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NCT ID: NCT05938439 Recruiting - Candy Cane Syndrome Clinical Trials

Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome

MAGUS-CCS
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%. A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS. This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years. After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.

NCT ID: NCT05937594 Recruiting - Clinical trials for Neonatal Abstinence Syndrome

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Start date: January 15, 2020
Phase:
Study type: Observational

Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.

NCT ID: NCT05937360 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Prevalence of Polycystic Ovary Syndrome In Trinidad

Start date: January 1, 2023
Phase:
Study type: Observational

According to World Health Organization (WHO), in 2010, Polycystic Ovarian Syndrome (PCOS) affected approximately 116 million women worldwide (3.4% of the population). It has been considered one of the most common causes of female infertility and the most common endocrine disorder. The standard diagnosis for the syndrome dates back to international conferences organized by the National Institutes of Health (NIH) in 1990 and the Rotterdam European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) sponsored PCOS consensus workshop group in 2003 and 2004. Clinical manifestations of the disease may include menstrual irregularities, amenorrhea, ovulation-related infertility, polycystic ovaries, and signs of androgen excess such as acne and hirsutism. This condition may also lead to chronic diseases such as obesity, type 2 diabetes (T2D), dyslipidaemia, and cardiovascular events. Despite the increasing knowledge concerning PCOS, the global picture of the disorder is deficient in a number of geographic regions. Understanding the global prevalence will help to better assess the public health and economic implications of PCOS in Trinidad, allow for improved screening methods, help elucidate the underlying factors and foster improved understanding of the molecular mechanisms in improving the evolutionary process.

NCT ID: NCT05935904 Recruiting - Metabolic Syndrome Clinical Trials

Progression of Metabolic Syndrome Components During Pregnancy

MetS_Preg
Start date: June 27, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this cohort study is to investigate the underlying risk factors to develop metabolic syndrome (MetS) during pregnancy, and the associations of MetS and its indicators with birth outcomes in southwest Ethiopia. The study population consists of low-risk pregnant ladies in their first antenatal care visit (ANC), from Jimma Medical center. The main question[s] it aims to answer are: i) How do MetS components progress during pregnancy, and what are the underlying risk factors? ii) What is the association between MetS components during early- and late pregnancy and adverse pregnancy outcomes? iii) What is the knowledge, attitude and practices of women toward dietary habits, food taboos, and cultural beliefs during pregnancy? The study population consists of low-risk pregnant ladies in their first trimester (<15 weeks of pregnancy) in their first antenatal care visit (ANC) who will be followed up until one-month postpartum. Enrolled women will be assessed four times: at enrolment ≤15 weeks of pregnancy, mid-pregnancy (at 24 weeks), and late pregnancy (at 36 weeks), and within two weeks post-partum for: 1. Sociodemographic data 2. Dietary intake 3. Biochemical analyses 4. Maternal anthropometry: 5. Body composition in a subsample. 6. Knowledge, attitudes and practices of dietary practices during pregnancy 7. Pregnancy and birth outcomes: During the final visit, new born babies will be assessed for Apgar score, weight, length, and head circumference. The mother will be examined for general health and mode of delivery.

NCT ID: NCT05935891 Recruiting - Clinical trials for Musculoskeletal Syndrome

A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)

Start date: April 1, 2023
Phase: Phase 1
Study type: Interventional

Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cancer treated with AIs experiences AIMSS, such as arthralgia, joint stiffness, and bone pain, and 30% of women with AIMSS report severe pain. AIMSS leads to poor adherence with therapy and discontinuation of therapy in up to 20% of patients. Despite the large number of women affected, current therapeutic interventions have shown only limited efficacy in improving AIMSS. Therefore, the presence of AIMSS may negatively impact breast cancer recurrence and survival. In this current trial, the plan is to utilize topical cannabinoid creams from Vireo Health that have been tested for potency and purity. Two distinct products with different THC/CBD ratios will be provided to patients at no cost; a) a THC-dominant cream (Red XS Balm with 375mg/jar and <20mg of CBD) and b) a CBD-dominant cream (Violet Balm with 2210mg CBD/jar and <0.3% THC). The study will explore the feasibility of doing larger, placebo controlled trials by first ensuring adequate patient interest, acceptable tolerability/safety of cream utilization, and preliminary efficacy measures. All patients completing assessments through day 14 will be allowed to choose either Red XS or Violet creams for an additional 2-week extension period.

NCT ID: NCT05935215 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Start date: February 28, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.

NCT ID: NCT05933603 Recruiting - Clinical trials for Obstructive Sleep Apnea

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

MOSAIC
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.

NCT ID: NCT05932927 Recruiting - Clinical trials for Hepatopulmonary Syndrome (HPS)

Analysis of Clinical Features of Chronic Liver Disease Complicated With Hepatopulmonary Syndrome

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

Hepatopulmonary syndrome (HPS) has unknown pathogenesis, limited treatment and poor prognosis. The onset of HPS is insidious and easy to be ignored. Many liver diseases such as "cirrhosis and related complications" are the core characteristics of Beijing You 'an Hospital, but the clinical characteristics of HPS patients in the center are still unclear. The investigators plan to make the diagnosis of HPS among chronic liver disease patients in the hospital according to the diagnostic criteria of HPS proposed in the Practice Guidelines of the International Society of Liver Transplantation in 2016, collect clinical data of HPS participants, evaluate the severity, analyze and summarize clinical characteristics, and conduct management and follow-up. At the same time, The investigators collect blood samples for proteomics tests. In order to improve the diagnosis and treatment level of HPS.

NCT ID: NCT05932589 Recruiting - Rett Syndrome Clinical Trials

Neurophysiologic Biomarkers in Rett Syndrome

Start date: October 11, 2023
Phase:
Study type: Observational

The goal of this observational study is to identify candidate biomarkers in individuals with Rett Syndrome (RTT). The main questions it aims to answer are: - Do these biomarkers change during clinical changes in individuals with RTT? - Are biomarkers stable over time in clinically stable individuals? - Do these biomarkers correlate with severity of RTT? Participants will be asked to undergo an electroencephalogram (EEG) with measurements of Evoked Potentials (EP) to measure electrical activity in the brain. Researchers will compare findings in individuals with RTT to those in typically developing individuals to see if there are differences between the two groups.

NCT ID: NCT05928949 Recruiting - Down Syndrome Clinical Trials

Pilates Exercises and Down Syndrome

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children. the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome