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NCT04509895
|
Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach
|
a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.
|
Calcaneal fracture occurred in about 2% of patients; they represented almost 60% of all tarsal fractures.
Calcaneal fractures are caused by high velocity Force to the heel, mostly vehicle accident or fall from height. There are many factors affect the fracture pattern: age of the patient, weight , type of fall . Male patients predominated (75%) and younger than 50 years. In most cases, these fractures are bilateral and conjoined with lumbar spine fractures.
According to the result of computed tomography (CT) scanning. The calcaneal fractures can be classified into 4 categories, among which the SANDERS TYPE Ⅱ and Ⅲ fractures are the most common types.2 Thus the development of effective and safe treatment strategies for these two fracture types has always been an issue among orthopedic surgeons.
The treatment of intra-articular calcaneal fractures has always been controversial. Currently open reduction and internal fixation through L-Shape extensile incision has been considered as the gold standard surgical therapy for calcaneal fractures. This approach provide a large view to expose the fracture, allowing accurate reduction of the deformed posterior facet and convenient placement of the plate to achieve stable fixation. Postoperatively, plaster cast is worn for 2 weeks, walking with the crutches for additional 8-12 weeks is prescribed, and return to work is achieved after 6-9 months. However, the high incidence (approximately 30%) of complications associated with this approach, including wound dehiscence and deep infection , remain a non-negligible problem .
To lower the wound complications , a minimally invasive approaches has been introduced such as percutaneously applied distraction systems K-wires or screw fixation of intra-articular fractures , the use of elizarov device , percutaneous arthroscopy assisted osteosynthesis and Sinus Tarsi approaches . The sinus tarsi approach has become one of the most frequently applied minimally invasive approaches because of its ability to provide adequate exposure for the posterior facet, the anterolateral fragment and the lateral wall. Wound complication rate with this approach have been reported to range from 0% to 15.4% . Nevertheless, the poor visualization of the lateral wall of the calcaneus through this small incision makes it difficult to insert the conventional plate for obtaining a stable fixation. Thus, the development of a plate that is adaptable to the anatomic characteristics of the calcaneus and sinus tarsi approach is important.
|
Inclusion Criteria:
1. patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
2. closed calcaneal fractures
Exclusion Criteria:
- 1)patients with calcaneal fractures classification according to sanders classification , are sanders type I or IV 2)patients who have systemic comorbidity as( cardic ,diabetec ,cirrhotic patients, etc.) or smokers or local lesion as (blisters,vasculopathy , swelling etc.).
3) open calcaneal fractures.
|
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] |
NCT04900740
|
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites
|
The study will evaluate a new type of cyanoacrylate tissue glue Secure PortIV on the insertion site of the PICC (Peripherally inserted central catheter) or Midline catheters. Fixation of the catheter with the tissue glue should prevent incidents of mechanical and infective phlebitis as well as external migrations of the catheters.
|
In the study, 125 subjects will receive the new tissue glue Secure PortIV and 125 subjects will be provided standard care. The tissue glue will be applied immediately after insertion. Evaluation and re-evaluation of the site will be done on the first and seventh day after insertion using VIP and CLISA (Central-Line Insertion Site Assessment) scale and on the seventh day with taking a swab from the insertion site; the external length will be measured on the first and the seventh day, in order to observe the migration or not.
The goal of the study is to evaluate the benefits of the cyanoacrylate tissue glue Secure PortIV in the prevention of mechanical and infective phlebitis and external migration of the catheter.
|
Inclusion Criteria:
* 18 years of age
* need of long-term venous access
* consent with participation in the study
Exclusion Criteria:
* pediatric population
* not signing the informed consent form
|
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] |
NCT01867632
|
Acellular Dermal Matrix in Primary Palatoplasty
|
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
|
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.
Objectives of the study:
Primary objectives:
The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.
Secondary objectives:
1. Incidence of wound dehiscence
2. Incidence of wound infection
3. Hospital length of stay
|
Inclusion Criteria:
* Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
Exclusion Criteria:
* Selection will be based on the parent's willingness to allow their child to participate in the study.
* Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
* Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
* Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
|
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] |
NCT05154266
|
Effectiveness of 'Taking it Further' (TiF) Programme
|
Meta-analyses have demonstrated that mindfulness-based programmes are more effective than no treatment across different populations and desired outcomes yet there is limited evidence on how to sustain these benefits beyond the traditional eight-week courses. The 'Taking it Further' (TiF) programme was developed by the University of Oxford Mindfulness Centre to help reinforce and deepen one's mindfulness practice to promote well-being and mental health for life. The proposed study aims to evaluate the effectiveness of this programme in graduates of MBCT/MBSR on well-being and mental health outcomes and explore the mediators (i.e. mindfulness, decentring, and self-compassion) through which this programme has an effect over the course of twelve weeks using a randomised controlled trial with a waitlist control. The planned research is part of an overall effort to optimize treatment effects and the long-term effectiveness of mindfulness-based programmes.
|
Participants that expressed an interest in taking part in the study were screened for research inclusion/exclusion criteria and for course suitability. Research inclusion/exclusion was assessed by the lead researcher whereas course suitability was assessed jointly by the lead researcher and a trained mindfulness teacher at the Oxford Mindfulness Centre (OMC). Eligible participants were invited to complete baseline measures that assessed the primary outcome and mediator (well-being and mindfulness respectively) around two weeks before the start date and then again around one week before the start date to establish a stable baseline. For one of these online questionnaires, participants were instructed to complete an online orientation video to ensure continued eligibility. Within a few days of the start date, participants were randomised to the treatment (online TiF programme) or wait-list control group. One day before the start date, all participants were invited to complete a battery of questionnaires which assessed the outcome measures (well-being, psychological quality of life, depression, anxiety), mediator measures (mindfulness, self-compassion, decentring), and an additional measure regarding perceived expectations about the mindfulness course. Participants were then invited to complete a battery of questionnaires at weeks 4, 8, and 12 (post-intervention). For the battery of questionnaires for weeks 4 and 8, participants completed the same measures assessed at baseline with additional questions that assessed: the amount of practice, quality of practice, side effects of practice, and overall experience. For week 12 (post-intervention), participants completed the same measures as weeks 4 and 8 with additional questions that assessed the perceived credibility of the mindfulness programme, perceived quality of mindfulness teaching, and potential harm. Data collection was divided into two phases, with the first phase running from June-September and the second phase running from October-December 2021. The TiF courses were run online and the surveys themselves were also administered online.
|
Inclusion Criteria:
* English-speaking
* Has access to computer for online mindfulness sessions and assessments
* Participants who have completed an MBSR and/or MBCT course in the past
Exclusion Criteria:
* Has taken TiF programme prior to the start of the study
* Has completed a mindfulness programme that does not fit within the parameters of a formal mindfulness-based programme.
* Those that have recently experienced a traumatic event or bereavement and/or has been abusing substances to manage stress and/or has been harming themselves recently
* Participants on mindfulness teacher training pathway
|
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] |
NCT00845533
|
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
|
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.
|
Inclusion Criteria:
1. Positive screening thick blood smear
2. Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours
3. Age ≥ 6 months to 10 years
4. Weight \> 5 kg
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. No history of antimalarial use in the previous two weeks
8. P. falciparum mono-infection
9. Parasite density 2000-200,000/ul
10. Provision of informed consent and ability to participate in 42-day follow-up
Exclusion Criteria:
1. Danger signs or evidence of severe malaria
2. Hemoglobin levels \< 5.0 gm/dL
|
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] |
|
NCT05080959
|
A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy
|
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing open inguinal herniorrhaphy with mesh.
|
A Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy.
|
Inclusion Criteria:
* Be willing and able to sign the informed consent form (ICF) prior to study participation.
* In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization
* Plan to undergo an elective open inguinal herniorrhaphy with mesh under general anesthesia without collateral procedures or additional surgeries. Endotracheal intubation is not required.
* Have a body mass index ≤ 39 kg/m2.
* In the judgment of the Investigator, be willing and able to complete study procedures and pain scales and to communicate meaningfully with study personnel and return for outpatient follow-up visits as required.
Exclusion Criteria:
* Has previously undergone herniorrhaphy with the exception of a pediatric herniorrhaphy prior to 2 years of age.
* Has undergone 3 or more surgeries within 12 months prior to signing the ICF, other than for diagnostic procedures (e.g., colonoscopy).
* Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition including a clinically significant existing arrhythmia, bundle branch block or abnormal electrocardiogram (ECG), myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
* Has history or evidence of impaired liver function (e.g., ALT \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Has a history of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix.
* Has or has had active COVID-19 infection within 3 months prior to surgery.
* Has a history of, or positive test results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at Screening.
* Within 7 days prior to the scheduled surgery, be taking any central nervous system ( CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, gabapentinoids, antidepressants (such as serotonin and norepinephrine reuptake inhibitors \[SNRIs\], selective serotonin reuptake inhibitors \[SSRIs\], and tricyclic antidepressants), benzodiazepines, sedative-hypnotics, clonidine and other central alpha-2 agents (e.g., tizanidine), ketamine, or muscle relaxants. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery. The dose must remain stable throughout the study.
* Use of benzodiazepines and non-benzodiazepines (eszopiclone, ramelteon, zaleplon and zolpidem) is permitted to treat insomnia during the postoperative period.
* Within 7 days prior to the scheduled surgery and throughout the study, be taking antiarrhythmics except beta-blockers, digoxin, warfarin (see exception below), lithium, or aminoglycosides or other antibiotics for an infection (ophthalmic use or for treatment or prophylaxis of postoperative surgical site infections is permitted).
* Within 14 days prior to the scheduled surgery and throughout the inpatient period, be taking or using any cannabidiol-containing products, dietary supplements, or over-the- counter (OTC) preparations (e.g., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian).
* Within 28 days prior to the scheduled surgery, has received parenteral or oral corticosteroid treatment (steroid inhaler for allergy or asthma treatment, topical steroid for a non-clinically significant skin condition not involving the area of surgery or ophthalmic steroids are permissible).
* Is taking an antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
* In the opinion of the Investigator, within the past year has a history of illicit drug use or prescription medicine or alcohol abuse (regularly drinks \> 4 units of alcohol per day, where 1 unit = 8 ounces beer, 3 ounces of wine, or 1 ounce of spirits).
* Has a positive alcohol breath/saliva test result indicative of alcohol use, or a positive urine drug screen result indicative of illicit drug use (unless results can be explained by a current prescription or acceptable OTC medication at Screening as determined by the Investigator) at Screening and/or prior to surgery.
* Has previously participated in a clinical study with CPL-01.
* Has participated in another clinical trial or used an investigational product within 30 d days or 5 half-lives, whichever is longer, prior to the planned surgery or is scheduled to receive any other investigational product while participating in the study.
|
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] |
NCT00936949
|
Posterolateral Surgical Approach Compared With Modified Lateral Approach
|
It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.
|
Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.
We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
|
Inclusion Criteria:
* osteonecrosis
* primary or secondary osteoarthritis of the hips
* femoral neck fracture.
Exclusion Criteria:
* Patients with previous hemi- or total hip arthroplasty
* highly dislocated or severe ankylosed hip
* patients who are considered potentially unreliable or who may not reliably attend study visits
|
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] |
NCT06292156
|
tACS Treatment for Cognitive Impairments in Methamphetamine Addicts
|
1. To evaluate the cognitive function of methamphetamine Patients.
2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients
|
Inclusion Criteria:
* Clinical diagnosis diagnosis of methamphetamine use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* None of participants had mixed use of other drugs
* None of participants had physical disability
* None of participants had acute physical or mental illness, hallucinations, acute withdrawal symptoms
* None of participants were receiving any medical treatment
Exclusion Criteria:
* Intracranial hypertension
* Cranial defects
* Tumors
* Serious physical illnesses (e.g., cardiovascular, liver, kidney, gastrointestinal disorders)
* Infectious diseases
* Immune system disorders
|
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] |
|
NCT06517810
|
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
|
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
|
Inclusion Criteria:
* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
Exclusion Criteria:
* Weight ≤10kg
* Age \>22 years
* Known allergy to any components of QUELIMMUNE
|
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|
NCT02304302
|
Down Syndrome Memantine Follow-up Study
|
The purpose of this research study is to learn if the medication Memantine Hydrochloride (the study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto Costa and his research team want to see if a 16-week treatment with this medication can improve the participant's ability to learn and remember things. In this study, memantine hydrochloride will be used. Thus, the researchers want to learn whether the study drug can help improve memory in young adults with Down syndrome. To test the effect of the study medicine, half of the people in the study will receive the study medicine and half will receive a placebo (an inactive substance). Memantine is an approved medication to treat memory and thinking problems in persons with Alzheimer disease. However, little is known about the effect of this medication in persons with Down syndrome and it has not been approved for use in persons with Down syndrome.
|
This study seeks to investigate if the medication Memantine Hydrochloride can help young adults with Down syndrome. Two hundred persons with Down syndrome from both genders and between 15 and 32 years of age will be recruited from two sites: Cleveland, OH, USA and São Paulo, SP, Brazil. Participants will be assigned randomly to either a placebo group or a group taking the active medication with a 50% probability of being on either group. Neither the participants nor the investigators will know who will be taking the study medication and who will be taking the placebo during the study. Only the investigational pharmacist will have access to this information.
Up to 60 people with Down syndrome of the recruited study participants will take part on an optional magnetic resonance imaging (MRI) study. This investigation is aimed at helping to make the EEG study more precise and to find out whether the study medication has any significant effect on the structure of the brain.
Additionally, we will recruit a control group of 60 age- and gender-matched participants without Down syndrome. The goal is to investigate how different groups of people activate their brains when they hear or see something, and if he can use high-density EEG and MRI to see how this study medication works in persons with Down syndrome. In other words, this additional control group should help us ascertain which parts of the test results are due to a person having Down syndrome and which ones are not. Persons without Down syndrome will only come for one EEG visit and one MRI visit, and not be asked to take the study medication.
The visits for the participants with Down syndrome will be as follows:
Screening visit (approximately 2-hour long). The subject will be asked about his/her health, medical history, social background, and work background, as well as some simple questions to determine performance on tests of memory and function that are part of this study. Informed consent and assent will be obtained in this visit. At the end of this visit, an EEG machine will be used to access brain responses to different auditory and visual stimuli. Some will be asked if they would be willing to have an MRI performed, but this portion is not imperative.
A urine sample will be collected and used to obtain cells that will be kept frozen for potential future studies. If the date of the screening visit is not convenient, this sample can be collected during any of the next five visits.
Visit 1 (approximately 1 hour). Pulse, blood pressure, and an electrocardiogram (ECG) will be taken. At the end of the visit, urine and blood samples will be taken. Pregnancy will also be checked.
Visit 2 (2-3 hours). Tests of memory, learning, and reasoning skills will be conducted before the start of the study medicine or placebo. At the end of this visit, a 60-day supply of either the study medicine or the placebo will be given. This will need to be taken for 16 weeks.
Visit 3 (approximately 30 minutes). Eight weeks after the beginning of the treatment, the participant will return to assess how she/he is doing under the treatment. Pulse, blood pressure, a physical exam, and pregnancy will be checked. At this visit, another supply of study medicine will be given.
Visit 4 (2-3 hours). Sixteen weeks after starting the medicine, the participant will take a second series of tests in learning, memory, and reasoning skills to find out whether there were any changes in these skills.
Visit 5 (approximately 1 hour). In the 16th or 17th week after starting the medicine, the participant will meet one more time with the doctor from visits 1 and 3. Vital signs, a physical exam, and an ECG will be taken, as well as a blood sample to ensure nothing has changed with the participant's general health. For women, a pregnancy test will be performed.
If for some reason the subject withdraws from this study prior to Visit 5, he/she will be asked to return to the clinic for a "Treatment Discontinuation Visit." In addition, if the participant discontinues the medication prior to the end of the study, he/she will be asked to complete a "Retrieved Dropout Visit" on the date that should have represented Visit 5. Study medication will not be provided beyond the study period.
|
Inclusion Criteria:
* Cytogenetically documented Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. Mosaic Trisomy 21 and partial translocations will be excluded from the study
* No pregnancy by serum testing at screening. Females of child-bearing potential, sexually active must be practicing a reliable method of birth control. Urine pregnancy tests will be done at the 2 follow-up medical visits
* Laboratory findings within normal limits or judged clinically insignificant at baseline
* Vital signs within normal limits for age. Stable, medically treated hypotension will be allowed
* ECG must demonstrate predominately normal sinus rhythm. Minor abnormalities documented as clinically insignificant will be allowed
* Participants and their authorized representatives will provide written informed consent
* Participants who have received any experimental drug for Down syndrome must undergo a washout
* All participants must: Be in general good health as judged by the investigators; Be able to swallow oral medication; Have a reliable caregiver or family member who agrees to accompany participant to all visits, provide information about the participant as required by the protocol, and ensure compliance with the medication schedule; Be sufficiently proficient in English (USA) or Portuguese (Brazil) to reliably complete the study assessments
* Age and gender matching participants without Down syndrome, must be: Males or females without Down syndrome aged-matching (within 3 years) participants with Down syndrome whom they are expected to serve as controls
Exclusion Criteria:
* Participant weighing less than 40 kg
* Current psychiatric or neurologic diagnosis other than Down syndrome (e.g., major depressive disorder, schizophrenia, bipolar disorder, autism, Alzheimer disease)
* Current treatment with psychotropic drugs
* Drug or alcohol abuse or dependence
* Significant suicide risk or who would require treatment with electro-convulsive therapy or with psychotropic drugs during the study or who have received treatment with a depot neuroleptic drug within 6 months of entering the study.
* Current or expected (within the next 6 months) hospitalization or residence in a skilled nursing facility (may reside in group homes or other residential settings with no skilled nursing)
* Active or clinically significant conditions affecting absorption, distribution, or metabolism of study drug (e.g. inflammatory bowel disease or celiac disease)
* Significant allergies to or other significant intolerance of memantine therapy, its ingredients, or with contraindications to memantine therapy as stated in the prescribing information
* Participants who are expected to require general anesthetics during the course of the study
* Presence or recent history of seizure disorder (\< 3 years).
* Clinically significant and/or clinically unstable systemic disease. (Those with controlled hypothyroidism must be on a stable dose of medication for at least 3 months prior to screening and have normal serum T-4 and TSH at screening; and those with controlled diabetes mellitus must have an HbA1c of \< 8.0% and a random serum glucose value of \< 170 mg/dl)
* Severe infections or a major surgical operation within 3 months prior to screening
* History of persistent cognitive deficits immediately following head trauma.
* Donation of blood or blood products less that 30 days prior to screening, while participating in the study, or four weeks after completion of the study
* Inability to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators
* Exclusion criteria for controls without Down syndrome: History of substance abuse, major psychiatric disorder, attention deficit disorder, or learning disability; Beck Depression Score greater than 10; Exclusion criteria specific to MR scanning; Pregnancy; Neurologic history
|
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] |
NCT04706442
|
Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes
|
The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (FAQ) expert advice section.
The aims of the study are to:
1. develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period
2. examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes)
3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and
4. examine the perceptions of parents in receiving this intervention.
When compared with those in the control group receiving standard care:
1. parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction.
2. new-borns of parents receiving SPA will have better physical, social and emotional development
3. It will be more cost-effective to provide SPA than the standard care
|
Inclusion Criteria:
* able to read and speak English
* have low-risk singleton pregnancy with more than 24 weeks of gestation (age of viability)
* have smartphone with internet access
Exclusion Criteria:
* have physical or mental disorders which would interfere with their ability to participate in the study
* have high-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc.
* have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother; and /or
* give birth to a newborn at still-birth or a newborn with congenital anomalies and/or medical complications including pathological jaundice, that required special care in hospital.
|
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] |
|
NCT05934929
|
Contribution of Residual Tumour DNA Testing on the Surgical Bed
|
The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.
|
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.
Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
|
Inclusion Criteria:
* Signed informed consent
* Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
* 18 years of age or older
* Member or beneficiary of a social security scheme.
Exclusion Criteria:
* Absence of signed informed consent
* Patient of protected age
* Psychosocial problems
* Not affiliated to or benefiting from a social security scheme
* Previous cervical irradiation
* Pregnant or breast-feeding women
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
|
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] |
NCT04407117
|
Appendicitis During the National Lockdown During the COVID-19 Pandemic
|
The study aims to examine whether a nationwide lock-down with an entire population subjugated to social distancing reduces the incidence of appendicitis. If a reduction is detected it supports the hypothesis that infectious disease may play a role in the etiology of appendicitis.
|
Inclusion Criteria:
Registered in the Danish National Patient Register during the study period
Exclusion Criteria:
None
|
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|
NCT00144118
|
The Effect of Isoflurane or Sevoflurane on Kidney Function
|
The purpose of this study is to determine if isoflurane and sevoflurane have similar effects on the kidneys of people with impaired kidneys when the drugs administered with low gas flow into anaesthetic machines.
|
Study Protocol Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial
Introduction
Sevoflurane is a volatile anaesthetic agent available for clinical use in most countries including Australia, the United States, the United Kingdom, and Canada. Since the first clinical use of sevoflurane in Japan during the 1980s, millions of anaesthetics have been given with sevoflurane. Sevoflurane has a number of advantages over other agents for general anaesthesia, particularly isoflurane. The benefits to patients and the environment include:
* A lower blood and tissue solubility allows patients to wake up faster after anaesthesia 1, 2.
* The lower blood solubility allows faster titration during surgery.
* Heart rate is more stable during increases in inspired concentration.
* Airway resistance is lower than with other volatile agents.
* A pleasant smell allows gas induction
* There is less nausea and vomiting than with isoflurane
* It is a fluorocarbon rather than a chlorofluorocarbon and does not worsen the atmospheric ozone hole.
The most important concern about sevoflurane is its effect on renal function due to breakdown products. When sevoflurane is exposed to the carbon dioxide absorbents soda lime and baralyme a vinyl breakdown product called Compound-A is formed. High dose exposure to Compound-A alters kidney histology in rats. Some, but not all, studies have found that Compound-A produces increases urinary secretion of renal tubule enzymes in humans. The clinical importance of enzyme secretion is unclear.
The most widely used indicator of renal function that has established clinical importance is plasma creatinine concentration. No study of sevoflurane has shown that sevoflurane produces greater increases in plasma creatinine concentration than other anaesthetic drugs. The Austin Health Department of Anaesthesia has recently completed a study in cardiac anaesthesia that included sevoflurane. We found that, comparing isoflurane, sevoflurane, and propofol, there was no difference in creatinine change after surgery between the three groups. This study will be published in Anesthesiology, the manuscript is attached.
The fresh gas flow into an anaesthetic machine is the amount of oxygen, or oxygen and air, or oxygen and nitrous oxide that flows into the anaesthetic circuit per minute. Moderate fresh gas flows are around 3 l/min. Low fresh gas flows are around 1 l/min. Low fresh gas flows have benefits for patients, the environment, and the hospital:
* Patients lose less heat
* Patients lose less water
* There is less environmental contamination with chlorofluorocarbons and nitrous oxide (a green house gas).
* Lower anaesthetic costs.
At low fresh gas flows, patients are exposed to higher concentrations of Compound A.
A recent multicentre study looked at creatinine changes after major surgery. This study found no difference between isoflurane and sevoflurane with low fresh gas flows of 1 l/min. Patients with pre-existing renal impairment were excluded.
Pre-operative renal impairment increases the risk of clinically important deterioration of renal function after surgery. Studies of changes in creatinine after sevoflurane have included only a small number of patients with pre-existing renal impairment 10. None of these small studies has shown that sevoflurane aggravates pre-existing renal impairment more than other anaesthetic drugs. This includes a subgroup analysis in our Cardiac Anaesthesia study. No study, however, has examined creatinine changes in those with pre-existing renal impairment and with low fresh gas flow. This would expose those with increased risk of further renal impairment to greater doses of Compound-A. From other research and our own, we believe that sevoflurane would not affect renal function more than isoflurane in patients with preexisting renal impairment receiving low flow anesthesia.
Research Question What are the post operative changes in serum creatinine after anaesthesia with sevoflurane or isoflurane using fresh gas flows of 1 l/min in patients with pre-operative renal impairment?
Methods The study methods draw heavily on our previous study 7, copy attached. The study design conforms to the Consolidated Standard of Reporting Trials (CONSORT) 11.
Study type Randomized, clinical trial.
Study Site Austin and Repatriation Medical Centre
Eligible patients
Adult patients for elective surgery who will:
1. need to stay at least one night
2. need general anaesthesia
3. have a pre-operative serum creatinine concentration greater than 130 umol/l.
Exclusions
1. The patient refuses.
2. The patient is less than 18 years of age.
3. The patient is on pre-operative dialysis
4. The anaesthetist plans to use only regional or total intravenous anaesthesia.
5. Specific types of surgery: craniotomy, carotid, and cardiac.
Recruiting One of the investigators will recruit patients as soon as possible after the patients are booked for surgery. We expect to enroll at least 3 patients per week.
Treatment arms
1. Isoflurane OR 2. Sevoflurane Anaesthesia maintenance will be with fresh gas flows of 1 l/min and inspired oxygen of 30% to 100% in nitrogen (oxygen/air) or nitrous oxide. Individual anaesthetists will determine all other aspects of the peri-operative care including fluid therapy.
Random allocation Patients will be randomly allocated to receive isoflurane or sevoflurane. Before the trial ARMC pharmacy staff will provide the allocation sequence using a table of random numbers. Allocations will be kept in opaque envelopes by the trial coordinator. Anaesthetists will be notified of the allocation to isoflurane or sevoflurane on the day of surgery.
Primary end point The primary end point will be the highest change in serum creatinine from before operation to the first three days postoperatively. Supporting data will be from the highest creatinine and urea in the first three postoperative days. Patients leaving hospital before 3 postoperative days will be included. Good clinical care for patients with renal impairment includes a creatinine measurement on admission and at least one postoperative creatinine measurement. The trial coordinator will oversee this. The data for this study will be from clinically indicated tests. Specific blood tests for this study will not be needed. Data will be collected from the ARMC clinical chemistry results. Data will be stored on computer in a secure are of the ARMC Department of Anaesthesia in line with the Therapeutic Goods Administration Guidelines for Good Clinical Research Practice in Australia.
Clinically important changes
When analysing the differences between the isoflurane and sevoflurane groups, two criteria will need to be met for the changes in creatinine to be clinically important:
1. at least one mean increase in creatinine will be greater than 45 umol/l above pre-operative concentration AND
2. the difference between the means will be greater than 20 umol/l. For example: The group 1 mean rises by 50 umol/l and the group 2 mean rises by 25 umol/l.
Power analysis Using a standard deviation of 50 umol/l from our Cardiac Anaesthesia trial data, for a power of 0.90, alpha \< 0.05, to detect a 20 umol/l difference between 2 groups we would need 270 patients. We estimate we would need two years to complete this study.
Data Collection and Statistical analysis Data will be collected and analysed by investigators blinded to the drug allocation. Statistical analysis will be by parametric tests if data are normally distributed. Otherwise equivalent non-parametric tests will be used.
The statistics will be the point estimate for the difference between the isoflurane and sevoflurane increases in creatinine, the 95% confidence interval for the point estimate, and the p value from an unpaired Student's t-test.
An additional analysis will be an estimate of the proportions of patients in the isoflurane and sevoflurane groups who have a postoperative creatinine change greater than 45 umol/l. The statistics will be the point estimate for the difference in the proportions, the 95% confidence interval for the point estimate, and the p value from a Chi square test.
Supporting statistics will be from the point estimates for the difference between the peak creatinine and urea, the 95% confidence interval for the point estimates, and the p values from unpaired Student's t-tests.
Adverse events. In addition to usual clinical care, patients in this study will have added surveillance of their clinical chemistry results. Important changes will be passed on to the surgical units caring for the patient. The investigators will notify the ARMC Human Research Ethics Committee of any death or serious morbidity of patients enrolled in this study.
Significance of the project For this large trial, with a simple design, our hypothesis is that sevoflurane will not produce greater increases in creatinine than isoflurane in patients with preexisting renal impairment. For this project an unequivocal finding would be that the 95% confidence intervals for the differences between the isoflurane and sevoflurane groups did not include clinically important differences and that any differences that were found had a p value of greater than 0.05. Unequivocal findings would lead us to two conclusions: (1) that it is highly unlikely that sevoflurane has clinically important adverse renal effects, and (2) that sevoflurane is safe to use with low fresh gas flows in patients with preexisting renal impairment.
The benefits of sevoflurane and low fresh gas flows are discussed in the introduction. A finding of no adverse renal effects would provide high quality evidence supporting the safety of using sevoflurane and low fresh gas flows in patients with preexisting renal impairment.
|
Inclusion Criteria:
Adult patients for elective surgery who will:
* Need to stay at least one night, and
* Need general anaesthesia, and
* Have a pre-operative serum creatinine concentration greater than 130 umol/l.
Exclusion Criteria:
* The patient refuses.
* The patient is less than 18 years of age.
* The patient is on pre-operative dialysis
* The anaesthetist plans to use only regional or total intravenous anaesthesia.
* Specific types of surgery: craniotomy, carotid, and cardiac.
|
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] |
NCT02192879
|
TEA vs. PVB vs. PCA in Liver Resection Surgery
|
This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults \>/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral analgesia may improve recovery times and decrease hospital length of stay, which would be beneficial for the patient as well as decrease hospital costs. In addition, if better postoperative pain management scores can be achieved with epidural or paravertebral analgesia, and no significant prolonged postoperative coagulopathy is associated with patients undergoing major hepatic resection surgical procedures, these regional analgesia strategies can be considered a safe option for pain management in this patient population.
|
Inclusion Criteria:
* Age \>/= 18 years and \</= 80 years
* Scheduled for elective hepatic resection surgery
Exclusion Criteria:
* Preexisting coagulopathy (INR \>1.5)
* Spinal stenosis
* Local infection in area where catheter will be inserted
* Severe cardiovascular disease (NYHA Class III/IV)
* Severe pulmonary disease (FEV1 \<50% of predicted value)
* Allergy or sensitivity to narcotics or local anesthetics
* BMI \>45
* Inability to give informed consent
|
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] |
|
NCT04360603
|
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
|
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
|
Inclusion criteria:
1. Highly myopic patients (axial length 26\~31mm)
2. Diagnosed with vitreoretinal pathology that require vitrectomy
3. Never received vitrectomy before
Exclusion criteria:
1. Surgical planning including scleral buckling during operation
2. Surgical planning including combined phacoemulsification
3. Surgical planning including the use of silicone oil and/or perfluorocarbon liquid
4. Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy
5. Previous vitrectomy
6. Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration
7. Medical history with known connective tissue disease(s)
8. Age younger than 20 years old
|
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] |
|
NCT06175182
|
Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis
|
No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.
|
Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.
|
Inclusion Criteria:
* Having been diagnosed with cystic fibrosis
* Being 18 years old and older
* Clinically stable condition
* Able to cooperate with the tests performed
* Volunteered to participate in the study
For the control group:
* Being 18 years old and older
* Volunteered to participate in the study
Exclusion Criteria:
* History of hospitalization or exacerbation in the last month.
* Chronic respiratory failure and long-term use of oxygen therapy
* Using noninvasive mechanical ventilator therapy
* Indication for lung transplantation
* Who had a lung transplant
* Forced expiratory volume in the first second (FEV1) value 30% and below
* CF-related diabetes
* Chronic liver disease
* Allergic bronchopulmonary aspergillosis
* Systemic steroid use
* History of diagnosed orthopedic or musculoskeletal problems affecting mobility
* Cardiovascular instability
* Serious psychiatric illness
For the control group:
* Known chronic or systemic disease
* Who did not volunteer to participate in the study
|
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] |
NCT00299039
|
T3AI-Pain After Breast Surgery
|
Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery.
|
Block randomization will be used to randomize patients to one of two combinations. Group A will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules are placed in identical dossettes containing a seven day supply. Patients are instructed to start taking their medications post-op and continue until they are pain free. All participants are given a series of blank Visual Analogue scales and Likert scales and instructed to record their level of pain intensity and pain relief four times per day for the entire week. Peri-operative pain management will be standardized. Patients will not receive pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as selected by anaesthesiology. No local/regional anaesthesia will be used. Intravenous ketorolac will not be allowed for trial participants. All patients will receive intravenous opioid and anti-emetic if required in PACU. Any patients with peri-operative complications or other problems requiring admission or alternative analgesics will be excluded.
|
Inclusion Criteria:
* ages 18 to 70 inclusive
* outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
Exclusion Criteria:
* allergies to acetaminophen, NSAIDs, ASA or codeine.
* asthma.
* recent reported history of upper GI bleeding.
* daily analgesic use (OTC or opioid) pre-operatively.
* any opioid use in the week prior to surgery.
* reported history of PUD if not on PPI regularly.
* anticoagulant use (low dose ASA excepted).
* renal disease or impairment.
* reported history of liver disease.
* pregnancy.
* major operative complications.
* patients requiring admission.
* communication barrier.
* cognitive or memory impairment.
* reported history of drug and/or alcohol abuse.
|
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] |
NCT04353973
|
Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients
|
This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.
|
Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.
This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.
Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.
|
Inclusion Criteria:
* 18 years of age or older
* Speak and understand English
* Male or Female
* A personal history of one or more of the following:
* metastatic breast cancer
* advanced ovarian cancer (Stage III-IV)
* metastatic pancreatic cancer
* metastatic prostate cancer
* Naive to previous cancer germline genetic testing
Exclusion Criteria:
* Communication difficulties such as:
* Uncorrected or uncompensated hearing and/or vision impairment
* Uncorrected or uncompensated speech defects
* Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
|
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] |
NCT01293552
|
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
|
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
|
Inclusion Criteria:
* diagnosis of moderate to severe facial acne
* 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
* no presence of nodules
* female subjects must be not pregnant and non-lactating
Exclusion Criteria:
* presence of 1 or more nodules
* use of topical steroids on the face 4 weeks prior and during the study
* use of systemic corticosteroids 6 weeks prior and during the study
* topical or systemic acne treatment in the 4 weeks prior to Baseline
|
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|
NCT06138561
|
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
|
The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.
|
In this prospective, observational study, investigators are assessing the optimal approach to treating bladder cancer in older participants with other disease that might put the participants at additional risk from cancer-directed treatments. Investigators are specifically assessing the impact on adverse events, quality of life, and treatment outcomes. Additionally, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants.
The research study procedures include screening for eligibility and completing questionnaires.
Participation in this research study is expected to last for up to 8 months.
It is expected that about 180 people will take part in this research study.
The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.
|
Inclusion Criteria:
* Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population)
* Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed
* Cisplatin-ineligible as determined by the subject's primary oncologist
* Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone
* Ability to understand and the willingness to sign a written informed consent document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family
Exclusion Criteria:
* Subjects who elect to not undergo cancer-directed therapy
* Subjects obtaining their care outside of DFCI or DFCI affiliate sites
* Advanced cognitive impairment or inability to complete surveys
* Participants who are receiving any other investigational agents for this condition (if appropriate only).
|
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] |
NCT03109184
|
Violence Prevention for Middle School Boys
|
This study will develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.
|
Over the past ten years dating violence (DV) has been recognized as a significant public health problem affecting adolescents. Emerging data suggest that boys and girls have different developmental trajectories toward violence and therefore prevention programs that target their unique pathways to DV are needed. Despite this need, there is a relative dearth of such gender-informed programs for early adolescent boys. This research project aims to prevent the emergence of DV perpetration/ victimization among boys by developing a web-based intervention that is informed by research on gender-specific pathways to violence and harnesses the influence of parents during the early adolescent years.
Among boys, the perpetration of delinquency-related violence and attitudes supporting violence has been found to predict later perpetration of DV. Thus, gender-informed interventions designed to prevent DV in boys need to target skills that underlie violent behavior and attitudes. The goal of this study is to develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.
Development and testing will occur in three phases. In the Development Phase, the intervention modules will be developed and iteratively reviewed by both a panel of experts familiar with the research in the field as well as an advisory group of parents and teens from the target population. In the Acceptability Testing Phase, testing will be conducted to assess acceptability and feasibility, and this will be followed by revisions to the intervention program based on feedback and observations. During the Randomized Controlled Trial (RCT) Phase, 120 families will complete the intervention program in an observed setting, to ensure fidelity to intervention dosing. Parents and adolescents will complete the program together and then complete assessments of aggressive and risk behaviors, parent-child communication, and emotion regulation at baseline, 3-,and 9-month follow-ups.
|
Inclusion Criteria:
* 1) adolescent enrolled in the 7th or 8th grade,
* 2) parent/legal guardian and teen are English speaking,
* 3) parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
* 4) adolescent is willing to provide assent for their own participation.
Exclusion Criteria:
* 1) observable cognitive or developmental delays that would preclude participation,
* 2) residing with participating parent/guardian less than half time
|
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] |
NCT01133262
|
Effectiveness in Head and Neck Cancer Detection Using Positron Emission Tomography (PET) Insert Device
|
We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging capability provides 6-fold improvement in volumetric image resolution over the current state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging applications, in particular for those cases where a lymph node involvement will drastically alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is known to be challenging because of the complex anatomy and large number of lymph nodes involved in this region. As a result, head and neck cancer imaging is an ideal candidate for evaluating the clinical usefulness of this novel imaging device.
|
In this project, we propose to conduct an exploratory clinical trial to investigate the effectiveness of this novel imaging device in detecting small lesions and lymph node involvements in the head and neck region, and compare its results to those obtained from a clinical PET/CT scanner. More specifically, we propose to (1) recruit 5 patients who have confirmed head and neck cancer and are scheduled to receive a whole-body PET/CT scan followed by surgical operation to remove the primary tumor and the regional lymph nodes. These patients will be imaged by a state-of-the-art PET/CT scanner using the standard whole-body PET/CT imaging protocol as standard of care for initial staging. On another day, following consent to participate in this research protocol, A patient will undergo images of the head and neck region using the same type scanner with and without our novel PET insert device attached; (2) The images obtained from the PET insert device will be reviewed by experienced nuclear medicine physicians to identify the extent of lymph node involvement. The PET insert images will be compared to the standard clinical PET/CT images. A detailed image obtained for purposes of research, centered at the level of the head and neck, acquired for approximately 3 times the length of time the standard clinical image is obtained for will also be compared to the PET insert image. Images will also be compared to the pathology report of the surgically removed specimen. (3) Estimate the performance of lesion detection for different sizes of tumors using the standard PET/CT scanner as well as the PET insert device.
|
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck with suspected lymph node metastasis. Subjects with histological confirmation of squamous cell carcinoma from a lymph node biopsy in the head and neck region for carcinoma of unknown primary would also be eligible.
2. Patient must be scheduled to receive (or have already received) clinical whole body PET/CT scan from a Siemens Biograph 40 PET/CT scanner as their standard of care staging.
3. Patient must be scheduled to receive surgical removal of the primary tumor and the regional lymph nodes. It is preferred that the surgery will occur within 21 days of research PET imaging.
4. Age \>18 years, as head and neck cancer is extremely rare in children.
5. Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document.
6. Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of 18FDG and determined to be negative
Exclusion Criteria:
1. The subject weight will be limited to 250 lbs and below due to the size limitations of the prototype PET insert device.
2. Subjects who are claustrophobic
3. Subjects with poorly controlled diabetes (fasting blood glucose \>200mg/dL)
4. Subjects with prior head/neck surgery or radiation as this may disturb the natural architecture of the tissues and impede the imaging analysis
|
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] |
NCT01187108
|
Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru
|
Chronic mountain sickness is characterized by excessive red blood cell production which causes sludging of the vascular system. This high viscosity blood causes heart failure, cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been previously been shown to be an environmental pollutant worsens the overproduction of red blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt from the blood) are evaluated in their potential to improve chronic mountain sickness.
|
Inclusion Criteria:
* Males over 17 years of age
* Hematocrit \> 70%
* Chronic Mountain Sickness score (CMS) \> 6
* Able to give informed consent and follow instructions in written Spanish
Exclusion Criteria:
* CMS \> 15
* Underlying lung disease, smoking, or oxygen therapy
* Asthma (bronchospasm can be caused by N-acetylcysteine)
* Phlebotomy in last 3 months
* h/o adverse reaction to acetazolamide or N-acetylcysteine
|
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] |
|
NCT00003248
|
Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia
|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine given with or without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating patients who have untreated B-cell chronic lymphocytic leukemia.
|
OBJECTIVES: I. Determine the response rate and toxicity profile of concurrent and consolidative chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (rituximab) therapy compared to consolidative rituximab therapy in patients with chronic lymphocytic leukemia treated with fludarabine. II. Assess the complete response (CR) rate in patients receiving concurrent therapy with rituximab and fludarabine. III. Assess the frequency of conversion of a partial response (PR) to a CR or stable disease to either PR or CR in patients receiving consolidative therapy with rituximab. IV. Follow the effects of rituximab and fludarabine on the immunologic markers CD4, CD8, IgG, IgA, and IgM. V. Assess the progression-free and overall survival of these patients.
OUTLINE: This is a randomized study. Patients are stratified according to stage (I and II vs III and IV). Patients are assigned to 1 of 2 treatment arms. Arm I consists of fludarabine and chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (rituximab) induction, and arm II consists of fludarabine induction. Arm I: Rituximab is administered IV over 4 hours on day 1, on day 3, and over 1 hour on day 5 of week 1. Subsequent doses are given over 1 hour on day 1 every 4 weeks for a total of 6 courses. Fludarabine IV is administered over 10-30 minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and 21 for a total of 6 courses. Following the sixth course of fludarabine, patients undergo clinical staging and are then observed for an additional 2 months, after which they undergo repeat clinical staging, including bone marrow aspiration. Patients achieving a complete or partial response or stable disease then proceed to consolidation therapy consisting of weekly intravenous infusions of rituximab once weekly for 4 weeks. Arm II (Fludarabine Induction): Patients receive fludarabine IV over 10-30 minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and 21 for a total of 6 courses. Patients then proceed as in arm I. Patients are followed every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 12 months.
|
DISEASE CHARACTERISTICS: Histologically proven B-cell chronic lymphocytic leukemia Stage I or II with evidence of active disease as defined by: Massive or progressive splenomegaly and/or lymphadenopathy Weight loss of greater than 10% within 6 months CALGB grade 2 or 3 fatigue Fevers of greater than 100.5 C or night sweats for over 2 weeks and no evidence of infection Progressive lymphocytosis Stage III or IV Patient registration on CALGB 9665 required
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No medical condition requiring chronic use of oral corticosteroids Direct antiglobulin test or direct Coombs test negative Not pregnant Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic: No prior biologic therapy for disease No concurrent erythropoietin Chemotherapy: No concurrent chemotherapy No prior chemotherapy for disease Endocrine: No concurrent chronic oral corticosteroids No prior corticosteroids for autoimmune complications developing since diagnosis No concurrent hormone therapy for disease related conditions No concurrent dexamethasone or other corticosteroid-based antiemetics Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified Other: No prophylactic therapy for viral, bacterial, or fungal infections
|
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] |
NCT03082235
|
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
|
Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.
|
Inclusion Criteria:
* Nonsmoking, male or female, age ≥18 years and ≤45 years old at the time of informed consent
* Body mass index (BMI) ≥18 and \<32 kilograms per meters squared (kg/m2) at Screening
Exclusion Criteria:
* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] or human chorionic gonadotropin \[hCG\] test with a minimum sensitivity of 25 International Units per Liter \[IU/L\] or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
* Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
* Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
* A prolonged QTcF interval (QTcF \>450 ms) demonstrated on ECG at Screening or Baseline
* Persistent systolic blood pressure \>130 mmHg or diastolic blood pressure \>85 mmHg diastolic at Screening or Baseline Heart rate less than 50 or more than 100 beats/min at Screening or Baseline
* Known history of prolonged QT/QTc interval
* Left bundle branch block
* Known history of myocardial infarction or active ischemic heart disease
* Known history of clinically significant arrhythmia or uncontrolled arrhythmia
* Known history of clinically significant drug allergy at Screening
* Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
* Known to be human immunodeficiency virus (HIV) positive at Screening
* Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
* History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug and alcohol test at Screening or Baseline
* Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
* Use of prescription drugs within 4 weeks before dosing
* Intake of over-the-counter (OTC) medications within 2 weeks before dosing
* Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) before informed consent
* Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing
|
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|
NCT01465919
|
Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
|
The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.
|
Depression is a common serious adverse event (30%-50%) during the interferon treatment for chronic hepatitis C. Adequate control of depressive symptoms might enable to adhere to antiviral therapy and lead to the favorable prognosis for patients with chronic hepatitis C.
Mirtazapine is an effective antidepressant for depressive mood as well as insomnia and anxiety. Mirtazapine has also relatively lower drug-drug interactions, which are important for patients with hepatic dysfunction.
In this study, the investigators are going to perform an 8-week, randomized, open label trial comparing anti-depressive efficacy between mirtazapine and supportive psychotherapy in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.
|
Inclusion Criteria:
* Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV)
* Hamilton Depression Scale (HAMD-17) ≥ 14
Exclusion Criteria:
* Any other axis I primary diagnoses except major depressive disorder
* Having serious adverse events or hypersensitivity to mirtazapine
* Having major depressive disorder prior to the first injection of interferon
|
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] |
NCT00893893
|
Very-low-density-lipoprotein Triglyceride (VLDL-TG) Uptake in Visceral Fat
|
Purpose:
To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals
|
Inclusion Criteria:
* Healthy
* Age: 20-50 years
* Premenopausal
Exclusion Criteria:
* Smoking
* Alcohol abuse
* Use of medications
|
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|
NCT04018040
|
Vegetarian Diet in IBD
|
To determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate IBD compared to a standard omnivorous diet.
|
This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC and CD as an adjunctive treatment to current medical therapies. The proposed studyT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management midl to moderate IBD. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy.
|
Inclusion Criteria I. Is able to provide informed consent. II. Is over the age of 18 years. III. Has a diagnosis of ulcerative colitis or Crohn's disease for over a 3-month duration that was confirmed by a specialist gastroenterologist IV. Pro-6 score of 2 to 4, partial mayo 3-6 (mild to moderate UC) or Harvey Bradshaw Index (HBI) 5 to 15 (Crohn's disease)
V. Medications:
1. Oral 5-Aminosalicylates: If taking an oral 5-Aminosalicylates the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
2. Oral Corticosteroids: If taking oral corticosteroids the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit at a dose of ≤30mg.
3. Oral Azathioprine/6MP, Methotrexate or tacrolimus: If taking one of these medications the patient has used them for a minimum of 12 weeks and has been on a stable dose for 4 weeks prior to screening.
4. Biologic therapy with infliximab, adalimumab or vedolizumab: If taking one of these medications the patient has used them for a minimum of 12 weeks
5. Rectal Preparations; 5-Aminosalicylates, corticosteroids or tacrolimus: If taking one of these medications the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
VI. Willing to participate in the study and comply with the proceedings by signing a written informed consent.
VII. Free of any clinically significant disease, other than ulcerative colitis/Crohn's disease, that would interfere with the study's evaluations.
VIII. Subjects can read and understand English and is able to adhere to the study methodology and visit schedules.
Exclusion Criteria
I. Has been on antibiotics within the last four weeks. II. Has a known food allergy to nuts, soy, eggs or dairy. III. Is pregnant or breast feeding. IV. Following a vegetarian, vegan or low FODMAP diet. V. Has known dementia and the inability to understand the trial requirements. VI. Ulcerative colitis: Patients with less than 15cm of disease (proctitis) VII. Crohn's disease: Patients with severe Disease (HBI \> 15) or remission (HBI\<5) VIII. Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease (Boneh et al, 2017)
|
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] |
NCT03618394
|
Bone Turnover and Parenteral Nutrition
|
Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.
|
Osteopenia is very common in premature infants, particularly in preterm infants born at extremely low birth weight This is probably related to inadequate calcium and phosphorus intake, which is considerably less than the accretion of these minerals during the last trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g. bronchopulmonary dysplasia \[BPD\]), chronic drug therapy (e.g. diuretics and systemic steroids), the need for total parenteral nutrition and prolonged immobility increase the risk of bone demineralization.
Total parenteral nutrition is associated with osteopenia in preterm infants. Insufficient calcium and phosphate are likely causes; aluminum contamination is another possible contributing factor as this adversely affects bone formation and mineralization.
The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at \<33 wk gestation. Smof lipid emulsion has a high density of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and turnover.
|
Inclusion Criteria:
* gestational age \<32 weeks
* birth weight \<1500g (VLBW infants)
* in need of Parenteral Nutrition support
Exclusion Criteria:
* \>32 weeks of gestation
* chromosomal or other abnormalities
* parenteral nutrition \<80% of calorie/fluid needs
* primary liver disease
|
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1.2154624462127686,
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] |
NCT05272995
|
Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop Erectile Function
|
The accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. In clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative IIEF-5 score and at that time the doctors ask them about their preoperative erectile function. With this study, the investigators would like to evaluate the agreement between a real-time preoperative IIEF-5 and a recalled one 3 months after radical prostatectomy.
|
Radical prostatectomy (RP) is a widely performed procedure for patients with clinically localized prostate cancer and its most common side effects include urinary incontinence and erectile dysfunction. These two side-effects become progressively more important to health-related quality of life (HRQOL) and thus the balance between cancer control and preservation of HRQOL is challenging. The postoperative changes in erectile function are directly related with the preoperative erectile function status of the patient. The most accurate evaluation of the pretreatment erectile function is the International Index of Erectile Function-5 questionnaire. The fact that in some cases the preoperative questionnaire results are negatively affected by several factors, indicates the necessity of the assessment of the degree of agreement between real time IIEF-5 scores and retrospective IIEF-5 scores after radical prostatectomy. Frequently the andrologists do not have a preoperative IIEF-5 score in their hands and this might happen for various reasons. The main reason is that urologists ask about the preoperative erectile function often with just a simple question. They rarely use a questionnaire mainly due to time constraints. According to the experience at the Sexual Rehabilitation Clinic of the University's General Hospital of Patras, 3 months is the usual time point when most patients come to the clinic after radical prostatectomy. In the first two months after surgery, patients are interested primarily in the oncological and continence issues and later they seek help for their erectile dysfunction.
|
Inclusion Criteria:
* Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy, with or without use of phosphoodiesterase-5 inhibitors
Exclusion Criteria:
* Penile anatomic defects
* Uncontrolled major medical illnesses such as uncontrolled diabetes, severe renal, hepatic or cardiovascular disease
* major psychiatrics disorders
* drug or alcohol abuse
|
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] |
NCT01759745
|
Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm
|
Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and situation specific modulations of their symptoms. So called "sensory tricks" are actions that minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing air, and applying pressure to the periocular or temple region. (Weiner 1984) Many patients describe that other tasks/situations are exacerbate their symptoms specifically under bright fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns differ between BEB patients and control during rest, reading and talking.
In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988) However, little is known about various task and emotion specific influences on symptoms of BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car).
Differences in emotion and gaze related blink patterns between patients and controls will contribute to the understanding of the pathophysiology of BEB. This might offer new therapeutic options, e.g. symptom modulation.
The investigators hypothesize that blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and control, when performing gaze shifts and emotion related blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and controls.
The aim of this pilot trial is to assess differences in gaze evoked and emotion related blink patterns between patients and controls. These differences might contribute to the understanding of the pathophysiology of BEB.
|
Inclusion Criteria:
Patients:
* Willing to participate
* Idiopathic blepharospasm
* Age 18-80
* Last botulinum toxin injection \<3months
Control:
* Willing to participate
* Age and sex matched with patients
* Age18-80
Exclusion Criteria:
Patients:
* Secondary blepharospasm
* Neurologic Comorbidities
* Other eye disease besides BEB
* History of neuroleptic medication
* Use of medications on the study day, that influence eye blinks\& attention
* Drinking of caffeine or theine containing beverages on the study day
Patients and Control:
* Intake of psychotropic drugs at day of examination
* History of neuroleptic medication
* present eye disease
* Neurologic diseases that influence blinking
* Use of medications on the study day, that influence eye blinks\& attention
* Drinking of caffeine or theine containing beverages on the study day
|
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] |
|
NCT04143815
|
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines
|
This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.
This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.
|
Inclusion Criteria:
* Male or female over 18 years of age
* Bilaterally symmetrical moderate to severe GL at maximum frown as assessed by both investigator and subject using FWS
Exclusion Criteria:
* History of facial nerve paralysis
* Any eyebrow or eyelied ptosis as determined by the investigator
|
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|
NCT03164031
|
Feasibility and Acceptability of Orthotic Shorts for People With Multiple Sclerosis
|
Walking can be slow and unsteady in people with multiple sclerosis (MS). This study will investigate whether orthotic shorts might help.
Orthotic shorts are similar to the tight clothing believed to improve performance in athletes. Research suggests that such shorts help stroke survivors to walk faster. Some people with MS find that similar garments improve coordination and stability. Public funding is controversial because there is no research investigating whether they work in people with MS.
This is a cross-over study in which participants will each trial two different pairs of shorts. The first aim is to determine whether these shorts are acceptable to people with MS. Secondly, the study will develop the tools required to test the shorts. For example, by determining which measures seem most appropriate and if specific factors predict whether the shorts might help. The hypothesis being tested is that the shorts are acceptable.
People with MS will be invited to participate in this mixed methods study, aiming for a sample size of 16 people. Participants will trial two different pairs of shorts, one of which will fit more closely than the other. The shorts will be tested in a movement laboratory and in daily life.
In the movement laboratory, participants will be measured in both pairs of shorts and in normal, loose clothing. Walking pattern, speed and variability will be measured when the shorts are first worn.
Participants will test shorts in their normal daily life for up to two weeks. They will complete questionnaires about their walking and balance in the different shorts and record how long they wear the shorts. Interviews will explore expectations and experiences of the shorts and of the research study.
In the analyses, data from interviews will be combined with the numerical information gained from laboratory measures, diaries and questionnaires. If the shorts are acceptable, this study will inform a larger trial investigating effectiveness.
|
Study design - This is a mixed methods, randomised cross-over study investigating two different pairs of orthotic shorts. The shorts will be tested in two main ways, firstly, the impact of the shorts on objectively assessed walking ability when first worn and, secondly, acceptability and impact of the shorts on self-perceived ability over a two-week period when the shorts are worn in the community.
Participants - Participants will be people with multiple sclerosis (PwMS) who identify themselves as having some difficulty walking, with a lack of stability around the hips and/or lower trunk. The study aims to recruit 16 PwMS over a 15-16-month period. It is felt that a sample size of 16 will enable the shorts to be trialled with participants with a range of different movement problems as well as different ages, genders and activity levels. These characteristics may impact upon the effect and acceptability of the shorts.
Recruitment - Participants will be made aware of the study through flyers, online advertisements and in discussion with local healthcare professionals. Potential participants will be identified through a local neurological therapy service.
Procedure - Each participant will visit Sheffield Hallam University on four occasions and be seen at home on three occasions.
The first Sheffield Hallam visit (Appointment 1) will include informed consent, collection of basic participant details, an initial interview around expectations and motivations, completion of self-report measures, assessment and measurement for shorts with a representative from the orthotics company and provision of a falls diary for completion over the following two weeks. Participants will be randomly assigned to the order in which the different shorts will be tested.
The second and third Sheffield Hallam visits (Appointments 3 and 5) follow the same structure with each visit testing one of the two pairs of shorts. Firstly, walking ability without the shorts will be measured. They will put the shorts on and spend about 30 minutes becoming familiar with wearing the shorts before the objective measures are repeated. After the objective assessments, participants will be provided with further information on wearing and caring for the shorts and a wear diary and falls diary to be completed whilst the shorts are trialed at home.
The final Sheffield Hallam visit (Appointment 7) will include a final measure of walking ability without shorts plus a semi-structured interview around the participants' experiences of the shorts and the trial.
In between the above visits to Sheffield Hallam, there will be three shorter visits. Each participant can choose to attend university or meet in an agreed location if preferred. The first of these (Appointment 2) will be with the representative from the orthotics company to check the fit of the shorts and measure the pressure exerted by the shorts. If adjustments are required at this point, this will be done within 3 days and the shorts will then be delivered to the chief investigator. Appointments 4 and 6 are to collect the shorts, the diaries and the self-report measures reporting the perceived impact of the shorts after the period of home wear.
Intervention - The orthotic shorts will be custom-made by a UK based company that specialises in dynamic, elastomeric orthoses for healthcare and sport. They will provide two pairs of shorts for each participant, which will differ in the closeness of their fit. The company representative, who will assess each participant, will decide the compression and fit of the shorts, such as whether support for the lower trunk is required. The shorts can be manufactured with a toileting hole, if preferred, allowing participants to toilet without removing the shorts. Shorts with a toileting hole are usually worn beneath usual underwear.
Randomisation and allocation - Counter-balancing will ensure that half the group use the more closely fitting shorts first and half the looser shorts first. A randomisation schedule will be created by a using the Sealed Envelope online system for blocked randomisation. Shorts will be placed into sealed envelopes labelled "Shorts 1" and "Shorts 2" by a third party using the randomisation schedule.
Data collection - Semi-structured interviews will be conducted on two occasions for each participant - at the first appointment and at the final appointment.
At Appointment 1, participants will be interviewed to explore their motivations for joining the study, their expectations of the shorts, their current daily activities and their readiness for change. The data from this interview will enable investigation of whether certain aims, motivations or perceptions impact upon the eventual acceptability of the shorts. This initial interview is likely to last 20 - 40 minutes.
At Appointment 7, participants will be interviewed about their experiences during the study. This interview aims to determine the acceptability of the shorts and participants' views on the study processes such as the information and support they received, and the outcome measures used. Prior to the interview, the interviewer will review the data and reflective notes from the initial interview; the wear diaries and the Participant Global Rating of Change scores at the initial assessment and will use this information to inform the questions that are asked. This will ensure the interviews are focussed on aspects that are important to each participant. This final interview is likely to last 40 - 60 minutes.
Measures of walking ability - Outcome measures are described elsewhere and have been chosen according to current guidelines on the most relevant assessment battery for walking in PwMS. In addition to movement laboratory measures, participants will complete self-report assessments of their walking and balance; a falls diary and a rating of the overall impact on the shorts on their walking ability.
Data analysis - Qualitative and quantitative data will first be analysed separately and then combined, partly by transforming qualitative into categorical data where this provides a valid representation of the data and partly by comparing, contrasting and relating the findings of the different data types for each objective.
Qualitative data analysis will use the Framework Approach to thematic analysis.
Descriptive quantitative data analysis will determine individual and average changes on each measure and effect sizes for the impact of the shorts. Effect sizes will indicate which measures are most responsive to this intervention and this information may be used to inform a sample size calculation for future studies.
|
Inclusion Criteria:
* Diagnosed as having multiple sclerosis of any type (relapsing-remitting, primary progressive or secondary progressive).
* Clinically stable - have not experienced relapse in the last 4 weeks; have not commenced a novel therapy in the last 3 months.
* Able to travel to Sheffield Hallam University for assessments.
* Have difficulty walking with a subjective feeling of instability around the hips or lower trunk.
* Able to walk for at least 2 minutes at a time.
* Able to provide a written record of informed consent.
Exclusion Criteria:
* People who do not meet inclusion criteria.
* Skin conditions that may be exacerbated by tight clothing.
* Circulatory problems that may be exacerbated by tight clothing, such as varicose veins, previous thrombosis, venous or arterial insufficiency.
* Cognitive problems including memory disturbance that may impact on recall of experience and adherence to guidance.
* Pregnancy - because of related circulatory problems.
* Living further than 10 miles from Sheffield if they are unable to provide own transport and the home visits would be too far for the researcher to travel.
* Have previously used orthotic shorts.
|
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] |
NCT02993016
|
Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
|
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.
This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.
|
The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.
The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
|
Inclusion Criteria:
* over 19 year old
* Patients for total knee arthroplasty of both knee
* over 5 degree in lateral bowing of femur
* having medicare insurance
Exclusion Criteria:
* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* over 40 of body mass index
* Chronic opioid use (taking opioids for longer than 3 months)
|
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] |
NCT04755101
|
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
|
The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope (NMS).
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Two-third of the patients will be randomized to the active arm and one-third to the control arm (sham).
The study procedure is described in the 'detailed description' and 'intervention description'.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If syncope-free survival (primary endpoint) is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
|
The efficacy of therapeutic strategies mentioned in the guidelines for patients with neurally mediated syncope (NMS) is limited. The first clinical study on cardiac denervation in humans was published in 2005. Derived from this first method, different approaches to cardioneuroablation (CNA) to treat NMS have been published. Such ablations are complex, bi-atrial, and extensive. Cardio-neuromodulation (CardNM) is a less extensive and right-sided approach to CNA, based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus. Evidence from a single-center, non-randomized, unblinded trial showed that CardNM was associated with a reduction in syncope burden exceeding 90%.
This third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope.
The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS.
Two-thirds of the patients will be randomized to the active arm and one-third to the control arm (sham).
In all patients, the endocardial site to potentially target during ablation will be annotated before the procedure by a target line (TL) on a computed tomographic image of the heart imported into the CARTO system (Biosense Webster, Diamond Bar, CA), as detailed in the 'intervention description'.
The study procedure will be performed under general anesthesia according to a standardized protocol. In all patients, a diagnostic electrophysiology study (EPS) and electroanatomical mapping of the right atrium and the surrounding veins will be performed first. This image will be merged with the CT image and the TL will be visible. Randomization will be performed electronically at this stage of the procedure.
In patients assigned to the active arm, the TL will be targeted by ablation as detailed in the intervention description'.
The ablation procedure is considered complete when one of the following conditions is fulfilled:
1. 10 radiofrequency applications have been delivered;
2. After 5 radiofrequency applications, the P-P interval is \<70% of the baseline procedural P-P interval and remains \>550 ms 5 min after the last radiofrequency application;
3. ≥5 radiofrequency applications have been delivered and the operator estimates that no additional P-P interval shortening will be obtained by additional radiofrequency applications;
4. 3 radiofrequency applications have been delivered and the P-P interval is \<550 ms after the last radiofrequency application and remains stable after 5 min of waiting.
In all patients, a pharmacological evaluation and new diagnostic EPS will be performed to further evaluate the sinus node and atrioventricular nodal intrinsic activity at the end of the procedure, either after the diagnostic part of the procedure in the sham group or after the ablation in the active arm.
Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires completed at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate.
The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months.
Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If the syncope-free survival, the primary endpoint of the study, is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.
|
Inclusion Criteria:
* Patients must be in sinus rhythm and have ≥3 syncopes during the last 18 months\* and a previous positive tilt table test (TTT) with a cardioinhibitory or mixed response (VASIS I, IIA or IIB classification).
\* syncopes occurring during TTT are not taken into account
* Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine.
Exclusion Criteria:
* \<14 years age
* Any unstable medical condition, life expectancy \<12 months
* Inability to provide consent or undergo follow-up
* Syncope due to a non-cardiac disease or due to an advanced neuropathy
* Moderate to severe valvular or subvalvular aortic stenosis or mitral stenosis
* Overt heart failure or left ventricular ejection fraction \<45%
* Current pregnancy
* Chronotropic negative medications unless judged mandatory
* 4 g amiodarone intake during the 2 months preceding enrollment
* Alternating RBBB and LBBB, HV interval \>70 ms
* LBBB, bifascicular block (RBBB + LAHB, RBBB + LPHB)
* PR interval permanently \>240 ms
* Pacemaker or automated implantable cardioverter defibrillator device
* Permanent AF, PAF or electrical cardioversion during the last 6 months
* Channelopathy
* Tilt table test with VASIS III response or with VASIS II response and AV-Block
|
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] |
NCT04165200
|
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
Patients eligible for the study will be selected on Fridays during the HIV consultation at the Infectious Diseases Department. Patients that meet the inclusion and exclusion criteria, will be randomized and assigned in two groups 1:1. A group will start intervention with FMT (fecal matter transplant) through frozen capsules and after seven days, antiretroviral therapy (ART) will be started. Patients in the other group will be given placebo capsules and after seven days ART will be started. The frozen capsules of FMT will be ingested orally with a frequency of 15 capsules every 12 hours for 4 doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Subsequently, blood samples will be taken to monitor the immune status with CD4 T lymphocytes and HIV viral load during week 0, 4, 8, 12 and 24 after ART start.
Throughout the study period, subjects can carry out a free diet, moderate alcohol intake, perform their daily activities and abstain from any of the elimination criteria. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.
|
Study design: Prospective controlled study experimental comparative Study duration: 1 year The number of patients to enroll: 20 patients. After being randomized, selected patients who meet the criteria for inclusion and exclusion will be assigned 1:1 in two groups. A group will start treatment with FMT through frozen capsules, and ART at the same time; and another group will star placebo capsules and ART.
The frozen capsules will be ingested orally at a frequency of 15 capsules every 12 hours for four doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Each capsule must be ingested over a period no longer than 1 hour of the anterior capsule.
Subsequently, blood samples will be taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the immune status with CD4 T lymphocytes and HIV viral load. A total of 4 blood samples will be taken during week 4, 8, 12 and 24 after ART start.
Medical consultations will be made every 4 weeks, on days -7 days prior ART start, day 1, 30, 60, 90 and 120 where vital signs, symptoms or signs of organ systems, determination of weight, BMI, adverse effects and elimination criteria will be assessed.
In addition, feces samples from each patient will be taken during medical consultation on week 0, 8 and 24 after ART start to evaluate the modification of the intestinal microbiome after the intervention on both groups.
During the study period, subjects may carry a free diet, moderate intake of alcohol and perform their daily activities as they refrain free from any of the elimination criteria.
The study will last 1 year and the samples taken will be frozen and stored in the Infectious Diseases Department of the Hospital.
Selection of Fecal Microbiota donors:
The selection of fecal microbiota donors is based on:
* Medical history, body weight, no medication uses such as antibiotics and proton pump inhibitors, no trips and no diarrhea 6 months prior donation.
* The absence of chronic infections such as Hepatitis B, Hepatitis C, and HIV determined by immunoassay.
* Negative Rose Bengal test and V.D.R.L
* Normal complete blood count and liver function tests.
Fecal sample analysis:
1. Fresh microscopy analysis to detect leukocytes and parasites (including protozoa and helminths)
2. Stool culture to rule out the presence of enteropathogens, including Salmonella spp., Shigella spp., Aeromonas spp., Plesiomonas spp., Vibrio spp. and Clostridiodes diffcile.
3. Gastrointestinal panel by multiple polymerase chain reaction (PCR) using BioFire Filmarray which includes the detection of:
Bacteria: Campylobacter (C. jejuni, C. coi, C. upsaliensis), Clostridiodes difficile (toxins A / B), Plesiomonas shigelloides, Salmonella spp., Yersinia enterocolitica, Vibrio (V. parahaemolytic , V. vulnificus and V. cholerae), Escherichia coli O157: H7, enteroaggregative E. coli (EAEC), enteropathogenic E. coli (EPEC), enterotoxigenic E. coli (ETEC), Shiga toxin producing E. coli (STEC) stx1 / stx2, Shigella sp. enteroinvasive E. coli (EIEC).
Virus: Adenovirus F 40/41, Astrovirus, Norovirus GI / GII, Rotavirus A, Sapovirus (I, II, IV and V) Parasites: Cryptosporidium sp., Cyclospora cayetanensis, Entamoeba histolytica and Giardia lamblia.
4. Detection of genes associated with drug resistance by endpoint PCR; including genes encoding extended spectrum beta-lactamases (TEM, CTX; SHV, CMY) and carbapenemases (VIM, NDM, IMP, KPC, OXA-48).
Once all the stages of evaluation are completed only negative subjects for all the tests and in which there is no evidence of infection are selected as donors. The scrutiny and laboratory tests are considered valid during the following 4 weeks, so if new donation of feces is required, the process will be carried out again.
Sample Preparation fecal microbiota All samples will be mixed with 10% glycerol and frozen at -70°C in a period not exceeding 60 minutes after collection. They will be mixed and then suspended in saline 0.9%. The final mixture will be filtered to remove particles greater than 330 microns, finally adding glycerol as cryoprotectant. This mixture is carried to the encapsulation process using sterile capsules for enteral liberation, in two sizes. The first capsule is filled with a mixture of feces and sealed with its counterpart, and then the sealed capsule becomes encapsulated in a second capsule. The final product is stored frozen until 60 minutes before use. The administration will only be oral.
|
Inclusion criteria:
* Patients over 18 years
* Confirmed HIV infection with any CD4 lymphocyte count
* Patients at the beginning of the study only taking antibiotic prophylaxis according to the CD4 lymphocyte count
* Patients agree to participate in the study through a signed informed consent
Exclusion criteria:
* Patients receiving probiotics
* Patients with anatomical abnormalities of the digestive tract such as colostomy or ileostomy
* Patients with previous bowel resection
* Patients with impaired AST and / or ALT greater than 4 times its normal value
* Hemodialysis patients Patients with gastrointestinal bleeding in the last 12 weeks
* Patients undergoing colonoscopy in the last 12 weeks
|
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] |
NCT01753050
|
HIP Surgery - Hemodynamic Optimization Project
|
Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery reduces morbidity and length of hospital stay. This quality improvement is design to evaluate the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary combined endpoints will be the incidence of postoperative complications and the secondary endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital postoperative mortality. We amended another 130 patients getting crystalloid fluids in the hemodynamic optimization protocol.
|
Inclusion Criteria:
* patients undergoing redo hip surgery
* age above 18 years
* signed informed consent
Exclusion Criteria:
* urgent or emergency surgery
|
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] |
|
NCT06682390
|
Role of Race in Nutritional Approach in Men on ADT
|
There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives:
1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.
We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.
|
Inclusion Criteria:
* \>12 months on ADT
* Expected continuation of ADT for \>6 months upon initiation of study procedures
* Serum testosterone \<50 ng/dL
* BMI \>25
* Age \>18 years old
* African American and Non-Hispanic white males
* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent
Exclusion Criteria:
* Life expectancy \< 1 year
* Females
* Radiation or chemotherapy treatment
* History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease
* Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator
* Any subject who currently uses tobacco products
* Any use of \>20 g of alcohol per day
* Any subject who is unable or unwilling to comply with the study protocol
* Any subject who is unable to provide consent
|
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] |
|
NCT02516943
|
The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery
|
Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. We test the guideline for its safety and efficacy.
|
Inclusion Criteria:
* Patient undergone elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
* Emergency surgery
|
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] |
|
NCT00362414
|
Beta-hCG + Erythropoietin in Acute Stroke
|
The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.
|
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.
|
Inclusion Criteria:
1. Age 21-85
2. NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating
3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed
4. Patient is 24-48 hours from time of stroke onset at time that first dose of B-E therapy is administered. Time of onset is when symptoms began, and stroke occurred during sleep, time of onset is when patient was last seen to be normal.
5. Reasonable expectation of availability to receive the full 9 day B-E therapy course
6. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
Exclusion Criteria:
1. Pre-existing and active major psychiatric or other neurological disease
2. History of significant alcohol or drug abuse in the prior 3 years
3. Serum hemoglobin \> 16 g/dL in a male patient or \> 14 g/dL in a female patient; or a platelet count \> 400,000/mm3 in either a male or female patient
4. Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined as a serum bilirubin \> 4 mg/dL, alkaline phosphatase \> 250 U/L, SGOT \> 150 U/L, SGPT \>150 U/L, or creatinine \> 3.5 mg/dL
5. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years, using a test that reliably detects beta-hCG levels \> 25 with normal levels being \< 8 IU/L.
6. Contraindication to study participation on the basis of any of the following:
1. Allergy or other contraindication to initiating either beta-hCG or Erythropoietin
2. Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin
3. A known diagnosis of prostatic cancer; note that prostate specific antigen will be collected for retrospective assessment of safety, but will not be used to ascertain study eligibility
4. Dysuria of unexplained origin
5. Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy
7. Current use of either beta-hCG or Erythropoietin
8. Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
9. Terminal medical diagnosis consistent with survival \< 1 year
10. Known hypercoagulable state, which for the purposes of this study will deficiency of proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene mutation; or an anti-phospholipid antibody syndrome as based on clinical and laboratory measures.
|
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] |
NCT04929548
|
Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP
|
This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.
|
Recruiting patients with clinical stage II to III HER2-positive breast cancer for primary treatment, eligible subjects will be enrolled as follows： This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.Eligible subjects who met the enrollment criteria and signed the informed consent form entered the trial period and received epirubicin 100 mg/m2, iv cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po for 4 weeks, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + pertuzumab 420 mg (first dose 840 mg), iv ,po 4 cycles of treatment. Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: trastuzumab + patuximab for 1 year.
Eligible subjects (20) who met the nadir criteria and signed the informed consent form entered the trial period and received the ECPy-THP regimen: i.e., epirubicin 100 mg/m2, iv + cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4 cycles, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + patuximab 420 mg (first dose 840 mg), iv, po 4 cycles of treatment. If the efficacy of 4 cycles was evaluated as PD or SD, the regimen was promptly adjusted for surgical treatment.
Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: patients who reached pCR continued trastuzumab + pertuzumab for 1 year, and non-pCR patients were treated according to the guideline-recommended backline regimen.
All patients underwent surgery or radiotherapy continuation within 16-20 d after completion of the neoadjuvant chemotherapy cycle, and the efficacy was assessed 1 to 2 d before continuation of treatment.
|
Inclusion Criteria:
* Female patients aged 18-70 years.
* ECOG score must be 0 or 1.
* Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).
* The presence of at least one measurable lesion according to RECIST 1.1 criteria.
* Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan prior to neoadjuvant chemotherapy, and for lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases without a history of remaining malignancies.
* Expected survival of not less than 12 weeks.
* No previous treatment, including chemotherapy, radiotherapy, targeted therapy, and biologic therapy. -Exclusion Criteria
Exclusion Criteria:
* Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.
* Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of \< 2 years for the above diseases.
* Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug
* Karnofsky scale score below 60
* Patients with metastatic breast cancer or bilateral breast cancer.
* Patients with inflammatory breast cancer.
* Those with a left ventricular ejection fraction (LVEF) \<55% on echocardiography
* Those who are deemed by the personnel to be otherwise unsuitable for clinical trials.
|
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] |
NCT02172651
|
Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
|
This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colon cancer.
Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study drug will be given 14-28 days prior to your surgery. The number of days will depend on when the surgery is scheduled.
|
The participant will be given a study drug-dosing diary to keep track of when they take the study drug. The participant will be taking the study drug once every day, for 14 - 28 days, prior to their surgery.
* Run-In Phase: The first 6-12 participants will receive high-dose vitamin D prior to surgery. The number of participants in this phase will be based on the results of the analyzed research samples.
* Randomized Phase: Because no one knows which of the study options is best, the participant will be "randomized" into one of the study groups: high dose vitamin D or standard dose vitamin D.
* 48 Participants will be randomized to receive high-dose vitamin D or standard-dose vitamin D. Randomization means that the participants are put into a group by chance. Neither the participant nor the research doctor will choose what group the participant will be in. The participant will have an equal chance of getting assigned to each arm (like flipping a coin). The randomized phase will enroll to two groups at the same time:
* Group A: 24 participants with a recent diagnosis of stage I, II or III colon cancer will be randomized to receive high-dose vitamin D or standard-dose vitamin D.
* Group B: 24 participants with resectable liver metastases from colon cancer will be randomized to receive high-dose vitamin D or standard-dose vitamin D.
Additional research procedures to be performed on study:
* Blood samples will be collected for research purposes (a little more than 2 teaspoons of blood). The samples will be collected immediately prior to the participant's surgery and used to study the vitamin D receptor and pathway, as well as its relationship to colon cancer. Some of this blood will be stored to be used for future cancer research.
* Tumor tissue will be collected for research purposes at the time of the participant surgery. This tissue will also be used to study the vitamin D receptor and pathway, as well as its relationship to colon cancer. Some of the tumor tissue collected will be sent for use in a separate, but related study. In this study, the participant's tumor will be used to grow cell lines. This means the participant's tumor cells will be multiplied in the lab. These cell lines will be used to study the binding sites in the genes of participants and learn more about vitamin D's role in preventing colon cancer.
|
Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned;
--OR
* Participants must have histologically or cytologically confirmed adenocarcinoma of the colon with resectable liver metastases for which liver resection is being planned.
* No prior radiation therapy or systemic treatment is allowed for patients undergoing resection of stage I, II, or III colon cancer.
* Prior systemic treatment or radiation therapy is allowed for patients with resectable liver metastases.
* The last dose of chemotherapy or radiation must have been administered at least 4 weeks prior to liver surgery.
* The last dose of bevacizumab must have been administered at least 6 weeks prior to liver resection.
* Age ≥18 years.
* ECOG performance status ≤ 1 (see Appendix A)
* Participants must have normal organ and marrow function as defined below:
* Total bilirubin ≤1.5× institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, or \<5x ULN if clearly attributable to liver metastases
* Serum calcium (corrected for albumin level) ≤ 1x institutional ULN
* Serum creatinine within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
* Participants on full-dose anticoagulation are eligible if the following criteria are met:
* Participant has an in-range INR (usually 2-3) on a stable dose of warfarin or is on a stable dose of low molecular weight heparin
* Participant has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices)
* Participants receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.
* Discontinuation of anticoagulation, aspirin, and/or anti-platelet agents prior to surgery will occur according to institutional standards of care.
* Non-pregnant and not nursing
* Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to study entry. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level \>35 mIU/mL). Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child-bearing potential.
* The effects of higher-dose vitamin D3 and colon or liver surgery (and associated perioperative medications and anesthesia) on the developing human fetus are unknown and may pose unacceptable risk. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
* Prior systemic therapy, radiotherapy, or investigational agent in participants undergoing surgery for stage I, II, or III colon cancer.
* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for bevacizumab) of liver resection.
* Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
* Inability to swallow pills.
* History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease significantly affecting gastrointestinal function that could interfere with absorption of oral medications.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin D.
* Regular use of supplemental vitamin D totaling ≥ 2,000 IU/day in the past year.
* Use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed during the treatment period of this clinical trial.
* In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator. Vitamin D levels will be assayed only as part of the research blood samples collected during the study. If there are concerns related to a participant's vitamin D status, the lead Principal Investigator should be contacted for further discussion.
* Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin (all of which can cause vitamin D depletion). Short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted.
* Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to an alternative anti-hypertensive agent.
* Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal).
-- The use of supplemental calcium or supplements containing calcium is prohibited during the treatment period of this clinical trial.
* Known active hyperparathyroid disease or other serious disturbance of calcium metabolism in the past 5 years.
* History of symptomatic genitourinary stones within the past year.
* Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
* Pregnant or nursing women or men/women of child-bearing potential who are unwilling to employ adequate contraception.
-- Pregnant and nursing women are excluded from this study because there is an unknown but potential risk of adverse events related to higher-dose vitamin D3 and colon or liver surgery (and associated perioperative medications and anesthesia) on the human fetus. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
* History of prior or synchronous malignancy except:
* A malignancy that was treated with curative intent, for which there has been no known active disease for \>3 years prior to randomization, and for which the risk of recurrence is low as determined by the investigator.
* Curatively treated non-melanoma skin malignancy, cervical cancer in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
* Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, particularly for active hepatitis B or C patients undergoing liver resection. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
|
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] |
NCT00034723
|
MRI Brain Studies in Patients With HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
|
This study will use three different magnetic resonance imaging (MRI) techniques to study HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/STP)-a disease of slowly progressive weakness in the legs. It is not known how the HTLV-1 virus causes this disease, but it is thought that as the body's immune system tries to destroy the virus, parts of the nervous system-primarily the spinal cord-are damaged.
Patients 18 years of age and older with HAM/TSP and healthy normal volunteers may be eligible for this study.
Participants will undergo diffusion tensor MRI, MR-spectroscopy, and magnetization transfer imaging to look at different compositional, architectural, and microscopic properties of the brain. All of these techniques are similar to conventional MRI, and like the conventional method they use a strong magnetic field and radio waves to measure structural and chemical changes in brain tissue. Each of the three scans will be done on separate days, each lasting about 1 hour. For the procedures, the patient or volunteer lies on a stretcher in a narrow metal cylinder (the scanner) and is asked to remain still for 15 to 30 minutes at a time. A special lightweight coil may be placed on the head to enhance the brain images. The subject can communicate with the person doing the scan at all times.
|
Magnetic Resonance Imaging (MRI) has become an important tool in the diagnosis of inflammatory CNS diseases such as Multiple Sclerosis (MS) and HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM-TSP). It is widely used as a marker for disease activity and progression. However, conventional MRI methods are only suitable to study gross anatomical features, such as size and shape of a particular area of the brain; questions regarding intrinsic microstructure and morphologic specificity cannot be addressed. But axonal damage or structural abnormalities even in normal appearing brain tissue may play an important role in the development of irreversible disability. Magnetization Transfer Imaging, Magnetic Resonance Spectroscopy and Diffusion Tensor MRI are imaging techniques described to be capable of the detection of such changes. Spectroscopy can detect molecular components in tissue, whereas the Magnetization Transfer Ratio (MTR) allows the measurement of water-macromolecule interactions. Diffusion Tensor MRI (DT-MRI) is an imaging modality that combines features of in vivo anatomical MRI and histopathology: it is an in vivo MRI method that provides information about tissue composition, microstructure, organization and architecture. This is possible because water diffusion properties in tissues, as measured by DT-MRI, are affected by tissue constituents, such as macromolecules, membranes, organelles, as well as by tissue microstructure, architecture and organization. A study comprising Magnetization Transfer-, Spectroscopy- and DT-MRI furnishes important information that cannot be obtained using conventional MRI methods.
|
INCLUSION CRITERIA:
Patients:
A. Established Diagnosis of HAM/TSP as defined by Osame, Igata, and Matsumoto and subsequently confirmed by Gessain and Gout and the WHO.
B. Age 18 or older
C. An initial cohort of 5 HAM/TSP patients with established disease with EDSS levels of 6.0 or greater and duration of disease of 2 years or more will be investigated. If MRI abnormalities can be demonstrated, the group will be expanded to 20. Of this 20, at least 5 patients have been identified that will be HLA A201.
Healthy Controls:
A. No history of disease of the nervous system or autoimmune disease
B. Age 18 or older
C. Subjects shall be sex- and age-matched to our patients
EXCLUSION CRITERIA:
A subject will be excluded if he/she has a contraindication to MRI scanning such as the following: Aneurysm clip; Implanted neural stimulator; Implanted cardiac pacemaker or autodefibrillator; Cochlear implant; Ocular foreign body or implant (e.g. metal savings, retinal clips); breast implants; or Insulin pumps. Subjects will be excluded if they have claustrophobia. A pregnancy test will be administered to women of childbearing age. Pregnant women will be excluded from the studies.
|
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] |
NCT00265811
|
Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
|
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.
|
OBJECTIVES:
Primary
* Compare the disease-free survival rates in patients with completely resected stage III colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil with vs without cetuximab.
Secondary
* Compare the 3-year disease-free survival rate and 5-year overall survival rate in patients treated with these regimens.
* Compare the overall survival of patients treated with these regimens.
* Compare the treatment compliance of patients treated with these regimens.
* Determine the prognostic factors and markers predictive for relapse and/or treatment efficacy in patients treated with these regimens.
* Compare the safety of these regimens in these patients.
OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are stratified according to obstruction/perforation status (no obstruction and no perforation vs obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
* Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on days 1 and 8.
In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
|
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III adenocarcinoma of the colon
* Must have undergone curative resection (R0) within the past 28-56 days
* No radiotherapy prior to surgery
* carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery
* No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery
* No metastatic spread at baseline assessment
* No prior or concurrent CNS disease by physical exam
PATIENT CHARACTERISTICS:
Performance status
* WHO 0-1
Life expectancy
* At least 5 years
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* Bilirubin ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No coronary artery disease
* No myocardial infarction within the past 12 months
* No high risk of uncontrolled arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No inflammatory bowel disease
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No significant traumatic injury within the past 28 days
* No known hypersensitivity to any of the components of the study drugs
* No medical, geographical, sociological, psychological, or legal condition that would preclude study participation
* No peripheral neuropathy ≥ grade 1
* No other significant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior chemotherapy
Radiotherapy
* See Disease Characteristics
* No prior abdominal or pelvic irradiation
Surgery
* See Disease Characteristics
* Recovered from prior surgery
* More than 28 days since prior major surgical procedure or open biopsy
* No concurrent major surgical procedure
|
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] |
NCT00067327
|
Treatment of Multiple Sclerosis Using Over the Counter Inosine
|
The purpose of this study is to determine whether raising low levels of the natural antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary progressive Multiple Sclerosis (MS).
|
Uric acid is a natural inhibitor of certain chemistries associated with peroxynitrite, a product of inflammation. In animal models of multiple sclerosis (MS), these chemical reactions have been associated with breakdown of the blood-brain barrier and CNS tissue damage. In addition, MS patients have serum uric acid levels that are lower than age- and sex- matched healthy individuals. The primary purpose of this study to determine whether raising low serum uric acid levels by daily oral administration of its precursor inosine has an effect on the cumulative number of newly active lesions on magnetic resonance imaging (MRI) and to evaluate the safety and tolerability of inosine in patients diagnosed with relapsing remitting and secondary progressive MS.
|
Inclusion Criteria:
* Nonpregnant, nonlactating females
* Females of child bearing potential must have a negative human chorionic gonadotropin (HCG) test result within 60 days before the first dose of study material.
* Males and females must practice adequate contraception, in the judgement of the investigator, during the course of the study.
* Subjects must have a diagnosis of clinically definite Relapsing Remitting Multiple Sclerosis based on medical history, physical examination, laboratory test results, and neurologic examination. Alternatively, subjects may have clinically probable MS characterized by 1 attack and the presence of at least 4 lesions on MRI within 12 months before the initial baseline evaluation.
* Subjects must have an Expanded Disability Status Scale (EDSS) test result of less than or equal to 5.0 within 60 days before the first dose of study material.
* Subjects will have serum uric acid levels less than 5 mg/dl.
* Have 1 clinical relapse in the last year
Exclusion Criteria:
* Presence of any medical disability or laboratory test result that, in the judgement of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of study material or would compromise the subject's ability to provide informed consent.
* Evidence of active infection characterized by requiring treatment with antibiotics within 7 days before the first dose of study material.
* Treatment with interferons, glatiramer acetate, lymphoid irradiation, cyclophosphamide, or with other immune modifying treatments within 3 months, or corticosteroids within 1 month before the initial baseline MRI assessment in this trial.
* Recent history (within the previous 2 years) of drug or alcohol abuse.
* Known allergy to Inosine products or history of anaphylaxis.
* Previous randomization into this study.
* Treatment with an investigational agent within 30 days before the first dose of study material.
|
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] |
NCT00704483
|
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
|
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
|
Inclusion criteria
* Men or women of at least 18 years old.
* Stable maintenance of renal replacement therapy 3 times per week.
* Controlled Serum phosphate if under phosphate-binder therapy.
* Serum phosphate level ≥ 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.
Exclusion criteria
* Peritoneal dialysis.
* Parathyroidectomy or transplant scheduled during the study.
* Uncontrolled hyperparathyroidism
* History of hemochromatosis or ferritin \> 1000 µg/L.
* Clinically significant GI disorder
* Unstable medical condition other than Chronic Kidney Disease.
* Treated with oral iron.
* Other protocol-defined inclusion/exclusion criteria may apply.
|
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|
NCT00227331
|
Equivalency Of Oral Amoxicillin Vs Injectable Penicillin In Children With Severe Pneumonia
|
This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to injectable penicillin (the standard treatment) in the treatment of WHO-defined severe pneumonia in children between the ages of 2 and 59 months.
|
BACKGROUND Injectable penicillin is recommended treatment for WHO-defined severe pneumonia (lower chest indrawing \[LCI\]). Oral amoxicillin, if found equally effective, could reduce referral, hospitalization, and treatment costs. We aimed to determine whether oral amoxicillin and parenteral penicillin were equivalent in the treatment of severe pneumonia in children aged 3-59 months.
METHODS This multicentre randomized, open label equivalency study was conducted at tertiary care centres in 8 countries. Children aged 3-59 months with severe pneumonia were hospitalized for 48 hours and, if improved, discharged with a 5-day course of oral amoxicillin. Follow-up evaluation occurred at 5 and 14 days after enrolment. The primary outcome was treatment failure (persistence of LCI or new danger signs) at 48 hours. Analyses were by intention to treat and per protocol.
RESULTS 1702 children were randomized to receive either oral amoxicillin (857) or parenteral penicillin (845) for 48 hours. Treatment failure was 19% in each group (risk difference -0.4; 95% CI -4.2 to 3.3) at 48 hours, 22% (cumulative) in each group at 5 days, and 25% in each group at 14 days. Relapse at day 5 and 14 occurred in 45/1375 (3.4%) and 65/1330 (4.8%) of the children, respectively. Infancy (OR 2.72, 95% CI 1.95-3.79), very fast breathing (1.94, 1.42-2.65) and hypoxia (1.95, 1.34-2.82) at baseline predicted treatment failure by multivariate analysis.
CONCLUSIONS Injectable penicillin and oral amoxicillin are equivalent in the treatment of severe pneumonia in developing world areas in a controlled environment. Additional research is needed in a public health setting in rural and urban areas before these finding can be recommended for widespread implementation. Potential benefits of oral therapy for pneumonia include a decrease in the 1) the risk of needle-borne infections; 2) need for referral or hospitalization; 3) administration costs and 4) costs to the family. (word count 294).
|
Inclusion Criteria:
* Children aged three to 59 months admitted with severe pneumonia. Severe pneumonia is defined as lower chest indrawing in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate. Known HIV infected patients in clinical category N or A (CDC) will be included.
Exclusion Criteria:
* Presence of any danger sign during current illness (convulsions, abnormally sleepy or difficult to awake, stridor in a calm child).
* Severe malnutrition defined as weight for age equal or less than -3 SD or kwashiorkor).
* Hospitalization in the last two weeks. This will exclude cases with possible nosocomial pneumonia that could require second line antibiotics.
* Known prior episodes of asthma. These patients may have respiratory distress without infection and most often do not need antibiotics. Children having had 3 or more episodes of wheezing in the past will also be excluded. Wheezing that improves after receiving bronchodilator therapy, as explained in the footnote . These children may have asthma.
* Measles in the last month. These patients may have immune suppression.
* Previous history of HIV infection in clinical category B or C (CDC). These patients have immune suppression and infections that may require other diagnostic or treatment measures (see annex 1, page 39).
* Known or clinically recognizable chronic conditions (congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or hematological diseases).
* Other diseases requiring antibiotic therapy on presenting, such as meningitis, evident tuberculosis, dysentery, osteomyelitis, septic arthritis, etc. Use of other antibiotics needed for treatment.
* Children Lower Chest Indrawing due to non-infective cause such cardiac failure, active rickets, or severe anemia, or with signs of severe dehydration according to WHO criteria (see annex 2, page 42).
* Children with SaO2 \<80% in room air at sea level, or SaO2 \< 75% in Bogota and Mexico (for measurement of oxygen saturation see Study Manual).
* Known prior anaphylactic reaction to penicillin or amoxycillin.
* Known antibiotic therapy for 48 hours or more prior to admission. Clinically, these children would be considered for a change of treatment to second line antibiotics on admission. Evidence of antibiotic use include any of the following: a) parental report that an antibiotics has been given; b) parent can provide evidence for prescription for antibiotics or c) has the container with antibiotic or d) recognizes medication when shown appropriate containers for locally available antibiotics. Children that have received antibiotics for less than 48 hours prior to admission will be accepted in the trial.
* Inability to receive oral medications (three or more episodes of vomiting per hour). These children should not be given oral antibiotics.
* Previous inclusion in the trial or children already included in another trial.
* Living outside the catchment area of the hospital. These patients may be difficult to follow after discharge.
* Parental or caretaker refusal to participate in the trial.
|
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] |
NCT00197522
|
Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2
|
We, the researchers at Hamilton Health Sciences, have developed a novel approach to cancer therapy using transfected dendritic cells (DCs) to generate enhanced immunity to defined tumor antigens. Dendritic cells are highly specialized antigen presenting cells found in the bone marrow, lymph nodes, skin and thymus. Infection of DCs with Adenovirus (Ad) vectors incorporating genes for defined tumor antigens enables intracellular expression and major histocompatability complex (MHC)-restricted presentation of tumor peptides by transfected DCs. Given the potent immunostimulatory properties of DCs and ability to use gene transfer to "load" DCs with tumor antigen, we hypothesize that administration of transduced autologous DCs may have potential therapeutic benefit as a cancer vaccine. We have examined Ad-tumor antigen DC based vaccination in murine models of breast cancer and melanoma. In both models, injection(s) of Ad-transduced DCs results in highly potent immune activation and antigen-specific anti-tumor responses. In these models, high levels of antigen-specific, cytotoxic effector lymphocytes that recognize and kill cancer cells directly correlates with a therapeutic response (tumor regression and/or complete protection of animals subsequently re-challenged with tumor cells). Animals demonstrating specific in vitro immunity are protected against subsequent injection of cancer cells. Moreover, we have observed complete resolution and significant long-term survival in animals with established metastatic disease with no demonstrable toxicity. As opposed to vaccination protocols with tumor peptides or purified epitopes that are MHC-I restricted (i.e. HLA-A2), we have found that injection of DCs transduced with a vector expressing the entire tumor antigen results in peptide presentation from both MHC-I and MHC-II complexes. The subsequent immune response is comprised of both CD4+ and CD8+ T cell populations. Thus, Ad-based gene transfer of tumor antigens appears to be an efficient approach: (1) enabling sustained endogenous peptide processing, and (2) facilitating DC-specific presentation to the host immune system. We have shown that using a replication deficient adenovirus vector expressing Her-2/neu DNA under the control of a human mouse mammary tumor virus (MMTV) promoter that we can transfect bone marrow derived DCs (AdHer2/DC). These cells are then used to immunize recipient mice against tumour challenge with Her2 transgenic tumour cells. The protection is antigen specific (anti Her2). On the basis of these pre-clinical studies we will initiate a pilot trial of the AdHer2/DC vaccine in Her -2/neu overexpressing patients with metastatic breast cancer. Long-term goals and implications of possible results: The goals of this initial pilot phase I study are to evaluate the safety and dosing schedule of the vaccine therapy. The vaccine will be tested in subsequent phase II and III studies to determine efficacy in comparison to standard therapies. The long-term goals are to eventually test this therapy in the adjuvant breast cancer setting in Her-2/neu overexpressing patients.
|
Following written, informed consent, consecutive cohorts of 3-6 patients, up to a maximum of 18 patients, will be treated at increasing dose levels based on a modified Fibonacci scheme. Peripheral blood progenitor cells will be obtained from each patient following cytokine mobilization (with GM-CSF and G-CSF). Selected CD34+ cells are then cultured with human GM-CSF, human TNFα, Flt-3 ligand and human interleukin-4. The CD34+ derived dendritic cells are then transduced with an adenovirus expressing rat HER2/neu. These transduced DCs are then injected intradermally into the patient. Patients will be injected with the AdHER2/neu transduced DCs every 21 days for a total of three treatment cycles. The starting dose of dendritic cells will be 10 X 10\^6 DCs. If none of the initial three patients treated at this dose experiences dose limiting toxicity (DLT) then a new cohort of three patients will be treated at a second dose level of 50 X 10\^6 DCs. If any patient experiences DLT then up to six patients will be treated at the current dose level; if 2/6 or fewer patients experience DLT, we will escalate to the to the second dose level. If 3 or more patients experience DLT, the maximum tolerated dose will be deemed as exceeded and a second cohort of 3 patients will be treated at a 10 fold dose reduction of the initial dose level. The third dose level will consist of 100 x 10\^6 DCs. All treatments will occur in the out-patient setting and patients will be seen prior to each injection and then monthly for at least three months following the last injection of AdHER2/neu DCs.
|
Inclusion Criteria:
* Patients with metastatic breast cancer who are HER2/neu positive (3+ by immunohistochemistry or FISH positive) and either
1. currently receiving hormonal therapy or are candidates for such or
2. being considered for trastuzumab or
3. their cancer has progressed on trastuzumab
Exclusion Criteria:
Patients are excluded from the study if they meet any one of the following criteria:
* Age less than 16 years.
* Pregnant or lactating female.
* Previous malignancy other than non-melanoma skin cancer.
* More than three prior courses of cytotoxic chemotherapy for metastatic disease.
* Concurrent use of chemotherapy, immunotherapy, or gene therapy. Concurrent hormonal therapy (tamoxifen, aromatase inhibitors or exemestane) is permitted.
* Treatment with trastuzumab within 16 weeks prior to first dose of vaccine therapy.
* Documented central nervous system metastases.
* Patients with any an acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy (ie. unstable angina, renal or liver failure, or severe chronic obstructive airways disease) are ineligible.
* Any patients requiring concurrent immunosuppressive therapy (eg. corticosteroids)
* Patients with a life expectancy of less than six months.
* ECOG performance status of \>2.
|
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] |
NCT02641834
|
Prevention of Cardiovascular Disease With Med or Veg Diets
|
The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet would benefit the cardiovascular risk profile of the participants, compared with a Mediterranean diet.
|
Nutrition is able to substantially alter the health status of the general population. In industrialized countries such as Italy the most important association between diet and health is certainly the relationship with cardiovascular disease, the leading cause of death and disability. The ability to identify with certainty, therefore, the relationship between diet and cardiovascular disease appears to be a key element in the implementation of specific primary prevention strategies.
Cardiovascular diseases would be the result of interactions between genetics and environmental factors. Many studies have evaluated the associations between food groups, foods, or nutrients and chronic diseases, and a consensus about the role of nutritional factors in the etiology of common diseases, such as cardiovascular and neoplastic diseases, has gradually emerged. Recent studies have been focused on examining the impact of a whole dietary approach rather than on isolating single nutrients; it is recognized that analyses of single nutrients ignore the important and complex interactions between components of a diet and, more importantly, because people do not eat isolated nutrients.
The optimal dietary strategy for the prevention of chronic degenerative diseases remains a challenging and a highly relevant preventive health issue. Over the last years, numerous evidence on the existing relationship between nutrition and chronic degenerative diseases have led investigators to search for the optimal dietary pattern to maintain a good health status. Several models of diet have been imposed on public attention, but those that got the most interest are certainly Mediterranean and vegetarian diets. These dietary patterns seem to exert protective effects on blood pressure, lipid profiles, cardiovascular diseases and metabolic parameters.
The term Mediterranean diet has been widely used to describe the traditional dietary habits of people in Crete, South Italy, and other Mediterranean countries during the decade of the 1960s. Since the first data from the Seven Countries Study, several studies in different populations have established a beneficial role for the main components of the Mediterranean diet on the occurrence of cardiovascular diseases and chronic degenerative diseases. This dietary pattern is characterized by plentiful plant foods (fruits, vegetables, breads, other forms of cereals, beans, nuts, and seeds), olive oil as the principal source of fat, moderate amounts of dairy products (mainly cheese and yogurt), low to moderate amounts of fish and poultry, red meat in low amounts and wine consumed in low to moderate quantities, usually with meals.
The vegetarian diet is a diet that excludes the use of animal foods (meat, fish) in its fresh, preserved and/or processed. The increase in the number of vegetarians is attributable to health, ethical, environmental, and social concerns.
Recently, meta-analysis conducted by our group have revealed, in a population of over than 2 million of people, that a strict adherence to a Mediterranean dietary pattern is associated with a significant improvement in health status, as seen by a significant reduction in overall mortality (10%) and incidence and/or mortality from cardiovascular diseases (9%).
During the past few decades, there has been a gradual abandonment of this dietary pattern by the inhabitants of the Mediterranean basin, especially by the younger generations. Several factors have contributed to this nutrition transition, such as the enhanced commercial availability of food, the urbanization of life, and the overall improvement in socioeconomic conditions in Europe, which has increased the food and energy supply and made food (especially of animal origin) more affordable. Consumption of milk, meat and animal fat products increased in all Mediterranean countries. Moreover, a stressful lifestyle, less time spent on cooking, and the enhanced variety and availability of household appliances have also been proposed as determinants of nutrition transition.
Because of the growing evidence in favor of link between red and processed meat and cardiovascular disease risk, cancer and diabetes, the interest towards vegetarian diets has increased. In the last years, the number of subjects who began to adopt a vegetarian dietary pattern has enormously increased with respect to the past, when the population of vegetarians was limited only to few and selected cohorts. Such increase has been mainly attributed to the supposed beneficial effect of this dietary pattern versus the occurrence of diseases.
Health benefits of Mediterranean and vegetarian diets have been widely described in case-control and prospective cohort studies during the last 50 years. There are several beneficial nutrients that are abundant in these diets, such as monounsaturated fatty acids, high amounts of fiber and antioxidants and low intake of total and saturated fats. However, it is unclear whether established health benefits for vegetarians are attributable to the absence of meat in the diet, the increased consumption of particular food component(s) the pattern of foods eaten within the vegetarian diet or other healthy lifestyle components often associated with vegetarianism.
In a recent systematic review with meta-analysis carried out on over than 130,000 vegetarians, plant-based diet was associated with many health benefits. Main findings were that vegetarian diet determines, among case-control studies, lower levels of the most important risk factor for chronic disease, along with a reduced risk of occurrence for ischemic heart disease (-25%) when cohort prospective studies were taken into account.
Currently there are no randomized controlled trials to compare, in a high-risk group of patients with risk factors for cardiovascular disease, the efficacy of nutritional interventions based on Mediterranean and vegetarian dietary patterns. From this comparison it would may be possible to obtain interesting results in order to identify the optimal diet for prevention of cardiovascular diseases.
OBJECTIVES:
The primary aim of the study is to compare the effects of vegetarian diet on risk markers (anthropometric and biochemical measures) associated with cardio-metabolic diseases (CMD) after a 3-month dietary-intervention phase, compared with a Mediterranean diet.
Secondary objectives of the study are:
* To improve knowledge about the pathophysiological role of vegetarian and Mediterranean diets in cardiovascular prevention
* To evaluate the feasibility and degree of adherence to a dietary substitution with vegetarian diet in a omnivorous population
* To evaluate the ability of a nutrition education intervention to reduce fresh and processed meat consumption in subjects at high cardiovascular risk, in order to enhance health and quality of life
* To explore the impact of food prices on consumption and to evaluate the overall cost of buying food products in different dietary patterns
STUDY DESIGN The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet would benefit the cardiovascular risk profile of the participants, compared with a Mediterranean diet.
The eligible participants are randomly divided into two groups, each assigned to either the experimental group (Group 1), which receives a vegetarian diet, or the control group (Group 2), which receives a Mediterranean diet. Following the first intervention phase, the subjects are crossed over in order to obtain the second intervention phase. Both diets are isocaloric and lasting three months each. The whole trial includes five clinical visits.
STUDY POPULATION Subjects in primary prevention with low-middle cardiovascular risk (1-5% according to the guidelines of the European Society of Cardiology), determined by the presence of BMI \>o=25 kg/m2 and no more than other 2 concomitant metabolic risk factors.
|
Inclusion Criteria:
1. Age 18-75 years
2. Willing and able to give informed consent
3. Presence of at least one of the following risk factors for cardiovascular disease (European Society of Cardiology guidelines on cardiovascular disease prevention):
* BMI \>o= 25 kg/m2
* Waist circumference \> 88 cm (women) or \> 102 cm (men)
* Circulating levels of total cholesterol \> 190 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
* Circulating levels of LDL cholesterol \> 115 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
* Levels of circulating triglycerides \> 150 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
* Circulating levels of fasting blood glucose \> 110 and \< 126 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
4. Wiling to participate in a randomized study comparing two dietary profiles, one of which is a vegetarian dietary pattern
5. Successfully completed 3-day food diary
6. Wiling to be contacted at least twice during the study period to evaluate diet compliance
7. Wiling to provide blood and fecal samples
Exclusion Criteria:
1. Presence of current serious illness or unstable condition that requires physician supervision of diet or physical activity (e.g., recent myocardial infarction, chronic liver disease, inflammatory bowel diseases)
2. Pregnancy or intention to become pregnant in next 18 months
3. Lactation
4. Current or recent (past 6 months) participation in weight loss treatment program or use of weight loss medication
5. Reporting no regular intake of meat, fish, or poultry for past month
|
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] |
NCT04994028
|
Effectiveness of Volume Spirometry and Deep Breathing Exercise for Dyspnea During Third Trimester of Pregnancy
|
During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Dyspnea is a common complaint in pregnancy related to change in respiratory centre threshold and sensitivity. Pregnant women who engaged in regular exercise have less pregnancy induced discomforts like dyspnea and leg cramps than who did not engage in exercise. During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Purpose of this study was to evaluate the efficacy of volume Spirometry and breathing exercise on dyspnea in third trimester of pregnancy. Rationale of the study was to find the effects of volume Spirometry and breathing exercise on dyspnea with focus on method of deep breathing exercise and volume Spirometry and outcomes. Significance of this study was to improve functional capacity and quality of life in pregnancy induced dyspnea. Subjects were randomly allocated to either two groups both groups received baseline treatment while interventional group received volume Spirometry and deep breathing exercise. Estimated sample size of 48 divided into 24 in either group by randomization. Modified Borg scale and visual analog scale were used to collect the findings. Non-parametric tests were used and analyzed by using spss22.
|
Inclusion Criteria:
* BMI 18.5-30
* Primigravida and multigravida with 3rd trimester
* Singleton and twin pregnancy
Exclusion Criteria:
* Cardiac and respiratory disorders
* Smoker
* Obesity
* Any type of allergy
* Autoimmune disorders
|
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] |
|
NCT04524559
|
Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
|
Children with CP encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.
|
this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic CP.
|
Inclusion criteria
* Diagnosed as spastic quadrilepgic CP
* Both genders
* Aged from 12 to 48 months
* Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
* Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
* Grade ≥ 2 spasticity according to the MAS
* Level IV and V motor function according to the GMFCS-R\&E.
* Partial head and trunk control. Exclusion criteria
* Gum and/or dental problems
* Congenital problems of mouth and soft plate
* Uncontrolled seizures
* Any metabolic disorders
* Cardiopulmonary disorders
* Significant mental problems.
|
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1.1358565092086792,
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] |
NCT04620200
|
Neo-adjuvant Nivolumab or Nivolumab With Ipilimumab in Advanced Cutaneous Squamous Cell Carcinoma Prior to Surgery
|
To determine the histopathological response rate to neo-adjuvant nivolumab and nivolumab plus ipilimumab at time of standard of care(surgery ± radiotherapy).in patients with cutaneous squamous cell carcinoma.
|
This is an investigator-initiated randomized non-comparative phase II trial consisting of 40 patients with resectable stage III-IVa CSCC randomized 1:1 to ARM A: 2 courses of nivolumab 3 mg/kg in week 0 and 2, or ARM B: 2 courses of nivolumab 3 mg/kg in week 0 and 2 plus 1 course of ipilimumab 1mg/kg in week 0. Both treatment arms are neo-adjuvant and applied prior to standard of care (consisting of surgery at week 4 with or without adjuvant radiotherapy).
|
Inclusion Criteria:
1. Age 18 years or older.
2. Patient is able to understand and comply with the protocol requirements and has signed the informed consent form.
3. World Health Organization (WHO) Performance Status 0 or 1 (Appendix B).
4. Patients with histologically or cytologically confirmed, primary or recurrent stage III-IVA CSCC of all body sites.
OR
Patients with histologically or cytologically proven stage I-II CSCC, only in the case of:
* Presence of multifocal disease for which extensive and/or mutilating surgery is necessary (e.g. near-total scalp resection).
* Situated in an anatomical localization that necessitates extensive and/or mutilating surgery (e.g. orbital exenteration).
5. Eligible for standard-of-care, curatively intended surgery with or without adjuvant radiotherapy.
6. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109 /L, Neutrophils ≥1.5x109 /L, Platelets ≥100 x109 /L, Hemoglobin ≥5.5 mmol/L, Creatinine ≤1.5x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN (except subjects with Gilbert Syndrome, who are eligible when total bilirubin \< 3.0 mg/dL).
7. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. They should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of the investigational drug.
8. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) prior to the start of nivolumab or nivolumab + ipilimumab.
9. Men who are sexually active with WOCBP must use a contraceptive method with a failure rate of less than 1% per year and will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Surgically sterile or azoospermic men do not require aforementioned contraception.
Exclusion Criteria:
1. Distantly metastasized (stadium IVb) CSCC.
2. SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip).
3. Patients for whom SOC consists of definitive (brachy)radiotherapy.
4. Primary or recurrent CSCC appearing in an area that has been previously irradiated.
5. Prior anti-CTLA4 or anti-PD1 immunotherapy.
6. Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
7. A positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C antibody (HCV Ab).
8. Subjects with any active autoimmune disease or a documented history of autoimmune disease, except for:
* Subjects with vitiligo
* Resolved childhood asthma/atopy
* Residual hypothyroidism due to an autoimmune condition requiring only hormone replacement
* Psoriasis not requiring systemic treatment
* Any condition not expected to recur in the absence of an external trigger.
9. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or AE.
10. A concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
11. Pregnant or nursing.
12. A history of allergy to study drug components and/or a history of severe hypersensitivity to any monoclonal antibody.
13. Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion.
14. Use of prohibited medication at start of study period
|
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] |
NCT05055115
|
Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis
|
Background:
The Eustachian Tube (ET) is a mucosa-lined connection between the nasopharynx and the middle ear cavity. It is believed to have three functions: 1) ventilation of and pressure equalization in the middle ear cavity, 2) mucus drainage from the middle ear, and 3) protection against sound and infection from the nasopharynx1. In adults, Eustachian Tube Dysfunction (ETD) can cause complaints from one or both ears. For many years, various definitions of ETD have been used, impairing the opportunity to compare studies. However, in 2015, an international consensus on definition, types, clinical presentation, and diagnosis of ETD was published by Schilder et al2, which has been adopted by all the Scandinavian countries. The symptoms include pressure (fullness), and/or pain in the ear, muffled hearing, and overall discomfort. Furthermore, chronic ETD can result in tympanic membrane retraction, atelectasis of the middle ear cavity, and ultimately formation of cholesteatoma3. Unfortunately, the symptoms of ETD are multiple and inaccurate giving rise to varying estimates of the prevalence. As an example, a study in UK found a 0.9 % prevalence of ETD4. In addition, clear guidelines on diagnostics and treatment are not currently available due to the fact, that no objective test for detection of ETD exists. In the need of a symptom scoring system, the patient reported Eustachian Tube Dysfunction Questionnaire (ETDQ-7) has been developed and validated in English5. Yet, translation into other languages as well as validation in other settings are necessary in order to substantiate the applicability of ETDQ-7. ETD is associated with a lack of opening of ET. It is believed that the length, diameter and angle of ET influences its ability to open regularly, thus affecting its function. A short, narrow and angled ET may predispose to ETD. However, the imaging available to visualize ET are not accurate enough to diagnose ETD. A direct test of the function of ET is not available. Tubomanometry is a relatively new method developed to directly test the opening of ET, but is yet to be validated6.
Both non-surgical and surgical treatment options to improve the function of the Eustachian Tube are available. Non-surgical management includes pressure equalization methods (e.g. the Valsalva maneuver), antihistamines, treatment with decongestants, and nasal douching with a saline solution. Surgically, ventilation tubes are often used to treat ETD. In case of adenoid hypertrophy obstructing the pharyngeal opening of ET, adenoidectomy is recommended. Balloon Eustachian Tuboplasty (BET) was introduced in 2010 by Ockermann et al7. BET is a non-invasive procedure performed under general anesthesia. During the procedure, a catheter is inserted either endonasally or transtympanic into ET, and a balloon is inflated with water for approximately two minutes. Various heterogeneous studies have shown a short-term effect of BET, but long-term effects are unclear8.
In summary, despite the assumption of being a common condition, the field of ETD suffers from lack of precise definition, diagnostic criteria, identification of underlying causes as well as purposeful treatment, and prognostic factors. Especially, long-term effects of BET need further investigation. Therefore, in an effort to fill out the gap of knowledge about ETD, the following specific aims are proposed:
|
Specific Aims:
Translation, modification, and validation of the ETDQ-7 in Danish settings Investigation of combined Cone-Beam CT and MRI of the Eustachian tube in order to determine a potential anatomical cause/disposition of ETD Clarification of the effects of BET using strict criteria for ETD To validate the process of tubomanometry as an objective tool in patients with ETD
Hypothesis
ETDQ-7 is a useful patient-reported symptom scoring tool in Danish patients with assumed ETD ETD is related to the dimensions and angles of the Eustachian tube detected by combining Cone-Beat CT and MRI-scans BET is effective in patients with chronic ETD Tubomanometry can be used as an objective tool in diagnosing and monitoring the effect of treatment in patients with ETD.
Study 1:
Danish translation, modification, and validation of the Eustachian Tube Dysfunction Questionnaire Holm NH1 \& Ovesen T1.
1) ENT Department, Regional Hospital West Jutland, Expected publication in Clinical Otolaryngology
The Eustachian Tube Dysfunction Questionnaire (ETDQ-7) was introduced in 2012 by McCloud et al. It scores symptoms of ETD, and it is the only validated patient-reported scoring tool. So far, ETDQ-7 has been translated and validated into German, Turkish, and Brazilian Portuguese. The aim of the present study is to translate, modify and validate the questionnaire in Danish settings to achieve a solid tool for optimal diagnostic and evaluation of treatment among patients with ETD.
Back and forth translation from English to Danish will be performed by a professional translator. Then, a modification/cultural adaption of the questionnaire will be conducted. Seventy-five patients older than 18 years referred to practicing ear nose and throat specialists will be included. Inclusion criteria are symptoms of ETD for more than three months including tympanometry compatible with negative middle ear pressure (C2 or B-curve). The seven questions in the ETDQ-7 are: 1) pressure in the ears, 2) pain in the ears, 3) a feeling that the ears are clogged or "under water", 4) ear symptoms when having a cold or sinusitis, 5) crackling or popping sound in the ears, 6) ringing in the ears or 7) feeling that the hearing is muffled. Patients will fill out the questionnaire before and after tympanostomy (insertion of ventilation tubes). Patients will then be referred to the ENT Department, Regional Hospital West Jutland for further follow up, including controlling the tympanostomy tubes. Here, a complete oto-rhino-laryngological examination, fiber optic naso-pharyngo-laryngo-scopy, pure tone audiometry, and tympanometry will be performed. SNOT-22 questionnaire is completed for differential diagnostics. Results will be compared to 75 age- and gender matched controls with no history of ETD or ear-surgery. In addition, patients undergoing BET will complete the questionnaire before and after surgery.
For test-retest data, 15 patients and 15 controls repeat filling out the questionnaire 14 days after the first reply. Patients are excluded from the retest in case of upper airway infection or travelling by airplane between the two tests. By comparing these results and calculating the Spearman's rank correlation coefficient, the test-retest reliability of ETDQ-7 is assessed. The internal consistency of the questionnaire will be investigated by using Cronbach's alpha coefficient and Spearman rho. Hence, it will be possible to conclude if ETDQ-7 can be used as a diagnostic tool to differentiate patients with ETD from individuals without ETD as well as to evaluate the effect of BET.
Study 2:
Cone-Beam CT combined with MRI as a diagnostic tool in patients with Eustachian Tube Dysfunction Holm NH1, Ovesen T1, Balazs M2 \& Pedersen M3
1. ENT Department, Regional Hospital West Jutland
2. Department of Radiology, Regional Hospital West Jutland
3. Institute of Experimental Clinical Research, Aarhus University Hospital Expected publication in Otology and Neurotology
The Eustachian tube (ET) is both skeletal and cartilaginous in nature. CT and/or MRI are often used preoperatively to identify potential pathology in the temporal bone. However, these techniques are not routinely used in order to diagnose ETD. It is unclear whether ETD is associated pathology in the skeletal or cartilaginous regions of ET. Length, diameter and/or angle of the ET may be a potential anatomical explanation for ETD, alternatively a disposition of ETD.
Cone-beam computed tomography (CBCT) is a relatively new imaging technique, where divergent X-rays form a cone. CBCT can accurately visualize the facial bones, and is often used by dentists and orthodontics. A study has shown no difference in the temporal bone between patients with patulous Eustachian tube and a control group. No other study has investigated ETD patients with CBCT. The cartilaginous part of ET is ideally visualized with MRI, whereas CBCT is the best choice for the skeletal part. Both MRI and CBCT are therefore needed in order to obtain a complete overview of ET. By implementing a brand-new software technique, MRI and CBCT sequences will be fused. This will enable a better visualization of the ET, where the length, diameter and angle of ET can be measured more accurately than with the current available methods. Thus, dimensions of the ET in ETD patients can be classified accordingly to normal dimensions of ET.
To achieve this, twelve patients with ETD and 12 healthy controls are examined with both MRI and CBCT. The sequences will be fused and two radiologists will describe the scans blinded and independently. The dimensions and angulations of the ET in the two groups are compared to identify significant differences.
Study 3:
Balloon Eustachian Tuboplasty: indications and effect of treatment Holm NH1, Ovesen T1 \& Sinkkonen ST2) 1) ENT Department, Regional Hospital West Jutland 2) Department of Otorhinolaryngology, Head and Neck Center, Helsinki University Hospital, Finland Expected publication in The Journal of Laryngology \& Otology
Patients with long-lasting symptoms of ETD, who benefits from tympanostomy tube insertion, will be offered Balloon Eustachian Tuboplasty (BET) of the cartilaginous part of ET. The procedure is performed endonasally under general anesthesia. It is believed that BET leads to micro-bleeding in the mucosa with subsequent scarring and expansion of ET. Apparently, the procedure has a high success rate and low complication rate. Currently, little evidence exists regarding the long-term effects of BET, and it remains unclear which patients will benefit from the procedure.
The aim of this study is to create a national cohort where all patients undergoing first time BET in Denmark, are registered. A REDCap-database is established. All patients are followed for 12 months by ETDQ-7, oto-microscopy and tympanometry. The patients, who benefit from the procedure, will be compared to those without effect. Hence, the investigators hypothesize that it will be possible to assess which factors increase the probability of effect from BET in order to select patients for BET more accurately in the future.
Study 4:
Tubomanometry: an objective tool in diagnosing patients with Eustachian Tube Dysfunction Holm NH1, Ovesen T1 \& Sudhoff H2
1) ENT Department, Regional Hospital West Jutland. 2) Klinikum Bielefeld, Head and Neck Surgery
Tubomanometry (TMM) was introduced in 2009 as an objective tool to measure the dynamic function of ET. While swallowing a small amount of water, a standardized air-pressure is applied through a nasal catheter. If the ET opens, pressure will be transferred to the middle ear cavity and the increased pressure will be measured with a probe in the ear channel. The test is harmless, relatively fast, and can be used even in case of perforation of the tympanic membrane or tympanostomy tube. In a control group, Schröder et al found an opening of ET in 97 %, opposed to 57 % in a group of ETD-patients. Another study showed that TMM has a high sensitivity, but low specificity for detecting ET opening. A reduced opening/lack of opening of ET is associated with ETD. Schilder et al concluded, that the existing evidence is weak, which is partly because of the disparate definitions of ETD. Finally, there is now consensus both internationally and in Denmark on definitions of ETD. Therefore, the investigators hope to develop new knowledge in an effort to develop a globally acceptable definition of ETD.
The investigators aim at examining 50 patients with ETD and compare them to 50 age- and gender matched controls to investigate TMM's ability to distinguish the two groups. The investigators believe that TMM has a great potential and most likely relates to the pathological process of the disease. It may be a useful tool in direct testing of the ET and monitoring the effect of treatment of ETD.
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Inclusion Criteria:
Patients are included in the study if they have presented constant or intermittent ETD symptoms for more than three months:
1. pressure in the ears,
2. pain in the ears,
3. a feeling that the ears are clogged or "under water",
4. ear symptoms when having a cold or sinusitis,
5. crackling or popping sound in the ears,
6. ringing in the ears,
7. feeling that the hearing is muffled.
Furthermore, objective signs of negative middle ear pressure are needed:
1. poorly retractable eardrum,
2. tympanometry compatible with negative middle ear pressure (C2 or B-curve).
Exclusion Criteria:
* patient refusal to participate in the study,
* head and neck surgery in the previous three months,
* head and neck irradiation,
* ETD symptoms \<3 months,
* adenoid hypertrophy,
* nasal polyposis,
* acute upper respiratory infection or acute sinusitis,
* tympanic membrane perforation,
* age \<18 years, cleft palate,
* craniofacial syndromes including Down's Syndrome,
* cystic fibrosis,
* ciliary dysmotility syndrome.
|
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] |
NCT01032382
|
Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
|
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
|
This study is a single-site, randomized, double-blind, two group trial assessing the PK, safety and efficacy of WR 279,396 Topical Cream and Paromomycin Topical Cream in subjects with CL. Subjects will be screened over a period up to 28 days for eligibility including parasitology for confirmation of ulcerative CL. Subjects will be randomized in a targeted 1:1 ratio to receive either WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n=15) or Paromomycin Topical Cream (15% paromomycin topical cream) (target n=15) by topical application to CL lesions once daily for 20 days. Because the primary objective of this trial is to determine PK in all age groups, subjects will be stratified by age: 5-11 yrs, 12-17 yrs, and ≥ 18 yrs with at least 6 PK subjects in each age stratum and no more than 18 total subjects will be randomized in any age range. A target of 30 subjects who complete the PK part of the study is the goal. Any subject who does not complete the PK portion of the study will be replaced with another subject from the same age group that will be given the same treatment assignment to maintain the balance. Safety will be assessed by monitoring adverse events (AEs), lesion site reactions, vital signs, and blood creatinine levels. The primary efficacy analysis will be by evaluation of an index lesion with secondary efficacy analyses including all lesions. Lesions will also be examined for parasite negativity by classical means (positive culture for promastigotes or microscopic identification of amastigotes in stained lesion tissue) on Day 21.
In adult subjects, on Days 1 and 20, blood will be collected prior to topical cream application and at 0.5h, 1h, 2h, 3h, and 4h ± 5 minutes and 8h, 12h, and 24h ± 15 minutes after completion of cream application to determine plasma levels of paromomycin and gentamicin to calculate PK parameters. Thus, the last blood draw in this series will occur on Day 21. In addition, blood will be collected on Days 4, 7, 12, and 17 ± 1 day before study drug application to examine trough plasma levels of paromomycin and gentamicin. A follow-up plasma sample for PK analysis will also be obtained on Day 28 ± 2 days.
Subjects under the age of 18 years will have a total of four blood samples drawn. The first will be drawn at pre-application and the second will be drawn at 4 hours ± 5 minutes after completion of application of the topical cream on Study Day 1. The third will be drawn pre-application and the fourth at 4 hours ± 5 minutes after completion of application of the topical cream on Study Day 20. Subjects who receive Paromomycin Topical Cream are not expected to have blood levels of gentamicin, but as the study is blinded, plasma specimens will be tested for both paromomycin and gentamicin.
The index lesion (primary ulcerated) and all other ulcerated lesions will be assessed for clinical response by measurement of the length and width of area of ulceration. A lesion will be considered to be completely cured if 100% re-epithelialization is observed (i.e., this is a measurement of ulceration of 0 x 0 mm). Non-ulcerated lesions will also be measured to monitor the total area of exposure of lesions to study drug and will be evaluated for cure (i.e., absence of signs of an active lesion).
Subjects will have an in-clinic follow-up weekly (Days 28, 35, 42, 49, 56, and 63 ± 2 days) after completion of treatment for safety assessments, lesion measurements, and lesion photographs. On Day 21, index lesions in adult subjects that have not completely re-epithelialized will be assessed for parasites by classical means (positive culture for promastigotes or microscopic identification of amastigotes in stained lesion tissue). An interim analysis of all of the data collected on all subjects who were randomized and completed the nominal Day 63 follow-up will be performed to make decisions about the final design of a Phase 3 trial. Subjects will continue to be followed for outcomes at Day 100 and 168 ± 14 days. A final analysis of outcomes after the longer term followup period has been completed for all subjects will be performed when the trial is closed. Follow-up evaluations include AEs, medication use, lesion measurements, and lesion photographs.
Patients who fail therapy (see definition of failure below) may be administered rescue therapy at the discretion of the patient's personal physician.
|
Inclusion Criteria:
* To be eligible for the study, the following must be answered "YES" or not applicable, as appropriate for the study subject:
1. Is the subject a male or female at least 5 years-of-age?
2. Is the subject or legal guardian able to give written informed consent or assent, as appropriate?
3. Does the subject have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes, or 2) microscopic identification of amastigotes in stained lesion tissue.
4. Does the subject have at least one ulcerative lesion ≥ 1 cm and ≤ 5 cm, that meets the criteria for an index lesion?
5. Is the subject willing to forego other forms of treatments for CL including other investigational treatments during the study?
6. In the opinion of the investigator, is the subject (or their legal guardian) capable of understanding and complying with the protocol?
7. If female and of child-bearing potential, did the subject have a negative pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 month after treatment is completed?
8. Does the subject have adequate venous access for blood draws?
Exclusion Criteria:
To be eligible for the study, the following must be answered "NO" or not applicable as appropriate for the study subject:
1. Does the subject have only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion \<1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drugs topically?
2. Does the subject have a lesion due to leishmania that involves the mucosa or palate or any signs of mucosal disease that might be due to leishmania?
3. Does the subject have signs and symptoms of disseminated disease in the opinion of the Principal Investigator?
4. Does the subject have \> 10 lesions?
5. Is the subject a female who is breast-feeding?
6. Does the subject have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed?
7. Does the subject have significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine greater than 15%, or aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than 1.5 times the above the upper limit of normal (ULN) as defined by the clinical laboratory defined normal ranges?
8. Has the subject received treatment for leishmaniasis including any medication with pentavalent antimony including sodium stibogluconate (Pentostam), meglumine antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed within 8 weeks of starting study treatments?
9. Does the subject have a history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides?
10. Does the subject have any other topical disease/condition which would interfere with the objectives of this study?
|
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] |
NCT04585698
|
QST, Blink Reflex and Nociceptive Flexion Reflex in Headache
|
The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).
|
20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.
|
Inclusion Criteria: patients with headache which are about to receive a treatment with fremanezumab
Exclusion Criteria:
* medication changes 1 month prior to the test
* neuropathy
* acute or chronic pain
* medications having effects on the central nervous system
* other disease
|
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] |
NCT04682210
|
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection
|
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
|
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
|
Inclusion Criteria:
* Patients with a first diagnosis of HCC who have undergone a curative resection
* Radiologic evidence of disease free ≥4 weeks after complete surgical resection
* Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization
* Randomization needs to occur within 12 weeks of the date of surgical resection
* High risk for HCC recurrence as protocol defined
* Child-Pugh Score, Class A
* ECOG performance status 0 or 1
* No prior systemic anticancer therapy for HCC
* Adequate hematologic and organ function
Exclusion Criteria:
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of residual, recurrent, or metastatic disease at randomization
* History of hepatic encephalopathy or organ transplantation
* Patients who are in the waiting list for liver transplantation
* Patients with Vp4 portal vein thrombosis
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
* Pregnant or lactating women
|
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] |
NCT04840836
|
Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
|
This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a telehealth reproductive health visit as part of their care. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation.
Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision.
Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods.
Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision.
Aim 4: Compare continuation rates across dimensions of telehealth experience.
|
Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use among this population and early discontinuation due to method dissatisfaction limits their potential to reduce unintended pregnancy. Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of unintended pregnancy. Data will be collected from patients who are receiving same-day LARC as a part of their normal care via telehealth services in school-based health centers (SBHCs). This implementation model, therefore, has the potential for replication and scale-up with wide reach. The findings from this study, given the SBHC setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New York City and the SBHC setting.
|
Inclusion Criteria:
* an enrolled patient at the participating SBHC
* age 13-22 years
* female
* had a visit at the SBHC during the study period that is coded as a "reproductive health visit" including contraceptive counseling, contraceptive management, and contraceptive method initiation
Exclusion Criteria (specifically for Aims 2 and 3):
* are younger than age 13 years
* are older than age 22
* are not an enrolled patient of the participating SBHCs
* did not initiate a LARC method
* are a person without a uterus
* are unable to read, speak, and understand either English or Spanish
|
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] |
NCT06847984
|
Antimicrobial Effect of Curcumin Versus Chlorohexidine on Oral Microbiome
|
Dental caries, one of the world's most common infectious diseases, is a biofilm-mediated, sugar-driven, dynamic disease. It has an impact on physical, mental, and social health and is extremely costly to society. It is a complex disease with microbiological, behavioral, genetic, and environmental components. Recently, it has been demonstrated in the literature that the development of dental caries is strongly related with the microbiota in the oral cavity. So, a detailed understanding of caries microbiology is needed.
Oral microbiome, oral microbiota or oral microflora refers to the microorganisms found in the human oral cavity that was first identified by the Dutchman Antony van Leeuwenhoek using a microscope constructed by him. In 1674, he observed his own dental plaque and reported "little living animalcules prettily moving".
Human microbiome consists of a core microbiome which is common to all the individuals and a variable microbiome that is unique to individuals depending on the lifestyle and physiological differences. Dental caries, as a process determined by lifestyle, may be subject to activation in each period of human life if hygiene and diet are neglected even for a period as short as a few weeks.
Previous hypotheses suggest that Streptococcus mutans is the primary pathogen in the development of dental caries in both children and adults. However, recently published papers provide a partially different perspective on the role of bacteria in the caries process, known as the "extended caries ecological hypothesis," which attempts to demonstrate that the role of S. mutans in the initiation of dental caries may not be as dominant as previously assumed, but there is agreement that they have the highest cariogenic potential.
It is now believed that the disease is caused by microorganisms belonging to the natural flora of the oral cavity: the oral microbiome. There is a dynamic equilibrium between microorganisms as well as between the micro flora and the 7 host, and the disease develops as a result of a microbiological imbalance within the biofilm.
Therefore, a better understanding of processes of oral biofilm formation and function is necessary to the development of novel, successful, rational approach for antimicrobial strategies and caries prevention and treatment.
Primary caries can be prevented, stopped and treated by regular plaque removal and remineralization mechanisms. Fluorides play a central role in the prevention of dental caries and are being used extensively and therapeutically for the inactivation of incipient carious lesions. However, regarding the high cost of dental clinic setting and difficult access to the oral health care service that is not well-covered in certain countries; the treatment strategy should move towards the preventive, simple, accessible, less costly methods.
The frequent use and abuse of the currently used therapeutic agents has led to the evolution of resistant strains of common pathogens as well as increased incidence of adverse effects associated with their usage. Therefore, natural phytochemicals extracted from plants used as traditional medicines are therefore seen as a good alternative source.
Pharmaceutical plants have been used throughout human history to treat a variety of diseases. According to the World Health Organization, almost 80% of the world's population relies on traditional medicinal plants for primary health care. In dentistry, there is a growing need to develop natural materials with anti-caries qualities.
Curcumin (CUR), a dietary natural product extracted from the root of turmeric (the major constituent of Curcuma longa L. or turmeric), which is widely used as a flavoring and coloring agent has many pharmacological activities including anti-inflammatory and antitumor properties. In addition, CUR has been shown to have anti-bacterial, whitening, and antioxidative activities. Various studies on widespread Polyphenolic compounds suggest that curcumin inhibits the bacterial effect by reducing the production of acid and stopping the adherence of bacteria to the tooth surface. Song et al. found that curcumin could significantly inhibit the adhesiveness of S. mutans by its effects on collagen and fibronectin. The antibacterial action of curcumin involves the disruption of the bacterial membrane, inhibition of the production of bacterial virulence factors and biofilm formation, and the induction of oxidative stress. These characteristics also contribute to explain how curcumin acts a broad-spectrum antibacterial adjuvant. So, the aim of the following interventional study is to evaluate the effect of curcumin on oral microbiome obtained from salivary samples of high caries risk patients in vitro and assess the antiplaque and anticariogenic effect of curcumin mouth wash in high caries risk patients in a randomized controlled clinical trial compared to chlorohexidine mouth wash.
|
Inclusion Criteria:
* Provide informed consent.
* Patients accept the one-year follow-up period.
* Cooperative patients.
* The study recruited volunteers of both genders
* Age from 21 to 45 years
* Patients classified at high risk of caries
Exclusion Criteria:
* Patients undergoing orthodontic treatment.
* Periodontal compromised patients.
* Smokers.
* Pregnant women.
* Patients with physical or mental disability
* Patient with removable prosthesis
|
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|
NCT02157350
|
The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT
|
The purpose of this study is to determine the threshold level of proliferative diabetic retinopathy progression and regression after standard panretinal photocoagulation. Predictors of progression and regression will be identified which will include retinal vessel geometry (caliber, fractals and tortuosity), retinal vessel oxygen saturation and retinal areas of non-perfusion.
|
IMPETUS 2018 - DETECT is a six-month prospective study involving 90 treatment-naïve diabetes patients with proliferative diabetic retinopathy (PDR) referred for panretinal laser photocoagulation (PRP) treatment to the Department of Ophthalmology, Odense University Hospital between July 1st 2014 and June 30th 2015.
Project information will be given prior to the study to the ophthalmological departments of and to all private practicing ophthalmologists in the Region of Southern Denmark. Patients will at baseline have a standard examination that will include wide-field fundus photography, wide-field fluorescein angiography and spectral domain optical coherence tomography (SD-OCT) in order to confirm the diagnosis of PDR. If they meet the criteria of inclusion and not those of exclusion, they will be informed of the study verbally and writing and offered the chance to participate. Prior to the first session of PRP patients enrolled in the study will receive the rest of the baseline examinations including retinal oximetry. Standard PRP treatment will be given in two sessions by a trained doctor.
Patients will be re-examined at month 3 and 6 and progression/regression of PDR will be evaluated by measuring the amount of fluorescein leakage by wide-field fluorescein angiography at 1, 5 and 10 minutes. For patients with regression, supplementary PRP will be offered. After the final examination at month 6, patients will be referred back to their primary ophthalmologist.
A study nurse and a photographer will be assigned to the project. All examinations will be standardized and the study crew will be fully certified. Data will be analyzed with respect to the endpoint of the study (Stata 13, StataCorp, College Station, Texas) and also used to create the algorithm to be used for individualized treatment in IMPETUS 2018 - TREAT.
In the Region of Southern Denmark it is estimated that 200 treatment naïve patients with PDR will be referred for treatment annually. With an estimated participation rate of 50% and a subsequent dropout rate of 10%, IMPETUS 2018 - DETECT will include 90 patients. A traditional power calculation is not feasibly due to the design of the study with multiple outcomes studies.
|
Inclusion Criteria:
* Diabetes mellitus
* Proliferative diabetic retinopathy of one or both eyes
Exclusion Criteria:
* Diabetic macular edema on current eye
* Earlier PRP treatment on current eye
* Cataract demanding treatment on current eye
* Pregnancy
|
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] |
NCT03719287
|
Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil
|
A multi-center, national prevalence study where: (1) baseline SPIVC therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the Hospital's evidence based practice will be measured in Brazil.
|
At each participating research site, select nurse clinicians who are experienced or experts in short peripheral I.V. catheter (SPIVC) therapy, will audit medical records and observe the SPIVC sites of adult patients in various hospital wards until a minimum total of 300 SPIVC sites are audited among 3 Brazilian acute care hospitals. The wards audited will be selected by the Investigator and will be audited during a specified time period until at least 100 SPIVCs are audited. The time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required.
There are no treatments. The short peripheral I.V. catheter-related medical devices (products) observed during the study are currently approved by Brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.
|
Inclusion Criteria:
* Male or female subject, aged 18 years or older at the time of the study's audit of the ward;
* Subject admitted into one of the wards audited at the study site;
* Subject available for observation at the time of the audit;
* Subject with at least one inserted PIVC;
* Subject that voluntarily signed and dated the informed consent form (ICF) prior to study entry, if required by the study site's Ethics Committee.
Exclusion Criteria:
* Subject under treatment at the study site's outpatient clinics;
* Subject admitted into a mental health ward, emergency ward or burn unit;
* Subject awaiting transfer to another facility.
|
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] |
NCT01115374
|
Lymphedema Therapy With Sound Wave Lymphatic Drainage
|
Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial spaces of the affected body part due to a blockage or malfunction in the lymph system. It can appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort and sometimes disability. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy.
In this study two treatments will be compared to reduce lymphedema: the manual lymphatic drainage (standard care) versus the low frequency sound waves.
|
Lymphedema, a sequela of breast cancer and breast cancer therapy, changes functional abilities and may affect a patient's psychosocial adjustment and overall quality of life. Lymphedema is the accumulation of lymph fluid in the interstitial space. Fluid accumulation in the limbs causes enlargement, often with a feeling of heaviness.Chronic inflammation leads to fibrosis of the lymphatics, which compounds the problem. Several studies have examined the incidence of lymphedema when axillary radiation is given after axillary dissection vs radiation to an undissected axilla. The risk of lymphedema is higher in women treated with axillary dissection and adjuvant radiation to the axilla, with edema reported in 9% to 40% of patients. Patients with lymphedema may report symptoms such as a sensation of arm fullness and mild discomfort, which are seen in the early stages of the condition. Joint immobility, pain, and skin changes are noted frequently in the later stages of lymphedema. Patients also may be predisposed to infections involving the affected extremity. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy. Manual lymphatic drainage is the standard decongestive therapy. Recently, low frequency sound waves has been used to reduce lymphedema. The aim of this study is to compare the efficacy of the manual lymphatic drainage versus the low frequency sound waves.
|
Inclusion Criteria:
* Lymphedema presence at least for 1 year
* No previous treatments for lymphedema in the last 6 months
Exclusion Criteria:
* Electronic devices or metalic implants
* Cardiac failure or hypertension
* Epilepsy
* Local infection
* Pregnancy
* Thrombophlebitis
|
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] |
NCT06280404
|
Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle
|
The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle.
|
Gallbladder disease is one of the most common reasons patients are referred to a general surgeon. Laparoscopic cholecystectomy (LC) is the current standard of care for symptomatic cholelithiasis. Despite being considered a low-risk surgery, bile duct injuries (BDIs) have occurred at a constant rate in the last 30 years, leaving devastating consequences on the affected patients. However vasculobiliary injury (VBI) is a rare but critical complication of (LC). So we need to follow critical view of safety. The critical view of safety (CVS) described by Strasberg is considered as the one of the most important critical factors for overall safety during LC. The CVS consists of three essential component or steps: 1) dissection of the hepatocystic triangle (HCT); 2) exposure of at least lower one third of the cystic plate (CP); and 3) demonstration of only two tubular structures (cystic duct and cystic artery) that remain attached to the gallbladder (after components 1 and 2 are achieved). All these three steps must be completed before considering that CVS has been achieved. However in some cases Calot's triangle can't be demonstrated due to dense adhesions. Conversion with retrograde approach (fundus first) was an option for these cases. However a retrograde approach can be achieved laparoscopically by starting dissection by body to use the fundus attachment for retraction which is called (the "body-first approach") that may decrease the possibility of VBI. Recent studies deficient in evaluation of outcome of (body first approach). So the interest of our study is to evaluate the outcome of body first approach in difficult cases and cases with obscure Calot's triangle in (LC) and to evaluate its feasibility and safety in (LC).
|
Inclusion Criteria:
- All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.
Exclusion Criteria:
* unfit patients.
* Patients with calcular obstructive jaundice.
|
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] |
NCT00571194
|
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
|
Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.
|
This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.
|
Inclusion Criteria:
1. Patients from 12 months to 18 years of age.
2. Patients with end stage renal disease who receive continuous cycling peritoneal dialysis.
3. signed informed consent
4. Physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject.
-
Exclusion Criteria:
1. Any clinically significant unstable medical condition or chronic disease other than those associated with ESRD.
2. Any clinically significant illness within 10 days or receiving single-sdoe of study medication
3. History of rhabdomyolysis
4. Clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism.
5. Clinical laboratory abnormalities: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(CPK) \> 2.5 times upper limit of normal; hemoglobin \< 8.5 g.dL.
6. Known hypersensitivity to pravastatin
7. Unwilling to have blood samples drawn
8. Has taken a HMG-CoA reductase inhibitor in the last week -
|
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] |
NCT01366599
|
CV Events in Emetogenic Chemotherapy
|
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
|
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
|
Inclusion Criteria:
* Enrollment in IHCIS in 2006
* At least one HEC or MEC claim in 2006
Exclusion Criteria:
* HEC or MEC claim three months before first HEC/MEC claim - "wash-in" period (i.e. must be enrolled for three months prior to first HEC/MEC claim. For patients whose first HEC/MEC event is between January 1,2006 and March 31, 2006, enrollment criteria for inclusion in the study may extend as far back as October 1, 2005)
* HEC or MEC claims prior to 45 days after last HEC or MEC claim - "wash-out" period. (For patients whose last claim in 2006 was seen after December 1, 2006 enrollment into 2007 to look for further treatment and the 45 day "wash-out" period will be required.)
|
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] |
NCT06010888
|
Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC
|
The goal of this clinical trial is to learn about the efficacy and safety of Fruquintinib with mFOLFOX6/FOLFIRI in patients with mCRC. The main question it aims to answer is:
The conversion surgery rate of the therapy mentioned above. The ORR, R0 surgery rate, DCR, PFS, OS, and safety will be evaluated.
|
Inclusion Criteria:
1. Provide written informed consent to participate in the study voluntarily.
2. Male or female aged 18-75.
3. Metastatic colorectal adenocarcinoma confirmed by histology or cytology.
4. Have not received systematic anti-tumor therapy before; Patients who have received neoadjuvant/adjuvant therapy may be screened from the time of last chemotherapy to recurrence or progression more than 6 months.
5. RAS/BRAF mutation status and UGT1A1\*28/\*6 gene polymorphism typing should be determined before enrollment.
6. The ECOG PS score is 0 or 1.
7. Life expectancy is at least 3 months.
8. According to RECIST 1.1, the investigators evaluated that there were measurable lesions at baseline (according to RECIST 1.1), which could be measured if they had not received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy could also be selected as target lesions if progression was confirmed).
9. The function of vital organs meets the following requirements (no blood component, cell growth factor correction therapy drugs are allowed within 14 days before the first use of the study drug);
1. Absolute neutrophil count (ANC) ≥1.5×109/L
2. Platelet ≥100×109/L;
3. Hemoglobin ≥9g/dL;
4. Serum albumin ≥2.5g/dL;
5. Total bilirubin ≤1.5 × ULN; ALT and AST≤2.5 × ULN, if there is liver metastasis, ALT and AST≤5 × ULN;
6. Serum creatinine ≤1.5 × ULN or creatinine clearance \> 60 mL/min (Cockcroft-Gault);
7. Activated partial thromboplastin time (APTT) and International Normalized ratio (INR) ≤1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the intended therapeutic range of anticoagulants can be screened)
10. Fertile female subjects are required to have a negative serum pregnancy test within 72 hours before the first dosing, are not breastfeeding, and use effective contraception (such as Iuds, contraceptives, or condoms) during the trial period and for at least 6 months after the last dosing of the study drug; Male subjects whose partner is a fertile woman should be surgically sterilized or agree to use effective contraception during the trial period and within 3 months after the last dose of the study drug. Sperm donation is not allowed during the study period;
Exclusion Criteria:
1. Local radiotherapy was received within 4 weeks prior to the first administration of the study drug, and adverse events due to radiotherapy have not returned to baseline levels. Participants who received palliative radiotherapy for peripheral sites (such as bone metastases) before 4 weeks may be admitted to the study, but must have recovered from any acute adverse effects;
2. Known active central nervous system (CNS) metastases and/or cancerous meningitis. Participants who have previously received BMS may participate in treatment provided they have stable BMS and have not been treated with steroids for BMS for at least 28 days prior to study start. This exception does not include cancerous meningitis, as patients with cancerous meningitis are excluded regardless of clinical stability;
3. Major surgery, open biopsy, or severe trauma occurred 28 days before the first medication;
4. Previous history of allergy to fluorouracil or irinotecan;
5. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
6. Subjects have poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:
(1) NYHA grade II or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias that remain poorly controlled without or after clinical intervention.
7. Clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic ulcer or vasculitis, have occurred within 3 months before the first medication.
8. Arteriovenous thrombosis events occurring within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Shallow vein thrombosis can be included after being determined by the researcher.
9. There is another malignant tumor that is progressing or in need of aggressive treatment, except for non-melanoma skin cancer and cervical cancer in situ for which potential treatment has been performed.
10. In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, serious abnormalities in laboratory test values, and family or social factors that may affect the subject's safety or the circumstances in which the trial data are collected.
|
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] |
|
NCT04481815
|
Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
|
It is a multicenter, open-Label, randomised phase 2 study to compare the efficacy and safety study of R2-MTX chemotherapy（Lenalidomide, Rituximab and Methotrexate）with R-MTX chemotherapy（Rituximab and Methotrexate ）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma.2-year Progression free survival (PFS) is the primary endpoint.
|
This is a multicenter, open-Label, randomised phase 2 study designed to evaluate the efficacy and safety of rituximab plus methotrexate with or without lenalidomide as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 240 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of maintenance chemotherapy. Follow-ups should be taken up to the first 3 years.The primary endpoints were 2-year PFS rate and and secondary endpoints including objective response rate (ORR), PFS, overall survival (OS), and adverse events.
|
Inclusion Criteria:
1. Histologically confirmed Primary Central Nervous System (CNS) lymphoma
2. Age range 18-75 years old.
3. Eastern Cooperative Oncology Group performance status 0 to 3.
4. Previously untreated. Patients treated with steroid alone are eligible.
5. Patient's who are not planned to undergo consolidation with autologous hematopoietic stem cell transplantation（HSCT）.
6. Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
7. Life expectancy of ≥ 3 months (in the opinion of the investigator).
8. Participants must be able to understand and be willing to sign a written informed consent document.
9. Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
10. Women of childbearing potential must have a negative plasma pregnancy test upon study entry.
11. Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
12. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value.
13. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.
Exclusion Criteria:
1. Patient with systemic, non-CNS lymphoma metastatic to the CNS.
2. Patient is concurrently using other approved or investigational antineoplastic agents.
3. Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
4. Patient is allergic to components of the study drug.
5. Patient has an active concurrent malignancy requiring active therapy.
6. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
7. Patient is known to have an uncontrolled active systemic infection.
8. Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
9. Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG) laboratory test of \> 5 mIU/mL.
10. The patient is unwell or unable to participate in all required study evaluations and procedures.
11. Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.
12. Patients considered unsuitable to participate in the study by the researchers.
|
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] |
NCT03269669
|
Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
|
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
|
PRIMARY OBJECTIVE:
I. To compare the complete response rate up to 6 cycles after randomization as defined by centrally read positron emission tomography (PET)/computed tomography (CT) (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + umbralisib \[TGR-1202\] or obinutuzumab + lenalidomide) with obinutuzumab + chemotherapy (cyclophosphamide, doxorubicin hydrochloride \[doxorubicin\], vincristine sulfate \[vincristine\], and prednisone \[CHOP\] or bendamustine hydrochloride \[bendamustine\]) in patients with early relapsing or refractory follicular lymphoma.
SECONDARY OBJECTIVES:
I. To validate the prognostic association of the m7-FLIPI model, demonstrating that the population of follicular lymphoma patients who respond poorly to chemoimmunotherapy are enriched for having a high-risk m7-FLIPI score, and that the score is associated with progression-free survival (integrated biomarker). (Primary translational medicine) II. To estimate the 30-month sustained complete response rate (CR30) defined by centrally read PET/CT with each of the regimens in this early relapsing or refractory follicular lymphoma population.
III. To estimate best response up to 12 cycles of therapy, progression free survival, duration of response and overall survival with each of the combinations in early relapsing or refractory follicular lymphoma.
IV. To evaluate the adverse effects of each of the regimens in early relapsing or refractory follicular lymphoma.
V. To evaluate the predictive performance of non-invasive genotyping (m7-FLIPI in circulating tumor deoxyribonucleic acid \[DNA\]) of plasma at study entry relative to standard tumor genotyping (m7-FLIPI) of formalin-fixed paraffin-embedded tumor tissue.
VI. To evaluate the association between the detection of active lymphoma by PET-CT and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (CLOSED TO ACCRUAL): Patients receive obinutuzumab intravenously (IV) on day 1 and umbralisib orally (PO) daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up 12 cycles in the absence of disease progression or unacceptable toxicity.
ARM III:
PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1 and bendamustine IV over 60 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity.
Patients in all arms undergo biopsy and echocardiogram (ECHO) or multigated acquisition scan (MUGA) during screening, and PET/CT scans and collection of blood throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|
Inclusion Criteria:
* Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible
* Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration
* Patients must have bone marrow biopsy performed within 42 days prior to registration
* Patients must have an indication for therapy as determined by the treating investigator
* All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form
* The intent is to enroll patients with follicular lymphoma (FL) relapsed within 2 years of completing their first course of chemotherapy (CHOP or bendamustine based therapy) + anti-CD20 therapy. Patient is still eligible if he/she received radiation therapy or anti-CD20 therapy prior to chemoimmunotherapy or if maintenance anti-CD20 therapy was administered after chemoimmunotherapy
* Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine; relapsed patients must not have received any intervening chemotherapy
* Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine; (note that no minimum dose of bendamustine is required)
* Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible
* Patients who additionally received any maintenance anti-CD-20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible
* Involved field or involved site radiation is not considered a line of therapy; examples of eligible prior treatment regimens (note this list is not all inclusive):
* 1st line rituximab treatment followed years later by bendamustine rituximab
* Bendamustine rituximab x 4 cycles
* 1st line rituximab treatment, 2nd line ibritumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance
* Bendamustine obinutuzumab x 3 cycles
* CHOP rituximab x 6 cycles followed by rituximab maintenance
* For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients prior treatment related toxicities (except alopecia) must have resolved to grade 1 or less prior to registration
* Patients must have tissue specimens collected prior to registration; patients must be offered participation in biobanking of residual specimens; with patient consent, residuals from the mandatory submission(s) will be banked for future research
* Patients must be \>= 18 years of age
* All patients must have a Zubrod performance status of 0, 1 or 2
* Absolute neutrophil count (ANC) \>= 1,500/mcL within 28 days prior to registration
* Platelets \>= 75,000/mcL within 28 days prior to registration
* Patients must have adequate renal function as documented by a calculated creatinine clearance \>= 60 mL/min, within 28 days prior to registration
* Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (=\< 5 x IULN if secondary to lymphoma, Gilbert's syndrome, or medication related \[e.g., indinavir, tenofovir, atazanavir\]) within 28 days prior to registration
* Direct bilirubin =\< 1.5 x IULN (=\< 5 x IULN if secondary to lymphoma) within 28 days prior to registration
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x IULN (=\< 5 x IULN secondary to lymphoma) within 28 days prior to registration
* Patients must have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 42 days prior to registration with a cardiac ejection fraction \>= 45%
* Patients with hepatitis B virus infection must have undetectable hepatitis B virus (HBV) on suppressive therapy and no evidence of HBV-related hepatic damage; patients with hepatitis C virus infection are eligible if complete eradication therapy has been successfully completed, and there is no detectable hepatitis C virus (HVC) or related hepatic damage; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria in addition to the other protocol eligibility criteria:
* Patient must have no history of acquired immune deficiency syndrome (AIDS)-related complications, other than a history of low CD4+ T-cell count (\< 200/mm\^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
* Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
* Patient must have serum HIV viral load of \< 200 copies/mm\^3
* Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy; (recommend a regimen of the integrase inhibitor dolutegravir combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine)
* Protease inhibitors and once daily formulations containing cobicistat are NOT allowed due to potential pharmacokinetic interactions with leukemia therapy
* Stavudine and zidovudine (AZT) are NOT allowed because of overlapping toxicity with protocol therapy
* Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients unable or unwilling to take any listed prophylaxis are NOT eligible
* No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years
* Patients must have a complete history and physical examination within 28 days prior to registration
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence \[e.g., calendar, ovulation, symptothermal or post ovulation methods\] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration
* Patients must have lactate dehydrogenase (LDH) and beta-2-microglobulin collected within 28 days prior to registration
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria:
* Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative
* Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide
|
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] |
NCT04588480
|
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
|
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.
The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:
* As 2 doses, separated by 21 days
* At a single dose level
* In adults 20 to 85 years of age
|
From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.
|
Inclusion Criteria:
* Japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization.
* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
* Capable of giving personal signed informed consent.
Exclusion Criteria:
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
* Receipt of medications intended to prevent COVID-19.
* Previous confirmed diagnosis of COVID-19.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* Women who are pregnant or breastfeeding.
* Previous vaccination with any coronavirus vaccine.
* Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
* Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
* Previous participation in other studies involving study intervention containing lipid nanoparticles.
* Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
|
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-0.19802291691303253,
-0.20659402012825012,
-0.0109131820499897,
-0.03483081981539726,
-0.5731942057609558,
-0.3167356848716736
] |
NCT05452512
|
Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch
|
The study will investigate the effect of smart monitoring on medication adherence.
|
In this study, multiple medication monitoring procedures will be performed: self-reporting, pill counting, smart monitoring and concentration monitoring. Subjects will take vitamin D supplement on the market which enables validated concentration monitoring. The study will last for 3 months.
|
Inclusion Criteria:
* Adults aged 19-64 years at the consent
* 25(OH) vitamin D \< 10 ng/mL
* Not taking vitamin D at the screening
* Fully understood the study procedures
Exclusion Criteria:
* Hypercalciuria, sarcoidosis
* Clinically significant hypersensitivity reaction to Vitamin D
* History of or current kidney stone
* One of the following findings:
1. Serum calcium level \> upper limit of normal
2. Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2
* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Unable to use smart clinical trial application or smart watch
* Expected to take vitamin D from 4 weeks before the first administration and until the last administration
|
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] |
NCT00912041
|
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia
|
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
|
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
|
Inclusion Criteria:
* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
* (There are additional inclusion criteria)
Exclusion Criteria:
* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study
* (There are additional exclusion criteria)
|
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] |
NCT00146081
|
Weight Management Skills in African American Outpatients
|
Our long-term goal is to identify new insights about effective approaches to obesity management and related lifestyle changes in African Americans and about factors that enhance or limit the response to specific treatment approaches. Our primary interest is in "natural social support" from family members or friends. However, since not all individuals seeking obesity treatment desire or are able to name family members or friends to participate with them, we will also study the benefits of social support by creating a "team" condition among individuals recruited alone.
Specific aims are to:
1. Recruit overweight or obese "index" participants together with 1 or 2 family members or friend co-participants who are also overweight or obese, for enrollment in a 2 year weight loss program;
2. Conduct a randomized comparison of the effects, on weight loss and related behavioral and clinical outcomes of the index participants, of involving both index and co-participants (Group A) in the counseling program with those obtained when co-participants are not directly involved (Group B);
3. Enroll otherwise eligible index participants who do not name co-participants in a parallel 2 year weight loss study; Conduct a randomized comparison of the effects, on weight loss and related behavioral and clinical outcomes of individual participants, of creating social support teams of unrelated individuals (Group C) with those obtained when no such teams are created (Group D).
Primary hypotheses are that:
1. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group A vs. Group B;
2. weight maintenance from 12 to 24 months will be significantly greater in Group A vs. Group B;
3. weight loss from 0 to 12 months and from 0 to 24 months will be significantly greater in Group C vs. Group D;
4. weight maintenance from 12 to 24 months will be significantly greater in Group C vs. Group D. Secondary analyses will compare the respective treatment and control groups on changes in diet, physical activity, and clinical CVD risk factor changes over time and will assess predictors of outcomes and cost-effectiveness.
|
Inclusion Criteria:
* African American Men and Women
* Ages 35-70 years
* Body Mass Index 27-54
Exclusion Criteria:
* Pregnant
* Taking Weight Altering Medication
|
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|
NCT00907569
|
Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer
|
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.
|
The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.
|
Inclusion Criteria:
* limited stage small cell lung cancer
* adequate pulmonary function test (FEV1 \>1.0 L, DLCO \>50%)
* signed study consent
* age at least 18 years
* Karnofsky performance status as least 70%
* eligible to receive standard concurrent small cell cancer chemotherapy
Exclusion Criteria:
* extensive stage disease
* mixed non small cell and small cell histology
* inadequate pulmonary function tests
* not eligible for concurrent chemotherapy
* subtotal or total tumor resection
* previous chest/neck radiotherapy
* prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
* pregnant
* prior chemotherapy for another malignancy
* patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias
|
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] |
NCT05542849
|
The Efficacy and Tolerability of Acarbose in Healthy Individuals
|
A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.
|
Inclusion Criteria:
1. Age 18-85
2. Any sex
3. Any ethnicity
4. Interest in taking Acarbose off-label
5. Approved by the AgelessRx Medical team to take Acarbose
6. Willing and technically able to use and operate a CGM
7. Own a CGM-compatible phone
8. Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
9. Adequate cognitive function to be able to give informed consent
Exclusion Criteria:
1. Diabetes of any type
2. Taking metformin or any other glucose lowering medication
3. Any uncontrolled endocrine disorder (thyroid, pancreatic, adrenal, etc...)
4. Active malignancy of any kind
5. Clinically relevant renal or kidney disease or dysfunction
6. History of eating disorder
7. Taking any medication, or has any medical condition that might interfere with the action of acarbose of the CGM sensor
|
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] |
|
NCT04532931
|
COVID-19 Treatment in South Africa
|
This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease at the time of enrollment.
|
This phase 2, exploratory study will be an adaptive, randomized, open label, trial for treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety evaluation, progression to LRTI (defined by resting blood oxygen saturation level \[SpO2\] \<93% sustained for two readings two hours apart and presence of subjective dyspnoea or cough), disease severity, clinical resolution rate, and cumulative incidence of hospitalization or mortality at Day 28.
|
Inclusion Criteria:
1. Age from 18 to 65 years of age, inclusive, at the time of signing the informed consent.
2. Willing and able to provide informed consent.
3. Women of reproductive potential must be using a highly effective method of contraception for at least 28 days prior to enrolment and must be able and willing to continue its use throughout the duration of the study.
4. Men must agree to use condoms when engaging in heterosexual sex during the study and for the period up to 91 days after the last dose of study medication. Men who are not randomized to a treatment arm including favipiravir (or another arm identified as having teratogenic potential through semen) will no longer need to adhere to this after randomization.
5. Laboratory confirmed SARS-CoV-2 infection, and any of the following self-reported symptoms within 72 hours prior to randomization: fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia.
6. Body weight ≥45 kg.
7. Access to reliable video conference, telephone, direct/text messaging, or other device permitting real-time, reliable information transfer.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms, or similar compounds.
3. Signs of respiratory distress prior to randomization, including:
* respiratory rate \>24 breaths/min
* SpO2 \<95% in room air.
4. Resting pulse rate ≥120 beats/min.
5. High likelihood of hospitalization in the opinion of the attending clinician.
6. QTcF \>470 msec for females, or \>450 msec for males, at screening.
7. Serum potassium \<3.5 mmol/L at screening.
8. History of clinically significant cardiovascular disease (including arrhythmias, QT-interval prolongation, torsades de pointes (TdP), history of coronary artery disease with graft or stent procedures/surgery, cardiac failure \[class 2 or higher using the New York Heart Association functional classification\]).
9. Known chronic kidney disease (Stage IV or receiving dialysis).
10. Known cirrhosis (Child-Pugh Class B or greater).
11. Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment.
12. Currently receiving, or recently received (within 60 days prior to randomization) treatment with any of the drugs in the treatment arms.
13. Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drugs.
14. Currently on treatment with drugs with known arrhythmogenic potential, or those known to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6.
15. Currently on treatment for tuberculosis (or on treatment with rifampicin for any other indication), or on treatment with a protease inhibitor-based antiretroviral regimen, or efavirenz, or carbamazepine.
16. Inability/unlikely to be in the study area for the duration of the 28 day follow-up period.
17. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history.
18. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
19. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
|
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