rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Status: Not yet recruiting

Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between 18 and 65 years old Meeting CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria CRPS patients with severe pain (NRS>3) that affects their daily life. CRPS patients with pain and other symptoms for more than 3 months.  Exclusion Criteria:  Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT). Systemic or local infection Malignancy Current or planned pregnancy within the study period. Uncontrolled medical and psychiatric condition Patients with known liver issues, including but not limited to end-stage liver disease, severe cirrhosis or an acute hepatic state. Patients who are currently using opioid drugs Patients who are currently using alcohol or considering using alcohol during the study period. Allergy to naltrexone or naloxone - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Autoguide Positioning Device for Multiple Stereotactic Biopsies
Status: Recruiting

The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.

The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.

On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.

To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18-80 years Diagnosis of a cerebral lesion with the indication for surgical resection Written informed consent to participate in the present study MRI and CT scanner compatibility  Exclusion Criteria:  Pregnancy, breast feeding Patients not able to reason Age <18 or >80 years Claustrophobia - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a preoperative suspected low grade glioma, in whom a tumor resection is planned. - SamplingMethod: Probability Sample
Assessment of Anti-aging Efficacy of Marine Collagen Peptides
Status: Recruiting

To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy adults aged above 18 years old  Exclusion Criteria:  Subjects who are not volunteers Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure Subjects who have known cosmetic, drug or food allergies. Patients are taking medicine for chronic diseases Subjects receiving treaments for scalp, hair transplant, and other scalp medical care in past 12 weeks. Subjects getting a manicure and perm in past 12 weeks. Female who is pregnant or nursing or planning to become pregnant during the course of the study. Subjects receiving facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 12 weeks. Students who are currently taking courses taught by the principal investigator of this trial. Subjects are not willing to reveal the results of pictures after taking the product Vegetarian. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Promoting Teenage Sleep for Improved Mental Health and School Performance
Status: Not yet recruiting

The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Students in Swedish high schools and upper secondary schools.  Exclusion Criteria:  - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 13 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult
Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric
Status: Not yet recruiting

• Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.

• Secondary outcome:

Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.
Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score
Parental satisfaction scores

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • Weight: 10 - 38 kg.  Age: 3-7 years. ASA physical status: I-II. Operation: elective hypospadias repair under general anesthesia  Exclusion Criteria:  • Parent's refusal.  Anticipated difficult airway. Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia. History of developmental delay or mental retardation or any neurological disease. Known hypersensitivity to any drug used in this study. Children with co-morbid conditions like congenital heart disease, respiratory pathology, central nervous system disorders or renal pathology - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: name of patient gender exposure on surgery only male participants are being due to surgery is hypospadias repair. - MinimumAge: 3 Years - MaximumAge: 7 Years - StdAgeList: Child
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Status: Not yet recruiting

Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:

Whether MB treatment reduces death to any cause as compared to no MB treatment.
Whether treatment with MB reduces the time to achieve normal blood pressure
Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.
Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.

Eligibility:
- EligibilityCriteria: Screening Criteria: preterm infants (<37 weeks, <28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following  Definite/probable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein >10 mg/dL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists.  Shock: adapted from the definition given by Davis et al 2017  Either SBP < age and gestation appropriate cut-off OR Presence of any 2 of the following 6 parameters i. HR >205/min ii. Central pulses either week OR bounding iii. CRT >3 sec OR flash refill (<1 sec) iv. skin mottled/cool OR flushed v. urine output <0.5 ml/kg/h in the preceding 6 hours vi. DBP < age and gestation appropriate cut-off Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml/kg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg/kg/min) or epinephrine (maximum dose 0.4 µg/kg/min) or norepinephrine (maximum dose 0.4 µg/kg/min).  Exclusion Criteria:  excluded if ≥1 criterion positive:  G6PD deficient or family history of G6PD deficiency Potentially lethal malformation Congenital heart disease Severe acute kidney injury Family history of allergy to methylene blue or food dyes - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Days - MaximumAge: 28 Days - StdAgeList: Child
Effect and Mechanism of tDCS on Anterior Cingulate Nerve Regulation in ASD
Status: Recruiting

In this proposed study, a transcranial direct current stimulator is used to intervene in the anterior cingulate gyrus of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 3-24 years old; Clinically diagnosed by a psychiatrist with autism spectrum disorder; Confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) of the United States; Evaluated by researchers (pediatric psychiatrists) using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), it is consistent with the diagnosis of autism spectrum disorders; Capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation.  Exclusion Criteria:  a) Existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc;  b) Imaging examination showed significant brain structural abnormalities;  c) Having serious neurological diseases, a clear family history, or potential risks;  d) Metal or pacemaker implantation in the body, holes or cracks in the skull;  e) Taking benzodiazepines or anticonvulsants;  f) The existence of clear or suspicious genetic diseases;  g) Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 24 Years - StdAgeList: Child, Adult
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
Status: Not yet recruiting

This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.

The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.

Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.

Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study 18 years of age or older Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.  Exclusion Criteria:  Pregnancy Urgent/non-scheduled surgery Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure) Baseline opioid use Planned post-operative admission Non-eligible for umbilical entry - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia
Status: Not yet recruiting

The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  men and women >19 years old patients with stroke confirmed by neuroimaging first-time stroke patients patients in subacute or chronic phases of stroke with 3 weeks or more after onset stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS).  Exclusion Criteria:  patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc. patients with deteriorated cognitive function unable to perform the clinical trial as instructed patients with evidence of delirium, confusion, or other impairment of consciousness patients with uncontrolled medical disease or surgical conditions patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant) patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia patients with history of uncontrolled epilepsy within 6 months patients with medical contraindications for neuroimaging test, such as MRI; patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes patients who are pregnant, breastfeeding, or planning pregnancy during the trial period patients considered medically ineligible for participation in the present trial beyond the criteria listened above. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis
Status: Recruiting

In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.

Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Disease Activity Score with 28 Joint Counts (DAS28) between 2.0-3.2 A rheumatoid arthritis diagnosis of minimum 1 year Under stable pharmaceutical treatment for at least 4 months and with no planned change in treatment within 8 weeks  Exclusion Criteria:  Daily smokers Diabetes Mellitus Pregnancy / planned pregnancy Lactation Prednisolone treatment DAS28 below 2.0 and above 3.2 Current dietary habits resembling intervention diet (e.g., 100% plant based diets) Participation in other intervention studies or clinical trials via the rheumatology outpatient clinic that will affect their adherence to plant based diets Not able to eat ad libitum meals because of e.g., allergy Unable to understand the informed consent and study procedures Alcohol and/or drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study
Status: Not yet recruiting

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  COHORT A: Healthy participants COHORT B: Participants with pre-existing lymphedema COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a >= 2-centimeter difference in contralateral arm circumference  Exclusion Criteria:  Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study
Status: Recruiting

The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.

The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.

The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.

The population consists of 48 adult patients with gonarthrosis divided into two groups:

24 patients Group A experimental group: partial denture surgical procedure

24 patients Group B control group: total denture surgical procedure with patellar resurfacing

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Grade 3-4 sec Kellgren-Lawrence medial gonarthrosis Patellar symptoms Primary gonarthrosis Patients with ligament integrity Age between 40 and 85 years inclusive Signing of the Informed Consent and consent to cooperate in all study procedures.  Exclusion Criteria:  Cognitive impairment Psychiatric disorders Neuromuscular disorders Age > 85 years and <40 years Lateral gonarthrosis grade 4 sec Kellgren-Lawrence Secondary medial gonarthrosis Revisions Minors Pregnant women self-declaration - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult