rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer
Status: Recruiting

About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy Upfront SCR not feasible Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment. Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.  Exclusion Criteria:  Non-epithelial or borderline tumors are excluded Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded. Patients using more than one line of chemotherapy are excluded. Patients who have platinum-resistant or refractory recurrence are excluded. Patients having second relapse or beyond are excluded. Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Digital Toolkit for Skin Diseases in LMICs: Part 2
Status: Not yet recruiting

Impact evaluation of eSkinHealth in improving case detection of skin NTDs and treatment outcomes in rural and urban settings

Eligibility:
- EligibilityCriteria: Healthcare providers (i.e., doctors, nurses, or community health workers/volunteers)  Inclusion Criteria:  18 years or older Working at primary health centers or clinics in Cote d'Ivoire Able to read and speak fluent French Willing to participate in the pilot study for the 12-month study duration Willing to use a provided tablet with the eSkinHealth app if they were assigned to the intervention group Able to consent for oneself  Exclusion Criteria:  Planning to leave their job at the clinics within the study period Difficulty operating mobile devices Patients with skin diseases  Inclusion Criteria:  Clinically suspected or diagnosed with skin NTDs (Buruli ulcer, leprosy, and yaws) or have other clinically diagnosed skin conditions Able to consent for oneself  Exclusion Criteria:  Clinically diagnosed skin conditions outside of the target site - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla
Status: Not yet recruiting

Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue & better long-term stability & less relapse rate.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Non growing cleft patients, age range (18-30 years) Unilateral or bilateral cleft patients Anteroposterior deficiency (1.5-2.5 cm) No sex predilection  Exclusion Criteria:  Syndromic patients. bone metabolism & systemic diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Personalized Depression Treatment Supported by Mobile Sensor Analytics
Status: Not yet recruiting

The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows:

Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process
Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 year or older Moderate level of depression as defined by a score of ≥ 11 on the 16 item Quick Inventory of Depressive Symptomatology (QIDS) self-report questionnaire Initiating a pharmacological treatment for depression as monotherapy or adjunctive treatment or reporting a dose increase with their existing depression treatment.  Exclusion Criteria:  Diagnosis of a primary psychotic disorder such as schizophrenia or schizoaffective disorder Currently active substance use disorder (within 1 month of enrollment) dominating clinical scenario Other clinically significant medical of psychiatric conditions that may adversely affect participants' study participation and/or affect their adherence to study protocol (as determined by study clinician) e.g., significant cognitive deficits - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome
Status: Recruiting

The VitDTracking study focuses on the relevance of maternal vitamin D levels and their association with prematurity, aiming to improve maternal and child health outcomes, particularly by reducing avoidable preterm births. In Portugal, vitamin D levels during pregnancy have never been studied. Epidemiological data from other countries reveal a high prevalence of vitamin D deficiency/insufficiency, especially in pregnant women.

The hypovitaminoses prevalence remains high even with a supplementation dosage of 400 to 600 IU/day during pregnancy (dosage used in Portugal), which is considered as a suboptimal dose. This phenomenon is associated with adverse maternal and child outcomes, such as intrauterine growth restriction, preeclampsia, cholestasis, hypertension, and gestational diabetes as major causes of prematurity.

Additionally, the Portuguese population has a higher prevalence of genome alterations that confer a lower capacity to produce vitamin D from sunlight exposure. These genetic characteristics are present in about 19% of the population, representing a prevalence four times higher than the European average (19% versus 4.75%), leading to a higher predisposition to vitamin D deficiency.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant women's living in the Alentejo region aged 16 years or older, who after disclosure and clarification of doubts, agree to participate in the study with signed informed consent.  Exclusion Criteria:  Language barrier (lack of basic understanding of Portuguese). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women's in the Alentejo region - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Pregnant women's in the Alentejo region - SamplingMethod: Non-Probability Sample
Red Light Ptosis Proof-of-Concept
Status: Recruiting

This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light.

We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months.

We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint.

Eligibility:
- EligibilityCriteria: Inclusion: Age 3 to less than 18 years Genetically confirmed diagnosis of primary mitochondrial disease (known pathogenic mutation(s) in mitochondrial or nuclear DNA known to cause primary mitochondrial disease) Ptosis  Exclusion: Genetic diagnosis not consistent with primary mitochondrial disease. No genetic diagnosis Unable to cooperate with light treatment or ophthalmological assessments. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Pectoralis Minor Release Versus Non-release in RSA
Status: Not yet recruiting

The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are:

whether releasing the pectoralis minor prophylactically could have better pain relief
whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes
whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients undergoing surgery for reverse total shoulder arthroplasty Patients willing and able to provide informed consent  Exclusion Criteria:  Revision arthroplasty Reverse shoulder arthroplasty for proximal humerus fractures Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
tACS Treatment for Cognitive Impairments in Methamphetamine Addicts
Status: Recruiting

To evaluate the cognitive function of methamphetamine Patients.
Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical diagnosis diagnosis of methamphetamine use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) None of participants had mixed use of other drugs None of participants had physical disability None of participants had acute physical or mental illness, hallucinations, acute withdrawal symptoms None of participants were receiving any medical treatment  Exclusion Criteria:  Intracranial hypertension Cranial defects Tumors Serious physical illnesses (e.g., cardiovascular, liver, kidney, gastrointestinal disorders) Infectious diseases Immune system disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)
Status: Not yet recruiting

This pilot study will test a digital care planning decision support system for patients with dementia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Mild or moderate dementia of any type Able to provide informed consent, or consent from surrogate decision maker Able to self-assess patient-related outcome (PROM) or experience (PREM) measures  Exclusion Criteria:  Ongoing delir Severe cognitive impairment (MMSE < 10 [22]) Unable to provide informed consent Life expectancy estimated less than 3 month - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke
Status: Not yet recruiting

The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.

The main questions this study aims to answer are:

What are the best strategies to implement this genetic test in the hospital?
Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?

Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women at least 18 years of age Presenting with symptoms of acute ischemic stroke or transient ischemic attack and without contraindications to dual antiplatelet therapy at time of clinical research coordinator screening Presenting within 24 of symptom onset; or, within 24-96 hours of symptom onset IF planned to receive or already on dual antiplatelet therapy  Exclusion Criteria:  Receiving therapeutic anticoagulation or clear indication for initiation of anticoagulation after event (e.g., known atrial fibrillation) History of allogeneic bone marrow transplant History of liver transplant Subject who is unable to consent and does not have a surrogate available to consent on their behalf - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Individuals evaluated in the Emergency Department or admitted inpatient at an academic medical center - SamplingMethod: Non-Probability Sample
Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
Status: Not yet recruiting

This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  POTS Patients  Age ≥ 14 years, able to provide informed consent (assent with parental consent for age < 18) and comply with procedures Meets consensus criteria for POTS: (1) sustained increase in heart rate ≥ 30 bpm above supine baseline within 10 min of quiet standing or upright tilt (≥ 40 bpm in individuals 12 to 19 years of age) OR sustained upright HR >120 bpm, (2) absence of orthostatic hypotension, (3) symptoms with standing that improve with sitting or lying down, (4) resting supine heart rate < 100 bpm, (5) orthostatic symptoms present for at least 6 months Stable oral medication regimen for at least 14 days  Non-POTS Control Patients  Healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures Does NOT meet consensus criteria for postural tachycardia syndrome No symptoms of orthostatic intolerance or dysautonomia. No history of other major medical disorder Resting supine heart rate < 100 bpm  Exclusion Criteria:  None of the following exclusion criteria:  Use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitor, anticholinergic medications (including tricyclic antidepressant medications), fludrocortisone, desmopressin in past 14 days Use of other autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours Currently receiving IVIG, subcutaneous IgG, or any investigational medication (in past year) Infusion of iv fluids in past 7 days History or evidence of another condition explaining symptoms or orthostatic tachycardia (e.g. structural heart disease, CSF hypovolemia, or severe traumatic brain injury) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 14 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: POTS patients and Normal Control - SamplingMethod: Non-Probability Sample
Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
Status: Not yet recruiting

This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states.

Eligibility:
- EligibilityCriteria: Teachers: The educator sample will include all educators within each of the schools. All educators that have regular contact with students (e.g., administrators, teachers, instructional assistants, school counselors) will participate in the school-wide ISLA intervention activities. All educators at both treatment and control schools, if they consent, will provide data through an annual survey administered at three time points: in the spring prior to the first year of ISLA implementation (baseline), in the spring of the first year of ISLA implementation (post-intervention), and in the spring of the second year of ISLA implementation (follow-up).  Inclusion criteria:  * Staff member in either a control or intervention condition school  Exclusion criteria:  None  Cohort Students: The student cohort sample will include all students in Grade 7 during the first year of ISLA implementation, who will be followed into Grade 8 during the second year of ISLA implementation (such that data can be collected from the end of Grade 6 to the end of Grade 8). With an average middle school size of 660 students per school, we project the cohort size to be 220 students per school, for a total of 11,880 to 13,200 students.  Sub-cohort Students: A random sample of 50 assenting 6th grade students (at the time of baseline data collection) per cohort per school will be selected to provide additional data, for a total of 2,700 to 3,000 students (consent will be gathered from parents/guardians). With the help of each school administrator, the research team will conduct the randomization process using each school's enrollment. School administrators will invite all 6th grade students to participate via recruitment emails to their parents/guardians. A random selection of students will be made from those parents who are consented.  Inclusion Criteria:  * 6th grade students in either intervention or control schools during first data collection period for each wave  Exclusion Criteria:  students who cannot complete the online survey independently (e.g., require assistance beyond text-to-speech files to comprehend the items and available responses) specifically: students who cannot comprehend written or spoken English or written or spoken Spanish, or students who are eligible for alternate assessment for statewide achievement testing. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 8 Years - MaximumAge: 15 Years - StdAgeList: Child
Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness
Status: Recruiting

The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy clinically staged as T1-4N0-2M0 having undergo neoadjuvant chemoimmunotherapy the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors having undergo surgery with lymph nodes (LNs) dissection having postoperative pathology reports with evaluation of primary tumor and LNs response having accessible pretreatment and preoperative radiology examinations imaging or reports  Exclusion Criteria:  using PD-1/L1 inhibitors in the phase of clinical trials the agents of neoadjuvant therapy including angiogenesis inhibitors having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with resectable NSCLC (clinically staged as T1-4N0-2M0) who underwent neoadjuvant chemoimmunotherapy followed by surgery between January 2017 and January 2024 in Sun Yat-sen University Cancer Center were retrospectively reviewed. - SamplingMethod: Non-Probability Sample
Human-centered Injury Thrivorship Pathway for Survivors of Physical Trauma
Status: Not yet recruiting

The goal of this clinical trial is to pilot and evaluate a human-centered injury thrivorship pathway in injury survivors. The main question it aims to answer is:

• Is the pathway appropriate, acceptable, and feasible to meet the medical and social needs of injury survivors?

Injury survivors will be purposively sampled to enroll in the pathway and asked to participate in in-depth interviews and their use of pathway resources will be tracked.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient ≥ 18 years old presenting with a physical injury to Zuckerberg San Francisco General Hospital Admitted to the hospital ≥ 24 hours Discharged from the hospital alive San Francisco resident or unhoused in San Francisco Capacity for informed consent  Exclusion Criteria:  Patient < 18 years old Deceased during index hospitalization Unable to provide informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult