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NCT01802658
|
Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)
|
Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.
Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.
No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.
|
Inclusion Criteria:
* Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable,
* level of injury C5 L2,
* AIS grade A to D.
* Female or male between 18 and 45 years.
* No pregnancy.
* No osteoporosis.
* Good oral health.
* Good glomerular filtration.
* No cons-indication to Zoledronic Acid.
* No drugs affecting bone metabolism
Exclusion Criteria:
* pregnancy.
* osteoporosis.
* cons-indication to Zoledronic Acid.
* drugs affecting bone metabolism
|
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|
NCT06394843
|
Fluid Currents During Hemodialysis
|
During dialysis, three objectives are achieved. 1. Blood is cleansed from waste products. 2. Excess water is removed. 3. Electrolytes are regulated. These processes occur simultaneously but vary from patient to patient depending on their specific needs. Some patients still produce urine, but of poor quality. Others have no residual urine production at all and require removal of fluid from both blood and tissues. Hypotension may occur during dialysis, related to intravascular hypovolemia and inadequate fluid reinfusion, which is common during ultrafiltration exceeding 400 ml/h. The amount of fluid removed is influenced by fluid recruitment from tissues. This mainly occurs in two different ways: osmotic recruitment across capillary membranes from the perivascular space or via lymphatic reflow. The proportions are not fully understood. When fluid is recruited from the perivascular space, the influx of albumin and immunoglobulins is unlikely. However, these should accompany lymph to the blood if lymphatic flow is increased. The content of albumin and immunoglobulins differs between lymph and plasma. Thus, the proportions of fluid recruitment from tissues should be calculable using mass balance calculations based on ultrafiltrate, colloid osmotic pressure, hemoglobin, albumin, and immunoglobulin concentrations. The rate and proportions of fluid reinfusion into the bloodstream are not fully understood. Therefore, in this study, the aim is to monitor fluid reinfusion and its proportions of lymph/osmotic recruitment into the bloodstream.
|
In Sweden, approximately 3200 patients undergo hemodialysis annually. In some cases, it is solely about blood purification, but for many patients, removal of excess fluid accumulated since the last dialysis treatment is also necessary. The amount of fluid removal/ultrafiltration prescribed by the physician during dialysis primarily depends on the amount of residual urine the patient produces but also on the patient's fluid intake between dialysis treatments. The most common complication of hemodialysis is hypotension during treatment, occurring in about 10% of treatment sessions according to previous studies. These hypotensive episodes lead to temporary hypoperfusion, and repeated episodes can cause permanent organ damage. The main cause of these hypotensive episodes is the reduction in circulating volume during ultrafiltration, i.e., fluid removal. The excess fluid that the patient accumulates between treatments is mainly located outside the bloodstream. Therefore, in connection with fluid removal during hemodialysis, there is compensatory fluid recruitment to the circulation, increasing the circulating volume and preventing hypotension. How this occurs and from which fluid compartment fluid is recruited is not yet mapped out. To increase understanding of hemodialysis and optimize treatment while minimizing the risk of hypotension, it is interesting to understand how fluid recruitment occurs and from which fluid compartments recruitment occurs. Using fluid kinetic calculations, it has been possible to measure whether fluid is recruited perivascularly or from the lymphatic system during albumin infusion depending on the concentrations of proteins such as IgG and IgM, as their concentrations differ. By measuring the concentrations of these proteins in blood samples over time, it has been possible to calculate from which fluid compartment fluid has been recruited.
Purpose and Objective
The aim is to study:
* How much fluid is drawn from the interstitial space during dialysis, depending on whether fluid removal is needed or not.
* The size and rate of fluid reinfusion during ongoing dialysis.
* The composition of the recruited fluid from the interstitium, i.e., the proportion consisting of lymph/lymph reflow and the proportion recruited across capillary membranes/venulae from the pericapillary space.
Hypotheses The null hypothesis is that no detectable difference in fluid flows or source of fluid recruitment is found, between patients where a large volume is dialyzed and those patients who do not have significant fluid removal during dialysis.
The alternative hypothesis is that a clinical relevant difference in fluid flows from the interstitium and the pathway for fluid recruitment to the bloodstream is detected.
Outcome Measures
Primary outcome variables are:
Recruitment of fluid from the interstitium calculated from fluid removal and hemoglobin changes. Proportion of recruited fluid via lymph or via capillary/venulae walls based on fluid recruitment and changes in plasma albumin and immunoglobulins G and M.
Secondary outcome variables are:
Weight, blood pressure impact, and changes in bioimpedance variables.
Study Design:
Open-label, prospective clinical observational study, where patients are divided into two groups. One group with an intact urine production, and dialysis is performed solely to "cleanse" the blood and second group with little or no urine production, which requires significant fluid removal, in addition to blood purification, .
|
Inclusion Criteria:
* Patients undergoing hemodialysis (\<500 ml or \>2000 ml ultrafiltration)
Exclusion Criteria:
* Patients who may be affected by blood sampling, i.e., have low hemoglobin concentration independent of dilution before dialysis (Hb 85 g/L).
* Patients who drink large amounts of water during regular dialysis (\> 2 glasses, approximately 0.5 L).
|
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] |
NCT06947122
|
Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain
|
The goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called Mindful Journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. The primary objective of this pilot study is to assess the feasibility and acceptability of Mindful Journey in this population.
|
There is a paucity of interventions for co-occurring opioid use disorder and chronic pain. Difficulty with emotion regulation is a key shared vulnerability factor underlying both conditions. Mindfulness-Based Interventions (MBIs) are a promising intervention approach, as they target core skills that can improve emotion regulation. However, research on MBIs for co-morbid opioid use disorder and chronic pain is limited. Existing MBIs are also limited by not providing adequate support "in the moment" when individuals are in high-risk situations. A responsive, momentary MBI for co-occurring opioid use disorder and chronic pain may be highly promising, but has yet to be established. In the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called Mindful Journey, for individuals with opioid use disorder and chronic pain. The core feature of the app is training in mindful acceptance and savoring skills via momentary "just-in-time" delivery of brief video-based exercises when individuals report elevations in challenging emotional states (e.g., craving, stress, and pain) and/or decreases in positive affect based upon ecological momentary assessments.
|
Inclusion Criteria:
* 18 years of age or older
* fluent in English
* enrollment in medication-assisted treatment for opioid use disorder
* report at least bothersome chronic pain, as indicated by Graded Chronic Pain Scale-Revised
* has a smartphone.
Exclusion Criteria:
* self-reporting of chronic malignant pain (e.g., cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus, and sarcoidosis)
* self-reporting of psychotic disorder symptoms
* participated in the previous phase of the study in which participants provided feedback to inform the development of the Mindful Journey app.
|
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] |
NCT06238063
|
Implementing a Nurse-led Advance Care Planning (ACP) Intervention in Residential Care Homes
|
The goal of this cluster randomized controlled trial is to examine the effectiveness of a nurse-led advance care planning (ACP) intervention on improving ACP discussion uptake in residential care homes (RCHs). The main question it aims to answer is: The effectiveness of nurse-led advance care planning (ACP) interventions implemented on eligible residents in residential care homes on improving ACP discussion uptake in this population.
Compared to participants in the control group who will only receive usual care with no ACP intervention, residents and their family members in the intervention group will be invited to attend the ICP meeting with ACP discussion. The ACP discussion will be guided by the established protocol, which was developed by the expert panel and delivered by trained nurses.
|
Targeted issue: The lack of ACP discussion and poor dyadic congruence pose challenges to the provision of good EOL care in Hong Kong RCHs.
Population: RCHs in Hong Kong with nurse-to-resident ratios ≥1:3 will be targeted to ensure adequate staffing to carry out ACP. Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin. Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention.
Intervention: a nurse-led advance care planning (ACP) intervention
Main study aim: To implement a nurse-led ACP intervention for improving ACP uptake in RCH residents in Hong Kong to bridge the evidence-practice gap.
Study method: This implementation science study will use a mixed methods approach, including a pair-matched cluster-RCT and qualitative interviews, and relevant outcomes will be followed for up to 2 years. RCHs will be randomized into two groups: a nurse-led ACP intervention group and a control group with usual care only.The ACP documentation (i.e., new documentation related to ACP and EOL care) in medical records of all RCH residents in the intervention and control groups will be audited by the research team at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH).
|
Inclusion Criteria:
* Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin.
* Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention. For residents who have moderate or severe cognitive impairment (as determined by a score of less than 19 in the Hong Kong version of the Montreal Cognitive Assessment), the participation of family members is mandatory.
Exclusion Criteria:
* They have a moderate or severe significant cognitive impairment but do not have family members, or
* They have prior ACP experience (e.g., AD completed).
|
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] |
NCT04003337
|
Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.
|
Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.
|
Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.
In order to obtain this objective, patients participating in the study will be randomly assigned to one of the following groups:
Group A: Patients who will perform an embryo transfer of a blastocyst using morphological criteria to evaluate que quality of the blastocyst (Gardner Classification), that is, based on the aspect or form of the embryo.
Group B: Patients who will perform an embryo transfer of a blastocyst using morphokinetics criteria to evaluate the quality of the blastocyst (Embryoscope®), that is, based not only in the aspect of the embryo but also in cell division times experimented by the embryos.
|
Inclusion Criteria:
* Egg-donation IVF patients
* IVF patients if \< 38 years
* Sperm concentration \> 2 million/ml
* Frozen eggs for
* Single embryo transfer
* ICSI fertilization
Exclusion Criteria:
* Uterine pathologies that may interfere with implantation
* Endometriosis
* Frozen eggs
* Pre implantation genetic testing of the embryos
* Day 3 embryo transfer
* Conventional IVF treatments
|
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] |
NCT03795584
|
Endoclip Papillaplasty Restores Sphincter of Oddi Function
|
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter \<8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.
|
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter \<8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.
The investigators will recruit patients according to admission criteria and exclusion criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. Complications including perforation, bleeding, and PEP were recorded. Blood routine, pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase, aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested at 4 and 24 h after ERCP. All participants were followed at 3 weeks. Symptoms were examined and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi monitoring through duodenoscope.
|
Inclusion Criteria:
- 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter)
Exclusion Criteria:
1. gallstone transverse diameter \>35 mm, which is not appropriate to be extracted;
2. history of previous sphincterotomy, previous EPBD;
3. accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet therapy, or Billroth II or Roux-en-Y reconstruction;
4. papilla located deep within a diverticulum;
5. small papilla and short intramural segment, which was not suitable for large EST;
6. medications known to affect the SO (calcium channel blockers, nitrates, opiates, and anticholinergics) taken within 48 h of the procedure;
7. benign or malignant biliary stricture.
|
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] |
NCT03343535
|
OCS Lung System EXPAND II Trial
|
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
|
Inclusion
At least one of the following:
* Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
* Expected cross-clamp time \> 6 hours for the second lung; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥ 55 years old
|
Inclusion Criteria:
* Male or female primary double lung transplant candidate
* Age ≥ 18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria:
* Prior solid organ or bone marrow transplant
* Single lung recipient
* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
* Participant in any other clinical or investigational trials/programs
|
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] |
NCT00124605
|
Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma
|
Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with pamidronate may kill more cancer cells. This phase I trial is studying the side effects and best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors or multiple myeloma
|
PRIMARY OBJECTIVES:
I. To describe the toxicities of the combination of arsenic trioxide in combination with pamidronate disodium at four dose levels.
II. To assess the pharmacokinetics of pamidronate disodium when given in combination with arsenic trioxide.
III. Utilizing 2-color immunofluorescence (IF) to determine if the treatment with combination of arsenic trioxide and pamidronate disodium affects the phosphorylation of epidermal growth factor receptor (EGFR) IV. In patients with multiple myeloma utilizing western blot to evaluate the pre- and post-treatment levels of protein tyrosine phosphatase 1B in lysates of multiple myeloma cells.
V. To obtain preliminary data for response to this regimen in this patient population.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive pamidronate IV and over 2 hours on days 1 and 15 and arsenic trioxide IV over 2 hours on days 1-5 and 15-19. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pamidronate and arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study.
|
Inclusion Criteria:
* Patients with histologically or cytologically proven diagnosis of solid tumors or multiple myeloma refractory to standard therapy or for which no satisfactory treatment exists at the time of enrollment
* Patient must be capable of understanding the nature of the trial and must give written informed consent
* Patients must have a WHO performance status of 0, 1, or 2
* Patients must have life expectancy of at least three months
* Absolute neutrophil count of \> 1x10\^9 /L
* Platelet count \> 75 x 10\^9 /L
* Calculated creatinine clearance of \> 50 mL/min
* Serum bilirubin =\< 1.5 x the institutional upper limit of normal
* SGOT (AST) and SGPT (ALT) must be =\< 2.5 x the institutional upper limit of normal
* All patients must be willing to use adequate contraception
* Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible
* Patients must not have a prolonged QT interval \> 460 milliseconds on baseline ECG in the presence of normal serum potassium and magnesium values; ECG must be obtained within 28 days prior to registration
* Patients must not be receiving or planning to receive drugs known to prolong the QT interval
* Patients previously or currently treated with pamidronate or other bisphosphonates are eligible after a wash-out period of 28 days; concurrent treatment with other bisphosphonates is not allowed
* Patients must not have a history of torsades de pointes type ventricular arrhythmia
Exclusion Criteria:
* Patients who have had radiotherapy or chemotherapy within three weeks (nitrosoureas or mitomycin C within six weeks) prior to anticipated first day of dosing; patients must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy
* Patients with uncontrolled electrolyte imbalance (NA \< 132 mmol/L; K \< 3.5 mmol/L; Mg \< 1.7 mg/dL)
* Patients undergoing therapy with other investigational agents; patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study
* Patients who are pregnant or breast-feeding will be excluded
* Patients with history of hypersensitivity to pamidronate or other bisphosphonates
* Patients previously treated with arsenic trioxide are not eligible
|
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] |
NCT05359887
|
PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery
|
Bariatric surgery (BS) is currently the most effective treatment in severe obesity. However, a considerable percentage of patients undergoing BS fail to lose sufficient weight or regain weight after initial weight loss during long-term follow-up, which may be attributed to personality traits and pathological eating behaviour. Previous positron emission tomography (PET) studies have shown reduced dopamine D2 receptor availability in obese patients and upregulation of this availability following successful BS in the brain's reward system. Dopamine D2 receptor availability in patients with unsuccessful BS has not been investigated to date.
|
Inclusion Criteria:
* Bariatric surgery 24-36 months prior to the study
* Adult (over 18y old)
* Mentally capable to understand the consequences of the procedure and make his or her own choice without coercion
* Able to undergo PET and MRI, according to the investigator's assessment
* Native speaking
* Able to participate in follow-up
* Written informed consent
Exclusion Criteria:
* Presence of a DSM-IV axis 1 disorder
* The use of drugs that bind to dopamine D2/3 receptors, including various classes of antipsychotics and antidepressants
* History of stroke, brain tumor, Parkinson's Disease or dementia
* History of head trauma with loss of consciousness
* Alcohol or substance abuse in the last 6 months
* Alcohol consumption 24h prior to PET scanning
* Smoking or other forms of nicotine intake 12 hours prior to PET scanning
* Use of anorectic drugs in the last 6 months
* Current pregnancy
* Medication for Diabetes Mellitus
* Claustrophobia
* The presence of implanted metal objects of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (such as certain implanted devices, shrapnel, ocular metal shavings)
* Patients with a bodyweight \> 200kg will be excluded to ensure the maximum load of the camera bed of the PET-scanner (227 kg) is not exceeded.
|
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|
NCT01865357
|
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI
|
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
|
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
|
Inclusion Criteria:
* Patients:
* Men and Women
* ≥16 years
* Fluent French speaker
* Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
* Between 60 and 180 days from the onset
* At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular
* Having a medical insurance
* Free and informed consent signed
* Controls:
* Men and Women
* ≥18 years
* Fluent French speaker
* Having a medical insurance
* Free and informed consent signed
Exclusion Criteria:
* Patients:
* Prior documented neurological episode suggestive of MS.
* Other ongoing neurological diseases.
* Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,...).
* Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica).
* Current dependence on alcohol or drugs.
* Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days
* MRI contra-indications.
* Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
* Controls:
* Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome
* Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease...).
* MS familial history
* Current dependence on alcohol or drugs
* Known cognitive impairment
* Prior neuropsychological testing with the same tests less than one year
* Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months
* Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
* MRI contra-indications
* Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
|
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] |
NCT02803853
|
Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities
|
The overall objective of the study is to reduce adult obesity in participating American Indian (AI) communities and to improve understanding of the behavioral and environmental factors affecting obesity in these settings.
|
The investigators plan to accomplish this objective by developing, implementing, and evaluating a randomized controlled trial of an intervention to improve diet and physical activity-related risk factors of obesity. A previous iteration of the intervention trial, called Obesity Prevention Research and Evaluation of InterVention Effectiveness in NaTive North Americans (OPREVENT) was implemented in five American Indian communities in Michigan and New Mexico. OPREVENT was a multi-level, multi-component intervention functioning at the community, institution, household, and individual levels and was implemented in schools, food stores, and worksites. Prior to OPREVENT, the research team has run multi-level interventions by working with schools and food stores in Native North American (NNA) communities1-6. For this new trial, named OPREVENT2, the research team will expand on the collective experience working on obesity prevention interventions in American Indian (AI) settings by developing complementary policy and social media components to support long-term sustainability of the OPREVENT intervention. OPREVENT2 will be implemented in six new AI communities.
|
Inclusion Criteria:
* With the exception of the school intervention, which will only include teachers of grades 2-6 and students in grades 2-6 (ages 6-13), all community members will be included in the intervention.
Gender, Age and Locale
* The investigators will work with male and female schoolchildren and adults, aged 6-13 and 18-75 years who live in one of the participating tribal communities.
Exclusion Criteria:
* No adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.
|
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] |
NCT00837122
|
Genetics of Type 2 Diabetes in West Africans
|
Background:
* Type 2 diabetes (T2D) and associated complications are major contributors to the global disease burden. T2D is already a major health threat in populations in developed countries and is rapidly taking hold in the developing world.
* It is believed that understanding the complex interplay between genetic and lifestyle characteristics in the etiology of T2D and related complications will lead to the development of better preventive and therapeutic strategies. In Addition, the results of this project will facilitate our understanding of causes of diabetes in African Americans, other US and world populations
Objectives:
* To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among the Yoruba people in Ibadan, Nigeria.
* To enroll and examine 300 unrelated cases of T2D and 300 ethnicity-matched Yoruba controls.
* To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort.
* To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples.
* To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in West Africans.
Eligibility:
* Patients 18 years of age with confirmed T2D who are newly diagnosed or on treatment of Yoruba ethnicity in Ibadan, Nigeria. Control subjects are nondiabetics ethnically matched to patients.
Design:
* The study design for both patients and controls consists of the following steps:
* Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff.
* Assign study ID (barcode)
* Administer questionnaires
* Obtain spot urine sample
* Measure blood pressure
* Obtain anthropometric measurements including body composition
* Perform finger prick for blood glucose level
* Obtain venous blood samples
* Perform eye examination
* On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in Nigeria.
* GWAS will be conducted using publicly available software packages.
|
Study Description:
This protocol is designed to study the genetic basis of Type 2 Diabetes (T2D) and related conditions in Africa.
Objectives:
Primary Objective: To conduct genetic association studies of T2D, T2D complications, and related traits in Africans of diverse ethnic groups
Secondary Objectives:
* To investigate the contribution of gene x environment interactions in T2D risk and in influencing related traits
* To develop a large-scale genetic epidemiological resource for the replication of findings in other studies of related traits
* To conduct trans-ethnic fine-mapping
* To describe the study population epidemiologically in terms of cardiometabolic traits and prevalence of related conditions
* To conduct population genetic analyses to describe population history and to develop statistical techniques appropriate for genetic analyses of African ancestry individuals
* To conduct deep phenotyping to facilitate additional research questions related to cardiometabolic traits and for follow-up previous findings
Endpoints:
Primary Endpoint: T2D
Secondary Endpoints: T2D Complications, Hypertension, Obesity, Dyslipidemia, Metabolic Syndrome, Chronic Kidney Disease, and other cardiometabolic traits
|
* INCLUSION CRITERIA:
As our primary interest is in T2D, it is important to exclude individuals who may have diabetes of another etiology. Elevated blood glucose in individuals 25 years old or younger is unlikely (in West Africa) to result from T2D and may reflect Type 1 Diabetes. Therefore, only individuals older than 25 years will be included in this study.
We are seeking to enroll persons without T2D or with previously or newly diagnosed T2D. Previously diagnosed cases will be determined by self-report of being treated with oral medication or insulin. Newly diagnosed cases will be determined by fasting blood glucose value \>= 126 mg/dl on more than one occasion. Individuals who have elevated blood glucose during their initial reading will be asked to return to the study site for a second test. If this test also has a fasting blood glucose value \>= 126 mg/dl, then they will be considered a new case. The control group will be individuals with no report of T2D diagnosis and fasting plasma glucose (FPG)\< 126 mg/dl.
Only unrelated individuals will be included in this phase of the study to avoid confounding genetic association studies by relatedness in the study population.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Incarceration.
* Lack capacity to consent to research participation.
* Pregnancy.
|
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] |
NCT04555434
|
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH
|
A study for evaluating the improvement effect of non-alcoholic steatohepatitis (NASH) of probiotics
|
Non-alcoholic fatty liver disease progresses to fatty liver, hepatitis, cirrhosis, and liver cancer, resulting in a high mortality rate. The prevalence of non-alcoholic fatty liver disease at home and abroad is a major social and economic burden. However, there is no cure for non-alcoholic fatty liver disease. Recently, intestinal axis theory related to the development of chronic liver disease and microbial community has emerged. Intake of probiotics is known to play a role in regulating gut microflora. Improvement of non-alcoholic fatty liver disease can be expected through administration of probiotics.
|
Inclusion Criteria:
1. Those who agreed to participate in this study and signed a written consent
2. Adult men and women over 20
3. Patients diagnosed with non-alcoholic fatty liver
※ Exclusion criteria for alcoholic liver disease
* Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
* 1 bottle of shochu 360 ml \* 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) \* 5% = 25 (16.5 g)
4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme
* AST, ALT: 40 or less
* ALP: 20-130
* GOT: 0-30, GPT: 0-38
* GGT: 10-62 (male), 7-35 (female)
Exclusion Criteria:
1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)
5. If you have any of the following
* Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
* systemic inflammatory disease or immune disease
* Hepatocellular carcinoma
* Uncontrolled cardiopulmonary disease
* Other serious systemic disorders in the heart, lungs, blood, and endocrine system
6. A person with a history of malignancy diagnosis within the last 5 years
7. Pregnant or lactating women
8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
9. Those who are not suitable for the clinical trial because the investigator judges
|
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] |
NCT00036153
|
Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
|
The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.
|
This is a Phase III, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. Patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.
|
Inclusion Criteria
* Willing to discontinue DMARDs, other than methotrexate
* Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration
* Have been receiving oral or parenteral methotrexate for at least 3 months
Exclusion Criteria
* Has received tacrolimus for any indication
* Has moderate or severe liver disease
* Has a known history of HIV infection
* Has serum creatinine outside the normal range
|
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] |
NCT02604134
|
Medical Management of Caries in the Primary Dentition Using Silver Nitrate
|
This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.
|
This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.
Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.
|
Inclusion Criteria:
* Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
* Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study
Exclusion Criteria:
* Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
* Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
* Known allergy/sensitivity to any of the dental materials.
|
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0.6169452667236328,
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-0.06654951721429825,
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] |
NCT01231893
|
Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
|
The purpose of this experimental therapy is an assessment of the safety and feasibility of transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained from the olfactory mucosa in patients with complete spinal cord injury.
|
The increasing number of patients (mostly young), who have sustained a spinal cord injury mainly as a result of motor vehicle accidents, falls or violence has become worldwide a serious clinical, social and economical problem. Most accepted treatment protocols for spinal cord injury focus on techniques of early neuro-protection aimed at maximal prevention of secondary spinal cord injury (administration of methylprednisolon and spinal cord surgical decompression) as well as on methods of stimulation of plasticity in the central nervous system (neurorehabilitation). While these methods have been shown to stimulate functional recovery in patients with incomplete spinal cord injury, the results of treatment of patients with severe incomplete and complete spinal cord injuries remain unsatisfactory. This is due to the lack of spontaneous regeneration of lesioned axons in the spinal cord. Results from a substantial number of animal experiments performed mainly on the model of mammalian spinal cord injury in the last 3 decades led to the establishment of numerous regeneration-promoting strategies including application of neurotrophic factors, antibodies blocking the myelin-associated proteins and transplantation of cells with neurotrophic activity. Olfactory ensheathing cells (OECs) are an unique population of macroglia found in the lamina propria of olfactory mucosa, around the olfactory nerve fascicles and in the two outer layers of the olfactory bulb. These cells have the natural ability to stimulate the regrowth of lesioned peripheral and central axons. In a Phase I non-randomized controlled prospective study we have tested the hypothesis that a combined approach for treatment of complete spinal cord injuries consisting of intraspinal transplantation of a mixture of autologous OECs and fibroblasts isolated from the olfactory mucosa, combined with intense neuro-rehabilitation is safe and feasible.
|
Inclusion Criteria:
* spinal cord injury at subacute or chronic stage
* a single spinal cord injury between segments C5 and L5
* myelopathy confirmed by MRI, not exceeding 2 spinal cord segments
* loss of sensory and motor function below the injury, confirmed in control studies (ASIA Category A)
* age from 16 to 65 years
* patient undergoing continuous rehabilitation
* good patient motivation and cooperation
* signed informed consent
Exclusion Criteria:
* a coexisting lesion of the nervous system
* progressive post-traumatic syringomyelia
* significant spinal stenosis or instability
* persistent neuropathic pain
* muscle atrophy or joint ossifications
* severe systemic disease (neoplasm, contagious disease, diabetes etc.)
* chronic sinusitis
* tumors or polyps of nasal cavities
* persistent hyposmia or anosmia
* pregnant or breastfeeding women
|
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] |
NCT03368664
|
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
|
Primary Objective:
To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (\<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT.
Secondary Objective:
To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).
|
The duration of study per participant will be approximately 5 years and 5 months.
|
Inclusion criteria :
* Participants with RRMS aged from 10 years to \<18 years at study entry are eligible. Participants must meet the criteria of diagnosis of MS as defined by the International Pediatric MS Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on 2010 McDonald criteria.
* Signed written informed consent/assent obtained from participant and participant's legal representative (parent or guardian) according to local regulations.
* Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening.
* At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a beta interferon therapy (IFNB) or glatiramer acetate (GA) after being on that therapy for at least 6 months, and was currently still taking the same therapy.
* At least 1 of the following:
* \>=1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or
* Two or more relapses in the prior year, or
* Tried at least 2 MS DMTs.
Exclusion criteria:
* Any progressive or non-relapsing forms of MS.
* Conditions/situations such as:
* Impossibility to meet specific protocol requirements.
* Current participation in another interventional clinical study. Participants who are treated with a comparator agent approved for screening inclusion (INF or GA) may be considered for this trial.
* Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Uncooperative participant or any condition that could make the participant potentially non-compliant to the study procedures in the opinion of the Investigator.
* Mental condition rendering the participant or parent/guardian unable to understand the nature, scope, and possible consequences of the study.
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.
* History of drug or alcohol abuse.
* History of known human immunodeficiency virus (HIV) positivity.
* Pregnant or breast-feeding female participants or those who had planned to become pregnant during the study.
* Unwilling to agree to use a highly effective contraceptive method when receiving a course of alemtuzumab treatment and for 4 months following that course of treatment (fertile participants only).
* Female participants who have commenced menstruating (i.e., are of childbearing potential) and are unwilling or unable to be tested for pregnancy.
* Previous treatment with alemtuzumab.
* Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or determined by the treating physician to had residual immune suppression from these or other MS treatments.
* Treatment with teriflunomide in the last 12 months except if the participant underwent the recommended elimination procedure as per Summary of Product Characteristics (SmPC).
* Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy.
* Previous treatment with any investigational medication (drug that had not been approved at any dose or for any indication). Use of an investigational medication that is subsequently licensed and nonstandard use of a licensed medication (e.g., using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) was not exclusionary. Prior treatment with herbal medications or nutritional supplements was also permitted.
* Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.
* History of malignancy.
* Prior documented history of thrombocytopenia, or platelet count at screening \< lower limits of normal (LLN).
* Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS.
* Participants with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent.
* Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that might predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis.
* Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the participant's ability to understand the participant information, to give informed consent, to comply with the trial protocol, or to complete the study.
* Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator.
* Epileptic seizures that are not adequately controlled by treatment.
* Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc).
* Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency).
* Prior history of invasive fungal infections.
* Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation.
* In the Investigator's opinion, participant is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection).
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
|
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] |
NCT03572777
|
Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.
|
The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.
The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.
In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.
The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
|
Inclusion Criteria:
* Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
* written informed consent
Exclusion Criteria:
* age under 18
* previously treatment of Helicobacter pylori infection
* malignancy of stomach or other site
* history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
* significant underlying disease (renal failure, psychiatric disorders)
* history of allergic reactions to any medications used in study
* refuse to participate in study
* breastfeeding and pregnancy
* quitting the study
|
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|
NCT06639477
|
Assessing Improvements in Mood and Sleep Trial
|
This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality.
Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
|
The main purpose of the study is to compare the effects of two approaches on sleep and mood including any symptoms of depression and suicidality. There will be 420 people invited to participate across three sites in the United States (University of Pittsburgh, UCLA, Augusta).
Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes. Each group will contain 210 participants. Researchers will enroll a total of 140 participants (70 in each group) at the University of Pittsburgh. Both groups will meet with a study therapist once a week to complete the assigned 8-week program. To determine which (if any) program has beneficial effect over time, researchers will ask participants to complete assessments of their sleep, mood, and health before and after the therapy. Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health. These would be:
* Before the therapy program begins
* Right after it ends
* Six months later
Around the time of each visit, researchers will ask participants to wear an actigraphy watch on their wrist 24/7 for a week while completing a sleep diary. The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participant's activity and sleep levels.
After the first main visit is complete, participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks (8 sessions total). Both groups will receive educational information and, depending on the group the participants are assigned to, may include guided discussions, activities, and/or support addressing any stressors participants face, sleep problems, and/or depression.
During the therapy period, researchers would ask participants to continue wearing the actigraphy watch. Researchers would also ask participants to answer questions on the phone with study staff weekly (that would take about 30-40 minutes a week).
After the participant's last therapy session, researchers would repeat the phone assessments once a month until the last main visit occurs (six-months after therapy ends).
|
Inclusion Criteria:
* Age 55 Years and older
* Patient Health Questionnaire -9 score of 10 or higher
* Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
* PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
* Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
Exclusion Criteria:
* Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
* Bipolar disorder
* Psychotic disorder
* Borderline personality disorder.
* Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
* Illness with life expectancy of less than 1 year or plans to leave the study area
* Incapacity to consent/dementia diagnosis
* Active substance use disorder of at least moderate severity
* Active night-shift work
|
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] |
NCT05360602
|
Alpha Lipoic Acid Effect on No-Reflow Phenomenon
|
Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.
|
All (70) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 35 patients undergoing PCI who will receive standard of care , the other 35 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 4 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 4 week after PCI.
Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. will be documented for each patient. Medication history in detail, as well as the background cardiovascular treatment, will be considered.
All patients will be followed up regularly during the hospital stay and after discharge, will be assessed for the occurrence of adverse cardiac events and occurrence of adverse effects from medications
|
Inclusion Criteria:
1. Female or male aged \>18
2. STEMI patients undergoing PCI
Exclusion Criteria:
1. Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
2. A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure)
3. Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
4. Infectious or inflammatory disease
5. Severe liver or renal disease, (AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
6. Neoplasm, or hematological disorders
7. Pregnant or breast-feeding patients
8. Active participation in another clinical study
9. Patients taking Alpha Lipoic Acid.
10. Systolic Blood pressure \<90
|
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] |
NCT05657093
|
Effect of the Beetroot Juice in Portuguese Swimmers
|
Objective: To investigate whether an acute intake of beet juice (BJ) improved the factors of total and split times (performance), stroke frequency and CMJ (biomechanics), lactate and HR (physiology) and RPE-TQR (psychophysiological) in a repeated (performance), stroke frequency and CMJ (biomechanics), lactate and HR (physiology) and RPE-TQR (psychophysiological) in a repeated maximal speed swimming effort in elite swimmers.
Methods: A total of 18 elite swimmers participated in this randomized, double-blind study. In 2 different trials, swimmers ingested a Beet-It injection (70 ml placebo (PL) or a Beet-It injection of 70 ml beet juice (BJ)) 3 hours before undergoing a 2x6x100 m intermittent maximal speed crawl performance test.
|
Inclusion Criteria:
1. - national and international level swimmers
2. - healthy swimmers
3. - no breakfast
4. - 48 hours with restricted diet of: other sports supplements and beetroot-rich foods
Exclusion Criteria:
1. -be on medication
2. - having had breakfast
3. - have brushed your teeth
|
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] |
|
NCT02589496
|
Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis
|
This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.
Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab.
Enrollment will begin with all subjects without regard for PD-L1 expression status. An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.
All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug adminstration for the first six months and every 12 weeks (+/- 7 days) thereafter until progression of disease is documented with radiologic imaging (computed tomography or magnetic resonance imaging).
In the expansion cohort (cohort B), it was expanded on the original cohort based on response analysis and will be opened separately.
Of the 5 MSI-high patients who were enrolled on to original cohort, all 5 MSI high GC patients (100% response rate) demonstrated dramatic response rate.
Based on this finding, in order to proven Pembrolizumab's efficacy to specific MSI-H GC population, we would like enroll 20 more patients in cohort B. Based on our screening protocol, the prevalence of MSI-high in GC is about 15 %. Only MSI-high GC patients will be included. All the eligibility will be the same.
|
Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of up to 28 days, eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for pembrolizumab.
Treatment with pembrolizumab or paclitaxel will continue until documented disease progression, unacceptable adverse event(s), undercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject withdraw consent, pregnancy of the subject, noncompliance with trial treatment o procedure requirements, subject receives 24 months of pembrolizumab, or administrative reasons requiring cessation of treatment. After the end of treatment, each subject will be followed for 30 days for adverse event monitoring (serious adverse events and events of clinical interest will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier).
Subjects within the pembrolizumab arm who discontinue after 24 months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression.
Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up.
All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.
|
Inclusion Criteria:
1. Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Biomedical Research. However, the subject may participate in the main trial without participating in Biomedical Research.
2. Be 19 years of age on day of signing informed consent
3. Have histologically or cytologically-confirmed diagnosis of gastric or Gastroesophageal Junction Adenocarcinoma
4. Have metastatic disease or locally advanced, unresectable disease.
5. Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum,fluoropyrimidine doublet.
6. Have measurable disease based on RECIST as determined by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
7. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained endoscopic biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded block specimens are preferred to slides.
8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
9. Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.
10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
13. (Only Cohort B) confirmed as MSI-H via the PCR or IHC staining by institutional standard.
Exclusion Criteria:
1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has squamous cell or undifferentiated gastric cancer.
3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
4. Has a known history of active Bacillus Tuberculosis
5. Hypersensitivity to pembrolizumab or any of its excipients.
6. Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier.
7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
9. Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
10. Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
11. Has known history of, or any evidence of active, non-infectious pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
17. Has a known history of Human Immunodeficiency Virus
18. Has known active Hepatitis B or Hepatitis C
19. Has received a live vaccine within 30 days of planned start of study therapy.
20. Is or has an immediate family member who is investigational site or staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
|
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] |
NCT05882162
|
Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate
|
The aim of this study was to compare the conventional coronectomy and the combined coronectomy technique with vital pulp treatment. The primary outcome of the study was to evaluate the success rates of two treatment techniques based on clinical and radiologic observations regarding inferior alveolar nerve injury, root exposure and formation of periapical lesion. The secondary outcome was to evaluate the change in periodontal condition of the second molar adjacent to the operation area, dentin bridge formation and root migration.
Between March 2018 and February 2022 eligible patients attended University Hospital for the removal of lower third molar with risk of inferior alveolar nerve (IAN) damage invited to the study. 60 teeth meeting the inclusion criteria in 52 participants were randomized to Test (with BiodentineTM, n=30) and Control (without BiodentineTM, n=30) groups. Neurological injury and post-operative pain were clinically evaluated at 12th months and 1st week, respectively. Root migration, dentin bridge formation and periapical lesion development were evaluated using Cone Beam Computed Tomography (CBCT) at 12th month. The change in the periodontal status of second molar was evaluated by measurement of pocket depth at 1st, 3rd and 12th months and the distance between base of the bone defect and the marginal crest and cemento-enamel junction and at 6th and 12th months month.
|
The surgical removal of mandibular third molar teeth is one of the most frequently performed oral surgical procedures. One of the complications might occur during surgical removal of these teeth is injury to inferior alveolar nerve (IAN) which may lead to altered or loss of sensation to lower lip, chin, teeth and gingiva on the operated side. The risk for IAN injury may not be avoidable, even though the surgery was performed by an experienced surgeon and the positional relationship between the mandibular third molar and IAN was assessed accurately prior to surgery.
Pericoronitis, dental caries and periodontal disease are the most common pathologies associated with mandibular third molar teeth. Theoretically, removal of crown part of the teeth with a vital pulp and leaving the roots behind might be adequate to relive clinical symptoms arise from these pathologies. This technique was first described by Ecuyer and Debien in 1984 as coronectomy to prevent injury in case of close relationship of mandibular third molar with inferior IAN.
As shown previously in randomized clinical trials, fewer complications in terms of post-operative pain, IAN deficiency and dry socket were observed after coronectomy. Systematic reviews have confirmed that incidence of IAN injury was lower with coronectomy when compared to total removal in case of the lower third molar radiographically closely related with the IAN. Nerve injury was reported to occur in up to 20% of cases temporarily and 1-4% of cases permanently after total extraction, whereas 0-5.5% of cases temporarily after coronectomy.
Radiographic assessment using panaromic radiographs is the first step for coronectomy procedure. Presence of the interruption of the white line of the mandibular canal wall, darkening around the root(s), diverging of the mandibular canal, narrowing of the mandibular canal, narrowing of the root(s) and deflection of the root(s) are the indicators of increased risk for IAN injury. In recent years, cone beam computer tomography (CBCT) scanning is widely used method for further investigation to demonstrate the three-dimensional relationship between the tooth and IAN. Additionally, eligibility of the third molar for coronectomy should also be evaluated to be free of caries, pulpal inflammation and abnormal surrounding tissue. Coronectomy is contraindicated for non-compromised patients with good healing potential due to medical conditions such as diabetics, long-term steroid use, chemotherapy or radiotherapy.
One of the possible complications after coronectomy is migration and eruption of the roots left in the bone. Bone formation over the retained roots is expected to avoid eruption of these roots in the oral cavity. In case of eruption, remaining roots should be extracted. Another possible complication is periapical lesion development due to necrosis of the pulp. With conventional coronectomy procedure, no pulp treatment of the remaining roots is performed. Previous in vivo studies demonstrated that pulp retained vital after coronectomy. However, presence of pain and infection after coronectomy was reported in randomized clinical trials. Vital pulp treatment of the remaining roots with a bioactive material may have the potential to enhance both dentin and bone formation leading to reduced complications related with periapical inflammation and tooth migration.
In the literature, there is no study concerned with the clinical success of coronecyomy in combination with vital pulp treatment, except a case report. Therefore, the aim of this randomized clinical trial was to compare clinical success of conventional coronectomy and coronectomy in combination with vital pulp treatment based on clinical and radiologic evalutions. The null hypothesis tested in this study was that application of calcium silicate (Biodentine, Septodont, St Maur-des-Fosses, France) after coronectomy had no benefits to reduce above mentioned post-operative complications.
|
Inclusion Criteria:
* - Patients without any systemic disorders
* Close relationship of the lower third molar and inferior alveolar nerve (IAN) on orthopantomography (OPTG) and Cone Beam Computed Tomography (CBCT)
* Pericoronitis around the third molar
* Caries presence or risk for caries development on the distal surface of adjacent second molar
* Follicle enlargement of less than 3 mm around the crown of the mandibular third molar on OPTG
* Teeth with complete apex development
Exclusion Criteria:
* -Presence of active infection (irreversible pulpitis) and/or pathology in the tooth
* In the presence of mobility in tooth
* Teeth with a horizontal position that are closely related to the IAN at the coronal portion
* Teeth undergoing resorption
* Smokers
* Patients who declined to take part in the study.
|
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] |
NCT04978831
|
The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs
|
Purpose of the research; To determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with COPD. This research will be conducted using a randomized controlled trial model. "Personal Description Form", "COPD and Asthma Fatigue Scale", Visual Analog Scale and pulmonary function tests will be used in data collection.
|
Inclusion Criteria:
* Having been diagnosed with COPD for at least 6 months or before
* Not having a respiratory system defect caused by diseases other than COPD
* Not in the GOLD-4 COPD stage
* Being able to read and write Turkish
* Have no problems communicating or speaking
* Being able to use basic information technologies
* Using a smartphone
* Having an active internet connection
Exclusion Criteria:
* Having non-COPD pulmonary problems and diagnosed cardiovascular disease
* Not volunteering to participate in the study
* Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process
|
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|
NCT04261270
|
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
|
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
|
Inclusion Criteria:
1. Age:18\~55 years old, unlimited gender.
2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
4. Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose.
5. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
6. Patients who voluntarily sign informed consent forms.
Exclusion Criteria:
1.2019-nCoV severe Pneumonia patients.
Meet the definition of severe pneumonia(Comply with any of the followings):
1. Respiratory distress ,RR≥30 bpm;
2. In a resting state:SPO2≤93%;
3. PaO2/ FiO2≤300mmHg.
2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment.
3.Severe liver disease(such as:the ChildPugh score≥C;AST \> 5 times the upper limit).
4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.
5.Patients with definite contraindications in ritonavir tablets.
6.Female subjects were positive for the pregnancy test during the screening period.
7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)
|
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] |
|
NCT05399082
|
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
|
This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.
|
Inclusion Criteria:
- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.
Lesion Criteria:
- Pulmonary nodules of 8-50mm in largest dimension.
Exclusion Criteria:
* Patients with known bleeding diathesis; Platelet count \< 50,000.
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
* Inability or unwillingness to give informed consent.
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
* Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg.
* Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
* International Normalized Ratio (INR) \< 1.5.
* Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
|
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] |
|
NCT02155946
|
Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
|
The aging US population threatens to overwhelm our healthcare infrastructure, especially since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades. Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies those with memory deficits but who remain relatively independent in everyday life. MCI provides a window for interventions that target memory functioning. The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from different types of memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.
|
Enrollment and interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval.
The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.
The general purpose of this study is to examine the effects of two types of treatments for memory impairment in those with mild cognitive impairment (MCI). One form of treatment is cognitive rehabilitation, which involves teaching new ways to learn and remember information. The second form of treatment uses a type of electrical brain stimulation called transcranial direct current stimulation (tDCS) to increase activity in certain brain areas that may be involved with memory. We will use brain imaging to see whether these treatments changed how individuals learn and remember information. We will also use cognitive tests and questionnaires to examine whether memory (and related abilities) changed because of treatment.
Values were updated in February 2023 after discovering coding errors in the original database. An exploratory outcome variable (effect of brain volumes) was removed at that time since the electrical field analyses are fundamentally dependent on brain volumes - the EF outcome measure remained but was modified to remove the two sham conditions since, by design, they did not receive any electric field (i.e., sham) and the statistical corrections could not be performed.
|
Inclusion Criteria:
General inclusion criteria (all patients):
* All medications stable for approximately 2-3 months;
* No history of severe mental illness;
* No current untreated alcohol or substance abuse/dependence;
* English as native and preferred language;
* MRI-compatible if taking part in fMRI studies
* Able to give informed consent.
MCI Inclusion Criteria:
- Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician
Exclusion Criteria:
* History of neurological disease or injury
* History of severe mental illness
* Current untreated alcohol or substance abuse
* Other conditions may exclude; please discuss with contact
|
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] |
NCT00612612
|
Obatoclax, Fludarabine, and Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia
|
Obatoclax may stop the growth of chronic lymphocytic leukemia by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving obatoclax together with fludarabine and rituximab may kill more cancer cells. This phase I trial is studying the side effects and best dose of obatoclax when given together with fludarabine and rituximab in treating patients with B-cell chronic lymphocytic leukemia.
|
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose of obatoclax mesylate in combination with fludarabine phosphate-rituximab (FR) in patients with relapsed chronic lymphocytic leukemia.
SECONDARY OBJECTIVES:
I. To evaluate toxicity of obatoclax mesylate in combination with FR in this patient population.
II. To determine objective response rate and progression-free survival of obatoclax mesylate in combination with FR.
III. To correlate levels of anti-apoptotic Bcl-2 family members with drug response.
IV. To determine whether apoptosis is induced via the mitochondrial pathway in response to obatoclax mesylate and further enhanced by FR.
OUTLINE: This is a dose-escalation study of obatoclax mesylate.
Patients receive obatoclax mesylate IV over 3 hours on days 1 and 3, fludarabine IV over 20-30 minutes on days 1-5, and rituximab IV over 4 hours on day 1 (days 1 and 3 of course 1 only). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo peripheral blood collection for correlative studies. Samples are analyzed for expression of pro- and anti-apoptotic Bcl-2 family members by western blot; apoptosis induction by measurement of lymphocyte count, Annexin V staining, and Caspase and PARP cleavage; activated Bax by immunoprecipitation; and Bax promoter polymorphism by PCR amplification and direct sequencing.
After completion of study therapy, patients are followed every 6 months.
|
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic leukemia (PLL) arising from CLL
* No de novo PLL
* Malignant B cells must co-express CD5 with CD19 or CD20
* Patients who lack CD23 expression on their leukemia cells may not have t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
* Must have documented lymphocytosis of \> 5,000/uL
* Must require therapy based on any of the following criteria:
* Massive or progressive splenomegaly and/or lymphadenopathy
* Anemia (hemoglobin \< 11 g/dL) or thrombocytopenia (platelet count \< 100,000/uL)
* Presence of weight loss \> 10% over the preceding 6-month period
* NCI grade 2 or 3 fatigue
* Fevers \> 100.5 F or night sweats for \> 2 weeks without evidence of infection
* Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of less than 6 months
* Must have received at least one prior therapy for B-CLL
* No known brain metastases
* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* Total bilirubin normal (unless due to Gilbert syndrome or compensated hemolysis)
* Life expectancy \> 3 months
* Creatinine normal
* Fertile patients must use effective contraception
* Not pregnant or nursing
* Negative pregnancy test
* Any number of prior therapies allowed
* At least 1 year since prior fludarabine phosphate-rituximab combination therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
* No other concurrent investigational agents
* AST and ALT \< 2.5 times upper limit of normal
* Recovered from all prior therapy
Exclusion Criteria:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to obatoclax mesylate or other agents used in study
* Active Coombs' positive autoimmune hemolytic anemia
* Chronic active hepatitis B patients if not on appropriate antiviral therapy (e.g., lamivudine, adefovir)
* Other neurological disorders or dysfunction or a history of seizure disorder
* Uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia including QTc \> 450 msec
* Psychiatric illness/social situations that would limit compliance with study requirements
|
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] |
NCT02654314
|
Prevention of Delirium in Inpatients Utilizing Melatonin
|
A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.
|
This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.
Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.
Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.
|
Inclusion Criteria:
* Inpatient admission to a general internal medicine service
Exclusion Criteria:
* expected lifespan or length of stay ≤ 48 hours
* Non-English speaking
* Already taking melatonin or ramelteon at the time of randomization
* Presence of delirium at the time of randomization
* Unable to take oral medications
* Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission
* ALT or AST (Liver function tests) \> 3 times the upper limit of normal
* Taking warfarin, nifedipine or fluvoxamine
* Allergy to melatonin
* Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday
|
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] |
NCT00828945
|
Compliance With Treatment For Patients With Hyperlipidemia
|
It is a prospective observational study.
Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.
We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.
|
Consecutive patient sampling
|
Inclusion Criteria:
* Aged 18 years or older and able to understand and sign the informed consent form.
* Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
Exclusion Criteria:
* Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study.
* Patients participating in other clinical trials or non-interventional studies.
|
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] |
NCT01973517
|
High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
|
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
|
Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.
In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
|
Inclusion Criteria:
* Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type.
* Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.
Exclusion Criteria:
* Children (age \< 18)
* Those who lack decision-making capability
* Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia
* Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions
* Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level.
* Pregnancy or breast feeding.
* History of renal disease or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) \<40ml/min/1.73m?
|
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] |
NCT05288049
|
Treating Early Stages With an Intervention Targeting Cognitive Reserve
|
This study proposes continuity in the implementation of a psychological approach program to enhance cognitive reserve (CR) in children, adolescent and young adults, off-springs of patients with schizophrenia or bipolar disorder (Off-SZBP), and first affective and non-affective episodes with three main objectives: to characterize the cognitive reserve in the early stages of the disease, to validate the adaptation of the intervention to first affective and non-affective disorders to assess the effectiveness of the intervention in a longer term.
|
The study will include a sample of High Genetic Risk-SZBD (HR-SZBD) subjects (N = 60), First Episode Psychotic Patients (FEP) (N = 60) and CC participants (N = 60). All groups will be evaluated with CR scales as well as clinical, neuropsychological, and neuroimaging tests at baseline. The FEP and HR-SZBD groups will then be randomly allocated to a psychological intervention to enhance CR (N = 30 FEP and 30 HR-SZBD) or a support group (N = 30 FEP and 30 HR-SZBD). Once the psychological intervention (3 months) is completed, the FEP and HR-SZBD groups will be re-assessed with the same clinical, neuropsychological, and neuroimaging tests as well as CR scales that were used at baseline. Between the third and twelfth month, follow-up sessions will be conducted to remind the participants of the contents of the intervention. Finally, clinical, CR, neuropsychological and neuroimaging assessments will be completed in the FEP, HR-SZBD and CC groups at 12 months to verify whether the effects of the intervention remain stable over time.
|
Inclusion Criteria:
1. - Inclusion criteria for the Off-SZBP will be: Subjects between 12 and 25 years with a parent (mother or father) diagnosed with bipolar disorder or schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
2. - Inclusion criteria for patients with a first affective (mania or depression with or without psychotic symptoms and hypomania) or non-affective episode (first psychotic episode) will be:
1. Patients between 12 and 45 years with a first affective or non-affective episode within the last 5 years.
2. Diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders and other psychoses according to DSM-5 criteria based on a semi-structured clinical interview.
3. Patients in full or partial clinical remission at the moment of assessment, defined as scores ≤ 10 in Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 scores in the Hamilton Depression Rating Scale (Hamilton, 1960).
4. Scores lower or equal to 3 during the previous two months in symptoms P1 (delusions), G9 (unusual thought content), P3 (hallucinations), P2 (conceptual disorganization), G5 (mannerisms and posturing), N1 (blunted affect), N4 (social withdrawal) and N6 (spontaneity and flow of conversation) on the scale for positive and negative schizophrenia syndrome (PANSS).
3. - Inclusion criteria for Community Control:s (CC) Children, adolescents and young adults between 12 and 45 years old without history of psychotic disorder or bipolar disorder in first degree relatives.
* Exclusion criteria, common to all participants, will be:
1. Estimated Intelligence quotient \< 70.
2. Any medical condition that could affect neuropsychological performance (such as neurological diseases) or history of head trauma with loss of consciousness.
3. To have participated in any structured psychosocial intervention within the past 6 months.
|
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] |
NCT02312739
|
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization
|
This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen.
The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.
|
Hysteroscopic permanent sterilization with Essure® is increasingly performed in the outpatient setting. No optimal outpatient analgesia regimen has been identified for the Essure® procedure. The investigators propose a study of inhaled nitrous oxide administered with oxygen, hereafter referred to as nitrous oxide (NO), as an intervention to lower pain experienced during the in-office procedure. The investigators hypothesize that, compared to standard oral medications, inhaled NO will decrease patient anxiety associated with the in-office procedure, as well as increase patient satisfaction and provider perceived ease of device insertion.
Women presenting to the clinic for family planning will receive our standard counseling on all forms of contraception, including short and long acting reversible contraception, and methods for permanent sterilization. Once the patient decides to have a sterilization procedure with the transcervical approach (Essure® procedure), she will undergo the standard pre-procedure evaluation, which includes a complete history, appropriate physical examination including pelvic examination, and urine pregnancy test.
Eligible women interested in sterilization will be advised of the study as an investigation evaluating nitrous oxide as an alternative to our current oral sedation pain management for in-office procedures. If they choose hysteroscopic sterilization, they will undergo informed consent for the Essure® procedure. Providers will assess patient eligibility criteria for possible enrollment into the study. If patients are eligible and choose to participate in the research study, consent for participation will be obtained. At this time patients will be randomized to treatment group based on a predetermined randomization scheme. For this research study comparing the use of NO versus oral pain medications, the NO group will receive two placebo pills and the standard group will receive one 5/325 mg oral tablet of Vicodin and one 1 mg oral tablet of lorazepam 30 minutes prior to the procedure. The standard care group will receive oxygen (instead of NO) during the procedure. All participants will receive 30 mg of intramuscular ketorolac 30 minutes prior to the procedure.
NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention. NO can be titrated up to a concentration of 70% nitrous oxide and 30% oxygen based on desired analgesic effects per a predetermined sedation scale as part of the University of New Mexico Center for Reproductive Health (UNM CRH) nitrous administration protocol. All patients will be monitored with a pulse-oximeter. The patient will be fitted to their mask once the procedure is ready to begin. A single nurse will administer nitrous oxide and oxygen for all procedures. Every study patient will receive a minimum of 3 minutes of oxygen at the end of the procedure to minimize the side effects of NO. Additional oxygen will be administered as needed if a patient is experiencing residual effects of NO.
Prior to the procedure and study medications, patients will complete patient information and demographics questionnaire and will receive instruction on the 0-100mm visual analogue scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI). A baseline pain score will be recorded using the 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable, as well as baseline anxiety level using the STAI. At placement of the paracervical block and deployment of the second device coil, pain will be assessed again with the same 0-100mm VAS. At 3 to 5 minutes following completion of the procedure, maximal pain experienced during transcervical sterilization will be assessed by the patient. Prior to discharge from the clinic, the patient will rate her pain level using the same 0-100mm VAS, rate her level of anxiety with the procedure using the same STAI, and rate her overall satisfaction with the procedure measured using a 5-point Likert scale.
Immediately after the procedure, the physician will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult. The physician will also complete a 0-100mm VAS on hysteroscopic procedure difficulty with anchors 0 equals no difficulty and 100 equals very difficult.
The standard transcervical sterilization procedure is not being evaluated in this study. After patients complete the procedure, they are contacted approximately 75 days from the procedure date to schedule a confirmatory test, hysterosalpingogram, which is required at 90 days to demonstrate successful sterilization.
|
Inclusion Criteria:
* Premenopausal women desiring permanent sterilization and have chosen to proceed with a transcervical sterilization approach
* Speaks English or Spanish
* If relying on state or federal funding for sterilization, must have appropriate federal consents signed 30 days prior to the sterilization procedure
* Agrees to either a hormonal endometrial preparation prior to the procedure or schedule the procedure during the follicular phase (days 5 through 12) of their menstrual cycle
* Sexually active who agrees to contraception for 3 months post procedure, including condoms, followed by a hysterosalpingogram (HSG) for confirmation of fallopian tubal occlusion.
Exclusion Criteria:
* With contraindications for nitrous oxide including: respiratory infection, chronic obstructive pulmonary disease (COPD), intoxication or use of street drugs, inability to breathe through their nose.
* Have taken narcotic pain medications prior to coming to their appointment
* Unsure about desire to end fertility
* History of pelvic inflammatory disease in the past 3 months
* Pregnancy or suspicion of pregnancy
* Delivery or termination of a pregnancy within the last 6 weeks
* Known allergy to contrast
* Uterine anomalies
* Previous tubal surgery
* Cervical or endometrial cancer
* Allergy to Vicodin, lorazepam, or lidocaine.
|
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] |
NCT06544941
|
Improving Maternal Sleep and Mental Health
|
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.
Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
|
The investigators propose to conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use the SB or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)).
The primary objective of this proposal is to randomly assign mother-infant dyads (N = 342) to the SB or the TAU condition and follow them monthly for 6 months. Mothers will complete online surveys monthly regarding infant sleep and behavior, maternal sleep, and maternal depressive symptoms. Prospective subjective and objective sleep data will also be collected from mother and infant for one week each month. This study represents the first empirical study to assess the efficacy of the SB to promote efficient infant sleep, and to assess longitudinal effects on maternal postpartum sleep and mood symptoms. This work is essential since few effective interventions are available that support infant sleep. A secondary objective is to explore maternal biomarkers of PPD, including markers of inflammation and epigenetic biomarkers, and determine if the SB intervention alters immune dysregulation and the risk associated with epigenetic biomarkers of PPD. The rationale stems from evidence regarding dysregulation of the immune system and inflammatory activity as potential mediating pathways between sleep disturbances and health.
This proposal will address the following aims:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. Hypothesis 1a: Infants who sleep in the SB will have better sleep (i.e., diary and Brief Infant Sleep Questionnaire as maternally reported) compared to TAU. Outcomes will include maternally reported sleep duration, awakenings, as well as objective assessed (actigraphy) wake after sleep onset (WASO), and sleep onset latency (SOL). Hypothesis 1b: Mothers of infants who sleep in the SB will have better subjectively reported (i.e., diary and Pittsburgh Sleep Quality Index) and objectively assessed (actigraphy) sleep compared to TAU. Outcomes will be the same as the infants.
Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep. Hypothesis 2a: Mothers of infants who sleep in the SB will have fewer postpartum depressive symptoms over time (i.e., Edinburgh Postnatal Depression Scale) compared to TAU. Hypothesis 2b: The SB improves infant sleep, which then predicts better maternal sleep, and thereby predicts lower maternal depressive symptoms.
Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups. Hypothesis 3: Peripheral cytokines, immune cells, and stimulated cytokine profiles of women with PPD assessed in late pregnancy, 3- and 6- months postpartum, will indicate greater innate immune activity compared to those who do not develop PPD. Hypothesis 3b: Mothers of infants who sleep in the SB will exhibit less innate immune dysfunction than TAU mothers.
Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.
Participants. Eligible Pregnant women (N = 342) will be enrolled and randomly assigned to SB or TAU stratified by epigenetic status in the late 3rd trimester and followed longitudinally every month for 6 months. Inclusion criteria: History of depression; singleton gestation; 18-45 years of age; ability to communicate during the screening process; access to a computer, responsive phone, or tablet with internet service; and willing to use the bassinet they are randomized to. Exclusion criteria: clinical confirmation of any current psychopathology (depression, anxiety, suicidal intent, bipolar disorder, etc.), use of psychotropic or sleep medications, multiple gestations, pregnancy/birth complications that would interfere with bassinet use, plans to co-sleep with infant exclusively, tobacco, alcohol, or substance abuse during pregnancy. Self-reported, untreated comorbid sleep disorders, including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea.
Initial clinical assessment of depression: Psychopathology will be assessed over the phone using The Structured Clinical Interview for DSM-5 Disorders (SCID-5-CV).
Randomization. Mothers-infant dyads (up to N = 342) will be randomly assigned to conditions by using a random number generating program found on a widely used and reputable website (www.randomizer.org)". This will further allow for comparability between the SB and current usual care/common sleep arrangements. The investigators will perform 1:1 randomization, stratifying for epigenetic status. The SB will be shipped to participants and returned at the expense of Happiest Baby, Inc. TAU participants will be shipped the Halo Bassinest Swivel Sleeper bassinet.
Data Collection. For each assessment, all participants will receive an email with a REDCap link for online data collection. To mitigate and minimize the possibility of missing data in the measures, electronic questionnaires will be programmed to prevent skipping questions. In addition, participants will receive a monthly package containing two actigraphs, maternal sleep diaries, the Baby's Day Diary, a certified blood mailer with tubes, and a prepaid return envelope.
|
Inclusion Criteria:
* Pregnant women with a singleton gestation who have a military affiliation
* Ages 18-45 years
* Ability to communicate during the screening process
* Access to a computer, smart phone or tablet with internet service
* Willing to use bassinet they are randomized to
* Willing to travel to a local Quest for blood draw
Exclusion Criteria:
* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.
* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.
* Under the age of 18 years or \> 45 years. The goal is to include women of childbearing age.
* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.
* Tobacco use (current). Smoking is associated with poor sleep and inflammation.
* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.
* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.
|
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] |
NCT05263973
|
The Effect of Music on Pain, Comfort and Physiological Parameters During Prematurity Retinopathy Examination
|
It is planned to determine the effect of music during Retinopathy of Prematurity (ROP) examination on pain, comfort and physiological parameters in preterm infants. This is single-center, randomized controlled trial, double blind, parallel.
Hypotheses:
H1: The music applied during the ROP examination has an effect on the Revised Premature Infant Pain Profile (PIPP-R) score of the preterm infant.
H2: The music applied during the ROP examination has an effect on the Preterm Infant Comfort Scale (PMI) score of the preterm infant.
H3: Music applied during the ROP examination has an effect on the physiological parameters (peak heart rate, O2 saturation) of the preterm infant.
H4: The music applied during the ROP examination has an effect on the crying time of the preterm infant during the procedure.
Method: The study will be performed with preterm infants (n=28) hospitalized in the neonatal intensive care unit of a tertiary hospital. Premature infants to be included in the study will be assigned to two study groups using the block randomization method created in the computer environment according to their gestational age, gender, birth weight.
The data in the study were will be collected using the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod. Data will be collected by researcher ABÇ. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study.
Questionaire Form for Preterm Newborns and Their Parents will be obtained from the nurse observation form and patient files. Four minutes before the ROP, the infant will be monitored and physiological parameters will be recorded, and three minutes before the ROP, the experimental group will start to listen to music (Video recordings will be evaluated by three experts, PIPP-R and PICS). The music recording will continue to be played during the ROP examination for music group. No application will be made for the control group other than the clinical routines.
|
This randomized controlled experimental study is planned in order to determine the effect of music on pain, comfort and physiological parameters in preterm infants in ROP examination matched for gestational age, gender and birth weight. The research sample will consist of 28 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 10 and 30 in different studies in which music was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 14 according to α=95% confidence level and 90% power. In the study, it was planned to have 14 infants in the music and control groups. After reaching 28 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. All bodies of preterm infants will be recorded with a visible video camera for an average of 10 minutes, 4 minutes before the start of the ROP examination and 4 minutes after the completion of the ROP examination (for PIPP-R and PICS scores). The infants in the music group (Acem Aşiran Maqam music prepared by TÜMATA group) will be applied music for a about total of 10 minutes, starting 3 minutes before the ROP examination and continuing during the ROP examination, 3 minutes after ROP examination. After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 45 cm from the head of infant and the sound level will be adjusted to an average of 45-60 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye (mean ROP time 1.61 ±1.59). The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Data will be collected with the Questionaire Form for Preterm Newborns and Their Parents, Physiological Parameters Observation Form, Revised-Premature Infant Pain Profile (PIPP-R), Premature Infant Comfort Scale (PICS), Pulse Oximeter, Music CD, Music box, Video camera, decibel meter, tripod.
|
Inclusion Criteria:
* Birth weight \<2000 g,
* Gestational age ≤32 weeks,
* Have not passed the first 2 ROP inspections,
* Not receiving ventilatory support (not intubated or positive pressure ventilation support) for the last 72 hours,
* Vital signs within normal limits (without tachycardia, tachypnea, hyperthermia, hypothermia, dyspnea, intercostal or subcostal retraction),
* Not having any congenital anomalies (eye, neurological) that may adversely affect the examination,
* No hearing problem,
* No painful intervention is performed at least 30 minutes before the ROP examination,
* Preterm newborns whose corrected/postnatal age is 28-36 weeks at the time of examination,
* Newborns whose mothers want to participate in the study will be included in the study.
Exclusion Criteria:
* Clinic condition worsening during working,
* Diagnosed with hydrocephalus, necrotizing enterocolitis, indirect hyperbilirubinemia,
* Receiving analgesic treatment,
* Newborns whose mothers want to withdraw from the study will be excluded from the study groups.
|
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] |
NCT04594239
|
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
|
* Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
* Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
|
Inclusion Criteria:
* Is a candidate for bilateral IOH treatment.
* Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.
Exclusion Criteria:
* Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
* Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
* Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
* Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.
|
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] |
|
NCT01105663
|
Pharmacologic Impact on Sedation Assessments
|
PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.
|
PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This project will use sophisticated modeling and simulation techniques to evaluate the impact of genetics and other variables such as degree of illness, age, weight and organ dysfunction on the pharmacokinetics and pharmacodynamics of morphine and midazolam in children who are mechanically ventilated for respiratory failure, and require sedation. This proposed work will allow the design of a pharmacologic model that can be used to individualize therapy in children requiring mechanical ventilation with the goal of optimizing sedation while minimizing the duration of mechanical ventilation. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.
|
Inclusion Criteria:• Enrolled in RESTORE clinical trial
* Be greater than or equal to 7 kg
* Receiving morphine and/or midazolam continuous infusions
* Give Informed Consent/Assent
Exclusion Criteria:
* Intubated and mechanically ventilated for immediate post-operative care and stabilization
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* History of single ventricle at any stage of repair
* Congenital diaphragmatic hernia or paralysis
* Primary pulmonary hypertension
* Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
* Ventilator dependent (including noninvasive) on Pediatric Intensive Care Unit (PICU) admission (chronic assisted ventilation)
* Neuromuscular respiratory failure
* Spinal cord injury above the lumbar region
* Pain managed by patient controlled analgesia (PCA) or epidural catheter
* Family/medical team has decided not to provide full support (patient treatment considered futile)
* Enrolled in any other sedation clinical trial concurrently or within the last 30 days
* Known allergy to any of the study medications.
|
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] |
NCT00314249
|
Study of Milnacipran for the Treatment of Fibromyalgia
|
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.
|
Inclusion Criteria:
* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
Exclusion Criteria:
* psychiatric illness,
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease
|
[
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|
NCT06141694
|
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
|
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
|
Inclusion Criteria:
1. The subject is age 22-80 years at screening.
2. The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
3. The subject has a clinical indication for an elective PVI.
4. The subject is willing and able to comply with all required study procedures.
5. Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
1. Guidewires: 0.014-0.018"
2. Catheters (Microcatheters): 2-3 Fr
3. Guide catheter: 4-6 Fr
Exclusion Criteria:
1. Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
2. Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
3. Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
4. Target vessel has been previously treated with any type of a bypass conduit.
5. Subject has a contraindication to standard anticoagulation for PVIs.
6. Subject has bleeding or a hypercoagulability disorder.
7. Subject has thrombocytopenia (\<50 x103 per µL).
8. Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
9. Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
10. Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
11. Subject has a known allergy to any material used or any component of the devices used that will be in direct contact with subject's tissue.
12. Subject is pregnant or lactating.
13. Subject with any medical, social, or psychological conditions which, in the opinion of the investigator, would prohibit appropriate consent or impair completion of the study protocol or study procedures.
14. Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
15. Subject is currently participating in an investigational drug or device study or post market registry, or participated in another investigational drug or device study within one month prior to enrollment.
|
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|
NCT03931655
|
Photoacoustic Lymph Node Imaging
|
In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to:
1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases.
The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.
|
The study is centered on determining whether photoacoustic imaging of blood oxygen saturation can detect lymph node metastases.
Patients who are returning for an ultrasound exam after detection of a suspicious node via magnetic resonance imaging will be enrolled in the study.
Enrolled patients will receive a clinical ultrasound exam, as is the current standard of care. Suspicious nodes will be identified and imaged with combined ultrasound and spectroscopic photoacoustic imaging. Measurements will be acquired with three to five replicates with slightly modified transducer positioning to measure system and intranodal variance of the measurements. One to five contralateral axillary lymph nodes will be imaged to serve as a control and to determine patient-to-patient variability in lymph node saturated oxygen. The distance from the skin to the lymph node will also be measured with ultrasound imaging for each node.
If the ultrasound imaging identifies a suspicious node, patients will undergo ultrasound guided biopsy to confirm the true metastatic state of the nodes. Suspicious nodes will be clipped to facilitate identification at the time of axillary node dissection. During the sentinel node procedure, investigators will use intraoperative photoacoustic imaging to measure the blood oxygenation in the sentinel lymph node immediately prior to its removal. Histology will be performed on all biopsy samples and excised nodes to determine the true metastatic state of the node(s).
|
Inclusion Criteria
1. Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection.
2. Subjects are capable of giving informed consent.
Exclusion Criteria
1. Subjects have had prior surgery in or near the axillary lymph nodes.
2. Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer.
3. Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy.
4. Subjects are homeless persons or have active drug/alcohol dependence or abuse history.
5. Subjects are pregnant or breast-feeding.
|
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] |
NCT04035460
|
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
|
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
|
Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.
|
Inclusion Criteria:
1. Age ≥ 18 years
2. AHRF defined as:
A ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) between 100 - 250 mm Hg while breathing O2 from Venturi mask, or other delivery system that allows quantification of FiO2 such as Mask-NIPPV or HFNC.
When no arterial blood gas (ABG) result available, use transcutaneous oxygen saturation measurement (SpO2) to impute PaO2 (Appendix A.2 for Table of PaO2 / FiO2 imputed from SpO2 \[Brown 2017\]. If no oxygenation data prior to use of Mask-NIPPV or HFNC are available, then P/F ratio 100 - 250 on Mask-NIPPV or HFNC meets this criterion.
3. Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)
Exclusion Criteria:
1. P/F Ratio \< 100 (Severe ARDS) on quantifiable FiO2
2. More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
3. Urgent need for intubation
Criteria for intubation:
i. RR\>40 ii. Lack of improvement of respiratory muscle fatigue iii. Copious tracheal secretions that require frequent suctioning iv. Acidosis with a potential Hydrogen (pH) \<7.35 v. Acute hypercarbia (PaCO2 \> 45 mm Hg) vi. SpO2 \< 88% for more than 5 minutes despite FiO2 and non-invasive support vii. Respiratory or cardiac arrest viii. Glasgow Coma Scale ≤ 8
4. Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
5. Upper airway obstruction, facial trauma
6. Copious secretions, airway bleeding, epistaxis or vomiting
7. Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma
8. Elevated intracranial pressure \>20 mm Hg
9. Home mechanical ventilation except for CPAP/BiPAP used solely for sleep disordered breathing
10. Persistent hemodynamic instability (systolic blood pressure (SBP)\<90 or mean arterial pressure (MAP)\<60 despite IV fluid resuscitation, or norepinephrine dose \> 0.1 mcg/kg/min or equivalent vasopressor dose)
11. Plan for procedure during which NIPPV or HFNC is contraindicated. Okay to enroll if procedure is complete and AHRF persists within 24 hours.
12. Absence of airway protective gag reflex or cough
13. Tracheostomy
14. Lack of informed consent
15. Pregnancy
16. Actual body weight exceeding 1 kg per cm of height
17. Diffuse alveolar hemorrhage
18. Severe acute pancreatitis as etiology for hypoxemia
19. Recent upper gastrointestinal surgical anastomosis within the past 30 days
20. Enrollment in another clinical trial within the past 30 days
21. Unsuitable for non-invasive ventilation in the judgment of the treating MD
22. Decision to withhold life-sustaining treatment. Patients with Do-Not-Resuscitate (DNR) or No Cardiopulmonary resuscitation (No CPR) order may be enrolled.
23. Do not intubate order
|
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] |
NCT04703816
|
Multifaceted Program to Improve Interpersonal Skills of Physicians
|
To determine whether the implementation of a multifaceted training program relying on the conceptual framework of the Four Habits Model improved the communication and interpersonal skills for hospital physicians during consultations compared with control physicians receiving no intervention, the investigators will conduct a prospective randomized, controlled, open-label, two parallel arms, superiority interventional trial. The unit of randomization is the physician.
|
Rationale: Interpersonal skills, encompassing communication and empathy, are key components of effective medical consultations and represent physician core competences that are most desired by patients. High-quality communication relates with enhanced patient satisfaction, greater adherence to treatment, better health outcomes, and decreased risk of malpractice claims. Many organizations have therefore implemented structured training programs to improve physician communication skills in North America and Europe. Yet limited evidence exists on the effectiveness of these programs in improving physician interpersonal skillsMost studies used unvalidated instruments that may not accurately reflect interpersonal skills, were underpowered to detect clinically meaningful differences in interpersonal skills due to relatively limited sample size, lacked a control group, or used a study design that was prone to evaluation bias. In addition, few studies examined whether these training programs dedicated to improve physician communication skills altered patient satisfaction therapeutic alliance or modified physician self-efficacy and professional achievement.
The "Four Habits Model" is a training program that has been developed within the US Health Maintenance Organization Kaiser Permanente and implemented for teaching effective communication to thousands of clinicians in this organization over the two last decades. The Four Habits Model refers to basic medical interview tasks that are organized within four dimensions, namely, Invest in the beginning, Elicit the patient's perspective, Demonstrate empathy, and Invest in the end. Since its development, the Four Habits Model has been successfully implemented outside the Kaiser Permanente system, in various settings in North America and Western Europe.
Our research team recently carried out the cross-cultural adaptation of the Four Habits Coding Scheme (4-HCS) scale into French. The 4-HCS is a standardized instrument designed to assess physician communication skills from an external rater's perspective, relying on the conceptual framework of the Four Habits Model.
The investigators hypothesize that the implementation of a multifaceted training program based on the Four Habits Model improved physician interpersonal skills without altering consultation duration, increased patient satisfaction and therapeutic alliance, and modified physician self-efficacy and professional achievement.
Primary objective: To determine whether the implementation of a multifaceted training program relying on the conceptual framework of the Four Habits Model improved the communication and interpersonal skills for hospital physicians during consultations compared with control physicians receiving no intervention.
Secondary objective:
To compare study arms with regard to:
* mean duration of medical consultation
* For patients:
* patient satisfaction with the consultation
* therapeutic alliance
* For physicians:
* 4-HCS subscale scores
* Professional achievement
Methodology: Prospective, randomized (with a 1:1 allocation ratio), controlled, open-label, two parallel arms, superiority interventional trial in one study site. The unit of randomization is the physician. Randomization will be performed by minimization, taking into account the status (attending versus non-attending) and specialty (medical versus surgical) of the physician.
Timeline:
* Pre-intervention trial period: The participating physicians will be invited to videotape medical consultations with at least four consecutive patients (consenting to the research) over a 3-month period. The video-recorded consultations will be independently evaluated by two raters using the 4-HCS scale
* Randomization: Physicians will be randomly assigned to study arms
* Intervention: Physicians in the intervention arm will receive the training program consisting of two half-day group workshops with a review of the skills needed to build effective patient relationships and a discussion of difficult consultations. Physicians in the control group will not receive any specific intervention at this stage.
* Post-intervention trial period: The participating physicians in the two study arms will be invited to videotape medical consultations with at least four consecutive patients (consenting to the research) over a 3-month period Personalized feedback will then be given on the acquisition of skills of the physicians in the intervention arm.
Number of subjects:
224 consecutive patients included (112 per arm) nested within 28 physicians (14 per arm). A sample of 56 patients included by 14 physicians in each arm would confer a power greater than 80% to show an average difference of 7.5 points in the 4-HCS score (alpha risk of 0.05 in bilateral situations). Each arm of the trial will include 56 pre-intervention and 56 post-intervention patients, for a total of 224 patients.
Randomization:
To ensure allocation concealment, participating physicians will be randomized at the end of the pre-intervention study period. A third party will generate allocation sequence, with a 1:1 ratio, using minimization stratified by physician specialty (i.e., medical versus surgical) and attending status (i.e., attending physician versus non-attending physician). The investigators will use the software RStudio with package Minirand.
Blinding:
In this open label trial, the participating physicians will not be blinded to allocation. Only the physicians who will rate video-recorded consultations and the statistician will be blinded to study arm.
Statistical analysis of data:
A statistical analysis plan (SAP) will be developed prior to database lock, reviewed by the principal investigator and an independent statistician, and approved by the steering committee. Any post-hoc or unplanned analyses not specified in the SAP will be clearly identified as such in the final statistical report (FSR) and manuscripts for publication. No formal interim analysis is planned.
Analysis populations A statistical analysis plan (SAP) will be developed prior to database lock, reviewed by the principal investigator and an independent statistician, and approved by the steering committee. Any post-hoc or unplanned analyses not specified in the SAP will be clearly identified as such in the final statistical report (FSR) and manuscripts for publication. No formal interim analysis is planned.
Analysis populations The intention-to-treat (ITT) population will consist of all observations for participating physicians who have been randomized. Patients and physicians will be analyzed in the study arm assigned by randomization. The per-protocol (PP) population will consist of all observations for randomized physicians without any major deviation from the protocol (non-compliance with the multifaceted training program) and evaluable. The numbers of patients and physicians in ITT and PP populations will be presented by study arm throughout a CONSORT-style flow-chart extension for cluster randomized trials.
Baseline characteristics Baseline and demographic characteristics will be summarized for both ITT and PP populations. Baseline patient and physician characteristics will be compared between the two study arms.
Analysis of the primary outcome The primary outcome analysis (i.e., 4-HCS overall score) will be conducted within the ITT population and, for sensitivity reason, repeated within the PP population. For this purpose, the investigators will use a difference-in-differences approach, with a two-sided alpha level of 0.05. To account for patient clustering within participating physicians, the investigators will analyze 4-HCS overall score using random-intercept linear regression model for continuous dependent variable.
Analysis of the secondary outcomes. The analysis of secondary outcomes will be exploratory in nature. Inferential comparisons for participating physicians between study arms will be performed using the Student t or Wilcoxon rank-sum test for unpaired data for continuous outcome variables. To account for patient clustering within participating physicians, the investigators will analyze secondary outcome measures using random-intercept linear regression model for continuous dependent variable. All tests of secondary outcome analyses will be performed on both ITT and PP populations at a two-sided alpha level of 0.05.
Subgroup analysis. No subgroup analysis is planned for the primary and secondary outcome measures. Missing data. The completeness of study data will be reported for baseline characteristics and outcome variables. The investigators will perform multivariate imputation using chained equations (MICE) for replacing missing primary and secondary outcome values
Study feasibility:
The investigators identified the American multidimensional Four Habits Coding Scheme (4-HCS) scale, which produces a composite score of the quality of interpersonal skills that can be used in initial or continuing education. No instrument for measuring interpersonal skills was available in French. Therefore, the investigators proceeded with the cross-cultural adaptation of this scale. The cross-cultural adaptation of this scale was used to evaluate simulated filmed consultations of approximately 200 students from the Grenoble Faculty of Medicine during the period 2017-2018. This experiment allowed for the verification of the feasibility of the evaluation of interpersonal skills via this scale and made it possible to constitute a sufficient sample of videos to validate the psychometric properties of the scale.
Thus, this tool can be used in initial or continuing education for the evaluation of interpersonal skills and allows for the measurement of the progression of these skills within the framework of an intervention aimed at improving them.
Interest of the study:
The intervention should increase the physician's skills in establishing a caregiver-patient relationship and in managing difficult consultations, particularly those with high emotional load, without significantly altering the duration of the consultation. The proposed trial should document the effect of this intervention on specific patient (satisfaction, therapeutic alliance) and clinician (professional fulfillment) outcomes.
|
Inclusion criteria
Physicians:
* Physicians board-certified in medical, surgical, or gynaecology-obstetrics specialty at Grenoble Alpes University Hospital
* Provision of written informed consent
Patients:
* Scheduled consultation in the public sector at Grenoble Alpes University Hospital
* Patient treated in the participating physician's department
* Initial consultation for new patient
* Age ≥18 years old
Exclusion Criteria:
Physicians:
- Problems expressing or understanding the French language for cultural or language reasons
Patients:
* Problems expressing or understanding the French language for cultural or language reasons
* Patients who are unable to provide written informed consent, because of cognitive impairment, altered mental status, or communication impairments for medical reason
* Patient subject to a legal protection measure or unable to express their objection
|
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] |
NCT04475705
|
Propofol vs Sevo for Paediatric Tumor Surgery
|
Background:
Retrospective studies and meta-analyses have shown a reduction in 5-year survival following inhalational based compared to propofol based total intravenous (TIVA) anaesthesia for cancer surgery. To date there have been no prospective trials published which evaluate the effect of anaesthetic technique on circulating tumour cells (CTC), oxidative stress, and recurrence rate following cancer surgery. Children with cancer often require surgery for tumour excision as well as for other diagnostic and therapeutic procedures. To date there has been no prospective randomized controlled trial evaluating the optimal anaesthetic technique for surgery on children with cancer.
Aim:
This is a pilot study in paediatric patients who require surgery for tumour excision. The aim is to investigate the effect of sevoflurane inhalational versus propofol intravenous anaesthesia on expression of hypoxia-inducible factor 1 (HIF-1), circulating tumour cells, DNA damage and biomarkers of immunity and inflammation in patients before and after tumour surgery. The patients will be followed up for up to 5 years for tumour recurrence after surgery.
Method:
This will be a single-blinded randomized controlled trial. One hundred children undergoing tumour excision surgery at the Hong Kong Children's Hospital will be recruited and randomized to receive TIVA or inhalational anaesthesia. Baseline, intraoperative and postoperative blood will be taken for tests of immunity and inflammatory markers, DNA damage and circulating tumour cells. Patients would be followed up to 3 years for tumour recurrence and survival.
|
Surgical resection is the main modality of treatment for many solid tumors. Despite successful tumor resection, some patients develop local recurrence or metastasis, causing morbidities and mortality. In recent years, there is growing interest in the pathophysiology of recurrence or metastasis. It is believed that the recurrence is caused by the liberation of circulating tumor cells during surgical manipulation of the tumors and the vascular invasive properties of the tumor cells. Perioperative events, such as surgical stress and anaesthesia may have immunomodulating effects, causing growth or inhibition of circulating tumor cells, which affect disease relapse. There is growing evidence that propofol is anti-inflammatory while sevoflurane is pro-inflammatory and their potential roles in cancer recurrence attract researchers' attention. In adults, there is increasing number of researches showing that propofol may improve patient outcomes in terms of disease survival, when compared to sevoflurane. However, such evidence in paediatric population is lacking. This study aims to compare the effects of propofol based intravenous anaesthesia with inhalation anaesthesia with sevoflurane on perioperative biomarkers of inflammation, circulating tumor cells and disease free survival in 3 years.
100 patients will be recruited for this single blinded randomised controlled trial. They will receive general anaesthesia in Hong Kong Children's Hospital for their primary tumor excision surgery. 50 patients will be randomised to sevoflurane group and 50 patients will be randomised to propofol group. They will receive standardised anaesthetic management in terms of death or anaesthesia, pain management, fluid or thermoregulation management. Sevoflurane group subjects will receive inhalational sevoflurane as main anaesthetic, while propofol group subjects will receive intravenous propofol. These patients will have 4 blood tests collected for analysis for biomarkers of inflammation, DNA damage, oxidative stress and circulating tumor cells.
* baseline: once patients have intravenous access established
* intraoperative: when the tumor is deemed resected by surgeons
* immediately postop: after wound closure
* 24 hours postop Early postoperative period follow up will look for wound recovery, sepsis, and time to start chemotherapy and need for second look operation for wound complication.
Patients will also followed up for 3 years for tumor recurrence and disease survival.
|
Inclusion Criteria:
* patients coming for elective primary solid tumor resection for curative intent in Hong Kong Children's Hospital
* AND patients \> 5kg
* AND patients within age limit
Exclusion Criteria:
* Autoimmune / Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) etc.
* Current Steroid therapy
* Surgery for tumour removal in the past year
* Allergy to Propofol
* intraoperative use of nitrous oxide
* Patient susceptible to Malignant Hyperthermia
* Patients / parents / legal guardians showing preference in anaesthetic techniques during recruitment process
|
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] |
NCT05888584
|
Improving Access and Recruitment to Clinical Trials for Lung Cancer Patients
|
There are \~85,000 lung cancer patients (LCPs) in the UK; yet only around 8% were recruited into clinical trials in 2021/22. LCPs need opportunities to take part in clinical trials to access new treatments, increasing their quality of life, treatment choices and life expectancy.
Discussions with nurses can help patients make better treatment decisions, improving experiences of care. However, research has shown that lung cancer nurses (LCNs) often feel unable to discuss participation in trials with patients due to lack of knowledge, confidence, time and training.
This study aims to develop and test a research recruitment tool for LCNs, to support LCPs to enter clinical trials.
Objectives include to:
* Explore reasons for low uptake of LCPs into clinical trials
* Develop a tool for LCNs to talk to patients about clinical trials
* Test whether the tool improves the number and quality of discussions nurses have with LCPs about clinical trials
The study has four phases:
Phase 1: A literature review will identify problems that make clinical trial uptake difficult for LCPs, carers and clinicians
Phase 2: Six group discussions with LCNs, patients and carers will explore issues that create potential barriers for patients taking part in clinical trials. The groups will take place online, last approximately one hour and be recorded.
Phase 3: Part 1\&2 findings will help us develop a LCN research recruitment tool. The tool will contain information on how nurses obtain information about LC clinical trials, research teams, communication issues, practical issues and how to reach LCPs.
Phase 4: The research recruitment tool will be tested in four UK NHS hospitals. A survey will identify any changes in nurses' clinical trials awareness and confidence before and after using the tool. Interviews with LCNs, patients and carers will explore their views on the tool, clinical trials participation and experiences of care.
|
Background: Patients who discuss taking part in research and those that go on to participate have better outcomes and experiences. Reported trial benefits for patients include greater access to new drugs; disease control; improved survival; enhanced quality of life; more intensive follow up and monitoring; better symptom management; enhanced care and support; and patient empowerment. In cancer care, the rate at which targeted treatments are translated into clinical practice for use by LCPs is reliant on accessible clinical trial opportunities; however, trial uptake remains low. Recruitment to research within the UK National Health Service (NHS) is challenging and COVID-19 saw a 59% reduction in cancer patients entering clinical trials in England, from 67,057 in 2017/18 to 27,734 in 2020/2021 \[7,8\]. Resultingly, the Institute of Cancer have recommended that trial information is made accessible and understandable to patients and that clinical staff have conversations about trials early in the treatment pathway.
Being assigned a LC clinical nurse specialist is associated with better experiences of care and studies have found that discussions nurses have with patients about clinical trial enrolment play a key role in decision-making and recruitment. However, LCNs often feel unable to discuss clinical trials with patients due to a lack of knowledge and confidence, time, expertise and training. Key barriers to trial recruitment include screening complexities; lack of resources, staff, skills and equipment; time; limited clinician awareness; perceived administrative burdens, concerns over trial suitability; inadequate information communicated to patients and clinicians and complex trial terminology. It is recommended that clinical trials are more closely integrated into clinical practice and that staff are adequately trained to support clinical research.
Study design: This mixed methods study consists of the following phases:
Phase 1: A systematic review of the best scientific literature will identify challenges and barriers to clinical trial recruitment amongst LCPs, carers and clinicians. PRISMA reporting guidelines will be followed.
Phase 2: Six qualitative focus groups with lung cancer patients, carers, lung cancer nurses and other members of the multidisciplinary team (MDT) will explore challenges and facilitators to LCPs' clinical trial entry. Focus group participants will be recruited through the participating sites lung cancer nursing teams.
Eligible clinician participants (nurses and other MDT staff) will be contacted through lead LCNs at participating sites (see phase 4), who will share invitation letters and participant information leaflets with their teams. If they are happy to proceed a researcher will organise a time, date and place with participants to proceed with the focus group. Participants will also be recruited through LCNUK and the National Institute for Health Research (NIHR) Local Clinical Research Networks.
Patients and carers will be recruited through the NCRI consumer forum and other cancer patient/carer networks, including RCLCF and Mesothelioma UK. LCNs at participating NHS sites will also share invitation letters and information leaflets with LCPs, inviting them to take part. If they are happy to proceed the researcher will organise a time, date and place with participants to proceed with the focus group. The study will also be promoted via social media channels such as Twitter, Healthcare Unlocked and closed Facebook groups. We intend to recruit \~48 participants to focus groups (eight per group); three focus groups will be with LCNs, research nurses and multidisciplinary team members from district general hospitals (DGHs) and tertiary centres, and two with LCPs and carers. A final group will include clinicians from the Christie and Royal Marsden cancer centres, where recruitment to trials is higher than in DGHs and tertiary centres, to identify transferable elements of best practice. Focus groups will be held remotely, via the online Zoom platform.
Focus groups facilitated by two researchers, will last one hour, and will be recorded and transcribed. Data will be thematically analysed using the Framework Method, to enable comparisons across groups to be identified and themes generated.
Phase 3: Phase 1\&2 findings will inform development of the LCN research recruitment tool. The tool, available in paper and online formats, will include information on finding out about LC clinical trials, the role of research teams, embedding research into multidisciplinary team meetings and health needs assessments, communication pathways, signposting LCPs, practical considerations and reaching underrepresented groups. Tool development will be guided by the Trial Steering Group (TSG), with representation from LC patient and public involvement (PPI) members, LCNs, multidisciplinary research and clinical teams. The tool will be tested for face and content validity by \~10 LCNs who participated in Phase 2, and \~4 PPI representatives. Relevant feedback will be used to make modifications to the tool.
Phase 4 pilot: Participants in the pilot study will pilot the research recruitment tool for proof of concept across four UK NHS sites, including tertiary centres and DGHs: Oxford, Derby\&Burton, Lanarkshire, Nottinghamshire. An additional two NHS sites, Surrey and Birmingham, will act as controls.
Each site's LCNs (n=36) will be invited to participate through their senior nurse manager who will provide eligible nurses with an online invitation letter and participant information sheet (PIS). If they are happy to proceed the researcher will organise a time, date and place with participants for the pilot phase of the study. Nurse participants will then have a briefing session, where the pilot study purpose will be explained. LCNs at the pilot sites (n=24) will be provided with a training session on using the tool, before implementing it in their teams for six months.
Survey data will be collected from each LCN (n=36) at baseline, three and six months and LCN's will reconsent electronically, via the Qualtrics survey platform, prior to completing each online survey. The survey will collect information on the following: 1) Items from the validated General Perceived Self-Efficacy Scale will measure LCNs' self-efficacy (primary outcome measure) in relation to their research roles 2) The number of LCPs each LCN has approached to discuss clinical trial opportunities will be recorded 3) Likert style survey data on LCNs' knowledge, confidence and awareness of clinical trials will be collected. These questions will be developed from phase 1\&2 findings and tested for reliability and validity by TSG members. The repeated tests measure ANOVA will compare survey responses between baseline, three and six months. Between groups ANOVA will compare differences in scores between pilot and control sites. No formal sample size calculation is required as this is a pilot study; however, all LCNs across the six sites will be invited to take part (n\~36).
Towards the end of the pilot, eight LCNs who have been taken part in the pilot will be invited, via an invitation letter and participant information sheet provided by the research team, to attend a 30-minute interview, via the online Zoom platform, or via telephone, to explore the tool's acceptability, in terms of ease of use and impact on recruitment.
Eight patients/carers who have joined clinical trials at the pilot sites will also be interviewed remotely, via the online Zoom platform or by telephone to explore their clinical trial experience and its impact on quality of life, care satisfaction, self-efficacy and symptom control will be explored. This will provide valuable information on the tool's impact on LCP experience.
|
Healthcare staff Phase 2:
Inclusion Criteria:
* Actively involved in the clinical care pathways of lung cancer patients
* Working at one of the six participating NHS trusts
* Age between 18-65 years of age
Exclusion criteria:
* Not actively involved in frontline clinical care
* Not involved in caring for lung cancer patients for at least 30% of their
Patients/carers:
Inclusion criteria:
* Must have a current diagnosis of lung cancer (any stage) or be the named carer of a person with a lung cancer diagnosis
* Under the care of (or caring for) one of the participating NHS Trusts lung cancer teams
* Aged 18 or over
Exclusion criteria:
* Mesothelioma diagnosis or caring for someone with a mesothelioma diagnosis
* Unable to provide informed consent
Phase 4 Healthcare professionals
Inclusion criteria:
* Registered nurse with Nursing and Midwifery Council
* Actively involved in the clinical care pathways of lung cancer patients
* Working at one of the six participating NHS trusts
* Age between 18-65 years of age
Exclusion criteria:
* Not actively involved in frontline clinical care
* Not involved in caring for lung cancer patients for at least 30% of their role
* Employed as a lung cancer research delivery nurse
Patients/carers:
Inclusion criteria:
* Current diagnosis of lung cancer (any stage) or be the named carer of a person with a lung cancer diagnosis
* Aged 18 or over
* Consented to (or carer of someone who has consented to) a clinical trial since start of pilot study
* Receiving care (or carer for someone receiving care) in one of the four NHS sites piloting the research readiness tool
Exclusion criteria:
* Mesothelioma diagnosis or caring for someone with a mesothelioma diagnosis
* Unable to provide informed consent
|
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] |
NCT04123444
|
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure
|
The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in up to a total of 380 patients with septic shock suffering from organ failure.
The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in septic shock patients suffering from organ failure caused by endothelial breakdown, ultimately improving survival.
|
Patients with the most severe type of sepsis, those with septic shock have a mortality rate between 30% to 45% due to multiple organ failure. The poor outcome of shocked patients, and especially those with sepsis, may by related to microvascular endothelial dysfunction. Evidence support that iloprost infusion significantly improved endothelial function and integrity,
The main objective in this trial is to investigate whether continuous infusion of lov dose iloprost at a dose of 1 ng/kg/min for 72-hours is safe and significantly reduce organ failure score in the intensive care unit (ICU) compared to infusion of placebo in patients with septic shock induced endotheliopathy (SHINE).
Patients that are eligible for this trial will be temporarily incompetent due to acute severe illness relating to septic shock, therefore informed consent will be obtained from a scientific guardian. Next-of kin and subsequently the patient will co-sign as soon as possible hereafter. During the trial, patient will be give continuous infusion of low dose iloprost or placebo for 72 hours as well as additional blood samples will be obtained daily for the first 72 hours. Follow up on organ failure, mortality and quality of life will be performed on dag 28 and 90.
This trial is conducted in accordance with the Helsinki 2 Declaration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice (ICH-GCP) and in compliance with the protocol. As part of the quality assurance on-site monitoring visit will be performed by the an independent GCP-unit including source data verification. Standard Operation Procedure (SOP) to address protocol specific procedures such as data collection and adverse event reporting are developed.
The number of patients participating is based on a power calculation using the data on mean daily SOFA score from a recent randomized, double blind, placebo controlled clinical trial in patients with septic shock: Levosimendan for the prevention of acute organ dysfunction in sepsis (LeoPARD). If the true effect of the intervention is a reduction in mean daily SOFA score of 20% (relative) and providing the trial with 90% power to detect this difference at a significance level of 0.05 will require a sample size of 380 patients.
A pre-planned, blinded interim analysis will be performed after 200 patients have been included in the trial and followed for 90 days.
|
Inclusion Criteria:
All the following criteria must be fulfilled:
1. Adult intensive care patients (age ≥ 18 years)
2. Septic shock defined according to the Sepsis-3 criteria:
* suspected or documented infection
* persisting hypotension requiring vasopressors to maintain a mean arterial blood pressure of 65 mmHg or above
* Lactate level of 2 mmol/L or above despite fluid therapy within the last 3 hours at screening
3. Soluble thrombomodulin (sTM) above 10 ng/mL
Exclusion Criteria:
Patients who fulfil any of the following criteria will be excluded:
1. Withdrawal from active therapy
2. Pregnancy
3. Known hypersensitivity to iloprost.
4. Life-threatening bleeding as defined by the treating physician
5. Known severe heart failure (New York Heart Association (NYHA) class IV)
6. Suspected acute coronary syndrome
7. Previously included in this trial
8. Septic shock for more than 12 hours at the time of screening
9. Informed consent cannot be obtained
10. Included in other clinical trials with prostacyclin within 90 days
|
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] |
NCT03053635
|
Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
|
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in the study. Bacillus Calmette-Guerin (BCG) intolerance or refractory disease are defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (a minimum of 5 instillations) followed by either a second induction (a minimum of 5 instillations) or at least 2 maintenance instillations. Subjects experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also considered refractory. The study will consist of 2 phases. In the first phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35 mg/cm\^2 (maximum recommended starting dose) TLD1433. If treatment with the maximum recommended starting dose does not raise significant safety concerns as determined by the safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm\^2 (therapeutic dose) TLD1433.
|
10.1 Overall Study Design and Plan: Description
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Non-muscle Invasive Bladder Cancer, Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in this study. BCG intolerance or refractory disease are defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (a minimum of 5 instillations) followed by either a second induction (a minimum of 5 instillations) or at least 2 maintenance instillations. Subjects experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also considered refractory.
The study will consist of 2 phases. In the first phase, 3 subjects will receive PDT employing 0.35 mg/cm\^2 (maximum recommended starting dose) TLD1433 and 90 J/cm\^2 of green light delivered by TLC-3200. If treatment with the maximum recommended starting dose does not raise significant safety concerns as determined by the safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm\^2 (therapeutic dose) TLD1433 and 90 J/cm\^2 of green light delivered by TLC-3200.
10.2 Screening Period
Subjects will be qualified for study entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 2 weeks.
10.3 Maximum Recommended Starting Dose Treatment Phase
Three subjects will receive a single instillation of 0.35 mg/cm\^2 TLD1433 followed by PDT (TLC-3200 System). If treatment with the maximum recommended starting dose doesn't raise safety concerns after 1 month of patient follow-up based on the judgment of the safety monitoring committee, the study will enroll an additional 3 subjects who will receive PDT at the maximum recommended starting dose.
10.4 Follow-Up Phase
All subjects enrolled, regardless of TLD1433 dose received, will be followed until the End of Study defined as completion of all required assessments after 6 months of follow-up or earlier due to early discontinuation or withdrawal of informed consent.
During the Follow-Up Phase, information on safety and efficacy will be collected. Assessments will be conducted at Day 7, Day 30 and monthly thereafter through Month 3, and every 3 months until End of Study.
10.6 Study Drug and PDT Administration
TLD1433 for intravesical administration is supplied as a lyophilisate for suspension in Sterile Water for Injection into the bladder and is packaged in the dark in amber borosilicate glass vials which can be stored at room temperature. Just before administration, it is reconstituted with Sterile Water for Injection to obtain the final clinical dilution.
TLD1433 will be supplied by Theralase Inc. Instillations cannot be done immediately following biopsy taken by TURBT. Investigators must wait a minimum of 7 days before dosing subjects after a TURBT/biopsy and/or until any bladder wall integrity issues have resolved. Dose/volume reductions are not allowed during this study.
Upon determination of the bladder volume (during the screening period) through a voiding diary or measuring instilled water volume, TLD1433 will be diluted to the proper concentration. On day 0 (treatment day), subjects will be asked to restrict fluid intake 12 hours before study drug instillation. Study drug must be instilled into the subject's empty bladder. Before instillation, a regular transurethral catheter should be inserted and the bladder drained. A single instillation of TLD1433 will be infused intravesically for 60 min (further TLD1433 will be instilled in case of leakage), followed by 3 washes with sterile water. Bladder will be distended using a fourth instillation of sterile water to prevent folds that prevent uniform light illumination. The laser technician worksheet must be completed during the procedure and data must be promptly transferred to the corresponding eCRF page. The optical fiber (with spherical diffuser) will be positioned in the center of the bladder with the aid of TLC-3200 and will be locked in place using an endoscope holder for continuous irradiation for the total exposure time. Exposure time will be calculated based on power (measured at the end of the optic fiber before inserting though a liquid-tight lock via catheter into the urethra) and bladder surface area to match the desired light dose at the bladder wall. Green laser light (wavelength = 532 nm, energy = 90 J/cm\^2) will be irradiated using the spherical cavity diffuser.
10.6.1 Dosing Schedule
A single whole bladder intravesical PDT with TLD1433 and the TLC-3200 System is planned.
10.6.2 PDT Disruption
Only those patients in whom no papillary tumours remain after TURBT will be treated on this protocol. If one or more papillary tumours are seen at the time of cystoscopy for laser light application (maximum 6 weeks after TURBT), a patient must not be treated with the TLC-3200 System as scheduled, even though previously instilled with TLD1433. Procedures will be followed as though the tumour were first detected at the 90-day follow-up evaluation. The patient may then be treated in whatever manner the physician deems appropriate. However, such patients must be followed for collection of safety information for at least 30 days after TLD1433 instillation, even though alternate therapy may have been initiated during this time. Adverse experiences, weekly assessment of urinary symptoms, and the results of laboratory tests of blood and urine will be recorded. Full disclosure of the details of any alternate therapy or other medications given during the 30-day observation period (e.g., drug, dose, route, frequency and dates of administration) must be provided. After this 30-day period, an interim medical history will be taken and the patient will undergo a physical examination (including ECG), clinical laboratory tests, a Karnofsky Performance Status rating, and an assessment of urinary symptoms and adverse experiences. The patient will then be considered off study.
|
Inclusion Criteria:
1. Be willing and able to provide written informed consent/assent for the trial.
2. Be \> 18 years of age on day of signing informed consent.
3. Have histologically confirmed NMIBC (T1, Ta, and/or Tis) according to the 2004 World Health Organization (WHO) classification within 8 weeks prior of treatment initiation. Participants with tumours of mixed transitional / non-transitional cell histology are eligible, but urothelial carcinoma must be the predominant histology. Participants with predominant or exclusively non-urothelial histology are not eligible. Confirmation of histology, grade and stage will be performed by local review and must be completed prior to enrolment.
4. For participants with Ta and T1, they must have undergone complete TURBT defined as absence of resectable disease after at least 2 cystoscopy / TURBT procedures. The most recent cystoscopy must have been performed no longer than 8 weeks prior to the first dose of trial treatment.
5. Have been considered intolerant or refractory to first-line BCG therapy defined as inability to tolerate or failure to achieve a tumour-free state after at least one induction (minimum of 5 instillations) followed by at either a second induction (minimum of 5 instillations) or at least 2 maintenance instillations. Participants experiencing disease relapse within 12 months or less after finishing the second course of BCG therapy are also considered refractory.
6. Are not candidates for cystectomy on medical grounds or refuse radical cystectomy.
7. Have a performance status of 70 or more on the Karnofsky Performance Status Scale as assessed within 28 days prior to treatment initiation.
8. Have no evidence of upper urothelial carcinoma (involving the upper urinary tract or the urethra) (confirmed by staging to exclude extravesical disease, which may include radiological imaging and/or biopsy) within 3 months of treatment initiation. If previous work up occurred more than 3 months prior to treatment initiation, staging for extravesical disease must be repeated prior to enrolment in order to determine eligibility.
9. Have satisfactory bladder function. Ability to retain instillate for a minimum of 1 hour, even with premedication.
10. Are available for the duration of the study including follow-up (approximately 12 months).
11. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
12. Female participants of childbearing potential must be willing to use 2 methods of birth control (oral contraceptive, pills, diaphragm, or condoms) or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year.
Male participants must agree to use an adequate method of contraception (oral contraceptive, pills, diaphragm, or condoms) starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
1. Past or current muscle invasive (i.e., T2, T3, T4) or metastatic urothelial carcinoma.
2. Has concurrent extravesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
3. Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; Prostate-Specific Antigen undetectable for 5 years while off androgen deprivation therapy.
4. Have a known psychiatric or substance abuse disorder that would interfere with meeting the requirements of the trial.
5. Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate.
6. Currently receiving any photosensitizing medications.
7. Have a known hypersensitivity to ruthenium.
8. Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
9. Participated in a study with an investigational agent or device within 3 months from the first dose of current study treatment.
10. Prior treatment with an intravesical chemotherapeutic agent within 3months of the first dose of current study drug, with the exception of a single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment).
11. Have an active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI), in the last month.
12. Has any contraindication to general or spinal anesthesia.
13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
15. Known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
16. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus (HCV) RNA \[qualitative\] is detected).
17. Received a live virus vaccine within 30 days of planned start of trial treatment.
18. Have a diagnosis of psoriasis.
|
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] |
NCT04125277
|
The SONImage Study
|
SONImage is a multicenter prospective imaging side study, in which a baseline FES-PET is added to conventional work up, in 100 patients with ER+ MBC who will receive endocrine treatment ± CDK 4/6 inhibition within the SONIA study (NCT03425838). SONImage will be executed in two Dutch centers: UMCG and Amsterdam UMC-location VUMC. The aim of the SONImage study is to (1) assess the relationship between FES/FDG-PET heterogeneity patterns at baseline and PFS for first-line endocrine treatment ± CDK 4/6 inhibition in ER+ MBC, and (2) to further improve that by developing a prediction model, within the SONIA study. This molecular imaging based multivariable prediction model may provide a unique measure of benefit of adding CDK 4/6 inhibition to first-line endocrine treatment, allowing patients and providers to weigh individual benefits and (long term) burden for optimized treatment decisions.
|
Estrogen receptor positive (ER+) breast cancer is the most common cancer and the most frequent cause of cancer-related death in women in the Western World. Cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors improve outcome, when added to standard first- and second-line endocrine therapy. However, they also add patient- and financial burden due to (long term) increased toxicity and hospital visits. Therefore, benefits of additional CDK 4/6 inhibitors should be weighed against their burden. Tools to support such treatment decisions by patients and providers are currently lacking. Whole body heterogeneity of ER expression, measured by 16α-\[18F\]fluoro-17β-estradiol (FES)-PET scan and 18F-fluorodeoxyglucose (FDG)-PET scan was related to time to progression on combined treatment in previous work. Therefore in SONImage a baseline FES-PET is added to conventional work up, in 100 patients with ER+ MBC who will receive first line endocrine treatment ± CDK 4/6 inhibition within the SONIA study. The objectives are 1. to correlate PFS1 (according to SONIA criteria) to baseline FES/FDG-PET heterogeneity; 2. to assess interaction between baseline FES/FDG-PET heterogeneity, treatment allocation, and PFS1 (according to SONIA criteria); 3. to correlate response measurements of individual lesions to baseline FES/FDG heterogeneity and detailed FES/FDG imaging features; 4. to develop a multivariable model to predict individual PFS benefit to first-line AI ± CDK 4/6 inhibition, based on detailed FES/FDG image features and standard clinicopathological information, in n=100 SONIA patients; 5. to validate this prediction model in two independent patient cohorts with baseline FES/FDG-PET scans (Dutch IMPACT-MBC trial; international ET-TRANSCAN trial). This molecular imaging based multivariable prediction model may provide a unique measure of benefit of adding CDK 4/6 inhibition to first-line endocrine treatment, allowing patients and providers to weigh individual benefits and (long term) burden for optimized treatment decisions. Particularly for the approximately 25% of patients with ER+ MBC who have an excellent- or poor outcome despite CDK 4/6 inhibition in the first-line, this could have profound implications, as they may refrain from combined treatment. Ultimately, this could potentially contribute to FES/FDG-PET based treatment decisions in clinical practice, reduction of unnecessary toxicity and costs, while improving patient outcome and QoL.
|
Inclusion Criteria:
1. Patient is eligible and participates in the SONIA trial for ER+ MBC.
2. Able to give written informed consent and to comply with the SONImage protocol.
3. Documentation of histologically confirmed diagnosis of estrogen receptor (ER) expression \>10% breast cancer based on local results. The receptor status can be determined on the primary tumor or on a tumor biopsy of a metastatic lesion.
Exclusion Criteria:
1. A patient who meets the exclusion criteria of the SONIA trial (see SONIA protocol).
2. Contra-indication for PET imaging.
3. Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) ≤ 5 weeks before FES-PET imaging.
|
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] |
NCT01780181
|
Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer
|
The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.
|
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO guidelines recommended that elderly patients with advanced NSCLC use single-agent chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST) of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is 6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong long-term survival and improve QOL, but high-level evidence is desperately needed to support this finding.
The investigators perform a multi-center, randomized, double-blind controlled, prospective study in elderly patients with advanced NSCLC. Patients are randomized over observational group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus single-agent chemotherapy). The investigators will observe 4 cycles and after that regular follow-up will be arranged. The primary end point is: PFS (progression-free survival); the secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3) TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (5) other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
|
Inclusion Criteria:
1. Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
2. Ages Eligible for Study: ≥65 years old;
3. Physical status score (ECOG PS) ≤ 2 scores;
4. Estimated life expectancy of at least 12 weeks;
5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥9g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin≤1.5ULN,alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range(1.2DLN-1.2ULN),creatinine≤1.5ULN;
6. Informed consent from the patient.
Exclusion Criteria:
1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
2. Patients who have received single-agent chemotherapy treatment；
3. Estimated life expectancy less than 12 weeks;
4. Serious problem of heart, liver or kidney with severe dysfunction;
5. Pregnant or child breast feeding women;
6. Mental or cognitive disorders;
7. Participating in other drug trials;
8. Who are allergic to the study drug.
|
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] |
NCT04664439
|
Follow-up With CT-FFR in CHD Patients After DCB
|
In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. Compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately.
|
Drug-coated balloon (DCB) intervention is a non-drug treatment of coronary heart disease with the advantage of "no implantation". In recent years, it is more and more used in primary coronary artery disease. Timely detection of restenosis after DCB is very important to ensure the safety of patients. Invasive coronary angiography (ICA) is the "gold standard" to reflect coronary artery stenosis, but it is difficult to become a routine follow-up tool for surgical trauma, radiation exposure and other reasons, let alone for elderly patients.
Coronary artery computed tomography angiography (CCTA) can provide a variety of anatomical information such as the degree of coronary artery stenosis and the nature of plaques. It is a commonly used tool for non-invasive imaging diagnosis of coronary heart disease. However, because of its low diagnostic specificity and can not reflect the lesion-related myocardial ischemia, the positive rate of coronary heart disease and the rate of revascularization in patients undergoing ICA are low. In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. A number of studies have shown that, compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately. Due to the absence of metal foreign body implantation, DCB intervention makes it possible for CT-FFR to be used in imaging evaluation after DCB. At present, there is no study on the use of CT-FFR in patients after DCB.
In this study, the self-developed CT-FFR based on artificial intelligence was used for the first time to analyze coronary artery lesions in patients after DCB, and to compare the guiding value of CT-FFR and simple CCTA in ICA and revascularization, in order to provide an ideal non-invasive imaging follow-up tool for elderly patients after DCB.
|
Inclusion Criteria:
1. Be able to understand the purpose of the test and sign the informed consent form.
2. 6-12 months after DCB for coronary heart disease, there is no contraindication of coronary artery CTA examination.
3. Non-target lesions of unplanned revascularization within 6 months.
4. According to the clinical manifestations and auxiliary examinations (such as EET, SPECT, CCTA), the attending doctor will make a comprehensive judgment on the patients who plan to undergo ICA.
Exclusion Criteria:
Patient exclusion criteria:
1. Previous coronary artery bypass (CABG) surgery, coronary artery stent implantation, artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation.
2. Persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA heart function III or IV) or acute pulmonary edema.
3. Acute myocardial infarction occurred within 7 days before selection.
4. Patients with other severe diseases are not suitable to participate in clinical trials, such as history of complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or extremely severe chronic obstructive pulmonary disease, chronic renal dysfunction (serum creatinine level \> 2.0mg / dl or creatinine clearance \< 30ml/ Kg ·1.73m2).
5. Allergic to iodinated contrast medium.
6. Other serious allergic diseases such as allergic asthma.
7. Pregnancy or pregnancy status unknown.
8. Life expectancy is less than 6 months.
9. There are any factors that other researchers think are not suitable for selection or completion of this study.
-
CCTA image exclusion criteria:
1. Obvious dislocation of coronary artery image.
2. CCTA images indicate that the reference vessel diameter of the stenotic segment is less than 2.0mm.
3. The image of coronary artery calcification accounting for more than 80% of the cross-sectional area of the lumen.
4. The standard deviation of CT value (SD value) of aortic root image was higher than that of 30HU.
5. Coronary artery occlusion.
6. The CT-FFR measurement can not be completed due to the quality problem of the image file.
7. The clinical trial could not be completed and no effective data were obtained due to other reasons.
|
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] |
NCT05537779
|
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
|
The study is a prospective, single-arm observational multicenter clinical investigation.
The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.
|
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.
100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.
|
Inclusion Criteria:
* Subject referred for a contrast-enhanced CT examination using a power injector
* Subject or legal representative for children, having provided written informed consent
Exclusion Criteria:
* Subject weighting less than 10 kg
* Pregnant or breastfeading woman subject
* Subject with known allergy or hypersensitivity to contrast media
* Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
* Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
* Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
|
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] |
NCT06793345
|
Walking Training Improves Thyroid and Cardiometabolic Markers in Postmenopausal Obesity
|
The goal of this clinical trial is to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. The main question it aims to answer is:
Does MIWT enhance thyroid function and reduce cardiometabolic risk factors in this population? Researchers will compare MIWT (designed to MIWT group) to non-training intervention (designed to control group) to see if the training program works to improve thyroid function and cardiometabolic risk factors.
Participants in MIWT group will: perform a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions).
Participants in control group will : not perform any physical training and maintain their usual daily activities.
|
This study aimed to investigate the impact of a 10-week MIWT program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. Thirty-six obese postmenopausal women (BMI≥30 kg.m-2, aged 50-60 yrs.) were randomized to either a moderate-intensity intermittent walking training (MIWT) group (n=18) or control group (CG, n=18). Participants performed a 10-week MIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Body composition, thyroid hormones (thyroid stimulating hormone (TSH) and thyroxine free (FT4)), lipid profile (triglycerides (TRG), total cholesterol(TC), high-density lipoprotein cholesterol(HDLC) and low-density lipoprotein cholesterol(LDLC)), blood pressure (systolic and diastolic blood pressure) and aerobic fitness (6MWT) were determined before and after the MIWT.
|
Inclusion Criteria:
* Body mass index≥ 30 kg.m-2.
* Age between 50 and 60.
* Amenorrhea for \>12 months.
* Stable eating habits.
Exclusion Criteria:
* Chronic diseases.
* Medical contraindications to physical activity.
* Hormone replacement therapy.
|
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] |
NCT06385418
|
Fluorouracil Treatment Via Colon for Colorectal Cancer
|
Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.
|
Inclusion Criteria:
1. Chinese individuals aged 18 to 75 years, both male and female;
2. Histologically confirmed diagnosis of colorectal cancer with measurable primary lesion according to RECIST 1.1;
3. ECOG performance status ≤2;
4. Expected survival of more than 3 months;
5. Multidisciplinary team consensus that the patient is suitable for adding local chemotherapy to the established tumor treatment regimen;
6. Adequate organ function meeting the following criteria: (1) Absolute neutrophil count ≥1.5 × 10\^9/L, platelets ≥100 × 10\^9/L, hemoglobin ≥90 g/L; (2) Total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); ALT and AST ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) Creatinine \<120 μmol/L, or MDRD estimated glomerular filtration rate \>60 mL/min; (4) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%;
7. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment, and sexually active men or women agree to use appropriate contraception during the trial and for 8 weeks after the last dose of investigational drug;
8. Suitable physical condition and personal willingness to undergo colonic transendoscopic enteral tubing;
9. Willingness to cooperate with physicians, and agree to regular follow-up visits and examinations as recommended after completion of treatment;
10. Agreement to specimen collection and voluntary signing of a written informed consent form.
Exclusion Criteria:
1. Uncontrolled cardiovascular diseases, such as congestive heart failure (NYHA III-IV), coronary artery disease, cardiomyopathy, arrhythmias, or hemodynamic instability at enrollment, with a risk of significant events during the treatment period;
2. Active severe clinical infections (≥ Grade 2 according to NCI-CTCAE version 5.0), including fungal, viral, or tuberculosis infections within the gastrointestinal tract;
3. Coagulation abnormalities with bleeding tendencies (who do not meet the criteria of having a normal INR without the use of anticoagulants within 14 days prior to enrollment). Participants receiving anticoagulants or vitamin K antagonists such as warfarin or heparin are excluded unless their international normalized ratio (INR) is ≤1.5, with allowance for low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for prophylaxis;
4. History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
5. Known progressive or actively treated other malignancies requiring intervention, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ;
6. Presence of other serious diseases that would render the subject ineligible for enrollment as determined by the investigator;
7. Breastfeeding women;
8. Known allergy or intolerance to the investigational drug or its excipients;
9. Participation in another drug clinical trial within the past four weeks;
10. Lack of legal capacity or restricted legal capacity.
|
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] |
|
NCT05477082
|
Blood Biomarkers in Pediatric Kidney Transplant Recipients
|
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
|
Inclusion Criteria:
* Kidney transplant recipients
* Participants undergoing a for-cause kidney biopsy to rule out graft rejection
* Ages 21 years and less
Exclusion Criteria:
* Participants who have opted out of research
* Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
* Participants, 18 years and older, who are illiterate and cannot read.
* Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
* Participants, 18 years and older, who do not speak English
* Participants who are pregnant as confirmed by medical records
|
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|
NCT06387459
|
Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
|
This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation.
|
Objectives:
* Primary Objective: To evaluate the safety and feasibility of the fabric-type knee extensor muscle-mimicking orthosis in improving gait among elderly patients.
* Secondary Objectives: To measure changes in walking speed, endurance, and muscle activity to infer potential benefits in daily mobility.
Study Design:
* Study Population: 30 elderly patients suffering from conditions affecting mobility (sarcopenia, diabetes, knee osteoarthritis).
* Intervention: Use of a fabric-type orthosis mimicking knee extensor function, equipped with shape-memory alloy for dynamic movement support.
* Methodology:
1. Training and Adaptation: Participants will undergo an initial training session to get accustomed to the orthosis, including donning and doffing, adjustment, and use in various environments (flat surfaces, inclines).
2. Assessment Protocol:
* Before wearing the orthosis-after wearing the orthosis (power off)-after wearing the orthosis (power on)
* Assessments will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system. 3. Safety Monitoring: Continuous monitoring of physiological responses (blood pressure, heart rate), musculoskeletal assessments, and skin integrity checks to monitor for adverse reactions or discomfort.
|
Inclusion Criteria:
Eligibility for participation in the study requires that all the following criteria are met:
1. Age: Participants must be 65 years of age or older.
2. Comprehension and Compliance: Able to fully understand and comply with the instructions and study procedures.
3. Mobility-Impacting Conditions: Must have at least one of the following conditions affecting mobility: (1)Sarcopenia:
* Muscle Strength: Handgrip strength of \<28 kg for men and \<18 kg for women.
* Muscle Function: Short Physical Performance Battery (SPPB) score of 8 or less.
* Muscle Mass: Bioelectrical impedance analysis (BIA) showing muscle mass \<7.0 kg/m² for men and \<5.7 kg/m² for women. (2)Diabetes:
* Diagnosed distal symmetric polyneuropathy.
* Sensory impairments in toes or feet. (3)Knee Osteoarthritis:
* Kellgren-Lawrence grade ≥2.
* Persistent pain (≥3 months) with a severity of at least 3 on the Numerical Rating Scale (NRS).
Exclusion Criteria:
Individuals meeting any of the following criteria will be excluded from study participation:
1. Inability to Consent: Unable to provide informed consent or not willing to participate in the study procedures.
2. Severe Sensory or Motion Limitations: Including severe visual or vestibular impairments that could increase the risk of falling.
3. Communication Barriers: Significant hearing, speech, or language problems that would hinder communication with study personnel.
4. Independent Walking Inability: Cannot walk independently without the aid of a walking device.
5. Other Significant Diseases or Conditions:
* Neurological disorders that affect walking ability (e.g., stroke, Parkinson's disease).
* Orthopedic or musculoskeletal conditions severely affecting lower limb function.
* Severe cardiovascular conditions including uncontrolled hypertension or heart failure.
* Respiratory diseases requiring regular oxygen therapy.
* Active cancer treatment or cancer treatment within the past 3 years (except basal cell carcinoma or localized prostate cancer).
* Severe psychiatric disorders like schizophrenia or bipolar disorder.
6. Other Exclusionary Factors:
* Past severe orthopedic surgeries on lower limbs which might affect gait and mobility.
* Severe back pain or any other condition affecting mobility not already listed.
|
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] |
NCT01437800
|
BIOAVAILABILITY OF GLI/METXR (4/850 mg)
|
Objective:
The purpose of this study is to evaluate the oral bioavailability of the combination Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers in fasting conditions.
Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24 volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg).
|
Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were plotted for each volunteer, and pharmacokinetic parameters (PK) were calculated. the pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 / 2 of glimepiride and metformin Adverse events were determined using clinical and laboratory test results, throughout the study. The statistical analysis will be descriptive for plasma concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin.
|
Inclusion Criteria:
* Healthy Mexican volunteers, considered healthy according to standard screening assessments
* Aged between 18 and 50 years old
* Body mass index (BMI) was 18 to 27.5
Exclusion Criteria:
* Those with a history or evidence of cardiovascular, renal, hepatic, gastrointestinal, neurologic, muscular, metabolic, or hematologic abnormality
* Any acute or chronic disease
* Any drug allergy and female volunteers positive to urinary pregnancy test or breastfeeding
|
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] |
NCT03629886
|
Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
|
This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period.
In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).
|
Treatment allocation depended on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study received HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study did not receive vaccination in this study.
|
Inclusion Criteria:
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject prior to performing any study specific procedure.
* Subjects previously enrolled in the HPV-039 study.
* Subjects with negative pregnancy test at Visit 1.
Additional inclusion criteria for subjects of HPV group undergoing vaccination ONLY:
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Previous vaccination against HPV outside of study HPV-039.
Additional exclusion criteria for subjects of HPV group undergoing vaccination ONLY:
* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone. Inhaled and topical steroids are allowed.
* Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before and after each dose of vaccine administration, with the exception of administration of routine vaccines e.g. meningococcal, hepatitis B, hepatitis A, inactivated influenza up to eight days before and after each dose of study vaccine. Enrolment will be deferred until the subject is outside of the specified window.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Previous administration of MPL or AS04 adjuvant.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Cancer or autoimmune disease under treatment.
* Hypersensitivity to latex.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature ≥37.0°C. The preferred location for measuring temperature in this study will be the axilla.
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
* Females planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
|
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] |
NCT03729063
|
Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking
|
The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking.
|
Smoking in France represents 25 billion euros per year in care, hospitalizations and drugs and 78000 deaths / year are linked to a pathology attributable to this addiction. In addition, active consumption of cigarettes is a destabilizing factor for chronic respiratory diseases. During hospitalization for acute respiratory illness, evaluation of smoking cessation remains declarative. Although stopping advice and possibly nicotine replacement therapy are prescribed, no objective measure of smoking is performed to assess the adequacy of this attitude.
This project aims to objectively evaluate smoking during hospitalization by measuring twice daily exhaled CO. The impact of this intervention on the duration of hospitalization and smoking 3m after initial admission will also be evaluated. Tobacco consumption patterns based on reason for hospital admission and background pathology will be highlighted.
Secondary objectives include:
* To measure the impact of expired CO measurement during hospitalization on the smoking status 1 month and 3 months after initial admission.
* To determine smoking patterns during hospitalization according to reason for admission and background pathology.
* To measure the effect of iterative CO measurement on the duration of stays.
* To measure and compare the quality of life of patients.
* To study the variability of expired CO measurements.
|
Inclusion Criteria:
* Patient hospitalized in pneumology for acute respiratory illness or scheduled hospitalization, for a minimum duration of 48h.
* Signature of informed consent
* Patient able to perform all visits and follow the procedures of the study
* Affiliatedor beneficiary of French social security (national health insurance)
Exclusion Criteria:
* Subject who can not read and / or write French
* Expected travel that precludes study completion
* Patient in palliative care
* Inability to maintain apnea more than 8 seconds
* Participation in another clinical trial or administration of an off-label drug within 4 weeks prior to inclusion
|
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] |
NCT06590909
|
Fractional CO2 Laser Delivery of Topical Insulin Versus Platelet Rich Plasma in Treatment of Atrophic Post Acne Scars
|
compare the efficacy and safety of treating atrophic post acne scars with topical insulin versus Platelet rich Plasma PRP combined with fractional ablative Co2 laser
|
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo".
Because of its long duration and exposure to affected areas, acne is associated with a major deterioration in a patient's quality of life and well-being .
Up to 95% of acne sufferers have some degree of acne scarring, with 30% reporting severe acne scarring. Scarring from acne is common when medical care is delayed or is not sufficient, although it can also occur even when treatment is adequate .
About 90% of acne scars are related with collagen loss (atrophic scars), whereas the remaining 10- 20% show collagen gain (keloidal or hypertrophic scars). Resulting from the contraction of fibrous tissue, atrophic scars appear as depressions. Atrophic acne scars can be classified into three distinct types: boxcar, icepick, and rolling.
|
Inclusion criteria:
patients aged equal or more than 18 years with atrophic post acne scars.
Exclusion criteria:
pregnancy and lactation. Hypertrophic scars. patients suffering from aggressive inflammatory acne. kidney or liver disease. active infection at site of lesion. patients use medications that reduce tissue healing during the study.
|
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] |
NCT03725839
|
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
|
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.
|
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
|
Inclusion Criteria:
* Adult (18+ years of age)
* Able to give written consent
* AHI ≥ 5 on diagnostic night
* Either prescribed APAP, CPAP or Bi-level PAP for OSA
Exclusion Criteria:
* Inability to give written consent
* Anatomical or physiological conditions making PAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or may think they are pregnant.
|
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] |
NCT01112553
|
Treximet Migraine Brain Imaging Research Study
|
We are looking for volunteers who suffer from acute migraine (\<14 episodes per month) to participate in a 2-visit brain imaging research study. The goal of the study is to observe the effect of acute administration of Treximet during a migraine episode on the pain pathways of the migraine brain. Visit 1 will consist of 1 hour, where participants will be signing the informed consent form, completing questionnaires, meeting with the study physician, and having QST (sensory testing to determine individual pain thresholds to a heat stimulus) performed. Visit 2 will occur during a migraine episode. Volunteers will be asked to contact the study team at the first onset of a migraine. Upon arrival at Visit 2, individuals will be given an IV for blood draws. Once these the IV is in place, subjects will enter the MRI and be asked to stay very still. Scanning will occur for about 20 minutes, and then subjects will be given a Treximet tablet to combat their migraine. More scanning will follow Treximet administration. Some scans will have no stimulation, and others will apply a heat stimulus that subjects will rate using a pain scale. Seven 5-mL blood samples will be drawn throughout the duration of the MRI session. Both Visit 1 and Visit 2 will be compensated.
|
Inclusion Criteria:
* Male or female (not pregnant or nursing)
* Age 18-65; with a focus on age 30-40 years
* Episodic migraine (experience migraine headache \<14 days out of the month), with focus on left-sided pain
* Currently taking Treximet routinely for migraine treatment
* No significant medical history (No illnesses such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.)
* No significant medication history, except for migraine
* Weight, \<285 pounds
* Not claustrophobic
* No contraindication to taking triptans
Exclusion Criteria:
* Age \<18 or \> 65
* Significant medical problems (aside from pain before, during and after migraine episodes)
* Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
* Use of opioid medications
* Claustrophobia
* History of dermatological hypersensitivity in the facial area
* Pregnancy
* Sensory loss detected on Quantitative Sensory Testing at screening
* Significant alcohol history (ingestion of 5 or more glasses (\> 40 oz) of alcohol per week)
* Metal implants of any type (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, etc.)
* Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could become heated up in the scanner, and potentially cause blistering or burning)
* Cardiac pacemakers
* Aneurysm clips and other vascular stents, filters, clips or other devices
* Prosthetic heart valves
* Other prostheses
* Neuro-stimulator devices
* Implanted infusion pumps
* Cochlear (ear) implants
* Ocular (eye) implants or known metal fragments in eyes
* Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
* Other metallic surgical hardware in vital areas
* Any known allergic side effects to Treximet
* Use of any of the following medications:
* Monoamine Oxidase A- Inhibitors (Azilect, Eldepryl, Marplan, Nardil, Parnate, Zelapar)
* SSRI's: citalopram/ Celexa, Lepraxo, paroxetine/ Paxil, fluoxetine/ Prozac, Sarafem, Symbyax, Sertraline/ Zoloft, Fluvoxamine/ Luvox
* SNRI's: duloxetine/ Cymbalta, venlafaxine/ Effexor
* Triptans: sumatriptan/ Imitrex, naratriptan/ Amerge, zolmitriptan/ Zomig, rizatriptan/ Maxalt, eletriptan/ Relpax, almotriptan/ Axert
* Ergotamine type medicines: Bellergal, Cafergot, Ergomar, Wiraine, Migranal/ DHE45, Sansert
|
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|
NCT04219462
|
Effect of ESWT on ED in Type 2 Diabetics
|
Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
|
ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:
Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg
|
Inclusion Criteria:
1. Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
2. Patients who will have erectile dysfunction ( ED) from 6 months.
3. Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
4. Body mass index ( BMI) will be \< 30 kg/m²
5. The age of patients will be between 40- 60 years.
Exclusion Criteria:
* History of pelvic trauma, pelvic surgery, psychiatric disease.
* Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
* Vascular surgical intervention that recommended for the patients.
* Other renal conditions, respiratory disease, liver failure.
* Prostatectomy and patients with prostatic disease.
* Patients lacking complete follow-up data.
* hypogonadism.
|
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] |
NCT03302624
|
Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
|
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.
The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.
|
Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.
Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.
Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.
|
Inclusion Criteria:
ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h
Exclusion Criteria:
Pregnant or nursing woman's job
|
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] |
NCT02905266
|
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
|
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
|
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate)
* Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Exclusion Criteria:
* Subjects with active brain metastases or leptomeningeal metastases
* Subjects with ocular melanoma
* Subjects with active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
|
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|
NCT06459388
|
Stabilizing Reversal and Rhythmic Stabilization vs Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patients
|
The goal of this clinical trial is to compare the effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patients. The main question it aims to answer is:
Is there any difference in effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patients?
Researchers will compare stabilizing reversal and rhythmic stabilization to pelvic proprioceptive neuromuscular facilitation to see if there any difference in effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patient.
Participants will be divided into two groups:
Group A will receive stabilizing reversals and rhythmic reversals technique. The patient will perform 3 sets with 15 repetitions in each session, 5 days per week for 8 weeks.
Group B will receive Pelvic PNF protocol. The treatment protocol will be followed 5 days a week for 8 weeks (i.e. 20 sessions) and each session will last for 30 minutes.
|
It will be a randomized clinical trial study in which non-probability convenience sampling will be used. The sample size will be 50. The participants fulfilling the inclusion criteria will be divided randomly into two groups through computerized table generator method of randomization. Baseline assessment of both groups will be done before the execution of interventions. Group A will receive stabilizing reversal and rhythmic stabilization protocols for 5 days per week for 8 weeks. Group B will receive pelvic PNF protocol 5 days per week for 8 weeks. Trunk Impairment scale will be used to assess trunk control, Postural assessment Scale and Functional Reach Test will be used to assess postural stability and Performance Oriented Mobility Assessment will measure the mobility at the baseline, at 4 weeks and after the completion of intervention at 8 weeks to find out the outcome measures of the participants. The data will be analyzed using SPSS version 24. Normality of data will be assessed through Kolmogorov-smirnov test. Difference between preintervention, mid-intervention and post-intervention readings will be calculated using repeated measure ANOVA for parametric data. For non-parametric data Kruskal Wallis test will be used. For between group analysis Independent sample t test will be used for parametric data and Mann Whitney test will be used for non-parametric data.
|
Inclusion Criteria:
* Diagnosed cases of ischemic stroke.
* Both genders of stroke patients.
* Age of stroke patients between 40-65 years.
* Duration of stroke less than 6 months.
* Participants should be able to understand and follow simple verbal commands (MMSE
* 24).
Exclusion Criteria:
* Recurrent history of stroke.
* Recent history of any trauma.
* Musculoskeletal disorders such as low back pain, arthritis, degenerative diseases of the lower limbs affecting motor performance, spinal deformity and contractures.
* Spasticity (modified Ashworth scale grade ≥3) or flaccidity in lower limbs and upper limbs.
* PNF treatment given to the pelvic region within 6 weeks.
|
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] |
NCT03605069
|
A Double-blind, Randomized, Intra-subject Placebo-controlled, Multicenter, Multiple Dose Study, Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With Confirmed DDEB or RDEB Diagnosis With One or More Pathogenic Mutations in Exon 73 in the COL7A1 Gene
|
A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis with one or more pathogenic mutations in exon 73 in the COL7A1 gene.
|
This clinical trial will evaluate the safety and tolerability, proof of mechanism, systemic exposure and preliminary efficacy following topical application of QR-313 to subjects with confirmed DDEB or RDEB with one or more pathogenic mutations in exon 73 in the COL7A1 gene.
Up to two Target Wound Areas (TWAs) per subject will be selected and randomized. Each TWA will be treated with IMP for 8 weeks, either QR-313 or matching placebo. All subjects will continue to be followed up for 8 weeks post last dose.
Subjects will be monitored through home visits and site visits. An imaging system will be used to assess the target wound at all home and study site visits.
QR-313 is a 21-nucleotide antisense oligonucleotide (AON) designed to hybridize to a specific sequence in the COL7A1 pre-messengerRNA (pre-mRNA).
|
Inclusion Criteria:
1. Male or female, ≥ 4 years of age at Screening with a clinical diagnosis of DDEB or RDEB and at least one pathogenic mutation in exon 73 of the COL7A1 gene.
2. Have at least one TWA, ie, a skin area of 7 x 7 cm that ishows no signs of local infection, and contains a target wound that is either new or shows dynamic wound healing and complies to the following additional criteria:
1. surface area of the target wound ranging from 5 to 30 cm2, located centrally in the selected 7 x 7 cm TWA.
2. exposed sub-epidermal tissue to allow absorption of the IMP.
3. no suspicion of current squamous cell carcinoma (SCC) upon visual inspection.
Exclusion Criteria:
1. Pregnant or breast-feeding female
2. Hemoglobin level at Screening requiring transfusion. The subject may be rescreened when the condition is considered stable.
3. Use of aminoglycosides, by any route of administration, except eye drops, 7 days or 5 half-lives, whichever is longer, prior to Baseline visit.
4. Untreated carcinoma of the TWA or history of carcinoma within 5 years prior to Screening, except adequately treated cutaneous squamous or basal cell carcinoma.
5. Life expectancy less than 6 months, as assessed by the Investigator
6. Current or known history of clinically significant hepatic or renal disease, that in the opinion of the Investigator, could impact subject safety or study participation.
7. Treatment with any systemic immunomodulators, immunosuppressants or cytotoxic chemotherapy within 2 months prior to the Baseline visit.
8. Use of any investigational drug or device within 28 days or 5 half-lives of the Baseline visit, whichever is longer, or plans to participate in another study of a drug or device during the study period. The washout of 5 half-lives does not apply to gene and cell therapy.
9. Known hypersensitivity to oligonucleotide treatment or excipients of the IMP.
10. Bleeding disorder or condition requiring the use of anticoagulants to be confirmed by aPTT by local lab within 48 hours of first treatment.
11. Use of systemic or topical steroids within 1 month prior to the baseline visit (inhaled and ophthalmic drops of corticosteroids or low dose topical solution of budesonide for esophagial strictures may be allowed).
|
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] |
NCT02625558
|
Riociguat for Sarcoidosis Associated Pulmonary Hypertension
|
Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary hypertension
|
Study design Patients will be recruited into double blind randomized trial of riociguat with 1:1 active drug to placebo. The table below summarizes the study design. Patients will have previously undergone right heart catheterization (RHC) within six months of initial dose dispensation and with no significant change in treatment for pulmonary hypertension. Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day.
The patient will be treated for 48 weeks or until clinical worsening of disease. An adjudication committee will review all cases of clinical worsening. This committee will be blinded to treatment. The determination by the adjudication committee will be used as the final determinant for the primary end point.
|
Inclusion Criteria:
* Patients with diagnosis of sarcoidosis
* Age ≥ 18 years.
* Life expectancy of at least 2 years.
* Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
* Females of reproductive potential (FRP) must have a negative, pre-treatment pregnancy test.
* FRP must obtain monthly pregnancy tests during treatment and one month after treatment discontinuation. Post-menopausal women (defined as no menses for at least 1 year or post-surgical from bilateral oophorectomy) and surgically sterilized women are not required to undergo a pregnancy test.
* Females of reproductive potential and all non-vasectomized male participants must agree to use reliable contraception when sexually active.
* Subjects (males and females) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug.
* Willing and able to comply with the protocol, including follow-up visits and examinations
Exclusion Criteria:
* Patients with an FVC of less than 30% of predicted during screening visit.
* Patients with severe airway obstruction
* Patients unable to perform the 6 minute walk test
* Pregnant women (i.e. positive serum ß-human chorionic gonadotropin test or other signs of pregnancy),
* Breast feeding women
* FRP not using reliable contraception as recommended in the Prescriber Guide for the riociguat pregnancy monitoring program
* Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
* Known significant left heart disease:
* Pulmonary venous hypertension indicated by baseline pulmonary capillary wedge pressure \> 15 mmHg
* Active state or history of hemoptysis or pulmonary hemorrhage
* Subjects requiring nitrates for any reason
* Subject using nitrates within one month of entering study
* Pulmonary veno-occlusive disease
* Subjects with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumor).
* Subjects with hypersensitivity to the investigational drug or any of the excipients.
* Women who are pregnant or breast-feeding.
* Severe proven or suspected coronary artery disease
* Clinical relevant hepatic dysfunction indicated by: bilirubin \>2 times upper limit normal at Visit 0 and/or: alanine aminotransferase (ALT) or AST aspartate aminotransferase (AST) \>3 times upper limit normal at Visit 0 and/or: signs of severe hepatic insufficiency (e.g. impaired albumin synthesis with an albumin \<32 g/L, hepatic encephalopathy \> grade 1a) at Visit 0
West Haven Criteria of Altered Mental Status in Hepatic Encephalopathy
* Severe renal insufficiency indicated by a glomerular filtration rate \<30 mL/min at Visit 0, e.g. calculated based on the Cockcroft formula or the Modification of Diet in Renal Disease Study Group (MDRD) formula
* Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Excluded therapies and medications, previous and concomitant
* Specific (e.g. sildenafil or tadalafil) or unspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline).
* NO donors (e.g. nitrates). Single applications of vasoactive drugs in connection with diagnostic vasoreactive testing are allowed.
* Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
* Major surgery within 30 days prior to start of study drug.
|
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] |
NCT00878956
|
Bicarbonate in Cardiac Surgery
|
With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one of the most common major surgical procedures worldwide (1). Acute kidney injury is a common and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50% of patients (2-4). Acute kidney injury carries significant costs (4) and is independently associated with increased morbidity and mortality (2,3). Even minimal increments in plasma creatinine are associated with an increase in mortality (5,6).
Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed, including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and activation of inflammatory pathways (7-10). To date, no simple, safe and effective intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad patient population has been found (11-14).
Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced by cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may also participate in kidney injury. Urinary alkalinization may protect from kidney injury induced by oxidant substances, iron-mediated free radical pathways, complement activation and tubular hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in combination with N-acetylcysteine (19,20) or without (21) - has recently been reported to attenuate acute kidney injury in patients undergoing contrast-media infusion.
In a pilot double-blind, randomized controlled trial the investigators found sodium bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now need to be confirmed or refuted by further clinical investigations in other geographic and institutional settings.
Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney function in patients at increased risk of acute kidney injury undergoing cardiopulmonary bypass needs to be confirmed in an international multicenter, double-blind, randomized controlled trial of intravenous sodium bicarbonate.
|
Renal impairment following cardiopulmonary bypass is common. While most of these patients do not require either short or long term renal replacement, the mortality of patients with acute renal failure is substantially greater than those who do not develop renal dysfunction.
In a pilot double-blind, randomized controlled trial we found sodium bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now need to be confirmed or refuted by further clinical investigations in other geographic and institutional settings.
There is evidence that sodium bicarbonate affects the cardiovascular, respiratory and immune systems and may be of benefit to patients undergoing cardiac surgery.
Study Design - overview and rationale
Patients will be randomised to receive sodium bicarbonate from the induction of anaesthesia until 24 hours postoperatively, or a placebo (sodium chloride).
Serum creatinine is the most commonly used clinical indicator of renal function along with urine output. Both will be measured for several days postoperatively - the time period during which renal impairment is most likely to develop.
Randomisation The randomisation will be based on random numbers generated by computer. Once consent is obtained, the allocation of either treatment with sodium bicarbonate or placebo will be organised by an independent person (clinical trials pharmacist) who will dispense the coded and blinded infusion bags (shrink-wrapped in extra black plastic bags). This will be delivered to the anaesthetic staff looking after the patient in theatre, and the ICU nurse caring for the patient postoperatively.
20 ml samples of heparinised blood and urine will be taken from the arterial line or urine catheter. Samples will be taken immediately after the preoperative insertion of the arterial/urine catheter, at 6, 24, 48, 72, 96 and 120 hours after commencement of cardiopulmonary bypass. Immediately following collection, the preoperative, 6 and 24 hour blood and urine will be centrifuged at low speed to separate the plasma from the cellular components. Urine and plasma will be stored in aliquots at -70 degrees prior to batch analysis.
The following variables will be obtained:
Code for patient, gender and age. Date and time of admission to ICU Operative procedure and date and time on and off cardiopulmonary bypass Preoperative assessment of left ventricular function, Comorbidities, Pre-, intra- and post-operative medication, Markers of renal function as described above, Doses of frusemide administered (or rate of frusemide infusion) Use of inotropes or vasopressors Cardiac output whenever measured for clinical purposes in the first 24 hours postoperatively Requirement of renal replacement therapy Urine output in each 6 hour period during the presence of urine catheter Acid base status and electrolytes at baseline, 6 and 24 hours after commencement of cardiopulmonary bypass, Time of intubation and extubation, Date and time of arrival on and discharge from ICU and hospital, death Resources required The principle of the study has been discussed with the involved cardiac anaesthetists, cardiac surgeons, intensivists and intensive care nurses, who have offered their co-operation. ICU research nurse to allocate patients and collect clinical data. Pharmacy will be required to prepare drug and placebo infusion bags. Clinical pathology will be required to perform 24 hour creatinine clearance estimation (in addition to those tests clinically indicated) Protocol violations All protocol violations will be recorded. It will then be decided whether the nature of such violation had been such that the patient should be excluded from primary data analysis. Such evaluation will be blinded to treatment.
Withdrawal
The treating clinician will have the right to withdraw the patient from the study if he or she believes that continued participation is jeopardising the patient's well being.
Ethical Issues
Sodium bicarbonate used in this study is considered to be very safe as has been demonstrated by its widespread clinical use in the management of critically ill patients with metabolic acidosis. We consider the potential benefit of this treatment theoretically significant. Given the balance of benefits and risks, we consider it ethical to proceed and seek informed consent.
Indemnity
This is an investigator-initiated study and, accordingly, no commercial sponsor's indemnity has been provided.
Informed consent will be obtained from the patient prior to the operation by one of the investigators or the ICU research nurse. The clinical care of a patient who does not consent for any reason will not be affected.
|
Inclusion Criteria:
* Age above 70 years
* Pre-existing renal impairment (preoperative plasma creatinine concentration \> 1.4 mg/dL
* New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction \< 50%)
* Valvular surgery or concomitant valvular and coronary artery bypass graft surgery
* Redo cardiac surgery
* Insulin-dependent diabetes mellitus
Exclusion Criteria:
* End stage renal disease (plasma creatinine concentration \> 3.4 mg/dL)
* Emergency cardiac surgery
* Planned off-pump cardiac surgery
* Known blood-borne infectious disease
* Chronic inflammatory disease on immunosuppression
* Chronic moderate to high dose corticosteroid therapy (\> 10 mg/d prednisone or equivalent)
* Enrolled in conflicting research study
* Age \< 18 years
|
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] |
NCT02332200
|
Rest Before Physical Therapy in Adolescents With Active Spondylolysis and Spondylolisthesis
|
This is a retrospective chart review with a short follow-up phone questionnaire for our patients who have been treated by Nationwide Children's Hospital physical therapy and sports medicine for a spondylolysis or spondylolisthesis injury.
Currently, no research exists to guide referral for safe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective study the investigators can gain information to better guide physical therapy referral time. This may also serve as foundation for a future prospective randomized trial.
Currently, Nationwide Children Hospital physicians vary from immediate referral to physical therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective chart review assessing time to referral to therapy and patient outcomes the investigator can gain some guidance for when it is safe to prescribe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries.
Patients with an active spondylolysis or spondylolisthesis injury who are referred to physical therapy early will return to activity/sport sooner without increased risk of adverse reaction.
|
Spondylolysis is as stress fracture in the pars interarticularis of the vertebral arch most commonly occurring in the lower lumbar spine. Spondylolisthesis is the forward displacement of a vertebra, especially the fifth lumbar vertebra, most commonly occurring after a break or fracture. These injuries to the spine are extremely common in adolescent athletes and some research reports that spondylolysis and spondylolisthesis account for over 40% of all adolescent athletes' low back pain.
While these injuries are common in the adolescent population there is very little research to guide treatment of these patients, particularly with rehabilitation. Conservative standard of care with the treatment of spondylolysis and spondylolisthesis injuries are to rest from sport, brace the lumbar spine, and begin physical therapy and return to sport as the patient is able. There is some evidence to show that patients should rest for 12 weeks prior to returning to sport, otherwise there is an increased risk of injury (El Rassi, 2013). There currently is no research to suggest when to begin physical therapy. Physical therapy for rehabilitation and return to sport is a part of standard of care, but recommendations for beginning therapy vary widely and are not supported by evidence. A concern for beginning physical therapy too soon is that the fracture will not have adequate time to heal and re-injury can occur. While a concern for waiting too long to begin therapy is increased muscle atrophy, high fear avoidance beliefs, and unnecessarily long avoidance of activity.
Currently, Nationwide Children Hospital physician's vary from immediate referral to physical therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective chart review assessing time to referral to therapy and patient outcomes we can gain some guidance for when it is safe to prescribe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries.
Currently, no research exists to guide referral for safe physical therapy rehabilitation for patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective study we can gain information to better guide physical therapy referral time. This may also serve as foundation for a future prospective randomized trial.
The are two primary objectives of this study: (1) Does time to referral to physical therapy affect time to full return to activity. (2) To assess the safety of an early referral to therapy compared with a long rest period prior to therapy. Safety will be determined by relative risk of adverse reaction and percent of patients able to fully return to activity.
Secondary objectives include:
Assessing pain with early and later referral to therapy. Number of physician visits Number of physical therapy visits Compliance
We will perform a chart review of all spondylolysis and spondylolisthesis patients who have been treated by Nationwide Children's Hospital Sports Medicine physicians and physical therapists since 12/2009 when electronic charting on these patients began. As we are unable to track the outcomes for this study of those patients referred to outside physical therapy, they will be excluded from the study.
The chart review will begin by running a report for all patients with a spondylolysis or spondylolisthesis diagnosis from 2009 to 2013.
Variables that will be automatically pulled in the report will be:
Age at time of diagnosis Gender Treating physician Pain Compliance Sports Played \*\*Any missing variable from the report will be gathered by reviewing the patients chart.\*\* Variables that will be gathered from reviewing the patients chart Diagnosis Level of injury Type of imaging Brace Results of imaging Rest before Physical Therapy Rest before cleared for return to sport Treating physical therapist Number of physical therapy visits Number of physician visits
Variables that will be gathered in a short follow-up survey by contacting the patients. Patients will be contacted by phone, or mail.
Recurrence of symptoms Michelli Function Score Modified Odom's criteria Current level of sport participation
Patients will be divided into 2 groups: Early referral to therapy and late referral to therapy by physician. To account for the fact that patients who are referred to physical therapy sooner may have a less severe injury we will be sub-grouping patients by physician. Patients of a physician with a median referral rate \< 10 weeks to therapy will be sub-grouped into Early referral to therapy and patients of a physician with a median referral time \>10 weeks will be sub-grouped into Late referral to therapy. To account for possible changes in the way a particular physician treats their patients with a spondylolysis or spondylolisthesis physician referral rate will be assessed yearly and patient grouped based on that calendar year referral rate. For example if a doctor has a median referral rate of 12 weeks to therapy in 2009, but 9 weeks in 2010, their 2010 patients will be placed into the late referral to therapy while there 2010 patients will be placed into the early referral group.
Data Analysis To assess the first primary object we will assess if there is a between group difference (early vs late referral to PT) for time to return sport. We will assess between group differences using a t-test if the data are parametric and a Mann-Whitney U test if the data are nonparametric.
To assess the safety of an early referral to therapy compared with a long rest period prior to therapy. We will examine the relative risk between groups for experiencing a significant recurrence of symptoms.
Secondary Outcomes for the following variables will be assessed by t-test (parametric) or Mann-Whitney U (nonparametric) for continuous data and chi-square analysis for categorical data.
Pain
* PT visits
* physician visits Michelli Function Score Compliance
Descriptive statistics will be reported for all other variables
|
Inclusion Criteria:
* Patient must have been treated by the Nationwide Children's sports medicine physicians as well as Nationwide Children's sports and orthopedic physical therapists for spondylolysis or spondylolisthesis from 2009-2013 confirmed by MRI or Bone Scan.
Exclusion Criteria:
* Diagnosis made by: X-ray, CT, suspicion
|
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] |
NCT04223544
|
Incidence of Influenza Infections and Determination of Vaccination Coverage Rate Among Healthcare Workers
|
The main aim of research is to determine of the prevalence of influenza virus and influenza vaccination coverage rate among hospital and GPs healthcare workers.
Course of research:
Participation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March).
In the last stage of the study, the results obtained from the survey questionnaire and the results of virological tests will be subject to statistical analysis and based on the data obtained, conclusions will be drawn from the study, indicating their practical application.
The results obtained from this study will be used to develop a quality improvement program to control influenza virus infection, which will improve the safety of both patients and medical staff.
|
Inclusion Criteria:
* Healthcare worker of selected General Practices or hospitals wards
|
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] |
|
NCT06868459
|
Pressure-enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease (PROTECT Registry): a Multicenter Registry
|
Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.
|
Inclusion Criteria:
1. Adults, 18 years and older
2. Having undergone PED-TAE using the TriNav Infusion System
3. Meeting one of the following criteria:
1. Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule \> 20 ml
2. Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation
3. Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure symptoms
4. Bethesda category 2-3 (benign, or atypia or follicular lesion of undetermined significance) on 2 separate fine-needle aspiration biopsy (FNAB) results with a benign molecular profile with patient declining surgical resection
Exclusion Criteria:
1. Renal insufficiency
2. Unable to tolerate angiography including pregnancy and severe allergy to contrast media
3. Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
4. \<18 years old
|
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] |
|
NCT03948412
|
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
|
This study is a multicentre, partially-blinded randomised controlled trial, with site stratified block randomisation and partial blinding of outcome assessments. Patients undergoing a renal transplant will be allocated to one of two treatment arms, where either a Prevena device of appropriate size or standard dressing is applied to the closed incision. In the case that a patient requires bilateral incisions, both incisions will be allocated to the same treatment arm and counted as a single incision.
Primary:
The primary objective of this study is to determine if the Prevena Incision Management System reduces wound complications at the surgical site following renal transplant, when compared to standard dressings. Secondary: Secondary objectives of this study include identification of risk factors for wound complications at the surgical site, as well as re-operation, prolonged hospital stay, allograft survival, delayed graft function. This study will also assess pain, scar healing and quality of life in each treatment arm, and aim to complete a cost-benefit analysis of the Prevena device in renal transplantation.
|
Inclusion Criteria:
The participant:
1. is an adult ≥ 18 years old, regardless of comorbidities or BMI
2. is able to provide their own informed consent
3. will undergo open renal transplant surgery, including those who undergo dual renal transplant or simultaneous pancreas transplant.
4. will require a surgical incision(s) likely to be able to be covered completely by one or more Prevena Incision Management Systems.
5. is willing and able to return for the required follow up assessments.
6. if concurrently enrolled in a clinical trial it must not impact on patient health or the surgical incision site and the study must be documented
Exclusion Criteria:
The participant:
1. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives.
2. Is not suitable for closure of the surgical wound, and as such the wound must be left open or an open NPWT device is required.
3. Is not willing to comply with the study procedures.
4. Has an unforseen intraoperative event mandating additional management including a planned re-exploration.
5. Has obvious intraoperative contamination of the surgical site.
6. Has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 7. Requires drains that cannot be covered by the Prevena dressing.
|
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] |
|
NCT00001261
|
Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies
|
Inflammatory myopathies are a group of muscle diseases characterized by muscle weakness, high levels of muscle enzymes in the blood, and inflammation of the tissue surrounding muscle fibers (endomysium).
The diseases making up the inflammatory myopathies are grouped into three subsets:
I) Polymyositis (PM)
II) Dermatomyositis (DM)
III) Inclusion Body Myositis (IBM)
Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids and immunosuppressive drugs. However, many patients who initially respond to these treatments develop resistance to the therapy or experience side effects causing the treatments to be stopped.
Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with PM, DM, and IBM a safer and more effective alternative to standard therapies for the diseases. IVIg is a drug that has been used successfully to treat other immune-related diseases of the nervous system.
The study will take 60 patients and divide them into two groups. Group one will receive 2 injections of IVIg once a month for three months. Group two will receive 2 injections of placebo "inactive injection of sterile water" once a month for three months. Following the three months of treatment, group one will begin taking the placebo and group two will begin taking IVIg for an additional 3 months. The drug will be considered effective if patients receiving it experience a significant improvement (\>15%) in muscle strength.
|
The inflammatory myopathies are a group of acquired muscle diseases characterized by subacute onset of progressive proximal muscle weakness, elevated serum muscle enzymes and endomysial inflammation. They comprise 3 clinically distinct subsets: polymyositis (PM), dermatomyositis (DM) and Inclusion Body Myositis (IBM). Because immune-mediated mechanisms are primarily responsible for the clinical manifestations of these conditions, the treatment of choice is with corticosteroids or immunotherapy drugs. Although most of the patients initially respond to these drugs, a number of them become resistant or develop unacceptable side effects that necessitate their discontinuation. The need for a more effective and safe immunotherapy in patients with PM, DM or IBM prompted the present study using high dose intravenous immunoglobulin (IVIg). IVIg is an immunomodulating agent which has been shown to be effective and safe in the treatment of a number of patients with immune-related neuromuscular diseases.
This is a double-blind, randomized, placebo-controlled study involving 30 patients, who will receive IVIg or placebo for 3 months and then will cross-over to the alternate therapy for another period of 3 monthly infusions. The monthly dose of IVIg is 2 GM/Kg divided into two daily doses. The drug will be considered effective if patients experience an increase of more than 15% in their baseline muscle strength. Muscle strength will be assessed with a series of objective dynamometric measurements performed before and at the end of each monthly infusion.
|
INCLUSION CRITERIA:
Selected patients should have PM, IBM or DM.
Specifically they should have a) proximal muscle weakness; b) no evidence of clinical, histological or family history of another neuromuscular illness; c) elevation of muscle enzymes during the course of the disease; d) typical skin rash in case of DM; and e) diagnostic muscle biopsy.
Suitable candidates for IVIg should be patients with active, bonefide disease who:
1. have been treated with steroids but had: a) no response or incomplete response (as defined by continued muscle weakness) to high-dose therapy or b) a good response to steroids but inability to taper the dose without a flare of disease activity or c) unacceptable steroid side effects such as gastrointestinal hemorrhages, osteonecrosis, hyperglycemia, extreme weight gain etc., and
2. have been treated with one immunosuppressive drug (such as azathioprine, Methotrexate, Cyclophosphamide, Cyclosporine) but without benefit or with unacceptable side effects.
EXCLUSION CRITERIA:
Pregnant or nursing women (confirmed by a screening pregnancy test).
Critically ill patients such as those requiring intravenous pressors for maintenance of cardiac output due to severe cardiomyopathy, patients with respiratory insufficiency and patients with severe muscle weakness requiring help for basic self care.
Children below age 18.
Patients with severe renal or hepatic disease, severe COPD or coronary artery disease or other systemic medical problems often seen when PM or DM is associated with severe cases of lupus, rheumatoid arthritis or scleroderma.
Patients with known allergic reaction to IVIg.
Serum IgA less than 11mg/dl.
|
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] |
NCT04808011
|
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
|
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes three periods:
1. First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
2. Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
3. Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
|
This is a multi-center, open label, cross-over clinical study. A total of 20 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). The expected timeframe between phase I and phase II is up to 4 weeks. An additional cohort, Cohort 2, will be added to Phase I, which will include additional ten (10) subjects. These subjects will undergo the same procedure at the dialysis clinic, with the addition of blood sampling for CBC and Chemistry two (2) hours ±30 minutes after the procedure. A total of 20 subjects from either cohort, meeting the inclusion and exclusion criteria of Cohort 1, will continue to complete the second phase of the study (Phase II).
Phase II of the study includes three periods:
First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
|
Inclusion Criteria:
* Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
* Male or female, Age \>18 years
* Mental ability to understand study procedures and provide an informed consent
* More than 3 months on PD (Peritoneal Dialysis)
* At least 3 daily exchanges
* Self-treated subject
* Stable PD prescription for the last month
Exclusion Criteria:
* Need of cycler (APD, Automated Peritoneal Dialysis)
* Known mechanical problem (drainage, fill) during the last month prior to enrollment
* Pregnant or breastfeeding women
* subject who is unwilling or unable to comply with study procedures
* Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
* Known Congestive heart failure stage III- IV
* Non-elective hospitalization during the last 3 months prior to enrollment
* Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
* Participation in any other clinical study within 4 weeks prior to enrollment
|
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-0.01913241483271122,
-0.6967880725860596,
0.2473273128271103,
0.03696348890662193,
0.03488677740097046,
-0.37728768587112427
] |
NCT03222778
|
Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery
|
In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid resuscitation guided by reliable preload indices is of pivotal importance as only half of them are fluid responsive, and that empiric fluid administration actually leads to dismal prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'), and LV stiffness (e'/a'). Although the left ventricular end-diastolic area (LVEDA) alone is not a valid predictor of fluid responsiveness, combining LVEDA with these indices would provide comprehensive information regarding the LV dimension, preload, and compliance as well as systolic function. Also, it seems logical to assume that patients with low LVEDA and high e' velocity indicating preserved early diastolic relaxation or low e (early mitral inflow velocity) /e' ratio indicating normal LV filling pressure would more likely be fluid responsive. Yet, these assumptions have not been tested before. Moreover, these values can be reliably obtained regardless of the heart rhythm, except for a', and do not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the aim of this prospective trial is to investigate the role of LVEDA combined with e, e', a' or s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump coronary bypass surgery, in closed-chest conditions.
|
Inclusion Criteria:
1. the patients scheduled for off-pump coronary bypass surgery
2. tha age ≥20 yrs old
3. the patients who are willing to provide written informed consent
Exclusion Criteria:
heart rhythm other than sinus, L, septal and/or lateral wall motion abnormalities, and a
1. New York Heart Association functional class ≥III
2. LV ejection fraction \<40%
3. emergency operation
4. the patients with preoperative septal and/or lateral wall motion abnormalities
5. contraindications to transesophageal echocardiography or balanced 6% hydroxyethyl starch 130/0.4
6. the patients with any valvular heart disease ≥moderate degree
7. No communication possible due to a language barrier or deafness
|
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|
NCT00803452
|
Lipids of the Human Tear Film and Their Effect on Tear Stability
|
This prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
|
Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for two months; treatment with topical azithromycin is for one month. Following treatment, meibomian glands are again expressed and the lipids measured by spectroscopy (FTIR, MALDI-TOF, NMR)for characterization of structure and function. Analysis for presence of doxcycline or azithromycin is also performed. Changes in lipid parameters are correlated with clinical signs and symptoms of disease.
|
Inclusion Criteria:
* Meibomian gland dysfunction
Exclusion Criteria:
* Lid margin scarring; herpetic blepharitis
|
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] |
NCT01168843
|
Computer Program for Evaluation of the Symmetry Between the Primary Sulci of the Two Fetal Brain Hemispheres and Midsagittal Fetal Head Biometry Using 3-dimensional Ultrasound Planes.
|
Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes
This retrospective study is based on the computerized analysis of the orthogonal fetal brain planes.
The images are obtained from the digital archive of the fetal sonographic examinations done in Bnai Zion Medical Center.
In addition, midsagittal measurements of fetal head will be obtained from this archive of 3-dimensional images.
Study measurements will provide the quantitative parameters of normal fetal brain sulcation. Normal fetal head growth in midsagittal plane will be studied also.
|
Inclusion Criteria:
* normal pregnancies
* proper dating
Exclusion Criteria:
* complications of pregnancy
* fetal malformations
|
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|
NCT02457689
|
The Safety and Immunogenicity of the DNA-GTU Vaccine Administered to HIV-infected Patients on ART vs Placebo
|
CUT\*HIVTHER 001 is a randomised placebo-controlled Phase I/II study aimed at exploring the safety and immunogenicity of two different modes of delivery of a GTU® DNA plasmid vaccine (GTU®-multiHIV B clade) in HIV infected volunteers on antiretroviral therapy (ART):
* Transcutaneous (TC) delivery to enhance intramuscular delivery and
* Electroporation (EP) enhanced intramuscular delivery Participants will be randomised 1:1:1 to TC:EP:saline for the purposes of analysis. Half the saline group will receive TC saline and half will receive EP saline.
30 HIV infected male and female volunteers aged 18-45 years, who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements \< 50 copies HIV RNA/ml prior to enrolment.
The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen which is a synthetic fusion protein consisting of full-length polypeptides of Rev, Nef, Tat, p17 and p24 and containing more than 20 Th and CTL epitopes of protease, reverse transcriptase (RT) and gp160 regions of the HAN2 HIV-1 B clade.
Vaccine is provided in sealed vials at 2mg/ml, and a single 1ml IM injection of 2mg GTU®-MultiHIV DNA IM (into the thigh) is required to deliver a 2mg dose. Individuals in Group 2 will receive a further 0.4mg GTU®-MultiHIV DNA in 0.2ml administered by TC, a novel needle-free method of vaccine delivery.
|
The investigators are exploring combination regimens with the overall aims of (i) optimising immune responses and (ii) developing safe and well tolerated strategies which will favour the development of T-cell responses that may enhance anti-HIV HIV therapy with the forward looking goal of working towards functional eradication of infection. The investigator proposes to combine the previously used IM and TC methods because preclinical data suggest that the combination of methods will favour the development of CD8 T cell responses. All groups will receive 6.0mg of the vaccine IM given in 3 doses over 12 weeks. Group 1 will receive the 6.0mg IM with electroporation (EP) and Group 2 will receive the 6.0mg IM without EP but together with an additional 1.2mg vaccine TC. The primary immunogenicity endpoint will be to determine whether either intervention group augments the cellular responses to vaccine specific peptides in relation to baseline. It is anticipated that none of subjects receiving saline placebo would have an increase in vaccine specific responses relative to those at baseline. Therefore if the differences between the active groups and saline placebo are sufficiently large, for example 80% responders in a GTU®-MultiHIV DNA active group, \<10% in the control group, this would be significant.
Should the regimes prove safe, acceptable and induce significant immunogenicity then the intention is to move one or both regimes into a larger study powered to determine their potential long-term impact on therapy when used in combination with conventional ARV regimens. Proof of concept that DNA vaccination can induce de novo HIV specific responses that are associated with control of viral replication, would justify further investigation of their use in immunotherapies combined with ART intensification and/or anti-latency drugs.
|
Inclusion Criteria:
1. Male or female
2. Aged between 18 and 45 years on the day of screening
3. BMI between 19-30
4. Available for follow-up for the duration of the study
5. Willing and able to give written informed consent
6. HIV-1 Clade B infection documented by confirmed antibody test
7. Confirmed on 2 separate occasions in the 6 month period prior to enrolment to have viral load \< 200 copies HIV RNA/ml whilst on ART
8. Nadir CD4+ \> 250 CD4 lymphocytes AND screening CD4 \>200 CD4 lymphocytes
9. Willing to avoid UV tanning or strong sun exposure during the immunisation period of the study
10. Willing to avoid all other vaccines within four weeks of scheduled study vaccinations
11. If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; consistent record with condoms if using these; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
12. If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
Exclusion Criteria:
1. Pregnant or lactating
2. Use of regular topical treatment on the injection or application site within the last four weeks
3. UV tanning sessions or strong sun exposure within four weeks prior to enrolment
4. Excessive terminal hair growth on the investigational skin areas (to be assessed by reference to a photograph which will be available during screening visit)
5. Individuals in which a skin-fold measurement (cutaneous and subcutaneous tissue) of the upper right or left thigh exceeds 40 mm
6. Clinically relevant abnormality on history or examination including
* history of grand-mal epilepsy, seizure disorder or any history of prior seizure
* history of syncope or fainting episodes within 1 year of study entry
* liver disease including active hepatitis B (surface antigen positive) or C (PCR positive)
* any skin condition which may interfere with the trial assessment of the injection site
* haematological, metabolic, gastrointestinal (excluding gastritis) or cardio-pulmonary disorders (excluding mild asthma)
* a clinically significant abnormality on the ECG
* autoimmune disease, or use of regular, systemic immunosuppressives in preceding 3 months
7. Known hypersensitivity to any component of the vaccine formulations used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents
8. History of severe local or general reaction to vaccination defined as
1. local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
2. general: fever \>= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
9. Receipt of live attenuated vaccine within 60 days of enrolment and any vaccine within 30 days of enrolment.
10. Receipt of an experimental vaccine containing HIV antigens at any time in the past
11. Receipt of immunoglobin within 4 months of screening
12. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
13. Grade 2 or above routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
14. Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
15. Presence of any surgical or traumatic metal implants at the sites of administration
16. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
17. Unlikely to comply with protocol.
|
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] |
NCT01745159
|
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
|
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
|
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
|
Inclusion Criteria:
1. Diagnosed as AD according to Williams diagnostic criteria.
2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
3. At least approximately 10 % of body area
4. Patient is able to reach the centre within 3 days in case of a disease exacerbation.
5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
|
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] |
NCT04064125
|
Dermal Cumulative Irritant Patch Study
|
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
|
Inclusion Criteria:
* Healthy males or females who were 18 years of age or older.
* Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema.
Exclusion Criteria:
* Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction.
* Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
|
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] |
|
NCT01592630
|
Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
|
The control of postoperative pain has become a major issue in surgery awareness and it is considered an important measurement of patient satisfaction. Improvements in pain relief, including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to the surgical patient. When pain is aggressively addressed, patients respond by recovering faster.
The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting local anesthetic wound infiltration has been widely recognized as a useful adjunct to multimodal postoperative pain management. On that basis, a system that delivers a continuous local anesthetic to the surgical wound was developed, and better pain control has been achieved after several surgical procedures.
In patients undergoing abdominal procedures, such as colon resection, adequate pain control remains an issue. It is known that innervation to the antero-lateral abdomen is provided by sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been described and has shown to be effective for immediate postoperative pain control.
Recently, the use of the On-Q pain relief system with catheters placed within the TAP has been evaluated. Published results have shown significant improvement of pain control (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of prospective trials investigating the effectiveness of a continuous wound infusion with local anesthetics after general surgery procedures the investigators sought to determine the efficacy of this technique after laparoscopic colon resection procedures.
|
Inclusion Criteria:
* Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
* Patients must be able to read and write English.
Exclusion Criteria:
* Patients undergoing open procedures.
* Lap converted to open procedures.
* Patients with known liver dysfunction, or the following laboratory assays: ALT/AST/alk. Phos/total bilirubin of 2x ULN
* Cirrhosis Child's class A-C, INR \>1.5. There is no specific isolated value of protein or albumin which would disqualify the subject.
* All emergent/urgent cases taken to the OR for colon resections.
* All patients with previous drug abuse/narcotic abuse history.
* Patients without the mental capacity to consent for the procedure/study.
* Subjects requiring a translator in order to sign the informed consent.
* Subjects with a history of an allergic reaction to local anesthetics or acetaminophen.
|
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] |
|
NCT00004114
|
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer
|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.
|
OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.
OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.
|
DISEASE CHARACTERISTICS: Histologically proven advanced hematologic malignancy unsuitable for standard allogeneic bone marrow transplantation One of the following types: Refractory or relapsed acute myelogenous or lymphocytic leukemia Over 55 years Chronic myelogenous leukemia and failed interferon treatment Over 55 years Lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, or multiple myeloma: Refractory OR More than 2 relapses OR Relapse after autologous peripheral blood stem cell transplantation Myelodysplastic syndrome other than refractory anemia Severe aplastic anemia Under 55 years and either organ dysfunction or not eligible for standard allogeneic bone marrow transplant due to one or more of the following: Chronic hepatitis LVEF less than 50% Karnofsky less than 70% Unrelated matched donor available
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
|
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] |
NCT05036902
|
The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer
|
Oral cancer (including the lip) alone, with 300.373 cases worldwide in 2012, is the predominant head and neck squamous cell carcinoma. With an incidence of 6.5 cases per 100.000, south - east asia has the highest incidence worldwide. Many of these cases do present at a locally advanced stage, which often requires combined modality treatment that includes extensive surgery to the primary site and neck and flap reconstruction. This is often followed by either adjuvant radiation or chemo-radiotherapy. This treatment can come with a significant morbidity affecting the self-care ability of the patients as well as impact the quality of life(QOL) (3,4).At the SingHealth Duke - NUS Head and Neck Centre 340 complex cases of head and neck cancer (HNC) involving flap reconstructions and extensive resections have been operated in 2014 alone. Almost all of these patients need further adjuvant treatment (radiotherapy and/or chemotherapy). Side-effects following such treatments, Significant number of patients underwent subsequent adjuvant treatment. The adjuvant treatment and surgery may render these patients weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the patient's fitness. While survival remains the most important outcome in oncologic treatment, recovery of treatment related morbidity and return to pre-treatment QOL for patients after cancer treatment is equally important.
The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients. By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients, the team aims to identify the risk factors that necessitate a more aggressive rehabilitation. This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner. Ultrasound (US) elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements. Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles, however no study thus far has correlated these findings with functional measurements. Hence this trial aims to establish the following:
1. Due to the limited available data: to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness, physical function of the neck and shoulder \& QOL of HNC patients
2. To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial
3. To identify performance markers in these patients, that allow a more targeted rehabilitation process
4. Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate. The understanding we gain through objective analysis apart from targeted treatment for every individual patient, in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden.
|
The investigators will conduct a prospective cohort study by recruiting patients who are admitted to NCCS for HNC surgery. It will be a pilot study targeting 10 patients to compare physical functions and QOL 1 to 2 weeks pre-surgery, 3-6 weeks post-surgery and 6 months post-surgery. The results from phase I will be used to plan the sample size for the following phase. Each visit will take approximately 4 hours.
Assessment of Physical Functions
1. Shoulder Range of Motion (ROM) and strength for both arms (1 hour):
Routinely practiced by Physiotherapists as a part of evaluation for any patient referred for shoulder physiotherapy. These will be measured by the Dynamometer (Biodex S4 Pro) with patients in a seated position. Active and passive shoulder movements include abduction, adduction, and flexion, and extension, internal and external rotation. Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer. The measures will be done in the positions stated below:
1. Bilateral knee extension at 90 degree knee flexion. Unit measure: kg
2. Bilateral shoulder flexion at 45 degree shoulder flexion. Unit measure: kg Shoulder Pain and Disability Index (SPADI) questionnaire will also be administered to evaluate shoulder pain and impairment.
2. Point of gaze measurement (30 mins):
A non-invasive assessment tool to assess head and neck movement. Head range of movement will be assessed pre and post treatment using a light source together with the motion capture system. Participants will be seated in the middle of the room with reflective markers placed on their head and shoulder. The participants will keep their gaze fixed on the light source and then rotate the head as far as possible without losing gaze fixation. The light source will move in different planes. This will allow the impact of surgical treatment on head and neck mobility to be assessed. Head movement, relative to the thorax will be measure in 3 dimensions. Restrictions in flexion, lateral flexion and rotation will be quantified along with angular velocity and acceleration.
3. Muscle activation patterns will also be evaluated using EMG (30 mins):
Routinely practiced in physiotherapy.
Sternocleidomastoid muscle:
Sternal head and clavicular head on cervical contralateral rotation and ipsilateral cervical flexion
Serratus anterior:
Supine, shoulder at 90° flexion, elbow fully extended - Resistance applied into shoulder retraction
Rhomboid major muscle:
Prone, head rotated ipsilaterally - Scapula adducted and elevated. Elbow fully flexed, shoulder extended and adducted Resistance applied into shoulder abduction and depression
Upper trapezius muscle:
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
Middle trapezius muscle:
Scapula elevation in sitting - Resistance applied into shoulder depression and cervical spine contralateral flexion
4. Grey-scale (B-mode) ultrasound and Shear-wave elastography imaging (1 hour) Non-invasive and of standard clinical care practice, however elastography, a non-invasive test is a new dimension to this test to assess the density and rigidity of muscles (practised in the area of breast surgery) and new application for head and neck cancer patients.
To allow assessment of tissue stiffness via elastography the following protocol will be employed:
Grey-scale and shear-wave ultrasound elastography will be performed at baseline (pre-op), 4-weeks and 6-months post-op. All examinations will be performed with the patient supine and neck extended; using the SuperSonic ultrasound machine (Aixplorer; SuperSonic Imagine, Aix-En-Provence, France) that equipped with a 15-MHz superficial linear transducer.
Grey-scale (B-mode) ultrasound:
The examination will begin with grey-scale ultrasound to assess the sternocleidomastoid (SCM, or trapezius) muscle thickness. In order to ensure consistency in image acquisition and reproducibility of the ultrasound scans at follow-up, the thickness of the SCM (or trapezius) muscle will be measured on the longitudinal plane, at the of the upper edge of the thyroid cartilage.
The thickness measurement will be repeated once (i.e. 2 sets of thickness measurements will be obtained) and the mean values will be recorded for final analysis.
After recording the grey-scale images, real-time shear-wave elastography will be obtained with the participants in the same position.
Shear-wave elastography imaging:
On longitudinal image, the SCM (or trapezius) muscle will be divided into proximal, mid and distal sections. The shear-wave elastography imaging mode will be activated.
A rectangular acquisition box displaying the color map of differential tissue stiffness (red: stiff area; blue: soft area; and green/yellow: intermediate stiffness) will be placed in the centre of the field of view. The shear-wave velocity (in meters per second) will be measured on the longitudinal shear wave image by placing a circle ROI that covers almost the entire muscle tissues in the rectangular acquisition box.
The shear-wave image acquisition will be repeated for mid and distal third SCM sections. 2 sets of muscle velocity (m/sec) and elasticity (kpasc) values will be recorded for each SCM section. The mean of the measurements will be used for final analysis \[Note: The velocity of shear wave propagation is directly related to tissue stiffness (Velocity increases with stiffness). The entire length of SCM muscle is approximately 13-15cm. The transducer length is 5cm. The investigators divide each SCM muscle into thirds for evaluation to allow overlapping scans and maximise assessment of SCM muscle stiffness
5. Fitness
Treadmill (Modified Bruce protocol) (45 mins):
Treadmill is a time tested test as a part of cardiac and pre-anesthetic work up, however in this study the application is new perspective to assess fitness in head and neck cancer patients. The modified Bruce commenced at 2.7km/h at 0% incline for 3 minutes followed by 2.7km/h at 5% incline for 3 minutes before going to the next stage which is the real STAGE 1 of the Bruce protocol. As for estimating the VO2- there is a linear relationship between HR and VO2 peak or HRR and VO2R, provided the subjects' HR is not attenuated eg. those on beta blockers.
6-minute walk test (6MWT) (10 mins) For the 6MWT, subjects are require to walk laps of 20m at the fastest they are able to perform over the period of 6 minutes. Subjects would be allowed to stop and rest within the allocated time period.
1. Total distance. Unit measure: m
2. Predicted distance: Unit measure: %
3. Predicted VO2 max: Unit measure: mL/(kg·min) 6. Assessing sensory loss secondary to incision / flap elevation and adjuvant therapy (5 mins) Routinely practised in Neurology the application specifically for head and neck cancer patients is focused way of assessing post-operative outcome may not be routinely practiced.
Mapping Sensory Loss: Dermatomes C2 to T5 via the sharp blunt test as routinely used in neurological assessment 7. Assessment of QOL (10 mins) Has been routinely practiced in head and neck cancer and is a component of standard clinical care, however not mandatory.
QOL will be evaluated by administering the evaluated SPADI, EORTC QLQ H\&N35 and EORTC QLQ C30 questionnaires, which are already used as part of the general QOL assessment of the head and neck cancer patients in the Singhealth DukeNUS Head \& Neck Centre. Besides the assessments, all subjects will undergo physiotherapy intervention (approx 1 hour) immediately after surgery, once stable and allowed by the medical team all subjects will be ambulated as tolerated, as per post-operative protocol.
Two weeks after surgery or when allowed by medical team, whichever is later, the subjects will be guided to progress follow the work-out with the following routine for the period of three to six months post-surgery.
|
Inclusion Criteria:
1. Patients with histologically proven cancers of the upper aero-digestive tract (oral cavity, oropharynx, nasopharynx or pharynx), skin, thyroid or salivary glands;
2. Case has been indicated for surgical treatment and following adjuvant treatment in the multidisciplinary head and neck tumour board
3. Age: 21 - 70 years
4. ECOG 0 or 1
5. Able to give informed consent
Exclusion Criteria:
1. Patients who are not able to undergo primary resection of their HNC(not fit for general anesthesia)
2. Patients with distant metastases or incurable recurrent disease
3. Patients who are currently pregnant or breastfeeding
4. Patients with a history of shoulder surgery or trauma, or any known joint pathology such as rheumatologic disorders, or prior neurological disease affecting the upper and or lower extremity such as stroke;
5. Patients who are receiving a free fibular flap as part of their reconstruction
6. Patients who are on a permanent tracheostomy e.g. after a total laryngectomy
7. Patient with ischaemic heart disease or with current beta blocker medication
|
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] |
NCT01725503
|
Creatine Kinetics, Synthesis From Glycine and Response to Creatine and Amino Acid Supplement in Healthy Humans
|
The goal of the present study is to quantify the rate of synthesis of creatine in healthy controls and endurance trained subjects. In addition, the effect of oral creatine supplement for seven days on creatine kinetics will be examined.
Ten healthy controls (age 20-35 years) and ten endurance trained subjects will be recruited by advertisement. Endurance trained subjects will be recruited from health clubs. They will be screened for absence of any chronic disease (history, physical examination, CBC, metabolic and liver panel, urinalysis). A DEXA measurement will be done to quantify whole body skeletal muscle mass.
For five (5) days prior to the study, they will be placed on a creatine-free (essentially meat-free) diet. Dietary compliance will be ensured by repeated communication with the subject, by nurse coordinator and the CRU Nutritionist. Subject will maintain daily record of the food intake for validation. On the last day, i.e. 24 hours prior to the tracer study, subject will collect the 24 hours urine sample and bring it to the CRU on the day of the study.
|
Creatine and phosphocreatine are the major intracellular buffers for adenosine triphosphate. They also function as the energy shuttle for high energy phosphate from the mitochondrial site of production to the cytoplasmic site of utilization. In addition, creatine has been shown to affect satellite cell proliferation and differentiation and increase cell mitotic activity during compensatory hypertrophy in rat skeletal muscle. Creatine is synthesized from three amino acids: glycine, arginine and methionine. Although creatine metabolism has been studied extensively in the rat, the data regarding the kinetics of creatine and their regulation in humans are limited. This is in part due to a large and slow turning over pool of creatine and lack of good tracer methods. Using a recently developed stable isotopic tracer method (by us), we propose to quantify the rate of synthesis of creatine and its regulation in healthy subjects and in those with large skeletal muscle mass as a result of endurance training. In addition, the response to oral creatine administration on creatine kinetics will be quantified. The site of regulation will be identified by the relative rate of appearance of tracer glycine in guanidinoacetic acid and creatine. It is hypothesized that the fractional rate of synthesis of creatine will be higher in endurance trained subjects, and that creatine will suppress the rate of synthesis of creatine. Since creatine is critical for the maintenance of skeletal muscle mass and satellite cell proliferation, these data will provide the normative physiological data for future studies of subjects with manifest sarcopenia, such as aging, and those with chronic diseases, e.g. cirrhosis of liver. These data will form the basis for the studies of creatine metabolism in neurodegenerative disorders where creatine is being increasingly used as a therapeutic agent.
|
Inclusion Criteria:
* Healthy controls and endurance trained subjects
* Both males and females will be studied.
Exclusion Criteria:
* any illness
* on any medications and/or supplements
|
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] |
NCT05484687
|
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
|
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.
|
Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.
|
Inclusion Criteria:
* colorectal tumor patients
Exclusion Criteria:
* Weight \<45kg and \>100kg
* Sensitivity or hypersensitivity to lidocaine
* Second or third degree heart block
* Severe heart failure (ejection fraction \< 20%)
* History of active rhythm disorder
* Acute severe liver and kidney injury
* History of uncontrolled seizures
* History of acute porphyria.
|
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] |
NCT03274258
|
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
|
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
|
PRIMARY OBJECTIVES:
I. To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
SECONDARY OBJECTIVES:
I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC.
II. To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|
Inclusion Criteria:
* Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy.
* Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry. Patients with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible. The principal investigator (PI) is the final arbiter in questions related to eligibility.
* Patients will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.
* Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures \>= 15 mm with conventional techniques or \>= 10 mm with more sensitive techniques such as magnetic resonance imaging (MRI) or spiral computerized tomography (CT) scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
* Patients should be willing to provide a newly obtained fresh core biopsy of a tumor lesion. Not required if there is a recently obtained fresh specimen on an Institutional Review Board (IRB) approved correlated trial up to 6 weeks (42 days) prior to initiation of treatment on day 1.
* Patients can be either naive for any previous systemic treatment or have had any number of prior systemic therapies. However, patients must not have received prior anticancer therapy with anti-PD1, anti-PD-L1, or anti-CTLA-4 immune checkpoint inhibitors.
* There must be evidence of progression on or after last treatment regimen received. NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Consent to MD Anderson companion laboratory protocol 2014-0938.
* Hemoglobin \>= 9 g/dl (treatment allowed) (within 14 days of the first dose of the study drugs).
* Absolute neutrophil count \>= 1000/mcL (within 14 days of the first dose of the study drugs).
* Platelets \>= 75,000/L (within 14 days of the first dose of the study drugs).
* Total bilirubin =\< 1.5 mg/dl (within 14 days of the first dose of the study drugs).
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (ULN), except in known hepatic metastasis, wherein may be =\< 5 x ULN (within 14 days of the first dose of the study drugs).
* Serum creatinine =\< 1.5 x ULN by gender (as long as patient does not require dialysis) (within 14 days of the first dose of the study drugs); May receive transfusion; Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days; If creatinine is not \< 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard and creatinine clearance (CrCl) must be \> 30 mL/kg/1.73 m\^2.
* International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 x ULN prior to study entry. Therapeutic anticoagulation with warfarin is allowed if target INR =\< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for \> 2 weeks (14 days) at the time of enrollment.
* Patients with controlled brain metastases are allowed on protocol if they had solitary brain metastases that was surgically resected or treated with radiosurgery or Gamma knife, without recurrence or edema for 1 month (4 weeks).
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of the study drug.
* Women must not be breastfeeding.
* WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion.
* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 90 days duration of sperm turnover for a total of 5 months post-treatment completion.
* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described in these sections.
Exclusion Criteria:
* Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Patients currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapy) within 2 weeks (14 days) prior to study day are excluded. Patients who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination ipilimumab plus nivolumab are eligible.
* Patients, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks \[28 days\] to heal) within 4 weeks (28 days) of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that are expected to require major surgery, other than cytoreductive nephrectomy +/- retroperitoneal lymph node dissection, during the course of the study.
* Patients who have organ allografts.
* Known or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's granulomatosis) are excluded from this study. Patients with a history of Hashimoto's thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. If hepatitis C antibody test is positive then active infection has to be confirmed by hepatitis C RNA testing for the patient to be excluded.
* Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting.
* Patients must not have received prior anticancer therapy with anti-PD1, anti-PD-L1, or anti- CTLA-4 immune checkpoint inhibitors.
* Patients receiving any concomitant systemic therapy for renal cell cancer are excluded.
* Patients must not be scheduled to receive another experimental drug while on this study.
* Patients who are on high dose steroid (e.g., \> 10 mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intraarticular, ocular, or intranasal corticosteroids (with minimal systemic absorption) are allowed. A brief course (\< 48 hours) of systemic corticosteroids for prophylaxis (e.g., from contrast dye allergy) is permitted. Physiological corticosteroid replacement therapy for adrenal insufficiency is also permitted.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a) Symptomatic congestive heart failure of New York heart Association class III or IV; b) Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; c) Severely impaired lung function as defined as oxygen (O2) saturation that is 92% or less at rest on room air; d) Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 x ULN; e) Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment; f) Known active or symptomatic viral hepatitis or chronic liver disease. Uncontrolled adrenal insufficiency.
* Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ipilimumab or nivolumab or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
* Patients should not receive immunization with attenuated live vaccines within one week (7 days) of study entry or during study period; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods as defined above. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception.
* Any patients who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.
|
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] |
NCT01355289
|
Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501
|
To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.
|
This study had three phases: Prerandomization (Screening), Randomization (Core Study), and Open-Label Extension (OLE). The Randomization Phase included Treatment Periods A1 and A2 and a Follow-up Period (for those participants not continuing into the OLE phase). The OLE Phase included Treatment Periods B1, B2, and B3 (depending on when a participant entered the OLE), and a Follow-up Period. Participants may have been followed for sustained viral response, if appropriate. In the Core Study (randomization phase) participants were randomized (in a 1:1:1:1 ratio) to receive one of four treatments (placebo or avatrombopag \[10mg, 20mg, and 30mg\] for up to 21 days. Participants who successfully completed Treatment Period A1, (platelet count \>=100x10\^9/L) initiated antiviral treatment with pegylated interferon (PEG-IFN) alpha-2a and progressed to Treatment Period A2. Participants with a platelet count \>=150x10\^9/L initiated antiviral treatment and progressed into Treatment Period B2, study drug was interrupted then eventually restarted at 10 mg daily once their platelet counts returned to acceptable levels. Those who were not considered successful after 21 days in Treatment Phase A1 were withdrawn from the Core Study (Part A) and were eligible to enter the OLE at Treatment Period B1. Participants who chose to not enter the OLE entered into the Follow-up Phase. At the end of Treatment Period A2, eligible participants could enter the OLE at Treatment Period B3. In the OLE Phase, participants entering into Open-label Treatment Period B1 began once-daily treatment with avatrombopag at a dose of 20 mg without titration for up to 21 days. Once the participant's platelet counts were sufficient, they entered Treatment Period B2. Participant's eligible to enter into Treatment Period B2 received avatrombopag and antiviral treatment for 13 weeks. Participants who successfully completed Treatment Period A2 or B2 could continue on antiviral treatment for up to a maximum of 48 weeks (including the 13 weeks in Treatment Periods A2 or B2) and open-label avatrombopag, at the investigator's discretion. In Treatment Period B3, the dose of avatrombopag was allowed to be titrated up or down in accordance with the participant's platelet count response, within the range of a minimum of 5 mg and a maximum of 50 mg. In the Follow-up Period, participants were seen at either a single 30-day follow-up visit or followed for the full 30 days after the last dose of avatrombopag.
|
Inclusion Criteria:
1. Males or females greater than or equal to 18 years of age
2. Women of childbearing potential must agree to use a highly effective method of contraception for at least one menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug
3. Subjects with chronic HCV-related thrombocytopenia (defined as a platelet count greater than or equal to 20x10\^9/L to 70x10\^9/L) who require antiviral treatment
4. Chronic HCV infection (defined as the presence of anti-HCV antibodies and detectable serum HCV RNA levels)
5. Model for End-stage Liver disease score greater than or equal to 24
6. Adequate renal function as evidenced by a calculated creatinine clearance greater than or equal to 50 mL/minute per the Cockcroft and Gault formula
7. Life expectancy greater than or equal to 3 months
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in the study:
1. Any history of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), thrombosis (partial or complete) in the main portal vein and portal vein branches, and thrombosis of any part of the splenic-mesenteric system
2. Any evidence of current portal vein thrombosis (PVT) as detected by Doppler sonography and portal vein flow rate less than 15 cm/second at Screening or within 30 days prior to Screening (revised per Amendment 02)
3. Any known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency)
4. Evidence of myocardial infarction in the last 6 months or uncompensated congestive heart failure (New York Heart Association Class III or IV)
5. Co-infection with human immunodeficiency virus (HIV) or hepatitis B or acute hepatitis C
6. Any prohibited concomitant medications or therapy that cannot be discontinued by Visit 1, e.g., subjects currently receiving interferon who cannot undergo a 4-week washout period prior to Screening, or subjects who receive blood products that affect platelet count within 1 week prior to Screening (revised per Amendment 02)
7. Weekly alcohol intake greater than 21 units (168 g) \[male\] and greater than 14 units (112 g) \[female\]
8. Any known medical condition, other than chronic liver disease, that can lead to thrombocytopenia
9. History of hepatocellular carcinoma, metastatic liver cancer, or liver transplantation (revised per Amendment 01) (revised per Amendment 02)
10. History of idiopathic thrombocytopenic Purpura (ITP)
11. History of myelodysplastic syndrome
12. History of pernicious anemia or subjects with vitamin B12 deficiency (defined as less than the lower limit of normal \[LLN\]) who have not had pernicious anemia excluded as a cause (Added per Amendment 02)
13. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that, in the opinion of the investigator, could affect the subject's safety or study conduct
14. Subjects with a history of suicide attempts
15. Subjects with a history of hospitalization for depression within the past 5 years
16. Subjects with any current severe or poorly controlled psychiatric or seizure disorder
17. Current use of recreational drugs
18. Subjects who have participated in another investigational study within 30 days prior to Visit 1
19. Subjects with hypersensitivity, intolerance, or allergy to E5501 or any anti-HCV therapies or their ingredients
20. Any past or current (revised per Amendment 01) medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study
21. Scheduled for surgery during the projected course of the study
22. Subjects who have any medical conditions or diseases that would contraindicate treatment with anti-HCV therapy (added per Amendment 01)
23. Subjects who are currently treated with proton pump inhibitors (PPIs) or H2-antagonist therapy but have not been receiving a stable dose for at least 6 weeks prior to randomization or have not completed these therapies more than 2 weeks prior to randomization (added per Amendment 01)
24. Fasting gastrin-17 blood levels exceeding 1.5 times the upper limit of normal (ULN) at Screening (including subjects on PPIs or H2 antagonists) (revised per Amendment 02)
25. Subjects with a history of gastric atrophy (added per Amendment 02)
|
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] |
NCT04413344
|
Repurposing Bromocriptine for Abeta Metabolism in Alzheimer's Disease
|
To investigate the safety and efficacy of an orally administered dose of TW-012R in patients with Alzheimer's disease bearing PSEN1 (presenilin 1) mutations (PSEN1-AD), using a placebo group as a control. In addition, long-term safety will be examined in an open-label extension trial.
|
Inclusion Criteria:
* Alzheimer's disease patients with PSEN1 mutations
* Patients diagnosed with "probable AD" according to the diagnostic guideline of NIA-AA or "probable Alzheimer-type dementia" according to the diagnostic criteria for Alzheimer's disease specified in DSM-5
* An MMSE-J score of \<= 25
* Patients whose cognitive function and everyday function are obviously impaired based on their medical record or information provided by a person who knows the patient well
* Patients for whom intellectual disability and mental disorders other than dementia can be ruled out based on their academic background, work history, and life history.
* Patients with a reliable and close relationship with a partner/caregiver
* Age\>=20 years at the time of giving informed consent
* Written informed consent has been obtained from the patient or his/her legally acceptable representative to participate in this trial
Exclusion Criteria:
* Difficulty with the oral intake of tablets
* Patients receiving anti-dementia drugs who have changed the dosing regimen during the 2 months prior to giving informed consent
* Patients with dementia due to pathology other than Alzheimer's disease (e.g., vascular dementia, frontotemporal dementia, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, Huntington's disease, and prion disease)
* Presence of clinically relevant or unstable mental disorders. Patients with major depression in remission can be enrolled.
* Imminent risk of self-harm or harm to others
* Body mass index (BMI) of \<= 17 or \>= 35
* Patients with a history of alcohol dependence, drug dependence, or drug abuse within the 5 years before providing informed consent
* HBs antigen positive
* Anti-HIV antibody positive
* Anti-HTLV-1 antibody positive
* Patients with an active infection, such as hepatitis C and syphilis (STS/TPHA)
* Patients with the following liver function values on the test before enrollment
* AST(GOT) \> 4.0 x Upper limit of the institutional reference range or
* ALT (GPT) \> 4.0 x Upper limit of the institutional reference range
* Patients who have uncontrolled, clinically significant medical conditions (e.g., diabetes melitus, hypertension, thyroid/endocrine disease, congestive cardiac failure, angina pectoris, cardiac/gastrointestinal disease, dialysis, and abnormal renal function with an estimated CLcr \< 30 mL/min)within 3 months prior to giving informed consent in addition to the underlying disease to be investigated in the trial and for whom the investigator or sub-investigator considers that there is a significant medical risk in the patient's participation in the trial
* Patients with long QT syndrome or tendency toward prolonged QTc interval (male: \>=470 msec, female: \>= 480 msec), or patients with a history/complication of torsades de pointes
* Patients with a history of malignancies within 5 years prior to providing informed consent. However, patients with the following diseases can be enrolled if they are treated appropriately:
* Skin cancer (basal cell, squamous cell)
* Cervical carcinoma in situ
* Localized prostate cancer
* Malignancies that have not recurred for at least 3 years since surgery and the patient's physician has determined that the risk of recurrence is low
* Patients with clinically significant vitamin B1/B12 deficiency or folic acid deficiency within 6 months prior to giving informed consent
* Patients who have participated in other clinical research/trials involving interventions within the 3 months prior to providing informed consent
* Patients who have previously received bromocriptine or TW-012R
* Patients with a history of hypersensitivity to bromocriptine or ergot alkaloids
* Patients with current or a history of thickened heart valve cusps, restricted heart valve motion, and the associated heart valve lesions, such as stenosis, confirmed by echocardiography
* Pregnant females, lactating females, females who may be pregnant, and females who wish to become pregnant
* Other patients who are considered inappropriate to participate in this trial at the discretion of the investigator or sub-investigator
|
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] |
|
NCT02528487
|
Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?
|
The present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.
|
Inclusion Criteria:
1. Patients over the age of 40 will be eligible if
2. they are diagnosed with moderate-severe COPD,
3. currently participate to a PR program, and
4. agree to participate.
Exclusion Criteria:
They will be excluded if:
1. they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than COPD (e.g., active cancer),
2. they have contraindications to exercise (though they will not likely be referred to PR),
3. they have participated in a PR program in the past year,
4. and if they are unable to provide informed consent due to language difficulties or cognitive impairment.
|
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] |
|
NCT05098535
|
Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
|
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior research into potential interventions to optimize the communication of risks.
Myocaridal injury (MINS) is the most common complication and this study is focused on determining the effectiveness of current communication strategies in our presurgical consultations and to quantifying the impact of introducing a visual aid and scripted risk discussions has on patients ability to recall their individualized perioperative risk of myocardial injury.
|
Informed consent is an important aspect of the patient-physician relationship. Prior to agreeing to undergo treatment patients must have risks and benefits disclosed to a "reasonable patient" standard.1 The 2016 Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment made strong recommendations emphasizing the need for clear communication of perioperative cardiac risk to patients.2 Myocardial injury is the most common post-operative complications and has significant impact on patient outcomes including survival.2. However, very few studies have examined the communication of risk to patients, particularly when communicating perioperative cardiac risk.
The aim of this study is to formally evaluate the effectiveness of perioperative risk communication and examine if the introduction of visual aids can improve communication and preoperative patient education. During this study, all patients presenting to the Presurgical Screening clinic for consultation with an anesthesiologist will receive a standardized scripted discussion of the risk of myocardial injury following noncardiac surgery (MINS) based on their revised cardiac risk index. During the study period, patients will be randomized in blocks to exposure to a visual aid representing their individualized risk of MINS during the risk discussion. Immediately following the anesthesiology consultation, all patient will be invited to participate in the study and complete a survey that will assess ability to recall individualized cardiac risk and examine current risk discussion practices, patient satisfaction with cardiac risk discussion, importance of cardiac risk disclosure, assess anxiety related to risk discussion, and seek general feedback from participants. This study is structured to assess the effectiveness of incorporating the use of structured, scripted risk discussion with and without the use of a visual aid. A subset of consenting patients will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.
The investigators hypothesizes that the use of visual representation of perioperative risk of Myocardial Injury after Non-Cardiac Surgery during the pre-anesthetic assessment will improve the patients' satisfaction with the cardiac risk discussion and the participant's understanding and retention of the risk in the post-operative period.
|
Inclusion Criteria:
* Patients 45 years of age or older
* Patient is assessed in person by an anesthesiologist at Presurgical Screening Clinic
* Patient schedule for elective non-cardiac surgery
Exclusion Criteria:
* Unable to provide consent due to communication/language barrier
* Prior enrollment in this study
* Unable to consent without a Substitute Decision Maker
* Scheduled for non-elective surgery
|
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] |
NCT06848426
|
Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial
|
Clinical Trial Protocol
Primary Objective:
To evaluate the efficacy of the Xingbaiji Formula combined with chemotherapy and Sintilimab as first-line therapy in patients with recurrent or metastatic Stage IIIB-IV EGFR/ALK/ROS-1 mutation-negative non-small cell lung cancer (NSCLC), using Objective Response Rate (ORR) of tumor lesions as the primary endpoint.
Secondary Objectives:
To assess secondary endpoints including Progression-Free Survival (PFS), Quality of Life (QoL), immune-related indicators, and safety profile (e.g., incidence of adverse events), and to further evaluate the efficacy and safety of the combination therapy.
Randomized Group Allocation:
Participants will be randomly assigned to two groups:
Control Group
Regimen for Advanced Non-Squamous NSCLC:
Drugs and Dosage:
Sintilimab 200mg + Pemetrexed + Cisplatin/Carboplatin via intravenous infusion, administered every 3 weeks (Q3W) for 4 cycles.
After completion of 4 cycles, patients enter the maintenance phase: Sintilimab 200mg Q3W (up to 24 months) + Pemetrexed Q3W until disease progression, intolerable toxicity, death, or voluntary withdrawal.
Regimen for Advanced Squamous NSCLC:
Drugs and Dosage:
Sintilimab 200mg + Gemcitabine + Cisplatin/Carboplatin via intravenous infusion, Q3W for 4-6 cycles.
Post-treatment, patients receive Sintilimab 200mg Q3W maintenance until disease progression, intolerability, or completion of 2 years of Sintilimab therapy.
Experimental Group Control Group Regimen + Xingbaiji Formula
Xingbaiji Formula Dosage:
1. Granule No. 1: 10g/bag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals.
2. Granule No. 2: 5g/bag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals. Treatment Duration: Both granules are taken concurrently with chemotherapy for 6 months, then discontinued.
|
Randomized Clinical Trial on Xingbaiji Formula Combined with Chemotherapy and Sintilimab as First-Line Treatment for Recurrent/Metastatic Stage IIIB-IV EGFR/ALK/ROS-1 Mutation-Negative Non-Small Cell Lung Cancer Primary Objective: To evaluate efficacy by measuring Objective Response Rate (ORR) in patients receiving Xingbaiji Formula combined with chemotherapy and Sintilimab.
Secondary Objectives: To assess Progression-Free Survival (PFS), Quality of Life (QoL), immune-related biomarkers, safety, and adverse event rates.
Study Arms Control Group
Non-squamous NSCLC:
Sintilimab 200mg + Pemetrexed + Cisplatin/Carboplatin (IV, Q3W for 4 cycles). After induction, maintenance with Sintilimab 200mg Q3W (≤24 months) + Pemetrexed Q3W until disease progression, toxicity, or withdrawal.
Squamous NSCLC:
Sintilimab 200mg + Gemcitabine + Cisplatin/Carboplatin (IV, Q3W for 4-6 cycles). Maintenance with Sintilimab 200mg Q3W until progression or maximum 2 years.
Experimental Group
Control Regimen + Xingbaiji Formula:
Xingbaiji Granule 1 (10g/sachet): Dissolved in warm water, 1 sachet twice daily (morning/evening, post-meal).
Xingbaiji Granule 2 (5g/sachet): Dissolved in warm water, 1 sachet twice daily (morning/evening, post-meal).
Duration: Concurrent with chemotherapy for 6 months, then discontinued.
|
Inclusion Criteria:
1. Signed written informed consent.
2. Age: 18-75 years, regardless of gender.
3. Histologically or cytologically confirmed non-small cell lung cancer (NSCCC), including adenocarcinoma, squamous cell carcinoma, or large cell carcinoma, with negative EGFR, ALK, and ROS-1 mutations confirmed by next-generation sequencing (NGS). Stage IIIB-IV NSCLC as per AJCC 8th edition staging criteria (required evaluations: neck contrast-enhanced CT or ultrasound, chest contrast-enhanced CT, abdominal contrast-enhanced CT or ultrasound, brain contrast-enhanced MRI, bone scan, or whole-body PET/CT).
4. ECOG performance status ≤2 and life expectancy ≥3 months.
5. Histologically or cytologically documented ineligibility for EGFR, ALK, or ROS-1 targeted therapies (written evidence required).
6. At least one measurable lesion per RECIST v1.1. Lesions within prior radiation fields or post-local treatment may be selected if progression is confirmed.
7. No prior systemic anti-tumor therapy for advanced disease. Adjuvant chemotherapy is permitted if ≥6 months have elapsed between recurrence and the last dose.
Exclusion Criteria:
1. History of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
2. Individuals with allergic reactions to the Xingbaiji formula;
3. Patients with mixed small cell lung cancer or those with a small cell lung cancer component;
4. Severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements;
5. Pregnant or lactating women (a pregnancy test must be performed to exclude pregnancy; women of childbearing age must agree to use effective contraception during the study);
6. Presence of any major illness or significant laboratory abnormalities that may interfere with receiving Xingbaiji formula, chemotherapy, or immunotherapy; 7Any other conditions deemed by the investigators to render participation in the trial inappropriate.
|
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] |
NCT03565276
|
Tranexamic Acid for Prevention of Postpartum Haemorrhage: a Dose-finding Study
|
Published trials on tranexamic acid (TxA) for prevention have used a variety of fixed (0.5gm or 1gm) and body-weight adjusted (10mg/kg or 15mg/kg) doses of TxA. Given the wide range of bodyweights of pregnant women in contemporary obstetric practice, it is critical to determine the minimum effective dose of TxA, so as to avoid under- or over-dosing. The rationale of this study is to determine the minimum effective dose of TxA that is required to attain therapeutic plasma levels of TxA, established at 5-15mg/L, following administration of a single dose of intravenous (IV) TxA after childbirth and the clamping the umbilical cord, and before delivery of the placenta. Following birth of the infant, and upon clamping the umbilical cord, the investigators will administer a single dose of IV TxA in 100ml of 0.9% sodium chloride at 50mg/min according to the dose-escalation schedule described below. The slow rate of infusion has been chosen to prevent untoward effects such as hypotension that have been noted when the rate of infusion has exceeded 100mg/min. As part of the dose-escalation design, the investigators will start with 5mg/kg, half the smallest described dose, on a sample of up to 5 women. They will continue to administer TxA doses in increments of 5mg/kg to each successive batch of 5 women. If the number of treatment successes cannot statistically rule out a value \< 75% (\< 4 of 5 women are successes due to values in the low range), the dose will be increased by 5mg/kg for the next set of 5 women, and so on, until a maximum dose of 30mg/kg is reached, a dose deemed safe based on earlier studies in different populations. Once treatment success is determined at a certain dose, i.e. 4/5 women have levels in the therapeutic range), a total of 20 women will be administered that dose to ensure that 75% i.e. 18/20 women are successes at that dose.
|
Research question: What is the minimum effective dose required for attainment of therapeutic plasma levels of 5-15mg/L in postpartum women?
Study design: Pharmacokinetic study using a dose-escalation design.
Trial treatment and dosage regimen: Following recruitment and prior to the caesarean delivery, the anaesthesiologist will insert a large-bore cannula into the participant's antecubital vein and draw blood for a complete blood count (CBC), which will be used in tandem with 24-hour post-delivery CBC to estimate blood loss, and serum creatinine to rule out elevated serum creatinine levels, a study exclusion criterion. Following birth of the infant, and upon clamping the umbilical cord, the anaesthesiologist will administer a single dose of IV TxA in 100ml of 0.9% sodium chloride at 50mg/min according to the dose-escalation schedule described below. All participants will receive oxytocin 20 international units (IU) IV in 1 litre of 0.9% sodium chloride at the rate of 125 ml/hour with placental delivery, as part of active management of the third stage of labour.
Endpoints Primary endpoints - Plasma levels of TxA: These will be obtained via serial blood draws at baseline (before TxA administration), and at 15, 30, 60 minutes and 120 minutes after administration of TxA, (as its maximum effect is within the 60 minutes and therapeutic plasma concentrations are maintained for 7-8 hours after administration). Blood will be drawn at baseline (before administration of TxA) in order to confirm zero plasma levels of TxA, as part of quality assurance. Blood will be collected in a standard citrate tube (Vacutainer, NJ, USA), centrifuged soon after collection and the plasma (supernatant) stored at -80°C before analysis. TxA will be extracted from plasma using solid phase microextraction, and concentrations measured using tandem liquid chromatography/mass spectrometry.
Secondary endpoints: (a) Total blood loss in 24 hours following childbirth will be determined by the reference standard methods - direct measurement (blood collected in suction apparatus) and gravimetric (weighing of linen) and by using formulae to determine blood loss using pre- and post-delivery haemoglobin and haematocrit as we have previously described (b) Early adverse events will be recorded prior to discharge and delayed events will be obtained at the six-week postpartum visit or via phone call.
Expected duration of subject participation, duration of all trial periods and follow up: The intervention will only be administered once, and blood drawn at baseline and 15, 30, 60 and 120 minutes after administration, as described above. Again, as described above, data on early adverse events will be collected prior to discharge from hospital and those on delayed adverse events will be obtained at the time of the routine 6-week postpartum visit in person or via a telephone interview. There will be no additional follow up.
Stopping rules: As the drug will be administered as a slow infusion in the operating room, it will be stopped immediately if any adverse events are noted. Thereafter, no further drug will be administered, and therefore stopping rules do not apply. Participants will be allowed to withdraw from the study at any point without affecting their clinical care.
|
Inclusion Criteria:
* Women 18 years of age or greater
* Pregnant with a single fetus
* Undergoing planned caesarean delivery for a non-medical indication
* ≥ 37 completed weeks of gestation
Exclusion Criteria:
* Contraindications to use of TxA (i.e. acute arterial/venous thrombosis, hypersensitivity to TxA, history of seizures, moderate to severe renal failure from any condition, defective colour vision, subarachnoid haemorrhage and disseminated intravascular coagulation (abnormally increased activation of pro-coagulant pathways))
* Medical conditions that could influence bleeding and/or the pharmacokinetics of TxA (i.e. personal/family history of bleeding disorders, receipt of warfarin seven days or heparin 24 hours prior to caesarean delivery, hypertensive disorders of pregnancy, need for intra- or post-operative blood transfusions and postpartum thromboprophylaxis)
* Women with morbidly adherent placentae scheduled for planned caesarean-hysterectomies
* Use of concomitant medications that could result in drug interactions (hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine or nitroglycerin)
|
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] |
NCT02280798
|
Endometrial Gene Expression in Different Protocols of Endometrial Preparation for Embryo Transfer'
|
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
|
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The clinical results in different publications showed different results, some of them described the natural cycle superior as the substituted cycles, and in contrast other large series showed superior results in substituted cycles than natural but with an increased of pregnancies losses. The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
|
Inclusion Criteria:
* age between 18 and 35 years
* regular menstrual cycles (between 25 and 35 days)
* normal basal hormones(follicle-stimulating hormone \[FSH\] and LH \<10 IU/ mL and estradiol \<60 pg/mL)
* normal karyotype
* body massindex between 18 and 25 kg/m2
* negative serology
* normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions
Exclusion Criteria:
* endometriosis
* polycystic ovariansyndrome
* use of an intrauterine device in the last 3 months.
|
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] |
NCT00015015
|
Dichloroacetate Kinetics, Metabolism and Toxicology
|
Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain industrial solvents, thus making it a chemical of environmental concern. However, DCA is also used as an investigational drug for treating various diseases of adults and children, at doses far greater than those to which humans are normally exposed in the environment. Our research involves how DCA is metabolized by healthy adults and by children with a fatal genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.
|
Children with congenital lactic acidosis Healthy adult volunteers
|
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] |
|
NCT04551196
|
Management of Post-Tonsillectomy Pain in Pediatric Patients
|
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
|
Inclusion Criteria:
* 4 to 17 years of age at time of enrollment
* Undergoing tonsillectomy with or without adenoidectomy
* Able to provide informed consent from parent or legal guardian
* Able to provide assent if subject is a minor of appropriate age
Exclusion Criteria:
* Allergy to acetaminophen or ibuprofen
* Inability for study participant to cooperate with pain assessments
* Known pregnancy
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
|
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|
NCT05681325
|
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
|
Aim of the study:
This study aims to evaluate the antioxidant and beneficial effects of matcha tea daily intake on periodontal health.
Objectives:
* To evaluate the salivary level of antioxidants (catalase, total antioxidant capacity) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the clinical periodontal parameters including bleeding on probing (BOP), probing pocket depth (PPD) and plaque index (PI) after matcha tea intake compared to green tea over a period of one month.
* To evaluate the salivary levels of IL-1B after matcha tea intake compared to green tea over a period of one month.
|
Inclusion Criteria:
* • having at least 20 teeth,
* underwent no medical treatment during the last 3 months before examination and sampling,
* non-smoker,
* no history of systemic disease,
* gingivitis patient (having \>10% bleeding sites with no PPD \>3 mm).
Exclusion Criteria:
* • wore orthodontic appliances,
* pregnant or currently in the breast-feeding period,
* periodontitis patient,
* smoker,
* has a history of systemic disease.
|
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] |
|
NCT03378804
|
PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial
|
The aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.
|
Usually, patient controlled epidural analgesia (PCEA) is performed with a constant background infusion and patient-controlled bolus applications. An alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (Programmed Intermittent Epidural Bolus injection; PIEB). In both cases, the patient has the option to trigger additional boluses. PIEB has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. It is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. In this study the PIEB-mode will be applied in major gynecological and abdominal surgery. In order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (Wertheim, Whipple, major colon surgery).
|
Inclusion Criteria:
* Abdominal tumors in gynecology and general surgery
* Enlightenment and written consent to the investigation
Exclusion Criteria:
* refusal to participate
* pregnancy and breast feeding period
* general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of DGAI)
* Impossibility to place the epidural catheter correctly
* Known allergy to the drugs used in the study
* Lack of understanding how to use the patient-controlled system
* postoperative follow-up respiratory assistance
|
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] |
NCT03745937
|
A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
|
This is a Phase 2a, randomized, blinded, placebo-controlled study in up to 20 overweight or obese participants with type 2 diabetes mellitus. The participants will participate in the study for approximately 18 weeks, including screening, run-in and treatment periods and a safety follow-up.
|
Inclusion Criteria:
1. Participants aged 18 to 74 years (inclusive) at screening.
2. Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures.
3. Body mass index (BMI) between 27 and 35 kg/m\^2 (inclusive) at screening.
4. Hemoglobin A1c (HbA1c) range of 6.5% to 8.5% (inclusive) at screening (Note: Participants may be re-tested for the HbA1c entry criterion only once.).
5. Willing and able to self-inject study drug for the duration of the study.
6. Diagnosed with type 2 diabetes mellitus with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease \>= 500 mg/day) has occurred in the three months prior to screening.
7. Female participants must have a negative pregnancy test at screening and randomization, and must not be lactating.
8. Female participants of childbearing potential who are sexually active with a male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of study drug.
Exclusion Criteria:
1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures during the run-in period.
2. Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
3. Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.
4. Any participant who has received any of the following medications prior to the start of the study:
* Herbal preparations or drugs licensed for control of body weight or appetite
* Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying
* Antimicrobials within the quinolone, macrolide or azole class
* Any change in antihypertensive medication
* Aspirin (acetylsalicylic acid)
* Paracetamol (acetaminophen) or paracetamol-containing preparations
* Ascorbic acid (vitamin C) supplements
5. Severe allergy/hypersensitivity to any of the proposed study treatments, standardized meals, or excipients.
6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the participant has been treated with daily SC insulin within 90 days prior to screening.
7. Acute pancreatitis, pancreatic amylase, and/or pancreatic lipase \> 3 × upper limit of normal range (ULN); history of chronic pancreatitis; or serum triglyceride levels \> 11 mmol/L (1000 mg/dL) at screening.
8. Significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures), which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
9. Significant hepatic disease (except for nonalcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
* Aspartate transaminase (AST) \>= 3 × ULN
* Alanine transaminase (ALT) \>= 3 × ULN
* Total bilirubin (TBL) \>= 2 × ULN
10. Impaired renal function defined as estimated glomerular filtration rate (GFR) \< 60 mL/minute/1.73m\^2 at screening.
11. Poorly controlled hypertension defined as:
* Systolic blood pressure (BP) \> 160 mm Hg
* Diastolic BP or \>= 90 mm Hg
12. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes.
13. Prolonged QT intervals corrected for heart rate or family history of long QT-segment at screening.
14. PR (PQ) interval prolongation, intermittent second or third-degree atrioventricular (AV) block, or AV dissociation.
15. Persistent or intermittent complete bundle branch block.
16. Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening.
17. Severe congestive heart failure.
18. Basal calcitonin level \> 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
19. Hemoglobinopathy, hemolytic anemia or chronic anemia or any other condition known to interfere with the interpretation of HbA1c measurement.
20. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer.
21. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
22. History of substance dependence, alcohol abuse, or excessive alcohol intake. Participants who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
23. Symptoms of depression or any other psychiatric disorder requiring treatment with medication.
24. History of severe allergy/hypersensitivity, including to any component of the investigational product formulation or other biological agent, or ongoing clinically important allergy/hypersensitivity.
25. Blood/plasma donation within 1 month of screening.
|
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|
NCT06230367
|
Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys
|
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.
|
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined.
|
Inclusion Criteria:
1. have been assigned male sex at birth and currently have a cisgender identity;
2. be aged 13-22 years old;
3. have had anal sex in the past 12 months;
4. be English-speaking;
5. exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
6. have Internet access to complete online surveys;
7. provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;
8. Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and
9. not currently enrolled in another HIV prevention program; or
10. know anyone already enrolled in the RCT.
Exclusion Criteria:
* Being HIV positive
|
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] |
NCT03896139
|
Identification of PAthways of Kinase Inhibitors TOxicity
|
The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.
|
Inclusion Criteria:
* Patient treated with a kinase inhibitor
* Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase
Exclusion Criteria:
-
|
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] |
|
NCT05409690
|
Renal Arterial Resistive Index for Differential Diagnosis of Acute Kidney Injury
|
early differential diagnosis of anticipated acute kidney injury via ultrasound renal resistive index calculation
|
acute kidney injury is a common clinical syndrome introducing to emergency services with varying symptoms. acute kidney injury is divided into 3 subgroups: prerenal, renal and postrenal. there is not any certain laboratory or imaging modality for early detection of injury's type. calculation of renal resistive index with doppler ultrasound at emergency setting can be helpful for early detection of etiology of acute kidney injury subgroup.patient will be selected according to clinical status and detailed history and laboratory parameters.renal resistive index will we calculated with doppler ultrasound of arcuate and interlober arteries of kidneys. resistive index values of acute kidney injury patients will be compared depending on further tests and resistive indexes of suggestive etiologies will be compared according to final diagnosis.
|
Inclusion Criteria:
1. age over 18
2. patient with acute kidney injury diagnosed according to KDIGO, AKIN or RIFLE criteria
Exclusion Criteria:
1. end stage kidney disease
2. patients receiving renal replacement treatment
|
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