rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Neuromodulation of the Autonomic Nervous System in Athletes
Status: Not yet recruiting

There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Professional athletes over the age of 15 and under the age of 35; Cyclic sports (swimming, modern pentathlon, athletics, triathlon); Difficult coordination sports (dance sports, rhythmic gymnastics); Sports category: no lower than candidate for master of sports; Voluntary informed consent.  Exclusion Criteria:  Atypical and unrelated to physical exertion changes on the ECG (T wave inversion, st-segment depression, pathological Q waves, signs of left atrial enlargement, signs of right ventricular hypertrophy, ventricular pre-excitation, complete right or left bundle branch block, prolonged or shortened Q-T interval, Brugada-like early repolarization); Heart rhythm and conduction disorders (frequent ventricular and supraventricular extrasystoles, first-degree atrioventricular block (P-Q > 0.21 s, not shortened during hyperventilation or physical exertion), second or third degree); Expressed sinus bradycardia with resting heart rate < 40 bpm; Taking glucocorticosteroids in the last 1 month; Taking any antiarrhythmic drugs, including beta-blockers. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult
Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris
Status: Recruiting

Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.

Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .

Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.

Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.

For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.

PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with facial acne vulgaris Age from 12 to 35 years old  Exclusion Criteria:  Pregnant or lactating women. patients with history of coagulation disorders. chronic diseases (chronic renal failure, hepatic insufficiency, cardiovascular disorders, uncontrolled diabetes mellitus, thyroid disorders, anemia, autoimmune diseases). patients with unrealistic expectations. Patients received any systemic treatment in the last 6 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult
Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
Status: Recruiting

The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  be male have an age of 18 years or older be biopsy naïve have a clinical suspicion of prostate cancer be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA have signed informed consent  Exclusion Criteria:  active (urinary tract) infection or prostatitis a patient history with a cardiac right-to-left shunt. allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent SonoVue current treatment with dobutamine known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome any (further) contraindication to undergo MRI or 3D mpUS imaging incapable of understanding the language in which the patient information is given. medical history of prostate surgery treatment of 5 alpha-reductase inhibitors for at least 3 months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Status: Not yet recruiting

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 or older Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site. Meets criteria for chronic insomnia Takes anti-hypertensive medication (same regimen for at least 3 months); or elevated blood pressure, defined as seated SBP ≥120 mmHg or DBP ≥80 mmHg, measured in the research clinic Body Mass Index (BMI) 18.5-<40 kg/m2  Exclusion Criteria:  Age < 18 Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site. Unwilling to share email address/cell phone number to accept survey links. Life time diagnosis of psychotic or bipolar disorder Current use of Positive Airway Pressure (PAP) therapy Does not meet criteria for chronic insomnia Meets criteria for narcolepsy or hypersomnia disorder Meets criteria for circadian rhythm disorder (including night shift work) Unstable medical conditions that would make participation unsafe or unfeasible Falls resulting in hospitalization, significant injury or fracture within past 12 months 2 hospitalizations or emergency room visits within past 12 months for chronic conditions Active chemotherapy or radiation therapy for cancer Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure Does not agree to refrain from other treatments for insomnia beyond what is offered in this study BMI less than 18.5 or greater than 40 Substance abuse or dependence in the past 12 months Current use of prescription or over the counter medications taken for sleep greater than 2 times per week Current use of systemic corticosteroids or opiate medications Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study Current use of medications contraindicated with trazodone Sleep apnea or periodic leg movement disorder as determined by sleep study Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg EKG corrected QT interval greater than or equal to 500 ms - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children
Status: Not yet recruiting

The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Critical care physicians working with critically ill children in Swedish intensive care units  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 100 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Please - SamplingMethod: Probability Sample
Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
Status: Recruiting

The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient is a pregnant woman 18 and older The mother must be healthy enough to have surgery The mother must be scheduled for surgery Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure  Exclusion Criteria:  Age <18 years Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy. Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
Status: Not yet recruiting

The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.

This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant patient 18 and older who is able to consent Singleton pregnancy Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal Patient has a support person who is able to stay with them for the duration of the pregnancy  Fetal:  Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants Diagnosis of isolated left CDH with liver up Gestation at enrollment prior to 29 weeks 5 days SEVERE pulmonary hypoplasia with ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) < 25%  Exclusion Criteria:  Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly Latex allergy Preterm labor, shortened cervix (<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa Severe maternal obesity pre-pregnancy (BMI > 40) Psychosocial ineligibility, precluding consent, as determined by clinic social worker during review Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care Right-sided or bilateral, left-sided CDH O/E LHR > 25% on ultrasound Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis History of incompetent cervix with or without cerclage Placental abnormalities (previa, abruption, accreta) known at time of enrollment Maternal-fetal RH isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy Maternal HIV, Hepatitis B, Hepatitis C status positive - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study of IBI363 in Subjects With Advanced Solid Malignancies
Status: Not yet recruiting

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; Male or female subjects ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; Anticipated life expectancy of ≥ 3 months;  Exclusion Criteria:  Inadequate bone marrow and organ function; Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study; Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug; Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Treatment With Aspirin After Preeclampsia: TAP Trial
Status: Not yet recruiting

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Postpartum individuals ≥18 years old Preeclampsia diagnosis  Exclusion Criteria:  Fetal anomaly Multiple gestation Pre-pregnancy hypertension Allergy or contraindication to low-dose aspirin Aspirin use during pregnancy or planned aspirin use in the postpartum period. Pre-pregnancy diabetes - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline
Status: Recruiting

The goal of this clinical trial]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:

Do Go and Chess improve cognition?
Is a game better than the other? Is the effect of both games on cognition synergistic?
Do Go and Chess improve quality of life?
Do Go and Chess improve mood?
Do Go and Chess improve lifestyle?

Participants will be randomized to one of four groups:

Group intervention with Go, once a week, for 12 weeks
Group intervention with Chess, once a week, for 12 weeks
Group intervention with Go and Chess, twice a week, for 12 weeks
Control group

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of mild cognitive impairment or subjective cognitive decline Willingness to participate in the board games classes Living within 20-minute driving distance from the center Signed informed consent  Exclusion Criteria:  Prior knowledge of the the game rules (in case the subject knows one of the two, they can be randomized to the other one) Significant linguistic or sensory impairment (according to clinical judgment) Significant behavioral or psychiatric disturbances (according to clinical judgment) Significant medical comorbidities (according to clinical judgment) - HealthyVolunteers: No - Gender: All - MinimumAge: 55 Years - StdAgeList: Adult, Older Adult
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
Status: Not yet recruiting

The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in &lt;1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  <1 years old Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU  Exclusion Criteria:  Open Chest On ECMO Deemed medically unstable by care team Cardiology, ICU, hospitalist or bedside nurse concerns - Gender: All - MaximumAge: 1 Year - StdAgeList: Child - StudyPopulation: children with a scheduled PCU the day of recruitment - SamplingMethod: Non-Probability Sample
Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25
Status: Not yet recruiting

For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.

In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18 to 25 years Male or female Regardless of their sexual orientation Agreeing to participate in the study  Exclusion Criteria:  Minors Refusing to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: People aged 18 to 25 years. - SamplingMethod: Non-Probability Sample
Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance
Status: Not yet recruiting

The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.

Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.

Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1.Patients undergoing hysteroscopy in the hospital;2. American Society of Anesthesiologists Classification (ASA) I-II;3.No significant cardiovascular disease, liver, and kidney function within normal limits;4.Fully informed about the study and willing to participate by signing the informed consent form.  Exclusion Criteria:  1. ASA III-IV, severe cardiovascular disease, or poor physical condition;2. History of mental illness;3. History of sedative or antipsychotic drug use (neuroinhibitors, anxiolytics, antidepressants, benzodiazepines) for any reason;4. History of sleep disorders or have night shifts;5. Surgical complications (bleeding, reoperation, meningitis);6. Nasal deformity or nasal trauma. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 23 Years - MaximumAge: 45 Years - StdAgeList: Adult