rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia
Status: Not yet recruiting

The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18+ years of age Diagnosed with ASD (see 2a). Verbal IQ >= 70 (Measured via the Weschler Abbreviated Scale of Intelligence 2nd Edition28); to ensure verbal skills sufficient to participate in treatment Able to undergo actigraphy assessment Can read and understand English Diagnosed with insomnia (See 3a). No prescribed or OTC sleep medications for 1+ month, or stabilized on medications for 6+ weeks.  2a) ASDb: a) previous DSM diagnosis of ASD (self-reported by ASD adult and guardian; confirmed by clinical documentation provided to project coordinator), 2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview -Revised [ADI-R]).  3a) Insomnia: a) insomnia complaints for 6+ months that b) occur despite adequate opportunity and circumstances for sleep, c) consist of 1 or more of the following: difficulty falling asleep, staying asleep, or waking up too early, d) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, f) baseline diaries and actigraphy indicate >30 minutes of sleep onset latency or wake after sleep onset on 6 or more nights.  Exclusion Criteria:  unable to provide informed consent diagnosis of sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15), Periodic Limb Movement Disorder (myoclonus arousals per hour >15)], comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment) other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders) severe untreated psychiatric comorbidity psychotropic or other medications (e.g., beta-blockers) that alter sleep participation in non-pharmacological treatment (including CBT) for pain, sleep or mood outside current trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People
Status: Not yet recruiting

This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female. Age 18 64 years (both inclusive) at the time of signing the informed consent. Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening. Body mass index between 18.5-29.9 kilograms per square meter (kg/m^2) (both inclusive). Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.  Exclusion Criteria:  Platelet count greater than (>) 400*10^9/ Liter (L) at visit 1 Absolute neutrophil count less than or equal to (≤) 1.5*10^9/L at visit 1  Female who is:  pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or of childbearing potential and not using highly effective contraceptive method and whose male partner is not using effective contraception, from screening until 6 months after the last dose of trial product Male of reproductive age with female partner of childbearing potential who does not agree to use condoms and whose female partner of childbearing potential is not using a highly effective contraceptive measure (or adequate contraceptive measure as required by local regulation or practice) from signing the informed consent form (ICF) until 6 months after the last dose. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI
Status: Recruiting

Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Able to give informed consent. Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5). Agrees to consume the meals provided. Agrees to not smoke during the breath hydrogen sampling period.  Exclusion Criteria:  • Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.  History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function. Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix). Intestinal stoma. Have contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury. Unable to lie flat and relatively still for less than 5 minutes. Any medical condition making participation potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances. Has a body mass index (BMI) value less than 18.5 or greater than 35. Will not agree to follow dietary and lifestyle restrictions required. Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an exclusion criteria). Participants who are taking antibiotics or probiotics as it might alters gut microbiota. Poor understanding of English language. Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM. Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g., cognitive dysfunction, chaotic lifestyle related to substance abuse. Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Mpox Prospective Observational Cohort Study
Status: Recruiting

The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:

The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
The transmissibility of Mpox infection
Viral shedding over time in infected individuals

The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):

Collection of clinical data through chart review and research staff interviews with study participants
Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Part 1:  • Being investigated for Mpox infection by a clinician based on clinical (i.e. symptoms) and/or epidemiologic (i.e. exposure to confirmed case) grounds;  Part 2:  Clinically confirmed to be in the convalescent phase (i.e. confirmed for Mpox infection previously) Within 12 weeks of symptom onset  Exclusion Criteria  • None - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Our overarching goal is to characterize key clinical and epidemiologic aspects of Mpox infection in Canada in the context of the rapidly emerging outbreak. As such we will deliberately include people both with (n=250) and without (number to be determined based on accrual of confirmed cases) the condition of interest because it is important to have a comparison group of people who are ultimately confirmed not to have the infection - SamplingMethod: Non-Probability Sample
Expediting Access to Services for Equity (EASE)
Status: Not yet recruiting

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism.

The main questions it aims to answer are:

Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?
Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?
Does Family Navigation improve caregiver well-being?

Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.

Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Caregiver of a child with a clinical diagnosis of autism spectrum disorder Over the age of 18 Their child with autism must be Black/African-American Speak conversationally fluent English.  Exclusion Criteria:  No access to a telephone or internet connection for phone calls or video conferencing. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth
Status: Not yet recruiting

The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.

Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants have a diagnosis on the autism spectrum Participants are enrolled in high-school based pre-employment transition services Participants have at least a fourth-grade reading level Are unemployed or employed and job-seeking  Exclusion Criteria:  - Not enrolled in a high-school based pre-employment transition services - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 26 Years - StdAgeList: Child, Adult
A Study to Evaluate the Efficacy and Safety of AD-224
Status: Not yet recruiting

The purpose of this study is to evaluate the efficacy and safety of AD-224

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent Patients with Essential Hypertension Other inclusions applied  Exclusion Criteria:  Patient with Secondary Hypertension Other exclusions applied - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
Status: Recruiting

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and Female who over 19 years old Moderate to Severe Dry Eye Disease Patients  Must meet all criteria listed below at least in one eye or both eyes.  TCSS (National eye institute (NEI) scale)≥ 4 Ocular discomfort score (ODS) ≥ 3 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs Written informed consent to participate in the trial  Exclusion Criteria:  Those who have clinically significant eye disease not related to dry eye syndrome Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period Those who have medical history with intraocular surgery 12months before screening visit Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks Participation in other studies within 4weeks of screening visit - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain
Status: Not yet recruiting

The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 18-65 Experiencing low back pain for at least 3 months Pain above 3 on the numeric pain scale The patient diagnosed with chronic low back pain by a specialist doctor does not have any contraindications to chiropractic applications No contraindications to exercise (systemic diseases, neurological diseases, etc.) Patients without joint-related listhesis, spinal stenosis and active discopathy Signing the voluntary consent form  Exclusion Criteria:  Having a fracture or dislocation of the spine, Presence of malignancy and infectious disease Presence of joint-related listhesis, spinal stenosis and active discopathy Presence of osteoporosis Those with a history of trauma within at least 3 months Pregnancy and suspected pregnancy Individuals with inflammatory low back pain Those who have undergone surgery and have neurological loss. Those with psychiatric problems - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision
Status: Recruiting

The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals  Exclusion Criteria:  none - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
Status: Not yet recruiting

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).

All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women ages of 18 to 70 years old Women who are able and willing to read understand and sign an informed consent document Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm) Patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC). Patients who are low estrogen reception (ER) expression (< 20%), progesterone receptor (PR) negative and human epidermal growth factor 2 (HER2) negative are eligible. Clinical stages IIA -IIIC (AJCC 2009) Chemotherapy-naïve patients (for this cancer) Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1  Non-pregnant and not nursing.  Granulocyte greater than or equal to 1,500/microliter Platelet count greater than or equal to 100,000/microliter Absolute neutrophil count (ANC) greater than or equal to l500/microliter Hemoglobin greater than or equal to 10g/deciliter Bilirubin less than or equal 1.5 x upper limit of normal aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) less than 2.5 x upper limit of normal  7. Creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation 10. Baseline left ventricular ejection fraction of greater than or equal to 55%  Exclusion Criteria:  Pregnant or lactating women. Patients with distant metastasis (brain and/or visceral metastasis) Serious, uncontrolled, concurrent infection(s). Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS) Participation in any investigational drug study within 4 weeks preceding the start of study treatment Other serious uncontrolled medical conditions that the treating investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Study will enroll women with breast cancer. - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Stopping Pneumonia Antibiotherapy Regimen Early
Status: Not yet recruiting

The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria:  Major criteria: Fever (> 38°C), Polypnea and Chest x-ray Minor criteria: Localized crackles, C-Reactive Protein (CRP) > 80mg/L, Alteration of general condition, Cough and Pulmonary condensation syndrome. Child with an episode that began less than 7 days before inclusion, in the community. Absence of hospitalization criteria  Exclusion Criteria:  Pre-existing underlying pathology: acquired or hereditary immune deficiencies, cardiac pathologies, chronic respiratory failure or pulmonary malformations, neurological or muscular diseases at risk of respiratory decompensation, serious chronic kidney diseases and nephrotic syndromes, sickle cell anemia, diabetes, chronic liver diseases, oncological pathologies and hematological, organ and hematopoietic stem cell transplants, inflammatory and/or autoimmune diseases receiving immunosuppressive treatment, people infected with HIV, obese people with a body mass index (BMI) ≥ the 97th percentile Wheezing during the episode Presence of pleural effusion on radiography Presence of toxin signs Antibiotic therapy within 48 hours before inclusion Anti-inflammatory therapy within 48 hours before inclusion Allergy or contraindication to penicillin History of more than 2 bacterial pneumonias per year Associated infection requiring more than 3 days of antibiotics Patient hospitalized within 15 days before inclusion Failure to obtain informed consent by the legal representative(s) Patient not affiliated with or not benefiting from a national health insurance scheme Patient participating in another interventional research involving human person - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 59 Months - StdAgeList: Child
Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
Status: Not yet recruiting

This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patient Unilateral or bilateral pulsatile tinnitus Pulsatile tinnitus > 1 month old Affiliated or beneficiary of by social security system  Exclusion Criteria:  Otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum Middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent MRI scan Abnormal eardrums excluding tympanosclerosis Non-pulsatile tinnitus Conductive hearing loss with abolition of stapedial reflexes Minor patient Major protected Abnormal tympanometry at 226 Hz Presence of rotatory vertigo Opposition to participation expressed by patient - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with Unilateral or bilateral pulsatile tinnitus - SamplingMethod: Probability Sample