rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome
Status: Recruiting

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL  Exclusion Criteria:  Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia. Type I diabetes or not well controlled type II diabetes Stage 2 hypertension (resting blood pressure ≥160/100mmHg) Psychiatric diagnoses or using psychiatric medications including antidepressants Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder
Status: Recruiting

Research background and project basis

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.

Research purpose

Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children with ASD diagnosed through DSM-V (Healthy controls do not have this requirement) IQ score ≥ 75（WISC-IV，Wechsler Intelligence Scale for Children） Age: 6-18 Not receiving psychotropic medication (Or stopping medication for at least 2 weeks before the experiment)  Exclusion Criteria:  In addition to ASD, other mental illnesses are also combined Presence of a sleep disorder, sleep apnea, periodic leg movements during sleep, or atypical EEG patterns Left handed - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: It is expected to recruit 60 participants aged 6-18, of which 30 in the case group are all inpatient and outpatient cases from Xi'an Traditional Chinese Medicine Brain Disease Hospital, and are designated as ASD according to unified diagnostic standards; The healthy control group consists of 30 individuals from nearby community kindergartens and primary schools at Xi'an Traditional Chinese Medicine Brain Disease Hospital, who have not suffered from ASD or other diseases related to ASD research factors. - SamplingMethod: Non-Probability Sample
Effects of Modern Board Games on Well Being in Older Adults
Status: Recruiting

The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Be residents of the Centro Doctor Villacián (Valladolid). Willing to commit to the study. Have literacy skills.  Exclusion criteria:  · Presentation of advanced dementia case. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - MaximumAge: 120 Years - StdAgeList: Older Adult
A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant has a diagnosis of adult-onset RA for at least 3 months prior to Screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria. Participant has moderate to severe RA at Screening and Baseline. Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs. Participant is positive for anti-citrullinated protein antibodies (ACPA). Participant has a C-reactive protein (CRP) > upper limit normal (ULN) (5.0 g/L). Participant has a negative tuberculosis test at Screening, defined as either negative QuantiFERON® test or purified protein derivative <5 mm of induration at 48 to 72 hours after the test was placed.  Exclusion Criteria:  Participant has Class IV RA according to ACR revised response criteria.  Participant has 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:  Poorly controlled diabetes or hypertension, Chronic kidney disease stage IIIb, IV, or V, Symptomatic heart failure according to New York Heart Association Classes II, III, or IV, Myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, within the past 12 months before randomization, Severe chronic pulmonary disease, for example, requiring oxygen therapy, Clinically significant hepatic diseases (i.e., hemochromatosis, Wilson's disease, alcoholic hepatitis, autoimmune liver disease, nonalcoholic steatohepatitis, or α-1-antitrypsin deficiency, Participant has known history of prosthetic or native joint infection or human immunodeficiency virus or neurologic symptoms suggestive of central nervous system demyelinating disease. Participant has a chronic inflammatory disease or connective tissue disease other than RA, including but not limited to; systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non radiographic axial spondylarthritis, reactive arthritis, gout, scleroderma, polymyositis, dermatomyositis and/or active fibromyalgia and/or multiple sclerosis. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities
Status: Not yet recruiting

Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Facial soft tissue volume deficiency deformity caused by congenital/acquired factors, meeting the indications for autologous fat grafting surgery. Good physical health, without severe systemic diseases or infectious diseases. Not pregnant and without plans for pregnancy. Signed informed consent form.  Exclusion Criteria:  Contraindications to general anesthesia. Patient refusal to participate in this study. Significant contour changes in non-filled facial areas during follow-up period leading to inability to register data. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 80 Years - StdAgeList: Child, Adult, Older Adult
Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke
Status: Not yet recruiting

The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.

It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.

In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having had a single stroke Having had at least 6 months since the stroke Having hemiparesis/hemiplegia following the stroke Having mental health sufficient to meet all evaluation and treatment procedures in the study  Exclusion Criteria:  Having a history of disease other than stroke that affects the use of the upper extremity - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult
Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use
Status: Recruiting

Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:

Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)
Are outcomes for ePACE are superior to those for eFACE
Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  12-17-years old live at home with at least one parent or parent figure reporting mild/moderate substance use reporting mental health issues sufficient English language skills for assessments and intervention  Exclusion Criteria:  a sibling has already participated in the study evidence of psychotic or organic state high problem severity indicating possible need for higher level of care - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - MinimumAge: 12 Years - MaximumAge: 17 Years - StdAgeList: Child
Topical Tacrolimus for Breast Cancer-related Lymphedema
Status: Not yet recruiting

The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:

How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age over 18 years BCRL ISL stage I or II Pitting edema Postmenopausal or use of Contraceptive drugs Healthy opposite arm L-Dex score over 10  Exclusion Criteria:  Pregnant, breast-feeding, or aiming to conceive within the next year Bilateral breast cancer Contralateral lymphadenectomy Allergy to tacrolimus, macrolides, or iodine Pacemaker Known kidney or liver disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
Status: Not yet recruiting

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire.  Exclusion Criteria:  - Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 150 patients affected by UC under the standard of care protocols at OSR, will be subjected to a questionnaire each 30 days about their habits. - SamplingMethod: Probability Sample
Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease
Status: Recruiting

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Renal/ureteral stones > 4 mm  Exclusion Criteria:  Anatomical abnormalities - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Effect of Vitamin C on Pain Reduction After an Emergency Department Visit
Status: Not yet recruiting

Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain.

The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months.

This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old Treated in the ED for acute MSK pain present ≤ 48 hours at triage (time to presentation for most acute MSK pain in our previous study) Numerical rating scale (NRS) pain intensity at triage of ≥ 4 on a 0-10 scale Discharged with instructions to take an NSAID for pain (need determined by treating clinicians) French or English-speaking  Exclusion Criteria:  Received an opioid prescription at ED discharge Currently using vitamin C supplements Active cancer Currently treated for chronic pain Unable to fill out a diary or unavailable for follow-up Allergy, to milk (lactose in the placebo), vitamin C, acetaminophen or NSAIDs Treated with cyclosporine or warfarin (interaction with vitamin C) Pre-existing oxalate nephropathy, liver cirrhosis or hemochromatosis Pregnant ≥ 20 weeks. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Gender is self identified by participants. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Status: Recruiting

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  gynecologic cancer patients >18 years old treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)  Exclusion Criteria:  other tumors > 90 years old - Gender: Female - GenderBased: Yes - GenderDescription: Gynecologic tumor patients - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Gynecologic cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT - SamplingMethod: Probability Sample