cyrilzakka/clinical-trials huggingface dataset:
New Imaging Procedure for the Localisation of Insulinoma

Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.


Eligibility Criteria:
Inclusion Criteria:

* Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
* Conventional imaging (CT,MRI or EUS) not older than 2 months
* Signed written consent
* Age above 18 years

Exclusion Criteria:

* Kidney failure (creatinine \> 140micromol/l)
* Known allergies against Exendin-4 (Byetta or Bydureon)
* Pregnancy
* Breastfeeding
* Medication with Byetta or Bydureon
* Evidence for malignancy (extrapancreatic tumor manifestations)
Revascularization Pretreated With Fingolimod in Acute Stroke

Acute ischemic stroke (AIS) is a common type of stroke in the elderly. Timely blood flow recovery can effectively improve the long-term prognosis of patients. According to five large-scale multicenter randomized controlled trials (MR clean, swift-prime, revascat, escape and extend-ia) in recent years, the effect of endovascular therapy (EVT) for acute anterior circulation occlusion of great vessels is significantly better than that of drug therapy alone. Therefore, for patients who meet the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke" (2018 Edition), the effect of EVT is better than that of drug therapy alone, Intravenous thrombolysis within 4.5 hours and endovascular mechanical thrombectomy within 6 hours can effectively relieve the clinical symptoms and reduce the mortality of AIS. However, due to the narrow application time window of intravenous thrombolysis and mechanical thrombectomy, although the thrombectomy time window of some eligible patients was relaxed to 24 hours after dawn and defuse3 and other related studies, the reperfusion injury after the blocked cerebral artery recanalization has brought huge obstacles to clinical application. Therefore, how to improve the prognosis of patients with endovascular therapy has become a hot research direction.

Fingomod is a kind of sphingosine analogues acting on sphingosine-1-phosphate (sipr). After phosphorylation in the body, fingomod combines with lymphocyte SIP receptor, changes lymphocyte migration route, prevents it from entering the area outside the lymphoid tissue, so as to avoid its infiltration into the central nervous system and achieve immunosuppression. Currently, it is the first-line disease modifying oral drug for multiple sclerosis. Fingolmod shows neuroprotective effects on many central nervous system diseases including cerebral ischemia. Fingomod not only reduced the number of lymphocytes invading the brain, but also decreased the number of lymphocytes in the microcirculation system


Eligibility Criteria:
Inclusion Criteria:

* The patient was over 18 years old;
* The NIHSS score was \< 30 and NIHSS \> 5;
* CTA / MRA / DSA confirmed occlusion of M1 segment of internal carotid artery or middle cerebral artery, and aspect score ≥ 6;
* CTP or MRI showed mismatch (ischemic core volume \< 70ml, CTP mismatch \> 1.2
* Normal to random time within 24 hours
* Written informed consent signed by patients or their families

Exclusion Criteria:

* Standard contraindications to alteplase or mechanical thrombectomy
* Cerebral hemorrhage confirmed by imaging
* Cardiovascular diseases (such as bradycardia, etc.)
* Systolic blood pressure \> 185mmhg or diastolic blood pressure \> 110mmhg, and oral antihypertensive drugs can not be controlled
* Pregnant or lactating women
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide

Study Design:

A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age 17 years or older
* Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
* Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)

Exclusion Criteria:

* Age \< 17 years old
* History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP \>21 mmHg)
* Adequate anatomical distances for treatment
* Patient received oral steroid treatment within two weeks prior to day of surgery
* Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
* Sinonasal tumors or obstructive lesions
* History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
* Contracted/underdeveloped ethmoid sinus
* Dehiscent lamina orbitalis
* Previous ethmoid surgery
* Ethmoid mucocele
* Extensive Nasal Polyps
* Asthmatic patients with aspirin sensitivity
* Pregnant or lactating females
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants

This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.

Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.

Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.

Objectives

* To compare the survival rates of preterm infants (\<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.
* To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.
* To assess the feasibility and acceptability of implementing early KMC in NICUs.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at \<37 weeks of gestation.
* Birth weight \<2000 grams.
* Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).

Exclusion Criteria:

* Infants with severe respiratory distress requiring mechanical ventilation.
* Infants with congenital anomalies or other significant health issues.
* Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).
Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy

The purpose was to investigate the performance of a new ostomy device measured with a measuring device.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Can use a product with max cut size 45 mm
5. Self-reported problems with leakage (3 x within 14 days)
6. Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period
7. Must be able to use custom cut product
8. Minimum change of product every third day
9. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP278) protocol.
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation
Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life

Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Therefore, the Purposeful Parenting was developed as a universal program of enhanced anticipatory guidance. At each well-child visit in the first year of a child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills, brain development and the importance of responsive parenting; and 2) a "reminder" item (e.g., a "Smile at Me" onesie) that allows for in-office role modeling and promotes practicing of an age-specific, nurturing parent-child interaction. If an in-office intervention is missed (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by telephone if possible by the site-based clinical interventionists and the "reminder" items will be mailed.

The investigators will conduct a two-phase study. Phase I (months 1-4) will entail a brief pilot of Purposeful Parenting in three Boston-based health centers to optimize quality and logistical details. Phase II (months 5-36) will determine, with a parallel group randomized controlled trial (RCT), whether delivering Purposeful Parenting leads to increased responsive parenting at the intervention's conclusion (in intervention vs control parents), assessed using a validated observational measure. The investigators will enroll 260 low-income families with a full term newborn infant who present for well-child care. Families randomized to the control group will receive usual anticipatory guidance at each well-child visit in the first 12 months of life. Families randomized to the intervention group will receive usual anticipatory guidance plus Purposeful Parenting. As secondary outcomes, the investigators will explore the degree to which Purposeful Parenting (in intervention vs control parents) increases parental knowledge about responsive parenting and child development, reduces parenting stress and improves perceptions of parenting self-efficacy (via validated parental self-report measures) at the conclusion of the intervention. Investigators will explore potential differences by study group in child SEL development at the conclusion of the intervention. In addition, investigators will examine differences in the above listed outcomes are 6 months following the intervention. The RCT will include the collection of process level data including cost.

Eligibility Criteria:
Inclusion Criteria:

* Families (parent \>=18 years of age) with a newborn, born at \>= 34 weeks, presenting for well-child care
* Family plans to remain at that practice
* English or Spanish speaking

Exclusion Criteria:

* Debilitating chronic condition; prematurity (\<34 weeks gestation)
The Effects of Cosmetic Acupuncture

The study recruited 40 subjects and divided them into an intervention group and a waiting list group in a 1:1 ratio using a randomized controlled trial. The changes in skin health and aging-related indicators before and after TCM cosmetic acupuncture treatment were analyzed. The subjects are of all genders and aged between 30 and 60 years old. The TCM cosmetic acupuncture treatment is arranged twice a week for a three-week course. The study will conduct a skin test before and after the TCM cosmetic acupuncture, and use the Antera 3D smart skin detector to comprehensively evaluate the subjects' skin condition. Antera 3D Skin Detector can detect multiple skin indicators, including wrinkle depth, skin tone uniformity and subtle changes in the skin surface, melanin, red pigment, etc. After the treatment, the subjects' acceptance and satisfaction with TCM cosmetic acupuncture were collected.


Eligibility Criteria:
Inclusion Criteria:

* both female and male
* 30 to 60 years old
* never had acupuncture beauty treatment, or the last time they had acupuncture beauty treatment has been more than six months.

Exclusion Criteria:

* medical cosmetic fillers on their face
* cosmetic surgery
* needle sickness
* afraid of acupuncture
* wounds on the facial skin
* poor wound healing
* abnormal coagulation function
* severe diabetes
* keloids
* dialysis
* cancer patients undergoing chemotherapy or radiotherapy
* pregnant
The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography

Less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (IVT) as most present later than the accepted 3 hour time window. Intra-arterial thrombolysis (IAT) is possible 3-6 hours post ictus, but is infrequently used. Mechanical thrombectomy (MT) with a MERCI device is a new intervention possibility but lacks large randomized studies. Although it is desirable to treat more stroke patients, clinical information and plain CT alone are insufficient to discriminate which patients are most likely to benefit or be harmed from treatment. Advanced imaging techniques can help predict patient outcome and provide the necessary information to weigh expected benefit against associated risk of treatment. Visualizing the penumbra, the hypoperfused tissue at risk of infarction around the irreversible infarct core, is one way of identifying patients most likely to benefit from intervention. Magnetic resonance imaging (MRI) based selection of patients with sufficient penumbra for thrombolysis is possible, however, MR has less 24-hour availability than CT in the acute setting. Plain CT is mostly used to exclude intracerebral hemorrhage, and can easily be extended with CT perfusion (CTP) and CT angiography (CTA). CTP compares well to MRI for imaging penumbra and infarct core, and it is faster and more feasible than MRI. Other image findings such as infarct core size and leakage of the blood-brain-barrier (permeability) on CTP, and site and extent of the occlusion and collateral circulation on CTA also influence stroke outcome but have not been combined in one study to assess their combined predictive value.

Hypothesis:

The investigators hypothesize that combined CTP and CTA parameters can predict patient outcome in acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Acute neurological deficit caused by cerebral ischaemia
* Admission \< 9 hours after onset of neurological deficit
* NIH Stroke Scale (NIHSS) of at least 2
* No absolute contraindications against intravenous contrast
* Informed consent from patient or family after admission scan
* Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours

Exclusion Criteria:

* Neurological deficit caused by another diagnosis than cerebral ischaemia (such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor)
* Patients with known contrast allergy or kidney failure
* Patients with the known combination of renal insufficiency and heart failure (New York Heart Association (NYHA) IV) will be excluded for the CTP and CTA scan at 3 days; they will have a non-contrast CT (NCCT) at that time.
Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma

The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase II trial, and ii) a dose-finding part.

The Phase II trial is an open label, non-randomized, multicentre trial without control group. A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in the trial will be recorded, the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes' theorem, which yields an estimated EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim analyses are planned to monitor the efficacy data (early stopping rules for futility or inefficacy).

The final analysis of efficacy will be made on an intention to treat basis, including all recruited patients, 3 years after recruitment of the last patient.

Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment, a dose-finding subtrial will be performed to address this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of medulloblastoma with no INI-1 loss
* High risk medulloblastoma defined by at least one of the following conditions:

  * Newly diagnosed classical metastatic medulloblastoma
  * Newly diagnosed anaplastic/large cell medulloblastoma or other unfavourable histology confirmed by review and coordinating investigator
  * Newly diagnosed medulloblastoma with amplification of c-myc or N-myc
* Age at initial biopsy less or equal than 5 years
* Weight compatible with leukapheresis
* Ability to comply with requirements for submission of materials for central review
* Nutritional and general status compatible with this therapy, Lansky play score \>/= 30%
* Estimated life expectancy \>/=3 months
* No organ toxicity other than neurological symptoms (grade \>2 according to NCI-Common Toxicity Criteria v4.0 grading system)
* No prior irradiation or chemotherapy (except Vepesid - CBP)
* Written informed consent from parents or legal guardian
* All patients must be affiliated to a social security regimen or be a beneficiary of the same in order to be included in the study.

Inclusion criteria for the Phase I part of the study:

* Complete response after intensification phase confirmed by central review
* Adequate hepatic and renal function

Exclusion Criteria:

* Desmoplastic medulloblastoma
* Atypical Teratoid rhabdoid tumour
* Uncontrolled active or symptomatic intracranial hypertension
* Patient incapable of undergoing medical follow-up
* Relapse of medulloblastoma
Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.

TAP block is the administration of local anesthetic agents into the anatomic neurofascial cavity between the internal oblique and transversus abdominis muscle in the antero-lateral region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We aim to show the effect of TAP block administration on analgesic consumption after varicocelectomy operations, side effects linked to analgesic use and analgesic quality.

The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing varicocelectomy operations under elective conditions, randomized with a lottery method. Patients will be informed of the study and included in the study after giving permission with a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25) and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the medications used, with infection in the operated area, and those who do not volunteer will be excluded from the study. At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4, 6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded. When patients are in pain, analgesic agent will be administered according to patient controlled analgesia protocol. The time of first requirement for analgesic agent and the amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction will be assessed by asking if the surgical method they experienced was bad, moderate, good or very good and recorded.

Eligibility Criteria:
Inclusion Criteria:

18-45 year old ASA I-II patient group

Exclusion Criteria:

1. Contraindications for spinal anesthesia
2. Coagulopathy
3. Known allergy to medications used
4. Infection in the operated area
5. Non-volunteer patient