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NCT03055273
|
SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
|
This research is being done to find out the best ways to help people with end stage kidney disease take care of their daily lives and improve their social functioning.
Investigators want to learn whether services in the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening, balance training, pain management, changes to houses and improved social support can be tailored to fit the needs of older adults with kidney disease to help improve their ability to balance, walk, and take care of themselves.
People aged 60 years and older who have end stage kidney disease and have been receiving dialyses for at least 6 months, may join.
|
Questionnaires:
Participants will be asked to answer questions about:
* social support and social functioning
* pain and depression
* physical function
Study intervention:
Participants will be randomly assigned (by chance, like the flip of a coin) to one of two groups: participant either will receive SOCIABLE (Seniors Optimizing Community Integration to Advance Better Living with ESRD) services now, or will receive the same services in six months from now. Participants have a 50:50 chance of getting into each group
SOCIABLE services involve receiving visits with a nurse interviewer. Participants will decide how you want to improve your social function and social support.
Participants will also receive:
* a group of services called CAPABLE which include home visits from a nurse (RN) and an occupational therapist (OT) and a handyman for repairs if you need them and
* help with improving social support
All participants will receive 10 home visits (6 OT, 4 RN) plus minor home repairs and assistive devices over a 4 month period of time.
|
Inclusion Criteria:
* 60 years and older
* End Stage Renal Disease on In-Center Hemodialysis for at least 6 months
* Functional limitations (difficulty in at least one of the following: bathing, dressing, walking across a room, grooming, getting on or off the toilet, getting on or off the bed);
* Low socioeconomic status (less than high School education, or household income \<$25,000/year)
* Signed informed consent
Exclusion Criteria:
* Inability to understand the informed consent process and give consent via signed written consent form
|
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] |
NCT03003533
|
A Gene Transfer Study for Hemophilia A
|
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
|
Hemophilia A is a condition in which blood is unable to clot effectively. It is caused by a mutation or deletion in the gene that is responsible for producing blood-clotting factor VIII protein. Individuals with hemophilia A suffer from repeated bleeding episodes, often into the joints, which can cause chronic joint disease and sometime results in death due to the inability of the blood to clot efficiently. This chronic joint disease can have significant physical, psychosocial, and quality-of-life effects, including financial burden. The current standard of care includes the use of factor-based therapies which are given either as prophylaxis or to treat bleeding, as well as new non-factor prophylaxis therapies.
|
Inclusion Criteria:
* Males age 18 years or older
* Confirmed diagnosis of hemophilia A as evidenced by their medical history with baseline FVIII activity levels \<=2%
* Have received \>150 exposure days (EDs) to FVIII concentrates or cryoprecipitate
* Have no prior history of allergic reaction to any FVIII product
* Have no measurable inhibitor against FVIII as assessed by the central laboratory and have no prior history of inhibitors to FVIII protein and no clinical signs or symptoms of decreased response to FVIII administration
* Agree to use reliable barrier contraception
Exclusion Criteria:
* Evidence of active hepatitis B or C
* Currently on antiviral therapy for hepatitis B or C
* Have significant underlying liver disease
* Have serological evidence\* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 and who are on an antiretroviral drug regimen (\* participants who are HIV+ and stable with CD4 count \>200/mm3 and undetectable viral load are eligible to enroll)
* Have detectable antibodies reactive with AAV-Spark200 capsid
* Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks
|
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] |
NCT04139993
|
RBX7455 Before Surgery for the Treatment of Operable Breast Cancer
|
This clinical trial studies the side effects and possible benefits of RBX7455 given before surgery in treating patients with breast cancer that can be removed by surgery (operable). RBX7455 contains live intestinal microbes (active drug), which are obtained from healthy human stool and may restore the normal balance of microorganisms in the intestines through the transplant of live and beneficial microorganisms.
|
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of microbiota-based formulation RBX7455 (RBX7455) given for at least 2 weeks and not more than 4 weeks prior to surgery.
II. To evaluate intratumoral immunomodulatory effects, including tumor infiltrating lymphocytes ( TILs), CD4, and CD8 T cells, in operable breast cancer patients.
SECONDARY OBJECTIVES:
I. To evaluate systemic immunomodulatory effects of RBX7455 by measuring circulating cytokines including IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, CXCL8 (IL-8), IL-10, IL-12, IL-13, IL- 17A, IFN-gamma, TNF-alpha, CCL2 (MCP-1), CCL4 (MIP-1beta), granulocyte-colony stimulating factor (G-CSF), and granulocyte macrophage (GM)-CSF before and after treatment with RBX7455.
II. To assess stool microbiome α-diversity, bacterial abundance, and bacterial taxonomy before and after treatment with RBX7455.
III. To assess the durability of bacterial engraftment of RBX7455 in the stool at 8 weeks and 6 months.
OUTLINE:
Prior to standard of care surgery, patients receive RBX7455 orally (PO) 4 days a week for 2-4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of surgery, patients are followed up at 8 weeks and 6 months.
|
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Histologically confirmed un-resected operable invasive adenocarcinoma of the breast \>= 0.5cm
* For cohort 1: Estrogen receptor (ER) and/or progesterone receptor (PR) positive \>= 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression
* For cohort 2: Human epidermal growth factor receptor 2 (HER2) amplification with fluorescence in situ hybridization (FISH) ratio \>= 2.0 or overexpression by immunohistochemistry 3+ with any ER and/or PR
* For cohort 3: Triple negative. Estrogen receptor (ER) and/or progesterone receptor (PR) negative \< 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression
* Patients must not receive neoadjuvant chemotherapy prior to surgery
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 75,000/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Creatinine =\< 2 x upper limit of normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x ULN
* Albumin \>= 3 g/dL
* Willing and able to swallow capsules
* Willing and able to complete the stool and serum testing required for the study
* Willing to provide blood samples for correlative research purposes
* Agrees not to take non-dietary probiotics through 8 weeks after receiving the course of study drug (including over-the counter \[OTC\] and prescription)
* Agrees not to take any oral vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide, bezlotoxumab and intravenous immunoglobulin therapy (IVIG) through the 8-week follow-up assessment unless newly prescribed by a treating investigator during the course of the study
* Willing to employ adequate contraception from the time of enrollment through 3 months after the final dose of RBX7455
* Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device
* Capable of understanding the investigative nature, potential risks, and benefits of the study
* Capable of providing valid informed consent
* Willing to return to enrolling institution for all study visits (blood draws, etc)
* Willing and able to complete the required Patient Medication Diary
* Willing and able to meet all study requirements, including attending all assessment visits and telephone calls
* Women of child bearing potential must have negative pregnancy test within 7 days of enrollment
Exclusion Criteria:
* Requires systemic antibiotic therapy for other condition
* Fecal microbiota transplant (FMT) within the past 6 months
* FMT with an associated serious adverse event related to the FMT product or procedure
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen
* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids \> 20 mg prednisone a day or prednisone-equivalent
* Note: Must be off systemic steroids at least 90 days prior to enrollment. However, topical steroids, inhalants or steroid eye drops are permitted
* Receiving any other investigational agent
* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
* Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria
* History of chronic diarrhea
* History of celiac disease
* Currently has a colostomy
* Intraabdominal surgery related to gastrointestinal tract within the last 60 days
* Evidence of active, severe colitis
* History of short gut syndrome or motility disorders
* Requires the regular use of medications to manage bowel hypermotility
* Active autoimmune disease that has required systemic treatment in the =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded
* Pregnancy
* Breast feeding
|
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] |
NCT04222192
|
Different Type Ultrasound Guided Epidural Block Methods
|
The nerve blocks applied with ultrasonography are used for pain and operation after many operations today.
Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.
However, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.
|
In this study the investigators will used the two different ultrasound -guided epidural block approach .
Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.
|
Inclusion Criteria:
* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Patients whom need medical epidural anesthesia
* Patients with consent to participate in the study
Exclusion Criteria:
* Patients with a known history of back surgery
* Bleeding diathesis disorder
* Allergy to local anesthetics
* Patient refusal
|
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] |
NCT03033407
|
A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System
|
The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.
|
The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering the fact that complications of diabetes result in greater expenditure and reduced productivity is a socioeconomic concern, adequate glycemic control is important not only as individual health problem but also as challenge to healthcare systems worldwide. To support patients' behavior change efforts, including healthy lifestyle choices, disease self-management, and prevention of diabetes complication, multifaceted professional interventions are needed. Ubiquitous healthcare based on information and communication technology is one of these approaches.
The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.
|
Inclusion Criteria:
* Korean policyholders with type 2 diabetes;
* Aged ≥ 19 years;
* Smartphone users;
* Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.
Exclusion Criteria:
* Currently had serious concomitant disease other than diabetes;
* Had admission histories due to malignancy, myocardial infarction, cerebral infarction, or organ transplantation;
* Pregnant or had plan for pregnancy within 6 months;
* Planned for attending other clinical;
* Illiteracy.
|
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NCT03673046
|
Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)
|
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).
|
The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
|
Inclusion Criteria:
* at least 18 years of age
* current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
* currently living in the United States
Exclusion Criteria:
* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in 4+ sessions of cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score \>2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) total score ≥ 21
* Concurrent psychological treatment
* Does not own a supported Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
|
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] |
NCT05076370
|
Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine
|
The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.
|
An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit 48 participants with comorbid OUD and chronic pain, for a total of 24 completers - 12 subjects (6 men and 6 women) receiving methadone and 12 subjects (6 men and 6 women) receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.
|
Inclusion Criteria:
* Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
* Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
* Having chronic pain, uniformly operationalized as grade II (high-intensity) non- cancer pain for ≥ 6 months 49.
* Capable of providing informed consent in English.
* Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer.
* Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
* No current medical problems deemed contraindicated for participation by principal investigator.
* For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception methods.
Exclusion Criteria:
* Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
* Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
* Methadone dose under 60mg or over 100mg
* Buprenorphine over 24mg.
* Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
* Candidates receiving products containing either THC or CBD will be excluded.
* Current use regular use other prescription opioids, gabapentinoids (pregabalin, gabapentin), antidepressants (SSRIs, SNRIs, TCAs), benzodiazepines, platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor), or NSAIDs.
* Current weight of less of 60 kg.
* Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.
* Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
* Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.
|
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] |
NCT05650970
|
Radial Nerve Mobilization in Hand Thumb Osteoarthritis Patients
|
Hand-thumb carpometacarpal (1st CMC) joint osteoarthritis is defined as the degeneration occurring between the articular surfaces of the 1st metacarpal bone and the trapezium bone. This degeneration causes deterioration in the cartilage tissue that forms the joint structure, and as a result, patients primarily complain of pain and related loss of function. Clinical observations and studies have shown that the level of pain expressed by patients is not always compatible with the amount of degeneration in the joint. In addition, it has been clearly stated in the studies that the pain complaints of the patients are not only due to the changes in the joint, but the irritation of the nerves that receive the sensation of this joint is also effective in the level of pain. In line with the findings of the studies on this subject, mobilization exercise for the relevant nerve is included in the treatment programs of patients diagnosed with 1st CMC joint osteoarthritis in the clinic for a while. The investigators observed that the radial nerve mobilization exercise given during the process contributed to the improvement in the pain level of the patients. The investigators planned our study because there was no publication in the literature examining this effect. This study aims to investigate the effect of radial nerve mobilization exercise on pain level, functional status, and grip strength of patients diagnosed with 1st CMC joint osteoarthritis.
|
Patients will be included in the study voluntarily, they will be informed about the study before their evaluation, and their consent to participate in the study will be obtained with an informed consent form. Evaluations will begin after patient consent is obtained. The patient's age, gender, height, body weight, dominant side, symptomatic side, surgical history, previous treatments for the disease, and the duration of pain will be recorded. Physical assessments will then follow. Evaluations will be made twice, before treatment and at the end of 4 weeks of treatment.
The pain level, coarse and fine grip strength, fine dexterity, functional status, and disability level of the patients will be evaluated. The evaluations made will be the same for the study and control groups. The pain level of the participants will be questioned with the visual analog scale (VAS) in three situations: rest, activity, and night, and will be recorded in cm. Factors that increase and decrease pain will also be questioned and recorded.
Coarse grip strength will be evaluated with a hydraulic hand dynamometer (Jamar®) and fine grip strength will be evaluated with a pinch meter. Grip strength measurement will be made in the standard sitting position determined by the American Association of Hand Therapists. This is the position in which the participant holds the evaluated arm next to the torso, with the elbow flexed to 90 degrees and the wrist in a neutral position. It has been shown in studies that the position of this test has high reliability for the results. During the assessment, the patient will sit in a supported chair. Fine grip strength will be measured in bipod pinch and lateral grip positions. The grip strength measurements will be repeated 3 times in a row for both sides and the patient will be asked to squeeze as hard as possible. The average value of the measurement results will be taken and recorded in kilograms.
The 9-Hole Peg test will be used to evaluate the functional status and fine dexterity of the hand. During this evaluation, the patient will sit in a comfortable position. Both parties will be evaluated separately. The patient will be taught the test to be performed first and will be allowed to make a trial. He will be asked to quickly reinsert all the sticks, starting from the position inserted in the holes and removing the last one as fast as he can using only the first two fingers of the side being evaluated. The total removal and insertion time will be recorded in seconds for each side separately.
The FIHOA (Functional Index of Hand Osteoarthritis) questionnaire will be used to evaluate the level of disability specific to the disease. The questionnaire consists of 10 items containing statements about hand use in daily life, and each item is scored between 0-3 points (0: no difficulty, 1: mild difficulty, 2: quite difficult, 3: impossible) according to the difficulty level. Total score 0-30 points. varies between As a result of this survey, a low score represents a better function, while a high score represents a worse function. It has been shown in studies that it has a high correlation with other osteoarthritis-specific questionnaires, and its validity and reliability. The Turkish version was found to be valid and reliable by Kılıçoğlu et al.
The Michigan Hand Outcomes Questionnaire (MHQ) is a questionnaire used in the general evaluation of the use of the hand on both sides and right-left separately in daily life. In addition, the MHQ has been shown to have good reliability, validity, and responsiveness in patients with 1st CMC joint osteoarthritis. Its use in this patient population is recommended as an appropriate assessment tool. The questionnaire evaluates pain, function, aesthetic appearance, and satisfaction as sub-parameters. Since the MHQ measures function/satisfaction, the higher the score, the higher the functionality/satisfaction a person reports. The validity of the Turkish version of the questionnaire was demonstrated by Öksüz et al. Patients in both groups will be included in the treatment program in the clinic for 4 weeks, 2 sessions per week. On the days when the patients do not come to the clinic, the treatment will continue as a home program. Patients will be asked to do the same treatment program as in the clinic, 3 times a day at home. Different from the control group, nerve mobilization exercises will also be included in the treatment program of the study group. All other practices and training will be done by the same physiotherapist for both groups. Nerve mobilization is a treatment consisting of stretching and sliding techniques that is frequently used in the clinic. The sliding technique is one of the neurodynamic techniques and unlike the stretching technique, it does not cause a decrease in the fluid flow and blood circulation in the nerve. Within the scope of our study, nerve mobilization exercise to be applied to patients with 1st CMC joint osteoarthritis is routinely used in the clinic as a part of conservative treatment. It has been observed that exercises for the nerve innervating the 1st CMC joint have a positive effect on the pain level of the patients in the clinic. Based on this situation, the effect of exercises on the improvement of pain level, function, and strength in patients will be investigated. The content of the treatment program given to the groups consists of the following:
* Patient education: During the treatment, patients will be told not to use their hands in heavy work and not to do any other practice other than treatment. It will be examined how the patients use their hands during the day in line with their daily life activities, hobbies, and profession, and the correct grip positions will be taught. Activity modification will be made (if necessary) for the use of the hand in the workplace.
* Activity modification and teaching correct grip/grip techniques: Patients will be taught correct holding techniques with objects of different sizes and shapes and will be instructed to maintain this position during their daily activities. By questioning their activities, hobbies, and occupation, modifications will be suggested for situations that will exacerbate the pain.
* Classical massage: It will be applied on the line where the superficial branch of the radial nerve passes in the forearm, including only the thumb. It will be done to provide relaxation in the tissue, to reduce pain with mechanical stimulation, to reduce edema that develops due to degeneration around the nerve and joint, and accordingly to contribute to healing.
* Nerve mobilization exercise: Radial nerve mobilization can be performed in two ways: from the isolated wrist (ulnar-radial deviation in the form of a fist by grasping the thumb in the palm) and in combination with the wrist-elbow (starting in the anatomical stance position, while the elbow is in extension, the wrist is in ulnar deviation, while the elbow is in flexion, the wrist is in radial deviation). will be done. This exercise will only be included in the study group.
* Ice application: At the end of the treatment, ice will be applied to the sensory area of the superficial branch of the radial nerve for 10-12 minutes. During the treatment, patients will be told not to use their hands in heavy work and not to do any other application other than treatment.
At the end of the study, if the nerve mobilization exercise shows a significant curative effect on the patients, the patients in the control group will also be given nerve mobilization exercises in the presence of a physiotherapist twice a week for 4 weeks, and they will be asked to do the same exercises 3 times a day within the home programs on the other days.
|
Inclusion Criteria:
Clinical diagnosis of Hand-thumb Osteoarthritis Disease Must have pain
Exclusion Criteria:
Wrist surgery history Poor communication Poor mental state
|
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] |
NCT04894630
|
Infective Keratitis in Minia Governate
|
The purpose of the study is to determine the microbiological aetiology, epidemiological factors, and clinical profile and treatment outcomes of infective keratitis in Ophthalmology department, Minia University. Egypt
|
Prospective, non-randomized, observational clinical series of cases, including 150 patients clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020.
Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.
|
Inclusion Criteria:
* clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine - Minia University, Minia, Egypt
Exclusion Criteria:
* healed keratitis
|
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] |
NCT05744128
|
CD8 Minibody Repeatability Study
|
Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.
|
Inclusion Criteria:
* Aged 18 years and above
* Patients with at least one imageable primary or metastatic lesion \> 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months
* Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy.
* Cohort 2: Patients with untreated renal cell carcinoma on active surveillance
* Women of child bearing potential must not be pregnant on study entry
* Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation.
Exclusion Criteria:
* Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator
* Patients with urinary catheters or stoma bags
* Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine
* Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded
* Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors
* Participant enrolled into another therapeutic intervention study
* Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
* Women who are pregnant or breast feeding
* Unable to provide informed consent
|
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] |
|
NCT02638571
|
Evaluation Nutrition Education Intervention on Pulse and Cereal Mix for Complementary Food in Southern Ethiopia
|
The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children.
|
Only 9% of the population in Southern Ethiopia consumes pulse and pulse total contribution of the diet is less than 4.9% for women and less than 3.3% for children.Young children are at risk of developing malnutrition because of dietary inadequacy. Educational interventions can improve feeding practices and growth of young children. The overall purpose of the study is to evaluate nutrition education interventions to promote pulse incorporated complementary food to the wider rural community through the government system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of young children (6 to 24 months). The hypothesis is that nutrition education improves mothers knowledge, attitude and practice of pulse incorporated complementary food and improves dietary intake of iron and zinc and nutritional status of young children. Before, at midline and end of the intervention we will assess the KAP of mothers, dietary intake of iron and zinc and nutritional status of young children. The nutrition education intervention will be given for 9 months. Serum ferritin, serum zinc, C-Reactive protein and hemoglobin and dietary intake of iron and zinc of young children will be measured at the beginning and ending of the intervention.
|
Inclusion Criteria:
* Age 6-15 months
* Apparently healthy
* Being breastfed at time of recruitment
* The mothers are permanent residents of the kebele
Exclusion Criteria:
* Infant undergoing treatment with supplemental foods for malnutrition
|
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] |
NCT00688441
|
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
|
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis
|
This multi-center, randomized, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in patients with seasonal allergic rhinitis. An estimated 500 patients who meet the eligibility criteria will be enrolled into this study at approximately 25 sites to ensure that approximately 400 patients are randomized and complete the study.
|
Inclusion Criteria:
* Able to read and understand informed consent and voluntarily consent to sign the informed consent form
* Able to comply with the requirements of the protocol (e.g., complete the diary within the protocol-specified window)
* Minimal 2-year history of Fall seasonal allergic rhinitis requiring pharmacotherapy
* Positive skin test to one or more Fall seasonal allergen (e.g., ragweed, birch pollen, etc.)
* Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test
Exclusion Criteria:
* History of asthma (other than mild intermittent)
* Acute or significant sinusitis or upper respiratory infection within 14 days of enrollment
* Existing serious medical condition (e.g., severe emphysema) that precludes participation
* Females who are pregnant or breast-feeding and/or who plan to become pregnant or to breast-feed during the study participation or within 7 days after the last study drug administration
* Initiation of immunotherapy or have a change in immunotherapy dose within the 6 months preceding enrollment (if on immunotherapy, the same dose must be maintained throughout the trial)
* Planned travel outside the study area for the duration of study period
* Participation in another clinical study within 30 days of planned enrollment date and for the duration of the study
* Participation in a previous study with Nasal CO2
|
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] |
NCT00852267
|
Lipoprotein Effects of Substituting Beef Protein for Carbohydrate
|
The purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.
|
The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.
|
Inclusion Criteria:
* Blood pressure less than 150/90
* Body mass index (BMI)≥ 20 and ≤ 35 kg/m2
* Non-smoker
* Agrees not to consume alcohol during the study
* Agrees to abstain from taking dietary supplements during the study
* LDL-cholesterol and total cholesterol \< 95th percentile for age and sex
* Fasting triglycerides \< 500 mg/dL
* Fasting glucose concentration \< 126 mg/dL
* Hematocrit (HCT) ≥ 36%
* At least three months of a weight-stable state (± 3% of body weight)
Exclusion Criteria:
* Personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, HIV or of cancer (other than skin cancer) in the last five years
* Taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin
* Abnormal thyroid stimulating hormone (TSH)
* Strength trains with resistance weights more than four hours per week
|
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] |
NCT03103776
|
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
|
Autoimmune thyroiditis and goitres are frequent pathologies.
|
Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic ground, environmental factors are potentially at their origin. Viral infections are the main factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..). However some viruses have an oncogenic potential and could be involved in goitrigenesis. It is also possible that some viruses are specifically implicated in the pathogenesis of Graves' disease or Hashimoto thyroiditis which combines goitre and autoimmunity.
The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is mainly known for triggering renal and bladder pathologies including urothelial tumors in the immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient, as well as hemorrhagic cystitis in the patient grafted to the bone marrow.
|
Inclusion Criteria:
* Major Patient Age ≥ 18 years
* Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto.
* Patients must have signed informed consent.
* Affiliation to a social security scheme
Exclusion Criteria:
* Minor Patients,
* Patient under tutorship or curatorship.
|
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] |
NCT00562250
|
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
|
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
|
Inclusion Criteria:
* Healthy subjects with BMI of 18-32 kg/m2
Exclusion Criteria:
* Abnormal physical or lab findings
* Allergies to any sulfonylurea or related compounds
|
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] |
|
NCT03144752
|
Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression
|
The purpose of this study is to determine if medical, biological, psychological, and social risk factors can be used to develop algorithms that will predict perinatal depression (PND). Data capture will include baseline participant medical, psychological and family history, blood biomarkers, and psychosocial assessments.
|
Inclusion Criteria:
* Participants must be English-speaking and able to understand and follow clinician/researcher/provider recommendations
* Participants must be able to read and comprehend written communications (English) and physically able to complete electronic patient-reported outcome (ePRO) assessments
* Participants must have access to a personal smartphone or a computer and an active personal email address for which they are willing to use for data collection
* Each participant must sign an informed consent form (ICF) indicating that she understands the purpose of and procedures required for this study and is willing to participate in and comply with all procedures in the study
* Participant must be willing and able to have blood draws and to complete the self-reported assessments via mobile electronic device during the study
Exclusion Criteria:
* Participant is not English speaking
* Lifetime mood disorder other than major depressive disorder (MDD) (example \[e.g.\], bipolar I) or anxiety disorder
* Lifetime psychotic disorder (eg, schizophrenia, schizoaffective disorder)
* Lifetime alcohol or illicit substance dependence (moderate-severe)
* Current Post-traumatic Stress Disorder (PTSD), significant alcohol or illicit drug use (Ethanol \[ETOH\]/nonprescription drug use) within 12 months greater than or equal to (\>=)occasional use
|
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] |
|
NCT04887753
|
Effect of Variance on Error Correction During Coupling (Cerrebellar Lesions)
|
This study is a case-control study, involving persons with persons with cerebellar lesions and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.
|
Inclusion Criteria:
* diagnosis of cerrebellar lesions
* walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)
Exclusion Criteria:
* cognitive impairment impeding understanding of
* instructions,
* beat amusia,
* deafness,
* pregnancy
|
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] |
|
NCT05676008
|
A Study of Positive Emotions With Long COVID-19
|
This study is testing a new brief mindfulness practice for people suffering from long COVID-19 symptoms. People suffering from long COVID are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. The goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long COVID.
|
This is a pilot randomized waitlist-controlled clinical trial (RCT) testing a new brief self-care intervention for people suffering from post-acute sequelae SARS-CoV-2 infection (PASC). The overarching goal of this study is to establish the feasibility and early efficacy of microdosing mindfulness as a self-care intervention. The purpose of the intervention is to promote a sense of well-being among PASC patients who currently have limited access to other proven self-care modalities.
Our research question is whether our newly developed training can assist PASC patients to self-microdose mindfulness (5-15 seconds activities in everyday life) and improve on perceived metrics of well-being (primary outcome). Our hypothesis is that self-microdosing mindfulness will evoke positive emotions that can improve well-being on patients suffering of PASC-related symptoms beyond 3 months post COVID-19 infection. If effective, an increased frequency of the mindfulness activity will then help buffer negative emotions (e.g., anger, loneliness, etc.) experienced during the pandemic and associated with ongoing stress and/or somatic symptoms.
|
Inclusion Criteria:
* Able to participate in online zoom sessions and complete online surveys for 3 months
* English speakers
* Had a mild to moderate in severity COVID-19 infection \> 3 months ago, feeling unwell, and are still experiencing in the present at least one PASC-related symptoms:
* Coughing or feeling short of breath
* Loss of smell or change in taste
* Recurrent Fever
* Body aches, headaches, chest pain, or stomach pain
* Brain fog (feeling like you can't think clearly)
* Having trouble sleeping
* Feeling very tired
* Mood changes
Exclusion Criteria:
* Adults that were admitted to an intensive care unit or placed on a respirator, had invasive heart (heart catheterization) or lung tests (bronchoscopy) performed.
* Prisoners
|
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] |
NCT04062175
|
Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery
|
efficacy of adding azithromycin to cephalosporin before cesarean delivery
|
efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women
|
Inclusion Criteria:
* age between 17 and 39 years
* gestaional age between 37 to 42 weeks
* elective cesarean delivery
* obese women
Exclusion Criteria:
* diabetic women on corticosteroids
* intraopertaive complication in previous section
* history of septic woun
* prelabour rupture of membrane \>12 hours
|
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] |
NCT00252135
|
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
|
This study is a multicenter, prospective, observational cohort study of \~5000 Xolair-treated and \~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.
|
Inclusion Criteria:
* Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
* ≥12 years of age
* Physician diagnosis of moderate to severe persistent asthma
* Evidence or history of positive skin test or in vitro reactivity to an aeroallergen
* Willingness to participate fully for the duration of the study (5 years)
* For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment
Exclusion Criteria:
* Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)
* Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
* Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
* Use of an experimental drug within 30 days prior to study screening
* Diagnosis of cystic fibrosis
* For patients in the non-Xolair-treated cohort, any prior treatment with Xolair
|
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] |
|
NCT05573776
|
A Pilot Study of the Effect of High Protein Supplement and Exercise Therapy on Preservation of Skeletal Muscle Mass and Quality of Life in Patients With Gastric Cancer and Pancreatic Cancer Treated With Chemotherapy
|
For gastric and pancreatic cancer patients scheduled for primary chemotherapy, we would like to report muscle mass preservation and improvement in quality of life in Chinese characters that received only exercise therapy and high protein supplements at the same time
|
Sixty patients with gastric and pancreatic cancer will be eligible, and 30 patients will be randomly assigned to the exercise therapy + high protein supplement group and 30 patients to the exercise therapy + placebo supplement group.
|
Inclusion Criteria:
1. Has provided signed written informed Consent
2. Has a histologically confirmed gastric or pancreatic cancer
3. Has a patient scheduled for chemotherapy - Patients who are scheduled to be treated with TS-1 or Xelox for gastric cancer-adjuvant chemotherapy - Patients scheduled for primary chemotherapy for pancreatic cancer-progressive/transitional diseases
Exclusion Criteria:
1. Age under 19 or over 90 year of age
2. Eastern Cooperative Oncology Group (ECOG) ≥ 2
3. Patients with severe malnutritional evaluation (PG-SGAC)
4. Any of the following within 3 months prior to study recruitment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
5. A person with previous uncontrolled seizures, central nervous system or psychological disorders
6. Have uncontrolled active infection or sepsis
7. Have deep vein thrombosis occurs within 4 weeks prior to the start of test recruitment
8. Severe acute or chronic conditions that may reduce the patient's ability to participate in clinical trials or make it difficult to interpret clinical trial results
9. Pregnant or lactating women. Pregnancy test results are positive in childbearing women
10. Gastrointestinal obstruction, malabsorption syndrome, or diseases that significantly affect digestive functions
|
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] |
NCT00715429
|
Vitamin D for Painful Nocturnal Leg Cramps
|
1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps?
2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison VA Medical Center(VAMC) or at the University of Wisconsin Hospitals and Clinics (UWHC). Individuals age 50 or more who have previously taken quinine for nocturnal leg cramps and meeting baseline criteria are eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin D levels, will undergo a 2-week "diary run-in" period to confirm cramp frequency. Those who report two or more leg cramps in each week will continue in the study and will be randomized to vitamin D or placebo. After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until a week after the last dose of study drug. Study investigators will call subjects at scheduled intervals to assess compliance, tolerability, and diary use.
3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and weakness. However, symptomatic hypercalcemia has not been reported except for those taking more than 40,000 units daily for several months. This is far above the cumulative dose in our study.
4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg cramps for subjects who receive it.
5. Consent Procedure: Flyers describing the study and telephone contact information will be mailed to patients who have received quinine during the period 2002-2007. The PI or Co-PI will return calls to describe the study and answer any questions. For persons meeting preliminary (pre-lab) study criteria, two copies of the consent form will be mailed, with the patient mailing back one signed consent to the PI.
|
This is a randomized, double-blind, placebo-controlled trial to determine if oral vitamin D administration reduces the number or severity of nocturnal leg cramps, compared to placebo. Symptom diaries will be used throughout the study to assess frequency and severity of cramps. We will enroll a total of 70 men and women at least 50 years of age who have nocturnal leg cramps at least twice weekly and have previously received quinine for this. Those meeting baseline laboratory criteria and who report at least two leg cramps per week in a two-week "diary run-in" period will be randomized to vitamin D or placebo. Baseline, mid-study, and final laboratory testing will assess any changes in 25-hydroxyvitamin D(OHD) and related variables (25-hydroxyvitamin D is the best measure of vitamin D status.) The time from the beginning of the diary run-in through the final dose of drug and last labs,will be about 14 weeks.
Optimal vitamin D status for health is unknown, although many experts aim for serum 25-hydroxyvitamin D of 35-40 ng/ml. Subjects in this study randomized to vitamin D will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Based on published literature on the ability of vitamin D to raise serum 25-OHD over time, we estimate that the loading doses will "boost" levels after 10 days by an increment of \~40ng/ml (up to \~65 ng/mL total, starting with a typical person's baseline of 25ng/ml). This achieved level of 65 is within the reference range of our VA's reference range of 20-100. (In the PI's experience, most veterans without special D supplementation have baseline levels between 15 and 40).
|
Inclusion Criteria:
* One or more prescription for quinine at the Madison VA in the last 5 years, or else be a UWHC (U Wisconsin Health Clinics) patient whose UWHC medication list had quinine listed in the last five years
* At least 50 years of age, with women being past menopause. This is defined as the woman reporting no periods in the last 12 consecutive months or longer.
* Leg cramps listed in medical record,
* Ability \& willingness to give informed consent,
* Stable estimated Glomerular filtration rate (GFR)\>35 ml/min for the prior 6 mos,
* No change in diuretic therapy in last 3 months,
* Stable pattern of two or more cramps per week for past three months,
* Ability to complete daily diary entry,
* Post-consent: serum 25-OH of 20-45 ng/mL, albumin- corrected calcium \<10.3 mg/dL, and urine calcium/creatinine ratio \<0.25.
Exclusion Criteria:
* Not receiving primary care at Madison VAMC, or at UWHC
* Hyperparathyroidism (1°, 2°, or 3°),
* Osteomalacia ,
* Paget's disease,
* Metastatic cancer,
* Taking vitamin D 50,000 units capsules,
* Serum Ca++ \>10.3 mg/dL in subject chart,
* Sarcoidosis or tuberculosis, and
* Peripheral vascular disease or other condition confounding assessment of cramps.
|
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] |
NCT03886389
|
Breast Cancer Diet Intervention Study
|
The investigators have already proven that Mitotic Activity Index (MAI)is the most robust measure of proliferation in breast cancer tissue.
The purpose was to study whether 18 and 2-4 hours pre-operative per-oral carbohydrate loading (often given in gastrointestinal surgery i.e. enhanced recovery after surgery=ERAS) influences proliferation in the tumor, serum insulin characteristics, metabolic profile and survival.
|
It has been postulated that a "Western-style" diet, rich in carbohydrates (especially high glycemic carbohydrates) may have an effect on the incidence of breast cancer, and perhaps also prognosis. This may be mediated through the insulin-related pathways in breast cells which may show insulin-dependent proliferation, which may alter outcome.
Aims:
To study:
1. The inter-patient variation in insulin and insulin-related characteristics in the blood taken just before the operation from breast cancer patients, on a usual pre-operative fasting schedule;
2. The influence of the variation in insulin and insulin-related characteristics on proliferation and other cell biological features in the breast cancers of these patients;
3. Whether 4 and 18-hours pre-operative hyperglycaemic glucose loading (to reduce postoperative insulin resistance) influences proliferation (Mitotic Activity Index (MAI) and other cell biological features in breast cancer\*
4. The influence of the short-term effect of a pre-operative low-glycaemic carbohydrate isocaloric diet on proliferation and other cell biological features of the primary breast cancer cells (Low-glycemic isocaloric diet intervention study);
5. Epidemiological risk factors: The correlation between epidemiological risk factors, insulin and insulin-related characteristics, proliferation, cell biological features and other biomarkers in breast cancer patients.
6. Estrogen Receptor positive tumors will be analyses separately.
7. Relapse free survival
8. Breast Cancer Specific Survival.
The Short-term effect of carbohydrates will be assessed in a randomized intervention study, where 30 patients receive oral carbohydrates 18 and 4 hours before surgery and 30 patients receive fasting procedure/water.
Primary Outcome
1. Proliferation in the tumor as measured by MAI.
Secondary Outcomes:
1. Serum insulin characteristics (S-insulin, S- insulin c-peptide, S-IGF and S-IGFBP3) will be measured at various peri-surgical timepoints
2. Changes in metabolic profile\* in the tumor and in serum samples
3. Patient Reported Outcome Measures (PROM) on well being
4. Relapse free survival
5. Breast Cancer Specific Survival
* Metabolic profile assessed by High Resolution Magnetic Resonance Spectroscopy (HR-MRS) in the tumor and in serum samples.
|
Inclusion Criteria:
* All consecutive operable patients in 2009-2010, with a clinical and/or radiologic and/or cytologic diagnosis of primary breast cancer, unless the exclusion criteria apply.
Exclusion Criteria:
1. Non-operable patients (i.e" patients with T3-4 (\>5 cm) disease or distant metastases at the time of operation).
2. All patients who refuse to participate.
3. All patients with DCIS, micro-invasive cancer \< 2mm diameter or tumors with histologic poor-quality material.
4. Co-morbidity (Insulin dependent Diabetes Mellitus, Cushing syndrome, previous or concurrent cancers except CIN and non-melanomatous skin cancer.
5. Mental inability to participate.
6. Persons allergic to one of the compounds in any of the two diets.
|
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] |
NCT02529436
|
Overuse of Antidepressant in Patients With Alzheimer Disease
|
Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population.
Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in prescription duration) Main objective: to assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in prescription duration) in patients aged 70 years and over with ADAD.
Secondary objectives:
1. To assess the prevalence of AD prescribed for a non validated indication
2. To assess the prevalence of AD prescribed with excess in prescription duration
3. To assess the prevalence of psychotropic coprescription and notably the prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health
4. To assess factors associated to AD overuse Method: A transversal monocentric study in the geriatric day Bretonneau unit will be performed. Study will be proposed to all eligible patients (with non-opposition of the patient or of his legal representative to the collection of his personal data). Included people will have no supplementary clinical or complementary investigations. The geriatrician in charge will have to systematically collect the indication and the history of the AD treatment. At the end of the evaluation performed in the geriatric day unit, the geriatrician will have to conclude to the AD overuse or not associated with off label prescription. Doubtful case will be examined by a validation committee.
Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and dementia according to DSMIV criteria, whatever its level and antidepressant prescription.
Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant (data from French Health Insurance), the number of eligible patients consulting in the geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their personal data and if the overuse of AD is near 50%, precision of the result will be 12.8% (95%CI bilateral).
Duration of inclusion: 6 months Duration of patient's participation: one day
|
According to the data of the French Health Insurance, near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. This confirms the international data on the prevalence of antidepressant prescription in people with ADAD ranging from 26% to 56.4% but always superior to those of the population with the same age.
If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population. This overuse has been described in people living in nursing home (among those, a majority suffers from ADAD) and would reach 62%. To assess this overuse in demented people whatever their place of living is necessary to further implement risk minimization actions.
Hypothesis : Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in the prescription duration) through a transversal study.
Main objective : To assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in the prescription duration) in patients aged 70 years and over with ADAD.
Secondary objectives :
1. To assess the prevalence of AD prescribed for a non validated indication
2. To assess the prevalence of AD prescribed with an excess in prescription duration
3. To assess the prevalence of psychotropic coprescription and notably the prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health:
* Any prescription of a long half-life benzodiazepine;
* Of neuroleptics in Alzheimer patients; or
* Of 3 or more psychotropic drugs)
4. To assess factors associated to AD overuse
Measurements : AD overuse with off label prescriptions, ie no validated indication or excess in prescription duration :
* Drug will be defined as AD if they are included in the list of AD designed by a national French Task Force including experts from over 30 associations and scientific societies (N06AA02 Imipramine, N06AA04 Clomipramine, N06AA06 Trimipramine, N06AA09 Amitriptyline, N06AA10 Nortriptyline, N06AA17 Amoxapine, N06AA21 Maprotiline, N06AB03 Fluoxetine, N06AB04 Citalopram, N06AB05 Paroxetine, N06AB06 Sertraline, N06AB08 Fluvoxamine, N06AB10 Escitalopram, N06AF03 Phenelzine, N06AF04 Tranylcypromine, N06AF05 Iproniazide, N06AG02 Moclobemide, N06AX03 Mianserine, N06AX11 Mirtazapine, N06AX14 Tianeptine, N06AX16 Venlafaxine, N06AX17 Milnacipran, N06AX21 Duloxetine, N06AX22 Agomelatine)
* Indication for AD will be the one declared by the prescriber of AD. This data will be collected through direct contact with prescriber or medical report or record or interview of patient's caregiver.
* Off label prescription will be defined by prescription for indication not listed in the Summary of Product Characteristics (SPC).
* Prescription duration will be considered as exceeded if superior to that recommended in market authorization:
* Duration\>14 months in major depressive disorder and in patient with remission
* Exceeded duration according to the geriatrician in charge according to the multidisciplinary evaluation performed during the geriatric day hospital . If the geriatrician could not conclude, an expert committee (including a psycho-geriatrician and a geriatrician expert in drug) will adjudicate to the overuse or not of the AD.
Method : A transversal monocentric study in the geriatric day Bretonneau unit will be performed. Study will be proposed to all eligible patients (with non-opposition of the patient or of his legal representative to the collection of his personal data). Included people will have no supplementary clinical or complementary investigations.
Data collected routinely in geriatric day hospital include :
Data collected by nurse: socio-demographic data/ functional abilities (ADL IADL)/ professional caregiver at home/ weight,pulse, blood pressure, orthostatic hypotension/ Zarit scale/ NeuroPsychiatric Inventory Data collected by geriatrician : medical history, medication conciliation, clinical exam, screening for depression (miniGDS or Cornell scale according to theMiniMental Status MMS score \> or \<18), MMSif latest score\>one year, Frontal assessment battery at bedside (FAB) Psychologic or psychiatric assessment as neuropsychometric assessment are performed according to the indication for the cause of the assessment in the geriatric day hospital .
The geriatrician in charge will have to systematically collect the indication and the history of the AD treatment.
At the end of the evaluation performed in the geriatric day unit, the geriatrician will have to conclude to the AD overuse or not associated with off label prescription. Doubtful case will be examined by a validation committee ( psychogeriatrician and geriatrician expert in drug).
Inclusion criteria : age ≥70 years / dementia according to DSMIV criteria, whatever its level/ Antidepressant prescription Non inclusion criteria: opposition of the patient or of his legal representative to the collection of his personal data/ Mild Cognitive Impairment Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant (data from French Health Insurance), the number of eligible patients consulting in the geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their personal data and if the overuse of AD is near 50% , precision of the result will be 12.8% (95%CI bilateral).
Duration of inclusion : 6 months. Duration of patient's participation : one day.
|
Inclusion Criteria:
* Age ≥70 years,
* Dementia according to DSMIV criteria, whatever its level,
* Antidepressant prescription.
Exclusion Criteria:
* Refusal of the patient or of his legal representative to the collection of his personal data,
* Mild Cognitive Impairment.
|
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] |
NCT03659786
|
Single-center Prospective Cumulus Cell Test Study
|
Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle
|
Inclusion Criteria:
* scheduled for intracytoplasmatic sperm injection (ICSI) and single or double embryo transfer on day 3
* patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with Highly Purified human Menopausal Gonadotropin (HP-hMG)
* undergoing first or second IVF or ICSI cycle with transfer
* Body Mass Index (BMI) between 17 and 33.
* regular menstrual cycle (between 24 and 35 days)
Exclusion Criteria:
* smokers (\> 10 cigarettes per day)
* patients requesting Pre-implantation Genetic Diagnosis (PGD)
* patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
* couples where the partner has an extremely low sperm count e.g.: extreme oligo-astheno-teratozoospermia (OAT) (\< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
* results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect
|
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|
NCT04504500
|
Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial
|
It is becoming increasingly apparent that there is an urgent need to systematically investigate the rising cesarean section (CS) rates in Greece and develop interventions to substantially reduce these rates. In this trial, to be conducted in Greece, the obstetricians will be exposed to educational, behavioral and/or organizational interventions while managing labor. The trial is expected to yield new information about effective interventions to reduce unnecessary cesarean sections in Greece, hopefully leading the way to their reduction worldwide.
|
The present study explains the planned implementation of a stepped-wedge trial in Greek maternity units. Twenty-two maternity units in Greece will participate in the trial involving 20,000 to 25,000 births, with two of the units entering the intervention period each month (stepped randomization). The maternity units will apply the interventions for a period of 6-16 months, depending on the time they enter the intervention stage of the trial. There will also be an initial baseline phase of the trial, lasting from 3 to 13 months; this phase will include observation and data collection of routine obstetric practices. The interventions are based on educational, behavioral and organizational modifications and will include the implementation of the Hellenic Society of Obstetrics and Gynecology (HSOG) guidelines on labor management and targeted training in cardiotocography (CTG), obstetric emergencies, and the classification of cesarean section through Robson criteria. During the trial period, the rates and indications for cesarean sections will be available to participating units on a live platform, using an anonymous reporting system. Participating obstetricians will be able to see their own and other units' performance and also get feedback on their rates. Τhe final three-month phase of the trial will be devoted to completion of questionnaires by the participating obstetricians. The total estimated duration of the trial will be 22 months. The primary outcome assessed will be the change in cesarean section rate and the secondary outcomes will be maternal and neonatal morbidity and mortality. The intervention and control periods will be compared using mixed effects logistic regression with adjustment for any underlying secular trends.
|
Inclusion Criteria:
* A minimum of 5 years' provision of obstetric services for the participating units.
* Top 22 units in Greece according to the number of deliveries and the type of unit (National Health System, private, university) and the unit's willingness to participate.
* Up to 11 obstetricians in each unit (based on the number of deliveries and their willingness to participate)
* Consent obtained from all participating professionals
* Consent obtained from all participating women
Exclusion Criteria:
* None
|
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] |
NCT00326417
|
Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)
|
The purpose of the current study is to continue to optimize conditioning regimens in high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible unrelated donors. Specifically, the study will determine whether the addition of fludarabine to the conditioning regimen previously described by Deeg et al. will permit a reduction in the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths is reduced.
|
BACKGROUND:
Aplastic anemia (AA) remains a life-threatening illness. Treatment options include supportive care (transfusions, growth factors, etc.), immunosuppression therapy and stem cell transplantation. Only the latter two have favorably impacted the natural history of the disease. The prognosis of AA patients, particularly severe aplastic anemia (SAA), as defined by Camitta et al., who fail to respond to immunosuppressive therapy (IS) or who relapse after an initial response to IS is poor. Although many of these patients can be supported in the short term with growth factors, transfusions and possibly rechallenged successfully with IS, the cumulative morbidity and mortality from infection, hemorrhage or transfusion-related complications is substantial.
While allogeneic bone marrow transplantation is potentially curative in AA, no more than 25% of patients have a human leukocyte antigen (HLA)-identical sibling donor. Cyclophosphamide (CY)-antithymocyte globulin (ATG) has been recommended as the preparative regimen of choice in sibling donor transplants. Results of bone marrow transplantation from alternative donors, such as matched unrelated donors and mismatched related donors in AA patients who have failed IS, have largely been unsatisfactory. The cyclophosphamide-ATG conditioning regimen has proved inadequate in ensuring engraftment in allogeneic transplants from matched, unrelated donors for AA. This was the major reason why total body radiation (TBI) has been added to the conditioning regimen.
Graft failure is a very serious and frequently life-threatening or fatal event following matched unrelated donor (MUD) allografts in aplastic anemia. It is an immunologically mediated event. Risk factors for graft failure include the use of HLA nonidentical or unrelated donors, a poor marrow nucleated cell dose as well as prolonged transfusional support prior to BMT (which increases the probability of patient sensitization to multiple antigens). While some patients may achieve autologous hematopoietic recovery, prolonged pancytopenia is common and infection-related morbidity and mortality are very substantial. Reconditioning for a second allograft from the same or a different donor is frequently not successful. While the addition of TBI and intensive pre-transplant conditioning has led to a sizable improvement in engraftment rates, this has come with a price, particularly in adult patients. Transplant-related toxicity has been a major and frequent problem. Radiation-induced pulmonary toxicity in particular has been common, usually in the form of diffuse alveolar damage or diffuse interstitial pneumonitis. In addition, Graft Versus Host Disease (GVHD)-related morbidity and mortality in these patients have also been substantial.
DESIGN NARRATIVE:
The study is a prospective Phase I/II dose optimization study. All patients are given a fixed dose of ATG (either thymoglobulin: 3 mg/kg IV daily x 3 or ATGAM 30 mg/kg IV daily x 3, on Days -4 to -2), Fludarabine (30 mg/m\^2 IV daily x 4, on Days - 5 to -2), and TBI (200 cGy (centigray) from a linear accelerator at less than 20 cGy/min on Day -1). The starting CY dose will be 150 mg/kg (50 mg/kg intravenously daily, Days -4 to -2), and will be de-escalated depending on engraftment and toxicity. The Phase I portion of the trial (maximum of 24-27 patients) tests each of four dose levels of CY for adequate safety and graft retention. The Phase II portion of the trial refines the dose selection and allocates an additional 70 patients to the optimal dose, at which two-year post-transplant survival will be assessed. The combined enrollment in Phase I and II will total 94 patients.
The study is a prospective single-arm Phase I/II dose-selection and evaluation study. The study will seek the optimal dose level of CY based on assessments of graft failure, toxicity and early death during 100 days of follow-up post-transplant. A brief synopsis is given below.
Phase I - Test Each Dose for Adequate Safety and Graft Retention
1. Proceed from the highest dose (150 mg/kg CY) to the lowest dose (0 mg/kg CY), treating a minimum of six patients at each dose.
2. Evaluate the 100-Day outcomes for toxicity, death and graft failure on each patient enrolled at the current dose, or until stopping criteria are met.
3. If there are three or more graft failures at the current dose, the current dose and all lower doses are closed to further enrollment.
4. If there are five or more severe regimen-related toxicities and/or early deaths at the current dose, the current dose is closed to further enrollment, and the next lower dose is tested.
5. Dose de-escalation ceases once all four doses are tested or closed to further enrollment.
Phase II - Refine Dose Selection and Allocate Patients to the Optimal Dose
1. Treat each newly enrolled patient at the most desirable of the dose levels remaining open to enrollment. This can involve de-escalation, escalation, or no change in dose.
2. As each patient completes the observation period, evaluate the 100-Day outcomes for graft failure, toxicity and/or early death for this patient, or until stopping criteria are met.
3. If there are excess (according to the criteria in Table 5.8) graft failures, that patient's dose and all lower doses are closed to further enrollment.
4. If there are excess (according to the criteria in Table 5.8) toxicities and/or early deaths, that patient's dose is closed to further enrollment.
5. Re-evaluate the desirability of the current dose level based on the 100-Day outcomes for toxicity and/or early death and graft failure.
6. Repeat steps 1-5 until 54 patients are enrolled in Phase II, or all dose levels are closed to further enrollment.
Dosage Levels for CY:
3 Days (Day -4, -3, -2): Dose of 50 mg/kg/day; total dose of 150 mg/kg; dose level 3
2 Days (Day -3, -2): Dose of 50 mg/kg/day; total dose of 100 mg/kg; dose level 2
1 Day (Day -2): Dose of 50 mg/kg/day; total dose of 50 mg/kg; dose level 1
0 Days (None): No dose; no total dose; dose level 0
There may be wait periods between enrollment of successive patients and/or cohorts for endpoint assessment. Under these circumstances, the final decision about waiting versus treating the patient off study will be made at the local transplant center.
|
Inclusion Criteria:
* Patients up to 65 years of age at time of registration with a diagnosis of SAA; SAA is defined as follows:
1. Bone marrow cellularity less than 25% or marrow cellularity less than 50% but with less than 30% residual hematopoietic cells
2. Two out of three of the following (in peripheral blood): neutrophils less than 0.5 x 10\^9/L; platelets less than 20 x 10\^9/L; reticulocytes less than 20 x 10\^9/L
* Patient must have an available unrelated donor with a 7/8 or 8/8 match for HLA-A, B, C, and DRB1 antigen; typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1; HLA-DQ typing is recommended but will not count in the match
* Patient and/or legal guardian able to provide signed informed consent
* Matched unrelated donor must consent to provide a marrow allograft
* Patients with adequate organ function as measured by:
1. Cardiac: left ventricular ejection fraction at rest must be greater than 40% or shortening fraction greater than 20%
2. Hepatic: serum bilirubin less than 2x upper limit of normal for age as per local laboratory) (with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome), alanine transaminase (ALT) and aspartate transaminase (AST) less than 4x upper limit of normal for age (as per local laboratory)
3. Renal: serum creatinine less than 2x upper limit of normal for age (as per local laboratory)
4. Pulmonary: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusing capacity (DLCO) (corrected for Hb) greater than 50% predicted; for patients in which pulse oxymetry is performed, O2 saturation greater than 92%
* Diagnosis of Fanconi anemia must be excluded in patients younger than 18 years of age by diepoxybutane testing on peripheral blood or comparable testing on marrow.
Exclusion Criteria:
* Clonal cytogenetic abnormalities associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) on marrow examination
* Diagnosis of other "congenital" aplastic anemias such as: Diamond-Blackfan; Shwachman-Diamond; congenital amegakaryocytosis
* Symptomatic or uncontrolled cardiac failure or coronary artery disease
* Karnofsky performance status less than 60% or Lansky less than 40% for patients younger than 16 years old
* Uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms)
* Seropositive for the human immunodeficiency virus (HIV)
* Pregnant (positive total HCG) or breastfeeding
* Presence of large accumulation of ascites or pleural effusions, which would be a contraindication to the administration of methotrexate for GVHD prophylaxis
* Known severe or life-threatening allergy or intolerance to ATG or cyclosporine/ tacrolimus
* Planned administration of alemtuzumab (Campath-1H) or other investigational agents as alternative agent for GVHD prophylaxis
* Concomitant enrollment in a Phase I study
* Positive patient anti-donor lymphocyte crossmatch in HLA-A or B mismatched transplants; the definition of match is in Section 2.2.1; the crossmatch would only apply to mismatches at HLA-A or B, not DRB1 or HLA-C
* Prior allogeneic marrow or stem cell transplantation
* Patients with prior malignancies except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent more than 5 years previously will be allowed
|
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] |
NCT06353204
|
Effectiveness of the Justice Diversion Halt-intervention
|
In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention.
|
The Halt-intervention is a widely used Dutch diversion measure for youth (aged 12-17) who committed a minor offence. In the current study, it will be investigated whether the Halt-intervention is successful in reducing recidivism and in achieving the intervention goals. The effectiveness will be assessed using a randomized controlled trial. Participants will be randomly assigned to the experimental condition in which participants will receive the halt intervention or to the control condition in which participants will not receive an intervention. Participants fill out three self-reported questionnaires over a time period of one year. With these questionnaires is it investigated whether the intervention is successful in achieving the different intervention goals (improving social skills, taking responsibility, correct wrongdoing or damage, improving conventional beliefs and improving support from the social network) and in achieving a reduction in recidivism. Furthermore, the adherence to children's rights in the practice of Halt is investigated. Lastly, two years after the first contact with Halt recidivism is assessed using official police and judicial records.
|
Inclusion Criteria:
* Juveniles who have been referred to Halt after committing a minor offence that is eligible for the Halt-intervention.
* Juveniles between the ages of 12 and 18.
Exclusion Criteria:
* Participants who do not speak Dutch or who do not speak Dutch fluently.
* Participants who have already participated in the study before.
* Participants who are participating in the following Halt-programs: 'Hack_right', 'Respect Online' or 'Sport en Spel'.
* Participants of whom it is suspected that their are serious concerns for their safety.
|
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] |
NCT00263965
|
ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
|
This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.
|
Inclusion Criteria:
* Provision of a written informed consent
* Men or women who are 30-70 years of age
* Female patients: postmenopausal, hysterectomized
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Exclusion Criteria:
* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
|
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|
NCT03692377
|
How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department
|
Children who present to the emergency department often require painful procedures (intravenous catheterization, laceration repair, fracture reduction, etc.). Virtual reality (VR) has been presented as a way of managing pain and anxiety in children undergoing painful procedures but most studies are limited to children 6 or older. The present study seeks to determine the youngest age (2-6) of future subjects in research of VR and clinical care.
Virtual Reality is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
Investigators will instruct and observe children age 2-6 in using a VR device and document how easy the device is to use for the child. The children will have the opportunity to select an application and play with the device for 10 minutes before being asked about their experience with the device. Parents/Guardians will also be asked about their child's experience with the device.
|
Inclusion Criteria:
1. Children age 2-6 years of age
2. Patients arrived with a legal guardian to the emergency department
3. Parents will sign a consent form and children will agree verbally to participate
4. Triage category 4 or 5 (lowest acuity)
Exclusion Criteria:
1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication)
2. Facial features or injury prohibiting wearing the VR goggles
3. Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair)
4. Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant
|
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] |
|
NCT05739890
|
Whole Genome Sequencing (WGS) on IVF Embryos and Individual Patients
|
This research project aims to utilise recent advances in whole genome sequencing of preimplantation genetic diagnosis embryos to investigate the impact of paternal age on de novo mutation rates in IVF embryos. Embryos that are deemed unsuitable for transfer following preimplantation genetic testing for monogenic/single gene disorders (PGT-M) due to the detection of genetic abnormalities will be utilized for this study. These embryos will undergo re-biopsy, and both the biopsied samples as well as the remaining embryo tissue will be subject to whole genome sequencing. This will allow the assessment of de novo mutation rates based on the paternal age.
|
This project proposes a paired non-inferiority trial utilizing the retrospective testing of research embryos to establish the optimized parameters for amplified trophectoderm biopsy and whole genome sequencing compared to traditional preimplantation genetic testing for aneuploidy (PGT-A).
The primary outcome is the de novo mutation rate, which will be compared between embryos subjected to trophectoderm biopsy and whole genome sequencing versus reanalysis with Sanger sequencing. Trio testing will be performed for each embryo using DNA from the genetic parents in addition to embryo. The study will compare cases that include couples with at least one embryo deemed unsuitable for transfer. A paired study design will be used, with embryos from each couple split into two arms - one subjected to trophectoderm biopsy and whole genome sequencing, the other to reanalysis with targeted sequencing.
Biopsied trophectoderm samples and the remaining embryo tissues from the whole genome sequencing arm will undergo sequencing. Sequencing will also be performed on DNA samples from each genetic parent.
Derivation of de novo mutation rates is a key goal, as these provide insights into effects of paternal age and other factors on germline mutations in preimplantation embryos, increasing the knowledge of the risks associated with advanced paternal age. Secondary metrics will be investigated to supplement the analysis, including clean reads and clean bases indicating the amount of high-quality data for the source templates. Mapping rate, unique rate and duplicate rate, assessing data accuracy and quality. Comparison of multiple metrics will determine the optimized parameters for performing amplified trophectoderm biopsy and whole genome sequencing. This can then inform future research and clinical studies.
The de novo mutation rate will be derived by modelling the observed mutation rate as a function of parental ages, specifically the paternal age. Whole genome sequencing of embryo samples as well as both parents will identify raw numbers of de novo mutations. The paternal age coefficient for the de novo mutation rate will be calculated using a regression model with the number of de novo mutations as the dependent variable and paternal age as the key independent variable. Covariates like maternal age and sequencing quality metrics will also be included to account for potential confounding factors. The regression model will determine the increase in de novo mutations per year of paternal age, providing the paternal age coefficient. Comparing embryos from older and younger males will reveal differences in mutation rates. The overall model will establish the quantitative relationship between paternal age and de novo mutations in preimplantation embryos based on the study's whole genome sequencing data.
|
Couples undergoing IVF with 1≥ embryo sample unsuitable for transfer due to genetic or chromosome abnormalities.
Cases with parental DNA available directly or consenting follow-up.
Exclusion Criteria:
* Female patients with low ovarian reserve (\< 10 follicles or FSH\>10, AMH \<1).
|
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] |
NCT03680066
|
Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.
|
This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.
|
Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children's Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
* cookies, max 30 g;
* chocolate, max 30 g;
* breakfast cereals, max 50 g.
Each meal will be administered with a 1 hour observation period in between and at the end.
If the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).
An age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.
For the following 3 months after "may contain food" challenges, the patients will be invited to eat on a regular basis any foods labeled as "may contain" tree nuts and/or peanuts and record the consumption on a diary. Such foods will only be eaten in presence of a family member instructed for the measures to be taken in case of a reaction. They will record any history of reaction and contact the study team. The brand name of the food, and if available the batch will be recorded. The participants will store the study food and its packaging safely in a box and bring it along at V2 for allergen content analysis.
If a reaction occurs, the food will be analyzed for allergen content by immunoaffinity capillary elecrophoresis-matrix assisted laser desorption/ionization mass spectrometry, as well as a simplified version of this technique, the immunomagnetic separation -matrix-assisted laser desorption/ionization mass spectrometry.
Visit 2 (V2): During this visit, the parents/patients will report on the brand, the frequency and the amount of "may contain" foods eaten since V1.
The quality of life questionnaire will be filled out again by the parents/patient.
|
Inclusion Criteria:
* Children aged 2-18 years at time of inclusion
* Tree nut or peanut allergy documented by:
* Positive skin prick tests (SPTs) to peanut and/or tree nuts
* Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)
* A recent (\< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.
* Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
Exclusion Criteria:
* History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
* Expected non-adherence to the study protocol.
* Severe or uncontrolled asthma.
|
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] |
NCT03887156
|
Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft
|
The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft
|
Acute Graft Versus Host Disease (aGVHD) is the most frequent complication in allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). It affects up to 50% patients, among whom 15% to 25% develop severe forms, often lethal, yet impossible to predict even for donors with a Human Leukocyte Antigene (HLA) 10/10 compatibility. Global Overall Survival (OS) after transplantation is 40% to 60% only due to post transplant severe complications. There is a major medical need for a technology that would predict the risk of aGVHD and would allow the selection of a favourable donor among multiple Human Leukocyte Antigene (HLA)10/10 compatible donors.
MT. Rubio and M. Bouillié at Pr Olivier Hermine's lab previously reported that enhanced early post-transplant invariant Natural Killer T (iNKT) cells reconstitution from donor cells was correlated to reduced risk of aGVHD, without impairment of the Graft Versus Leukemia (GVL) effect. They subsequently demonstrated that the expansion of donors CD4neg invariant Natural Killer T (iNKT) cells subpopulation was predictive of a reduced risk of aGVHD, and developed a method for predicting this risk based on the expansion factor of CD4neg invariant Natural Killer T (iNKT) cells in the peripheral blood stem cell (PBSC) graft. This invariant Natural Killer T (iNKT) cells functional test reaches its optimal predictive capacity with 94% sensitivity and 100% specificity in allo-HSCT performed with Human Leukocyte Antigene (HLA) 10/10 matched peripheral blood stem cell (PBSC) grafts for non-progressive hematological malignant diseases, in complete response, which represent the majority of the indications of allogeneic HSCT. Similar predictive value was also observed when the test was performed from donor's peripheral blood before G-CSF mobilization. It was not associated with an increased risk of relapse. This test could therefore allow to easily selecting the best donor if different siblings or unrelated donors are available before PBSC allo-HSCT.
|
Inclusion Criteria:
* PATIENT :
* Age between 18 and 65 years ( included )
* Being candidate to a graft of peripheral hematopoietic stem cells , according the following criteria :
* HLA compatibility 10 / 10 with the selected donor
* Malignant haematological disorder as described below :
* Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or 2d complete remission
* Aggressive lymphoma in complete remission
* Non - progressive myeloproliferative syndrome ,
* Myelodysplasia with stable blasts is cell number and \< 10 % of blastocysts,
* Acute leukemia biphenotypic in 1st or 2d complete remission
* Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG
* Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR
* Adult ( ≥ 18 year old) up to the maximum authorized by each National Transplantation Authority
* Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry or a national registry
* Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt Antigen (HLA) 10 / 10 compatibility with the recipient ,
* Signed and dated informed consent ( in accordance with local regulation of the country in which the observation is performed )
Exclusion Criteria:
* Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study ,
* Being placed under legal supervision ,
* Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
|
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] |
NCT05556174
|
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers
|
Postoperative Pulmonary Complications (PPC) are common. It severely affects postoperative recovery, particularly in abdominal surgery. Several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. Other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. The purpose of this study was to compare the effects of the above two regimens on postoperative pulmonary complications.
|
Inclusion Criteria:
1. Undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h)
2. had an intermediate to high risk of developing postoperative pulmonary complications as indicated by an Assess Respiratory Risk in Surgical Patients in Catalonia score (≥26)
3. Pulse oxygen saturation in room air ≥ 94%
Exclusion Criteria:
1. younger than 18 years
2. had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery
3. had a history of pneumonia within 1 month prior to surgery
4. had severe chronic obstructive pulmonary disease or pulmonary bullae
5. had a progressive neuromuscular illness
6. severe heart dysfunction (New York Heart Association classification ≥4)
7. with an American Society of Anesthesiologists (ASA) physical status of IV or higher
8. Intracranial hypertension
9. were pregnant (excluded by laboratory analysis)
10. were involved in other interventional studies
|
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|
NCT05879692
|
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
|
The purpose of the study is to find out the response of Irritable Bowel Syndrome (IBS) to abdominal fat reduction in central obese patients using: application of High Intensity Focused Ultrasound (cavitation) on the abdominal region, aerobic exercise and a dietary regimen that will be low in calories (Low Caloric Diet) and low in fermentable oligo-, di-, mono- saccharides and polyols (low-FODMAPs).
|
Irritable bowel syndrome is a common functional gastrointestinal (GI) disorder, with a high global prevalence and a strong impact on the quality of life. There is a positive association between irritable bowel syndrome (IBS) and increased BMI and volume of android fat, according to waist circumference.
Central obesity and Irritable Bowel Syndrome (IBS) are common medical conditions with similar etiologic mechanisms. There are several studies considering obesity as the risk factor for (IBS), but limited studies that to evaluate the association between abdominal obesity and the incidence of irritable bowel syndrome (IBS). Establishing such association is important in the management of IBS.
Focused ultra sound cavitation is a noninvasive safe technique for reducing localized subcutaneous adipose tissue by generating molecular vibrations that elevate the local tissue temperature and produce rapid cell necrosis in targeted tissues.
the investigators believe that focused ultrasound cavitation could improve the overall of Irritable Bowel Syndrome severity as a consequence of abdominal fat reduction.
To the best of the investigators' knowledge, there are limited studies to confirm the improvement of irritable bowel syndrome (IBS) as a result of abdominal fat reduction by focused ultrasound cavitation.
Therefore, this study is a trial to investigate the effect of focused ultrasound cavitation augmented with aerobic exercise and dietary regimen on improvement of Irritable bowel syndrome (IBS) in patients with central obesity.
Sixty volunteer central obese patients (males and females) with Irritable Bowel Syndrome (IBS) which will be diagnosed according to Rome IV criteria will be participated in this study and will be referred from the Gastroenterology outpatient clinic of El-Sahel Teaching Hospital, Cairo. The study will be conducted at El-Sahel Teaching Hospital.
|
Inclusion Criteria:
* All patients will be 20-45 years of age.
* Both genders will be participated.
* sedentary (exercise \< 2 times/week).
* Body mass index (BMI) will be ranged from 30 to 39.9 kg/m² and their waist circumference ≥ 102 cm for men and ≥ 88 cm for women.
* Patients will have the criteria of Irritable Bowel Syndrome (IBS) according to Rome IV Which are: recurrent abdominal pain on average at least one day per week during the previous three months associated with two or more of the following features must fulfill: (1) Pain is related to defecation; (2) Pain associated with a change in frequency of stool; and (3) Pain associated with a change in form or appearance of stool.
* mild to moderate Irritable Bowel Syndrome with score of 75- 300 according to the questionnaire of Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).
Exclusion Criteria:
* • Under 20 or above 45 years of age.
* Athletics
* Musculoskeletal, Carcinogenic, or kidney diseases, diabetes, hepatitis and cardiac disorders.
* Any condition that may prevent the use of the focused ultrasound on the abdominal region such as scarring, hernias or skin diseases in the abdominal area.
* Patients with severe Irritable Bowel Syndrome (IBS) or other known organic gastrointestinal disorders rather than IBS including: (1) Fever, Weight loss or Jaundice; (2) Change in the color of stool; (3) Signs of anemia or Thyroid disease; (4) Abdominal mass or Organomegaly; (5) Signs of intestinal obstruction.
|
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] |
NCT04618991
|
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
|
The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.
|
This assessment will be done using the following elements:
* The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time.
* The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness.
* Gender, age group, BMI
* The radiological assessment
* The results of polysomnography
Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice.
These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.
|
Inclusion Criteria:
* Adult patients
* With obstructive sleep apnea confirmed by polysomnography
* Surgical indication for surgically maxillary expansion
Exclusion Criteria:
* - Patients refusing to participate in the survey having formulated their opposition
* Diabetes,
* Obesity (BMI\> 30)
* Failure to provide informed written consent
* Refusal or inability to return to all follow-up visits and sleep studies
* Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding
* Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed)
* Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction)
* Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment.
* Patients included in another clinical study (excluding registers).
* Patients taking medicines such as opiates which may affect sleep, alertness or breathing
|
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] |
NCT01030900
|
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas
|
Background:
* Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs may be more effective if given by continuous infusion into the vein rather than by the standard method of rapid intravenous injection. One combination of six chemotherapy drugs, known as etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R), has had a high degree of effectiveness in people with certain kinds of cancer.
* Recent evidence also indicates that the effects of chemotherapy may be improved by combining the treatment with monoclonal antibodies, which are purified proteins that are specially made to attach to foreign substances such as cancer cells. A monoclonal antibody called campath (alemtuzumab) has been manufactured to attach to a protein called Campath-1 antigen (CD52) that may target tumor cells or the surrounding inflammatory cells.
* Researchers are interested in developing new treatments for large B-cell lymphoma or Hodgkin lymphoma that can best be treated with chemotherapy. This protocol is specifically for people with diffuse large B-cell or Hodgkin lymphomas that have not responded to standard treatments.
Objectives:
- To test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.
Eligibility:
- Individuals 18 years of age and older who have large B-cell lymphoma or Hodgkin lymphoma that has not responded well to standard treatments.
Design:
* During the study, patients will receive standard EPOCH-R chemotherapy, which includes the following drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The additional drug, campath, will be given by intravenous (IV) infusion on the first day of treatment over several hours.
* When the campath IV infusion and rituximab IV infusion are complete, the drugs doxorubicin, etoposide, and vincristine will each be given by continuous IV infusion over the next 4 days (that is, continuously for a total of 96 hours). Cyclophosphamide will be given by IV infusion over several hours on Day 5. Prednisone will be given by mouth twice each day for 5 days.
* Patients may be given other drugs to treat the side effects of chemotherapy, to prevent possible infections, and to improve white blood cell counts.
* The campath-EPOCH-R therapy will be repeated every 21 days, as a cycle of therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles (approximately weeks 12 and 18) of campath-EPOCH-R treatment, study researchers will perform blood tests and computed tomography (CT)/magnetic resonance imaging (MRI) scans on all patients to assess their response to the treatment.
|
Background:
Two signatures of the microenvironment were recently identified that are predictive of outcome in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL), treated with rituximab, cyclophosphamide, hydroxydaunorubicin hydrochloride (doxorubicin hydrochloride), vincristine (Oncovin) and prednisone (R-CHOP). These signatures, called stromal 1 and stromal 2, are associated with genes expressed by infiltrating mononuclear cells. The stromal 2 signature, which includes genes associated with angiogenesis, is predictive of an inferior outcome. Based on these observations, we are interested in targeting the reactive cells in the microenvironment as a therapeutic strategy in patients with relapsed and refractory DLBCL. Along the same principles, we are also including patients with relapsed Hodgkin lymphoma (HL). The surrounding reactive cells around Hodgkin Reed Sternberg (HRS) cells are now not thought to be bystander cells and they appear to provide important survival signals to HRS cells.
* Campath-1 antigen (CD52) is one such promising target that is highly expressed in most of these infiltrating cells and on most DLBCL although not on HRS cells specifically. Anti-CD52 antibodies may have therapeutic value by depleting reactive B and T cells, and monocytes from the microenvironment.
* The dose of alemtuzumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH) is 30 mg intravenous (IV), as determined by a prior study done in patients with untreated peripheral T-cell lymphoma. The main toxicities of this combination are myelosuppression and opportunistic infections.
* An important component of this study will be to obtain tumor tissue for gene expression profiling and to assess microenvironment signatures and look at other molecular signatures and targets before treatment and in patients who progress and ultimately correlate response and outcome with these various end-points.
Objectives:
- Assess response, progression free survival (PFS) and overall survival (OS) in relapsed/refractory DLBCL and Hodgkin Lymphoma.
Eligibility:
* Previously treated or refractory classical large B-cell lymphomas, Grey-zone lymphoma and Hodgkin lymphoma, including Lymphocyte predominant Hodgkin Lymphoma (LPHL).
* Age greater than or equal to 18 years with adequate organ functions.
* Human immunodeficiency virus (HIV) negative and no active central nervous system (CNS) lymphoma.
Study Design:
* Patients will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
* Tumor biopsies will be done before treatment, after 1 cycle of therapy and at relapse.
* It is anticipated that up to 10-15 patients per year may be enrolled onto this trial. Thus, accrual of up to 52 patients is expected to require approximately 4-5 years.
|
* INCLUSION CRITERIA:
1. Previously treated or refractory classical large B-cell lymphomas, Grey-zone lymphoma and Hodgkin lymphoma, including Lymphocyte predominant Hodgkin Lymphoma (LPHL).
2. Confirmed pathological diagnosis by the Laboratory of Pathology, National Cancer Institute (NCI).
3. Age greater than or equal to 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance 0-2
5. Laboratory tests: absolute neutrophil count (ANC) greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3). Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal (ULN). Total bilirubin \< 2.0 mg/dl except \< 5mg/dL in patients with Gilbert's (as defined as \> 80% unconjugated hyperbilirubinemia without other known cause); unless impairment due to organ involvement by lymphoma.
EXCLUSION CRITERIA:
1. Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If echocardiogram (ECHO) is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%.
2. Human immunodeficiency virus (HIV) positive, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression.
3. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and two years beyond treatment completion.
4. Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotrophin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without childbearing potential.
5. Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion.
6. Invasive or active malignancy in past 2 years.
7. Serious concomitant medical illnesses that would jeopardize the patient s ability to receive the regimen with reasonable safety.
8. Active central nervous system (CNS) lymphoma. These patients have a poor prognosis and because they frequently develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
9. Systemic cytotoxic therapy within 3 weeks of treatment.
|
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] |
NCT00254189
|
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
|
To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
|
Inclusion Criteria:
* Healthy women of legal age of consent who are willing to use a combination OC.
* Subjects must be under the age of 36 at the time of enrollment (visit 3).
* Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.
Other inclusions apply.
Exclusion Criteria:
A history or the presence of any of the following will prevent enrollment:
* Thrombophlebitis, thrombosis, or thromboembolic disorders.
* Deep vein thrombosis.
* Pulmonary embolism.
Other exclusions apply.
|
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|
NCT04298918
|
A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
|
This two-part study is composed of two stages: a Phase Ib stage consisting of a dose-escalation phase and an expansion phase; and a Phase II, randomized, placebo-controlled, double-blind, multicenter stage. The Phase Ib stage will assess the safety and tolerability, determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), and evaluate the preliminary efficacy of trastuzumab emtansine in combination with venetoclax in participants with previously treated human epidermal growth factor receptor 2 (HER2) positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). Additional patients may be enrolled in an expansion phase to evaluate the safety, tolerability, and efficacy of trastuzumab emtansine in combination with venetoclax at RP2D in patients with previously treated HER2-positive LABC or MBC who have previously received either trastuzumab emtansine or trastuzumab deruxtecan (DS-8201a). The Phase II randomized stage will evaluate the safety, efficacy, tolerability, and pharmacokinetics of trastuzumab emtansine in combination with venetoclax at RP2D compared with trastuzumab emtansine plus placebo in participants with previously treated HER2-positive LABC or MBC who have not received prior trastuzumab emtansine therapy, either alone or in combination with other anti-cancer therapies.
|
Inclusion Criteria
* Histologically or cytologically confirmed invasive metastatic breast cancer (MBC) or locally advanced breast cancer (LABC) that is incurable, unresectable, and previously treated with multimodality therapy
* Measurable disease that is evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Willing to provide tumor biopsy sample at the time of screening
* Local histological or cytological confirmation of estrogen receptor (ER) and/or progesterone receptor status as defined by using immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists criteria
* Percentage of ER and/or progesterone receptor positivity, if available
* Willing to provide blood samples at the time of screening, on-study, and at progression for exploratory research on biomarkers
* HER2-positive BC as defined by an IHC score of 3+ or gene amplified by in situ hybridization (ISH) as defined by a ratio of \>/= 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies
* Adequate hematologic and end-organ function
* Screening left ventricular ejection fraction (LVEF) \>/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan
* Negative HIV test, hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 7 months after the last dose of trastuzumab emtansine
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm during the treatment period and for at least 30 days after the last dose of venetoclax or 7 months after the last dose of trastuzumab emtansine
Inclusion Criteria for Expansion Phase Only
In addition to the general inclusion criteria, participants in the expansion phase must also meet the following criteria for study entry:
* Trastuzumab emtansine experienced cohort: Disease progression during or after trastuzumab emtasine in the advanced/metastatic setting or disease recurrence in the neoadjuvant/adjuvant setting; At least 50% of participants in the expansion cohort must have a tumor that is Bcl-2 high (defined as \>50% of tumor cells stained with an intensity of immunohistochemistry (IHC) 2+ or 3+)
* Trastuzumab deruxtacan (DS-8201a) experienced cohort: Disease progression during or after trastuzumab deruxtecan in the advanced/metastatic setting; Prior trastuzumab emtansine in any setting is allowed; At least 50% of participants in the expansion cohort must have a tumor that is Bcl-2 high
Exclusion criteria
* Receipt of any anticancer drug/biologic or investigational treatment 21 days prior to Cycle 1, Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1, Day 1
* Radiation therapy within 2 weeks prior to Cycle 1, Day 1
* History of exposure to the following cumulative doses of anthracyclines as specified: Doxorubicin \>500 mg/m2; Liposomal doxorubicin \>500 mg/m2; Epirubucin \>720 mg/m2; Mitoxantrone \>120 mg/m2; Idarubicin \>90 mg/m2. If another anthracycline or more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
* History of other malignancy within the previous 5 years
* Cardiopulmonary dysfunction
* Current severe, uncontrolled systemic disease
* Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis, or active infection with HBV or HCV)
* Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
* Known HIV infection or human T-cell leukemia virus 1 infection
* Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \> 2 weeks prior to randomization
* Known central nervous system (CNS) disease
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
* Current Grade \>/= 3 peripheral neuropathy
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, excipients of any drugs formulated in polysorbate 80 or 20 or fusion proteins
* Prior allogeneic stem cell or solid organ transplantation
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the last dose of venetoclax or 7 months after the last dose of trastuzumab emtansine after the final dose of study treatment, whichever is later
* Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before anticipated first dose of study drug until the last dose of study drug
* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* History of active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) requiring specific medication in the 12 months prior to randomization, or active and uncontrolled bowel inflammation (e.g., diverticulitis) at time of randomization
* Inability or unwillingness to swallow a large number of tablets
* Known hypersensitivity to venetoclax or trastuzumab emtansine or to any of their excipients
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Other medical or psychiatric conditions that, in the opinion of the investigator, may interfere with the patient's participation in the study
* Blood transfusions if performed within 2 weeks prior to screening
Exclusion Criteria for Randomized Phase II Stage
In addition to the general exclusion criteria, participants in the randomized Phase II stage who meet the following criteria will be excluded:
* Prior treatment with trastuzumab emtansine in any setting (neoadjuvant/adjuvant or advanced/metastatic setting)
* Prior treatment with venetoclax in any setting
* Prior treatment with anti-HER2 antibody drug conjugates (e.g. trastuzumab deruxtecan \[DS-8201a\]), margetuximab, pyrotinib, or tucatinib)
|
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|
NCT03849547
|
Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects
|
This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.
|
Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.
CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.
|
Inclusion Criteria:
* At least one ankle sprain history
* At least 2 times of sprain and feeling unstable
* Diagnosed as functional ankle instability
* Full recovered from injury
* Cumberland Ankle Instability Tool\<24
* Ankle Instability Instrument \>5 yes
* Identification of Functional Ankle Instability \>11
Exclusion Criteria:
* Diagnosis as mechanical instability
* Neurological deficits
* Lower extremity injury within the past 6 wk
* History of lower-extremity surgery
* Other conditions known to affect balance
|
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] |
NCT01852305
|
Obstructive Sleep Apnea in Bariatric Surgical Patients
|
Purpose:
The purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea.
Hypotheses:
Compared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.
To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two groups:
The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups
* sleep study group (group 1) or
* oximetry group (group 2).
|
The potential patients will be screened by the STOP-Bang questionnaire. Those with a score ≥4 will be randomized into Sleep Study group or Oximetry group. The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Depending on the sleep study results and medical history, a decision will be made regarding therapeutic options. If the patient has severe sleep apnea (AHI\>30) or moderate sleep apnea (AHI\>15 to \<30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI\>5 to \<15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI\>10 events/hour will be referred to the sleep medicine specialist. Since the patients with ODI\>10 had a high probability 69%) to have moderate and severe OSA. A split- night PSG will be employed to confirm OSA diagnosis and to titrate CPAP with in patients with ODI\>10. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Compared to Sleep Study group, only one night instead of two nights of sleep studies is needed in patients with ODI\>10 events/hour. The patients with ODI ≤ 10 events/h will undergo surgery with routine care plus sleep apnea perioperative precautions.
|
Inclusion/Exclusion criteria: The patients who meet the following criteria will be recruited.
* Patients undergoing bariatric surgery with American Society of Anaesthesiologists (ASA) score 1-4 will be approached.
* The patients with any of the following conditions will be excluded:
1. Unable or not willing to give an informed consent;
2. Potential problems with EEG;
3. Patients with diagnosed OSA.
4. Patients having sleep study before.
5. Age: \< 18 years having sleep study before. -
|
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] |
NCT06320119
|
Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study
|
To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.
The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).
This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed.
|
Inclusion Criteria:
1. Male and female patients aged ≥18 years;
2. Patients with a documented diagnosis of mild/moderate asthma, according to GINA, for at least 6 months before visit 1;
3. Patients on LABA/ICS chronic inhaled treatment (\> 4 weeks before visit 1);
4. ACT values \<20 points
5. No smoking patients, or former smokers (at least 1 year since quitting smoking, and no more than 10 pack/year, according the WHO definition);
6. Patients able to set up a personal outcome according to the protocol instruction, and willing to improve their personal outcome;
7. Patients able to understand written and spoken Italian;
8. Patients who give their informed consent to participate in the study.
Exclusion Criteria:
1. Patients treated with oral corticosteroids (OCS) and/or biological for severe refractory asthma;
2. Patients treated with OCS for any other chronic disease;
3. Subjects with current evidence of chronic obstructive pulmonary disease (COPD), pneumonia, active tuberculosis, active lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or respiratory abnormalities other than asthma;
4. Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
5. Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
|
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] |
|
NCT01313624
|
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
|
The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.
|
Inclusion Criteria:
* Male/Female 18 years or older with non-CF bronchiectasis
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements
Exclusion Criteria:
* History of CF
* Hospitalized within 14 days prior to joining the study
* Previous exposure to AZLI
* Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
* Must have met liver and kidney function requirements
* Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
* Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
* Other serious medical conditions.
|
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] |
|
NCT01766752
|
Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management
|
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward
|
Inclusion Criteria:
* Informed consent obtained after being advised of the nature of the study
* Male or female aged 18 - 90 years (both inclusive)
* Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four
Exclusion Criteria:
* Impaired renal function (serum creatinine ≥3.0mg/dL)
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
* Pregnancy
* Any mental condition rendering the patient incapable of giving his consent
* Terminally ill patients
* Participation in a trial within 3 months prior to this trial
* Known or suspected allergy to insulin
|
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] |
|
NCT04404023
|
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
|
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.
|
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.
|
Inclusion Criteria:
* Subjects with age between 20 to 65 years old (inclusive).
* Subjects who are able and willing to provide the informed consent.
* Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
* Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities
Exclusion Criteria:
• The investigator considered that the subjects were not suitable to participate in this study.
|
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] |
NCT02770534
|
Evaluating Thromboelastography (TEG) and ETP in Sickle Adults
|
The primary aim of this study is to investigate the reported enhanced coagulation status (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests; thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results to healthy race matched controls to ascertain if there is a significant difference. Race matching of the control participants is being carried out due to the well reported racial differences in coagulation parameters that exist in healthy individuals. The investigators are aiming to study the clotting state in sickle patients on regular transfusion therapy and those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the condition. The study will assess the reported prothrombotic state using TEG and ETP.
|
Sickel cell disease (SCD) is the most common inherited red cell disorder worldwide, the genetic mutation in SCD results in the production of abnormal haemoglobin (HbS). This leads to anaemia and unpredictable painful episodes referred to as a sickle cell crisis. Sickle cell crises result in significant chronic health problems including stroke, kidney failure, breathing problems, leg ulcers and chronic and ultimately leads to a decrease in life expectancy.
The method by which sickling results in the above issues is recognised as very complex and it is thought these patients may have enhanced blood clotting which may play a role in the complications they get. Sickle cell patients are reported to have higher risk of blood clots such as deep vein thrombosis.
The primary aim in this study is to investigate the reported enhanced coagulation status in sickle cell adult sickle cell patients using 2 laboratory tests, thromboelastography (TEG) and Endogenous Thrombin Potential (ETP) , the investigators will compare the results in sickle participants to healthy race matched control participants to show if there is a significant difference. The investigators also aim to study the coagulation status in sickle participants on a variety of treatments such as transfusion and hydroxycarbamide, both treatments offered to sickle patients. Many trials have shown the benefits of both transfusions and hydroxycarbamide in SCD, they reduce the risk of stroke and frequency with which patients get crises.
To the best of teh investigators knowledge this will be the first study evaluating the clinical utility of TEG and ETP in adult patients with SCD
The trial will be conducted in compliance with the principles of the Declaration of Helsinki and the principles of Good Clinical Practice. It has been submitted for approval to the London NHS Research Ethics Committee.
Trial Design \& Flowchart This is a cross sectional case controlled clinical study in patients with sickle cell disease. Control participants will be race and age matched participants without sickle cell disease. Written informed consent will be obtained from all participants. The samples will be taken as part of the usual clinic or inpatient procedure with 10 extra millilitres of blood venesected at a phlebotomist or nurse scheduled to venesect participants as part of their usual medical care. Healthy controls will be asked to provide a 10ml blood sample which will be taken by a qualified member of staff. The investigators are aiming to collect samples from 100 patients in total and 20 healthy controls for comparison
|
Inclusion Criteria: Patient participants must be over 16 years of age with sickle disease HbSS or HbSb0, SCD genotype which must have been previously confirmed by high performance liquid chromatography with results on GSTT trust electronic patient record (EPR), all participants must be able to give written consent.
Exclusion Criteria:
currently pregnant have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease on anticoagulant therapy, have severe liver disease with liver transaminases greater than 5x upper limit of normal.
Healthy control paticipants will be race and age matched to the patient cohort and must also not be currently pregnant, have a known diagnosis of an inherited bleeding disorder such as e.g. von willebrand disease. The investigators will also exclude healthy participants on anticoagulant therapy as well as those with severe liver disease and liver transaminases greater than 5x upper limit of normal.
|
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] |
NCT03970525
|
Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
|
This study will compare two methods of vacuum (peristaltic or venturi) commonly used during the removal of a femtosecond treated cataract. The investigators will observe which method uses less energy, is gentler on the eye, reduces corneal swelling and if the vision recovers faster with one method compared to the other.
|
This is an open, prospective, randomized study to evaluate efficiency and outcomes of femtosecond laser cataract surgery with phacoemulsification performed with one of two standard vacuum systems.
It is estimated that the duration of study participation will be up to 24 months.
There will be randomization to 1 of 2 groups. Both eyes of each subject will be enrolled in the study. The first eye will be randomized to either the Venturi or peristaltic-based vacuum pump. The second eye will then receive the other type of vacuum pump for that procedure.
Study Phases:
Pre-operative Visit Procedure Post-operative Follow up The subject will be seen 1 day, 5-10 days, and 90 days following the procedure.
Surgical Procedure
* The cataract removal procedure will be performed under sterile technique and according to standard procedures. The femtosecond laser treatment will be followed by phacoemulsification removal of the cataract and implantation of an intraocular lens.
* Peri-operatively, subjects will be treated with a regimen of antibiotic, steroid and nonsteroidal anti-inflammatory eye drops per standard of care.
* All surgeries will be performed by the same experienced surgeon/principal investigator using the Catalys® SYSTEM femtosecond laser platform and WHITESTAR SIGNATURE® PRO Phacoemulsification System.
* Phacoemulsification Settings:
* For Venturi pump: 600 mmHg vacuum
* For Peristaltic-based pump: 600 mmHg vacuum and aspiration flow of 50 mL/min
* Other settings: ultrasound energy application parameters will be the same for the two groups
Study Procedures
* The study will include routine cataract pre-operative testing with Nidek OPD, Galilei G4, and IOLMaster, and repeated at the post-op visits. An endothelial cell count of the cornea will be performed at the pre-operative visit and at the 90 day follow up visit.
* Subjects will be randomized to phacoemulsification settings of Venturi vacuum of 600 mmHg or peristaltic vacuum of 600 mmHg and aspiration flow of 50 mL/min. All other phacoemulsification settings will be identical. The laser settings will be based on the grade of cataract only and will not be altered for this study.
* The phacoemulsification time, energy Ellips FX EFX, and average phacoemulsification energy will be recorded. The laser procedure time and total procedure time will be recorded. Complications will be recorded. Additional patient characteristics will also be recorded.
* Pre-Operative Visit:
* Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
* Complete eye examination (standard of care)
* Brightness Acuity Test (BAT) (standard of care)
* Review and confirm eligibility (research)
* Informed Consent for study (research)
* Randomization (research)
* Endothelial Cell Count (research)
* Medical Record Review (research)
* Surgical Procedure (Day 0) (standard of care)
* Medical Record Review (research)
* Adverse Event Assessment (research)
* Post-operative Visit 1 (Day 1):
* Eye exam to include uncorrected and pinhole visual acuity, Intraocular pressure (IOP) and slit-lamp exam (standard of care)
* Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
* Medical Record Review (research)
* Adverse Event Assessment (research)
* Post-operative Visit 2 (Day 5-10):
* Eye exam to include uncorrected and best corrected visual acuity, Pinhole visual acuity, IOP, and slit-lamp exam (standard of care)
* Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
* Medical Record Review (research)
* Adverse Event Assessment (research)
* Post-operative Visit 3 (Day 60-90 days):
* Eye exam to include uncorrected and best corrected visual acuity, Pinhole visual acuity, IOP, and slit-lamp exam (research)
* Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (research)
* Endothelial Cell Count (research)
* Medical Record Review (research)
* Adverse Event Assessment (research)
* Unscheduled Visit:
* A medical record review and an adverse event assessment will be performed at any unscheduled visit.
* Additional evaluations will be completed at the discretion of the Principal Investigator based on the subject's presenting complaint.
Statistical Analysis
Sample Size and Power:
· The study aims to enroll 250 study subjects for a total of 500 eyes with bilateral grade 1-3 nuclear sclerotic cataracts who will be undergoing planned femtosecond laser cataract surgery.
Statistical Methods:
· The statistical analysis plan will include use of descriptive statistics and statistical tests including unpaired t-tests.
|
Inclusion Criteria:
* Males and females ages 22-90 yrs
* Diagnosis of senile cataract
* Grade 1-3 Nuclear sclerosis
* Cataract removal required for both eyes
* Scheduled for femtosecond laser cataract surgery at Mercy Surgery Center or Mercy National Eye Center in Springfield, MO
Exclusion Criteria:
* Diagnosis of Fuch's dystrophy
* Presence of cornea scars
* Planned laser astigmatism treatment
* Diagnosis of pseudoexfoliation
* History of direct ocular trauma with secondary iris or lens trauma
* Presence of grade 4 cataracts
* History of previous eye surgery
* Severe glaucoma or retina disease impairing vision
* Planned surgery that is will be combined with other surgical eye procedures
|
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] |
NCT01178034
|
Early Identification of Warfarin Maintenance Dosage
|
Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.
|
The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.
|
Inclusion Criteria:
* Age \>18 years
* Indication to warfarin with INR between 2.0 and 3.0
Exclusion Criteria:
* Pregnancy
* Drug interactions
* Basal INR \> 1.2
|
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] |
NCT01652222
|
Experimental Study to Validate the "Therapeutic Game" CONEM-BETA
|
The purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia.
|
Alzheimer's disease (AD) is clinically diagnosed based on memory and cognitive deterioration, and the loss of other functional abilities. Nevertheless, for the caregivers and the patients themselves, the psychological and behavioral symptoms of dementia (PBSD) are specially relevant aspects.
These PBSD are a source of stress for the caregiver. PBSD treatment starts with non-pharmacological treatment, but if the symptomatology is moderate to severe, then pharmacological treatments are indicated on top of the non-pharmacological ones. The symptoms that better respond to non-pharmacological interventions are depression and mild apathy, wanderings and repetitive behaviors.
Once dementia progresses, the ability to interact at cognitive and emotional levels are reduced, and then, alternative approaches are needed. In this circumstance, it has been postulated that the caregivers should not try to bring -patients with AD back to the objective reality, but that they should rather empathize with them and establish an emotional connection. This is a complex process, and requires intervention tools that favor this connection and improve the subjective welfare of the caregivers of persons with dementia.
The current study is based on a previous experience in implementing the Montessori method at SARquavitae nursing homes and daycare centers. The "therapeutic game" called CONEM-BETA contains a subset of these activities that have been adapted from the original texts from the Myers Research Institute. We aim to prove that CONEM-BETA may have also socio-emotional benefits for the caregivers when they systematically use them at home with their AD relatives. These potential benefits will be assessed by using validated questionnaires that measure changes in subjective welfare, anxiety and depression, coping strategy, overload level and perceived social support.
|
Inclusion Criteria Family Caregivers:
* to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia
* show interest in participating
* Sign informed consent
Inclusion Criteria Alzheimer's or dementia person:
* to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit
* GDS 5-6 and a minimental equal or lower than 12.
* to preserve a verbal comprehension of basic instructions
* to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities.
Exclusion Criteria Caregivers:
* to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member
* Unavailability
* to participate in other socio-educative interventions during the study period.
* Any other situation that makes the caregiver as not suitable according to investigator's criteria
Exclusion Criteria Alzheimer's or dementia person:
* Do not have the sensorial or motor capacities needed for the interaction.
* Serious impairment of the verbal comprehension
* Disabling health conditions
|
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] |
NCT05835427
|
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
|
Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.
|
Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.
|
Inclusion Criteria
* Volunteer
* Being diagnosed with fibromyalgia Exclusion Criteria
* Known neurological disorder
* Serious orthopedic disorders that will prevent him from exercising
* Cognitive impairment
* Using regular NSAIDs
* Being malnourished and malnourished
|
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] |
NCT01708928
|
Feasibility Study: Lifting and Tightening Neck Skin in Patients
|
Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.
|
This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.
|
Inclusion Criteria:
* Male or female, aged 30 to 65 years
* Subject in good health
* Body Mass index of less than 30
* Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
* Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
* Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
* Willingness and ability to comply with protocol requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
* Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control
Exclusion Criteria:
* Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
* Has an active systemic or local skin disease that may alter wound healing
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
* Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy
|
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] |
NCT03373890
|
Cerebral Palsy: Short-burst Interval Training
|
This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.
|
Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.
This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.
|
Inclusion Criteria:
* Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III
Exclusion Criteria:
* undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior
|
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] |
NCT05626608
|
Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™
|
Many patients have benefited from the implantation of brain stimulation electrodes for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations. This technique has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in the field of deep brain stimulation (DBS) could improve the benefit of this therapeutic tool. therapeutic tool. While using directional electrodes, it remains possible to program the stimulation in conventional ring mode.
|
Idiopathic Parkinson's disease represents the second degenerative disease after Alzheimer's disease, with progressive motor and non-motor symptoms, affecting the dopaminergic system (at the origin of the cardinal symptoms) and the other systems, cholinergic, noradrenergic and serotonergic (responsible for the dopa-resistant symptoms). The functional repercussions are important and a source of handicap in the more advanced phases of the disease. Many patients have benefited from the implantation of deep brain stimulation (DBS) electrodes, associated with dopaminergic replacement therapy, for the treatment of various motor signs of Parkinson's disease in the phase of motor fluctuations.
It is an advanced symptomatic therapy that does not prevent the progression of the disease. DBS is intended for Parkinson's patients in the phase of motor fluctuations. The aim of this treatment is to complement the therapeutic effect of pharmacological treatments that patients will have to continue as well as to compensate for certain effects induced by the drugs. The effectiveness of DBS therapy may decrease over time, especially in the context of a progressive pathology, and requires a change of batteries after several years (4 to 15 years, depending on the type of neurostimulator, non-rechargeable or rechargeable).
Beyond these constraints, this adaptable therapy has significantly improved the motor symptomatology of Parkinson's disease and the dyskinesias induced by pharmacological treatment. Technological advances in DBS could improve the therapeutic benefit of this technique and limit its side effects (dysarthria, hypophonia, oculomotor disorders, muscular contractions induced by the diffusion of the current), by using different modalities of brain stimulation. Implantation of Boston Scientific Cartesia™ directional electrodes for Parkinson's patients who are candidates for deep brain stimulation of the subthalamic nucleus (STN) would allow reorientation and variation of the volume of the stimulated structure, which could improve therapeutic performance, by stimulating key target volumes for obtaining the clinical effect, limiting side effects by diffusion of the current on neighboring structures. While using directional electrodes, it remains possible to program the stimulation in ring mode, conventional stimulation modality, in monopolar or bipolar.
The hypothesis is that the efficacy of DBS in directional mode will be more effective on the motor signs of Parkinson's disease compared to omnidirectional stimulation and bipolar mode, with a better tolerance profile (fewer side effects).
|
Inclusion Criteria:
* A diagnosis of bilateral idiopathic Parkinson's disease according to the British Brain Bank criteria (bradykinesia and rigidity or resting tremor)
* Parkinson's disease that has been evolving for several years (\>4 years)
* Persistence of a good sensitivity to L-Dopa, essential criterion in the selection, except for tremor (Improvement in Parkinson's disease symptoms of at least 30% measured on the UPDRS, section III)
* A UPDRS (Unified Parkinson Disease Rating Scale) part III motor score \>25 under MEDOFF conditions
* Patient with tremor not controlled́ by treatment and which represents the bulk of the symptomatology. Patient will require stable treatment throughout the study.
* Patient with major motor fluctuations with prolonged blocking and/or dyskinesias
* Be a candidate for PCS and bilateral electrode implantation in the STN.
* A Hoehn and Yahr scale score ≤ 2.5 under best MED-ON conditions
* A UPDRS section II activities of daily living score \> 6
* Patient without comorbidities that do not allow the patient to undergo general anesthesia general anesthesia or a neurosurgical procedure or interfering with the follow-up required by the protocol
Exclusion Criteria:
* Characterized depressive episode (BDI\>25) (depressive episodes prior to inclusion and completed at the time of inclusion will not be considered as a non-inclusion criterion)
* Psychotic episodes (Brief Psychiatric Rating Scale, BPRS) (mild hallucinations or acute psychotic episodes preceding the screening and inclusion period and completed at the time of inclusion will not be considered as non-inclusion criteria)
* Dementia (Mattis DRS score \<125)
* Contraindication to general anesthesia
* Absolute MRI contraindications: Pacemaker or neurosensory stimulator or implantable defibrillator; Cochlear implants; Ocular or cerebral ferromagnetic foreign bodies close to nerve structures
* Relative MRI contraindications: Metallic prostheses, especially orthodontic braces; Patient agitation; Pregnant women; Ventriculoperitoneal neurosurgical shunt valves; Tattoos containing iron particles
* Contraindication revealed by abnormal cerebral MRI (after-effects of stroke, vascular malformations, major cerebral atrophy)
* Serious intercurrent pathology
* Surgical contraindication
* Pregnancy in progress or planned during the study period, Pregnant or breastfeeding women or women in a state of procreation without contraception Women who are pregnant or breastfeeding or in a state of procreation without effective contraception
* Impossibility or refusal of regular follow-up of at least 30 months
* Participation in other interventional research
* Adult protected by law or patient under guardianship or curatorship
* Patient unable to use the remote control and charging system properly or who does not have a person who can assist them in this process
* Failure to obtain written informed consent after a period of reflection
* Not being affiliated to a French social security system or being a beneficiary of such a system
|
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] |
NCT00004231
|
Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.
|
OBJECTIVES:
* Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation and/or interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma.
* Determine the complete response rate in these patients after these treatments.
* Evaluate the prognostic factors in this patient population.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy consisting of cyclophosphamide IV, doxorubicin IV, and teniposide IV over 2 hours on day 1, oral prednisone on days 1-5, vincristine IV and methotrexate IV over 2 hours on day 21, cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22, and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover. Treatment repeats every 42 days for 2 courses. Patients achieving complete response or partial response receive an additional course of induction therapy. Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation.
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation (BMT). Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 3.5 days. At 24 hours following the last dose of busulfan, patients receive cyclophosphamide IV over 2 hours daily for 2 days. Patients receive allogeneic bone marrow infusion on day 0.
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell (PBSC) transplantation. Patients undergo PBSC mobilization following completion of cyclophosphamide, doxorubicin, and teniposide portion of induction therapy of course 3. Patients receive cytokines subcutaneously (SQ) beginning 2 days following chemotherapy and continuing through PBSC collection. If insufficient stem cells are collected and there is negative bone marrow involvement, patients undergo bone marrow harvest. Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT. Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim (G-CSF) SQ beginning on day 0 and continuing until blood counts recover. Following blood count recovery, patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks. Treatment repeats every 8 weeks for 2 courses.
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT. Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy.
Patients are followed at 30 days post transplant, every 3 months for 1 year, and then at least every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study over 3 years.
|
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma
* CD5 positive OR
* Evidence of bcl-1 oncogene overexpression
* Measurable or evaluable disease with at least one of the following:
* Clear cut radiographic findings
* Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan
* Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only
* Enlarged liver with proof of lymphoma by biopsy
* CNS involvement allowed
* Fully HLA matched donor for allogeneic transplantation
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 3.0 mg/dL
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No significant cardiac disease
Other:
* No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other medical problems that would preclude study
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* Prior chemotherapy, including doxorubicin, allowed
Endocrine therapy:
* See Disease Characteristics
* Prior steroids allowed
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed excluding the indicator lesions
Surgery:
* Not specified
|
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] |
NCT01744574
|
Sex Differences, Hormones & Smoking Cessation
|
Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.
|
Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).
Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.
|
Inclusion Criteria:
* Male 18 to 60 years old
* Female 18 to 50 years old
* Self-report regular smoking
* Motivated to quit smoking
* In stable physical/mental health
* Self report of regular menstrual cycles (female only)
* English fluency
* Understand the study procedures and able to provide informed consent
* Ability to participate fully in research elements for the duration of the trial.
Exclusion Criteria:
* Current or recent (\< 3 months) breastfeeding (females only)
* Current or planned pregnancy within the next three months (females only)
* Conditions contraindicated to progesterone treatment.
|
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] |
NCT00940797
|
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
|
The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.
|
Inclusion Criteria:
* Ages eligible for study: 40 to 60 years
* With type 2 diabetes evolution \< 5 years without pharmacological treatment 1 month prior to the screening
* Fasting glucose = 130-200 mg/dL
* AIc of 7% to 9%
* Blood pressure \< 140/80 mmHg
* Ability to communicate and meet the requirements of the study
* Signed Written Informed Consent before to conducting any study
* Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2
Exclusion Criteria:
* Suspected or confirmed pregnancy
* Nursing
* Inability to secure the non-pregnant during the study duration
* Hypersensitivity to any biguanides
* Use of an investigational drug within 30 days prior to the screening
* Liver failure, heart failure, kidney failure or thyroid disease
* Periods of acute or chronic diarrhea or vomiting
* Chronic hepatic disease
* Total Cholesterol \> 300 mg/dL
* Triglycerides \> 400 mg/dL
|
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|
NCT00250042
|
A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec
|
1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease.
1.2 To determine the toxicity associated with this therapy.
|
* Chronic myelogenous leukemia (CML) results from the clonal expansion of immature myeloid cells with the t (9,22) (Ph) translocation, that encodes the constitutively active tyrosine kinase oncogene, bcr/abl. Patients with chronic phase CML are currently being treated with either hemopoetic stem cell transplantation (HSCT), or with the recently approved tyrosine kinase inhibitor, imatinib. Previous data, using interferon in patients with CML, has shown that patients who do not achieve a major cytogenetic response (defined as \>35% Ph+) have a shortened survival. These patients are often considered for HSCT. However, due to constraints of age, suitable donor, and patient choice, only a minority of patients will undergo this potentially curative procedure.
* The aim of this study is to create a uniform approach to the treatment of CML in New Mexico, with an aim of achieving complete cytogenetic response as the primary goal. A graded approach will be taken, starting out with the standard treatment (imatinib 400 mg per day), and then in patients identified as poor responders an imatinib, and arsenic combination will be offered to patients. It is hoped to find a complete cytogenetic response that exceeds the \~20% response with gleevec 800mg per day.
|
Inclusion criteria:
* All patients, 18 years of age or older, with a diagnosis of CML.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have an ECOG performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
* Patients with CML in chronic phase on gleevec as first line therapy who fulfill the following criteria:
* Failure to achieve a complete hematologic response (CHR) after 3 months of therapy (hematologic resistance)
* Failure to achieve a complete cytogenetic response (CGCR) after \> 9 months of therapy.
* Cytogenetic relapse, defined as an increase in the Ph+ cells by at least 30%.
* Hematologic relapse defined as the appearance of any of the following, confirmed by a second determination \> 1 month later:
* WBC count \>20, 000,
* Platelet count \>600,000,
* Progressive splenomegaly \> 5 cm below the left intercostals margin,
* \>5% myelocytes and/or metamyelocytes in the peripheral blood,
* Blasts or promyelocytes in the peripheral blood
Exclusion Criteria:
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
|
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] |
NCT04948216
|
Management and Healthcare Utilization of Patients With Chronic Airway Disease During the COVID-19 Epidemic
|
During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the influencing factors during the COVID-19 epidemic.
|
During the COVID-19 epidemic, the medical treatment, disease status, and medication status of patients with chronic airway disease have not been studied. The purpose of this study is to investigate the management and healthcare utilization of patients with chronic airway disease and the relevant factors during the COVID-19 epidemic. Using cross-sectional research methods, telephone interviews and questionnaire surveys were used to investigate the management and healthcare utilization of patients with chronic airway disease （COPD and asthma）during the COVID-19 epidemic.
|
Inclusion Criteria:
* COPD patients and asthma patients in the Chronic Airway Disease Database in Peking University Third Hospital.
Exclusion Criteria:
* Refusal to participate in this study; cognitive dysfunction.
|
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] |
NCT04101721
|
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
|
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
|
Key Inclusion Criteria:
* Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g
* Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as:
* Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
* Zone II Stage 2 plus or 3 plus, or
* Aggressive posterior retinopathy of prematurity (AP-ROP)
Key Exclusion Criteria:
* Known or suspected chromosomal abnormality, genetic disorder, or syndrome
* Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
* Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure)
* Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist
* Presence of active ocular infection within 5 days of the first treatment
* Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5)
* ROP involving only Zone III
NOTE: Other protocol defined inclusion/exclusion criteria apply.
|
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] |
|
NCT06483659
|
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
|
This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.
|
152 women will be randomized into one of two arms; participants in the first arm (Intervention) will receive oxytocin infusion, 30 IU in 500 ml IV infusion at a rate of 5 IU/h (83.33 ml/h), the second arm (Control) will receive 0.9% normal saline 500 ml IV infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm.
The investigational research pharmacy will perform randomization; participants will be randomized in a 1:1 ratio to receive either Oxytocin or Placebo (0.9% normal saline). Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study. Participants, surgeons, clinicians, and raters will be blinded with respect to treatment assignments. The investigational pharmacy will prepare the study drug based on the randomization assignment received.
The investigators will identify patients who have been scheduled for an elective, minimally invasive hysterectomy at Brigham and Women's Hospital by reviewing the operating room booking schedule.
Patients will be pre-screened for inclusion and exclusion criteria. Subsequently, they will be recruited for participation in this study by phone/ MGB Zoom and will be consented by electronic consent.
Once the patient is recruited and consented, they will be randomized for either the intervention group (oxytocin IV infusion) or the control group (0.9% normal saline IV infusion).
An email will be sent to those who consent with a link to the secure REDCap system containing a set of baseline questionnaires to assess relevant medical and surgical history, pre-operative pain, analgesic medication use, and psychosocial variables.
Both groups (intervention and control) will be treated pre-operatively with the following Early Recovery After Surgery (ERAS) medications, as per usual institutional practice:
* acetaminophen 1,000 mg orally
* celecoxib 400 mg orally The Investigational Research Pharmacy will be informed and prepare blinded infusions for perioperative administration (oxytocin or placebo).
The primary anesthesiology team will receive either the study medication or placebo in a 500 ml bag labeled as "Oxytocin Study Drug for IV infusion".
A recommended "Intra-Operative Analgesia Management" algorithm will be given to the primary anesthetic team. The recommended algorithm for intra-operative analgesia management will include the following:
* Fentanyl 100 mcg IV for induction.
* Dexamethasone 8 mg IV after induction but prior to skin incision.
* Small, titrated doses of Hydromorphone IV boluses (0.2-0.4 mg) during the operation and before emergence, according to primary team judgment.
* Ketorolac 30 mg IV prior to skin closure, unless otherwise contraindicated.
* Avoidance of other multimodal analgesic agents not included in this protocol to limit confounders.
The infusion will be started after the skin incision and will continue until the infusion is completed or the post-anesthesia care unit (PACU) criteria are met, whichever occurs first.
Other aspects of each patient's routine clinical care will continue as per standard care at the attending physician's discretion under whom the patient is admitted, regardless of treatment arm status.
In the PACU, a brief postoperative pain questionnaire will be performed, including the Surgical Pain Scales (SPS).
The SPS is a validated scale consisting of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify the unpleasantness of worst pain. This scale has been validated in a number of different types of postoperative pain, including women after gynecologic surgery.
Vital signs, numeric rating scale (NRS) pain scores, and opioid consumption in PACU will be collected from the patient's medical record.
Patients whose surgery was converted to open, estimated blood loss (EBL) \>500 ml, or any other surgical complication that necessitates hospitalization will be excluded from the trial.
For secondary outcomes, including total opioid consumption in 24, 48, and 72 hours and pain scores at postoperative day (POD)1, 2, and 3, an online survey will be done at POD1, 2, and 3, and follow-up will continue until 3 months post-op.
|
Inclusion Criteria:
* Ages 18-65 years old
* ASA category 1-3
* Scheduled to undergo minimally invasive hysterectomy
* No documented allergy to oxytocin
Exclusion Criteria:
* American Society of Anesthesiologists (ASA) group 4 or greater
* Age \>65 years old
* Additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and/or ablation of endometriosis.
* Active opioid prescription of the equivalent of oxycodone \>10 mg /day
* Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone)
* Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone.
* Epidural/Regional anesthesia for intra-operative or post-operative pain.
* Inability to understand the questionnaires
* Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL \>500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications
|
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NCT06667102
|
Strategic and Interactive Signing Instruction
|
Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Growing evidence demonstrates that more complex sign language skills positively predict literacy skills and may lead to improved health outcomes. This project involves new applications of theory-driven strategic and interactive approaches in an intervention program to target sign language development in deaf children between 5 and 8 years old who are at high risk of language delays.
|
Deaf children who reach the age of eight without a foundation in language have longitudinal struggles in the areas of receptive and expressive language, working memory, executive functions, literacy and academic skills, and behavioral, mental, social, and physical health. The lack of intervention programs targeting sign language competencies during the critical period of development is a critical barrier to making progress in preventing or addressing language delays in deaf children. Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Cross-linguistic transfers between oral and writing skills within and across first and second languages are well-established in the literature. Taking these factors into account in addition to growing evidence that sign language skills positively predict literacy skills and may lead to improved health outcomes, it is critical to systematically support deaf children's sign language competences as early as possible. To address the identified critical barrier to progress, these are the aims of this project: (1) develop Strategic and Interactive Signing Instruction (SISI), an intervention program to target the development of sign language skills in deaf children aged 5-8; (2) refine SISI training and implementation protocols; and (3) test the efficacy of SISI in improving deaf children's sign language skills. First, a SISI manual will be developed for standardization and consistency in training, implementation, and fidelity. The SISI manual will include: (a) descriptions of strategic and interactive approaches and their new applications to develop sign language skills, (b) SISI intervention protocols, (c) SISI fidelity checklist, and (d) list of sign language skills that are targeted in SISI. Second, an experimental study will be conducted to assess the extent of training and support required from teachers to become proficient in SISI implementation. Meanwhile, child progress in meeting their target sign language skills will be monitored formatively, and modifications may be made in an iterative design fashion to strengthen the intervention design. Third, another experimental study will be applied to assess the efficacy of SISI in improving deaf children's sign language skills. Findings will provide robust data on the mechanisms of successful training dose, intervention design and fidelity, and data collection protocols in preparation for subsequent R01 application involving a large randomized controlled trial with sufficient statistical power to further strengthen evidence of SISI in improving deaf children's sign language skills along with examinations of cross-linguistic interactions in the written form. This project is innovative in its new applications of theory-driven strategic and interactive approaches to target sign language development in deaf children.
|
Inclusion Criteria:
* Deaf students in prekindergarten to 3rd grade classes
* Teachers of the deaf in prekindergarten to 3rd grade classes
Exclusion Criteria:
* Hearing students, deaf students aged 0-3 or 4th grade and beyond
* Non-teachers of the deaf or teachers of the deaf in 4th grade and beyond
|
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] |
NCT02529514
|
Usage of Baclofen for Sleep Improvement After Cardiac Surgery
|
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.
|
This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery.
The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.
|
Inclusion Criteria:
* Elective cardiac surgery
Exclusion Criteria:
* Haemodynamic instability
* Epilepsy
* Psychotic disturbances
* Acute / Chronic respiratory failure
* Morbid obesity (BMI \> 45 kg/m2)
* Sleep apnea (treated)
* Severe hepatic or renal failure
* Patient refusal
|
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] |
NCT06015750
|
Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia
|
The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).
|
The administration of biological drugs to patients, especially for chronic conditions, carries a risk of eliciting anti-drug antibodies. Neutralizing antibodies can neutralize the clinical benefit of the agent. In postmarketing safety surveillance, some patients treated with asfotase alfa demonstrated an initial response, but subsequently recurrence and progression of disease. Consequently, the FDA requested a study to assess a potential serious risk of immune-mediated loss of effectiveness.
|
Inclusion Criteria:
* Reoccurrence or worsening of rickets for at least the past 3 months in participants who showed an initial efficacy response to asfotase alfa after at least 6 months of continuous treatment and currently receiving asfotase alfa. RSS will be used to determine severity at Baseline.
* Presence of ADAs, with or without NAbs, irrespective of their titers.
* Confirmation by the TMB that both the clinical evidence and immunogenicity-mediated association noted above are present.
* Female participants of childbearing potential and male participants with partners of childbearing potential must follow protocol-specified contraception guidance as described in Section 10.5.
* Participant, or participant's legal guardian, is capable of signing informed consent or assent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent or assent form and in this protocol.
Exclusion Criteria:
* Known history of human immunodeficiency virus (HIV) infection (evidenced by HIV type 1 or type 2 \[HIV 1, HIV 2\] antibody) or hepatitis B or C viral infection.
* Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to Screening.
* Inability of the participant, or the participant's legal guardian, to provide informed consent.
* Pregnant, breastfeeding, or intending to conceive during the course of the study.
* Inability to travel to the clinic for specified visits during the Treatment Period caused by disease per se or logistics (does not apply to external travel restrictions).
* The participant is at risk of reactivation or has an active significant viral infection such as hepatitis B, cytomegalovirus, herpes simplex, human polyomavirus (also known as John Cunningham \[JC\] virus), parvovirus, or Epstein Barr virus.
* The participant is at risk of reactivation of tuberculosis or has regular contact (eg, in the household) with individuals who are being actively treated for tuberculosis.
* The participant has had or is required to have any live vaccination within 1 month prior to enrollment.
|
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1.0404077768325806,
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] |
NCT05703048
|
The Effect of Esmolol Versus Dexmedetomidine on Postoperative Pain Control in Endoscopic Sinus Surgery: A Randomized Trial
|
Hypotensive techniques are associated with certain disadvantages. Hence, anesthesiologists are still in search of drugs with fewer side effects.
Various drugs such as high-concentration volatile anesthetics, magnesium sulfate, remifentanil, clonidine, calcium channel blockers, tranexamic acid, intravenous nitroglycerin, and sodium nitroprusside have been evaluated to control blood pressure and decrease blood loss during surgery, thereby improving the surgical field quality.
Opioids are the mainstay of treatment for perioperative pain, but their administration increases the incidence of respiratory complications, slows down normal gastrointestinal motility, and prolongs hospital stay. With the development of enhanced recovery after surgery (ERAS), reducing the use of opioids in the perioperative period has become the common goal of anesthesiologists. The dosage of opioids should be strictly controlled whenever possible, which should not only meet the needs of analgesia perioperatively, but also minimize the incidence of adverse reactions.
Opioid-free anesthesia (OFA) represents a step forward in anesthetic practice as it potentially spares the use of opioids by administrating nonopioid agents and adjuncts. The rationale to propose OFA is based on the aim to avoid the negative impact of intraoperative opioids on a patient's postoperative outcomes.
Several studies showed that β adrenergic receptor antagonists withhold the upsurge of catecholamines circulating in blood which induced by surgery, as well as having analgesic sparing effect itself. Esmolol is an ultrashort acting β1 blocking drug that has been uncovered to own opioid-sparing effects likely due to resemblances in its structure with local anesthetic agents. Esmolol's short course of action and titrability offer it as an attractive drug to use, although the mechanism of action of its analgesic effect has yet to be established.
Dexmedetomidine hydrochloride is a specific alpha-2 adrenoreceptor agonist that has intrinsic analgesic and sedative properties coupled with anxiolytic and sympatholytic effects. It minimizes the hemodynamic and neuroendocrine responses to anesthesia and surgery by suppressing the sympathetic tone. This hemodynamic stability can improve the surgical outcome as well as both patient and surgeon satisfaction. Dexmedetomidine accompanied by other anesthetics causes a controlled reduction in blood pressure and heart rate and improves the quality of the surgical field.
Alpha-2 adrenergic agonists (dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia.
Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system. Dexmedetomidine is a highly selective and potent a2-adrenoceptor agonist. Its intrathecal administration leads to anti-nociceptive effects, although it does have some undesired side effects (e.g., hypotension, bradycardia, and sedation).
|
This randomized prospective study will be carried out in Tanta university hospital in the ENT surgery department on 70 Patients with American Society of Anesthesiologists (ASA) Physical Status Class I \&II, aged \> 18 years and scheduled for FESS.
After approval from the institutional ethics committee, informed consent will be obtained from all participants parents in this research.
A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give it to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. The anesthesiologist, participant and outcomes Assessor will be blinded to the collected data until the end of the study and administered the medication.
The patients will be taken to the preoperative room 30 minutes before the operation. Patients are randomly divided into two groups ( 35 each):
In group A (dexmedetomidine group): 35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation.
In group B (Esmolol group): 35 patients will be received i.v. received a loading dose of esmolol 0.5 mg/kg in 30 mL isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min. infusion stopped immediately upon extubation.
In all groups, Anesthesia induction with propofol 1% 2 mg/kg, lidocaine 1mg/kg and rocuronium 0.5 mg/kg. No supplemental opioids will be used during the surgery.
The airway will be secured with an appropriate size tracheal tube. Anesthesia will be maintained using a mixture of O2 and air in a ratio of 1:1 mixture with 2% sevoflurane (MAC adjusted to keep the BIS index between 40 and 60). The ventilator settings will be adjusted to maintain normocapnia. Intraoperative monitoring included electrocardiogram, pulse oximetry, blood pressure, end tidal carbon dioxide, end tidal sevoflurane concentration (Et.Sev), and temperature. Fluids will be given at 10 ml/kg/h in the form of dextrose 5% and normal saline at a ratio of 1:1.
Controlled hypotension will be defined as mean arterial pressure (MAP) of 55-65 mmHg. Any intraoperative or postoperative complications, such as excessive hypotension (MAP \<50 mmHg), hypertension (MAP \>10% of baseline), need of additional hypotensive agents or vasopressors, tachycardia, bradycardia, bronchospasm, arrhythmias or delayed recovery will be noted. Rescue antihypertensive agent will be nitroglycerine and the patients requiring it will be excluded from the study. In the case of a higher MAP leading to excessive bleeding in the surgical field, a nitroglycerin infusion will be started at a dose of 0.5 μg/kg/min. If the arterial blood pressure fell to less than 30% of the baseline MAP, first an intravenous fluid infusion will be used to correct the blood pressure, with a bolus ephedrine dose of 5 mg being administered if the former will be insufficient.
Bradycardia will be generally self-limiting and will be corrected spontaneously after stopping infusion of esmolol if required. If the heart rate dropped to less than 44 beats per minute, atropine 0.6 mg will be given as a bolus. All prescribed drugs will be recorded.
The end of the operation will be defined as when the surgeon and the assistant surgeon performed the dressing and announced the completion of surgery. At this time, all anesthetics will be discontinued, and the patient will be ventilated with 100% oxygen. After the return of respiratory signs or any movements, the patients will be given neostigmine (0.05 mg/kg IV) and atropine (0.02 mg/kg IV). Once the patient's tidal volume reached two-thirds of the expected value and the patient would obey orders, he or she will be extubated. The bed of each patient will be situated in the head-up (10 degrees) position. When an Aldrete score of ≥ 9 will be achieved, patients will be discharged from the PACU.
Postoperative pain management included oral acetaminophen 500 mg\\6 h as a fixed dose.
Blindness For injection of medication ahead of anesthesia induction, identical syringes (in equal volumes) containing three used drugs and normal saline will be prepared by a physician not involved in the research based on a table provided by the statistician. The syringes will be delivered to the treating physician, who injected them at the specified time without knowing the type of drug. All patients and physicians will be unaware of the type of drug and study group.
Measurements:
1. A demographic information, including age, sex and weight of the patient, and duration of the operation will be recorded.
2. Monitoring of the depth of anesthesia will be conducted by the Bispectral Index (BIS). The BIS will be measured by a BIS monitor (BIS; Aspect Medical Systems, Newton, Massachusetts) which then calculates the depth of anesthesia by the BIS as a number. A BIS less than 40 demonstrates very deep anesthesia, 40-60 means surgical anesthesia, 61-80 means light anesthesia, more than 81 demonstrates sedation, and 100 shows full awareness.
3. Assessing VAS score for pain will be done by the blinded investigator in the PACU (on arrival, 1 h) and in surgical ward (at 6 h, 12 h and 24 h). IV 5 mg morphine will be given if VAS score exceeded 4.
4. The patients' behaviour during emergence from anesthesia and in the PACU will be rated the 6-point RSS scores (1 = patient anxious and restless, 2 = cooperative and awake, 3 = responding to verbal commands, 4 = responding to mild stimulus, 5 = responding to deep stimulus, 6 = no.
5. Percentage of patients receiving rescue opioids.
6. Patient's satisfaction will be also evaluated depending on a 5-point Likert scale as follow: (1-very unsatisfied, 2-unsatisfied, 3-unsure, 4-satisfied, and 5-very satisfied).
7. These included increased sleepiness (Ramsay sedation scale (RSS) score \> 3), respiratory depression (SpO2 \< 90% in room air or respiratory rate \< 8/min).
8. Subjective assessment of the surgical field for bleeding will be carried out by the surgeon according to category scale adapted from Fromme et al., Category scale values of 2 and 3 for the surgical field will be considered as ideal. The blood will be sucked in a preheparinized suction canister. The amount of blood loss will be calculated from the fluid volume of the suction canister (V), the Hb concentration of the suction canister, and the patient's mean Hb concentration at the beginning and end of surgery (Hbm) using the following equation:
9. Blood loss (mL) = Hb (gdL/1) × V (mL)/Hbm (g/dL).
10. The recovery time (time between the cessation of maintenance anesthetics and eye-opening) by the minute.
11. Time to extubation (time from the discontinuation of sevoflurane to the removal of endotracheal tube) by minute.
12. Length of staying in PACU will be defined as the time between arrival and discharge time will be measured. using Aldrete scale, a score of 9 or greater allows the patient to leave the postanesthesia unit.
13. Frequency of nausea, vomiting, on a four point scale (1 = no nausea, 2 = mild nausea, 3 = severe nausea, 4 = retching and/or vomiting),and pruritis during the first 24 hours postoperatively. Subjects experiencing nausea or vomiting received ondansetron 0.15 mg/kg iv every six hours as needed. PONV grade 3 \& 4 will be treated with metoclopramide 10 mg IV.
14. The mean arterial pressure (MAP) and heart rate (HR) will be recorded at entering the room (T1), after loading dosage (T2), after anesthesia induction (T3), 1 min after intubation (T4), 5 min after skin cutting (T5), 1h after skin cutting (T6), 2h after skin cutting (T7) and 5min after extubation (T8), respectively.
15. Level of sedation: The level of sedation will be evaluated with the Richmond Agitation Sedation Scale (RASS). This scale ranges from a score of -5 (unarousable) to +4 (intense agitation) in PICU.
16. The incidences of intubation and extubation response will be recorded separately. Intubation response will be considered to have occurred when MAP or HR at 5 minutes after intubation exceeds 15% or more than that at 5 minutes after induction of anesthesia (before intubation). At the same time, when the MAP or HR at 5 minutes after extubation will be 15% or higher than that at 5 minutes before spontaneous breathing occurred before extubation, it will be considered as extubation response.
17. Surgeon satisfaction with surgical field quality: This will be evaluated according to the surgeon's opinion using the Likert scale below:
* Score 1 (very poor): Uncontrollable bleeding.
* Score 2 (poor): Severe bleeding requiring repeated suctioning, with the quality of the field collapsing immediately after suctioning.
* Score 3 (satisfactory): Moderate bleeding requiring intermittent suctioning.
* Score 4 (good): Partial bleeding, sometimes requiring suctioning; the quality of the surgical field will be good.
* Score 5 (excellent): No bleeding/bloodless field; the surgery field will be excellent.
|
Inclusion Criteria:
* 70 patients with American Society of Anesthesiologists (ASA) Physical Status Class I\&II, aged \> 18 years. and scheduled for FESS.
Exclusion Criteria:
* 1. The patients on β-blockers and cardiovascular active drugs 2. History of neuromuscular disorder, diabetic neuropathy, pregnancy 3. Prolonged QT interval and ventricular arrhythmia, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease, and use of medications that would increase the risk of bradycardia.
4. Current (Within the last 30 days) opioid use for pain control as sickle cell disease, substance abuse or benzodiazepine addiction 5. History of end stage hepatic, renal, diabetes mellitus, and bleeding disorders, 6. Allergy and hypersensitivity to the drugs used in the study 7. Excessive use of analgesics/non-steroidal anti-inflammatory drugs 8. Morbid obesity (body mass index (BMI) \> 40) 9. A positive history of motion sickness, women who had a history of nausea and vomiting before menstruation.
|
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] |
NCT04752618
|
Safe Mothers, Safe Children Initiative
|
The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.
|
This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-8 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.
|
Inclusion Criteria:
* Receiving preventive services
* Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
* Having 1-8-year-old child
* Being the legal guardian for the child with physical and legal custody
* Being able to read, write, and speak English or Spanish
Exclusion Criteria:
* Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)
* Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving)
* Having current or active symptoms of psychosis in the past month
* Having a disability affecting communication, such as deafness
* Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
* Having an index child with current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past 3 months
* Experiencing current or history of intimate partner violence (IPV) or family violence:
If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship is ongoing, there must not have been an IPV/family violence event for at least one year
|
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] |
NCT00007384
|
Longitudinal LDL-C Studies in Black and White Families
|
To longitudinally investigate multigenerational familial clustering of plasma low density lipoprotein cholesterol (LDL-C), with particular emphasis on the influences of apoE genotypes and various 'behaviors'.
|
BACKGROUND:
Elevated concentrations of plasma low density lipoprotein cholesterol (LDL-C), a major risk factor for coronary heart disease, cluster significantly in families. This clustering has been observed in cross-sectional studies in both black and white families, but longitudinal data on the familial clustering of LDL-C are virtually nonexistent.
DESIGN NARRATIVE:
The longitudinal study will provide new and important information about changes in the familial low density lipoprotein cholesterol (LDL-C) correlations in black and white families from the period of shared household environments to that of separate households, using families from the Princeton Lipid Research Clinics (LRC) Prevalence (1973-75) and Family Studies (1975-76). The study will also provide important information on changes in individual LDL-C levels over the same 25 year period. The former student participants were six to 18 years of age and are now 32 to 45 years of age; their parents were (largely) 26 to 55 years of age and are now 51 to 80 years of age. Plasma LDL-C concentrations in children and adults have been shown to associate with the apolipoprotein (apo) E genotype, with obesity, and with such elective behaviors as diet, cigarette smoking, and physical activity. In the LRC Study, measurements were made of LDL-C, body habitus, elective behaviors, and the family history of cardiovascular disease (CVD). The study will obtain repeat measures of these factors, plus determine the apo E isoforms. Changes in individual LDL-C levels and in familial associations can then be assessed in association with apo E isoforms, body composition, elective behaviors, and family history of CVD. Family members share ranges of body weight, patterns of fat distribution, dietary and smoking habits, and physical activity levels. The extent to which the familial clustering of LDL-C levels is determined by apo E isoforms interacting with the similar levels of obesity, and with the similar behaviors, is not currently known.
|
No eligibility criteria
|
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] |
NCT04280497
|
Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis
|
Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity.
Secondary objectives and endpoints:
* Mortality and health-related quality of life at 6 months;
* Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
* Daily secondary infections (up to 90 days)
* Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
* Daily gastroduodenal bleeding (up to 28 day)
* Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).
|
The potential benefits of a lower dose ( ≤ 400 mg of hydrocortisone or equivalent per day), and a longer duration at full dose ( ≥ three days) of treatment, have been investigated in numerous randomized controlled trials over the past three decades. In the past two years, guidelines for clinical practices about corticosteroids use in sepsis have been released. All but one of the guidelines, recommended against the use of corticosteroids in sepsis, except in patients with septic shock and poorly responsive to fluid replacement and vasopressor therapy. Some guidelines suggested that corticosteroids should be given as a continuous infusion rather than intermittent boluses.
Corticosteroids survival benefit is not affected by age, gender, disease severity, type of infection, source of infection, or type of pathogens. There is currently no diagnostic test for CS sensitivity/resistance in sepsis. The scientific community is competing to identify markers delineating between patients who draw survival benefit from corticosteroids (CS-sensitive sepsis) and those who may be harmed (CS-resistant sepsis). In sepsis, the deregulated response may result in systemic inflammation and organs damage, or immune paresis and secondary infections. Obviously, patients with systemic inflammation may benefit from CS whereas those with immune paresis may deteriorate. The study team had have looked for an interaction between survival in response to corticosteroids and the presence of CIRCI according to the ACTH test results (cortisol increment of less than 9µg/dL). The benefits from corticosteroids were more important in patients with CIRCI in the Ger-Inf-05 trial but not in the APROCCHS trial. Thus, current sepsis guidelines suggest that the ACTH test may not reliably guide the use of corticosteroids. Indeed, this test provides information neither on corticosteroids bioactivity nor on patient's immune status, when this information should precede any corticotherapy. Recent studies suggested that a transcriptomic signature based on 100 genes may identify a subset of paediatric sepsis that had increased risk of death when exposed to corticosteroids. Another study found transcriptomic based sepsis response signatures (SRS) associated with immune paresis (SRS1) or with systemic inflammation (SRS 2). In this study, patients with a SRS 2 transcriptomic signature had significantly higher mortality when treated with hydrocortisone. Thus, we have started exploring the mechanisms of sensitivity/resistance to corticosteroids in sepsis, namely by investigating endocan, as a surrogate of patient's inflammatory status, and GILZ expression as a marker of corticosteroids bioactivity.
This is a new multicentre concealed-allocation multi-arms, parallel-group, adaptive blinded randomized controlled trial. The overall objective of the trial is to determine whether different signatures of immune status and/or corticosteroids biological activity influence the responses to hydrocortisone plus fludrocortisone of adults with sepsis. To remain pragmatic, this trial has broad eligibility criteria and includes all patients admitted to the ICU with a primary diagnosis of sepsis. Patients will be randomly assigned to hydrocortisone plus fludrocortisone or placebo for 7 days, targeting 1800 patients with full follow-up up to 6 months.
|
Inclusion Criteria:
1. Patient ≥18 years old;
2. Admitted to ICU with proven or suspected infection as the main diagnosis;
3. Community acquired pneumonia related sepsis or vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) or septic shock (vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) or acute respiratory distress syndrome (ARDS: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 ≤ 300 mm Hg, - PEEP ≥ 5 cm H2O;
4. Patients who have been tested for one or more RECORDS specific biomarkers:
1. CIRCI
2. Endocan
3. GILZ
4. DUSP-1
5. MDW
6. lymphopenia
7. Transcriptomic SRS2
8. Endotype B
9. PCR COVID-19
10. PCR Influenza
11. PCR other respiratory virus
12. Cutaneous vasoconstrictor response to glucocorticoids
5. Patient who has signed an informed and written consent whevener he/she is able of consent, if not, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion;
6. Patient affiliated to a social security system or to an universal health coverage (Couverture Maladie Universelle (CMU) in France;
7. Patient under guardianship or curatorship will be included;
8. Patient in case of simple emergency (legal definition) will be included;
9. Patients managed with covid 19 and having biological samples available.
Exclusion Criteria:
1. Pregnancy;
2. Expected death or withdrawal of life-sustaining treatments within 48 hours;
3. Previously enrolled in this study
4. Formal indication for corticosteroids according to most recent international guidelines
5. Vaccination with live virus within past 6 months
6. Hypersensitivity to hydrocortisone or fludrocortisone or (microsined betamethasone dipropionate\*) or any of their excipients (spc)
7. Women of childbearing potential not using contraception
8. Nursing women \* For patients included in this stratum, if applicable, do not apply the cream to an infected or ulcerated area
|
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] |
NCT01631201
|
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
|
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
|
Inclusion Criteria:
* Female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection.
* Use an effective method of contraception.
* Agree to be abstinent or to have partners use condoms for all sexual activities during the study.
Exclusion Criteria:
* Subject or sexual partner is known to have gonorrhea.
* History of repeated chlamydia trachomatis infection.
* HIV, syphilis, or active Hepatitis B or C infection.
* Treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.
|
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|
NCT03018002
|
Intervention for Sustained Testing and Retention Among HIV-infected Patients
|
The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.
|
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.
|
Inclusion Criteria:
* HIV-infected pregnant women identified during baby showers programs at participating worship centers.
Exclusion Criteria:
* HIV-infected women already on treatment
|
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] |
NCT03209505
|
The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
|
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)
|
The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson \& Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night \& Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.
|
Inclusion Criteria:
1. Must be able to read and understand the study informed consent
2. Must be a minimum of 18 years of age and less than 46 years of age at study enrollment
3. Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
4. Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
5. The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
Exclusion Criteria:
1. Pregnant and/or lactating females by self-report
2. Presence of current LWE on the upper eyelid (\>0.5 in height or width)
3. Has greater than -1.00DC of refractive cylinder
4. Has greater than 1.00D of anisometropia
5. Is aphakic
6. Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye
7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome
8. Has clinically significant corneal vascularization or central corneal scaring
9. Has active ocular surface infection (e.g. conjunctivitis)
10. Has a positive history of eyelid surgery or trauma
11. Has a positive history of refractive surgery
12. Takes medications that significantly impact contact lens comfort and/or ocular surface health
13. Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days
14. Is unwilling to have eyes photographed or video recorded
|
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] |
NCT06821113
|
Vale+Tú Salud: Corner-Based Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
|
The purpose of this study is to determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.
|
Inclusion Criteria:
* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work
Exclusion Criteria:
* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours
|
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0.1989973932504654
] |
|
NCT06729255
|
A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
|
The purpose of the study is to learn more about a new device, the EpiZact Epidural Device, that may be helpful for reducing the likelihood of wet tap when a labor epidural is placed. When epidurals are placed correctly the needle stops just in front of the space in the body that contains cerebrospinal fluid. When the epidural is advanced a short distance further, leakage of cerebrospinal fluid can occur. This is known as a wet tap. A wet tap can result in a severe headache and at times other complications. The goal of this clinical trial is to learn if the use of the EpiZact device prevents wet taps in pregnant women receiving epidurals for relief of labor pain. The main questions this study aims to answer are:
1. What the rate of wet tap with the EpiZact device?
2. What is the rate of failed epidural placement with the EpiZact device?
All patients in the study will receive an epidural with the EpiZact device. The investigators will compare the results with patients not in the study that receive an epidural without the EpiZact device.
|
The purpose of the study is to learn if use of the EpiZact device decreases the number of wet taps that occur when epidurals are placed. The EpiZact device has a technology that automatically stops the epidural needle when it enters the epidural space. In theory, this should decrease the likelihood of a wet tap. The standard epidural to treat labor pain does not have this capability. The study device may cause fewer wet taps than the standard epidural. All study participants will receive an epidural to treat labor pain with the EpiZact device. Results will be compared with patients receiving epidurals around the same time without the EpiZact device.
If a participant's screening questions show that they can take part in the study, and the participant chooses to be a part of the study, medical records from OHSU or other facilities may be reviewed. Information reviewed may include treatment history, medications, surgeries, allergies, scans, and lab results. The participant will then receive an epidural with the EpiZact device. After the epidural is placed, the participant will be asked a few questions to determine how well the epidural is working and if a complication occurred. The questions are expected to take less than 5 minutes to answer. Participants will also be called 1 week after receiving an epidural to determine if a complication occurred. This call is expected to last less than 5 minutes.
|
Inclusion Criteria:
* Pregnant women requesting labor epidural analgesia
* Women pregnant with a single baby (not twins or triplets)
Exclusion Criteria:
* Women requesting not to have a labor epidural
* Height less than 150 cm
* A bleeding disorder, nerve problem, or skin infection that contraindicates receiving an epidural
* A women receiving a combined spinal epidural (CSE) or a dural puncture epidural (DPE)
* A history of spine surgery
* Allergy to local anesthetics (numbing medicine) or skin cleaning solutions
* Decisionally impaired individuals
|
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] |
NCT05956249
|
Online Group Therapy for Mothers of Babies With Congenital Heart Disease
|
Introduction: Mothers of babies with congenital heart disease tend to have higher levels of depression, stress and anxiety. Currently, psychological support group technology has been a resource increasingly used by health professionals, with a therapeutic objective as an instrument to promote care. Objective: The aim of this study is to evaluate the effectiveness of a group intervention in improving depression, anxiety and the psychological well-being of mothers of babies with congenital heart disease. Methods: Randomized, parallel clinical trial, in which the factor under study will be online group therapy and the outcome the level of depressive symptoms, anxiety and psychological well-being, assessed using the instruments: BECK-II, BAI and Wellness Scale Ryff's psychological well-being at the beginning and after the intervention. The fellow who will reapply the instruments will be blinded to the groups. Patients will be randomized 1:1, with odd numbers assigned to treatment (online group therapy) and even numbers assigned to controls (no online group therapy). The intervention group will have 8 weekly group consultations, psychoeducational and focused on depression, anxiety and psychological well-being. The sample size was calculated at 36 individuals for each group. Data will be analyzed using the statistical program Statistical Package for Social Sciences (SPSS) version 27.0. For comparison between groups, Student's t test or Kruskall-Wallis or Chi-square test will be used. A two-tailed value of p≤ 0.05 will be considered significant. The normality of instrument scores will be evaluated using the Kolmogorov-Smirnov test. Covariance analysis will be performed to assess the influence of initial scores of anxiety, depression and well-being and their changes after intervention. The effect size will also be calculated. Expected results: It is expected to know and describe the population studied with regard to the level of depressive symptoms, anxiety and psychological well-being. In addition to seeking knowledge about the effectiveness of Group Therapy for these variables.
|
Design: Randomized, parallel clinical trial, with blinding for the application and evaluation of the instruments.
Participants: 72 mothers (≥ or equal to 18 years old) of babies with congenital heart disease will be included.
Procedures: Patients will be invited to participate in the study on the day of the outpatient consultation or during their children's hospitalization. All participants who agree to participate in the research will respond to the following instruments: BAI, BDI-II and Ryff Psychological Well-Being Scale.
Randomization envelopes will be opened during the interview. Patients in the control group will be informed that they will receive care after the second evaluation.
Patients will be randomized 1:1 according to the order of interviews. Odd numbers assigned to treatment (intervention group therapy) and even numbers assigned to controls. The randomization sequence was generated by the website www.random.org and can be found here: https://www.random.org/sequences/?min=1\&max=50\&col=1\&format=html\&rnd=new. Sealed and sequentially numbered envelopes will be made in the order of randomization.
From the randomization, the participants will be allocated to the intervention group (GI) or control group (CG). The intervention will be carried out in 6 groups of 6 participants.
|
Inclusion Criteria:
* Mothers of babies with congenital heart disease, over 18 years of age, assisted at the outpatient clinic or during their child's hospitalization in the pediatric hospitalization or Pediatric ICU of a cardiac hospital who agree to participate and sign the Informed Consent Form.
Exclusion Criteria:
* Mothers unable to answer the questionnaires at the time of application.
* Mothers who do not wish to continue answering the survey.
* Mothers of children over two years old.
|
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0.21197503805160522,
-0.32270729541778564
] |
NCT06345092
|
Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain
|
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
|
Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement
|
Inclusion Criteria:
Patients with internal TMJ derangement (anterior disc displacement with reduction)
Exclusion Criteria:
Pathological conditions ; trauma TMJ cases or any blood diseases
|
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] |
NCT00766545
|
Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.
|
The multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.
|
Inclusion Criteria:
1. Prior cerebral infarction Onset at 1 to 6 months before randomization
2. CT or MRI detection of responsible site
3. Without serious complications (malignant tumor, liver cirrhosis, renal failure, or heart failure)
Exclusion Criteria:
1. History of intracranial hemorrhage
2. Possibility of cardiogenic cerebral embolism in the past or future All patients with any of the following complications were excluded: mitral valve stenosis, prosthetic valve, endocarditis, myocardial infarction within 6 weeks after onset, ventricular aneurysm, intraventricular or intraatrial blood clots, mitral valve prolapsed (age under 45 years old, lacking other causes for cerebral embolism induction), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy
3. Severe cerebral deficits rendering the patient bed-ridden, totally dependent, or demented
4. Contraindications to the study drug Hemostatic disorders or systemic bleeding Pregnant or possibly pregnant women, or nursing mothers
5. Requirement for nonstudy antiplatelet drugs, anticoagulant drugs, or fibrinolytic drugs for another disease
|
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] |
|
NCT02143648
|
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
|
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.
|
Inclusion Criteria:
* Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
* Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
* Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
* Have demonstrated pruritus intensity on the Itch NRS during screening
* Male or female who are at least 18 years old at the time of Screening
Exclusion Criteria:
* Subject had a significant alteration in dialysis regimen during the Screening Period
* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
* Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
* Has had a history of substance abuse within 6 months prior to completing Screening
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female.
|
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|
NCT02576379
|
The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
|
Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each year; one-third die and one-third are left permanently disabled. Because the risk of stroke increases with age, it has been considered a disease of the elderly, but stroke also occurs in middle-aged people.
Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system delays including prolonged transportation.
In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was implemented in the Eastern part of Denmark. An observational study evaluating the short-term effects of HEMS implementation compared patients transported by conventional ground ambulance (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients transported by helicopter had increased time to specialized care. However, both 30-day and 1-year mortality was slightly lower in patients transported by HEMS, although not significant, as was the degree of disability at three months measured by the modified Rankin Scale (mRS).
|
Inclusion Criteria:
* All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013.
Exclusion Criteria:
* For patients with multiple contacts; only the first contact is included in the data for analysis.
|
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|
NCT02137122
|
Neuromodulation of Cognition in Older Adults
|
This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.
|
The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.
|
Inclusion Criteria:
* Men and women
* Age: 65 to 90 years
* English speaking
* Physically mobile
* working memory function between 0-75th percentile determined by screening results on the POSIT Baseline Cognitive Training computerized tasks.
Exclusion Criteria:
* Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
* Evidence of dementia (NACC UDS scores of 1.5 standard deviations below the mean for age, sex and education adjusted norms in a single cognitive domain on the task).
* Past opportunistic brain infection.
* Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality).
* Unstable (e.g., cancer other than basal cell skin) and chronic (e.g, severe diabetes) medical conditions.
* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).
* Physical impairment precluding motor response or lying still for 1 hr and inability to walk two blocks without stopping.
* Certain prescription medications may possibly reduce effects otherwise induced by the tDCS stimulation protocol.
* Hearing or vision deficits that will not allow for standardized cognitive training.
* Left handedness
|
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] |
NCT06409481
|
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
|
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.
|
Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).
|
Inclusion Criteria:
1. Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
2. Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
3. Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
4. The number of reports corresponding to each drug or adverse event is at least three.
5. The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.
Exclusion Criteria:
1. Any of the information in the baseline information such as gender, age, region, date of report is empty.
2. The severity level of the reported adverse event is empty.
3. Adverse events were reported in patients whose drug indications included cardiovascular disease.
|
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] |
NCT04353076
|
Physiological Responses in Young and Older Adults During a Prolonged Simulated Heatwave
|
Climate change not only affects the planet's natural resources, but also severely impacts human health. An individual's ability to adequately cope with short- or long-term increases in ambient temperature is critical for maintaining health and wellbeing. Prolonged increases in temperature (heatwaves) pose a serious health risk for older adults, who have a reduced capacity to efficiently regulate body temperature. However, information regarding the impact of age on body temperature regulation during prolonged exposure to extreme heat is lacking, as is research on the effectiveness of interventions aimed at reducing heat strain in such situations. This project will address these important knowledge gaps by exposing healthy young and older adults to a prolonged (9 hour) heat exposure, with conditions representative of heatwaves in temperate continental climates. An additional cohort of older adults will complete the same heatwave simulation but will be briefly (2 hours) exposed to cooler conditions (22-23°C) mid-way through the session (akin to visiting a cooling centre or cooled location). The investigators will evaluate age-related differences in the capacity to dissipate heat via direct air calorimetry (a unique device that permits the precise measurement of the heat dissipated by the human body) and their effect on the regulation of body temperature. The investigators anticipate that older adults will exhibit progressive increases in the heat stored in the body throughout the simulated heatwave, resulting in progressive increases in body core temperature. Further, older adults exposed to brief-mid day cooling will rapidly gain heat upon re-exposure to high ambient temperatures. As a result, by the end of exposure body temperatures will be similar to the group not removed from the heat.
|
OBJECTIVES Intervention 1: Evaluate the effect of age on whole-body heat storage, body core temperature, and the development of cardiovascular strain and acute inflammation during day-long (9 hours) exposure to simulated heatwave conditions.
Intervention 2: Determine whether short-duration exposure (2 hours) to an air-conditioned environment following extreme heat exposure results in lasting reductions in physiological strain in older adults upon return to the heat.
Hypotheses Intervention 1: Older adults will experience greater heat storage throughout the 9-hour simulated heatwave compared to the younger participants. Consequently, body core temperature will be greater in the older adults and between-group differences will be exacerbated as exposure progresses. We will also explore the secondary hypothesis that differences in body temperature will be paralleled by greater alterations in cardiovascular variables and acute circulatory and intracellular inflammation in the older adults.
Intervention 2: Body heat storage will be exacerbated in the older adults exposed to the cooling centre intervention upon return to the heat (hours 5-6) compared to the older adults from Intervention 1 who remained in the heat. Consequently, body core temperature will be comparable (statistically equivalent) between groups by the end of exposure.
Methods Participants A total of 20 young (age: 18-31 years) and 40 older (age: 64-80 years) adults will be recruited for the proposed project, with an approximately even distribution of men and women in each intervention arm. Young (n = 20) and older (n = 20) adults will complete Intervention 1 and a separate cohort of older adults (n = 20) will complete Intervention 2. Participants will be homogenous for anthropomorphic characteristics as well as habitual physical activity levels as verified via standardized questionnaires.
Experimental Design Pre-trial instructions All participants will be asked to avoid strenuous physical activity and alcohol for 24 hours prior to all preliminary and experimental sessions and to eat a light meal 2 hours before the start of each session. Participants will also be asked to consume a minimum of 500 ml of water the night before and morning of each session to ensure adequate hydration. Adequate hydration will be verified upon arrival to the laboratory (urine specific gravity \<1.025). For all sessions, participants will wear athletic shorts (and a sport top for women).
Preliminary screening All participants will complete one preliminary evaluation a minimum of 7 days before the first experimental session. During this session they will be familiarized with all procedures and measurement techniques and will complete the Get Active Questionnaire (GAQ) and the American Heart Association Pre-participation screening Questionnaire to assess their eligibility to participate. The GAQ will also be used to assess habitual activity levels along with the Kohl Physical Activity Questionnaire. Participants will also provide verbal and written informed consent at this time. Body height and mass will be determined via a physician stadiometer and a high-performance weighing terminal, respectively, and from these measurements body surface area will be calculated.
Experimental Protocol (Intervention 1) Each session will commence at 07:00-09:00. Upon arrival to the laboratory, the participant will provide a urine sample for the assessment of urine specific gravity, after which a measurement of nude body mass will be obtained. Participants will then insert a temperature probe for the continuous measurement of rectal temperature. Thereafter, participants will be instrumented for the measurement of skin temperature and 5-lead echocardiogram. Baseline cardiovascular parameters will be evaluated via a brief (\~45 min) cardiovascular test battery, performed as follows. Brachial arterial systolic and diastolic pressures reconstructed from arterial pressure waveforms measured at the right middle finger (volume clamp technique) and 5-lead echocardiogram recordings will be collected for 10-min while the participant rests quietly (spontaneous breathing). Immediately thereafter, arterial systolic and diastolic pressures will be measured in triplicate via manual auscultation (\~30 sec between measures), after which forearm and calf blood flows on the right side of the body will be measured via automated venous occlusion plethysmography. Throughout the test battery, the participant will be seated with both feet on the floor, except for during the measurements of limb blood flow, where the instrumented limbs will be elevated to facilitate venous drainage. Finally, a venous blood sample and body mass measurement will be obtained.
Participants will then be transferred to the whole-body direct calorimeter chamber, regulated to 40°C and \~10-15% humidity. These conditions were chosen to simulate peak temperatures experienced during heatwaves and are similar to peak conditions in recent heatwaves in North America in 2018 (Ottawa, Ontario; 34°C and 58%, heat index: 41°C) and Europe in 2003 (Paris, France; 38°C and 25%, heat index: 38°C). The participant will rest quietly for 3-hours (hours 1-3) within the calorimeter chamber while whole-body heat production and exchange are measured continuously. At the 3-hour mark, the participant will exit the calorimeter and the brief cardiovascular test battery will be performed again followed by a measurement of body mass. Hours 4-6 will be spent resting in the heat in the thermal chamber adjacent to the calorimeter. During this time, participants will be allowed to consume a light, self-provided lunch with low water content. Tap water will be provided ad libitum via a self-service insulated water cooler located in the thermal chamber. Another cardiovascular battery will then be performed followed by a measurement of body mass. The participant will then re-enter the calorimeter where the final 3 hours will be spent (hours 6-9). At the end of this period, the participants will undergo a fourth and final cardiovascular test battery and a final venous blood sample and body mass measurement will be procured.
Statistical analysis and sample size calculations Primary and secondary variables will be evaluated using linear mixed-effects models. Time will be modelled as a repeated within-subject fixed effect, and age-group will be modelled as a between-subject fixed effect. Pre-heat exposure values of the outcome variable, participant sex, and self-reported weekly physical activity (min/week, as assessed via the GAQ) will be included as covariates. Participant identification will be modeled as a random effect in all analyses. Akaike's information criterion will be used to determine random effect and variance/covariance structures.
Post hoc multiple comparisons will be made on model estimated marginal means. Given the small number of comparisons for each variable, multiplicity corrections will not be employed. Homoscedasticity will be evaluated for all models by visual assessment of residual plots. Approximate normal distribution of residuals will be assessed via visual inspection of histograms and Q-Q plots. Data will be log-transformed in the event that the distribution of residuals meaningfully deviates from normality. For all analyses, alpha will be set at 0.050. Descriptive statistics will be presented as means and standard deviations. Comparisons between groups and/or time-points will be presented as means and 95% confidence intervals \[lower limit, upper limit\].
An a priori power analysis determined that a total sample size of 19 young and 19 older adults was required to detect a difference in the rate of whole-body heat storage between groups at the end of each calorimeter session (i.e., hours 3 and 9) with 80% statistical power. In lieu of clinically meaningful data (i.e., what would be considered a clinically meaningful change in whole-body heat storage), the standardized effect size (Cohen's d=1.06) was calculated based on the difference in the rate of whole-body heat storage between young and older adults over the final 30-min of a 3-hour heat exposure protocol (young: -2 \[26\] kJ/hour, older: 43 \[54\] kJ/hour) in our previous work.
Experimental Protocol (Intervention 2) Experimental design The protocol for Intervention 2 is identical to that of Intervention 1 except that after the first calorimeter session and subsequent cardiovascular battery, participants will exit the thermal chamber and spend \~2 hours (hours 5-6) resting in an air-conditioned room (\~23°C, \~50% relative humidity). Similar to Intervention 1, participants will be allowed to eat a small self-provided lunch during this time and consume water (tap) ad libitum. The third cardiovascular battery will also be performed in the cooled environment. As in Intervention 1, participants will then re-enter the calorimeter for the final 3 hours, where they will rest in the heat for the remainder of the experimental session.
Statistical analysis and sample size calculations Statistical analysis for Intervention 2 will be performed to assess whether mid-day exposure to a cooled room results in greater body heat storage following exposure such that physiological responses are similar to those of the non-cooled group by the end of the 9-hour heatwave simulation. Cumulative whole-body heat storage will be evaluated using a linear mixed-effects model with experimental group modelled as a between-subject fixed effect. Cumulative heat storage over the first three hours of the 9-hour exposure will be included as a covariate to account for the influence of any inter- or intra-individual factors (e.g., sex, physical activity levels), measured or unmeasured, impacting whole-body heat exchange and storage. Comparisons of heat storage between groups will be made using model estimated marginal means.
Body core temperature, as estimated by rectal temperature (primary outcome), will be analyzed with a linear mixed effects model with experimental group (two levels: cooling and no-cooling) modelled as a between-subject fixed effect and time as a repeated within-subject fixed effect (0-, 1-, 2-, and 3-hours post-cooling intervention). Like the model for heat storage, rectal temperature at the end of the first calorimetry session (i.e., hour 3 of the 9-hour exposure) will be included as a covariate to account for the influence of any measured or unmeasured inter- or intra-individual factors impacting the body temperature responses to resting heat exposure.
The effect of cooling on rectal temperature will then be assessed via two one-sided tests performed on the mixed-effects model derived estimated marginal means at each timepoint. Equivalence bounds will be set to ±0.3°C, which corresponds to the typical day-to-day variation of core temperature and has been suggested to reflect a meaningful/detectable change in body temperatures in a recent study assessing the influence of cooling strategies on physiological strain in young adults. Secondary variables will be similarly evaluated. The level of significance will be set at P \< 0.050. Descriptive statistics will be presented as mean (standard deviation) and comparisons between groups will be presented as mean ± 95% confidence interval.
An a priori power analysis determined that a total sample size of 18 older adults in each group (36 participants total) is required to confirm whether between-group differences in rectal temperature are equivalent within upper and lower bounds of +0.3°C and -0.3°C, respectively, with 80% power. This corresponds to an effect size (Cohen's d) of 1.0, based on the pooled-standard deviation of 0.3°C, determined from published data from our laboratory demonstrating a 0.2°C (SD 0.3) difference in core temperature between young and older adults and a 0.0°C (SD 0.3) difference in core temperature between older adults with and without type 2 diabetes following 3 hours of rest in a hot environment.
|
Inclusion Criteria:
* male or female (non-pregnant) adults with or without a) chronic hypertension (elevated resting blood pressure; as defined by Heart and Stroke Canada and Hypertension Canada), b) type 2 diabetes as defined by Diabetes Canada, with at least 5 years having elapsed since time of diagnosis and or c) obesity as defined by the World Health Organization (Body Mass Index \[BMI\] greater than or equal to 30).
* non-smoking.
Exclusion Criteria:
* Episode(s) of severe hypoglycemia (requiring the assistance of another person) within the previous year, or inability to sense hypoglycemia (hypoglycemia unawareness).
* Serious complications related to your diabetes (gastroparesis, renal disease, uncontrolled hypertension, severe autonomic neuropathy).
* Uncontrolled hypertension - BP \>150 mmHg systolic or \>95 mmHg diastolic in a sitting position.
* Restrictions in physical activity due to disease (e.g. intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
* Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable.
* Cardiac abnormalities identified in your physical health screening form (adults \<65 years of age and older; adults \<60 years of age and older with diabetes and or hypertension) or during exercise stress testing as assessed by 12-lead (all adults ≥65 years of age and older).
|
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] |
NCT05148117
|
Mitochondrial Dysfunction Contributes to Sepsis Induced Cardiac Dysfunction
|
This proposal hypothesizes that mitochondrial bioenergetics in the patient will correspond to mtDNA DAMPs levels and markers of inflammation. We predict these will serve as a prognostic indicator of Sepsis induced cardiac dysfunction (SICD) outcomes. Successful completion of these studies will provide a clearer understanding of the etiology of SICD development and therefore will have a high impact on biomedical research by identifying a new mechanism for understanding sepsis induced organ failure. Importantly, they will also provide a means for more directed and focused therapies, based upon individual bioenergetic/mitochondrial-mediated inflammation profiles. The combined, complementary expertise of the Mentor/co-primary investigators (Drs. Mathru and Ballinger) provide an excellent combination in both basic and translational research. They also have experience conducting studies and publications that will strengthen this research project. Importantly, the methods for characterizing mitochondrial bioenergetics from platelets were developed here at UAB, and methods for quantitative assessment of mtDNA DAMPs have been recently developed.
|
Sepsis induced cardiac dysfunction (SICD) occurs in \~ 50% of the patients with severe sepsis and septic shock, with significant implications for patient's survival. Currently, the precise pathophysiological mechanisms leading to cardiac dysfunction are not fully understood, nor is there an effective therapy for SICD except antibiotics, source control and restoration of hemodynamics to improve organ perfusion.
SICD is characterized by minimal cell death, normal coronary perfusion, preserved tissue oxygen tension and reversibility in survivors. These characteristics point toward an oxygen utilization problem due to mitochondrial dysfunction; interestingly, sepsis mouse models demonstrated an improvement in cardiac function and decreased mortality when they were treated with mitochondrial targeted therapies, consistent with a growing body of evidence that suggests dysregulated mitochondrial metabolism plays a pivotal role in the pathogenesis of SICD. Ultrastructural and functional abnormalities of mitochondria have also been demonstrated in early sepsis, and reactive oxygen species (ROS) generated from mitochondria along with calcium overload trigger mitochondrial permeability transition pore (mPTP) opening which facilitates the externalization of mitochondrial DNA (mtDNA) fragments. These mtDNA fragments, or mtDNA Damage Associated Molecular Patterns (mtDNA DAMPs), activate innate immune response pathways - these pathways are well known to be significant components of intramyocardial inflammation.
|
Inclusion Criteria:
* Subjects 18 years old
* With clinical symptoms suggestive of sepsis Control Group
* age matched
* gender matched
* cardiovascular risk factor matched
Exclusion Criteria:
* n/a
|
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0.5165973901748657,
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] |
NCT00317057
|
Outpatient Management of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease
|
Patients admitted to the hospital with chronic obstructive pulmonary disease are evaluated with regard to early follow-up by a specialized nurse in the home after discharge.
|
Patients admitted to Department of Internal Medicine M, Glostrup University hospital, with Chronic Obstructive Pulmonary Disease (COPD) are evaluated with regard to early follow-up by a specialized nurse in the home after discharge. Eligible patients receive education about disease management. The intervention is evaluated by comparing the number of readmissions for COPD and the duration of admissions during the study period to the the period prior to the implementation of this intervention.
|
Inclusion Criteria:
* Admission for chronic obstructive pulmonary disease
Exclusion Criteria:
* Other severe acute or chronic diseases
|
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] |
NCT01627015
|
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
|
In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
|
Inclusion Criteria:
* generally healthy infants born
* weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
* age between 5 - 7th month of life at study entry
* fully formula fed for at least 4 weeks before intervention start
* parents/caregivers understand the German language and are able to fill out questionnaires
* parents/caregivers agree to study participation and sign the informed consent form
Exclusion Criteria:
* acute or chronic illness of infant or mother
* drug and/or alcohol abuses of mother
* chronic medication
* participation of the infant in another intervention study
* gestational diabetes of the mother
|
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] |
|
NCT01247506
|
Different Genetic Features Associated With Hepatic Carcinogenesis
|
The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.
|
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.
MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.
|
Inclusion Criteria:
* clinical diagnosis of hepatocellular carcinoma
Exclusion Criteria:
-
|
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] |
NCT00388375
|
Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?
|
The purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung.
|
Central venous catheterization (CVC) of the subclavian or internal jugular veins is a common procedure performed in the emergency department (ED). This procedure is followed by complications in 0.3 to 12% of cases. Pneumothorax (PTX) and catheter-tip misplacement can occur. The diagnosis of these complications requires a chest radiograph (CXR). In certain cases, CXR may be time-consuming, requiring more than 30 minutes. This could be harmful in the case of critically ill patients. Moreover, several investigators have questioned the need of routine post-procedural CXR in the absence of clinical complications.
Recent data has shown that ultrasound can accurately detect PTX in critically ill patients. Furthermore, bedside ultrasound is an easy technique to investigate the subclavian and internal jugular veins, and can improve the success rate of catheter insertion. Ultrasound also allows visualization of central venous catheters in vivo. Ultrasound has been reported as a tool to detect catheterization complications and misplacement when performed by ICU physicians, but has never been studied in the ED.
This method could be valuable in hemodynamically unstable patients, who quickly need a CVC for the measurement of central venous pressure, immediate fluid resuscitation, and infusion of vasoactive medications. Similarly, bedside ultrasound examination could quickly confirm PTX and allow immediate chest tube insertion in case of respiratory distress after catheter insertion.
We hypothesize that bedside ultrasound examination performed by ED physicians could accurately detect placement of the CVC and the presence or absence of a PTX after catheterization of the jugular and subclavian veins.
|
Inclusion Criteria:
* Male or female 18 years or older
* Signed consent
* In need of subclavian or internal jugular central line placement
Exclusion Criteria:
* Any subject who refuses or whose family refuses to sign consent
* Any subject in whose immediate transfer from the care of the ED to another location is mandated by clinical presentation
* Any subject under the age of 18
* Any subject being evaluated for chest trauma.
|
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] |
NCT02512913
|
Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity
|
The purpose of this research is to adapt and implement a pregnancy and postnatal smoking cessation intervention for couple that will begin early in pregnancy and have an additional postnatal component.
|
Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes.
Building on ongoing pilot work led by Dr. Meghea with Babes-Bolyai University (BBU) in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same target population as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component.
The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania.
The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction.
This study will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline.
|
Inclusion Criteria:
* the woman is pregnant,
* she is a smoker
* 18 years or older (legal age for consent and for consuming tobacco in Romania)
* married or in a stable relationship
* phone service in the home or mobile phone
* willing to have the partner contacted for participation, upon brief explanation of the study.
|
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] |
NCT00001153
|
Visual Function and Ocular Pigmentation in Albinism
|
To study the relationship between visual function and ocular (iris, retina/choroidal) pigmentation in patients with albinism and other hypomelanotic disorders. To identify the carrier state in relatives of patients with ocular albinism.
|
Visual function and ocular pigmentation are being studied in patients with albinism and other disorders associated with hypopigmentation. The degree of ocular pigmentation is assessed clinically by estimating the melanin content of the iris, retinal pigment epithelium, and choroid. Visual function is measured in the conventional manner to study central vision, and electrophysiological methods to detect a misrouting of the visual pathways. The purpose of this study is to document the visual deficit and the pigmentary changes of patients with albinism, to observe their natural course, and to determine whether misrouting of the visual pathways is present and is correlated with pigmentation.
|
Patients have been recruited into the study by referral from an ophthalmologist or pediatrician.
Entrance into the study was dependent upon clinical evidence of decreased or absent pigmentation in skin, hair, and/or eyes.
The definition was purposefully broad to include the broad range of phenotype variations and clinical heterogeneity.
The purpose of the study id to be able to document iris and retina/choroidal pigmentation and correlated these finding with visual function.
|
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] |
NCT04163211
|
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study
|
The investigators performed a retrospective review of all patients undergoing appendicectomy from March-November 2018 using the online theatre database and discharge letters. CA was defined as patients with perforated or gangrenous appendicitis on histology. Patients were divided into 2 groups; Group 1 (G1) included patients with CA who had a drain inserted; Group 2 (G2) included patients with CA and no drain.
|
Inclusion Criteria:
* All patients over the age of 16 with complicated appendicitis (CA) were included
Exclusion Criteria:
* Patients with evidence of caecal/ appendicular malignancy were excluded.
|
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] |
|
NCT05454020
|
A Study of Topical XG004 in Participants With Osteoarthritis of the Knee
|
This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee
|
The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day Safety follow-up period that will be conducted by telephone for each Cohort.
Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and assigned treatment on a 3:1 (XG004: placebo) ratio.
|
Inclusion Criteria:
1. Participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent form.
2. Body Mass Index (BMI) of 18 to 39, inclusive, at the time of Screening visit.
3. Participant who is diagnosed with primary knee OA fulfilling the American College of Rheumatology (ACR) Clinical and Radiographic criteria for ≥ 26 weeks prior to Screening visit.
4. Kellgren-Lawrence Grade II to IV as confirmed by X-ray during Screening visit or within 6 months prior to Screening visit in the study knee.
5. The average daily walking pain scale in the study knee over Day -4 to Day -2 during the Baseline period must be ≥ 4.0 on NRS 0-10 scale.
Exclusion Criteria:
1. Participants with any systemic or dermatological disorder that may interfere with the evaluation of the test site reactions (e.g., atopic dermatitis, contact eczema, psoriasis).
2. Participants with scars, moles, tattoos at application site or other abnormal pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results.
3. Participants with any of the following conditions on the test area: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, acne vulgaris, atrophic skin, striae atrophic, fragility of skin veins, ichthyosis, ulcers or wounds.
4. Participants exposed to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, solarium); and waxing, laser/IPL hair removal, fake/spray tanning is prohibited 14 days prior to enrollment or who may foresee an intensive UV exposure or swimming during study participation.
5. Known hypersensitivity or allergy to NSAIDs or gabapentinoids or any component(s) of the investigational products. This includes participants exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
6. Participants with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), hematological, or psychiatric system as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECG evaluations, or in the opinion of the Investigator.
7. Participants with any report of acute illness or febrile event within 72 hours prior to randomization.
8. Known positive coronavirus disease 2019 (COVID-19) viral test during Screening or within 3 days prior to Day -1, or suspected COVID-19 infection at check-in on Day -1 visit.
9. Participants who cannot refrain from strenuous exercise from 72 hours prior to first study dose through completion of the Safety follow-up visit
10. Any other condition that, in the opinion of the investigator, would jeopardize the safety of the study participant or impact the validity of the study results
|
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] |
NCT02949258
|
Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer
|
Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.
|
Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.
|
Inclusion Criteria:
* histologically confirmed gastric adenocarcinoma;
* males or females, aged 30-70 years;
* gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
* no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* eastern Cooperative Oncology Group performance status of 0 or 1;
* no serious concomitant diseases that make survival period \< 3 years;
* no prior anti-tumor therapy;
* have signed informed consent before the beginning of treatment.
Exclusion Criteria:
* patients can not bear surgical procedure;
* pregnant or lactating women;
* previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
* with peritoneal metastasis or distant metastasis;
* history of another malignancy within the last five years;
* history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;
* clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;
* organ allografts requiring immunosuppressive therapy;
* serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;
* moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN);
* hypersensitivity to any drug of the study regimen;
* unwilling or unable to comply with the protocol for the duration of the study.
|
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] |
NCT02331342
|
Comparison of NICOM and Innocor for Non-Invasive Determination of Cardiac Output
|
Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously showed promising results.
|
Inclusion Criteria:
* hemodynamic stability
* respiratory stability
Exclusion Criteria:
* patient unwilling to participate
|
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|
NCT06912347
|
Acupoint Application With Herbal Fumigation and Wash for Preventing Diarrhea-induced Perianal Infection in Allo-HSCT Patients
|
The goal of this clinical trial is to evaluate whether the combination of herbal fumigation and acupoint application can effectively prevent diarrhea in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).The main questions it aims to answer are:
Does the combination of herbal fumigation and acupoint application reduce the incidence of diarrhea in allo-HSCT patients? Does this intervention improve patients' quality of life and reduce the risk of perianal infections? Researchers will compare the intervention group (herbal fumigation + acupoint application) to the control group (povidone-iodine warm water fumigation) to determine the effectiveness of the TCM-based approach in preventing diarrhea and related complications.
Participants will:
Receive either herbal fumigation and acupoint application or povidone-iodine warm water fumigation twice daily, starting from 24h before transplant conditioning until 30 days post-transplantation (Day +30).
Undergo daily monitoring of perianal and local skin conditions, as well as diarrhea symptoms, by trained professionals.
This study aims to provide evidence for a non-invasive, low-risk TCM approach to improving outcomes for allo-HSCT patients.
|
Diarrhea is one of the most common complications following hematopoietic stem cell transplantation (HSCT), with an incidence rate of 50%-70%. During HSCT, high-dose chemotherapy drugs can damage the intestinal mucosa, especially in allogeneic haploidentical hematopoietic stem cell transplantation, where the pre-treatment dosage is 5-10 times higher than that of conventional chemotherapy. This makes patients prone to chemotherapy-related diarrhea. Additionally, due to the patients' compromised immune systems, they are susceptible to other related types of diarrhea. Prolonged diarrhea can easily lead to damage to the perianal skin and intestinal mucosa, severely affecting the quality of life while increasing the risk of perianal infections. This, in turn, may trigger severe systemic infections, sepsis, organ failure, and ultimately transplant failure. Currently, the main causes of diarrhea are believed to include chemotherapy toxicity, infections, acute graft-versus-host disease (aGVHD), engraftment syndrome, and thrombotic microangiopathy. Chemotherapy-related diarrhea is most common in the early stages of transplantation, with an incidence rate of 78.5%, and a median onset time of -3 days (range: -9 to +10 days). The clinical manifestations of diarrhea are complex, and the mortality rate is high, with some studies reporting rates as high as 38.7%. Effectively preventing diarrhea is of great significance for improving patients' quality of life and prognosis.
In Western medicine, the management of diarrhea primarily focuses on symptom control, promoting mucosal repair, preventing secondary infections, and maintaining water and electrolyte balance. While these approaches have achieved certain clinical efficacy, they still have limitations, particularly in the prevention of diarrhea. Traditional Chinese medicine (TCM), characterized by its principles of "syndrome differentiation and treatment" and a "holistic approach," offers greater flexibility. With ongoing research, the efficacy of TCM in treating diarrhea has gradually become evident. Previous studies have shown that the mechanisms of TCM in alleviating diarrhea in chemotherapy patients include: increasing colonic cyclooxygenase-2 and prostaglandin B2 levels, reducing the movement of water and electrolytes into the intestinal lumen; promoting the production of serum IL-15, increasing cecal pH, reducing colonic β-glucuronidase activity, and protecting the structural integrity of the intestinal mucosa; promoting the secretion of intestinal IgA, increasing the content of vasoactive intestinal peptide, reducing pro-inflammatory factors such as IL-15, and regulating intestinal immune barrier function.
Herbal fumigation and external application are important components of TCM external therapies. Warm liquids can promote blood circulation, working synergistically with herbal medicine to unblock qi and blood, dredge meridians, and dispel cold and pain. High concentrations of active drug components act locally on the body, while also avoiding the metabolic burden on the liver and kidneys associated with oral administration of herbal medicine. With minimal side effects, these methods are worthy of clinical promotion. This study aims to explore the clinical application of herbal fumigation and acupoint application in preventing diarrhea in HSCT patients, with the goal of reducing the incidence of diarrhea and improving patients' quality of life and prognosis.
If the participant agree to participate in this study, he/she will be randomly assigned to either the intervention group or the control group, with an equal probability of being placed in either group. Each group will include 90 participants.
* Intervention Group: Starting 24 hours before pre-treatment, the participants will receive herbal fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 5 minutes. Additionally, starting 30 minutes after each meal, acupoint application will be performed on five acupoints: Shenque (CV8), Tianshu (ST25), and bilateral Zusanli (ST36). The application will last 4 hours per day.
* Control Group: Starting 24 hours before pre-treatment, the participants will receive povidone-iodine warm water fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 15 minutes.
After enrollment, the participants will be assigned a unique identification number, and a medical record will be created for them. During the study,the participants will be required to cooperate with the research team in implementing the assigned perianal care measures. The research team will observe and record their daily perianal and local skin conditions, as well as any occurrences of diarrhea. All interventions will be performed and monitored by trained professionals.
All information will be managed by the project contact person (Qin Liyuan) and will only be accessible to members of the research team. It will not be shared with individuals outside the research team. If any remaining data is to be used for future research after the study concludes, it will only be used with the participants' consent.
By participating in this study, the participants will receive either herbal fumigation and acupoint application or standard perianal care, depending on your group assignment. The research team will closely monitor the participants' health status, aiming to reduce the incidence of diarrhea and improve prognosis.
|
Inclusion Criteria:
* First-time recipient of allogeneic hematopoietic stem cell transplantation.
* Age between 14 and 70 years old, regardless of gender.
* Primary disease type: Hematologic malignancies or aplastic anemia, with no restrictions on disease stage or remission status.
* Transplant type: Matched sibling donor, haploidentical related donor, or unrelated donor.
* Transplant conditioning regimen: Myeloablative, reduced-intensity, or non-myeloablative.
* Informed consent and voluntary participation in this clinical study.
Exclusion Criteria:
* Presence of intestinal infection within 2 weeks prior to enrollment.
* Previous diagnosis of inflammatory bowel disease or irritable bowel syndrome.
* Pathologically or radiologically confirmed involvement of the primary disease in the intestines.
* ECOG performance status ≥ 2, or presence of organ failure, rendering the patient unable to tolerate allogeneic hematopoietic stem cell transplantation.
* Allergy to the trial medications or physical conditions unsuitable for sitz baths.
* Individuals with mental disorders or those unable to provide informed consent.
* Poor compliance, such as failure to implement the intervention measures for 3 consecutive days.
* HIV-infected individuals, or those with a history of drug abuse or chronic alcoholism that may affect the evaluation of trial results.
|
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] |
NCT00651820
|
Effect of Collagenase on Healing and Scarring
|
A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.
|
Inclusion Criteria:
1. Provide written informed consent
2. Willing to attend all required study visits
Exclusion Criteria:
1. Known hypersensitivity to Clostridial collagenase
2. Anticoagulants (blood thinners, including aspirin) within two weeks
3. Congenital skin disorder which affects keratinocytes, elastin, or collagen
4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure
5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
6. At risk of keloid or hypertrophic scar formation
7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
8. Any skin disorder which causes delayed healing
9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs
|
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] |
|
NCT00612664
|
Phase II, 2nd Line Melanoma - RAND Monotherapy
|
The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
|
Inclusion Criteria:
* Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
* Men and women, who are at least 18 years of age
Exclusion Criteria:
* Ocular or mucosal melanoma
* Complete surgical resection of all identifiable sites of disease
* Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
|
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] |
|
NCT04979364
|
French Version of POMI Scale
|
French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.
|
Chronic pain prevalence in the general population was estimated at 31% in the world, which makes it a major public health problem, not only because of its enormous impact on patients' quality of life, but also because of its significant economic impact on society, with direct and indirect costs. Despite the lack of scientific evidence demonstrating their long-term benefits, analgesic opioids are largely used for treating chronic non-cancer pain (CNCP) lead to an increase of opioid use in recent decades in developed countries. Indeed, worldwide, opioid analgesic prescription use more than doubled from 2001 to 2013, most significantly in North America and in Western and Central Europe. Between years 2004 and 2017 in France, while overall analgesic opioid prescription use in the general population decreased by 8.9%, the used strong opioids increased by 104%. The same finding about increase in the use strong opioids was made in USA, Canada and UK. However, the use of opioid analgesics is not without risk, several international studies showed an increase opioid use disorders, hospitalizations and deaths related to the use of opioid analgesics. In France, rates of prescribed opioid-related hospital admissions increased by 167% from 2000 to 2017 and opioid-related deaths significantly increased by 146% (1,3 à 3,2 deaths / 1,000,000 habitants from 2000 to 2015). A similar observation can be made in the United States, where deaths from prescription opioid overdose have risen sharply in recent years, but in a much higher proportion than in France (in 2016 in the U.S., more than 42,000 overdose deaths, or an annual prevalence of 133 deaths/1,000,000 population).
In the context of CNCP, opioid analgesics are subject to increasing misuse in relation to a greater number of prescriptions but also through other sources of obtaining (doctor shopping) hat may contribute to the increase in risks associated with the use of opioid analgesics (hospitalization, death). Few studies in France, assessed the misuse of analgesic opioids, based on the evaluation of "doctor shopping" from healthcare databases, and particularly, Chenaf et al., showed an increase of analgesic opioids shopping behavior by 34%, between 2004 to 0.67% in 2017. It is therefore important to be able to identify analgesic opioid misuse. Actually Prescription Opioid Misuse Index (POMI) scale was validated in 2008 by American team in 137 patients recruited from community substance abuse treatment programs, regional jails, pain clinics and private internal medicine practices.
The primary objective was the cross-cultural validation of French version of an opioid analgesic misuse screening scale (POMI) in chronic pain patients in primary care. The secondary objective was the assessment of the relationship between pain intensity and analgesic opioid misuse.
|
Inclusion Criteria:
* patients aged 18 or more, suffered from chronic non-cancer pain for at least 6 months, with at least one analgesic opioid daily for 3 months, and follow in pain clinic.
Exclusion Criteria:
* inability to read or understand questionnaires alone, cancer, and impossibility to do test and retest questionnaires.
|
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] |
NCT01700725
|
Gulf War Illness Nasal Irrigation Study
|
The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.
|
Background: Gulf War Illness (GWI) results in tremendous impact to quality of life. Symptoms of chronic rhinosinusitis (CRS) and fatigue are the first (47%) and third (41%) most common symptoms of patients with GWI, respectively. These symptoms are biologically characterized by a milieu of elevated levels of proinflammatory cytokines; to date, the profile of these cytokines in serum and nasal secretions is incompletely understood and has not been assessed in response to therapy. Nasal irrigation (NI) is a therapy which bathes the nasal cavity with a solution (liquid). There are two promising forms of NI; saline NI (S-NI) is hypothesized to improve sinus symptoms by thinning and clearing mucus and inflammatory mediators, decreasing mucosal edema and improving ciliary function. Xylitol NI (X-NI) has been shown to change the salinity of the mucosal surface resulting in enhanced antimicrobial properties. Although NI is an evidence-based adjunctive therapy for CRS and has been reported to be effective for CRS and fatigue, it has not been assessed in a GWI population.
Specific Aims, Hypotheses and Study Design: The specific aims of this proposal are to determine whether routine care plus S-NI, or X-NI, compared to routine care alone, result in improved health-related quality of life (HRQoL), are cost-effective and decrease proinflammatory bias in subjects with GWI who suffer from CRS and fatigue.
Consistent with our specific aims, we will test the following hypotheses: In an RCT setting, at 26 weeks post-enrollment, adults with GWI and symptoms of CRI and fatigue, treated with routine care plus S-NI or X-NI, compared to those treated with routine care alone, will demonstrate:
H1: improved HRQoL: a) sinus-disease specific HRQoL as evaluated by the validated Sinonasal Outcomes Test (SNOT-20) questionnaire (primary outcome measure); b) fatigue-specific HRQoL as assessed by the validated questionnaire, the Multidimensional Fatigue Inventory (MFI); and c) overall HRQoL as assessed by the validated questionnaire the Medical Outcomes Survey Short Form-36 (SF-36; mental and physical health domains) augmented with 18 sleep- and breathing related questions.
H.2: greater cost-effectiveness as measured by the average cost of the intervention divided by the average effectiveness (as assessed by a improvement in SNOT-20 scores), and reported as the "dollars spent per subject restored to health."
H.3: improved treatment satisfaction as assessed by a single-item treatment satisfaction score and a qualitative exit interview.
H.4: improved proinflammatory bias: a) reduced activation and dysregulation of proinflammatory pathways as determined by a reduction in URI-specific inflammatory cytokines in serum and nasal secretions; and b) improved serum-based complete blood count, sedimentation rate or C-reactive protein, or nasal swab-based neutrophil or eosinophil counts.
Study Design: 26 week duration of follow-up, 3-arm RCT (N=75). All groups will utilize routine care for their GWI and symptoms of CRS and fatigue. Groups 1 and 2 will in addition add S-NI or X-NI twice daily to their routine care, respectively. Group 3 will continue to use routine care with no other additions (control group); control group participants will be offered NI training and related materials (xylitol or saline per subject preference) after they complete their 26-week follow-up period.
Impact: Positive findings would suggest a number of important effects:
* Statistically positive results on HRQoL outcome measures would suggest that NI can provide effective adjunctive therapy for CRS and fatigue in adults with GWI, improving health of affected patients and potentially providing gains to society through reduced health care utilization and absenteeism related costs.
* Positive biomarker findings would contribute to our better understanding of the etiology of CRS and fatigue in the GWI population and of possible biological pathways underlying the NI efficacy.
* The finding that either form of NI is cost effective would provide economic justification for its clinical use.
|
Inclusion Criteria:
* English fluency and basic reading and writing literacy.
* Deployment to the Persian Gulf (e.g., Iraq, Kuwait, Saudi Arabia) for the purpose of Operation Desert Shield or Operation Desert Storm during the first Gulf War (1990-1991).
* Meeting criteria for a diagnosis of GWI as based on the "Kansas" GWI case definition; only the Kansas case definition (from among the several currently used case definitions) can differentiate between Gulf War-deployed and non-deployed Gulf era veterans.
* Meeting criteria for a diagnosis of chronic rhinosinusitis (CRS) using self-reported symptoms and based on clinical guidelines; eligible subjects will report: • sinonasal symptoms for at least 12 weeks; • a constellation of sinonasal symptoms including either two or more major factors, or 1 major and 2 minor factors (see Table 1 below), or chronic nasal purulence for 12 or more weeks; and • a moderate to severe HRQoL impact (≥ 3 points on a 0-10 Likert severity scale) as assessed by a single item question:11 "What has been the average level of your sinus symptoms daily over the past month on a 0-10 scale?" This item is consistent with eligibility criteria used in prior NI studies.
* Chronic fatigue of moderate-to-severe severity defined as scoring at least 3 points on a single question (0-10 Likert scale): "What has been the average level of your daily fatigue over the past month on a 0-10 scale?"
Exclusion Criteria:
* Self-reported pregnancy.
* Current use of liquid NI or xylitol nasal spray; regular use is defined as 1 or more irrigations weekly for 3 consecutive weeks.
* Self-reported neurological or musculoskeletal conditions that could facilitate aspiration, or patients who otherwise cannot physically perform the NI procedure.
* Self-reported borderline personality disorder.
* Inability or stated reluctance to reliably participate in study activities.
* Severe or unstable mental health problems that would preclude safe or reliable study participation as based on an in-person evaluation by a psychiatry team; active delusional disorder, depressive disorder or alcohol/drug abuse or dependence will be a primary target of this interview using both a structured clinical interview (MINI ref) and psychiatry team evaluation.
|
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] |
NCT01325142
|
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
|
This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.
|
The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.
This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors
|
Inclusion Criteria:
* The study candidate must have sufficient Formalin Fixed Paraffin Embedded (FFPE)Specimens (lymph node or tumor) for DNA extraction available for study SNP assessment
* Patients over the age of 21 with a histologically confirmed diagnosis of cancer who have received nitrogen containing bisphosphonate therapy for metastatic bone disease.
* FFPE tissues are to have been removed for clinical indication and sufficience study volume of specimen must be available in an established tissue repository.
* - Study FFPE tissues include:
* formalin fixed paraffin embedded leukocytes from lymph nodes with or without involvement by tumor AND/OR
* formalin fixed paraffin embedded tumor tissue (tumor block without invasive cancer is acceptable if the specimen is believed to be sufficiently cellular (breast tissue or noninvasive cancer) to yield adequate DNA)
* Medical records available for data abstraction
Exclusion Criteria:
* Insufficient specimen available to perform the assays proposed for specimen DNA analysis
* No accessable medical records
|
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] |
NCT01466140
|
Effects of Writing Down the Request for Help on Patient Satisfaction in General Practices
|
The primary objective of this study is to determine whether exploring the request for help more thoroughly improves patient satisfaction in general practice (primary care).
|
Patient satisfaction has been an important topic of interest in primary health care during the last decade(s). Many factors during the consultation influence patient satisfaction. One of the aspects in a consultation is the request for help; especially in primary care the request for help has been recognised as an important aspect influencing patient satisfaction. The investigators hypothesized that exploring the request for help more thoroughly would improve patient satisfaction in general practice.
|
Inclusion Criteria:
* All patients with a new request for help.
Exclusion Criteria:
* Dementia
* Mental disability
* No or little knowledge of the Dutch language
* Illiteracy
* Limited vision
|
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] |
NCT03446391
|
Matched Pair Study - Kinematic Vs Mechanical Alignment
|
The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.
|
The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.
|
Inclusion Criteria:
1. Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
2. Patients necessitating primary Total Knee Replacement
3. Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
Exclusion Criteria:
1. Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
2. Previous osteotomy around the knee
3. Ligament instability likely to require higher level of constraint
4. Previous infection or inflammatory disease
5. Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.
|
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] |
NCT06213428
|
Effects of Probiotics on Synaptic Plasticity During the Menstrual Cycle
|
Modulation of our gut microbiota through probiotics, can improve our emotional state, decrease pain sensitivity, improve cognitive processes, increase neurotransmitter levels and alter functional connectivity. In addition, probiotics regulate estrogen levels. Estrogen levels have been recognized to influence the gut microbiota, impact neural activity, memory, and cognition.
This study aims 1) to determine whether probiotics can increase the propensity for synaptic plasticity in females and 2) to determine if there are differences in the propensity for plasticity depending on the phase of the menstrual cycle.
|
The human gastrointestinal (GI) tract is comprised of trillions of bacterial strains. Recent work has focused on investigating the influence of the gut microbiota on the processing and function of our brain; this is known as the 'gut-brain axis'. Our gut microbiota can be altered through diet, antibiotics, prebiotics and probiotics (Hemarajata et al., 2013). Probiotics are live microorganisms, which when delivered in adequate amounts, can offer beneficial health outcomes to the host (Hill et al., 2014). Modulation of our gut microbiota through probiotics, can improve our emotional state (Bagga et al., 2018; Messaoudi et al., 2011; Tillisch et al., 2013), decrease pain sensitivity (Weizman et al., 2016), improve cognitive processes (Chung et al., 2014; Kim et al., 2020), increase neurotransmitter levels (Mittal et al., 2017) and alter functional connectivity (Rode et al., 2022; Bagga et al., 2019). In addition, probiotics regulate estrogen levels (Guo et al., 2016; Urbaniak et al., 2016).
Estrogen levels have been recognized to influence the gut microbiota. The gut produces β-glucuronidases which is the enzyme required to breakdown conjugated estrogen into its active form (Dabek et al., 2008; Ervin et al., 2019). Low β-glucuronidases production occur in the presence of diminished bacterial diversity levels in the gut. The consequence of the low β-glucuronidases is a reduction in active forms of estrogen (Siddiqui et al., 2022; Pugh et al., 2021; Kwa et al., 2016, Baker et al., 2017). Further, gastrointestinal symptoms increase during menstruation (Pugh et al., 2021). Last, irritable bowel syndrome is more prevalent in females, indicating a possible role of sex hormones in relation to the gut microbiome (Pugh et al., 2021).
Estrogen has been found to impact neural activity, memory, and cognition (Inghilleri et al., 2004; Luine 2014). EEG brain activity was collected from women in their follicular and luteal phase (Brotzner et al., 2014). When estrogen levels were highest, individual alpha frequency oscillations (IAF) were lowest (Brotzner et al., 2014), the latter is associated with reduced cognition and working memory (Li et al., 2023). In addition, estrogen was found to reduce the firing threshold in some neurons which can promote excitability in the cortex (Gregory et al., 2019). Conversely, high progesterone levels are known to increase GABA activity which reduces neural activity (Guennoun et al., 2015). Furthermore, a 5Hz repetitive transcranial magnetic stimulation (rTMS) protocol was delivered over the motor cortex during the early and late follicular phase (Inghilleri et al., 2004). Corticospinal activity was increased when estradiol levels were highest (Inghilleri et al., 2004) showing the association between estradiol and synaptic plasticity.
Collectively, the literature suggests that women may have a reduced capacity for synaptic plasticity during the luteal phase when estradiol levels are low. Introducing a probiotic will increase β-glucuronidases which leads to greater availability of circulating estrogen which should promote synaptic plasticity. It is hypothesized that increases in synaptic plasticity will occur in the follicular and luteal phase in the presence of probiotics. This study aims 1) to determine whether probiotics can increase the propensity for synaptic plasticity in females and 2) to determine if there are differences in the propensity for plasticity depending on the phase of the menstrual cycle.
Methods:
Participants will be randomized into Group A or Group B. Twenty participants will be in Group A and 20 participants will be in group B. If randomized to Group A, all visits will be conducted between day 6-9 (mid-follicular phase) when estradiol levels are highest. If randomized to Group B, all visits will be conducted during day 19-23 (mid-luteal phase) when progesterone levels are highest. This will be a randomized, crossover, double-masked study whereby participants will receive both real probiotic and placebo probiotic for 28 days. Assessments will be acquired during four visits (Before and after each intervention, separated by a 28 day washout). The McMaster University Medical Centre (MUMC) pharmacy will be responsible for the preparation of the blinded probiotic kits and randomization schedule. The probiotic used will be a commercially available product called Progressive Perfect Probiotic (https://www.progressivenutritional.com/products/perfect-probiotic-120-billion).
The following dependent measures will be used: Active motor threshold, Resting motor threshold, short interval intracortical inhibition, motor evoked potentials.
These measures will be taken before and after a synaptic plasticity inducing protocol
To assess synaptic plasticity, repetitive TMS will be performed using a 70mm inner diameter figure-of-eight coil with a Magstim Super Rapid2 Plus Stimulator (Magstim, Whitland, UK). Biphasic magnetic pulses will be delivered over the primary motor area of the dominant hemisphere to find the optimal position for eliciting a MEP in the contralateral APB muscle. Intermittent theta burst stimulation (iTBS) protocol will be delivered using biphasic pulses in burst of three pulses delivered in 6Hz trains that will last 2s, this will be followed by 8s with no pulse delivered. iTBS will be repeated for a total of 612 pulses at 80% of AMT (Fassett et al., 2017).
|
Inclusion Criteria:
* right handed, females between 18-35 years old with a regular menstrual cycle (approximately 26-30 days)
Exclusion Criteria:
* contradictions to TMS
* contradictions to probiotic
* Females who use hormone altering devices (i.e. oral contraceptives)
|
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