rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
The Effect of a Brief Educational Intervention for Adults With ADHD
Status: Not yet recruiting

This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Confirmed ADHD-diagnosis Speaking a Scandinavian language Willing to participate  Exclusion Criteria:  Unable to give informed consent In-patient on a acute psychiatric ward Severe learning difficulties Involvement in other research studies - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK)
Status: Not yet recruiting

The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient's age ≥ 18 years First occurrence of aneurysmal subarachnoid hemorrhage Patients without any craniotomy treatment before onset Hunt-Hess grade III-V mRS grade 0 or 1 before onset Aneurysm treatment within 48 hours of onset Informed consent given by the subject or guardian  Exclusion Criteria:  Subarachnoid hemorrhage caused by arteriovenous malformation or moyamoya disease or other cerebrovascular disease modified Fisher Scale grade 0 Prothrombin time (PT) and activated partial thromboplastin time (APTT) are less than 2 times the extended range Absolute contraindications for lumbar puncture (e.g., brain hernia, puncture site infection) Patients with a life expectancy of less than 1 year due to other causes Other concomitant serious diseases that are difficult to treat; Pregnant woman Patients who were known to be allergic to urokinase and excipients or had a history of severe allergy and were deemed unsuitable for inclusion by the investigators Participated in another interventional clinical trial within 30 days before randomization Other reasons deemed unsuitable for study participation by the investigator - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.
Status: Not yet recruiting

The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the accuracy and timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with Idiopathic Parkinson's Disease Taking four or more doses of levodopa daily Experiencing fluctuations in motor function with regards to OFF time and/or dyskinesia. Able to utilize a digital product, either alone or assisted by a caregiver. Likely to be referred for advanced treatment within two years, as evaluated by the referring physician.  Exclusion Criteria:  Consistent use of a wheelchair or walker which may interfere significantly with the remote monitoring of PD motor symptoms. Lack of understanding and proficiency in the Danish language. Lack of motivation to use a digital product. Inability to use wearable devices due to non-compliance, physical and/or skin sensitivity. Suffering from severe psychiatric disorders. Otherwise not qualified to receive advanced treatment (e.g., advanced cancer, severe heart failure). Already undergoing advanced treatment. Diagnosed with atypical or secondary parkinsonism. Other patient groups otherwise deemed ineligible by the project manager. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Status: Recruiting

The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.

Eligibility:
- EligibilityCriteria: Inclusion criteria for WP1:  CFTR mutations eligible for treatment with ETI Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024. Included in the Norwegian CF Register and consented to participation in CF general research biobank  Exclusion criteria for WP1:  Other CFTR modulators commenced the last 6 months before inclusion Use of probiotics or prebiotics last 2 months Current pulmonary exacerbation  Inclusion criteria for WP2:  Age 3-18 years CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months Included in the Norwegian CF Register and consented to participation in CF general research biobank  Exclusion criteria for WP2:  CFTR modulators commenced the last 6 months before inclusion Use of probiotics or prebiotics last 2 months Current pulmonary exacerbation - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds
Status: Recruiting

The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  adult patients with post-surgical wounds subjects capable of complying with the protocol procedures signing of informed consent  Exclusion Criteria:  Pregnancy or breastfeeding inadequate contraceptive procedures in fertile women chronic concomitant treatment with local antiseptics, use of anti-inflammatory drugs (steroids and non-steroids), analgesics, antineoplastics or immunosuppressants non-therapeutic use of psychoactive substances, drug and/or alcohol abuse immunodeficiencies (including HIV infection) Oncology patients; known allergies, hypersensitivity or intolerance to any of the substances administered in this study any medical or non-medical condition that may significantly reduce the possibility of obtaining reliable data and achieving the objectives of the study Participation in clinical trials with devices or drugs within 3 months prior to the screening visit. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Ankle Assistance and Resistance in Older Adults
Status: Recruiting

The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 65 and 85 years old, inclusive. Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination. Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used. The ability to read and understand English. Able to walk at least 30 feet with or without a walking aid Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking  Exclusion Criteria:  Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time. Note: For elderly participants, a history of joint replacement or joint degeneration that does not impair their ability to walk safely is allowable. Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 85 Years - StdAgeList: Older Adult
Uveal Melanoma - Comparative Study
Status: Recruiting

The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of uveal melanoma  Exclusion Criteria:  Inadequate or missing information on the clinical course in patient charts Imaging not feasible due to any reason. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with uveal melanoma will be included in this study. - SamplingMethod: Non-Probability Sample
Ketamine as a Supplement to Local Anesthesia for Minor Procedures
Status: Recruiting

This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).

Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Undergoing Minor Procedure in the ED Weight not to exceed 115kg  Exclusion Criteria:  Altered Mental Status Pregnancy Breastfeeding Acute head or eye injury Intercranial Hypertension Hx of seizures Hx of chronic pain Unstable vital signs Allergy to Ketamine Hepatic or Renal Insufficiency Hx of Psychiatric Illness Hx of alcohol/drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
Barriers to Cervical Cancer Screening
Status: Recruiting

This study evaluates barriers to cervical cancer screening among non-compliant women.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women between the ages of 21-65 Non-compliant for cervical cancer screening within Mayo Clinic Primary Care  Exclusion Criteria:  Women less than 21 or older than 65 Complaint for cervical cancer screening within Mayo Clinic Primary Care Women who decline participation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 21 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Women aged 21-65 that are non-compliant for cervical cancer screening within the Mayo Clinic Health System - SamplingMethod: Non-Probability Sample
Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
Status: Not yet recruiting

The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:

pain scores at hip and jaw sites
opioid use in amount and frequency
scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients that are 6 and older who have a diagnosis of cleft lip and/or palate with a scheduled surgery that involves an alveolar bone graft.  Exclusion Criteria:  Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - StdAgeList: Child, Adult, Older Adult
Durometer for Measuring Uterine Tone
Status: Recruiting

This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center Patients ages 18-50  Exclusion Criteria:  Patients undergoing unscheduled (intrapartum) cesarean delivery Ages <18 or >50 years old Intrapartum cesarean hysterectomy Inability to provide independent, informed consent due to impairment or intellectual disability Non-English speaking patients - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Centralized Screening Unit (CSU) at Montefiore-Einstein
Status: Not yet recruiting

This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinic level:  a NYC RING affiliated clinic, Opt into and agree to research protocol;  Patient level:  Age 50-77 for participants, past or current smoker, 20+ pack-years tobacco, has quit smoking within the last 15 years, without chest CT within the past 12 months, and, no history of lung cancer or and at least 5 years since the diagnosis of any other malignancy  Exclusion Criteria:  Clinic level:  only treats pediatric patients, Opt out of research protocol;  Patient level:  Primary care provider instruction to not contact an individual for any reason. Any individual inadvertently contacted who does not meet these criteria will be excluded from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - MaximumAge: 77 Years - StdAgeList: Adult, Older Adult
Two Schemes Response in Multiple Myeloma
Status: Recruiting

Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.  Exclusion Criteria:  Incomplete clinical records Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues Clinical records of patients who presented severe sepsis before the beginning of either treatment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023. - SamplingMethod: Non-Probability Sample
Interaction Between Early Trauma and Odor-induced Dopamine Release
Status: Not yet recruiting

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 years or older Have been selected based on the Childhood Trauma Questionnaire score Non-smoker Be able to speak and read French Sign a consent form before intervention.  Exclusion Criteria:  A pre-existing condition that affects olfaction including congenital anosmia, upper respiratory tract infection, nasal and/or sinus disease, Be on medication, with the exception of oral contraceptives Pregnant or breast-feeding woman (check with urine pregnancy tests); Contraindications to TMS or MRI (implanted medical devices or metallic foreign body in the head); Psychiatric disorders Use of psychotropic drugs Have participated in a study involving the injection of a radiotracer during the year - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Video Messages for Smoking Cessation Campaign
Status: Not yet recruiting

240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eighteen years and older Current smoker every day or some days Has smoked a minimum of 100 cigarettes in a lifetime  Exclusion Criteria:  Non Smokers Must have internet access to complete questionnaires - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
CHARGE Study: CHoice ARchitecture Genetic tEsting
Status: Not yet recruiting

CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care.

Eligibility:
- EligibilityCriteria: Proband Inclusion Criteria:  Have a newly reported pathogenic or likely pathogenic variant in one or more of the following genes: APC, ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, PTEN, TP53 18 years of age or older English fluency Have at least 1 adult living genetically related relative who resides in Texas  Proband Exclusion Criteria:  Referred for genetic testing by a relative with a pathogenic variant Unwilling to be randomized to a study arm  Relative Inclusion Criteria:  18 years of age or older English fluency Residing in Texas - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult