rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
Status: Not yet recruiting

People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.

The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Age 18 years or older History of spinal cord injury Time since diagnosis longer than six months Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity [range from 0 to 10]) If needed, agreement to reduce antispastic medication  Exclusion criteria:  Neurological level of spinal cord injury below T11 Ventilatory-dependent Change in neurological status over the past 2 months Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints Botulinum toxin injections in lower extremities in the previous 3 months before enrollment Systolic blood pressure at rest lower than 90 mm Hg Implanted active devices (e.g., intrathecal baclofen pumps) Passive implants (plates, screws) between T11 and L2 vertebras Skin conditions precluding placement of electrodes Pressure ulcers stage 2 or higher on the gluteal area or lower extremities Receiving antibiotics for infections Pregnancy Difficulty following instructions Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study Other medical risks/contraindications as determined by the study physicians - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Exparel vs. ACB With Bupivacaine for ACL Reconstruction
Status: Recruiting

Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who are 7-17 years old undergoing elective ACL reconstruction/repair with American Society of Anesthesiologists (ASA) Classification 1-2 at Children's Hospital of Orange County (CHOC). Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Surgery scheduled between the hours of 8am - 4pm  Exclusion Criteria:  No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries) Learning disability or developmental delay. Learning disability or developmental delay will have been assessed by an outside specialist. Diagnosis will have either been communicated to attending physician by the patient or will be located in patient's medical record. Anything that would impede survey completion. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 17 Years - StdAgeList: Child
Telehealth Behavioral Activation for Teens
Status: Not yet recruiting

Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study; Be between the ages of 12- 18 or currently enrolled in high school; Have a caregiver that is willing to participate in the program; Be able to commit to weekly sessions for eight weeks; Be currently experiencing depressive symptoms; Be able to participate in telehealth services within the state of Texas; Be willing to provide consent/assent (parents/legally authorized representative (LAR)/guardian or young adult participant, aged 18 or older, must be willing to provide consent; youth, aged 12-17, must be willing to provide assent); Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study; Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent/LAR/guardian and youth) Be able to provide a reliable means of contact.  Exclusion Criteria:  Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe; Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns); Have active psychotic or manic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention; Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17). - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth
Status: Not yet recruiting

The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Youth is a patient in a participating community health center.  Youths meet criteria for clinically significant anxiety and / or depression as indexed at baseline assessment by either:  research diagnosis of anxiety (Social Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder) and / or depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder). scores in the clinically elevated range on a standardized anxiety and / or depression symptom measure . Youth lives with a legal guardian (hereafter referred to as "parent") >= 50% of the time who consents to study participation. Youth speaks English. Parent speaks English or Spanish.  Exclusion Criteria:  Youth requires alternate treatment as indexed by:  current clinically significant Post-Traumatic Stress Disorder symptoms (meets diagnostic criteria in research interview and / or scores in the clinically elevated range on a standardized symptom measure) at baseline. current suicidal ideation with plan at baseline and / or suicidal behavior within the last year. current substance dependence at baseline. experience of physical or sexual abuse within the six months prior to baseline. parent /guardian does not identify anxiety and / or depression as a treatment priority at baseline. Youth is in an active, alternate psychosocial intervention for anxiety or depression that would be concurrent with study participation. Youth is on an unstable regimen of psychotropic medication (i.e., receives medication but has not been at a stable dose for at least 8 weeks, or if medication has been discontinued for less than 4 weeks) at baseline. Youth is receiving lithium or and anti-psychotic medication at baseline. Youth is placed in a special education program for greater than 50% of the school day and / or youth school placement is below the second-grade level at baseline. Youth is placed in foster care at baseline. - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 16 Years - StdAgeList: Child
Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome
Status: Not yet recruiting

The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women 18-65 years of age Experienced intermittent tingling and/or numbness in one or both hands that has occurred within two weeks of the start date of this study.  Exclusion Criteria:  Pregnant Body mass index (BMI) over 30 kg/m2 (obese) Prior surgery, broken bones, or known birth defects affecting the thoracic outlet, such as clavicular fracture or congenital first rib - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Explore the Relationship Between Platelet Count and Bleeding Score in ITP
Status: Recruiting

Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis of primary ITP .  Exclusion Criteria:  Malignancy disease  Virus infection:  HIV Hepatitis B virus Hepatitis C virus Pregnancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: adults(≥18 years old) , diagnosed as primary ITP - SamplingMethod: Probability Sample
Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.
Status: Not yet recruiting

The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors.

Eligibility:
- EligibilityCriteria: Inclusion criteria  Age ≥ 18 years. Cisgender men who have sex with men. Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or on-demand, with a documented PrEP prescription. Agreeing to be contacted personally by telephone (call, SMS) or e-mail. Person affiliated with or a beneficiary of a social security scheme (article L1121-11 of the Public Health Code). Informed and written consent, signed by the person and the investigator on the day of inclusion, at the latest, and before any examination carried out within the setting of the study (article L1122-1-1 of the Public Health Code).  Non-inclusion criteria  Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed. Symptoms and/or clinical signs consistent with an acute HIV infection. History of seizure disorder. Ongoing Post-Exposure Prophylaxis (PEP) for HIV. Last titer of hepatitis B surface antibody (anti-HBs) < 10 mIU/mL. Concomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. Participants having a non-treated chronic HCV infection. Current or chronic history of liver disease or known hepatic or biliary abnormalities. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL). Creatinine clearance lower than 50mL/min. History of chronic renal disease, osteoporosis or osteopenia. Inflammatory skin conditions which compromise the safety of intramuscular (IM) injections. Known thrombocytopenia or any other known bleeding disorder, which would contraindicate IM injection. Treatment with oral anticoagulant (antiplatelet agents are allowed). Known or suspected allergy to study product components. Surgically placed buttock implants. Planned trip abroad of more than 2 consecutive months or planned move outside the Ile de France region. Individuals who, upon the investigator's judgement, will not be likely to comply the clinical trial procedures, or with any condition incompatible with study participation. Person participating in another research study with an exclusion period still in progress at inclusion. Participants in the ANRS PREVENIR study are authorized to participate in the ANRS CABOPrEP trial. Person under guardianship or curatorship or deprived of liberty by judicial or administrative decision. - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Cisgender Men - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Reduction of Dentine Hypersensitivity After Use of Different Dentifrices
Status: Recruiting

To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants must be between 30 and 65 years old. Participants should be in good general health. Participants must have a diagnosis of generalized chronic periodontitis according to the 1999 classification definition. Participants should complain of at least two teeth with dentinal hypersensitivity. Participants must exhibit moderate to severe dentinal hypersensitivity (Schiff's scores of 2 to 3) or tactile stimulation (Visual Analogue Scale (VAS) score >4) after at least one scaling and root planing session.  Exclusion Criteria:  Individuals with dentinal hypersensitivity symptoms prior to periodontal treatment. Those who have used agents to treat hypersensitivity in the past 3 months. Participants who are allergic to the test products (5% CSPS or 8% arginine). Dentinal hypersensitivity caused by factors such as dental caries, defective restorations, fractured teeth, abrasion or abfraction, extensively restored teeth, or restorations extending into the test area. Individuals who have undergone orthodontic treatment within the past 3 months. Patients with crowded teeth or serving as abutment teeth for fixed or removable prostheses are also excluded from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia
Status: Not yet recruiting

Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.

Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.

Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Community dwelling 18 years of age or older History of dementia or mild cognitive impairment in the problem list in the NM EHR. A history of mild cognitive impairment will be identified using the ICD-10 code G31.84 (mild cognitive impairment) or ICD-10 codes suggestive of ADRD as described in the Bynum-standard algorithm: F01.50-F01.51 (vascular dementia), F02.80-F02.81 (dementia), F03.90-F03.91 (unspecified dementia), F04 (amnestic disorder), G30.0/30.1/30.8/G30.9 (Alzheimer's disease), G31.01 (Pick's disease), G31.09 (frontotemporal dementia), G31.83 (dementia with Lewy bodies), G31.1 (senile degeneration), G31.2 (degeneration of nervous system), R41.81 (age-related cognitive decline). Able to participate in medication reconciliation as determined by the pharmacist per usual care OR a care partner with knowledge of the patient's current medications is present in the ED or is available by phone. Has had prior outpatient care performed at Northwestern Medicine location(s) Arrives to the emergency department between 7am and 7pm, Monday-Friday  Exclusion Criteria:  Emergency Severity Index (ESI) of 1 (critical) ICU consult placed in the ED Reside in nursing facility or assisted living facility - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Status: Recruiting

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation. Rupture of membranes confirmed by biochemical testing. Membrane rupture within the past 36 hours. Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission. Age ≥18 and <50 years.  Exclusion Criteria:  Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission. Allergy to penicillin, erythromycin, or azithromycin. Multiple gestations. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
Status: Recruiting

Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years; Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma that are subjected to surgery; Adequate biological material to be able to carry out the analyzes previously described; Written informed consent (only for patients in the prospective part and/or in follow-up); For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.  Exclusion Criteria:  Comorbidities not controlled with adequate medical therapy; Infections of the endometrial cavity (pyometra); Synchronous tumors; Neoadjuvant treatments; Previous radiation treatments on the pelvic region. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The population is represented by patients with endometrial cancer who have undergone, or who have will undergo surgery - SamplingMethod: Non-Probability Sample