed targeting children demonstrating behaviors consistent with ADHD, and the ADHD symptoms will be measured pre-post. However, children are not required to have a diagnosis of ADHD or show elevated levels of ADHD symptoms for the parents to sign up.  Exclusion Criteria:  Parents who do not understand Japanese (the language the program is offered in). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery
Status: Recruiting

Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.

Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.

Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.

The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:

Does using PSIs provide accurate movements of the maxilla pieces?
Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
Does using PSIs provide stable movements of the maxilla pieces after 2 years?
Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?

Participants will get orthognathic surgery as part of their normal orthodontic treatment.

Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Mandibular retrognathia Occlusion class II Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty  Exclusion Criteria:  Cleft lip Craniofacial syndromes Former trauma Obstructive sleep apnea - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
Status: Not yet recruiting

This study will compare the effectiveness of three different treatments to treat peanut allergy

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 1-10 years. >7kg (the weight considered safe for the administration of an adrenaline injector); Confirmed diagnosis of peanut allergy as defined by a failed DBPCFC with peanut and a positive SPT or sIgE to peanut at screening; Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf  Exclusion Criteria:  History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction) Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines) Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis Use of beta-blockers, and angiotensin converting enzyme (ACE) inhibitors Reacting to the placebo component during the study entry DBPCFC Have received other food immunotherapy treatment in the preceding 12 months Currently taking immunomodulatory therapy (including allergen immunotherapy) Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE) Subjects who in the opinion of the Site Investigator are unable to follow the protocol Another family member already enrolled in the trial (to maintain blinding, safety and equity of access) or in any other clinical trial from the same study group. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Year - MaximumAge: 10 Years - StdAgeList: Child
Lifestyle Care for Fertility Outcome Evaluation
Status: Recruiting

An observational outcome evaluation of the Lifestyle Care for Fertility program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult with a uterus aged from 18 to 50 years Participating in the Lifestyle Care for Fertility program Able to speak and understand English. Has email address and access to mobile device with a functioning data plan. Infertility-related diagnosis  Exclusion Criteria:  Age < 18 or > 50 years Having a significant and uncorrected visual, hearing, or cognitive impairment Inability to provide consent Current pregnancy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program - SamplingMethod: Non-Probability Sample
Type 1 Diabetes, Exercise and Mentoring Trial
Status: Not yet recruiting

The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  want to increase their daily PA currently use a continuous glucose monitor (CGM)  Exclusion Criteria:  were diagnosed with T1D within 12 months of randomization have diabetes secondary to medications or surgery have cancer evidence of drug/alcohol abuse have an eating disorder an orthopedic injury or illness that would limit their ability to engage in daily PA a suicide attempt in the previous 12 months - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child
Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.
Status: Not yet recruiting

Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Over 18 years of age and under 64 years of age. Subjects presenting right shoulder pain at the time of enrollment in the study. Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain. That they agree to participate in the project by signing the informed consent form.  Exclusion Criteria:  Patients with chronic pain due to other diseases such as malignant disease. Patients with rheumatic diseases. Cutaneous infection in the area of pain. Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain. Uncooperative subject. Severe psychiatric disease. Loss of cognitive capacity. Contraindication to electrotherapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
Status: Recruiting

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Be at least 18 years of age of either gender and any race. Provide written informed consent and sign the HIPAA form. Be willing and able to follow all instructions and attend all study visits.  Exclusion Criteria:  Use of any of the disallowed medications during the washout and study period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Written Exposure in Substance Treatment
Status: Recruiting

The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 18 years old Fluent in English Cognitively able to provide consent to the research Enrolled in inpatient treatment at the clinical site where the research takes place Meet criteria for probable PTSD based on PCL-5 score Be early enough in their residential stay to allow time to complete the WET protocol Have a clear memory of the traumatic event so they are able to write about itin detail  Exclusion Criteria:  Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult