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{
"NCT_ID" : "NCT02550756",
"Brief_Title" : "Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)",
"Official_title" : "An Open Label, Ascending Dose Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)",
"Conditions" : ["Morton's Neuroma"],
"Interventions" : ["Drug: CTNX-4975"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-11",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-09-14",
"First_Posted(Estimated)" : 2015-09-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-14",
"Last_Update_Posted(Estimated)" : 2015-09-15",
"Last_Verified" : 2015-09"
}
}} | #Study Description
Brief Summary
The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study.
#Intervention
- DRUG : CTNX-4975
- Other Names :
- Capsaicin | #Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged >=18 years at the time of the Screening Visit.
* Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.
* Diagnosis of intermetatarsal neuroma (Morton's neuroma) based on medical history and physical examination with evidence of focal tenderness and pain in the area of the neuroma, confirmed by ultrasound or other imaging modality. Typically the subject will have sensory symptoms in the distribution of the affected common digital nerve. However, provided the imaging study is positive, the presence of these sensory symptoms is not required. The neuroma may be in either the second or third intermetatarsal space.
* An average pain score of 4.0 to 9.0 (during the 7 days prior to dosing) on the Numeric Pain Rating Scale (NPRS), as rated daily at bedtime for average pain while walking in the last 24 hours, relevant to the affected foot. At least 4 of 7 scores during the week prior to dosing must be recorded.
* For female subjects: reproductive status is such that the subject is surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control; if of child-bearing potential, is not pregnant (negative urine pregnancy test prior to enrollment), is not planning to get pregnant during the course of the study, and is not lactating.
* Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and diaries, and to communicate meaningfully with the study personnel.
* Signed an Informed Consent Form approved by the Institutional Review Board.
Exclusion Criteria:
* Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
* The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
* Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
* Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
* The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
* Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis, etc.) or evidence of clinically meaningful ischemia which in the opinion of the investigator would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. For example, if the subject has pain from a bunion but that pain is easily distinguished by the subject from the neuroma pain, then the subject would still be a candidate for the study. Note, however, that the subject should also be able to distinguish the neuroma pain from the bunion pain in terms of foot function. In general, if another foot pain condition (in the same foot) gives rise to pain that is greater than the neuroma pain, then that subject should in most instances be excluded.
* Signs of arterial insufficiency in the feet.
* Ulcer and/or wound in the foot affected by the neuroma.
* Active cutaneous disease, or other anatomical or physiological foot disorder, at the anticipated site of study drug injection.
* History of clearly documented allergic reaction to local anesthetics or capsaicin.
* Presence of any medical condition or instability that, in the judgment of the Investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
* Clinically significant laboratory result at the Screening Visit (in the opinion of the Investigator).
* Has diabetic neuropathy or other length dependent neuropathy.
* Use of any investigational medication in the 30 days prior to the current study, is scheduled to receive such an agent while participating in this study, or received a topical or injected investigational medication in the index foot within the past 60 days.
* Use of topical medication on the index foot within 7 days of screening (including lidocaine or capsaicin).
* Prior participation in an ALGRX 4975 study.
* History of substance abuse disorder within the past year as defined by DSM-IV, has current evidence for a substance abuse disorder, is receiving medicinal treatment for drug abuse, or tests positive upon urine drug screen for a substance of abuse.
* Has any condition or is taking any medication that would be contraindicated for study participation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02550756 | 201,152 |
{
"NCT_ID" : "NCT05486065",
"Brief_Title" : "A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight",
"Official_title" : "Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study",
"Conditions" : ["Diabetes Mellitus, Type 2"],
"Interventions" : ["Drug: Semaglutide", "Drug: Placebo"],
"Location_Countries" : ["Poland", "United States", "Puerto Rico", "Hungary", "Greece"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-08-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-10-12",
"Study_Completion_Date(Actual)" : "2023-12-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-07-31",
"First_Submitted_that_Met_QC_Criteria" : 2024-10-10",
"First_Posted(Estimated)" : 2022-08-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-07-31",
"Last_Update_Posted(Estimated)" : 2024-11-05",
"Last_Verified" : 2024-10"
}
}} | #Study Description
Brief Summary
This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.
#Intervention
- DRUG : Semaglutide
- Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
- DRUG : Placebo
- Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. | #Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Aged 18 <= age <= 64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus greater than equal to (>=) 180 days prior to the day of screening.
* Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
* Body Mass Index (BMI) >= 27.0 kilograms per meter square (kg/m^2).
* Stable daily dose(s) >= 90 days prior to the day of screening of any metformin formulations.
Exclusion Criteria:
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05486065 | 21,949 |
{
"NCT_ID" : "NCT05129657",
"Brief_Title" : "CSD201001: Study to Assess Elements of Abuse Liability for Three Nicotine Pouches",
"Official_title" : "An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Three P10 Nicotine Pouches",
"Conditions" : ["Smoking", "Tobacco Use", "Tobacco Smoking"],
"Interventions" : ["Other: Product N", "Other: Product D", "Other: Product C", "Other: Product B", "Other: Product A"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-11-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-24",
"Study_Completion_Date(Actual)" : "2022-06-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-10-29",
"First_Posted(Estimated)" : 2021-11-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-11-09",
"Last_Update_Posted(Estimated)" : 2024-04-30",
"Last_Verified" : 2022-06"
}
}} | #Study Description
Brief Summary
This is a two-site, open-label, randomized, 5-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Detailed Description
Cigarette smokers and smokers also using smokeless tobacco products (ST) will be recruited into this AL study to evaluate elements of AL of three nicotine pouches compared to combustible cigarettes (CC) and nicotine polacrilex gum. At least one-third of the study population will include smokers who also use ST.
Potential subjects may complete a pre-screening telephone interview. Subjects will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled and confined for 6 days. Subjects will be randomized to one of 10 product use sequences (using a Williams Design) in which the subjects will evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three IPs, and both a high-AL comparator (subject's usual brand \[UB\] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy \[NRT\] nicotine gum).
On Day 2 and continuing through Day 6, subjects will participate in Test Sessions that will last for approximately 4 hours. Each Test Session will include collection of both PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
On the half day prior to each respective Test Session, a Product Acclimation Period will allow subjects ad libitum use of the randomized IP (at least two trial uses) for product familiarization prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco abstinence begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.
#Intervention
- OTHER : Product A
- Usual Brand (UB) filtered, non-menthol or menthol cigarette
- OTHER : Product B
- P1012914, A nicotine pouch product with 4 mg of nicotine
- OTHER : Product C
- P1012915, A nicotine pouch product with 8 mg of nicotine
- OTHER : Product D
- P1012919, A nicotine pouch product with 12 mg of nicotine
- OTHER : Product N
- Nicorette® White Ice Mint 4 mg nicotine gum | #Eligibility Criteria:
Inclusion Criteria:
* 1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
* Generally healthy males or females, 21 <= age <= 60 of age, inclusive, at the time of consent.
* Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
* Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.
* Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening, will be enrolled.
* Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the subject.
* Expired breath carbon monoxide (ECO) level is >= 10 ppm and <= 100 ppm at Screening and at check-in Day 1.
* Positive urine cotinine test at Screening.
* Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ('How soon after you wake up do you smoke your first cigarette?') is either 'Within 5 minutes' or '6 <= age <= 30 minutes' (Heatherton et al., 1991).
* Willing to use the UB cigarette, IPs, and Nicorette® nicotine gum during the study period.
* Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of five Test Sessions.
* Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
Examples of acceptable means of birth control are, but not limited to:
1. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
2. physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
3. non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
4. vasectomized partner; and
5. post-menopausal and not on hormone replacement therapy.
* Agrees to an in-clinic confinement of 6 days (5 nights).
Exclusion Criteria:
* Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
* History, presence of, or clinical laboratory test results indicating diabetes.
* Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
* History or presence of bleeding or clotting disorders.
* Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
* Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
* Weight of <= 110 pounds.
* Hemoglobin level is < 12.5 g/dL for females or < 13.0 for males g/dL at Screening.
* Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
* A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or check-in Day 1.
* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
* Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (<=) 30 days prior to signing the informed consent.
* Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (<=) 30 days prior to signing the informed consent.
* Any use of daily aspirin (>= 325 mg) or any use of other anticoagulants.
* Individuals >= 35 years currently using systemic, estrogen-containing contraception or hormone replacement therapy.
* Whole blood donation within 8 weeks (<= 56 days) prior to signing the informed consent and between Screening and check-in Day 1.
* Plasma donation within (<=) 7 days prior to signing the informed consent and between Screening and check-in Day 1.
* Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
* Participation in another clinical trial within (<=) 30 days prior to signing the informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the informed consent in the current study.
* Drinks more than 21 servings of alcoholic beverages per week.
* Has a positive alcohol result at Screening or check-in Day 1.
* Determined by the PI to be inappropriate for this study.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05129657 | 38,765 |
{
"NCT_ID" : "NCT03994250",
"Brief_Title" : "Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)",
"Official_title" : "Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)",
"Conditions" : ["Osteo Arthritis Knee"],
"Interventions" : ["Other: Kinematic Alignment for total knee replacement surgery", "Other: Mechanical Alignment for total knee replacement surgery"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-02-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-01",
"Study_Completion_Date(Actual)" : "2021-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-15",
"First_Posted(Estimated)" : 2019-06-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-06-20",
"Last_Update_Posted(Estimated)" : 2021-04-01",
"Last_Verified" : 2020-03"
}
}} | #Study Description
Brief Summary
Total knee replacement (TKR) is a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment. However the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales.
In an attempt to improve patient satisfaction recent developments have included the individualization of component alignment with the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, a technique called kinematic alignment (KA). The outcomes of kinematic alignment have been assessed in case series but so far only one randomised controlled trial (RCT) \[Digital Object Identifier (DOI)10.1302/0301-620X.96B7.32812 Published 1 July 2014\] undertaken in the USA has compared the clinical results of kinematic alignment using patient-specific instruments with the traditional technique of mechanical alignment, demonstrating a substantial benefit in postoperative patient pain relief and function. Therefore, for direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators would like to undertake a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematical aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
Detailed Description
In order to be able to undertake a randomized controlled trial (RCT) comparing the efficacy of kinematic alignment versus conventional mechanical alignment for total knee replacement a robust assessment of the expected standard deviation of the primary outcome measure (Oxford Knee Score \[OKS\]) in both arms of the proposed RCT must be undertaken, hence this pilot study.
To determine whether there are improved postoperative outcomes in the investigative arm using the following patient reported outcomes: Knee Implant Performance (PKIP - pre and post surgical), Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Knee Noise and Front of Knee Pain Score and Quality of Life score EQ-5D which will be completed at baseline(pre-operatively) and post-operatively at 6 weeks (normal clinical follow up), 1 year (normal clinical follow up) and 2 years. In addition, x-rays of the knee (AP, lateral \& skyline) will be taken at the same time. These outcomes are identical to the data collected in the previous mechanically aligned study which will be used as the control arm.
Much attention has been given to the alignment of the components in total knee replacement (TKR) and this is relatively easy to quantify, particularly in the coronal plane. However, due to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment, the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales. The relationship between in-range and varus (turned inward toward the mid line of the body to an abnormal degree) and valgus (turned outward) outlier categories of the limb and implant survival of a primary total knee replacement is weak at 15 years. Leaving a limb, knee, or tibial component within a natural range of varus does not reduce implant survival at 3, 5, 7, and 10 years.
With the development of individualization of component alignment and the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, the kinematic alignment technique has shown in case series and one RCT in the USA a substantial benefit in postoperative patient pain relief and function.
For direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators will conduct a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematic aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
#Intervention
- OTHER : Kinematic Alignment for total knee replacement surgery
- Using Kinematic Alignment for total knee replacement surgery
- Other Names :
- Kinematic Arm
- OTHER : Mechanical Alignment for total knee replacement surgery
- Using mechanical alignment for total knee replacement surgery
- Other Names :
- Control Arm | #Eligibility Criteria:
Inclusion Criteria:
* Male or female between the age of 22 and 80 years inclusive
* Diagnosis of non-inflammatory degenerative joint disease
* Suitable candidate for cemented primary total knee arthroplasty
* Voluntary, informed consent to participate in the study
* Subject is not currently bedridden
* Able to understand (in the opinion of the clinical investigator) the clinical investigation and co-operate with clinical investigations
* Subject is able to comfortably speak, read and understand questions
Exclusion Criteria:
* Females who are pregnant or lactating
* Contralateral knee already enrolled in the study
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
* Contralateral amputation
* Currently experiencing radicular pain from the spine
* Participated in a study with an investigational product in the last 3 months
* Currently involved in any personal injury litigation, medical-legal or workers compensation claims
* Known drug or alcohol abuser or a psychological disorder that could affect their ability to complete patient reported questionnaires
* Diagnosed with fibromyalgia that is currently being treated with prescription medication
* Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease)
* Suffering with inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis,psoriatic arthritis, systemic lupus erythematosus
* Medical condition with less than 2 years life expectancy
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03994250 | 144,528 |
{
"NCT_ID" : "NCT04000243",
"Brief_Title" : "Diagnosis of Helicobacter Pylori Based on Gastric Collecting Venules",
"Official_title" : "Interobserver Agreement of Endoscopic Diagnosis of Helicobacter Pylori Based on the Arrangement of Gastric Collecting Venules: Prospective and Multicenter Study",
"Conditions" : ["Helicobacter Pylori Infection", "Upper Endoscopy", "Regular Arrangement of Collecting Venules"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-07-01",
"Study_Completion_Date(Actual)" : "2020-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-06-21",
"First_Posted(Estimated)" : 2019-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-06-26",
"Last_Update_Posted(Estimated)" : 2023-03-01",
"Last_Verified" : 2023-02"
}
}} | #Study Description
Brief Summary
Helicobacter pylori (Hp) is the major cause of gastritis and gastritis-associated diseases. Detection of a regular arrangement of collecting venules (RAC) pattern in the lesser gastric curvature correlates with negative Hp status with a sensitivity and negative predictive value (NPV) higher than 90% in Asian countries.
In a recent study carried out in our hospital, it has been shown that the presence of RAC pattern in the lesser gastric curvature, evaluated with high definition endoscopy, can accurately identify patients without Hp.
The aim of this study is to confirm the validity of the endoscopic diagnosis of Hp infection in the West by means of the RAC pattern in a multicenter prospective study and to evaluate interobserver variability before establishing its applicability in clinical practice.
Detailed Description
We designed a prospective study including patients who will undergo upper gastrointestinal endoscopy from July 2019 to June 2020 at the Endoscopy Unit of Hospital Clinic of Barcelona.
The Ethics Committee of Hospital Clinic of Barcelona approved the study.
Upper gastrointestinal endoscopies will be performed with high definition endoscopes (Olympus, Germany) without magnification by three endoscopists. One of the endoscopists is considered as an expert with more than 20 years of experience and prior training in Japanese centers. All the examinations will be performed with sedation controlled by an anesthesiologist. After the routine examination of the esophagus, stomach, and duodenum, close observation will be carried out at the distal part of the lesser curvature and pictures will be taken. The Olympus system will be used for image storing and text reporting.
The presence of a regular or irregular arrangement of collecting venules will be evaluated in real time during gastric exploration in the lower part of the lesser curvature of the gastric body with good insufflation, close to the incisura angularis. If minute red points were visible regularly and homogenously, the finding will be scored as RAC positive (RAC+). If this finding was absent or there was a patchy distribution at the site of close observation, it will be defined as RAC negative (RAC-).
The following baseline characteristics will be collected: age, sex, antibiotics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), antithrombotic or anticoagulant use in the last two weeks, history of Hp eradication and detection of significant endoscopic findings (erosive duodenitis, non-erosive duodenitis, duodenal ulcer, erosive gastritis, gastric ulcer and signs of atrophic gastritis or intestinal metaplasia).
Hp infection status will be determined by mucosal biopsies. We will perform 5 samples for histological study according to Sydney criteria (2 in antrum, 1 in incisura angularis and 2 in gastric body); or 2 biopsies (1 in antrum and 1 in gastric body) for histology and immunohistochemical study for Hp. Patients were classified as Hp positive if one of these two tests are positive.
For the histological study, samples will be fixed in formalin and stained with hematoxylin and eosin for the evaluation of gastritis and with Giemsa for Hp status. The immunohistochemical study will be carried out systematically in the case of a negative histological study for Hp. The pathologist has access to the endoscopic diagnosis but not to RAC status.
Statistical analysis
The quantitative variables will be described by the mean and the standard deviation, while the qualitative variables by proportion. The sensitivity, specificity, positive predictive value (PPV), NPV and accuracy of RAC for the diagnosis of uninfected Hp patients will be calculated. 95% confidence interval will be calculated by using standard formula. Comparisons will be done using Chi-square test for categorical variables and t test for continuous variables. In addition, a multivariate logistic regression analysis will be carried out to assess the existence of predictive factors of RAC and the odds ratio (OR) was calculated to indicate the associated risk. P \<0 .05 will be considered statistically significant. All statistical analyses will be performed using the SPSS, version 23 (SPSS Inc., Chicago, USA).
#Intervention
- DIAGNOSTIC_TEST : Endoscopic diagnosis of Hp
- Detection of a regular arrangement of collecting venules (RAC) pattern in the lesser gastric curvature | #Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years who have an upper gastrointestinal endoscopy
Exclusion Criteria:
* Taking antibiotics in the last 4 weeks
* Presence of alimentary or hematic remains that prevent the correct visualization of the mucosa
* Bleeding from the upper gastrointestinal tract
* History of portal hypertensive gastropathy or lymphoma
* History of partial or total gastrectomy
* Refusal to participate
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04000243 | 184,402 |
{
"NCT_ID" : "NCT03602300",
"Brief_Title" : "A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study",
"Official_title" : "A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir in Healthy Adult Volunteers Under Fasting Conditions",
"Conditions" : ["Bioequivalence Study"],
"Interventions" : ["Drug: Ravidasvir test formulation produced by Doppel", "Drug: Ravidasvir reference formulation produced by EEPI"],
"Location_Countries" : ["Malaysia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-06-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-17",
"Study_Completion_Date(Actual)" : "2018-08-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-21",
"First_Posted(Estimated)" : 2018-07-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-18",
"Last_Update_Posted(Estimated)" : 2020-01-31",
"Last_Verified" : 2020-01"
}
}} | #Study Description
Brief Summary
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t.
A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%
Detailed Description
During the course of development, a new batch of ravidasvir tablets has been prepared by the proposed commercial manufacturer (Doppel Farmaceutici, Italy). Tablets manufactured by Doppel Farmaceutici are intended to be used in subsequent clinical trials and be registered as the commercial product. The purpose of this Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study is to assess if ravidasvir 200 mg tablets supplied by European Egyptian Pharmaceutical Industries (EEPI) and tablets from Doppel Farmaceutici are bioequivalent.
Primary objectives:
To compare the rate and extent of absorption for ravidasvir (RDV) when administered as a single 200 mg oral dose of the proposed commercial product ('test') produced by Doppel Farmaceutici with the clinical trial product ('reference') manufactured by EEPI in healthy volunteers, under fasted conditions.
Secondary objectives To evaluate the safety and tolerability of single oral doses of RDV in healthy volunteers.
#Intervention
- DRUG : Ravidasvir test formulation produced by Doppel
- To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ('test') produced by Doppel Farmaceutici with the clinical trial product ('reference') manufactured by EEPI in healthy volunteers, under fasted conditions.
- DRUG : Ravidasvir reference formulation produced by EEPI
- To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ('test') produced by Doppel Farmaceutici with the clinical trial product ('reference') manufactured by EEPI in healthy volunteers, under fasted conditions. | #Eligibility Criteria:
Inclusion Criteria:
* Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
* Must be between 18 and 55 years, inclusive.
* Must be a non-smoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. Users of electronic cigarette are not allowed to participate in this study. A smokerlyzer test will be performed to estimate the amount of carbon monoxide in the breath.
* Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
* Must be HIV-1 antibody negative.
* Must be hepatitis B (HBV) surface antigen negative.
* Must be hepatitis C (HCV) antibody negative.
* Females of childbearing potential must have a negative serum pregnancy test at Screening and on Day 0.
* Females of childbearing potential must agree to utilize highly effective contraception methods (with the exception of hormonal contraceptive) from 3 weeks prior to baseline (Day 0) throughout the duration of study treatment and for 30 days following the last dose of study drug. Female healthy volunteers who utilize hormonal contraceptive as one of their birth control methods are not allowed to participate in this study.
* Men who participate in this study must not father a child and must agree to use contraceptive protection in the form of a double barrier method (condom or diaphragm) from the moment they sign the ICF until the Post-Study Safety Assessment.
* Healthy volunteers must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs), and screening laboratory evaluations (haematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance.
* Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the Investigator.
* Must have negative urine screen for drugs of abuse (including ketamine, amphetamines, tetrahydrocannabinol, morphine, methamphetamine, and benzodiazepines)
* Must be willing and able to comply with all study requirements
Exclusion Criteria:
* Healthy volunteers with any hematologic or urinary analyte that is outside the normal limits of the study laboratory and have been determined by the Investigator to have clinical significance at Screening will be excluded
* Pregnant or lactating female healthy volunteers.
* Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
* Have participated in an investigational trial involving administration of any investigational compound within 90 days prior to the study dosing or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
* Have poor venous access and unable to donate blood.
* Have donated or lost blood (>=500ml) within two months of study dosing.
* Have donated plasma within 7 days of study dosing.
* Have difficulty in swallowing solids like tablets.
* Have taken any prescription medications or over-the-counter medications including herbal products within 1 week of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen.
* Female healthy volunteers who utilize hormonal contraceptive as one of their birth control methods.
* Have a history of significant drug allergy.
* Smokers and users of electronic cigarette.
* Unable to comply with study requirements.
* Believed by the study Investigator to be inappropriate for study participation for any reason
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03602300 | 163,273 |
{
"NCT_ID" : "NCT00089960",
"Brief_Title" : "Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)",
"Official_title" : "An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate",
"Conditions" : ["Gastrointestinal Cancer"],
"Interventions" : ["Drug: AMG 706"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-06",
"Study_Completion_Date(Actual)" : "2008-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2004-08-18",
"First_Posted(Estimated)" : 2004-08-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2004-08-19",
"Last_Update_Posted(Estimated)" : 2013-04-29",
"Last_Verified" : 2013-04"
}
}} | #Study Description
Brief Summary
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
Detailed Description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
#Intervention
- DRUG : AMG 706
- AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity. | #Eligibility Criteria:
Inclusion Criteria
* Age >= 18 years;
* Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
* Presence of at least one measurable (per RECIST)
* Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
* Karnofsky performance status >= 60;
* imatinib treatment terminated at least 7 days before study day 1;
* Adequate hepatic, renal, and cardiac function.
Exclusion criteria:
* Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for >= 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class > II),
* uncontrolled hypertension (systolic > 145 mmHg or diastolic > 85 mmHg),
* History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
* Absolute neutrophil count < 1.5x109/L, platelet count < 100x109/L, hemoglobin < 9.0 g/dL;
* Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
* The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00089960 | 4,809 |
{
"NCT_ID" : "NCT06306937",
"Brief_Title" : "Serum Levels of Vitamin D and IL8 in Patients With Periodontitis",
"Official_title" : "Serum Levels of Vitamin D and IL8 in Patients With Periodontitis: A Case-control Study",
"Conditions" : ["Periodontal Diseases"],
"Interventions" : ["Diagnostic Test: Evalution of serum levels of vitamin D and IL8"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-30",
"Study_Completion_Date(Actual)" : "2023-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-03-06",
"First_Posted(Estimated)" : 2024-03-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-03-11",
"Last_Update_Posted(Estimated)" : 2024-03-12",
"Last_Verified" : 2024-03"
}
}} | #Study Description
Brief Summary
We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis.
Detailed Description
The primary objective of this study is to assess the levels of vitamin D and IL8 in the serum of individuals diagnosed with periodontitis and compare them with those of a healthy control group. The study also aims to establish correlations between these serum levels and the degree of periodontitis severity.
Two groups will be recruited: patients diagnosed with periodontitis and a control group consisting of individuals without periodontal disease.
The participants will be matched for age, gender, and other relevant demographic factors to minimize confounding variables.
Serum samples will be collected from both groups. Periodontitis severity will be determined using established clinical indices, such as probing depth, clinical attachment loss, and bleeding on probing.
Vitamin D levels in the serum will be measured using standardized laboratory techniques.
IL8 levels in the serum will also be quantified using appropriate assays. Statistical analyses will be performed to identify any significant correlations between vitamin D levels, IL8 levels, and the severity of periodontitis.
Subgroup analyses may be conducted to explore potential variations based on demographic factors or other relevant variables.
The study will adhere to ethical guidelines, ensuring participant confidentiality, informed consent, and responsible data handling.
The study anticipates finding associations or correlations between serum levels of vitamin D and IL8 and the severity of periodontitis. This information may contribute to a better understanding of the role of these factors in periodontal health and could have implications for future preventive and therapeutic strategies.
#Intervention
- DIAGNOSTIC_TEST : Evalution of serum levels of vitamin D and IL8
- Group 1 (Periodontitis Group): The intervention involves observing and analyzing individuals diagnosed with periodontitis based on established clinical criteria. The focus is on assessing vitamin D and IL8 levels in the serum and correlating these levels with the severity of periodontitis, determined by clinical indices such as probing depth, clinical attachment loss, and bleeding on probing.
Group 2 (Control Group): The intervention involves observing and analyzing individuals without any signs or history of periodontal disease. The focus is on assessing vitamin D and IL8 levels in the serum for comparison with the periodontitis group. This group serves as the healthy control for the study. | #Eligibility Criteria:
Inclusion Criteria:
* presence of at least twenty teeth.
* Periodontitis patients with a minimum of 40% of sites with a clinical attachment level (CAL) >=2 mm and probing depth (PD)>=4 mm.
* presence of >=40% sites with bleeding on probing.
* Healthy individuals matched for age and gender, who presented no systemic disease, no drugs were taken, no sites with PD >=4 mm or CAL >=4 mm, or radiographic signs of bone loss were enrolled, such as a control group.
Exclusion criteria
* Intake of contraceptives, immunosuppressive, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study.
* Pregnant and lactating females.
* Diabetic patients.
* History of medications that might affect bone and mineral metabolism and/or periodontal health.
* Taking multivitamins and food supplement which contain vitamin D.
* Malabsorption syndrome or patient with chronic diarrhea.
* Treatment with bisphosphonates in the past 12 months or lifetime exposure to bisphosphonates for more than 3 years.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT06306937 | 200,244 |
{
"NCT_ID" : "NCT00248794",
"Brief_Title" : "Cognitive Rehabilitation in Schizophrenia",
"Official_title" : "The Effects of Cognitive Rehabilitation on Function in Schizophrenia",
"Conditions" : ["Cognitive Impairment", "Schizophrenia"],
"Interventions" : ["Behavioral: Skills Group (SDG)", "Behavioral: Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)", "Behavioral: Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-12",
"Study_Completion_Date(Actual)" : "2009-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-11-02",
"First_Submitted_that_Met_QC_Criteria" : 2016-03-14",
"First_Posted(Estimated)" : 2005-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-11-02",
"Last_Update_Posted(Estimated)" : 2016-05-25",
"Last_Verified" : 2016-04"
}
}} | #Study Description
Brief Summary
The study will investigate the viability of two cognitive rehabilitation strategies to improve functional outcomes for people with schizophrenia. Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments have been shown to precede the onset of illness and represent a vulnerability factor which is exacerbated by emerging psychotic symptoms. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicals and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. Each approach has demonstrated some rehabilitation benefits. This study will investigate the effectiveness of a combination of these two approaches on outcomes in schizophrenia.
Detailed Description
Objective: Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicians and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. This study investigates the effectiveness of a combination of these two approaches on outcomes in schizophrenia. This will be a three group randomized clinical trial investigating the effects of cognitive rehabilitation on outcomes ranging from proximal (training tasks performance and neuropsychological test performance), to more distal outcomes (treatment group performance and quality of life ratings). We believe that the cognitive augmentation will have significant impact on training task and neuro-psychological test performance and attenuated, but significant effect on performance in the treatment groups. Finally, we hypothesize that the combination of adaptive training and cognitive rehabilitation will have measurable impact on the most distal outcomes such as daily living skills and quality of life. Method: One hundred (100) individuals will be invited to participate in a 30-week program. After informed consent is obtained and diagnosis established, participants will receive an extensive assessment of neuropsychological, psychological and psychosocial functioning. Participants will be randomly assigned to one of three conditions using a stratified procedure based on cognitive test performance (this will ensure that there are similar numbers of severely and less severely impaired participants in each condition). The three conditions will be: (1) a usual care control group which is the Life Skills Development Group (LSDG), (2) Individualized computer based cognitive rehabilitation (ICBCR) augmenting the LSDG; and (3) Cognitive Remediation Therapy (CRT) with LSDG. Participants will be compared on: (1) LSDG performance, (2) neuropsychological test performance and (3) psychosocial functioning. Attendance in groups and remediation sessions will be compensated at a rate of $5 per session. The key questions t be answered are which Cognitive Rehabilitation strategy is more effective at improving cognitive function? Does Cognitive Rehabilitation produce better performance in the Life Skills Development Group (LSDG)? Does Life Skills Development Group augmented by Cognitive Rehabilitation produce better psychosocial outcomes than the standard care control group?
#Intervention
- BEHAVIORAL : Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)
- CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.
- BEHAVIORAL : Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)
- ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.
- BEHAVIORAL : Skills Group (SDG)
- Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.
- Other Names :
- Standard care | #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of schizophrenia or schizoaffective disorder. Between the ages of 18 <= age <= 65. Stable medication regime (no changes in last 30 days)Minimum of 30 days since last hospitalization. No hx of TBI
Exclusion Criteria:
* Current Substance abuse, no comorbid neurological disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00248794 | 50,612 |
{
"NCT_ID" : "NCT00206778",
"Brief_Title" : "Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania",
"Official_title" : "A Randomized Open-Label 6 Month Acute and Maintenance Trial of Lamotrigine vs. Standard of Care Sodium Valproate Monotherapy for Treatment of Mixed Mania.",
"Conditions" : ["Mixed Mania Bipolar Disorder"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-07",
"Study_Completion_Date(Actual)" : "2007-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-16",
"First_Posted(Estimated)" : 2005-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-16",
"Last_Update_Posted(Estimated)" : 2010-11-25",
"Last_Verified" : 2010-11"
}
}} | #Study Description
Brief Summary
We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.
Detailed Description
Mixed mania is a clinically distinct affective state which is likely to be more severe than classical euphoric mania and to have longer episode duration. Mixed mania is associated with longer duration of illness, suicidality, and poor outcome (McElroy et al, 1995). Although at present there is no universally agreed on definition for mixed states, 40-60% of patients in acute manic states also meet criteria for either major depression or dysphoria (Dilsaver et al,1999; Calabrese et al, 1999; Secunda et al,1985; Sporn and Sacks,1997). Dilsaver at al (1999) in their factor analytic study of manic symptoms were able to differentiate dysphoric and depressed mania. Patients with depressed mania (30% of all patients with mania) were as manic as patients with euphoric mania and also met criteria for the Major depressive disorder. Patients with dysphoric mania were less manic and less depressed, but more irritable than both depressed and euphoric manic patients.
At present there is no accepted treatment algorithms for mixed affective states including depressed and dysphoric mania in Dilsaver definition. Currently used antimanic agents (lorazepam, typical antipsychotics, olanzapine) and mood stablizers (lithium, divlaproex sodium) have little or no antidepressant activity. Therefore, treatment of mixed mania frequently results in emergence of bipolar depression that is often treatment-refractory. Thus is an urgent need for effective treatment of mixed mania that will not result in bipolar depression.
Lamotrigine is an anticonvulsant that prolongs the refractory phase of voltage sensitive channels, an action that is associated with antimanic properties (Hurly, 2002; Sporn and Sacks, 1997; Calabrese et al; 1999, Normann et al; 2002). Lamotrigine was postulated to decrease glutamate release by acting at voltage-sensitive sodium channel in their refractory phase, stabilizing presynaptic neuronal membranes and inhibiting pathologic release of glutamate. As abnormalities in glutamatergic system have been implicated in depression, and NMDA receptor antagonists reverse anxiety or depression in various stress models, lamotrigine could act as an antidepressant. . Thus, lamotrigine has a potential to have both antimanic and antidepressant activity (for refs, see Sporn and Sacks, 1997), and in theory should be uniquely effective for mixed mania (Dilsaver et al, 1999). Indeed, clinical trials reviewed in detail by Hurley (2002), demonstrated that lamotrigine is somewhat effective an antimanic agent, and has significant antidepressant activity in bipolar depression. Lamotrigine was used in a combination with other agents or as monotherapy, and the response rates for depressed, mixed and rapid cycling states were similar, ranging from 52% to 63%. With slow dose titration (6 weeks), side effects were few and the incidence of exfoliative dermatitis was 1 in 500. Of note, although Sporn and Sachs (1997) reported a switch from depression to rapid cycling, such incidences were few. In our institution, lamotrigine was effective for treatment of mixed mania and bipolar depression in patients receiving standard maintenance treatment for Bipolar Mood Disorder. Lamotrigine did worsen agitation in two elderly patients with symptoms of irritable mania.
Based on the above evidence, it appears that lamotrigine, either in combination with a proven antimanic agent or in monotherapy, is uniquely suited to be the agent of choice for treatment of mixed mania. Therefore, we here propose a randomized open-label trial of lamotrigine vs. standard of care sodium valpoate for treatment of mixed mania. Within this framework, the following are the study's hypotheses and objectives:
Hypothesis/Objectives Objective One. To compare the efficacy of the lamotrigine with sodium valproate (standard of care) for treatment of depressive symptoms of acute mania in patients with Bipolar Mood Disorder.
Hypothesis One:
Lamotrigine will be more effective than sodium valproate in treatment of depressive symptoms in acute mixed mania.
Objective Two. To compare the efficacy of the lamotrigine with that of sodium valproate for treatment of manic symptoms in acute mixed mania.
Hypothesis Two:
Lamotrigine and sodium valproate will be equally effective in treatment of manic symptoms in acute mixed mania as measured by the Young Mania Rating Scale scores.
Objective Three. To compare the efficacy of lamotrigine to that of sodium valproate in maintenance treatment of patients with bipolar mood disorder and a recent past episode of mixed mania.
Hypothesis Three:
(i)The lamlotrigine will be more efficacious than sodium valproate in maintenance treatment of patients with bipolar mood disorder and a recent past episode of mixed mania.
(ii) The lamotrigine patients will have lower relapse rate. (iii) The lamotrigine patients will have lower rates of depression than patients treated with sodium valproate.
Objective Four: To compare the side effect profile of lamotrigine treatment of mixed mania to sodium valproate treatment of mixed mania in patients with bipolar mood disorder and a recent past episode of mixed mania.
Hypothesis four:
Lamotrigine acute treatment will result in comparable side effect profile with that of sodium valproate while lamotrigine maintenance treatment will be superior to that with sodium valproate.
Methods We plan to study two eighteen-subject groups (36 subjects total) of male and female study participants between ages 18 and 65 over a 1 1/2 year period. The subjects will be enrolled from the inpatient units at the Beth Israel Medical Center and at the St. Lukes-Roosevelt Hospital Center (Continuum Health Partners) and will be followed at the Center for Treatment of the Affective Disorders in the Department of Psychiatry at BIMC. An independent evaluator (Paul Teusink, M.D.) not affiliated with the study will determine capacity of consent. We will select patients who would have had at least one prior manic episode and who meet inclusion and exclusion criteria for depressed acute mania (Dilsaver et al, 1999). The study criteria for an acute episode of irritable depressed mania will be a Young Mania Rating Scale (YMRS) score of at least 11 and the Hamilton Depression Rating Scale (HDRS) score of at least 18 with 72 hours prior to entering the study. Patient could be randomized on study medication if she/he came to clinic on lamotrigine or Sodium valprole, but she/he has low blood level of this drug.
The study will have two phases.
Phase 1, The Acute Phase. Index medications schedule. Following randomization, during the first 8-week phase, the index manic episode will be treated with either adjust lamotrigine or sodium valproate will be started at 25 mg po daily and will be increased biweekly until a maximal dose of 200 mg/day. Dose escalation schedule: weeks 1-2 25 mg po qd, week 3-4 25 mg po bid, weeks 5-6 50 mg po bid, weeks 7-8 100 mg po bid. The dose could be decreased to as low as 50 mg/day to reduce side effects other than rash. The sodium valproate treatment will be initiated with a loading dose of 20 mg/kg, and the dose will be adjusted in 250 mg/day increments to achieve a therapeutic level of 100-120 mcg/kg.
Concomitant medications schedule. If a patient is receiving mood stabilizers such as lithium, , carbamazepine, gabapentine, trileptal, lamotrigine or sodium valproate at the beginning of the study, these medications will be discontinued in 72 hours informed consent is provided. The following medications will not be permitted during the acute phase of the trial: clozaril, depot neuroleptics antipsychotic, antidepressant and benzodiazepines other than lorazepam.
Rescue medications. Since neuroleptics and lorazepam will be liberally allowed for treatment of acute manic symptoms, no rescue medications will be necessary in the acute phase.
Crossover design for subjects with treatment failure. If subject's condition deteriorates after randomization to lamotrigine or valporate, subject will be crossed over to the other arm of the study, i.e. those who failed sodium valproate will be treated with lamotrigine and vise versa and vise versa. Subjects who will have failed the crossover switch will be removed from the study. Deterioration will be defined as a three-point worsening in the patient's YMRS score lasting more than 72 hours.
Outcome measures. The severity of illness will be measured with Young Mania Rating Scale (MRS), Hamilton Rating scale for depression, and the CGI rating scale. The primary outcome measures will be the YMRS total score change from baseline until the endpoint of Phase 1. The secondary outcome measures will be the HRSD total score change and the CGI score change from baseline until the Phase 1 endpoint. Other secondary outcome measures will be the amount the incidences of seclusion and restraint, the length of hospital stay, and the medical indeces such as HgA1C, weight changes, and lipid profile
Phase 2, The Maintenance Phase. If after two month of treatment patient improve on 50% compare to initial level of YMRS , HDRS and YMRS\<11, HDRS\<18 patient will be transferred to the Maintenance Phase. Index Medication Schedule.
The acute phase will be followed by the 4 months maintenance phase. In the maintenance phase, all medications but lorazepam (\< 4 mg/ day dose) and lamotrigine or sodium valproate will be typed over for initial 4 weeks period. In the last 3 month of the study the lamotrigine subjects will receive only lamotrigine monotherapy. The dose will be adjusted by the study physicians as clinically necessary within the same dose range as in the Phase 1. The sodium valproate dose will be maintained to achieve a therapeutic level of 50-100 mcg/ml. The subjects will be followed weekly for the first 5 weeks of the study. For the rest of the study the subjects will be followed biweekly
Rescue medications schedule. During the maintenance phase, lorazepam will be tapered to a minimal dose that would allow nightly sleep of at least 8 hrs. The dose adjustment will be done weekly according to the following dose reduction schedule: 4 mg - 3 mg - 2 mg - 1 mg - 0 5 mg - 0 mg and will take up to five weeks depending on the initial dose.
Outcome measures. The primary outcome measures will be the number and the time to either manic or depressive episodes. The secondary outcome measures will be an average change from baseline in YMRS, HRSD, and CGI scores from baseline until the endpoint of Phase 2. We will also evaluate medication side effects, the need for adjunct lorazepam treatment, the reasons for premature discontinuation, the demographic data, and the medical endpoints (HgbA1C, weight changes, lipid profile). We will use SPSS and appropriate statistical methods for statistical analysis.
Study Population
The patient population will consist of psychiatric inpatients at the Beth Israel Medical Center and the St. Lukes-Roosevelt Hospital Center, who meet criteria for the DSM-IV diagnosis of Bipolar Mood Disorder I, manic episode. At present, the patient ethnic and racial mix is 26% Hispanic, 30% African American, and 45% Caucasian. The gender distribution is 46% male, 54% female. The inpatient payer mix is 26% Medicare and 50% Medicaid. The average length of stay for the three units is 19 days for all patients and 26 days for patients without co-morbid substance use.
In 1999-2001, inpatient units at the BIMC registered on average 1500 yearly admissions, 1350 of them ages 17-65. Upon admission, approximately 200 patients carried a diagnosis of Bipolar Mood Disorder I, manic episode, without comorbid substance abuse. The inpatient units at Saint Lukes Roosevelt admit 100 manic patients yearly. If the admission demographics remain unchanged for 2003, we expect that 40 patients per year will meet diagnostic inclusion criterion for the study. Based on our previous experience with recruitment for research studies, we expect that 30 % of patients meeting the diagnostic criteria will also meet other inclusion and exclusion criteria, will sign the inform consent and participate in the study. Therefore we expect to recruit 36 patients per year and to complete the study accrual in 18 months. We plan to complete the data analysis for the acute phase within one year.
Inclusion Criteria
1. Males and females, ages 18-65.
2. Ability to sign an informed consent
3. Diagnosis of Bipolar Mood Disorder I, manic episode.
4. Mania Rating Scale (MRS) score of at least 11
5. HDRS score of at least 18
6. Global Assessment Scale (GAS) scores more than 60. Exclusion Criteria
1) Alcohol or substance abuse within the last 6 months 2) Current diagnosis of Obsessive-Compulsive Disorder 3) Current diagnosis of Schizophrenia or Schizoaffective Disorder 4) Previous adverse reaction or allergies to lamotrigine or sodium valproate
Study Design and Drug Regimens The study will be months open label parallel comparison (with a blinded rater) of combination therapy lamotrigine 25-200 mg/day(flexible dosing) and sodium valproate (flexible dosing) monotherapy for treatment of mixed mania in two groups of patients with Bipolar Mood Disorder I. The study will have acute and maintenance phases. Each group will consist of 18 subjects matched for age, gender, and education.
Data Analysis
All patients who were randomly assigned to treatment groups and had at least one post-baseline assessment will be included in the efficacy analysis. The primary time points will be the endpoints of Phases 1 and 2 (i.e. the last available observation during Phases 1 and 2). The primary comparison will be between the lamotrigine/ sodium valproate groups. The analysis of covariance model will be used to test differences between treatments at endpoint. The model will include factors for treatment, and baseline scores on MRS and HRDS as a covariate. MRS scores at all time points will be analyzed jointly by means of repeated measures model. HRDS scores will be analyzed in the same way as MRS scores. Treatment over time will be used as a factor in the model. Gehan's generalized Wilcoxon test will be used to evaluate differences in time to discontinuation (ref from Sachs), and Van Elteren test will be used to evaluate differences in the CGI scores (ref from Sachs).
Scientific Relevance and Health Implications
The successful completion of this study will indicate that lamotrigine combination should be the preferred first-line treatment for mixed mania that should be continued as the preferred maintenance treatment for mixed mania.
#Intervention
- DRUG : Lamotrigine
- DRUG : Sodium Valproate | #Eligibility Criteria:
Inclusion Criteria:
* Males and females, ages 18 <= age <= 65.
* Ability to sign an informed consent
* Diagnosis of Bipolar Mood Disorder I, manic episode.
* Mania Rating Scale (MRS) score of at least 11
* HDRS score of at least 18
* Global Assessment Scale (GAS) scores more than 60.
Exclusion Criteria:
* Alcohol or substance abuse within the last 6 months
* Current diagnosis of Obsessive-Compulsive Disorder
* Current diagnosis of Schizophrenia or Schizoaffective Disorder
* Previous adverse reaction or allergies to lamotrigine or sodium valproate
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00206778 | 235,365 |
{
"NCT_ID" : "NCT00133614",
"Brief_Title" : "Prone Positioning in Pediatric Acute Lung Injury",
"Official_title" : "Prone Positioning in Pediatric Acute Lung Injury",
"Conditions" : ["Acute Lung Injury"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-08",
"Study_Completion_Date(Actual)" : "2004-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-08-19",
"First_Posted(Estimated)" : 2005-08-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-08-19",
"Last_Update_Posted(Estimated)" : 2005-10-30",
"Last_Verified" : 2005-08"
}
}} | #Study Description
Brief Summary
The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.
Detailed Description
Multicenter, randomized, controlled clinical trial conducted from August 28, 2001 to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs. prone positioning. Randomization was concealed and group assignment was not blinded.
Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines.
#Intervention
- PROCEDURE : Prone Positioning | #Eligibility Criteria:
Inclusion Criteria:
* Age >42 weeks post-conceptual age and <18 years
* On mechanical ventilation (defined as presence of an endotracheal/tracheostomy tube and currently using ventilator support)
* All of the following in the same 48 hour period:
* acute pulmonary parenchymal disease (i.e., chest radiograph report of diffuse bilateral pulmonary alveolar infiltrates)
* mechanical ventilation for at least 1 hour and anticipated need to continue mechanical ventilation for at least 24 hours
* at least one PaO2/FiO2 ratio <300 (adjusted for barometric pressure: if altitude > 1000m, then PaO2/FiO2 <= 300x(B.P./760), regardless of mean airway pressure)
* functional arterial catheter for blood gas analysis
Exclusion Criteria:
* Persistent hypotension (defined as systolic blood pressure of 70mmHg+(2x age in years)); i.e. patients requiring either intravenous fluids and/or increases of additional cardiotonic medications every 2 hours
* Active bleeding that requires ongoing blood/fluid volume replacement
* Currently on extracorporeal membrane oxygenation (ECMO)
* Severe chronic lung disease (cystic fibrosis or bronchopulmonary dysplasia)
* Respiratory failure presumed to be the result of cardiac disease
* History of symptomatic or uncorrected congenital heart disease or a right to left intracardiac shunt
* Bone marrow or lung transplant
* Current known diagnosis of any of the following:
* upper airway disease (i.e., tracheitis, tracheomalacia)
* reactive airway disease (receiving beta agonists or acute doses of systemic corticosteroids)
* refractory cerebral hypertension (intracranial pressure [ICP] >20mmHg for 1 hr)
* neuromuscular respiratory failure (chronic assisted ventilation)
* spinal instability (uncleared cervical spine)
* unstable long bone fractures
* Nonpulmonary condition that may be exacerbated by the prone position (for example, osteogenesis imperfecta, craniofacial surgery in the past week)
* Draining abdominal surgical wound
* Pregnancy
* Subject's family/medical team have decided not to provide full support (patient treatment considered futile)
* Enrollment in any other clinical trial within the last 30 days
Sex :
ALL
Ages :
- Minimum Age : 2 Weeks
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00133614 | 140,932 |
{
"NCT_ID" : "NCT03337737",
"Brief_Title" : "The Effects of 10 Days of Extreme Endurance on Performance",
"Official_title" : "The Effects of 10 Days of Extreme Endurance on Performance, Buffering Capacity During Exercise and Post Exercise Muscle Damage, Oxidative Stress and Inflammation",
"Conditions" : ["Human Performance"],
"Interventions" : ["Other: Placebo", "Dietary Supplement: Extreme Endurance"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-10-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-11-01",
"Study_Completion_Date(Actual)" : "2017-03-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-11-03",
"First_Posted(Estimated)" : 2017-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-11-07",
"Last_Update_Posted(Estimated)" : 2017-11-09",
"Last_Verified" : 2017-11"
}
}} | #Study Description
Brief Summary
The study will be a double blind, placebo controlled cross over design with equal treatment and washout periods. Participants will sign an informed consent document prior to data collection and will provide descriptive information about their physical activity by filling out the Leisure and Physical Activity Survey. The participants will be 12 healthy, active college aged males. The participant will have height and weight determined via a triple beam balance with stadiometer, and their body fat% determine via a Bod Pod Gold Standard system.
After wards the participants will supplement with either Placebo or Extreme Endurance (random assignment for order) for ten days. The first 4 days will the participants will ingest four tablets in the morning and evening (8 tablets total) followed by 6 days of three tablets in the morning and evening (6 tablets total). Following the supplementation period the participant will report to the human performance lab where they will be fitted with a mask to collect expired gases and will perform a 25 watt ramp protocol on an electronically braked cycle ergometer. During this test the participant will have a short warm up period, and then a computer will automatically adjust the workload on the bike such that a slope of 25 watts/min is achieved. The test will conclude when the subject reaches volitional exhaustion. Expired gases will be assessed with a COSMED QUARK CPET system. Prior to, and every two minutes during the exercise lactate will be assessed via dermal puncture and a handheld monitor. Ten minutes after the cessation of exercise, a venipuncture will be performed in the antecubetal space and blood will be collected into a serum separator tube. This blood will be spun down in a clinical centrifuge and the serum drawn off and ammonia determined via enzymatic reaction. The remaining serum will be aliquoted and stored at -80 degrees Celsius for later analysis (muscle damage, oxidative stress, inflammation). Participants will then have a ten day rest period after which they will begin the 10 day supplementation period and exercise trial with the opposite supplement.
Detailed Description
Background and Purpose:
Extreme Endurance has been studied in Europe and the data from these studies suggested that the supplement may reduce acidity and increase exercise performance. The purpose of the present investigation is to assess the total effects of Extreme Endurance during exercise. The investigation will assess the following:
Performance:
Performance will be measured as the peak wattage achieved at the lactate, and ventilator thresholds as well as the peak wattage attained during a 25 watt ramp protocol on a electronically braked cycle ergometer. During this test expired gases will be assessed breath by breath, and lactate will be measured every 2 minutes.
Buffering Capacity:
In the human body decreased inter-muscular pH can be quantified through changes in the amount of expired CO2 and increases in serum ammonia (highly correlated with changes in pH associated with high intensity exercise) and lactate measured in whole blood during the exercise.
Muscle Damage:
Post exercise stress and damage to muscle tissue can be quantified by examining the blood for substances normally contained in the muscle tissue only. For this study both creatine kinase and lactate dehydrogenase will be assessed, both have been used as markers of muscle damage in a plethora of scientific publications.
Oxidative Stress:
During exercise free radicals are generated, which a supplement such as Extreme Endurance can potentially reduce. For this study 8OHdG will be measured, this is a marker of oxidative damage to DNA caused by free radicals produced during exercise.
Inflammation:
Exercise produces a well documented inflammatory response. To examine the effects of Extreme Endurance on inflammation a custom multiplex assay will be run that will measure IL-2, IL-6, TNF alpha and C-reactive protein. These are all common markers for inflammation.
Research Questions:
1. Does Extreme Endurance improve performance and increase power output during a graded cycling protocol compared to placebo?
2. Does Extreme Endurance improve buffering capacity during a graded cycling protocol compared to placebo?
3. Does Extreme Endurance reduce muscle damage caused by a graded cycling protocol compared to placebo?
4. Does Extreme Endurance reduce oxidative stress caused by a graded cycling protocol compared to placebo?
5. Does Extreme Endurance reduce inflammation caused by a graded cycling protocol compared to placebo?
Methodology
Study Design
The study will be a double blind, placebo controlled cross over design with equal treatment and washout periods. Participants will sign an informed consent document prior to data collection and will provide descriptive information about physical activity history by filling out the Leisure and Physical Activity Survey. The participants will be 16 healthy, active college aged males. The participants will have height and weight determined via a triple beam balance with stadiometer, and body fat% determine via a Bod Pod Gold Standard system.
After wards the participants will supplement with either Placebo or Extreme Endurance (random assignment for order) for ten days. The first 4 days will the participants will ingest four tablets in the morning and evening (8 tablets total) followed by 6 days of three tablets in the morning and evening (6 tablets total). Following the supplementation period the participants will report to the human performance lab where a mask will be fitted to collect expired gases and will perform a 25 watt ramp protocol on an electronically braked cycle ergometer. During this test the participant will have a short warm up period, and then a computer will automatically adjust the workload on the bike such that a slope of 25 watts/min is achieved. The test will conclude when the participant reaches volitional exhaustion. Expired gases will be assessed with a COSMED QUARK CPET system. Prior to, and every two minutes during the exercise lactate will be assessed via dermal puncture and a handheld monitor. Ten minutes after the cessation of exercise, a venipuncture will be performed in the antecubetal space and blood will be collected into a serum separator tube. This blood will be spun down in a clinical centrifuge and the serum drawn off and ammonia determined via enzymatic reaction. The remaining serum will be aliquoted and stored at -80 degrees Celsius for later analysis (muscle damage, oxidative stress, inflammation). Participants will then have a ten day rest period after which they will begin the 10 day supplementation period and exercise trial with the opposite supplement.
Immunoassays
At the conclusion of data collection, serum aliquots will be thawed and analyzed via colormetric or chemiluminescent immunoassays.
Timeframe
Mar 2016 - Begin Subject Recruitment
Sept 2016 - Finish Data collection
#Intervention
- DIETARY_SUPPLEMENT : Extreme Endurance
- Study will compare (in a crossover) placebo vs dietary supplement Extreme Endurance.
- OTHER : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Able to participate in vigorous exercise
Exclusion Criteria:
* Any exercise contraindication
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03337737 | 191,172 |
{
"NCT_ID" : "NCT05120206",
"Brief_Title" : "The Impact of Cigarette Smoking on Periodontal Therapy",
"Official_title" : "Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis",
"Conditions" : ["Periodontitis", "Cigarette Smoking"],
"Interventions" : ["Procedure: Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA)."],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-03-01",
"Study_Completion_Date(Actual)" : "2015-03-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-10-05",
"First_Posted(Estimated)" : 2021-11-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-11-02",
"Last_Update_Posted(Estimated)" : 2021-11-15",
"Last_Verified" : 2021-11"
}
}} | #Study Description
Brief Summary
Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.
Detailed Description
The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.
Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.
Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.
#Intervention
- PROCEDURE : Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).
- Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
- Other Names :
- Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK). | #Eligibility Criteria:
Inclusion Criteria:
* healthy subjects
* age 35 <= age <= 75 years
* diagnosed with chronic periodontitis
* at least four non-adjacent teeth with proximal sites with a PD >=6 mm and clinical attachment loss >=5 mm with BoP and no radiographic signs of apical pathology.
* either smokers (>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).
Exclusion Criteria:
* subjects who presented with any current medical condition or used medications known to affect periodontal healing
* incorrectly reported smoking status
* use of antibiotics within 6 months of the study
* received subgingival scaling within 6 months of the study
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05120206 | 149,456 |
{
"NCT_ID" : "NCT00716521",
"Brief_Title" : "Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers",
"Official_title" : "Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers",
"Conditions" : ["Methodology Study"],
"Interventions" : ["Drug: placebo", "Drug: zolpidem"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-10",
"Study_Completion_Date(Actual)" : "2008-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-06-23",
"First_Posted(Estimated)" : 2008-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-07-15",
"Last_Update_Posted(Estimated)" : 2009-04-24",
"Last_Verified" : 2009-04"
}
}} | #Study Description
Brief Summary
This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.
#Intervention
- DRUG : placebo
- single oral dose placebo
- DRUG : zolpidem
- single oral dose, 5 mg zolpidem
- DRUG : zolpidem
- single oral dose, 10 mg zolpidem | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55
* BMI 18 <= age <= 30 kg/m2
* body weight > 50 kg
Exclusion Criteria:
* no history of sleep disorder
* no concurrent medications
* no alcohol use
* no medical issues
* no smoking
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00716521 | 178,998 |
{
"NCT_ID" : "NCT00721227",
"Brief_Title" : "Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates",
"Official_title" : "Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates",
"Conditions" : ["Obesity"],
"Interventions" : ["Procedure: Reduction Gastroplasty"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03",
"Study_Completion_Date(Actual)" : "2010-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-07-09",
"First_Submitted_that_Met_QC_Criteria" : 2010-07-21",
"First_Posted(Estimated)" : 2008-07-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-07-22",
"Last_Update_Posted(Estimated)" : 2010-09-08",
"Last_Verified" : 2010-09"
}
}} | #Study Description
Brief Summary
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
Detailed Description
The overall plan for all subjects consists of the following elements:
* Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
* Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
* Subjects are followed for 12 months to evaluate outcomes and potential complications.
#Intervention
- PROCEDURE : Reduction Gastroplasty
- * Subjects will undergo reduction gastroplasty by gastric plication
* Subjects are followed for 12 months to evaluate outcomes and potential complications. | #Eligibility Criteria:
Inclusion Criteria:
Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
* Subject is willing to give consent and comply with evaluation and treatment schedule;
* 21 <= age <= 60 of age (inclusive);
* BMI > 35 kg/m2 and < 50 kg/m2 (BMI 35 <= age <= 40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);
* Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
* Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, per site standard of care (SOC); and
* Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.
Exclusion Criteria:
Subjects will be excluded from the study for any of the following:
* Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
* Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
* Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
* Scheduled concurrent surgical procedure;
* Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
* Any condition which precludes compliance with the study, including:
1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
2. Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
3. Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
4. Uncontrolled hypertension;
5. Portal hypertension;
6. Treatment with insulin (more than 50 units a day);
7. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
8. Cirrhosis;
9. Congenital or acquired intestinal telangiectasia;
10. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
11. Presence of hiatal hernia;
12. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
13. Pancreatitis;
14. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
15. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
* History or presence of pre-existing autoimmune connective tissue disease;
* Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT00721227 | 404 |
{
"NCT_ID" : "NCT02708355",
"Brief_Title" : "Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment",
"Official_title" : "A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn",
"Conditions" : ["Heartburn"],
"Interventions" : ["Drug: Placebo", "Drug: Esomeprazole 20 mg"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-04",
"Study_Completion_Date(Actual)" : "2016-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-21",
"First_Submitted_that_Met_QC_Criteria" : 2017-03-08",
"First_Posted(Estimated)" : 2016-03-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-09",
"Last_Update_Posted(Estimated)" : 2017-04-19",
"Last_Verified" : 2017-03"
}
}} | #Study Description
Brief Summary
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
#Intervention
- DRUG : Esomeprazole 20 mg
- Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
- Other Names :
- Nexium
- DRUG : Placebo
- Placebo capsules | #Eligibility Criteria:
Inclusion Criteria:
* Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
* Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
* When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.
Exclusion Criteria:
* A history (past or present) of erosive esophagitis verified by endoscopy.
* The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
* Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02708355 | 105,570 |
{
"NCT_ID" : "NCT01692613",
"Brief_Title" : "Endomicroscopy, IBS and Food Intolerance",
"Official_title" : "Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome",
"Conditions" : ["Endomicroscopy", "Inflammatory Bowel Syndrome", "Food Intolerance"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09",
"Study_Completion_Date(Actual)" : "2014-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-20",
"First_Posted(Estimated)" : 2012-09-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-20",
"Last_Update_Posted(Estimated)" : 2015-06-03",
"Last_Verified" : 2015-06"
}
}} | #Study Description
Brief Summary
Background:
The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.
Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.
N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.
Methods:
The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:
After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
Detailed Description
The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.
| #Eligibility Criteria:
Inclusion Criteria:
* > 18 yearsyears
* ongoing abdominal symptoms such as bloating and abdominal pain
* negative routine testing for food intolerance (or known lactose/fructose intolerance)
* written informed consent
Exclusion Criteria:
* no consent
* known reason for the abdominal pain and bloating other than lactose/fructose intolerance
* M. Whipple
* known infectious gastrointestinal disease
* stricture in the upper gastrointestinal tract
* age >18years
* impaired renal function (Creatinine >1.2 mg/dL)
* pregnancy or breast feeding
* inability to obtain informed consent
* active GI Bleeding
* known allergy to Methylene blue or Fluorescein
* participation in other clinical trials within the last 4 weeks
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01692613 | 151,456 |
{
"NCT_ID" : "NCT04599075",
"Brief_Title" : "Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus",
"Official_title" : "Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial",
"Conditions" : ["Type 1 Diabetes", "Pregnancy, High Risk"],
"Interventions" : ["Drug: Insulin"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-03-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-01",
"Study_Completion_Date(Actual)" : "2023-05-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-10-16",
"First_Submitted_that_Met_QC_Criteria" : 2024-07-02",
"First_Posted(Estimated)" : 2020-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-10-21",
"Last_Update_Posted(Estimated)" : 2024-07-08",
"Last_Verified" : 2024-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.
Detailed Description
Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option.
The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.
#Intervention
- DRUG : Insulin
- IV Insulin Infusion
- Other Names :
- Insulin via IV Infusion
- DRUG : Insulin
- Continuous Subcutaneous Insulin Infusion (Pump)
- Other Names :
- Insulin via Pump | #Eligibility Criteria:
Inclusion Criteria:
* Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy
* Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
* Patients able to provide written informed consent
Exclusion Criteria:
* Patients who are under the age of 18
* Patients with altered state of consciousness
* Critically ill patient requiring intensive care unit admission
* Patient at risk for suicide
* Patient refuses or is otherwise unable to participate in own care
* Patient without pump supplies
* Patients presenting with diabetic ketoacidosis on admission
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04599075 | 193,752 |
{
"NCT_ID" : "NCT04008823",
"Brief_Title" : "Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons",
"Official_title" : "Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons. Analysis of Direct Medical Costs",
"Conditions" : ["Influenza Virus Infection"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-10-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11-02",
"Study_Completion_Date(Actual)" : "2017-12-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-07-01",
"First_Posted(Estimated)" : 2019-07-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-07-03",
"Last_Update_Posted(Estimated)" : 2019-07-05",
"Last_Verified" : 2019-07"
}
}} | #Study Description
Brief Summary
This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed
Detailed Description
A better knowledge in our environment of the characteristics of the Influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child
#Intervention
- OTHER : Retrospective and observational epidemiological study, by review of clinical histories,
- Retrospective and observational epidemiological study, by review of clinical histories, | #Eligibility Criteria:
Inclusion Criteria:
* Boys and girls under 15 years.
* With a clinical diagnosis of influenza virus infection.
* With infection by influenza virus confirmed microbiologically.
* Hospitalized more than 24 hours
Exclusion Criteria:
* Age equal to or greater than 15 years.
* That the clinical diagnosis is not influenza virus infection.
* Influenza virus not confirmed by microbiological diagnosis.
* Not hospitalized or hospitalized for less than 24 hours.
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04008823 | 135,230 |
{
"NCT_ID" : "NCT03230786",
"Brief_Title" : "Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes",
"Official_title" : "A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes",
"Conditions" : ["Type 2 Diabetes Mellitus"],
"Interventions" : ["Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin"],
"Location_Countries" : ["Poland", "United Kingdom", "Romania", "Moldova, Republic of", "Czechia", "Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-08-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-09",
"Study_Completion_Date(Actual)" : "2018-07-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-07-24",
"First_Posted(Estimated)" : 2017-07-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-07-24",
"Last_Update_Posted(Estimated)" : 2018-09-11",
"Last_Verified" : 2018-09"
}
}} | #Study Description
Brief Summary
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type 2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of metformin.
The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and United Kingdom
#Intervention
- DRUG : Daily injection of KBP/placebo for 12 weeks as add-on to metformin
- Daily subcutaneous injection | #Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, 18 <= age <= 75 years, both inclusive, at the time of the first screening visit. Women must be either using adequate, highly effective methods of contraception, be post-menopausal or be considered sterile due to tubal ligation or other surgical procedures at the time of randomization. Sexually active men with a female partner of childbearing potential must agree in the use of highly effective method of contraception by the female partner throughout the trial period.
* Subjects with type 2 diabetes mellitus diagnosis whose HbA1c levels are >=7.0% and <=10.0% (53 mmol/mol to 86 mmol/mol, respectively) at screening.
* Stable therapy (for at least 90 days prior to randomization) with metformin.
* Body mass index (BMI) >= 25.0 kg/m², and <= 45.0 kg/m².
* The subject is able to understand and comply with protocol requirements.
* The subject is able and willing to give written informed consent.
Exclusion Criteria:
* Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
* Past or present significant co-morbidity (other than type 2 diabetes mellitus) including, but not limited to: Active liver disease (other than asymptomatic non-alcoholic fatty liver disease), significant renal disease (including creatinine clearance < 45 ml/min by the Modification of Diet in Renal Disease (MDRD) method, congestive heart failure (NYHA class III or IV), myocardial infarction within the past 12 months, unstable angina pectoris.
* Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
* Currently receiving medical treatment for obesity.
* History of bariatric surgery.
* Current alcohol abuse.
* Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors, DPP4-inhibitors (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1) analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
* Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days of randomization.
* Regular use of insulin or insulin analogues.
* History or presence of sensitivity or allergy to the study drug or drugs, to their components, or drugs of these classes or a history of drug or other allergy that contraindicates participation.
* History of sarcoma or other malignancy within the past five years, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
* Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.
* Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to randomization or during the treatment phase of the trial.
* Breast-feeding women.
* Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
* ALT (alanine transaminase) or AST (aspartat transaminase) > 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities.
* Clinically significant ECG abnormalities, as judged by the investigator.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03230786 | 62,292 |
{
"NCT_ID" : "NCT00596713",
"Brief_Title" : "Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City",
"Official_title" : "Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City",
"Conditions" : ["Healthy"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-12",
"Study_Completion_Date(Actual)" : "2007-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-09",
"First_Posted(Estimated)" : 2008-01-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-16",
"Last_Update_Posted(Estimated)" : 2012-07-12",
"Last_Verified" : 2012-07"
}
}} | #Study Description
Brief Summary
Sleep disturbances are of great relevance within the context of public health as they affect a sizable portion of the population with far reaching consequences. Many automobile and labor accidents as well as poor school and work performance can be traced to sleep disturbances, which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive alterations.
OBJECTIVES:
1. Establish the epidemiologic profile of sleep disturbances among the adult population of the city of Sao Paulo in 2007;
2. Investigate associations between sleep patterns and disturbances in that population, taking into account the following variables: social-demographic status, anthropometrics, clinical, activity/rest cycle, eating and physical activity habits, mood disturbances, sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical, hematological, endocrine, immunologic and inflammatory indicators;
3. assess the compatibility of the results collected in the current study with those of epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the aim of determining the secular sleep disturbance trend.
METHODS:
The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo, representing the population proportionally to gender, age groups and social classes. Data were amassed as follows:
1. the application of home and institution questionnaires;
2. description of the sleep patterns and disturbances through polysomnography and actigraphy, performed at the Sleep Institute;
3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic assays.
STATISTICS:
Subsequent to double typing (inputting) and analysis of data consistency, descriptive and analytical statistical assessments will be performed with the aim of describing patterns of sleep disturbances associated to the explanatory variables under investigation. In the light of bi-varied analysis, predictive/explanatory multivaried models were adjusted.
| #Eligibility Criteria:
Inclusion Criteria:
* Both genders aged 20 <= age <= 80 and living in private households in the city of São Paulo.
Exclusion Criteria:
* Pregnant or lactating women
* People with physical or mental impairment: and
* Workers in night shifts.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00596713 | 128,778 |
{
"NCT_ID" : "NCT02796872",
"Brief_Title" : "The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)",
"Official_title" : "The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)",
"Conditions" : ["Dietary Modification"],
"Interventions" : ["Dietary Supplement: Mother's breast milk", "Dietary Supplement: GOS", "Dietary Supplement: B-GOS 2%", "Dietary Supplement: B-GOS 3%"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12",
"Study_Completion_Date(Actual)" : "2017-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-30",
"First_Posted(Estimated)" : 2016-06-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-06-07",
"Last_Update_Posted(Estimated)" : 2017-07-19",
"Last_Verified" : 2017-02"
}
}} | #Study Description
Brief Summary
This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.
#Intervention
- DIETARY_SUPPLEMENT : GOS
- GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
- DIETARY_SUPPLEMENT : B-GOS 3%
- Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
- DIETARY_SUPPLEMENT : B-GOS 2%
- Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
- DIETARY_SUPPLEMENT : Mother's breast milk
- exclusively breastfed infants for at least 7 days prior to enrollment | #Eligibility Criteria:
Inclusion Criteria:
* o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)
* Singleton birth
* Gestational age of 37 <= age <= 42 weeks (36 weeks and six days is considered 36 weeks gestational age)
* Birth weight of 2500g to 4000g
* Signed informed consent obtained for infant's participation in the survey
* Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
* APGAR score after 5 minutes of life > 7
* Consuming only one source of nutrition
* Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
* Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration
Exclusion Criteria:
* Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
* Diseases jeopardizing intrauterine growth
* Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
* Infant born from mother suffering from metabolic and/or chronic diseases
* Infant with an acute infection or gastroenteritis at time of randomization or registration
* Infant consuming supplemental foods
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
Sex :
ALL
Ages :
- Minimum Age : 12 Days
- Maximum Age : 18 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT02796872 | 112,816 |
{
"NCT_ID" : "NCT00792597",
"Brief_Title" : "Comparison of Three Methods of Hemoglobin Monitoring",
"Official_title" : "Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.",
"Conditions" : ["Blood Loss"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-04",
"Study_Completion_Date(Actual)" : "2010-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-11-14",
"First_Posted(Estimated)" : 2008-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-11-17",
"Last_Update_Posted(Estimated)" : 2013-03-07",
"Last_Verified" : 2013-03"
}
}} | #Study Description
Brief Summary
The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™, 2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.
Detailed Description
See above
| #Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female 18 y/o or older
* American Society of Anesthesiology Classification 1, 2 or 3
* Scheduled to undergo spine or hip revision surgery
Exclusion Criteria:
* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00792597 | 242,926 |
{
"NCT_ID" : "NCT02300038",
"Brief_Title" : "Lidocaine and Neuroma Pain Related Modalities",
"Official_title" : "Differential Analgesic Effects of Subanesthetic Concentrations of Lidocaine on Spontaneous and Evoked Pain in Human Painful Neuroma",
"Conditions" : ["Neuropathic Pain"],
"Interventions" : ["Dietary Supplement: NaCl", "Drug: Lidocaine (Xylocaine)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-08",
"Study_Completion_Date(Actual)" : "2014-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-11-16",
"First_Posted(Estimated)" : 2014-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-21",
"Last_Update_Posted(Estimated)" : 2014-11-24",
"Last_Verified" : 2014-11"
}
}} | #Study Description
Brief Summary
Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.
Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.
Detailed Description
Patients were recruited by using a postal follow up questionnaire . The number of enrolled subjects in this study- 16 patients, Study design
* The patients visited the Pain Clinic twice.
* The same investigator (AM) performed all study procedure assessments.
* Neuroma was localized by Tinel's sign 14 and when possible (7 patients out of 16), the localization of a neuroma was verified by ultrasound.
Administration of study drug The patients were randomized by a computer generated random list to receive either 1ml lidocaine 0.5% (A) or 1 ml 0.1% (B-control) injected perineuromally.
Pain assessments Duration of the present pain condition was recorded. The patients were asked to rate the mean, maximum, minimum pain intensity of their spontaneous and evoked pain in the week prior to both visits. The pain score was measured from baseline until 60 min after injection. Assessments of pain were done post injection at 15 s, 30 s, 1 min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then pinprick hyperalgesia.
Spontaneous pain Evaluation of sensory function was performed in the affected limb using bedside examination according to EFNS (European Federation of Neurological Societies)guidelines: light touch, pinprick sense, warmth (40°) and cold (25°) temperature stimuli were tested.
#Intervention
- DRUG : Lidocaine (Xylocaine)
- perineuromally administration of 1 ml lidocaine
- Other Names :
- Xylocaine, Lidocaine
- DIETARY_SUPPLEMENT : NaCl
- perineuromally administration of NaCL
- Other Names :
- Sodium chloride, salt | #Eligibility Criteria:
Inclusion Criteria:
* >= 18 years,
* with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement),
* who scored an average daily pain intensity of at least 4 on a 0 <= age <= 10 point numerical pain scale (NRS) interfering with daily activities and who had pain at least 3 months duration.
* They all had neuromas after upper extremity surgery or other trauma affecting the radial, ulnar, median or digital nerves and were eligible to participate in the study after giving written informed consent.
Exclusion Criteria:
* Patients with other conditions that might confound assessment of pain attributed to posttraumatic upper limb pain or
* any condition/disease that could interfere with the study measurements, such as drug abuse, diabetes, vascular disease, polyneuropathy or psychiatric diseases were excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02300038 | 100,497 |
{
"NCT_ID" : "NCT03140540",
"Brief_Title" : "TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery",
"Official_title" : "Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery",
"Conditions" : ["Fluid Therapy"],
"Interventions" : ["Other: Stroke volume variation guided intravenous fluid.", "Other: TEE guided fluid therapy will be administered"],
"Location_Countries" : ["India"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-02-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02-27",
"Study_Completion_Date(Actual)" : "2020-02-27},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-04-15",
"First_Posted(Estimated)" : 2017-05-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-03",
"Last_Update_Posted(Estimated)" : 2020-10-26",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively, after 12 hours and 48 hrs postoperatively
Detailed Description
TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery.
GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h.
If (velocity time integral) VTI \<20, 250 mL colloid bolus administered. Dose repeated every 10 min until goal of VTI \>20 met. Norepinephrine titrated to maintain MAP(mean arterial pressure) \> 65 mm Hg. Blood transfused for haemoglobin \<8 g Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis at time of incision intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications, morbidity, mortality, duration of mechanical ventilation and ICU stay.
#Intervention
- OTHER : TEE guided fluid therapy will be administered
- Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta \<20 ,200ml colloid bolus to be administered.
- OTHER : Stroke volume variation guided intravenous fluid.
- Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV \>10, 200 ml of colloid bolus to be given | #Eligibility Criteria:
Inclusion Criteria:
* ASA 1, 2 and 3
* Undergoing major abdominal oncosurgery
Exclusion Criteria:
* Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03140540 | 27,712 |
{
"NCT_ID" : "NCT03554291",
"Brief_Title" : "Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension",
"Official_title" : "Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension",
"Conditions" : ["Pulmonary Arterial Hypertension", "Right Heart Failure"],
"Interventions" : ["Other: Placebo", "Drug: Famotidine 20 MG"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-11",
"Study_Completion_Date(Actual)" : "2023-07-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-31",
"First_Submitted_that_Met_QC_Criteria" : 2024-08-06",
"First_Posted(Estimated)" : 2018-06-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-05-31",
"Last_Update_Posted(Estimated)" : 2024-08-09",
"Last_Verified" : 2024-08"
}
}} | #Study Description
Brief Summary
This is a Phase 2, single-center, randomized placebo controlled trial of famotidine (an H2 receptor antagonist) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of famotidine.
Detailed Description
Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medications to treat PAH, there are currently no medications that act directly on the heart to improve right heart function. This is different than left heart failure where one of the cornerstones of treatment is medication targeted at the heart to improve left heart function.
Famotidine is a well-tolerated, over-the-counter, and inexpensive medication. Preliminary results suggest that famotidine may help the right heart to adapt and strengthen when stressed instead of fail; however, these results are suggestive and not definitive. A randomized controlled trial is required to evaluate the possibility that famotidine can impact right heart function.
Participants in the study will take famotidine or placebo for 24 weeks. They will have three study visits at 0, 12, and 24 weeks. These visits will add 20-30 minutes to the standard clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24. There will also be one phone visit at 4 weeks to check-in. Some participants may elect to participate in exercise testing and/or right heart catheterization at weeks 0 and 24; however, this is not required to participate in the trial.
#Intervention
- DRUG : Famotidine 20 MG
- Famotidine 20 mg capsule taken daily for 24 weeks.
- OTHER : Placebo
- Placebo capsule taken daily for 24 weeks. | #Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 to 80
* WHO Group 1 Pulmonary Arterial Hypertension
* NYHA Functional Class II, III, or IV at screening
* Stable dose of pulmonary vasodilators for 30 days prior to randomization
* Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of >= 25 mmHg, occlusion pressure of <= 15 mmHg, and pulmonary vascular resistance of >= 3 wood units
* Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of >= 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance >= 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy
* Able to walk with/without a walking aid for a distance of at least 50 meters
Exclusion Criteria:
* Pregnant or lactating
* Non-group 1 pulmonary hypertension or veno-occlusive disease
* History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity of >= 60 %
* Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
* Left sided myocardial disease as evidenced by left ventricular ejection fraction < 40%
* Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data
* Anticipated survival less than 1 year due to concomitant disease
* Regularly taking an H2 receptor antagonist within 30 days of enrollment
* Creatinine clearance < 30 mL/min
* History of bariatric surgery
* Current treatment for HIV
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03554291 | 61,813 |
{
"NCT_ID" : "NCT00249873",
"Brief_Title" : "Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)",
"Official_title" : "A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation",
"Conditions" : ["Atrial Fibrillation", "Vascular Risk"],
"Interventions" : ["Drug: placebo", "Drug: clopidogrel (SR25990C)"],
"Location_Countries" : ["Netherlands", "United States", "Poland", "Germany", "Singapore", "Austria", "Switzerland", "Hong Kong", "Finland", "United Kingdom", "France", "Sweden", "Taiwan", "South Africa", "Australia", "Hungary", "Italy", "Argentina", "Denmark", "Mexico", "Norway", "Brazil", "Czech Republic", "Chile", "Portugal", "Canada", "Malaysia", "Spain", "Belgium", "Greece"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-03",
"Study_Completion_Date(Actual)" : "2009-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-11-04",
"First_Submitted_that_Met_QC_Criteria" : 2010-03-08",
"First_Posted(Estimated)" : 2005-11-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-11-04",
"Last_Update_Posted(Estimated)" : 2015-06-15",
"Last_Verified" : 2015-05"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.
#Intervention
- DRUG : clopidogrel (SR25990C)
- oral administration (tablets)
- Other Names :
- Plavix®
- DRUG : placebo
- oral administration (tablets) | #Eligibility Criteria:
Inclusion Criteria:
To be eligible for ACTIVE A patients must have in same time the three following conditions :
* Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two ECGs recorded at two weeks a part during 6 months prior to study enrollment.
* Evidence of high risk of vascular events : at least one of the following risk criteria must be present :
* are 75 years greater;
* on treatment for systemic hypertension;
* prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System (non-CNS) systemic embolus;
* left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
* peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
* age 55 <= age <= 74 and either; f1) diabetes mellitus requiring drug therapy, or f2) documented previous myocardial infarction or documented coronary artery disease.
* To have either a contraindication to use an oral anticoagulant treatment or they are unwilling to take an oral anticoagulant treatment.
Exclusion Criteria:
Patients will be excluded from ACTIVE if any of the following are present :
* requirement for clopidogrel (such as recent coronary stent procedure)
* requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
* prior intolerance to ASA or clopidogrel;
* documented peptic ulcer disease within the previous 6 months;
* prior intracerebral hemorrhage;
* significant thrombocytopenia; (platelet count < 50 x 10(9)/L)
* psychosocial reason making study participation impractical;
* geographic reason making study participation impractical;
* ongoing alcohol abuse;
* mitral stenosis,
* pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study; (severe comorbid condition such that the patient is not expected to survive 6 months;
* patient currently receiving an investigational pharmacologic agent;
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00249873 | 1,015 |
{
"NCT_ID" : "NCT05730400",
"Brief_Title" : "Histological Assessment of BMAC Utilized in Sinus Lift",
"Official_title" : "Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)",
"Conditions" : ["Implant Site Reaction"],
"Interventions" : ["Drug: Bovine graft only", "Drug: BMAC loaded on bovine graft"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-10-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-30",
"Study_Completion_Date(Actual)" : "2023-09-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-01-26",
"First_Posted(Estimated)" : 2023-02-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-02-13",
"Last_Update_Posted(Estimated)" : 2024-02-06",
"Last_Verified" : 2024-02"
}
}} | #Study Description
Brief Summary
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
Detailed Description
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment.
Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
#Intervention
- DRUG : BMAC loaded on bovine graft
- Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation
- Other Names :
- Bone marrow aspirate concentrate loaded on bovine graft
- DRUG : Bovine graft only
- Bovine graft only for sinus floor augmentation
- Other Names :
- Unloaded bovine graft | #Eligibility Criteria:
Inclusion Criteria:
* Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm
* Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
* Highly motivated patients
Exclusion Criteria:
* Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
* Patients suffering from any sinus pathosis.
* Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness.
* Heavy smoker (> 20 cigarettes daily)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05730400 | 168,964 |
{
"NCT_ID" : "NCT01840657",
"Brief_Title" : "Myotubular Myopathy Event Study",
"Official_title" : "Prospective Study of Adverse Event Rates in Males With X-Linked Myotubular Myopathy",
"Conditions" : ["X-linked Myotubular Myopathy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-10",
"Study_Completion_Date(Actual)" : "2015-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-04-18",
"First_Posted(Estimated)" : 2013-04-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-04-23",
"Last_Update_Posted(Estimated)" : 2018-03-07",
"Last_Verified" : 2017-01"
}
}} | #Study Description
Brief Summary
X-Linked myotubular myopathy (XLMTM), a form of centronuclear myopathy (CNM) is the result of a mutation in the MTM1 (myotubularin) gene which leads to altered myotubularin. Myotubularin is essential for optimum muscle function. To date, over 100 mutations have been described resulting in a range of disease onset and symptom severity. The early onset form presents with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing requirement for continuous ventilatory support with the inability to maintain a sitting position once placed. Males with both later onset and milder symptoms usually do not require ongoing ventilatory support, achieve a higher maximal motor function with ability to sit when placed and even walk, and have improved survival rates. Males with XLMTM may experience complications (events) at birth and throughout their lifetime. The goal of the study is to identify the number of events over twelve months in males with genetically confirmed XLMTM. Parents or affected individuals over the age of 18 years who are able to access telephone will provide answers to an established event survey to evaluate the frequency and types of events. Emergency department, hospital admissions and mortality will be confirmed by obtaining medical reports.
The investigators hypothesize that there will be no association between the frequency of events and markers of clinical severity including the need for ventilatory support at birth, current level of ventilatory support (no support, support less than 12 hours, support more than 12 hours) and current motor function (walking, sitting without support, inability to sit without support).
| #Eligibility Criteria:
Inclusion Criteria:
* males with a confirmed MTM1 mutation OR
* males with a muscle biopsy consistent with myotubular myopathy AND family history consistent with X-linked inheritance AND
* English-speaking parent/guardian of a living male child or a decisionally impaired adult OR English-speaking affected male > 18 years who can access telephone
* signed study consent
* enrolled in the Congenital Muscle Disease International Registry (CMDIR)
Exclusion Criteria:
* males with only a clinical diagnosis of XLMTM but without family history of XLMTM
* an affected male who has a genetically confirmed form of centronuclear myopathy (CNM) that is not caused by a mutation in the MTM1 gene
* females with MTM1 due to the limited number of females affected and the variability of clinical presentation
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01840657 | 226,156 |
{
"NCT_ID" : "NCT04567641",
"Brief_Title" : "Early Nutrition Impact on Post Abdominal Surgery Outcome",
"Official_title" : "Impact of Early Enteral & Parenteral Nutrition on Post-operative Outcome After Abdominal Surgery",
"Conditions" : ["Postoperative Nutrition"],
"Interventions" : ["Dietary Supplement: postoperative nutrition"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06",
"Study_Completion_Date(Actual)" : "2019-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-09-20",
"First_Posted(Estimated)" : 2020-09-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-09-23",
"Last_Update_Posted(Estimated)" : 2020-09-30",
"Last_Verified" : 2020-09"
}
}} | #Study Description
Brief Summary
Introduction: Nutritional support is a vital therapy of most surgical patients. Early initiation via the enteral route has a significant effect on postoperative recovery. The prognostic role of CRP and albumin can be explained by their abilities to reflect inflammation in the acute phase in critical settings and assess the nutritional status of critically ill patients, respectively. This indicates the prognostic value of the CRP/ALB ratio in postoperative patients admitted to the ICU.
Aim of work: Determine the effect of early enteral \& parenteral nutrition on ICU outcome \& nutritional status in postoperative abdominal surgical patients and investigate the effect of enteral \& parenteral nutrition on CRP/albumin ratio as an inflammatory marker \& its correlation with SOFA score.
Methods: A prospective cohort non randomized study included 80 postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration. Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures. Nutritional status and inflammatory markers were screened. All patients were followed up during the ICU stay \& up to 3 months. SOFA scoring was done every 48 hours.
#Intervention
- DIETARY_SUPPLEMENT : postoperative nutrition
- Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures. | #Eligibility Criteria:
Inclusion Criteria:
* postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration.
* age between 18 <= age <= 80 years
Exclusion Criteria:
* renal failure
* liver failure
* extensive burns
* hemodynamic instability.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04567641 | 129,473 |
{
"NCT_ID" : "NCT04605068",
"Brief_Title" : "Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee",
"Official_title" : "Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial",
"Conditions" : ["Hypospadias, Penoscrotal", "Chordee"],
"Interventions" : ["Procedure: Transverse preputial island flap (Duckett's technique)", "Procedure: Double-faced preputial flap (DFPF)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09",
"Study_Completion_Date(Actual)" : "2020-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-10-09",
"First_Posted(Estimated)" : 2020-10-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-10-21",
"Last_Update_Posted(Estimated)" : 2020-10-27",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.
Detailed Description
Type of study: RCT
Review of literature:
* Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).
* Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..
* Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain \& New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for one-stage repair is respected but does not deprive the patient from getting surgical care by two-stage repair.
Preoperative preparation:
All patients will be subjected to history taking, clinical examination, and necessary laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests, Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF). Both techniques will be done by all members of the surgical team equally.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data were collected using a data collecting sheets (annexes) and were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows, IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation (SD), range, and average and categorical variables were expressed as frequency count \& percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A two-sided p-value \< 0.05 was considered statistically significant.
Discussion:
It will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias with chordee. The results obtained from this study will be compared between both group and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by estimated urine caliber and micturition time. At the end, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
#Intervention
- PROCEDURE : Transverse preputial island flap (Duckett's technique)
- PROCEDURE : Double-faced preputial flap (DFPF) | #Eligibility Criteria:
Inclusion Criteria:
* Uncircumcised male patients with penoscrotal hypospadias,
* rudimentary urethral plate
* with moderate-to-severe chordee and
* no history of previous repair
Exclusion Criteria:
* circumcised patients,
* patients with other types of hypospadias such as glanular or distal shaft or
* with mild chordee corrected after penile degloving,
* recurrent hypospadias, or
* lost to follow-up.
Sex :
MALE
Ages :
- Minimum Age : 6 Months
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT04605068 | 50,990 |
{
"NCT_ID" : "NCT01318304",
"Brief_Title" : "Vaginal Innate Immunity in Normal and HIV-Infected Women",
"Official_title" : "Vaginal Innate Immunity in Normal and HIV-Infected Women",
"Conditions" : ["HIV", "Pregnancy"],
"Interventions" : ["Other: Vaginal lavage specimen"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-04",
"Study_Completion_Date(Actual)" : "2013-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-29",
"First_Posted(Estimated)" : 2011-03-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-03-16",
"Last_Update_Posted(Estimated)" : 2016-05-09",
"Last_Verified" : 2016-05"
}
}} | #Study Description
Brief Summary
The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection.
The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.
#Intervention
- OTHER : Vaginal lavage specimen
- Collection of 3cc of saline used in the vagina to collect innate immunity markers | #Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 18 - 40 years
* Able to provide informed consent
Exclusion Criteria:
* Women with the following conditions will be excluded:
* Currently active Syphilis or Herpes simplex infection
* Other (non-HIV) comorbid conditions causing acute or chronic inflammatory states or immunosuppression (i.e., transplant recipients, active systemic lupus)
* Current use of hormonal birth control or with IUD in place
* History of Hysterectomy or bilateral oophorectomy
Women with the following conditions will require rescheduling of the study visit:
* Use of hot tub or pool, vaginal creams, douches, vaginal medications, or vaginal intercourse within 48 hours
* Current vaginal bleeding
* Recent treatment for vaginal infection will require 4 - 6 week delay in enrollment
Pregnant women with the following conditions at the time of examination will be excluded:
* Active labor or other conditions of duress
* Signs or symptoms of preterm labor
* Vaginal bleeding
* Placenta previa
* History of prior preterm birth
* Ruptured amniotic membranes
* Multifetal gestation
* Stillbirth or intrauterine fetal demise (IUFD)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01318304 | 49,407 |
{
"NCT_ID" : "NCT04965662",
"Brief_Title" : "The Role of Home Packs of HIV PEPSE in High Risk Individuals",
"Official_title" : "The Role of Home Packs of HIV Post-Exposure Prophylaxis for Sexual Exposure (PEPSE) to Improve the Speed and Appropriate Uptake of PEPSE in High Risk Individuals",
"Conditions" : ["HIV-1-infection"],
"Interventions" : ["Drug: Maraviroc", "Drug: Truvada"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-16",
"Study_Completion_Date(Actual)" : "2021-03-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-07-07",
"First_Posted(Estimated)" : 2021-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-07-07",
"Last_Update_Posted(Estimated)" : 2021-07-22",
"Last_Verified" : 2021-07"
}
}} | #Study Description
Brief Summary
The study is looking at a new way to reduce the risk of catching HIV. Post-exposure Prophylaxis for sexual exposure (PEPSE) is where a month of HIV drugs can be given to reduce the chance of getting HIV, after a risk. To improve its use the Investigators want to see whether providing a 5-day course of PEPSE for people to keep at home (HOME PEPSE) will lead to it being taken much quicker than having to get it from sexual health clinics or A\&E. The HOME PEPSE packs contain HIV tablets that are used in routine HIV care. However the type of HIV drugs are slightly different to those currently used in PEPSE and the Investigators hope that they will have fewer side effects. HOME PEP consists of Truvada and Maraviroc.
140 gay men who are at high risk of getting HIV will be randomised to one of two groups. Group A will receive HOME PEPSE immediately and group B will receive HOME PEPSE after 48 weeks on the study.
Detailed Description
HIV causes significant morbidity and the estimated lifetime cost of one HIV transmission is £0.5-1 million. Despite enormous prevention efforts, transmission rates in the UK remain stable. The population most at risk of acquiring HIV in the UK are men who have sex with men (MSM), who are estimated to number over 500,000 (3.6% of the male population). The estimated prevalence of HIV among MSM aged between 15 and 44 years old is approximately 5%.
In 2013 the highest ever number of new HIV diagnoses (3,000) among MSM was reported and 85% of these were estimated to have been acquired in the UK.
This is supported by a concomitant increase in reported high risk behaviours such as condomless anal sex, from 24.3% to 36.5% of the cohort surveyed in London gyms in 1998 and 2008 respectively. In London, approximately 80% MSM are HIV negative: however high-risk sex continues in the presence of an increasing pool of HIV infected individuals. As such effective HIV prevention interventions are urgently needed to keep such individuals uninfected.
Despite sustained education and public health messages high levels of condomless sex among MSM are reported. HIV prevention tools include condoms, Post-Exposure Prophylaxis following Sexual Exposure (PEPSE), HIV pre-exposure prophylaxis (PrEP), HIV testing to reduce the undiagnosed fraction, antiretroviral treatment (ART) -as-prevention and circumcision. Clinical trials are underway to evaluate the efficacy and cost effectiveness of these approaches.
PEPSE is a key component of HIV prevention. A prospective randomised-controlled trial to determine the efficacy of PEPSE has been precluded due to the high number of participants that would be required for such a study. A case-control study conducted in healthcare workers suggested that the use of zidovudine (AZT) for post exposure prophylaxis after percutaneous exposure to HIV-infected blood was associated with a significant (OR 0.19 (95% CI 0.06-0.52) decrease in the risk of HIV transmission. In addition, mother to child transmission studies where only the neonate received ART have demonstrated a protective effect.
The efficacy of PEPSE is dependent upon the following key factors:
1. Speed of uptake from sexual exposure :
The time from exposure to initiation of PEPSE is critical for efficacy. Once HIV crosses a mucosal barrier it may take up to 48-72 hours before HIV can be detected within regional lymph nodes and up to five days before HIV can be detected in blood. Initiation of ART has been shown to reduce dissemination and replication of virus in all tissues if initiated early after inoculation in an animal model.
Animal models mimicking sexual exposure either vaginally or rectally also show protective benefits of the use of ART and demonstrate that time to initiation and duration of PEPSE influence outcome of PEPSE, with delays and shorter courses reducing effectiveness (Tsai J Virol 1998). For example, a phase I/II clinical trial using PMPA (Tenofovir) administered subcutaneously for PEPSE demonstrated that simian immunodeficiency virus (SIV) infection was prevented following an intravenous inoculation in 100% of macaques if administered within 24 hours and continued for 28 days. As either the time to initiation of PEP was increased or the duration of PEPSE was reduced then the number of macaques protected declined.
Following rectal SIV challenge however, PEPSE offers no protection if taken \>24 hours post exposure, with most protection occurring within a 2 hour exposure timeframe. This is of enormous concern for those practicing unprotected receptive anal sex, which is the highest risk sex act for HIV transmission. In the UK, the median time to first PEPSE dose is 24 hours; this unsatisfactory duration has been attributed to the fact that most exposures to HIV occur outside routine clinic hours and a lack of knowledge of where to access PEPSE out-of-hours. Learning from the emergency contraception model women provided with an advance provision of emergency contraception use it to a greater extent and more rapidly after condomless vaginal sex without engaging in increased sexual risk-taking behaviour compared to standard of care.
2. Uptake following sexual exposure. In the Gay Mens survey, 1.7% of gay men reported ever using PEPSE despite 94% reporting at least one sexual partner sex in the preceding year. Approaches to increase PEPSE uptake are therefore required.
3. Adherence
The British Society for Sexual Health and HIV (BASHH) guidelines for PEPSE recommend Truvada and Kaletra for 28 days and the indications for its use are shown in table 1. It is well recognized that ritonavir-boosted protease inhibitors including Kaletra are commonly associated with gastrointestinal side effects and elevations in lipids (Kaletra Spc). Kaletra inhibits cytochrome p450 CYP3A and therefore has many drug-drug interactions. Within the ABT-730 study 37% patients experienced grade 3 or 4 adverse events and laboratory abnormalities in the BD Kaletra arm.
As delayed initiation and non-completion of PEPSE due to side effect are likely to reduce efficacy, it is important to explore regimens that is likely to be better tolerated and ways in which PEPSE could be taken sooner after exposure. Maraviroc (MVC), a CCR5 antagonist has been shown to be an effective antiretroviral agent in the MOTIVATE and MERIT studies. In MERIT the percentage of patients achieving HIV-1 RNA \<50 copies/mL was comparable to those receiving efavirenz where they had CCR5-tropic virus at baseline. Maraviroc does not inhibit any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4). Maraviroc appears to have fewer drug-drug interactions than Kaletra and the frequency of grade 3 or 4 adverse events was low (20%) in the MERIT study. Maraviroc acts pre-integration which may have theoretical advantages for PEPSE/PrEP against HIV. Animal data demonstrates that the use of a CCR5 inhibitor reduced the likelihood of macaques acquiring SIV following vaginal exposure. Maraviroc has also been demonstrated to penetrate the male and female genital tract well and achieve high rectal tissue concentrations which may be beneficial for PEP or PrEP. In the event of failure of MVC based PEPSE, it is unlikely treatment options will be affected. Maraviroc is given for HIV treatment twice daily, however safety data supports once daily use and may confer advantages in adherence. Trials evaluating the safety of Maraviroc (MVC) as PEPSE are currently underway in the UK and Spain.
Overall, the cost of PEPSE is minimal in comparison to an HIV transmission and may provide potential cost saving and adherence benefits over daily PrEP. The Investigators propose reducing the time from HIV exposure to first dose of PEPSE in high risk individuals by providing HOME PEPSE (a 5-day pack of PEPSE to be kept at home by the individual in case of need). By removing traditional logistical barriers to PEPSE use, this approach aims to improve the appropriate and immediate access of PEPSE, reduce attendance at A \& E, reduce time to first dose (and hence increase efficacy) and further empower individuals to prevent HIV acquisition. If a positive preventative effect is shown then this approach will be evaluated in a large randomised controlled study, rolled out to other NHS providers and is likely to lead to a revision of the UK PEPSE guidelines. Maraviroc lends itself well to episodic, HOME provision PEPSE - it is stable over a long period of time, has fewer drug-drug interactions than protease inhibitors and is well tolerated.
The Investigators hypothesize that advanced provision of PEPSE using Truvada/Maraviroc 600mg OD, so called 'HOME' PEPSE to high HIV risk individuals will improve the speed and appropriate uptake of PEPSE and be extremely well tolerated.
140 men who have sex with men and who are at high risk of getting HIV will be randomised to one of two groups. Everyone will be seen at 12 weekly intervals for a sexual behaviour questionnaire and sexual health screen. A more detailed questionnaire will be given at week 0 , week 48 and week 72.
Group A will receive HOME PEPSE immediately and finish the study at week 48. Anyone starting HOME PEPSE will be advised to come to clinic as soon as possible to be assessed for the need for a 28 day PEP course. As starting HOME PEPSE (or standard PEPSE for Arm B) is dependant on participant risk behaviour, HOME PEPSE could not be taken at all during the trial or could be taken multiple times. Therefore how many time certain standard of care/research procedures occur during this trial, such as phlebotomy, is dependant on how many times participants take PEPSE.
Group B will receive HOME PEPSE after 48 weeks on the study and finish the study at week 72. For the first 48 weeks, people in this group will be able to get PEPSE from the normal places i.e. an A\&E department or a sexual health clinic. If people do start PEPSE they will be advised to contact the research team so that they can record this and complete a short questionnaire summarizing what happened.
At 48 weeks, everyone will receive a HOME PEPSE pack and have a urine test and blood test to test the kidneys and liver. They will then be followed up for a further 6 months.
#Intervention
- DRUG : Maraviroc
- Maraviroc 300 mg, TWO tablets once daily.
- DRUG : Truvada
- Truvada one tablet once daily
- Other Names :
- tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg | #Eligibility Criteria:
Inclusion Criteria:
* Male gender at birth, age >=18 years
* HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomization
* Willing and able to provide written informed consent
* And any one of:
1. condomless anal sex with a male on >1 occasion within the 90 days prior to randomization
2. bacterial rectal sexually transmitted infection (STI) within the 90 days prior to randomization
3. use of PEPSE in the 12 months prior to randomization following possible exposure to HIV through unprotected anal intercourse (UAI) with a male
Exclusion Criteria:
* An acute viral illness that could be due to HIV seroconversion
* Any contraindications to Truvada or maraviroc according to the current SmPC
* allergic to soy or peanuts
* concomitant use of antihypertensive agents
* history of postural hypotension
* known hepBsAg positive
* current participation in a HIV PrEP or PEPSE study
* Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04965662 | 56,178 |
{
"NCT_ID" : "NCT01100255",
"Brief_Title" : "Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)",
"Official_title" : "Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine",
"Conditions" : ["Obsessive-Compulsive Disorder"],
"Interventions" : ["Drug: Ketamine infusion", "Other: Saline"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-04-05",
"First_Submitted_that_Met_QC_Criteria" : 2016-09-06",
"First_Posted(Estimated)" : 2010-04-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-04-07",
"Last_Update_Posted(Estimated)" : 2017-02-20",
"Last_Verified" : 2017-01"
}
}} | #Study Description
Brief Summary
In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
Detailed Description
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.
#Intervention
- DRUG : Ketamine infusion
- 0.5mg/kg IV over 40 minutes
- Other Names :
- Ketamine hydrochloride
- OTHER : Saline
- saline infusion | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55
* Physically healthy and not currently pregnant
* Primary Diagnosis of OCD
* Sufficient severity of symptoms
* Able to provide consent
Exclusion Criteria:
* Psychiatric conditions that make participation unsafe
* Currently on psychotropic medication
* Medical conditions that make participation unsafe
* Allergy to ketamine
* Any metal in the body
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT01100255 | 118,012 |
{
"NCT_ID" : "NCT01044524",
"Brief_Title" : "Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion",
"Official_title" : "An Open Label Study to Determine ADME of 14C Labeled SLV334 and Its Metabolites After Single Intravenous Dose Infusion",
"Conditions" : ["Pharmacology, Clinical"],
"Interventions" : ["Radiation: SLV 334"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03",
"Study_Completion_Date(Actual)" : "2010-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-12-11",
"First_Posted(Estimated)" : 2010-01-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-01-07",
"Last_Update_Posted(Estimated)" : 2010-09-17",
"Last_Verified" : 2010-09"
}
}} | #Study Description
Brief Summary
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.
#Intervention
- RADIATION : SLV 334
- 2000 mg via i.v. solution | #Eligibility Criteria:
Inclusion Criteria healthy non-smoking subjects Exclusion Criteria QTc > 430 ms; positive drug screen
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01044524 | 122,402 |
{
"NCT_ID" : "NCT06139900",
"Brief_Title" : "How Virtual Reality is Impacting Balance: An Examination of Postural Stability",
"Official_title" : "The Effect of Different Visual Stimuli Provided by Virtual Reality on Postural Control in Healthy Subject",
"Conditions" : ["Healthy"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-04-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-30",
"Study_Completion_Date(Actual)" : "2021-06-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-11-14",
"First_Posted(Estimated)" : 2023-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-11-17",
"Last_Update_Posted(Estimated)" : 2023-12-29",
"Last_Verified" : 2023-11"
}
}} | #Study Description
Brief Summary
There are several studies examining the effects of different sensory stimuli on balance in healthy young people. Our study will especially explain how the same environment will affect postural control, when projected into VR environment. In this way, we aim to contribute to the literature and virtual reality programs used in rehabilitation.
Detailed Description
Thanks to the development of technology in recent years, virtual reality applications have started to be included in physiotherapy. Virtual reality is used in both clinical and academic studies for the purpose of training rather than evaluation. In the literature, it has been emphasized that traditional balance training does not have any superiority over virtual reality and virtual reality training can be used as a practical alternative in the long term (12,13). Furthermore, the feedback provided by virtual reality games is effective in the patient\'s participation in the treatment. Different visual stimuli created using virtual reality can affect postural control in different ways (14). In addition, there is no study comparing the effect of real image and virtual reality image on postural control by transferring the current environment to virtual reality. The aim of this study is to reflect the real environment to virtual reality; To explain how postural control is affected by eyes closed, eyes open and in virtual reality. Two hypotheses were determined in this study.
H0: There is no significant difference between the real environment and three virtual environment on postural control in healhty subject.
H1: There is a significant difference between the real environment and three virtual environment on postural control in healthy subject.
#Intervention
- OTHER : Assessment
- No intervention will be applied to the participants. Postural stability will be evaluated in the virtual reality environment and real environment. | #Eligibility Criteria:
Inclusion Criteria:
* Being between the ages of 18 <= age <= 30
* The absence of any medical diagnosis
* Having visual acurity or corrected visual acurity
* Being volunteer
Exclusion Criteria:
* The presence of any medical diagnosis
* The presence of any neurologic symptoms
* The presence of any sensory problems
* The presence of any balance problems
* The presence of any vestibular problems
* Previous ortophedic surgery
* The use of an additional assistive device
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT06139900 | 165,421 |
{
"NCT_ID" : "NCT01960140",
"Brief_Title" : "A Study of Baricitinib and Simvastatin in Healthy Participants",
"Official_title" : "Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects",
"Conditions" : ["Healthy Volunteers"],
"Interventions" : ["Drug: Simvastatin", "Drug: Baricitinib"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2013-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-10-08",
"First_Submitted_that_Met_QC_Criteria" : 2017-03-10",
"First_Posted(Estimated)" : 2013-10-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-08",
"Last_Update_Posted(Estimated)" : 2017-06-06",
"Last_Verified" : 2017-05"
}
}} | #Study Description
Brief Summary
The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).
#Intervention
- DRUG : Baricitinib
- Administered orally
- Other Names :
- LY3009104
- DRUG : Simvastatin
- Administered orally | #Eligibility Criteria:
Inclusion Criteria:
* Male participants - Agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
* Female participants - Women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
* Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive
* Have clinical laboratory test results within the normal reference range
* Have normal renal function
* Have normal blood pressure and pulse rate
Exclusion Criteria:
* Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
* Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
* Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
* Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin formulations, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a history of, or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including hypothyroidism), hematological, or neurological disorders
* Have current or recent history of myalgia or muscle weakness
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
* Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
* Have an absolute neutrophil count (ANC) less than 2 × 10^9/liters (L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug. For abnormal values, a single repeat will be allowed
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C infection and/or positive hepatitis C antibody
* Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
* Are women who are lactating
* Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
* Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from Day 1 until discharge from the Clinical Research Unit (CRU)
* Have consumed or intend to consume grapefruit or grapefruit-containing products within 14 days prior to the first dose and throughout the study
* Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months
* Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of Period 2
* History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per day
* Currently smoke more than 10 cigarettes per day
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01960140 | 27,532 |
{
"NCT_ID" : "NCT01221194",
"Brief_Title" : "Therapeutic Stockings to Prevent Foot Ulcers",
"Official_title" : "Therapeutic Stockings to Prevent Foot Ulcers",
"Conditions" : ["Diabetes"],
"Interventions" : ["Behavioral: Standard therapy", "Device: PFC Stockings"],
"Location_Countries" : ["United Kingdom", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02",
"Study_Completion_Date(Actual)" : "2016-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-13",
"First_Submitted_that_Met_QC_Criteria" : 2020-08-12",
"First_Posted(Estimated)" : 2010-10-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-10-13",
"Last_Update_Posted(Estimated)" : 2020-08-26",
"Last_Verified" : 2020-08"
}
}} | #Study Description
Brief Summary
1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.
Detailed Description
We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.
#Intervention
- BEHAVIORAL : Standard therapy
- Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
- DEVICE : PFC Stockings
- A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. | #Eligibility Criteria:
Inclusion Criteria:
* Men or women 18 years or older
* Diagnosis of Diabetes Mellitus*
* History of diabetes related foot ulceration
Spanish-speaking subjects will be eligible to participate.
Exclusion Criteria:
* Active Charcot Arthropathy
* Gangrene, active infection
* Midfoot or higher level amputation
* Alcohol or substance abuse within 6 months
* Unreliable, unwilling or unable to comprehend informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01221194 | 82,844 |
{
"NCT_ID" : "NCT04992000",
"Brief_Title" : "Self-Care of Hypertension Among Older Adults During COVID-19",
"Official_title" : "Self-Care of Hypertension of Older Adults During COVID-19 Lockdown Period: A Randomized Controlled Trial",
"Conditions" : ["Hypertension"],
"Interventions" : ["Other: 4-free app + PHN intervention"],
"Location_Countries" : ["Cyprus"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-01",
"Study_Completion_Date(Actual)" : "2020-12-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-07-29",
"First_Posted(Estimated)" : 2021-08-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-07-29",
"Last_Update_Posted(Estimated)" : 2021-08-12",
"Last_Verified" : 2021-08"
}
}} | #Study Description
Brief Summary
This study aimed to examine the effects of a public health nursing intervention plus m-Health applications for hypertension management on enhancing the Self-care, systolic and diastolic blood pressure, and quality of life in older adults during the lockdown period in Jordan.
Study Hypothesis:
There are no differences between the three groups in:
H01 HTN self-care (SC-HI) score. H02 Health-related quality of life (SF-36) score. H03 The management of systolic and diastolic BP levels.
Detailed Description
COVID-19 pandemic has affected all health aspects and aggravated chronic diseases health disparities because it is more common among vulnerable populations such as seniors 1. Hypertension (HTN) is a long-term chronic disease, affects more than 1 billion people around the world 2. In Jordan, one-third of Jordanian adults are hypertensive 3, one study expected that the prevalence of hypertension in 2013 may increase 7.2% by 2030 4, the HTN deaths rate touched 5% of total deaths, ranks Jordan number 7 in the world, and ranks the HTN at number 6 of leading causes of death, after coronary heart disease and stroke, the first and second leading causes of death in Jordan 5. If high blood pressure is uncontrolled, HTN is the main contributor to heart failure, cardiovascular disease, stroke, kidney disease, and death 2.
Concurrent with COVID-19, care is compromised in the context of lockdown and social distancing. Patients with chronic illness at his time have the risk that they are not obtaining the necessary hospital care, and alternative solutions are required, such as improving patient's self-care of his or her chronic disease 6. Since the hospitals are occupied with COVID-19 cases, the elderly have a perceived threat of COVID-19 and have begun avoiding or delaying health care follow-up 1. It is essential that the investigators find innovative solutions and sustainable methods for patients with HTN to control the blood pressure (BP), enhance self-care, and protect them from COVID-19, and ultimately improve their quality of life.
Engaging the patient in self-care makes him/her an active participant in the management of illness 7. Researchers worked to provide patients with the essential knowledge, skills and abilities to follow treatment recommendations and tolerate blood pressure control 8,9. Although they agreed that the best ways to prevent and manage high BP are through reasonable lifestyle changes, i.e., weight loss, low salt diet, stop smoking, limited alcohol, stress management, exercise, and medication 8, this makes the managing of high BP neither more difficult, nor easier.
However, to support healthy behaviors, the big electronic revolution provides a good opportunity to involve patients suffering from HTN in the health care process and self-care engagement in a safe space 10,11. Moreover, in order to adapt to disruptions during COVID-19, telehealth, mobile health (m-health), and other technologies which support the self-care process and facilitate access to care are appropriate approaches to protect vulnerable populations who are living with chronic diseases 1,12,13. However, improving the self-care of HTN using m-health is not a new approach; it has been studied previously by researchers from different disciplines such as technical medicine, family medicine, and pharmacy 14-19, with less attention given to the nursing role.
In literature, especially nursing literature, there is a lack of sufficient scientific research on the effectiveness of m-Health, guided by nurse's intervention, on self-care of HTN, particularly among older adults12,13. Recently, one study provided a nurse-led program as an example of an effective method to HTN management among older adults 20. The consequences of the COVID-19 pandemic (isolation, social distancing, quarantine) show major challenges in provision of care for older adults with chronic illness 1,6. The m-Health offers a great chance for providing care during the lockdown period, which can be applied via mobile apps 21. Thus, examining m-Health Apps guided by public health nursing (PHN) interventions for the management of HTN in older adults during the pandemic can provide important empirical evidence of effectiveness of such new innovative self-care of HTN interventional methods.
In this study, the investigators aim to examine three patients outcomes; self-care of HTN, change of systolic and diastolic of BP, and quality of life in three groups of older adult patients with HTN: the interventional group (4-free Apps + PHN interventions + education), control groups 1 (4-free Apps + education), and control group 2 (education) during the imposition of lockdown in Jordan as a result of COVID-19 pandemic.
#Intervention
- OTHER : 4-free app + PHN intervention
- same mentioned in groups | #Eligibility Criteria:
Inclusion Criteria:
* Participants were 55 years and above,
* have follow-up with out-patients of KAUH,
* had been diagnosed with hypertension,
* on anti-hypertension medication- at least one drug,
* reported that he/she has a personal smartphone (Android) - internet access is not important,
* able to read and understand the Arabic language.
Exclusion Criteria:
* Participants have Apple phones,
* had any psychiatric or mental illness,
* had a terminal-stage disease or were blind or deaf.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04992000 | 166,619 |
{
"NCT_ID" : "NCT02225002",
"Brief_Title" : "Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors",
"Official_title" : "Phase 1, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors",
"Conditions" : ["Advanced Solid Tumors"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-02",
"Study_Completion_Date(Actual)" : "2006-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-08-22",
"First_Posted(Estimated)" : 2014-08-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-08-22",
"Last_Update_Posted(Estimated)" : 2018-08-28",
"Last_Verified" : 2018-08"
}
}} | #Study Description
Brief Summary
CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell lung cancers. In preclinical models, activation of CD40 results in increased antigen presentation and induction of apoptosis. CD40 is also expressed on antigen presenting cells (APCs) (B cells, dendritic cells, monocytes) and is a key regulator of both cellular and humoral immune responses. Activation of CD40 by CP-870,893, an agonistic anti-CD40 monoclonal antibody, enhances host immune responses and abrogates the growth of tumors independently of the expression of CD40 on tumor cells. Therefore, it is hypothesized that therapeutic intervention with CP-870,893 may be beneficial to a large number of cancer patients either through an immunomodulatory effect or through a direct effect on CD40-positive tumor cells.
#Intervention
- DRUG : CP-870,893 | #Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 18 years with advanced solid tumors relapsed or refractory to standard therapy or for whom no effective therapy exists;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 1;
* Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
* White blood cell (WBC) count >3000 cells/μL without growth factor support;
* Absolute neutrophil count (ANC) >=1500/μL without growth factor support;
* Platelets >100,000/μL without growth factor support; and
* Hemoglobin >=10 g/dL;
* D-dimer WNL;
* Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
* Total bilirubin <1.5 times the upper limit of normal (ULN);
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <2.5 × ULN;
* Creatinine clearance (CLcr, measured or calculated) >80 mL/min; and
* Life expectancy of at least 12 weeks;
* Fully recovered from the acute effects of prior cancer therapy: 4 weeks for chemotherapy (8 weeks for mitomycin C or nitrosoureas), 10 days for prior palliative radiation therapy or hormonal therapy, and 4 weeks for prior immunotherapy or other biologic therapy; and
* Signed written informed consent.
Exclusion Criteria:
* Previously treated with any other agent that targets CD40;
* Concurrent treatment with any anticancer agent;
* History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory boweldisease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
* Treatment with any other investigational therapy within 4 weeks prior to baseline;
* History (within the previous year) of congestive heart failure, stroke, or myocardial infarction;
* Patients with known hereditary or acquired coagulopathies (eg. hemophilia, von Willebrand's disease, cancer-associated DIC, abnormal D-dimer);
* Patients with known brain metastases. Patients with clinical evidence suggestive of new brain metastases prior to enrollment are excluded if brain metastases have not been ruled out via CT or MRI. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable;
* Patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline;
* Known sensitivity to immunomodulating agents or monoclonal antibodies;
* Alcohol abuse or illicit drug use within 12 months of enrollment;
* History of serum creatinine >=2 mg/dL for any duration and for any reason;
* Patients, other than menstruating females, with urine dipstick 1+ or more positive for blood or 2+ or more positive for protein;
* Patients with clinically significant presence of granular or cellular casts in centrifuged urine sediment;
* Patients with renal carcinoma or renal metastases;
* Patients that have had a partial or complete nephrectomy;
* Patients requiring dialysis (peritoneal or hemodialysis);
* Prior treatment with Amphotericin B or cisplatin;
* Patients with history of insulin-dependent diabetes for greater than 5 years;
* Concomitant treatment with systemic high dose corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
* Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
* Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (eg, rituximab or immunoglobulin G);
* Ongoing or active infection;
* Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections.
Topical use of antibiotics or antifungals is allowed;
* Other uncontrolled concurrent illness that would preclude study participation; or
* Psychiatric illness or social situation that would preclude study participation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02225002 | 178,677 |
{
"NCT_ID" : "NCT05697120",
"Brief_Title" : "Long-term Effects of Individualized Follow-up With an App for One Year",
"Official_title" : "Effect of Using a Smartphone Application to Promote Adherence to Healthy Behaviour Post-cardiac Rehabilitation: Five Year Follow-up of a Randomized Controlled Trial",
"Conditions" : ["Coronary Artery Disease"],
"Location_Countries" : ["Norway"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-02-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-07",
"Study_Completion_Date(Actual)" : "2023-09-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-11-03",
"First_Posted(Estimated)" : 2023-01-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-16",
"Last_Update_Posted(Estimated)" : 2023-09-11",
"Last_Verified" : 2022-10"
}
}} | #Study Description
Brief Summary
The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.
Detailed Description
Recently, our research group demonstrated that individualized follow-up with an app for one year post-Cardiac Rehabilitation (post-CR) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care. To prepare for real-world implementation of an app to promote healthy behaviour post-CR, we will investigate the long-term effects (3-5 year post intervention). The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR. We hypothesize that patients allocated to the intervention group post-CR have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.
| #Eligibility Criteria:
Inclusion Criteria:
* Included in the RCT of which this study is built on
Sex :
ALL
Ages :
- Minimum Age : 41 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05697120 | 20,159 |
{
"NCT_ID" : "NCT01841619",
"Brief_Title" : "IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus",
"Official_title" : "Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus",
"Conditions" : ["Cutaneous Lupus Erythematosus"],
"Interventions" : ["Drug: IVIg"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-11",
"Study_Completion_Date(Actual)" : "2014-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-04-21",
"First_Submitted_that_Met_QC_Criteria" : 2015-07-14",
"First_Posted(Estimated)" : 2013-04-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-04-23",
"Last_Update_Posted(Estimated)" : 2015-08-10",
"Last_Verified" : 2015-03"
}
}} | #Study Description
Brief Summary
The purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients.
Detailed Description
The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies.
From the review of literature, it can be postulated that:
1. the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks;
2. clinical improvement should last several weeks after the last infusion; and
3. remission may be prolonged by maintenance IVIg therapy.
Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.
#Intervention
- DRUG : IVIg
- All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in \<25% subjects, the subjects will be re-treated by the standard protocol.
- Other Names :
- Intravenous Immunoglobin | #Eligibility Criteria:
Inclusion Criteria:
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Be at least 18 years at time of informed consent.
* Have had a diagnosis of CLE
* Currently has active CLE (any subtype) established by standard clinical and histo- and immunopathologic criteria
* Falls into one of the two following cohorts:
* Cohort 1 - Has received a standard systemic therapy without a therapeutic response for a minimum of one month
* Cohort 2 - Has not received any systemic treatment
Exclusion Criteria:
* Subject is not > 18 years.
* Subject cannot understand or follow directions.
* Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
* Subject is pregnant, planning to get pregnant, or breast feeding.
* Subject has a known history of immunoglobulin A (IgA) deficiency.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01841619 | 127,016 |
{
"NCT_ID" : "NCT04326699",
"Brief_Title" : "Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse",
"Official_title" : "Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study",
"Conditions" : ["Lumbar Disc Herniation", "Sciatica", "Low Back Pain, Mechanical", "Spine Stiffness"],
"Interventions" : ["Procedure: Bilateral SIJ injection"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-03-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-15",
"Study_Completion_Date(Actual)" : "2020-10-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-03-25",
"First_Posted(Estimated)" : 2020-03-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-03-26",
"Last_Update_Posted(Estimated)" : 2020-11-04",
"Last_Verified" : 2020-11"
}
}} | #Study Description
Brief Summary
Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.
Detailed Description
86 Patients with lumbar disc prolapse diagnosed by either MRI or CT will be included. All of them aged \> 18 years with no special condition for the duration of disc prolapse. All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility. All participants had no or poor response to conservative treatment. Previous surgery, severe facet arthropathy, ankylosing spondylitis, sensory or motor deficit and wedge fracture were considered as exclusion criteria. Distraction, compression, thigh thrust, and sacral thrust were used to assess SIJ dysfunction only at baseline before injection. Fingertip to floor and Oswestry disability index (ODI) were used to assess mobility and function of the spine at baseline (before and after injection) and after 2 and 16 weeks. Visual Analogue Scale (VAS) was used for pain appraisal at the same intervals. Participants will be randomly assigned into active and control group using 1:1 allocation. In the active group bilateral SIJ injection will be performed under ultrasound US guidance. Under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ.
#Intervention
- PROCEDURE : Bilateral SIJ injection
- under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ | #Eligibility Criteria:
Inclusion Criteria:
* Lumbar disc prolapse diagnosed by either MRI or CT were included.
* All of them aged > 18 years
* No special condition for the duration of disc prolapse.
* All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility.
* All participants had no or poor response to conservative treatment
Exclusion Criteria:
* Previous surgery
* Severe facet arthropathy
* Ankylosing spondylitis
* Sensory or motor deficit
* Wedge fracture
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04326699 | 162,993 |
{
"NCT_ID" : "NCT04751214",
"Brief_Title" : "New Technique For Laparoscopic Appendicectomy",
"Official_title" : "Zaragoza Technique For Laparoscopic Appendicectomy",
"Conditions" : ["Appendicitis Acute"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12",
"Study_Completion_Date(Actual)" : "2020-01-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-02-05",
"First_Posted(Estimated)" : 2021-02-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-02-09",
"Last_Update_Posted(Estimated)" : 2021-02-12",
"Last_Verified" : 2021-02"
}
}} | #Study Description
Brief Summary
Introduction: Appendectomy is one of the most frequent emergency surgical procedures, currently with a preference for laparoscopic management worldwide. Objective: To report a new laparoscopic appendectomy technique and its results. Material and methods: study of patients with a diagnosis of appendicitis who are managed laparoscopically. In a total 1063 patients, 148 were operated on with the Zaragoza technique during the period from January 2002 to December 2018. The technique consists of making a window in the appendicular base between the meso and the appendicular wall, two prolene or silk sutures are placed, and the cecal appendix is cut between the two sutures, finally the mesoappendix is sectioned with a harmonic scalpel or bipolar clamp.
Detailed Description
this is a retrospective study based on files
#Intervention
- PROCEDURE : APPENDICECTOMY | #Eligibility Criteria:
Inclusion Criteria:
* patients with a diagnosis of appendicitis who are managed laparoscopically.
Exclusion Criteria:
* Less than 18 year old
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04751214 | 105,787 |
{
"NCT_ID" : "NCT04086004",
"Brief_Title" : "Dual Task Balance Training With Additional Motor Imagery Practice in Stroke",
"Official_title" : "Additional Effects of Motor Imagery Practice With Dual Task Training in Stroke Patients",
"Conditions" : ["Stroke"],
"Interventions" : ["Other: Dual task training", "Other: Group I Experimental Motor Imagery"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-04-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-01",
"Study_Completion_Date(Actual)" : "2020-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-04",
"First_Posted(Estimated)" : 2019-09-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-09",
"Last_Update_Posted(Estimated)" : 2020-10-14",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
The importance of potent rehabilitation with dual task balance and gait training is improving and also there have been divergent opinions about the effectiveness of Motor Imagery on balance and gait function. Dual tasking has also proved beneficial results on stroke patients. Mental stimulation with task performance is a new intervention.. So the purpose of my study is to investigate the combination of Motor Imagery Practice and dual task rehabilitative training on balance and gait targeting the population of post stroke patients
Detailed Description
Stroke is a disease which occurs when the blood flow to the brain is cut off due to hemorrhage or ischemia in the blood vessels.Stroke is the second leading cause of death and a major cause of disability worldwide. Its incidence is increasing because the population ages . The quantity of individuals influenced by stroke will unavoidably ascend as global life expectancy increases. The frequency of motor deficits following a stroke can be up to 80% in a defined elderly population. Only a small percentage of this group (approximately 20%) will partially recover from impaired motor ability, leaving approximately 50-60% who are left with some form of chronic motor deficiency the burden of stroke seems to be high in Pakistan as in other south Asian countries. Not only the mean age of patients with stroke is less compared to patients in the developed world, approximately 20% of patients are under the age of 45 years. Hypertension is by far the most common risk factor also in young stroke patients. Hypertension and other conventional risk factors are highly prevalent in the country.To function in daily life, an individual must be able to maintain and adopt various postures, react to external disturbances, and use automatic postural responses that precede voluntary movements. A major focus of rehabilitation programs, therefore, is to improve balance and optimize function and mobility.Balance is the ability to maintain the body's center of mass over its base of support. Balance is a term used to describe the ability of a person to maintain or move within a weight-bearing posture without falling.Stroke patients experience various symptoms such as sensory disorder ,mobility defects and cognitive disorder which negatively affect functions for carrying out activities of daily living.The inability of stroke survivors to swing the involved leg rapidly might be the most critical factor adding to the enormous number of falls to the paretic side.balance and gait ability revival is a critical goal in stroke rehabilitation. A variety of interventions, such as virtual reality, robotics and mental practice with motor imagery, have been studied to improve the gait ability of stroke patients.Cognitive-motor and motor dual tasks assume significant role in day by day life: strolling while at the same time talking, utilizing a cell phone, carrying a pack or watching traffic.The dual-task program is effective in improving dual-task mobility, reducing falls and fall-related injuries in ambulatory chronic stroke patients with intact cognition. During dual-tasking, individuals with stroke have shown more pronounced performance decreasing in either the cognitive, mobility, or both tasks, compared with healthy older adults (ie, cognitive-motor interference) Mental practice is a new rehabilitation method that refers to the mental rehearsal of motor imagery content with the goal of improving motor performance.Motor imagery training is a helpful elective methodology for physical recovery following stroke, and offers protected, accessible, and cheap treatment strategy that is the utilization at home without specific equipments. Motor imagery training is free from physical execution of a disabled limb, and takes into account utilization of the mind to in restoring the circuitry that mediates voluntary movement. The preparation can make cortical plasticity changes like those made after physical action, in this way, these systems point to the capability of utilizing motor imagery practice in the neurological recovery of people following stroke.Hui yang cho et al concluded that Gait training with motor imagery training improves the balance and gait abilities of chronic stroke patients significantly better than gait training alone . According to recent study, conducted by Young Hyeon Bae et al. concluded that specific balance training with motor imagery is much beneficial and improve both balance and gait. Gye Yeop Kim et al found that dual-task training improves cognitive and walking abilities of patients with stroke.In another study conducted by Gui Bin Song et al reported that dual task training is more effective for increasing balance ability.
#Intervention
- OTHER : Group I Experimental Motor Imagery
- The experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks
- Other Names :
- Group II Experimental Dual Task Training
- OTHER : Dual task training
- group will receive dual task balance training for 40 minutes for three days/ week for eight weeks | #Eligibility Criteria:
Inclusion Criteria:
* Modified Rankin scale disability level 2 <= age <= 3
* Sub acute and chronic stroke patients.
* Ability to walk independently over ground for at least 10 m with or without use of an assistive device
* absence of any cognitive impairment
* No significant body or visual spatial hemi-neglect,
* Good ability for imagery functioning (a score of 32 or higher on the revision of Movement Imagery Questionnaire)
Exclusion Criteria:
*The patient will be excluded if he/she reported serious visual or somatosensory, orthopedic impairments.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04086004 | 46,427 |
{
"NCT_ID" : "NCT03435627",
"Brief_Title" : "Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)",
"Official_title" : "Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)",
"Conditions" : ["Genetic Disorder", "Noonan Syndrome"],
"Interventions" : ["Drug: Somatropin"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-02-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-18",
"Study_Completion_Date(Actual)" : "2022-01-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-01-31",
"First_Posted(Estimated)" : 2018-02-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-02-09",
"Last_Update_Posted(Estimated)" : 2022-11-14",
"Last_Verified" : 2022-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as agreed with the study doctor.
#Intervention
- DRUG : Somatropin
- Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician. | #Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-4020.
* For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
* Male or female, 3 years or over, bone age: less than 17 years for male / less than 15 years for female.
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Known or suspected allergy to study products or related products.
* In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03435627 | 9,337 |
{
"NCT_ID" : "NCT04759170",
"Brief_Title" : "The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby",
"Official_title" : "The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby: Prospective Randomized Controlled Study Mom, Dad and Music Therapist Singing Voice",
"Conditions" : ["Music Therapy"],
"Interventions" : ["Other: Music therapy"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-08-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-02-10",
"Study_Completion_Date(Actual)" : "2021-12-27},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-01-28",
"First_Posted(Estimated)" : 2021-02-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-02-16",
"Last_Update_Posted(Estimated)" : 2022-04-20",
"Last_Verified" : 2022-04"
}
}} | #Study Description
Brief Summary
The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.
Detailed Description
In preterm infant, oral feeding requires significant maturation of the nervous system to support coordination of the oropharyngeal muscles and breathing. Additionally, the energy expenditure required by nutritional sucking attempts further complicates the acquisition of oral feeding skills and must be balanced by caloric intake to achieve sufficient growth. Achievement of exclusive autonomous sucking typically occurs only between 34 and 36 post-conception weeks. However, delays in achieving full oral sucking are common and may prolong the infant's hospitalization.Non-nutritive sucking (NNS) is a coordinated motor skill that can be taught through an educational activity that conditions neuronal responses through positive reinforcement.The international literature demonstrates that, through a behavioral approach, the use of the pacifier during non-nutritive sucking promotes nutritional sucking in preterm infants, improving their attachment and bottle feeding, and determines the reduction of the length of stay in intensive care. and improved general well-being of the newborn.The use of receptive music therapy can therefore be supportive and represent a positive reinforcement for the development and acquisition of oral and nutritional skills of the preterm infant. By taking advantage of non-nutritive sucking it is possible to improve the suckling capacity of the newborn, his feeding speed, weight gain and consequently reduce the length of hospital stay. It is essential to achieve this result without negatively affecting the well-being and stability of the preterm infant.
Although musical studies in premature infants are limited, a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infant.On the other hand, the possible similar effects of reproduction, through the use of receptive music therapy of the song of the father and / or the music therapist, have not yet been investigated. The investigators therefore decided to design a prospective, randomized and controlled study to test the hypothesis that the parental (maternal and / or paternal) and / or music therapist's chant influences the well-being and / or stress of the newborn, evaluated through the parameter Heart Rate Variability (HRV), NNS development, nutritional sucking capacity, weight growth, and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation . 40 premature babies will be recruited to be divided into 4 groups, after computerized randomization: n. 3 musical groups (mother song, father song, music therapist song) and 1 control group (not subjected to musical stimulation). Infants with gestational age at birth between the 23rd and 34th week of gestation will be included. Neonates with intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) may also be enrolled. Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment. Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake.Infants who have not passed the subsequent hearing screening test using AABR (Brain Stem Automatic Response Test) will be excluded from the analysis, which is expected to be performed after reaching the correct age limit.
OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant. Evaluating how this can affect the clinical stability of the newborn (and therefore on his state of stress, measured in terms of HRV) represents a fundamental and primary point to explore, in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement. The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention (in terms of clinical stability, assessed through the HRV parameter) by the enrolled infants and to investigate any benefits of positive reinforcement obtained, through its use, on the acquisition of nutrition and growth skills of preterm infants.
Primary outcomes: clinical stability by measuring Heart Rate Variability (HRV)
• The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy (in terms of measurement of the clinical stability parameter HRV) by infants during music therapy treatment.
Secondary outcomes: effects of positive reinforcement (carried out through the use of receptive music therapy) on the acquisition of food skills and the growth of preterm infants. In particular:
* Evaluation of the achievement of exclusive oral sucking (determined as a week post-conception and / or days of life).
* Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention (measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption).
* Evaluation of the weight gain of the newborn in the 24 hours following stimulation
* (expressed as a percentage of weight gain from enrollment).
* Assessment of the growth rate from the last day of treatment to discharge.
* Length of hospital stay.
#Intervention
- OTHER : Music therapy
- The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby | #Eligibility Criteria:
Inclusion Criteria:
* Infants with gestational age at birth between the 23rd and 34th week of gestation
* Neonates with intraventricular hemorrhage (IVH)
* Neonates with periventricular leukomalacia (PVL)
Exclusion Criteria:
* Only newborns in ventilatory support at the time of evaluation
* Newborns with maxillofacial malformations
* Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake
* Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term
Sex :
ALL
Ages :
- Minimum Age : 23 Weeks
- Maximum Age : 34 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT04759170 | 160,775 |
{
"NCT_ID" : "NCT00059722",
"Brief_Title" : "This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.",
"Official_title" : "A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.",
"Conditions" : ["Carcinoma, Non-Small-Cell Lung"],
"Location_Countries" : ["United States", "Germany", "South Africa", "Argentina", "Belgium", "United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-05",
"Study_Completion_Date(Actual)" : "2007-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2003-05-02",
"First_Posted(Estimated)" : 2003-05-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2003-05-02",
"Last_Update_Posted(Estimated)" : 2016-08-24",
"Last_Verified" : 2016-08"
}
}} | #Study Description
Brief Summary
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
#Intervention
- DRUG : ZD6474
- DRUG : Placebo
- DRUG : ZD1839 | #Eligibility Criteria:
Inclusion Criteria:
* Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
* Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC
Exclusion Criteria:
* Subjects who have received second-line or subsequent chemotherapy
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00059722 | 66,203 |
{
"NCT_ID" : "NCT00175565",
"Brief_Title" : "Inhaled Steroid Reduces Systemic Inflammation in COPD",
"Official_title" : "Effects of Fluticasone On Systemic Markers of Inflammation in Chronic Obstructive Pulmonary Disease",
"Conditions" : ["Chronic Obstructive Pulmonary Disease", "Emphysema", "Chronic Bronchitis"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-01",
"Study_Completion_Date(Actual)" : "2003-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-11",
"First_Posted(Estimated)" : 2005-09-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-11",
"Last_Update_Posted(Estimated)" : 2010-07-28",
"Last_Verified" : 2010-07"
}
}} | #Study Description
Brief Summary
Systemic inflammation is present in chronic obstructive pulmonary disease (COPD), which has been linked to cardiovascular morbidity and mortality. We determined the effects of oral and inhaled corticosteroids on serum markers of inflammation in patients with stable COPD.
Detailed Description
We recruited patients aged 45 to 80 years, who had stable symptoms of COPD in the previous 3 months before study entry. All patients had a forced expiratory volume in one second (FEV1) after bronchodilation with 400 mcg salbutamol that was 25 to 90% of predicted, a change of less than 20% of predicted FEV1, 30 minutes following bronchodilation, and a FEV1/forced vital capacity (FVC) of less than 75%. Patients also had a history of at least 10 pack-years of smoking or prolonged exposure (\>10 years) to noxious gases (e.g. diesel fumes).
At the first visit, patients, who were taking inhaled corticosteroids, were asked to immediately discontinue the use of these medications. They were allowed to take other anti-COPD medications. None of the patients took theophyllines at the time of study entry and no new medications were commenced between the first and second visits. The patients returned 4 weeks later for a second visit, at which point, they were randomized into one of the three arms of the trial: placebo capsules and a placebo puffer, fluticasone (500 mcg twice daily) and placebo capsules, or prednisone (30 mg once daily) and a placebo puffer. The trial period lasted 2 weeks. Patients were then assigned to fluticasone (500 mcg twice daily) for 8 weeks in an un-blinded fashion, followed by an additional 8 weeks of fluticasone at 1000 mcg twice daily. At each visit, we measure the participants' serum C-reactive protein (CRP) level using nephelometry in accordance with recommendations from Center for Disease Control and the American Heart Association. We also measured serum concentrations of interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1). IL-6 was measured because it is a powerful signaling cytokine for CRP expression by the liver and is a known, independent risk factor for cardiovascular events.22,23 MCP-1 was measured because it may play a central role in the pathogenesis of COPD24 and by itself is a known risk factor for atherosclerosis, myocardial infarction and cardiac deaths. All samples were analyzed in duplicate.
For analytic purposes, continuous variables that were not normally distributed (including CRP values) were log-transformed to achieve normality. We used a paired t-test to compare the log-transformed CRP values between visit 2 (i.e. at the time of randomization) and visit 3 (at the end of the randomized trial phase) within each treatment group. Similarly, using visit 2 as the referent CRP value, we used paired t-tests to compare log-transformed CRP values across the visits. To assess whether there was a gradient in the log-transformed CRP values between placebo, fluticasone and prednisone groups, we also used a Mantel-Haenszel test for trend. We reasoned a priori that oral prednisone, a more potent systemic corticosteroid than inhaled fluticasone, would have the largest effect on CRP, followed by fluticasone. Linear regression was used to examine the association between changes in interleukin-6 and log-transformed CRP values between visit 1 and 2 and between visit 2 and 3. Continuous variables are expressed as meanSD, unless otherwise specified.
#Intervention
- DRUG : inhaled fluticasone 500 mcg b.i.d. | #Eligibility Criteria:
Inclusion Criteria:
* stable symptoms of COPD in the previous 3 months before study entry; forced expiratory volume in one second (FEV1) after bronchodilation with 400 mcg salbutamol that was 25 to 90% of predicted, a change of less than 20% of predicted FEV1, 30 minutes following bronchodilation, and a FEV1/forced vital capacity (FVC) of less than 75%; history of at least 10 pack-years of smoking or prolonged exposure (>10 years) to noxious gases (e.g. diesel fumes).
Exclusion Criteria:
* active malignancy; unable to follow instructions; patients taking any anti-inflammatory medications
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00175565 | 21,447 |
{
"NCT_ID" : "NCT00612131",
"Brief_Title" : "Medical Residents Performance: Effect of Simulation-Based Training",
"Official_title" : "Medical Residents Performance in Maximum Barrier Precautions During Central Venous Catheter Placement: Effect of Simulation-Based Training",
"Conditions" : ["Healthy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-01",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-28",
"First_Posted(Estimated)" : 2008-02-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-28",
"Last_Update_Posted(Estimated)" : 2012-10-17",
"Last_Verified" : 2007-09"
}
}} | #Study Description
Brief Summary
I Hypothesis:
1. Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement is superior to general videotape-based training
2. Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical residents, certified in CVC placement, is poor
3. PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal barrier precaution technique during central venous catheter (CVC) placement
4. PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement have good recall after 3 months
Detailed Description
Central line associated bloodstream infection (CL-ABI) is an important and preventable cause of nosocomial infections and is responsible for considerable morbidity and mortality. It is estimated that 5 to 26% of patients experience an infectious complication from their central venous catheter \[1\]. In the United States, it is estimated that nearly 50,000 patients develop central line associated bloodstream infections in the ICUs annually, at a rate of approximately 5 infections per 1000 catheter days \[2\] and as many as 15,000 deaths annually. Central line associated bloodstream infections are also associated with increased hospital and ICU lengths of stay in the ICU (2). Estimates of the cost of CL-ABI to hospitals range from $25,000 to $65,000 per patient \[3, 4\].
The Centers for Disease Control have published guidelines for the prevention of CL-ABI that represent a collaborative effort by a multidisciplinary coalition of professional organizations that provide evidence based recommendations to prevent catheter related infections \[5\]. The interventions emphasize five distinct practices, including: education and training of healthcare providers who place and care for catheters, utilizing maximum sterile barrier precautions during catheter placement, skin preparation using 2% chlorhexidine, avoiding routine replacement of central lines as a strategy to reduce infection, and using antiseptic or antibiotic coated lines in the event that infection rates remain high despite adherence to the above measures \[5\].
Several studies have demonstrated impressive reductions in CL-ABI from the application of these strategies, ranging from 18 to 100% reductions and realizing significant reductions in mortality and cost \[2\]. The simple introduction of maximum sterile barrier precautions to insert central lines has been observed to dramatically reduce infection rates for over a decade \[6\]. However, the CDC's guidelines, despite their seeming simplicity, have been found to be frequently insufficiently applied, whether by ignorance or omission (2) In the past 12 months there have been a total 24 documented central venous catheter (CVC) infections at SLRHC. At RH the total number of central line days since June 2005 was3,567 with a cumulative rate of infection of 2.8 per 1000 central line days and at SLH a total of 8,524 central line days with an infection rate of 4.3 per 1000 central line days. These infection rate figures are above the benchmark experience. The cost of CVC infections to hospitals in the United States is estimated to be $45,000 per infection (7). For SLRHC the cost incurred over the past 12 months is estimated to be $1,080,000.
Training and education of healthcare personnel and the utilization of maximum sterile precautions are two important areas. Residents still most frequently learn central line placement techniques by the 'see one, do one, teach one' method, which by its very definition allows for a multitude of techniques in practice. While this teaching theoretically includes the utilization of maximal sterile precautions for central line placement, the focus of teaching, and of residents' anxieties, is most often focused on the proper placement of the line, not the sterile technique used to place it. Residents in non-surgical fields may not be comfortable with maximum sterile technique in bedside procedures, and surgical residents may be somewhat blasé about the need for such detail.
Medical simulators allow residents to practice skills in a realistic and interactive environment that minimizes risk to patients. Studies have found simulation to be an effective means for teaching skills as diverse as ACLS and airway management to laparoscopic surgical skills (8, 9, 10). Additionally, the use of audio-visual equipment in a medical simulator to record a resident's performance gives valuable firsthand feedback that is otherwise not available, as it allows residents to visualize their own missteps (11). This is hypothesized to be of particular value in the proper acquisition of physical skills such as maximum sterile precautions.
We plan to examine the utility of a medical simulation environment that replicates an ICU setting to first assess medical residents' ability to utilize and maintain maximum sterile precautions in the placement of central venous lines using a standardized scoring tool and subsequently, assess the impact of videotape training vs. individual simulated debriefing on performance of correct MBP.
We hypothesize that medical residents, who have baseline training in the placement of central venous lines, will show improvement following simulation and viewing of the training videotape, and that greatest improvement will be seen in the residents who go through a debriefing simulated method. We hypothesize that PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement will have good recall after 3 months
| #Eligibility Criteria:
Inclusion Criteria:
* Medical residents who completed one year training in internal medicine program who are certified by their program to place and supervise medical interns in placement of CVC
Exclusion Criteria:
* Refusal to participate in the study
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT00612131 | 11,023 |
{
"NCT_ID" : "NCT00046306",
"Brief_Title" : "Nevada Environmental Tobacco Smoke and Health Study",
"Conditions" : ["Cardiovascular Disease", "Cancer"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Completion_Date(Actual)" : "2005-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2002-09-26",
"First_Posted(Estimated)" : 2002-09-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2002-09-27",
"Last_Update_Posted(Estimated)" : 2013-01-14",
"Last_Verified" : 2013-01"
}
}} | #Study Description
Brief Summary
Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease.
The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks.
#Intervention
- DRUG : Antioxidants | #Eligibility Criteria:
Inclusion Criteria:
Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases.
Exclusion Criteria:
Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00046306 | 155,576 |
{
"NCT_ID" : "NCT04577521",
"Brief_Title" : "The Safety and Efficacy of Single IA-HA Injection in Patients With Knee Osteoarthritis: A Prospective Study",
"Official_title" : "Prospective Single Centre Open Label Investigator Initiated Clinical Study to Evaluate the Efficacy and Safety of Cross-linked Intra-Articular Hyaluronic Acid (HA)(Biovisc Ortho Single) in Patients With Knee Osteoarthritis (OA)",
"Conditions" : ["Gonarthrosis"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-03-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-29",
"Study_Completion_Date(Actual)" : "2020-01-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-09-22",
"First_Posted(Estimated)" : 2020-10-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-09-30",
"Last_Update_Posted(Estimated)" : 2020-10-14",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
This prospective study was planned to carried out among the patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients clinic to evaluate the effectiveness and safety of viscosupplementation with intra-articular hyaluronic acid injection.
Detailed Description
The study was designed as prospective, single-center, single-arm, open-label, observational study. The patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients were planned to enroll the study. Patients between the age 18-80 years who did not achieve remission of pain despite receiving the first-line treatment for gonarthrosis including nonsteroidal anti-inflammatory drugs medication, activity modification and ice, were planned to included in the study. A single dose of HA will be injected into the target knee joint. Clinical evaluation will be done using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the short form-36 questionnaires (SF-36 v2) at baseline, 3 months and 6 months by a clinical secretariat.
#Intervention
- DEVICE : BioVisc Ortho Single
- BioVisc Ortho Single consisted of a prefilled syringe containing 90 mg/3 mL of IA-HA and is an injectable-grade HA from a biofermentation origin. Biovisc ortho single prefilled syringes are intended for single-use only, and the entire content of the syringe was injected into the target joint. | #Eligibility Criteria:
Inclusion Criteria:
* Patients Age should not be less than 18 years.
* Patients must be able to understand and follow the study procedures and must provide written informed consent.
* Radiologically Grade II or III osteoarthritis of knee according to the Kellgren and Lawrence classification.
* Mild to moderate documented diagnosis of knee osteoarthritis that fulfill the ACR (American College of Rheumatology) criteria.
* Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or combination of these symptoms) of knee osteoarthritis for at least 3 months prior to screening. If bilateral knee pain is present, the more painful knee will be selected.
* Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain. However patients will be allowed to use only acetaminophen or aspirin as a rescue pain medication during the study period. The patients must abstain from medication use 24 hours prior to any study visit.
Exclusion Criteria:
* Patients with secondary osteoarthritis of the knee according to ACR criteria.
* Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception.
* Patients unable to stay in the study for 6 months, non- cooperating, not able to understand
* Patients having previously undergone surgery on target knee, including arthroscopy.
* Patients with neurological deficit in the lower extremities, with primary inflammatory joint disease, intra-articular tumours.
* Any severe systemic disease(s).
* Any significant osteoarthritis symptoms in other joints apart from the target knee which may require pharmacological treatment during the study.
* Patients who have received intra-articular hyaluronic acid within the previous 6 month and/or intra-articular steroids or articular lavage in the target knee within the previous 3 months prior to their inclusion in the study.
* Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
* History of allergy or hypersensitivity to hyaluronic acid.
* Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04577521 | 172,502 |
{
"NCT_ID" : "NCT01038999",
"Brief_Title" : "Accelerated Aging, HIV Infection, Antiretroviral Therapies",
"Official_title" : "Accelerated Aging, HIV Infection, Antiretroviral Therapies",
"Conditions" : ["HIV Infection", "Aging Accelerated", "Antiretroviral Therapies"],
"Interventions" : ["Biological: Peripheral blood biological tests"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-04",
"Study_Completion_Date(Actual)" : "2012-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-12-23",
"First_Posted(Estimated)" : 2009-12-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-12-23",
"Last_Update_Posted(Estimated)" : 2012-12-27",
"Last_Verified" : 2012-12"
}
}} | #Study Description
Brief Summary
The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing that antiretroviral therapies induce an accelerated aging through the same mechanisms than genetic laminopathies or than 'physiological ' aging, that is through the synthesis and persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV infection and of antiretroviral therapies on markers of cell ageing (proteasome, mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using the same drug combination that will be used in few weeks in Marseille to treat children suffering from progeria
Detailed Description
Protease inhibitors block viral protease, as well as various other cell enzymes : ZMPSTE24 cliping off prelamin A into mature lamin A ; at least one of the Golgi proteases involved in the release of SREBP, controlling the transcription of lipid metabolism regulating genes ; mitochondrial proteases involved in the importation and further maturation of nuclear genome encoded proteins ; proteasome regulating the transcription of several genes through NF-B ; P450 cytochromes. Nucleosides inhibitors of the viral reverse transcriptase exhibit nuclear and mitochondrial DNA toxicity, disrupt lipid and protein glycosylation and inhibit telomerase. Therefore antiretroviral therapies target several pathways involved in accelerated or normal aging. Their combined effects are added to viral infection direct symptoms or to cell abnormalities induced by viral proteins.
Our multicentric (the 3 CISIH from Marseille, Nice and Montpellier) 3 year- long study will analyse 50 HIV1-infected naive patients (A group), apparied to 50 age- and sex-matched seronegative control subjects (recruited by CIC-UPCET of Marseille) and 100 HIV1-infected patients in first line of antiretroviral therapy for at least 12 months (B group). Patients of group A and B will be recruited in the 3 clinical unit. The HIV1- infected patients will be evaluated four times, at baseline, then every 12 months during 3 years. In case of initiation or changing of antiretroviral therapy, patients will be evaluated once more. Control subjects will be only evaluated at baseline.
Peripheral blood biological tests will be the following \[Laboratory designation\] : i/ viral load measurement, PBMC isolation, DNA extraction, proviral DNA measurement, cell and DNA storage \[Virology, Timone CHU, Marseille\]; ii/ assays of CD4, CD8, glycemia, insulinemia, HOMA, total-, LDL- and HDL-cholesterol, triglycerides \[Biochemistry labs from the 3 CHU\] ; iii/ antiretroviral drug assay (mass spectrometry) \[Pharmacokinetics, Timone CHU, Marseille\]; iv/ detection (western blotting, immunocytochemistry combined to image analysis of nuclear abnormalities) of PBMC nuclear, cytosolic and mitochondrial targets of antiretroviral drugs : A and B lamins, NF-B + I-B and proteasome activity assay, CD36 (glycosylation), mitochondrial Hsp70, ROS mitochondrial production, mitochondrial inner membrane potential, cytochrome C oxidase subunits 2 and 4 \[Cell Biology, Timone CHU, Marseille\] ; v/ genotyping the antiretroviral targets : lamin A (ZMPSTE24) and B (Rce1) processing proteases, Golgi SREBP-releasing proteases (MBTPS1 and S2), mitochondrial deoxynucleoside transporters (SLC25A4 to A6), mitochondrial proteases (MPPA, paraplegin) involved in processing of nuclear encoded proteins during their mitochondrial import ; quantitative PCR measurement of telomere length \[Molecular Genetics, Timone CHU, Marseille\]. Marseille's CIC-UPCET collaborated to the protocol design, will recruit control subjects and will be responsible for statistical treatment of data.
#Intervention
- BIOLOGICAL : Peripheral blood biological tests
- A group and B group will be evaluated three times, at baseline, then every 12 months during 3 years. In case of initiation or changing of antiretroviral therapy, patients will be evaluated once more. Control subjects will be only evaluated at baseline. | #Eligibility Criteria:
Inclusion Criteria:
Age >= 18 years and <65 years Able to give written consent Covered by French Social Security Non infected by HIV-2
* - A group HIV1-infected naive patients
* -B group infected patients in first line of antiretroviral therapy for at least 12 months
* -C group HIV seronegative Confirmed by a fast test of screening of the HIV at day one of study
Exclusion Criteria:
* Age < 18 years and > 65 years
* Not Able to give written consent
* Not Covered by French Social Security
* Infected by HIV-2
* treated by statin or biphosphonat amino
* concomitant treatment: diabetic or testosteron
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01038999 | 150,159 |
{
"NCT_ID" : "NCT01077037",
"Brief_Title" : "Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients",
"Official_title" : "Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial",
"Conditions" : ["Acute Coronary Syndrome"],
"Interventions" : ["Other: Decision Aid"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-02",
"Study_Completion_Date(Actual)" : "2011-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-02-24",
"First_Posted(Estimated)" : 2010-02-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-02-25",
"Last_Update_Posted(Estimated)" : 2015-05-06",
"Last_Verified" : 2015-05"
}
}} | #Study Description
Brief Summary
We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.
#Intervention
- OTHER : Decision Aid
- Chest pain choice decision aid | #Eligibility Criteria:
Inclusion Criteria:
* Adults with a primary complaint of chest pain.
* Treating clinician's next consideration is observation unit admission for cardiac stress testing.
Exclusion Criteria:
* Initial cardiac troponin T value >99th percentile (>0.01ng/mL)
* History of coronary artery disease
* coronary revascularization procedure within the previous 30 days
* cocaine use within 72 hours by the clinician's initial history
* pregnancy
* patient cannot read English or have, in their clinician's judgment, major learning barriers, such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01077037 | 199,938 |
{
"NCT_ID" : "NCT01474369",
"Brief_Title" : "Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease",
"Official_title" : "A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.",
"Conditions" : ["Non-erosive Gastroesophageal Reflux Disease"],
"Interventions" : ["Drug: Placebo", "Drug: TAK-438"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-02",
"Study_Completion_Date(Actual)" : "2013-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-10-24",
"First_Posted(Estimated)" : 2011-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-11-15",
"Last_Update_Posted(Estimated)" : 2013-07-03",
"Last_Verified" : 2013-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.
#Intervention
- DRUG : TAK-438
- TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
- DRUG : TAK-438
- TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
- DRUG : Placebo
- TAK-438 placebo-matching tablets, orally, once daily for 5 weeks. | #Eligibility Criteria:
Inclusion Criteria:
* Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
* Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).
* Participants with severity* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)
* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)
* Outpatients (hospitalization for testing possible)
Exclusion Criteria:
* Participants with an esophagus-related complication [Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) are allowed to be included.
* Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
* Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.
* Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
* Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
* Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01474369 | 110,133 |
{
"NCT_ID" : "NCT02162745",
"Brief_Title" : "Nasal Irrigation in Infants With Bronchiolitis.",
"Official_title" : "Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis",
"Conditions" : ["Bronchiolitis"],
"Interventions" : ["Drug: Hypertonic solution (NaCl 3%)", "Drug: Isotonic solution (NaCl 0.9%)"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-05",
"Study_Completion_Date(Actual)" : "2014-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-06-11",
"First_Posted(Estimated)" : 2014-06-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-06-12",
"Last_Update_Posted(Estimated)" : 2014-06-13",
"Last_Verified" : 2014-06"
}
}} | #Study Description
Brief Summary
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.
Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.
The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.
#Intervention
- DRUG : Isotonic solution (NaCl 0.9%)
- DRUG : Hypertonic solution (NaCl 3%) | #Eligibility Criteria:
Inclusion Criteria:
* infants <1 year
* diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
* oxygen saturation between 88 and 94%
Exclusion Criteria:
* previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
* chronic illness
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 365 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT02162745 | 259,214 |
{
"NCT_ID" : "NCT01556204",
"Brief_Title" : "Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial",
"Official_title" : "Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial",
"Conditions" : ["Endometriosis"],
"Interventions" : ["Procedure: Robotic surgery", "Procedure: Laparoscopic Surgery"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-03-13",
"First_Submitted_that_Met_QC_Criteria" : 2016-06-23",
"First_Posted(Estimated)" : 2012-03-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-03-14",
"Last_Update_Posted(Estimated)" : 2017-02-14",
"Last_Verified" : 2016-12"
}
}} | #Study Description
Brief Summary
The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.
Detailed Description
This is a prospective randomized control trial. Study subjects will be recruited from patients that present to the Department of Gynecology who are to have surgery for endometriosis at the Cleveland Clinic.
Patient that require bowel resection and/or ureteral reanastomosis are not included due to the fact that these events impact operating time significantly and are not commonly performed as part of endometriosis surgery (subjects may not be equally distributed among both arms).
Eligible patients that agree to participate will be provided written informed consent administered by the collaborators listed on this Institutional Review Board (IRB) at the above clinic locations. In addition to a standardized evaluation including the history and physical examination, the patients will complete the validated health-related quality of life questionnaires SF-12 and Endometriosis Health Profile-30 (EHP-30) with additional questions to determine baseline pain and activity scales as well as daily pain medication use.
Surgeries will be performed by two board certified gynecologic surgeons (TF and JG). JG will participate in the laparoscopic arm of the study (Beachwood Family Health and Surgery Center) while TF will participate in both arms (Cleveland Clinic main campus). The patients of JG randomized to robotic surgery will be performed by TF at Cleveland Clinic main campus.
Additionally, after the surgery, the patients will complete the above questionnaires as well as diaries addressing narcotic use and quality of life at 6 weeks and 6 months. Completion of questionnaires and diaries is the only additional assessment that is specific to participation in this study that is not usually included as part of the standard care for the treatment of endometriosis. It should take no more than 10 minutes to complete the questionnaires and less than 5 minutes each day to complete the diaries. The study subjects will not be exposed to any additional risk by participating in this study except for the inconvenience of completing the questionnaires and daily diaries.
The participants will be randomized preoperatively (at the time of surgery scheduling) according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package (SAS Institute, Cary, NC). All patients will be blinded to their assignment. Intraoperative randomization of the patients is not feasible due to the fact that the operating room staff and operating room assigned for a given case is different for robotic and traditional laparoscopic cases.
Patients who do not choose to participate in this study will still be offered the standard evaluation and management including laparoscopic treatment of endometriosis as deemed appropriate by the primary surgeon. Robotic-assisted laparoscopic treatment of endometriosis is not routinely performed in this institution however, and thus is not considered part of the standard of care.
Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm. ports. An umbilical port will be placed for the laparoscope and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using up to five ports as needed. An umbilical port will be placed for the laparoscope (10/12mm), a 5mm assistant port will be placed in the right lower quadrant and two or three 8 mm robotic ports will be placed in the lower quadrants bilaterally.
The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
Patients that are found not to have endometriosis at the time of surgery will be excluded from the study. The robot will be docked for all cases assigned for this arm irrespective of the amount of disease encountered (including mild endometriosis).
Data points recorded during the procedure will include: operating room time of entry and exit and time from incision to closure. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital (in cases that warrant admission) will be calculated. The standard American Society of Reproductive Medicine (ASRM) intraoperative endometriosis scoring system will be documented at the end of each surgery. Procedure and inpatient hospital costs (if applicable) will also be determined. All the operating room data (including the primary outcome) will be collected by a research nurse or coordinator that will be assigned for this task (to optimize reliability of these measurements).
Patients will complete their daily narcotic use, which will include oral as well as patient-controlled analgesia IV narcotic use in the hospital when applicable as well as quality of life diaries. Patients will return to clinic for a two week post-operative visit.
Prior to surgery, the patients will undergo a physical examination by a physician who is blinded to the patient's surgical group assignments. Additionally, patients will fill out the SF-12 health survey, EHP-30 and activity assessment questionnaires, pain scale and daily pain medication / narcotic use at baseline.
At the 2 week postoperative visit, a routine physical exam will be performed, the daily pain medication diary will be retrieved and the questionnaires for surgical pain and activity assessment will be applied.
At 6 weeks and 6 months, the nurse or physician will repeat the questionnaires by email (using Redcap), mailed questionnaires or over the telephone (SF-12, EHP-30, pain scales, daily pain medication / narcotic use and activity assessment questionnaires). The physician or nurse will also collect all the intraoperative and inpatient data for this project as well as review the medical record for possible admissions and postoperative complications.
All data points and demographic information will be recorded in a secured, password protected database on the Gynresearch drive that will only be assessed by the collaborators on this IRB. Subjects will only be identified by their Cleveland Clinic medical record number. It is necessary to identify patients in this manner so that their clinical progress (e.g. postoperative complications, emergency room visits) can be located and recorded on the database.
#Intervention
- PROCEDURE : Robotic surgery
- The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
- PROCEDURE : Laparoscopic Surgery
- The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
- Other Names :
- Laparoscopy | #Eligibility Criteria:
Inclusion Criteria:
* women 18 years or greater who are to undergo laparoscopic treatment of presumed endometriosis, as determined clinically by the operating surgeon.
Exclusion Criteria:
* suspected malignancy,
* medical illness precluding laparoscopy,
* inability to give informed consent,
* morbid obesity (BMI > 44), or
* need for concomitant bowel resection and/or ureteral reanastomosis.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01556204 | 52,528 |
{
"NCT_ID" : "NCT02574520",
"Brief_Title" : "Trial of Extended Release Bupivacaine for Pain Relief After Surgery",
"Official_title" : "A Placebo-controlled (Part 1) or Active-controlled (Part 2) Trial of SABER® -Bupivacaine for the Management of Postoperative Pain Following Laparoscopic Cholecystectomy (PERSIST)",
"Conditions" : ["Post Operative Pain"],
"Interventions" : ["Drug: Saline Placebo", "Drug: Bupivacaine HCl", "Drug: SABER-Bupivacaine (Part 1)", "Drug: SABER-Bupivacaine (Part 2)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-06",
"Study_Completion_Date(Actual)" : "2017-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-09",
"First_Submitted_that_Met_QC_Criteria" : 2021-06-21",
"First_Posted(Estimated)" : 2015-10-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-09",
"Last_Update_Posted(Estimated)" : 2021-07-13",
"Last_Verified" : 2021-06"
}
}} | #Study Description
Brief Summary
This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.
The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).
#Intervention
- DRUG : SABER-Bupivacaine (Part 1)
- 5 ml once at end of surgery
- Other Names :
- POSIMIR® bupivacaine solution
- DRUG : SABER-Bupivacaine (Part 2)
- 5 ml once at end of surgery
- Other Names :
- POSIMIR® bupivacaine solution
- DRUG : Saline Placebo
- 5 ml once at end of surgery
- Other Names :
- placebo
- DRUG : Bupivacaine HCl
- 0.5%, 15 ml, once at end of surgery | #Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for elective outpatient laparoscopic cholecystectomy using a conventional 4-port laparoscopic procedure.
* Must be able and willing to provide written informed consent, complete trial-related procedures, and communicate with the trial staff.
* Males and females 18 years or older.
* ASA Class I, II, or III.
* Patients of child-bearing potential must agree to use a medically acceptable method of contraception to prevent pregnancy for the duration of their participation in the trial.
* Must be living close enough to the investigative site to attend the four scheduled follow-up clinic visits.
Exclusion Criteria:
* Pregnant or nursing females.
* Patients with absolute or relative contraindications to laparoscopic cholecystectomy.
* Patients with prior midline abdominal surgery who are at risk for adhesions that may complicate laparoscopic cholecystectomy and/or accurate pain assessments.
* Patients requiring emergency surgery or urgent surgery (fewer than 5 days between screening and surgery).
* Patients with a pre-planned overnight stay or pre-planned hospital admission.
* Patients scheduled for single incision, mini trocars, natural orifice transluminal endoscopic surgery (NOTES), robotic laparoscopic procedures, or any procedure (other than cholangiograms and minimal adhesiolysis) in addition to laparoscopic cholecystectomy.
* Patients with known hypersensitivity to amide local anesthetics such as bupivacaine.
* Patients with acute pain that is not due to cholecystitis.
* Patients with a history of chronic pain unrelated to gallbladder disease.
* Patients with ongoing depression or psychosis.
* Patients undergoing long-term treatment with opioids or other analgesics, including acetaminophen, NSAIDs, anticonvulsants (gabapentin or pregabalin), and antidepressants (SSRIs, SNRIs, and tricyclics), but not including daily low-dose aspirin.
* Patients who are being treated chronically with systemic corticosteroids or who will require peri-operative corticosteroids because of adrenal insufficiency (inhalational or topical corticosteroids are permitted).
* Patients who may be unsuitable for opioid administration (such as sensitivity [e.g., history of severe nausea and vomiting] hypersensitivity, known history of abuse or addiction, or unwillingness to take prescribed rescue opioids).
* Use of anticoagulants and antiplatelet drugs (with exception of low dose aspirin) in the 1 week prior to surgery.
* Patients who are incapable of operating the electronic diary.
* Patients participating in any other trial with an investigational drug or device concurrently or less than 30 days prior to surgery for this trial.
* Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial procedures for any reason.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02574520 | 17,640 |
{
"NCT_ID" : "NCT04441801",
"Brief_Title" : "Optimal Duration of Stretching of the Hamstring Muscle Group",
"Official_title" : "Optimal Duration of Stretching of the Hamstring Muscle Group : A Randomized Controlled Trial",
"Conditions" : ["Physical and Rehabilitation Medicine"],
"Interventions" : ["Other: stretching exercise"],
"Location_Countries" : ["United Arab Emirates"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-06-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-01",
"Study_Completion_Date(Actual)" : "2020-09-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-06-12",
"First_Posted(Estimated)" : 2020-06-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-06-19",
"Last_Update_Posted(Estimated)" : 2020-10-30",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures were assessed immediately after the treatment session and 24 hours after the treatment session.
Detailed Description
A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection.
Inclusion Criteria Subjects who demonstrate 'tight' hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects will also be screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position Exclusion Criteria Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.
#Intervention
- OTHER : stretching exercise
- Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position | #Eligibility Criteria:
Inclusion Criteria:
* Subjects with 'tight' hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine.
Exclusion Criteria:
* Using of medical aids.
* suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
* had undergone recent surgery (within the past 12 months).
* Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04441801 | 114,065 |
{
"NCT_ID" : "NCT00589134",
"Brief_Title" : "The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration",
"Official_title" : "The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration",
"Conditions" : ["Exercise Induced Hyponatremia"],
"Interventions" : ["Other: ganirelix acetate", "Dietary Supplement: Gatorade Endurance Formula"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-02",
"First_Posted(Estimated)" : 2008-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-02",
"Last_Update_Posted(Estimated)" : 2020-03-30",
"Last_Verified" : 2010-07"
}
}} | #Study Description
Brief Summary
Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration) and this risk has been attributed to their lower body weight and size, excess water ingestion and longer racing times relative to men. While these factors contribute to the greater incidence of hyponatremia in women, it is likely that their greater levels of estradiol in plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More importantly, estradiol may also leave women more susceptible to the extreme consequences of hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most important hormone controlling water retention in the kidney. Earlier studies in our laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP release during exercise. The purpose of these studies is to test the hypotheses that in women with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release, leading to greater fluid retention, lower blood sodium concentration during endurance exercise in the heat. However, we further hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on the regulation of thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance exercise in the heat. In women without a history of hyponatremia, we expect that estradiol administration will lower the thresholds for thirst and AVP release, but will not increase fluid retention or reduce blood sodium concentration during endurance exercise in the heat. We hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or serum sodium concentration during endurance exercise in the heat. To test these hypotheses, women will perform endurance exercise in the heat under three hormonal conditions: 1) during Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+ progesterone. During exercise, fluid will be replaced with either water or a carbohydrate-electrolyte beverage (random assignment).
#Intervention
- DIETARY_SUPPLEMENT : Gatorade Endurance Formula
- carbohydrate electrolyte beverage
- OTHER : ganirelix acetate
- GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days.
- Other Names :
- Antagon | #Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers (18 <= age <= 35 yrs) with and without previous exercise induced hyponatremia
Exclusion Criteria:
* conditions that would preclude safe exercise or safe use of hormones
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00589134 | 91,362 |
{
"NCT_ID" : "NCT05804253",
"Brief_Title" : "Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.",
"Official_title" : "Clinical, Radiographic and Histological/Histomorphometric Analysis of Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral: a Randomized Controlled Clinical Trial",
"Conditions" : ["Histomorphometry"],
"Interventions" : ["Procedure: Maxillary sinus augmentation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06-30",
"Study_Completion_Date(Actual)" : "2018-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-03-14",
"First_Posted(Estimated)" : 2023-04-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-03-26",
"Last_Update_Posted(Estimated)" : 2023-04-07",
"Last_Verified" : 2023-03"
}
}} | #Study Description
Brief Summary
The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:
Detailed Description
Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.
#Intervention
- PROCEDURE : Maxillary sinus augmentation
- Maxillary sinus grafting with 2 different xenogenic materials | #Eligibility Criteria:
Inclusion Criteria:
* maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure
Exclusion Criteria:
* drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05804253 | 259,747 |
{
"NCT_ID" : "NCT04392271",
"Brief_Title" : "A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy Participants",
"Official_title" : "Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Multiple Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LY3316612 in Healthy Subjects",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: LY3372689", "Diagnostic Test: [18F]LSN3316612"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-08-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-14",
"Study_Completion_Date(Actual)" : "2020-10-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-04-21",
"First_Posted(Estimated)" : 2020-05-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-05-14",
"Last_Update_Posted(Estimated)" : 2020-11-04",
"Last_Verified" : 2020-11"
}
}} | #Study Description
Brief Summary
This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to about 10 weeks. Screening must be completed within four weeks prior to enrollment.
#Intervention
- DRUG : LY3372689
- Administered orally.
- DIAGNOSTIC_TEST : [18F]LSN3316612
- Administered intravenously (IV).
- Other Names :
- [18F]MNI-1068 | #Eligibility Criteria:
Inclusion Criteria:
* Overtly healthy males or females who do not have child-bearing potential
* Have a body mass index (BMI) of greater than (>)18 to less than or equal to (<=32) kilograms per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have venous access sufficient to allow for blood sampling
Exclusion Criteria:
* Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milliSievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
* Are current smokers or have used tobacco or nicotine-containing products as determined by the cotinine test
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
* Participate in regular vigorous exercise
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04392271 | 207,611 |
{
"NCT_ID" : "NCT01092559",
"Brief_Title" : "Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide",
"Official_title" : "An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Interventions" : ["Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-07",
"Study_Completion_Date(Actual)" : "2011-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-02-16",
"First_Submitted_that_Met_QC_Criteria" : 2013-04-18",
"First_Posted(Estimated)" : 2010-03-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-03-23",
"Last_Update_Posted(Estimated)" : 2013-06-04",
"Last_Verified" : 2013-04"
}
}} | #Study Description
Brief Summary
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.
Detailed Description
TREATMENT/FOLLOW-UP:
Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.
#Intervention
- DRUG : Nitric Oxide generated by the GeNO nitrosyl delivery system
- single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system. | #Eligibility Criteria:
Inclusion Criteria:
* Have a confirmed diagnosis of PAH, WHO Group 1.
* WHO Functional Class II or III equivalent, PAH.
* Have been clinically stable with regard to signs and symptoms of PAH for at least 30 days prior to RHC.
* May be receiving approved mono therapies or combination PAH therapies.
* Females that are surgically sterile or post-menopausal. Females of chil-bearing potential must have negative pregnancy test and must be practicing adequate birth control.
Exclusion Criteria:
* Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
* Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
* Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
* CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
* Have a history of uncontrolled sleep apnea within three months of RHC.
* Have a history of hemodynamically significant left-sided heart disease
* Have evidence of left-sided heart disease
* Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
* Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
* Have used prescription appetite suppressants within 3 months prior to wean/transition.
* Have chronic kidney disease stage IV or worse or the requirement for dialysis.
* Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
* Have had an atrial septostomy.
* Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
* Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
* Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial
* Participant is pregnant or lactating
* Significant, ongoing alcohol or drug abuse.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01092559 | 192,714 |
{
"NCT_ID" : "NCT03131713",
"Brief_Title" : "Preoperative Acetaminophen and Carbohydrate Loading",
"Official_title" : "Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers",
"Conditions" : ["Non-melanoma Skin Cancer"],
"Interventions" : ["Drug: Acetaminophen"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12-31",
"Study_Completion_Date(Actual)" : "2017-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-03-06",
"First_Submitted_that_Met_QC_Criteria" : 2019-10-04",
"First_Posted(Estimated)" : 2017-04-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-04-26",
"Last_Update_Posted(Estimated)" : 2019-10-07",
"Last_Verified" : 2019-10"
}
}} | #Study Description
Brief Summary
The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.
#Intervention
- DRUG : Acetaminophen
- Acetaminophen 1000mg | #Eligibility Criteria:
Inclusion Criteria:
* Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)
Exclusion Criteria:
* history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03131713 | 128,148 |
{
"NCT_ID" : "NCT04259593",
"Brief_Title" : "Exercise for Elderly Lymphoma Patients",
"Official_title" : "Exercise Training is a Feasible and Active Complementary Therapy in Adult and Elderly Patients Receiving Anti- Lymphoma Treatments",
"Conditions" : ["Elderly Lymphoma Patients"],
"Interventions" : ["Other: exercise training"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-01-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-31",
"Study_Completion_Date(Actual)" : "2018-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-02-05",
"First_Posted(Estimated)" : 2020-02-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-02-05",
"Last_Update_Posted(Estimated)" : 2020-02-06",
"Last_Verified" : 2020-02"
}
}} | #Study Description
Brief Summary
This pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined Exercise Training (ET) program in adult and elderly lymphoma patients undergoing cancer-treatments.
Detailed Description
Eligible patients were assigned to the ET group. All the patients eligible for exercise but not partiticpating to the ET program because of logistical reasons, were considered as the control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and 6-months (T2) after the beginning of the exercise.
#Intervention
- OTHER : exercise training | #Eligibility Criteria:
Inclusion Criteria:
* >=18 <= age <= 80 years, histologically confirmed HL or NHL, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy
Exclusion Criteria:
* Patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were >= 65 years and frail on the basis of comprehensive geriatric assessment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04259593 | 234,286 |
{
"NCT_ID" : "NCT00199641",
"Brief_Title" : "Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients",
"Official_title" : "Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients",
"Conditions" : ["-Mechanically Ventilated Patients"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-07",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-14",
"First_Posted(Estimated)" : 2005-09-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-14",
"Last_Update_Posted(Estimated)" : 2008-12-04",
"Last_Verified" : 2008-12"
}
}} | #Study Description
Brief Summary
The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.
#Intervention
- DEVICE : enteral nutrition | #Eligibility Criteria:
Inclusion Criteria:
* Adult (> 18 ans)
* Mechanical ventilation for > 72 hours
* Planned enteral nutrition
* Informed consent
Exclusion Criteria:
* Body Mass Index < 20 kg/m2
* Enteral nutrition non indicated (ileus, splanchnic ischemia..)
* Shock (use of catecholamines, arterial blood pressure < 90 mmHg, peripheral hypoperfusion, elevation of lactates > x 1,5 normal value)
* Contraindications for gastric tube
* Pregnancy
* Previous enrollment in the present study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00199641 | 129,695 |
{
"NCT_ID" : "NCT04870398",
"Brief_Title" : "Partial Pulpotomy in Mature Permanent Teeth With Signs and Symptoms of Irreversible Pulpits",
"Official_title" : "Treatment Outcome of Partial Pulpotomy by Using Two Different Bioactive Materials in Mature Permanent Teeth With Signs and Symptoms of Irreversible Pulpitis. A CONSORT Randomized Clinical Trial",
"Conditions" : ["Irreversible Pulpitis"],
"Interventions" : ["Procedure: Vital Pulp therapy-Partial pulpotomy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-23",
"Study_Completion_Date(Actual)" : "2021-04-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-24",
"First_Posted(Estimated)" : 2021-05-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-04-28",
"Last_Update_Posted(Estimated)" : 2021-05-03",
"Last_Verified" : 2021-04"
}
}} | #Study Description
Brief Summary
The main purpose of the present study is to assess the outcome of partial pulpotomy by using two different bioactive materials, namely MTA \[MTA Angelus (Angelus, Londrina, Brazil) and Total Fill BC putty (FKG, La Chaux-de-Fonds, Switzerland) bioceramic material in mature teeth with deep caries and clinical symptoms indicative of irreversible pulpitis. A secondary aim is to evaluate whether age, tooth type and coronal restoration play a significant role on the outcome of partial pulpotomy in the evaluated cases.
Detailed Description
Study design This is a randomized controlled clinical superiority trial, parallel designed which will be conducted in compliance with the CONSORT and PRIRATE 2020 guidelines for reporting randomized trials in Endodontology recently published by the ESE (Nagendrababu et al. 2020a, b). During the study, two different bioactive materials will be tested upon their placement on exposed pulps of mature teeth with preoperative signs and symptoms indicating the presence of irreversible pulpitis. Patients referred to the Postgraduate Clinic of Endodontology of Dental School of National and Kapodistrian University of Athens, will participate in the study.
Sample size calculation For sample size calculation, the Stata version 15.1 software (Stata Corp, College Station, Texas, USA) has already been used. Based on the results of a previous study by Taha \& Khazali (2017) and expecting a 85% success rate for tested materials with 80% power of analysis and determining the level of statistical significance at 5%, the number of patients in each group was determined to be 65 (n = 65).
Randomization/Allocation concealment/Bliniding The randomization of the patients in the study has been taken place by using the web-based software of www.randomizer.org. This software gives automatically numbers to patients allocating them randomly in the study groups. Patients will be blinded to the type of the material used in their tooth. The operator could not be blinded during the study. An experienced endodontist (more than 15 years of clinical experience) will assess the follow-up radiographs and will be blinded to the capping material used in each case.
Data collection Demographic data such as age and sex and data regarding the tooth type and location will be collected.
Preoperative clinical and radiographic examination At the first appointment, the medical and dental history including the chief complaint will be recorded and then clinical and radiographic examination will take place. Accurate history of pain will take place to assess the severity of pain including the spontaneity or the lingering of pain after temperature stimulation and the sleep disturbance. The patients that meet the inclusion criteria will be informed in details about the aims of the study and those who will give permission will sign an informed consent and will be added to the study with a recognition number.
Clinical examination will consist of:
* Visual inspection of the caries lesion under operating microscope.
* Restorability of the tooth.
* Percussion and palpation tests.
* Cold and electric pulp sensibility tests.
* Periodontal examination (pocket depth, attachment loss and mobility). A clinical diagnosis indicating the establishment of irreversible pulpitis will be set in all cases based on the history of severe spontaneous or lingering pain reproducible during clinical examination.
Radiographic examination Preoperative periapical radiographs will be taken using the parallel cone technique using the Rinn set. (Rinn, Dentsply, Elgin, IL).
Clinical Intervention All the procedures will be carried out by the same experienced operator (GT, more than 15 years of clinical experience in his practice limited to Endodontics) and under operating microscope by using high magnification. High quality photographs will be taken throughout the procedures. Profound local anesthesia of the tooth and the surrounding tissues will be achieved by using lidocaine with 1/80000 epinephrine (Lignospan Special, Septodont, France). The tooth will be isolated with a rubber dam and initial caries removal will be performed by using a sterile high speed diamond bur. The deeper layers of caries will be removed by using a series of different diameters sterile low speed burs. After complete caries removal and pulp tissue exposure, first cut of pulp tissue will be performed using a new sterile high speed diamond bur. After the inspection of the surgical field for residual caries and the irrigation of the cavity with physiologic saline solution, a sterile cotton pellet will be gently placed over the pulp tissue for 3 minutes. If bleeding continues after the removal of cotton pellet, NaOCl 2.5% will be used for irrigation of the pulp tissue and a new sterile cotton pellet will be placed over the pulp for another 2 minutes. In case where bleeding continues after the removal of the new cotton pellet, a second cut of the pulp tissue will be performed to reach a tissue free of inflammation. Then, a new sterile cotton pellet will be placed over the amputated pulp for 5 minutes. If bleeding continues, the case will be excluded from the study and full pulpotomy or root canal treatment will be considered. Once hemostasis is achieved, a blood-filled homogenous tissue without dark or yellowish areas will be considered essential for the placement of pulp capping material. All the materials tested will be prepared according to the manufacturers' instructions. After the placement of the materials, a resin modified glass-ionomer cement (Ultrablend Plus, Ultradent Products Inc.) will be placed over the capping material and the cavity will be sealed with resin-bonded composite (Estelite Quick, Tokuyama Dental, Tokyo, Japan). A telephone call will be scheduled with the patient after one, two, three and four days in order to get information about the clinical condition of the tooth, the pain relief and the anti-inflammatory drugs needed postoperatively. In case of severe pain persisting one week after the intervention, the patient will be scheduled for root canal treatment and the case will be recorded as clinical failure.
Recall protocol Follow-up clinical and radiographic examinations are scheduled at 3, 6, 12, 24, 36 and 48 month intervals. A dental history will be obtained, including possible pain experience or pain and discomfort during mastication as well as the functionality of the tooth. The teeth will also be clinically examined for signs and symptoms such as pain or discomfort during percussion, swelling or sinus tract, presence of periodontal pocket and absence of positive response to cold testing. Radiographic examination will include the assessment of periapical status, the formation of dentin bridge and the presence of internal resorption or root canal obliteration. Finally, the quality of coronal restoration will be assessed clinically and radiographically.
Statistical analysis Descriptive statistics with cross tabulations will be performed. Baseline characteristics of the sample will be tabulated and frequency distributions will be presented for all covariates (sex, age, type of tooth, dentin bridge formation, type of coronal restoration), across type of pulp capping material. Chi-squared and Fisher's exact tests will be applied as appropriate. Kaplan-Meier survival curves for pulp capping materials, type of tooth, age band and sex will be also drawn. Log-rank tests for equality of survivor functions will be applied. A univariable and multivariable random effects Cox regression model, using the date of entry to the study as the time-scale, will be built based on pre-defined covariates, such as pulp capping material, tooth type, sex, age, dentin bridge formation and type of coronal restoration. All predictors will be retained in the final multivariable model. The proportional hazards assumptions will be checked through Nelson Aalen plot for log cumulative hazard by type of pulp capping material. A two-sided p-value of 0.05 will be used to determine statistical significance for all analyses, along with 95% CIs. All analyses will be performed using Stata v.14.1.
#Intervention
- PROCEDURE : Vital Pulp therapy-Partial pulpotomy
- Removal of inflamed pulp tissue, hemostasis and placement of pulpotomy material | #Eligibility Criteria:
Inclusion Criteria:
* Patients older than 10 years.
* Written consent after their update regarding the study and its aims.
* Noncontributory medical history.
* Extremely deep caries extending to the pulp chamber.
* Positive response to cold sensibility testing.
* Presence of spontaneous pain or provoked lingering pain to cold stimuli.
* No clinical signs of pulp necrosis such as swelling or presence of a sinus tract.
* Restorable and periodontally sound teeth.
Exclusion Criteria:
* Immature teeth.
* Cariously involved teeth with no response to pulp sensibility tests.
* No signs and symptoms of irreversible pulpitis.
* Bleeding not controlled in 10 minutes after partial pulpotomy.
* Teeth with no evidence of bleeding after communication with the pulp chamber (necrosis of the coronal pulp tissue)
* Teeth with the pulp chamber exposed to the oral environment.
* Detection of periodontal pocket with depth greater than 4mm.
* Teeth suspected for crack or incomplete crown fracture possibly responsible for pulp pathology.
* Medically compromised patients.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT04870398 | 242,804 |
{
"NCT_ID" : "NCT01178788",
"Brief_Title" : "Progestagens for the Tertiary Prophylaxis of Preterm Delivery",
"Official_title" : "Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial",
"Conditions" : ["Preterm Delivery", "Neonatal Complications"],
"Interventions" : ["Drug: micronized Progesterone", "Drug: 17 alpha-hydroxy progesterone caproate", "Procedure: Control"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-07-08",
"First_Posted(Estimated)" : 2010-08-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-08-09",
"Last_Update_Posted(Estimated)" : 2016-09-23",
"Last_Verified" : 2016-09"
}
}} | #Study Description
Brief Summary
Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy.
Main outcome: Delivery before 37 weeks.
Secondary outcomes: Gestational age at delivery, Delivery \<32, \<35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies.
Allocated treatments will be:
Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation
Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded.
Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting.
Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients.
Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.
Detailed Description
Background: According to the last reviews Progesterone (P) and (17P) are able to reduce preterm delivery (PTD), either as prophylactic administration in the presence of previous PTD or as a treatment of the actual pregnancy, becoming at risk because of cervical shortening/preterm labour. At present is difficult to distinguish the clinical effects of P from the one of 17P as well as it is impossible to choice among the diverse doses and formulations utilized in the RCTs published so far, as well as in those under recruitment.
Protocol: Women will be treated with P, 17P or just clinically observed according to on-line randomization assignment provided by the Methodological Unit. Treatments end at the completion of 36th week. Randomization will be stratified for early (22-27+6th) and late (28-31+6th wks) PTD risk. Interim analysis will be done at 50% enrollment.
Sixty women will be allocated to each Clinical Centre to reach 480 enrollments, in the 3 arms.
Drugs will be provided by manufacturers.
#Intervention
- DRUG : 17 alpha-hydroxy progesterone caproate
- weekly injection of 17 P
- Other Names :
- Lentogest
- DRUG : micronized Progesterone
- daily administration of vaginal progesterone
- Other Names :
- Utrogestan
- PROCEDURE : Control
- Other Names :
- Routine clinical cares | #Eligibility Criteria:
Inclusion Criteria:
* Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length <=25 mm, after an episode of preterm labour.
Exclusion Criteria:
* Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01178788 | 213,920 |
{
"NCT_ID" : "NCT03807440",
"Brief_Title" : "DIA_CENTRAL:T2D Treatment Pattern in Central Europe",
"Official_title" : "CORDIALLY® - CEE: Characteristics of Patients With Type 2 Diabetes Treated With Modern Antidiabetic Drugs. A Real World Data Collection of Patient Baseline Characteristics, Treatment Patterns and Comorbidities in Central Eastern European (CEE) Countries",
"Conditions" : ["Diabetes Mellitus, Type 2"],
"Interventions" : ["Drug: Glucagon-like peptide 1 agonist", "Drug: Dipeptidyl-peptidase 4 inhibitor", "Drug: Sodium Glucose Transporter 2 inhibitor", "Drug: Empagliflozin"],
"Location_Countries" : ["Poland", "Russian Federation", "Bulgaria", "Hungary", "Czechia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-08-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-08-31",
"Study_Completion_Date(Actual)" : "2021-08-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-15",
"First_Submitted_that_Met_QC_Criteria" : 2023-02-23",
"First_Posted(Estimated)" : 2019-01-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-15",
"Last_Update_Posted(Estimated)" : 2023-12-01",
"Last_Verified" : 2023-02"
}
}} | #Study Description
Brief Summary
This is a non-interventional study using existing data including medical chart review.
#Intervention
- DRUG : Empagliflozin
- Empagliflozin
- Other Names :
- Jardiance® Synjardy® Trajenta® Jentadueto®
- DRUG : Sodium Glucose Transporter 2 inhibitor
- Sodium Glucose Transporter 2 inhibitor
- Other Names :
- Jardiance® Synjardy® Trajenta® Jentadueto®
- DRUG : Dipeptidyl-peptidase 4 inhibitor
- Dipeptidyl-peptidase 4 inhibitor
- Other Names :
- Jardiance® Synjardy® Trajenta® Jentadueto®
- DRUG : Glucagon-like peptide 1 agonist
- Glucagon-like peptide 1 agonist
- Other Names :
- Jardiance® Synjardy® Trajenta® Jentadueto® | #Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to participation
* Female and male patients age >= 18 years
* Patients with T2D diagnosis
* Patients who have been newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)
* Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1
Exclusion Criteria:
* Patients age < 18 years
* Patients with diagnosis of other types of diabetes than T2D
* Patients who do not provide written consent to the terms of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03807440 | 23,960 |
{
"NCT_ID" : "NCT03955809",
"Brief_Title" : "Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.",
"Official_title" : "Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for",
"Conditions" : ["Arthroscopy"],
"Interventions" : ["Drug: Ketamine 0.5", "Drug: % 0.9 NaCl", "Drug: Ketamine 1"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08",
"Study_Completion_Date(Actual)" : "2016-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-14",
"First_Posted(Estimated)" : 2019-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-05-16",
"Last_Update_Posted(Estimated)" : 2020-01-22",
"Last_Verified" : 2020-01"
}
}} | #Study Description
Brief Summary
the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy
Detailed Description
All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.
Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.
VAS scores and total analgesic requirement is going to be evaluated.
#Intervention
- DRUG : Ketamine 0.5
- İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
- Other Names :
- Group 1
- DRUG : Ketamine 1
- İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
- Other Names :
- Group 2
- DRUG : % 0.9 NaCl
- Intraarticular %0.9 NaCl
- Other Names :
- Group 3 | #Eligibility Criteria:
Inclusion Criteria:
* Artroscopic surgery
* ASA I-II
Exclusion Criteria:
* Long time NSAID use
* Travmatic knee injury
* Long ter analgesic use
* Intraartiular catheter insertion at the end of surgery
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03955809 | 230,907 |
{
"NCT_ID" : "NCT02346591",
"Brief_Title" : "Mobile-Web Emotion Self-management Tool",
"Official_title" : "Emotion Management Training: An Innovative Stress Reduction Program",
"Conditions" : ["Stress", "Depression"],
"Interventions" : ["Behavioral: Online stress management information", "Behavioral: Jauntly"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-11",
"Study_Completion_Date(Actual)" : "2013-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-01-21",
"First_Posted(Estimated)" : 2015-01-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-01-26",
"Last_Update_Posted(Estimated)" : 2015-01-27",
"Last_Verified" : 2015-01"
}
}} | #Study Description
Brief Summary
The investigators developed a responsive mobile-web app, 'Jauntly,' which was designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience. The app's goal was to lead users through research-proven positive emotion-enhancing exercises and relevant educational materials. Intervention activities covered five well-being-generating content areas: 1) promoting the experience and recognition of gratitude; 2) encouraging positive social relationships and feelings of social support; 3) improving stress resilience via mindfulness and other relaxation-focused activities; 4) focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses); and 5) general positive mood inducing activities. Program content was adapted from a variety of stress-relevant research areas including health psychology/psychosomatic medicine, social/personality psychology, positive psychology, and clinical psychology.
Detailed Description
The overarching goal of the Jauntly mobile app was to experience exercises that encourage one to take care of oneself emotionally, improve positive emotions, and decrease stress and other negative emotions. The user interacted with the app through evidence-based activities (e.g. writing gratefulness notes, helping others, practicing mindfulness). The activities were selected based on the goals the user selected upon initiation of program and throughout engagement with the app. In order to promote sustained use of the program and mastery of the positive emotion based skills, the design of the program included activities that range in difficulty so that the user could progress and improve (i.e., simple '1 and done' types of goals versus multi-week goals).
Research in positive psychology interventions suggests that increases in well-being are highest when the activity: 1) fits the person's interests and values and 2) is performed neither too frequently nor too seldom. Because of our desire to have a product with long-lasting usability and sustained engagement, it was critical that there were a diverse number of activities from which individuals could choose based on interest, current mood, and past success. The Jauntly user experience is structured around free use of the app partnered with regular emails, in-app messaging, videos, and articles. Emails remind users to utilize program content (including users in the control group who were reminded to visit the stress-management website). Use of the app and viewing of videos and other content is not restricted and users are able to self-tailor use according to their interest.
#Intervention
- BEHAVIORAL : Jauntly
- Mobile app designed to encourage positive emotion-enhancing and stress reduction activities.
- BEHAVIORAL : Online stress management information
- Online educational information about stress management | #Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Employed at least part-time
* Self-report stress at work
* English speaking
* Access to a computer with high-speed internet connection, audio-video capability and an active email account
Exclusion Criteria:
* High level of self-reported grief
* High level of self-reported depression (PHQ-2)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02346591 | 61,629 |
{
"NCT_ID" : "NCT03523325",
"Brief_Title" : "Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women",
"Official_title" : "Recovery of Symptoms, Function, Tendon Structure and Mechanical Properties in Patients With Achilles Tendinopathy: A Comparison Between Men and Women",
"Conditions" : ["Achilles Tendinopathy", "Achilles Tendonitis", "Achilles Tendon Pain", "Achilles Degeneration", "Achillodynia"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-07-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-01-12",
"Study_Completion_Date(Actual)" : "2024-03-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-01",
"First_Posted(Estimated)" : 2018-05-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-05-01",
"Last_Update_Posted(Estimated)" : 2024-06-27",
"Last_Verified" : 2024-06"
}
}} | #Study Description
Brief Summary
This study will evaluate if there is a difference in recovery of tendon structure and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. It will evaluate recovery of tendinopathy with exercise intervention using outcome measures for tendon structure and mechanical properties along with validated measures of muscle-tendon function and symptoms.
Detailed Description
Achilles tendinopathy has an incidence rate of 2.35 per 1000 in the general population and is most prevalent in middle-aged individuals (35-55 y/o), but occurs in men and women of all ages. The primary symptom is pain during daily activities such as walking and exercising such as running. Aside from the pain, Achilles tendinopathy has been shown to significantly decrease physical activity level, resulting in further negative effects on overall health and well-being. The treatment for Achilles tendinopathy with the highest level of evidence is eccentric exercise, providing mechanical loading of the muscle-tendon unit. In a recent systematic review, all studies reported significant improvements in patient-reported symptoms but at 12 weeks the means ranged from 69-80 (100 being fully recovered) indicating that even with the most effective treatment individuals continued to have symptoms. At this time, other more invasive interventions such as injection therapies (ex. platelet-rich plasma) and surgery are recommended for patients who fail exercise treatment despite a lack of understanding of what factors are related to continued problems. Just achieving a reduction in pain and symptoms with treatment also does not ensure resolution of the tendon's structural abnormalities. In fact, studies evaluating the recovery of tendon structure with exercise suggest that at least 24 weeks may be needed to observe a significant change. Other individual factors such as sex, degree of tendon structural damage and functional deficits are also proposed to influence both the time course and success rate of recovery. The long-term goal of our research is to advance understanding of tendon injuries and repair, enabling tailored treatments to be developed. This study begins to address this long-term goal by evaluating the time-course of recovery in terms of tendon structure (ultrasound imaging) and viscoelastic properties (elastography) along with symptoms (patient-reported outcomes) and muscle-tendon function (functional test-battery) in males and females with Achilles tendinopathy treated with an exercise program. Aim 1 is to evaluate if there are differences in change over time in symptoms, muscle-tendon function, tendon structure, and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. Aim 2 is to investigate whether the presence and magnitude of tendon structural abnormality at baseline will affect the ability and time-course of recovery with exercise treatment for Achilles tendinopathy. Aim 3 is to explore if patients who continue to have symptoms at the 16-week evaluation will further improve in symptoms, muscle-tendon function, tendon structure and mechanical properties over the course of one year.
#Intervention
- OTHER : Exercise treatment
- Treatment protocol is an exercise program consisting of four different phases (Silbernagel protocol). The progression consists of increasing number of repetitions, resistance, speed and range of motion of the exercises. A pain-monitoring model is used to adjust the exercise loads and progression through the four phases.
- Other Names :
- Rehabilitation exercise, Physical Therapy treatment | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of midportion Achilles tendinopathy
Exclusion Criteria:
* Previous Achilles tendon rupture
* Diagnosis of only insertional Achilles tendinopathy or bursitis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03523325 | 39,298 |
{
"NCT_ID" : "NCT01952821",
"Brief_Title" : "Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck",
"Official_title" : "The Validity and Reliability of the Six-Minute Walk Test, Ten-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modified Brief Fatigue Inventory in Patients With Cancer of the Head and Neck",
"Conditions" : ["Head and Neck Cancer"],
"Interventions" : ["Other: Six-Minute Walk Test", "Other: Linear Analog Scale of Function", "Other: 10-Meter Walk Test", "Other: Modified Brief Fatigue Inventory", "Other: FACIT-Fatigue", "Other: 30-Second Chair Stand"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09",
"Study_Completion_Date(Actual)" : "2015-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-09-21",
"First_Posted(Estimated)" : 2013-09-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-09-27",
"Last_Update_Posted(Estimated)" : 2015-05-22",
"Last_Verified" : 2015-05"
}
}} | #Study Description
Brief Summary
The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30 Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory as reliable and valid outcome measurements for patients with head and neck cancer.
Detailed Description
This study will be looking at the test-retest reliability and validity of various outcome measures in patients with cancer of the head and neck. Testing will occur in 2 visits within one week.
#Intervention
- OTHER : Six-Minute Walk Test
- OTHER : 10-Meter Walk Test
- OTHER : 30-Second Chair Stand
- OTHER : Linear Analog Scale of Function
- OTHER : Modified Brief Fatigue Inventory
- OTHER : FACIT-Fatigue | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 85
* Within 3 months of surgery, or are currently undergoing radiation and/or chemotherapy for a diagnosis of head and neck cancer
* Community dwelling
* Able to provide informed consent, answer relevant questionnaires,follow instructions provided during testing
Exclusion Criteria:
* Vulnerable populations (minors, prisoners)
* Medical comorbidities which limit the safe completion of the 6MWT, gait speed, and strength testing
* Inability to return for a second day of testing within one week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01952821 | 173,416 |
{
"NCT_ID" : "NCT01652313",
"Brief_Title" : "Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women",
"Official_title" : "A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women",
"Conditions" : ["Parkinson's Disease"],
"Interventions" : ["Drug: Rasagiline"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-06",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-07-23",
"First_Posted(Estimated)" : 2012-07-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-07-25",
"Last_Update_Posted(Estimated)" : 2012-07-30",
"Last_Verified" : 2012-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.
#Intervention
- DRUG : Rasagiline
- 1 mg/day, tablets for 7 days, orally
- Other Names :
- Lu 00-773; Azilect® | #Eligibility Criteria:
Inclusion Criteria:
* The subject is a Chinese man or woman
* The subject is, in the opinion of the investigator, generally healthy
* If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
Exclusion Criteria:
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Other inclusion and exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01652313 | 156,542 |
{
"NCT_ID" : "NCT05696379",
"Brief_Title" : "Angiography Derived Index of Microcirculatory Resistance in Patients With Acute Myocardial Infarction",
"Official_title" : "Angiography Derived Index of Microcirculatory Resistance in Patients With Acute Myocardial Infarction",
"Conditions" : ["Acute Myocardial Infarction (AMI)"],
"Interventions" : ["Other: Angiography derived index of micro-circulatory resistance (Angio-IMR)"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-31",
"Study_Completion_Date(Actual)" : "2022-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-13",
"First_Posted(Estimated)" : 2023-01-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-13",
"Last_Update_Posted(Estimated)" : 2023-01-25",
"Last_Verified" : 2022-12"
}
}} | #Study Description
Brief Summary
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of acute myocardial infarction (AMI) patients, and has been shown to be associated with poor prognosis. Angiography derived index of micro-circulatory resistance (Angio-IMR) is a novel pressure-wire free approach to assess coronary microvascular disease with great diagnostic performance. The current study will further investigate the prognostic value of Angio-IMR in patients with AMI in multicenter retrospective cohort.
#Intervention
- OTHER : Angiography derived index of micro-circulatory resistance (Angio-IMR)
- Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention. | #Eligibility Criteria:
Inclusion Criteria:
* Acute myocardial infarction patients who underwent successful percutaneous coronary intervention
Exclusion Criteria:
* No appropriate coronary angiography images (inferior image quality, image loss, severe arteries overlap, or significant artifact)
* Previous coronary artery bypass graft
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05696379 | 186,843 |
{
"NCT_ID" : "NCT03578926",
"Brief_Title" : "Performance of Two Toric Silicone Hydrogel Contact Lenses",
"Official_title" : "Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear",
"Conditions" : ["Astigmatism"],
"Interventions" : ["Device: senofilcon A toric lens", "Device: fanfilcon A toric lens"],
"Location_Countries" : ["Mexico"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-06-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-08",
"Study_Completion_Date(Actual)" : "2018-10-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-25",
"First_Submitted_that_Met_QC_Criteria" : 2019-11-21",
"First_Posted(Estimated)" : 2018-07-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-25",
"Last_Update_Posted(Estimated)" : 2019-12-10",
"Last_Verified" : 2019-11"
}
}} | #Study Description
Brief Summary
Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
Detailed Description
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.
#Intervention
- DEVICE : fanfilcon A toric lens
- contact lens
- Other Names :
- Avaira Vitality toric lens
- DEVICE : senofilcon A toric lens
- contact lens
- Other Names :
- Acuvue Oasys for Astigmatism | #Eligibility Criteria:
Inclusion Criteria:
* Is between 18 and 40 years (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
* Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule
Exclusion Criteria:
* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2 <= age <= 4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization > 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT03578926 | 30,355 |
{
"NCT_ID" : "NCT02284724",
"Brief_Title" : "Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain",
"Official_title" : "The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Subjects With Low Back Pain",
"Conditions" : ["Low Back Pain, Mechanical"],
"Interventions" : ["Procedure: Sham Needling", "Procedure: Dry Needling"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-30",
"Study_Completion_Date(Actual)" : "2018-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-11-03",
"First_Posted(Estimated)" : 2014-11-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-05",
"Last_Update_Posted(Estimated)" : 2018-10-24",
"Last_Verified" : 2018-10"
}
}} | #Study Description
Brief Summary
To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles.
Detailed Description
Consenting subjects will be pre-screened for contraindications for dry needling and whether or not they meet the criteria for low back pain. Following acceptance and prior to intervention sessions, subjects will complete a pre-participation questionnaire. This will be used to check for any needle phobia or previous adverse reactions to needling in prospective subjects and analyze potential confounding variables within the subjects participating. Once consented and accepted into the study, subjects will be taught the deep corset contraction (DCC), which is the isolated co-contraction of bilateral transversus abdominis and the deep fibers of lumbar multifidus. Following DCC training, the subject will have a real-time ultrasound transducer applied to the lateral abdominal wall in order to image the three abdominal muscle layers external oblique, internal oblique and transversus abdominis. A relaxed state measure will be taken from the ultrasound image. Subjects will then perform the DCC and a second measure of the abdominal muscles will be taken. A percentage thickness change will be calculated. Prior to treatment, subjects will have been randomly assigned to one of 2 intervention ordered groups: 1) Dry needling: subjects will be placed prone and dry needling to the bilateral multifidus muscles will be performed. Subjects will sense light pressure and their skin will be penetrated by the needle. 2) Sham needling: subjects will be placed prone and the plastic tubes which house the needles for dry needling will be pressed into the bilateral multifidus muscles.Subjects will sense light pressure, but their skin will not be penetrated. All needling and sham needling interventions will be performed under 'clean needle' conditions using appropriate skin preparation and use of clean protective gloves by the PI. The needles used will be single-use disposable acupuncture-style needles which come in a plastic tube for easy insertion. Dry needling techniques are techniques that many practicing therapists use for various musculoskeletal conditions, and are also taught by the PI as part of the requirements for the Doctor of Physical Therapy degree. For this study, all needling and sham needling interventions will be performed by the PI who has over 27 years experience in such interventions. Immediately following the needling or sham needling, the real-time ultrasound will be reapplied to measure thickness of the abdominal muscles in the relaxed state and contracted state using the DCC, and percent changes will be calculated. Measurements will be collected by one of three independent researchers who will be blinded to the intervention. An average of 3 measurements will be used to calculate the percent thickness change after the treatment. In addition, the PI performing the needling will remain blinded to ultrasound measurements. Subjects will then be contacted by phone 48 hours as well as one week after the intervention was given in which they will verbally complete questionnaires regarding their degree of pain and level of disability.
#Intervention
- PROCEDURE : Dry Needling
- PROCEDURE : Sham Needling | #Eligibility Criteria:
Inclusion Criteria:
* Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC.
* Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled.
* If subjects express fear of needles or being needled, they will be excluded from the study.
Exclusion Criteria:
* History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer.
* If a subject reports a fear of needles.
* History of adverse reaction to needling (or injection) in the past.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02284724 | 123,961 |
{
"NCT_ID" : "NCT03473977",
"Brief_Title" : "Benralizumab for Eosinophilic Gastritis (BEGS)",
"Official_title" : "A Randomized, Double-Blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis",
"Conditions" : ["Eosinophilic Gastritis or Gastroenteritis"],
"Interventions" : ["Biological: Benralizumab", "Biological: Placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-04-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-22",
"Study_Completion_Date(Actual)" : "2022-01-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-02-28",
"First_Submitted_that_Met_QC_Criteria" : 2021-07-26",
"First_Posted(Estimated)" : 2018-03-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-03-15",
"Last_Update_Posted(Estimated)" : 2022-02-03",
"Last_Verified" : 2022-01"
}
}} | #Study Description
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.
Detailed Description
Primary Objective:
To assess the efficacy of repeat subcutaneous (SC) doses of benralizumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with Eosinophilic Gastritis
Secondary Objectives:
To assess changes in endoscopic score, histological features, blood and biopsy eosinophil counts, clinical symptoms, and gastric tissue transcriptome before and after treatment with benralizumab.
26 subjects are planned to be enrolled into the study at Cincinnati Children's Hospital Medical Center. Qualifying Subjects will receive subcutaneous injections every 4 weeks (3 total) of benralizumab/Placebo, followed by optional Open Label Extension periods.
#Intervention
- BIOLOGICAL : Benralizumab
- Benralizumab (anti-IL5Ra) will be injected every 4 weeks in doses of 30 mg (total of 3 injections) in subjects with active Eosinophilic Gastritis.
- Other Names :
- Fasenra
- BIOLOGICAL : Placebo
- Placebo will be injected every 4 weeks (total of 3 injections) as a comparator to Benralizumab in subjects with active Eosinophilic Gastritis. | #Eligibility Criteria:
Inclusion Criteria:
* Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
* Males and females between the ages of 12 <= age <= 60 years with confirmed diagnosis of EG involving stomach; involvement of eosinophilic inflammation in other gastrointestinal segments will be allowed but not required or sufficient.
* Histologically active EG at time of screening, with a peak Gastric count of >= 30 eos/hpf in at least 5 hpfs.
* Must be symptomatic (defined as having experienced symptoms within 4 weeks prior to enrollment).
* Blood eosinophilia (defined as having an absolute eosinophil count > 500 cells per microliter of blood) at least once during the 6 months prior to enrollment.
* Must be on baseline anti-eosinophilic gastritis/eosinophilic gastroenteritis therapy as long as there is agreement to not change their dosage unless medically indicated; OR, must have failed anti-eosinophilic gastritis/eosinophilic gastroenteritis in the past, including diet therapy.
* Clinical symptoms (i.e., abdominal pain, bloating, vomiting, diarrhea) severe enough to impact daily life (e.g., school/work attendance, social activities) >= 2 days/week for 3 of the 4 weeks prior to enrollment despite treatment (such as diet, proton pump inhibitors or corticosteroids).
* Female subjects: Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/ levonogestrel Intrauterine system, Depo-Provera(tm) injections, oral contraceptive, and Evra Patch(tm) or Nuvaring(tm). WOCBP must agree to use effective method of birth control, as defined above, from enrollment, throughout the study duration and within 16 weeks after last dose of investigational product, and have negative serum pregnancy test result on Visit 1.
* Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of visit -1 without an alternative medical cause. The following age-specific requirements apply:
* Women <50 years would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
* Women >=50 years would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
* All male subjects who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from Visit 1 until 16 weeks after their last dose.
Exclusion Criteria:
* Concurrent H. pylori gastritis or parasitic infection
* Other gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease, eosinophilic granulomatosis with polyangiitis (EGPA), drug hypersensitivity or connective tissue rheumatological disorders,
* Esophageal stricture that prevents the easy passage of a standard endoscope
* Use of any investigational biologic drug within 6 months prior to screening
* Hypereosinophilic syndrome, defined by multiple organ involvement (with the exception of atopic disease or EGID) and persistent blood absolute eosinophil count >=1500/mcL.
* History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent when applicable was obtained. Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
* A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
* Pregnant or nursing
* Receipt of any investigational non-biologic within 30 days or 5 half-lives prior to visit 1, whichever is longer.
* A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
* Any other medical illness that precludes study involvement
* Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to be enrolled.
* Patients who are currently receiving or have previously received benralizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, reslizumab, lebrikizumab etc.) within the last 6 months or 5 half-lives whichever is longer.
* History of anaphylaxis to any biologic therapy or vaccine.
* Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03473977 | 265,853 |
{
"NCT_ID" : "NCT05275595",
"Brief_Title" : "COVID-19 Among Children With Chronic Renal Diseases in Qatar",
"Official_title" : "A Descriptive Study of COVID-19 Among Children With Chronic Renal Diseases in Qatar",
"Conditions" : ["Chronic Kidney Diseases", "COVID-19 Infection", "Acute Kidney Injury", "Chronic Renal Failure in Children", "COVID-19 Pandemic"],
"Interventions" : ["Other: Medical records review"],
"Location_Countries" : ["Qatar"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31",
"Study_Completion_Date(Actual)" : "2022-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-08",
"First_Posted(Estimated)" : 2022-03-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-03-10",
"Last_Update_Posted(Estimated)" : 2023-07-25",
"Last_Verified" : 2022-03"
}
}} | #Study Description
Brief Summary
Coronavirus disease 2019 is a novel viral disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 virus. The original cases occurred in Wuhan, China, in December 2019 and rapidly spread to other areas worldwide, constituting a pandemic with unimaginable health and economic consequences. the World Health Organization elevated the disease to the category of a pandemic on March 11, 2020.
In children, the reported mortality rates were far below 1%, while in people above the age of 70 years it was above 5% or higher. So, in this retrospective study, the investigators describe the clinical features and outcomes of children with chronic kidney diseases who were diagnosed with Severe Acute Respiratory Syndrome Coronavirus 2 infection at pediatric centers in Doha from 1st March 2020 till January 20th, 2022. This review looks into the literature on pediatric patients with chronic kidney diseases to verify whether they were more prone to developing more severe symptoms when diagnosed with Coronavirus disease 2019 compared to children without chronic kidney diseases and adults with chronic kidney diseases, and the Prevalence of COVID-19 infection between patients with chronic kidney diseases, and the role of COVID-19 infection in increasing the relapses and deterioration of chronic kidney diseases.
Detailed Description
In this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory-confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records from 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included:
* Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia).
* Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection.
* Admission for management of the underlying disease. Testing for SARS-CoV-2 infection was performed on nasal and oropharyngeal swabs using reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen test.
Indications for hospital admission were:
* symptomatic infection, particularly in an immunosuppressed host.
* management of the underlying illness.
* inability to ensure home isolation. Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, the severity of COVID-19 and associated complications, testing methods for SARS-CoV-2 virus and duration of RT-PCR positivity, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. In patients with nephrotic syndrome, the presence of nephrotic-range proteinuria at evaluation at onset, relapse, or following non-response to immunosuppression, was considered as 'relapse'.
The Patients will be followed up until discharge, death, or 4weeks after diagnosis of COVID-19, whichever was earlier, until 20 January. Hypertension was defined using standard guidelines. The estimated glomerular filtration rate (eGFR) was calculated using the modified Schwartz formula.
Investigators will look for the clinical manifestations, radiological and laboratory findings, severity of COVID-19 infection, prevalence and difference between waves of the pandemic, median age, gender, and ethnic background. Underlying illness, renal treatment, reinfection, correlation with vaccination.
Participants are divided into three groups; first wave, second wave, and third wave
#Intervention
- OTHER : Medical records review
- Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, severity of COVID-19 and associated complications, testing methods for SARS-CoV-2 virus and duration of RT-PCR positivity, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. In patients with nephrotic syndrome, the presence of nephrotic-range proteinuria at evaluation at onset, relapse or following non-response to immunosuppression, was considered as 'relapse'.
The Patients will be followed up until discharge, death or 4weeks after diagnosis of COVID-19, whichever was earlier, until 20 January.
- OTHER : Medical records review
- Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, associated complications, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. | #Eligibility Criteria:
Inclusion Criteria:
* All children and adolescents (<= 18 years).
* who have underlying kidney disease.
* laboratory-confirmed SARS-CoV-2 infection.
Exclusion Criteria:
* Patients with SARS-CoV-2 infection who developed AKI during the hospital stay but lacked evidence of pre-existing kidney disease.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT05275595 | 140,507 |
{
"NCT_ID" : "NCT04152083",
"Brief_Title" : "A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine",
"Official_title" : "A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine",
"Conditions" : ["Migraine"],
"Interventions" : ["Drug: Placebo", "Drug: Eptinezumab"],
"Location_Countries" : ["Georgia", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-07-08",
"Study_Completion_Date(Actual)" : "2020-07-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-11-02",
"First_Submitted_that_Met_QC_Criteria" : 2021-08-13",
"First_Posted(Estimated)" : 2019-11-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-11-02",
"Last_Update_Posted(Estimated)" : 2021-08-17",
"Last_Verified" : 2021-08"
}
}} | #Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
Detailed Description
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.
#Intervention
- DRUG : Eptinezumab
- Injection for IV administration
- DRUG : Placebo
- Injection for IV administration | #Eligibility Criteria:
Inclusion Criteria:
* Greater than 1-year history of migraine, with or without aura, with onset of first migraine before age 50.
* Migraine on 4 to 15 days per month in the 3 months prior to screening.
* Headache free for at least 24 hours prior to onset of a qualifying migraine.
Exclusion Criteria:
* Unable to differentiate migraine from other headache or pain disorders.
* Use of the following medication, for any indication, within the 24-hour period prior to dosing with study drug:
1. triptans, ergotamines and ergot-derivatives
2. analgesics (including but not limited to acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs [NSAIDs], combination analgesics, caffeine-containing analgesics, and opioids/narcotics) and other acute migraine medication(s)
3. antiemetic medications (including but not limited to prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide)
4. antihistamines
5. devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections, spinal manipulation)
* Use of the following medication, for any indication, in each of the 3 months prior to screening:
1. opioids/narcotics or butalbital containing products (including combinations) on more than 4 days per month;
2. triptans, ergotamines, or combination analgesics for 10 or more days per month;
3. acetaminophen, aspirin or NSAIDs for 15 or more days per month (except if participant is taking 81 mg dose of aspirin for cardiac prophylaxis)
* History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine and migraine with neurological accompaniments that are not typical of migraine aura (for example, diplopia, altered consciousness, or long duration).
* Any changes to preventive migraine treatment(s) within 1 month prior to screening and up to treatment with the study drug (Day 0).
* Any use of approved devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections) within the 24-hour period prior to treatment with study drug (Day 0).
* Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 7 days prior to treatment with study drug (Day 0).
* Any use of systemic corticosteroid for migraine or any other reason within 3 months prior to treatment with study drug (Day 0).
* Evidence or medical history of clinically significant psychiatric diseases that are uncontrolled and/or untreated.
* Receipt of any monoclonal antibody treatment, for migraine or any other indication, (within or outside a clinical study) within 6 months prior to screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04152083 | 217,841 |
{
"NCT_ID" : "NCT04993560",
"Brief_Title" : "Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain",
"Official_title" : "Comparing the Safety and Efficacy of Homologous and Heterologous COVID-19 Prime-boost Vaccination in Bahrain",
"Conditions" : ["SARS-CoV 2 Infection", "Covid19"],
"Interventions" : ["Biological: BBIBP-CorV", "Biological: BNT162b2"],
"Location_Countries" : ["Bahrain"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-07-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-17",
"Study_Completion_Date(Actual)" : "2021-10-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-08-04",
"First_Posted(Estimated)" : 2021-08-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-08-05",
"Last_Update_Posted(Estimated)" : 2021-10-26",
"Last_Verified" : 2021-08"
}
}} | #Study Description
Brief Summary
Coronavirus disease 2019 (COVID-19) is potentially a deadly disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that targets the lung mainly, resulting in respiratory tract infections in humans. It has developed into a pandemic with serious global public health problems.
Recent research has shown that the new SARS-CoV-2 variants reduces the efficacy of the vaccinations and are predominantly more transmissible or infective. A few countries namely Bahrain, United Arab Emirates, and Turkey have recently started introducing a booster dose following primary two doses of the COVID-19 immunization series.
This study aims to identify which booster dose is more effective; taking a booster dose from the same vaccine initially taken or a booster dose from a different vaccine than initially taken.
Detailed Description
According to the World Health Organization COVID-19 Dashboard, the coronavirus disease 2019 pandemic, has caused over 181 million infections and more than 3 million deaths worldwide as of July 1, 2021. COVID-19 is potentially a deadly disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that targets the lung mainly resulting in respiratory tract infections in humans. This has become a serious concern for public health.
Among the currently approved COVID-19 vaccines in the Kingdom of Bahrain, BBIBP-CorV (inactivated virus) vaccine and BNT162b2 (mRNA vaccine) is being administered to the population.
Inactivated vaccines have been extensively studied. In a phase 1/2 trial, the BBIBP-CorV vaccine has shown to be generally safe against COVID-19 and induce antibody responses. However, WHO's Strategic Advisory Group of Experts (SAGE) experts have summarized information from clinical trials in Bahrain, United Arab Emirates, Egypt, Jordan, and China indicating that individuals with comorbidities and older adults (≥60 years) who received 2 doses of BBIBP-CorV have low confidence in the efficacy of preventing COVID-19.
Current clinical trials have played a key role in the approval of different COVID vaccines based on their efficacy data, however, there is still uncertainty regarding the duration of protection from these vaccines towards the COVID -19 virus. Recent evidence has shown that the new SARS-CoV-2 variants reduces the efficacy of the vaccinations and are predominantly more transmissible or infective.
A few countries namely Bahrain, United Arab Emirates, and Turkey have recently started introducing a booster dose following primary two doses of the COVID-19 immunization series. The enhanced humoral response has been seen in homologous vaccination. Heterologous vaccination has shown to significantly induce more immunogenicity than homologous vector boost, and higher or comparable to the homologous mRNA regimens. Strong humoral and immune response has also been induced by heterologous vector-mRNA boosting with an acceptable reactogenicity profile.
To our knowledge, there has been no research conducted to date on the reactogenic and immunogenetic response of a COVID-19 booster dose after completing the primary two doses of the COVID-19 immunization series. This study will compare the reactogenic and immunogenetic response of heterologous BNT162b2 booster dose after completing two doses of BBIBP-CorV vaccination versus homologous BBIBP-CorV booster after completing two doses of BBIBP-CorV vaccination.
#Intervention
- BIOLOGICAL : BBIBP-CorV
- Inactivated virus COVID-19 vaccine
- Other Names :
- Sinopharm COVID-19 vaccine
- BIOLOGICAL : BNT162b2
- mRNA-based COVID-19 vaccine
- Other Names :
- Pfizer-BioNTech vaccine | #Eligibility Criteria:
Inclusion Criteria:
* Adults aged >=21yo.
* Asymptomatic 24h before the administration of booster dose.
* Has no active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
* Completed three months to six months after the second dose of BBIBP-CorV.
* Have at least one Antibody test done before receiving the BBIBP-CorV booster dose OR can be done if the participant is yet to receive the BNT162b2 booster dose.
* Tested negative using Rapid Antigen Detection Test on the day of receiving the booster (positive results will confirm with RT-PCR).
* Study participants must have the ability to give informed consent.
Exclusion Criteria:
* Children aged <21yo.
* Symptomatic within 24h before the administration of booster dose.
* Has active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
* Did not complete three months to six months after the second dose of BBIBP-CorV.
* Does not have at least one Antibody test done before receiving the BBIBP-CorV booster dose
* Tested positive using Rapid Antigen Detection Test on the day of receiving the booster (positive results will be confirmed with PCR).
* Patients unable to give informed consent.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04993560 | 4,748 |
{
"NCT_ID" : "NCT01953822",
"Brief_Title" : "Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom",
"Official_title" : "An Observational Cohort Study to Assess the Risk of Autoimmune Diseases in Adolescent and Young Adult Women Aged 9 to 25 Years Exposed to Cervarix® in the United Kingdom",
"Conditions" : ["Infections, Papillomavirus"],
"Interventions" : ["Other: Data collection"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08",
"Study_Completion_Date(Actual)" : "2014-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-09-26",
"First_Posted(Estimated)" : 2013-10-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-09-26",
"Last_Update_Posted(Estimated)" : 2016-12-26",
"Last_Verified" : 2016-12"
}
}} | #Study Description
Brief Summary
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
Detailed Description
GSK's vaccine Cervarix® protects against Human Papilloma Virus Types-16 and 18-related pre-cancerous lesions. GSK is committed by the US Food and Drug Administration (FDA) to conduct a safety study to evaluate the incidence of new neurological and eye-related autoimmune diseases and other pre-specified autoimmune diseases in subjects receiving Cervarix® in the US. Because of the very low Cervarix® uptake in the US, the observational GSK study to address this commitment is due to be stopped, as it will take too long to recruit the target subjects.
The unexposed male cohorts will be enrolled in order to assess a possible change over time in the incidence rate of new onset of autoimmune disease(s) (NOAD) in the UK Clinical Practice Research Datalink General Practitioner OnLine database (CPRD GOLD) independent of Cervarix® introduction. The cohorts will be frequency matched for the age (age class of one year) and practice region identifier at reference date (age at first dose of Cervarix).
Additionally, the reference date (time = 0) for the vaccinated (exposed) cohort will be the date of the first dose of Cervarix® recorded in CPRD GOLD. The reference date for the unexposed (unvaccinated) cohorts will be a date randomly selected among the reference dates of the exposed subjects and minus 3 years for the historical cohorts.
The other observational study model is a self-control case-series (SCCS) analysis for confirmed NOAD in the exposed female cohort, using a risk period of one year after the first Cervarix® dose, a control period of one year and a six month buffer period between risk and control periods.
Human Papillomavirus Bivalent (Types 16 and 18) vaccine (recombinant) exposed cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
The unexposed concurrent male cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
Unexposed historical female and male cohorts were investigated between 1-SEP-2005 and 31-AUG-2007.
#Intervention
- OTHER : Data collection
- Data collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD. | #Eligibility Criteria:
Inclusion Criteria:
Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses.
Inclusion criteria for the exposed female cohort:
* Female aged from 9 <= age <= 25 at the reference date (01 September 2008 through 31 August 2010).
* Recorded in the CPRD GOLD for at least 12 months before the reference date.
* The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available.
* Subject defined as acceptable in CPRD GOLD.
Inclusion criteria for the unexposed historical female cohort:
* Female aged 9 <= age <= 25 at the reference date (01 September 2005 through 31 August 2007).
* Recorded in the CPRD GOLD for at least 12 months before the reference date.
* Subject defined as acceptable in CPRD GOLD.
Inclusion criteria for the unexposed concurrent male cohort:
* Male aged 9 <= age <= 25 at the reference date (01 September 2008 through 31 August 2010).
* Recorded in the CPRD GOLD for at least 12 months before the reference date.
* Subject defined as acceptable in CPRD GOLD.
Inclusion criteria for the unexposed historical male cohort:
* Male aged 9 <= age <= 25 at the reference date (01 September 2005 through 31 August 2007).
* Recorded in the CPRD GOLD for at least 12 months before the reference date.
* Subject defined as acceptable in CPRD GOLD.
Exclusion Criteria:
Exclusion criteria for all cohorts:
* Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date.
* Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date.
* Subjects who have been included in the other cohort.
Exclusion criteria for the non-exposed cohorts:
* Subjects who received any dose of Cervarix at any time before the reference date.
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01953822 | 86,188 |
{
"NCT_ID" : "NCT02176382",
"Brief_Title" : "Denosumab and Teriparatide Study (DATA-HD and DATA-EX)",
"Official_title" : "Denosumab and Teriparatide Study (DATA-HD and DATA-EX)",
"Conditions" : ["Postmenopausal Osteoporosis"],
"Interventions" : ["Drug: Zoledronic acid", "Drug: teriparatide", "Drug: denosumab"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02",
"Study_Completion_Date(Actual)" : "2020-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-06-25",
"First_Submitted_that_Met_QC_Criteria" : 2021-01-01",
"First_Posted(Estimated)" : 2014-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-06-26",
"Last_Update_Posted(Estimated)" : 2021-02-09",
"Last_Verified" : 2021-01"
}
}} | #Study Description
Brief Summary
The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.
#Intervention
- DRUG : denosumab
- denosumab subcutaneous injection
- Other Names :
- Prolia
- DRUG : teriparatide
- teriparatide daily subcutaneous injection
- Other Names :
- Forteo
- DRUG : Zoledronic acid
- zoledronic acid infusion
- Other Names :
- Reclast | #Eligibility Criteria:
Inclusion Criteria:
* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture
Exclusion Criteria:
* no significant previous use of bone health modifying treatments
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02176382 | 15,485 |
{
"NCT_ID" : "NCT05673174",
"Brief_Title" : "Avicena LVDP Validation Study in Healthy Volunteers",
"Official_title" : "Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers",
"Conditions" : ["Healthy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-06-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-30",
"Study_Completion_Date(Actual)" : "2022-08-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-21",
"First_Posted(Estimated)" : 2023-01-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-21",
"Last_Update_Posted(Estimated)" : 2023-01-06",
"Last_Verified" : 2022-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
#Intervention
- DIAGNOSTIC_TEST : Non-Invasive Estimation of Left Ventricular Diastolic Pressure
- Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP | #Eligibility Criteria:
Inclusion Criteria:
* Adult subjects >21 years.
* No known significant health problems.
* Willing and able to participate in all study evaluations.
* Ability to understand and sign informed consent.
Exclusion Criteria:
* Open skin lesions at the site of Vivio application / examination.
* Inability to obtain brachial artery blood pressure.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05673174 | 224,786 |
{
"NCT_ID" : "NCT00806312",
"Brief_Title" : "The Expression and Significance of MiRNA",
"Official_title" : "The Expression and Significance of miRNA Profile and Markers of Inflammation in Patients With Pulmonary Arterial Hypertension",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-16",
"Study_Completion_Date(Actual)" : "2018-08-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-12-09",
"First_Posted(Estimated)" : 2008-12-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-12-09",
"Last_Update_Posted(Estimated)" : 2021-11-02",
"Last_Verified" : 2021-10"
}
}} | #Study Description
Brief Summary
It is not always known what causes PAH or what the best treatment is. The doctors doing this study would like to understand more about why some people develop PAH and other do not. They also would like to learn more about which treatments might help PAH and which people might respond better to treatments.
Doctors think that testing certain substances found in blood cells might help answer these questions. These substances are normally released by our bodies to protect us from infection and to tell the difference between normal and foreign substances in our body. Finally, a new test will study very small molecules called microRNA that control how our genes are expressed. This study is being done to see if blood samples can be tested to determine who might develop PAH, how well drugs will work to treat PAH and to learn more about the development of PAH.
Detailed Description
You will be asked to donate blood when you have your right heart catheterization and also at the 3-4 month follow-up visit. The amount of blood collected during your heart catheterization is about 20cc (about 4 teaspoons). This blood is discarded as part of the clinical catheterization procedure, but we are asking that we use it for this research study. Then, at the follow-up right heart catheterization, you will be asked to donate 20 cc (which is about 4 teaspoons) of blood.
If the second right heart is not required for clinical purposes then you will be asked to give a blood sample during your 3-4 month follow up clinic visit.
If you require an additional right heart catheterization, within one year, we will ask that you donate additional samples at the subsequent RHC.
Other data collected as part of your clinical care, such as medical history, chest x-ray (picture of your lungs), echocardiogram (picture of your heart), ventilation perfusion scan (determines how much blood goes to your lungs), chest CT (thin pictures of my lungs as slices), pulmonary function tests (breathing tests), and lab blood tests, will be used as part of this research.
| #Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Not pregnant
* Undergoing right heart catheterization for PAH diagnosis
Exclusion Criteria:
* Pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00806312 | 118,874 |
{
"NCT_ID" : "NCT05294939",
"Brief_Title" : "Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists",
"Official_title" : "Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of a Ketone Supplement on Performance in Professional Cross-country Road Cyclists",
"Conditions" : ["Ketoses, Metabolic", "Ketosis"],
"Interventions" : ["Dietary Supplement: Control product consumption", "Dietary Supplement: Ketone monoester"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-31",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-02-05",
"Study_Completion_Date(Actual)" : "2022-03-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-01-10",
"First_Posted(Estimated)" : 2022-03-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-03-19",
"Last_Update_Posted(Estimated)" : 2022-04-13",
"Last_Verified" : 2021-11"
}
}} | #Study Description
Brief Summary
Randomized, controlled, double-blind, crossover clinical trial, depending on the product consumed, to analyze the efficacy on physical performance of a sports supplement consumed prior to and during competition or training.
Detailed Description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). On the second day, participants will consume the product that subjects did not consume on the first day.
The product to be consumed will be ketone monoester. Participants will consume 800 mg/kg body weight, distributed in two intakes. The first one, half an hour before exercise and the same dose will be consumed one hour and a half after the first dose. The intakes will be accompanied by carbohydrates and bicarbonate.
The tests that the cyclists will perform are a time trial on a cycloergometer to measure performance, as well as a 30' sprint. Afterwards, the cyclists will do a 4 and a half hour training session at competition pace. After this training session, the participants will do the same time trial and the 30'' sprint.
#Intervention
- DIETARY_SUPPLEMENT : Ketone monoester
- Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
- DIETARY_SUPPLEMENT : Control product consumption
- Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, 90g of carbohydrates should be consumed every hour. | #Eligibility Criteria:
Inclusion Criteria:
* Male professional cyclists.
* Start the study with previous rest.
Exclusion Criteria:
* Participant suffering from chronic illness.
* Suffering a long-term injury that prevents her from training in the month prior to the intervention.
* Inability to understand the informed consent.
* Having consumed ketone bodies chronically in the previous four weeks.
* To have undergone cholecystectomy.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05294939 | 26,790 |
{
"NCT_ID" : "NCT06732271",
"Brief_Title" : "LC-Smart: A Deep Learning-Based Quality Control Model for Laparoscopic Cholecystectomy",
"Official_title" : "LC-Smart: A Deep Learning-Based Quality Control Model for Laparoscopic Cholecystectomy",
"Conditions" : ["Laparoscopic Cholecystectomy"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-10-24",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-11-24",
"Study_Completion_Date(Actual)" : "2024-11-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-12-09",
"First_Posted(Estimated)" : 2024-12-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-12-11",
"Last_Update_Posted(Estimated)" : 2024-12-13",
"Last_Verified" : 2024-12"
}
}} | #Study Description
Brief Summary
Objective: Critical view of safety (CVS) is a successful technique to reduce bile duct injury during laparoscopic cholecystectomy (LC). We aimed to create a deep learning-based quality control model for LC and reduce the learning curve for junior surgeons, which would automatically assess whether surgeons are CVS conscious during procedures.Methods: We retrospectively collected 308 LC videos from public datasets (Cholec80, Endoscapes) and Sun Yat-sen Memorial Hospital. Video frames were labeled using binary classification and feature optimization methods, such as black border clipping and sliding windows. Two neural networks, ResNet-50 and EfficientNetV2-S, were trained and evaluated based on F1 scores and accuracy. Additionally, We created an online CVS recognition system (LC-Smart), tested it using 171 films from two hospitals, and compared the results to two local senior doctors.
| #Eligibility Criteria:
Inclusion Criteria:
* complete video data with no missing footage;
* surgical procedure identified as laparoscopic cholecystectomy;
* full visibility of the surgical area in the video;
* successful completion of the procedure;
* absence of significant anatomical variations
* video resolution no less than 720×560.
Exclusion Criteria:
* substantial intraoperative adhesions
* a history of previous abdominal or pelvic procedures
* a conversion to open surgery during the procedure
* significant bleeding that obscured structural identification.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT06732271 | 234,677 |
{
"NCT_ID" : "NCT00658554",
"Brief_Title" : "Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers",
"Official_title" : "Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers",
"Conditions" : ["Healthy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-05",
"Study_Completion_Date(Actual)" : "2008-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-04-11",
"First_Posted(Estimated)" : 2008-04-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-04-14",
"Last_Update_Posted(Estimated)" : 2008-06-19",
"Last_Verified" : 2008-06"
}
}} | #Study Description
Brief Summary
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
Detailed Description
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
#Intervention
- DRUG : ARQ 197
- Treatment with ARQ 197 | #Eligibility Criteria:
Inclusion Criteria:
* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years
* Male participants must have been surgically sterilized
* Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test
* All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.
Exclusion Criteria:
* Males who are not surgically sterilized
* Females of child-bearing potential who are not surgically sterilized
* Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
* Any clinically significant abnormality in the screening laboratory tests or ECG
* Received any investigational drugs within four weeks
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00658554 | 248,683 |
{
"NCT_ID" : "NCT02622256",
"Brief_Title" : "Twitter and CV Health",
"Official_title" : "Twitter & Cardiovascular Health",
"Conditions" : ["Cardiovascular Disease", "Hypertension"],
"Interventions" : ["Behavioral: Health System: HTN Intervention"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10",
"Study_Completion_Date(Actual)" : "2018-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-11-23",
"First_Posted(Estimated)" : 2015-12-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-12-03",
"Last_Update_Posted(Estimated)" : 2019-01-24",
"Last_Verified" : 2018-02"
}
}} | #Study Description
Brief Summary
Cardiovascular (CV) disease is associated with significant morbidity and mortality. In the current digital age, needed is a better understanding of how information on social media sites may inform our approaches to improving CV health through novel methodologies. Investigators propose to study the conversation on Twitter about several CV diseases and their associated sequelae.
Detailed Description
Cardiovascular (CV) disease remains the leading cause of morbidity and mortality in the US and is associated with significant economic burden. To advance against this major public health problem, the American Heart Association (AHA) and others have identified the need for a targeted focus on improving the CV health of populations, emphasizing an array of new tools and competencies for implementing public health policy and population- and community-level interventions to complement the traditional, predominantly medically oriented interventions that have been promoted successfully in the past. Social media channels like Twitter offer a new opportunity to explore health related communication generated by the public and for the public.
Understanding and harnessing these new communication channels is of particular importance as the digital divide narrows and individuals across age and demographic groups increasingly share information online with known networks of friends (e.g., Facebook), and broader networks of friends and others (e.g., Twitter). Person-to-person word-of-mouth communication is one of the most enduring and persuasive ways in which people deliver and receive information. Until recently, person-to-person communication was effectively impossible to intercept, study, and alter. Central to this proposal is the recognition that these changes make some person-to-person communication observable that was previously private. It is the observability of these new communication channels that provides both innovation and promise to this area of inquiry.
This proposal evaluates social media for both its efferent and afferent pathways as a source not just to communicate to communities, but also to learn from them. There is considerable evidence that letting people know what other people do is one of the most effective ways of increasing that behavior. This social norming of behaviors is facilitated through online sharing enabling others to model behavior against broader groups whose actions would have been invisible and therefore uninfluential without these new media channels. For individuals with chronic illnesses, automated self-management support (e.g. mHealth) and online communities have been shown to improved clinical outcomes, patient satisfaction, and reduce health care costs and utilization. This proposal seeks to improve CV health and reduce the burden of CV disease by understanding how patients communicate about CV health online and improving patients ability to manage their CV disease(s).
Twitter as a global social media platform: Twitter allows users to send and receive 140-character messages referred to as tweets. Tweets may include embedded web links to information such as news articles, home pages, and pictures. Tweets originate from a single person or organization (a tweeter) and are distributed broadly to individuals with an interest in the topic of the tweet and to individuals who have voluntarily signed up to follow that tweeter. Followers can then share messages with their own followers, a process of message propagation known as re-tweeting. Tweeters can choose to share information about themselves on their profile (e.g. age, race, gender, occupation, location, likes/dislikes, picture, webpage link).
Both patients and researchers have used health-related Twitter data in novel ways. In natural disasters (e.g. Hurricane Sandy, Haiti earthquake), Twitter was used in real time to link people in need with resources. In pandemics (e.g. H1N1) Twitter was used as a surveillance tool to target flu hot-spots more rapidly than traditional data collection tools. Twitters impact in organizing individual and social attitudes was dramatically revealed in the 2011 political events in Northern Africa. In this setting Twitter, and similar social media such as Facebook, allowed the propagation and concentration of ideas sufficient to threaten and in some cases topple restrictive governments. In non-emergent settings, linguists have used Twitter to pinpoint local dialects and sociologists have used tweets to forecast the mood and emotion of specific geographic regions. Others have also used Twitter to characterize medical misconceptions (e.g. sequelae of concussions) and propagation of poor medical compliance (e.g. antibiotic use).
Studying person-to-person communication: An estimated 400 million tweets are posted daily by more than 200 million active users. Twitter is representative of big data that are increasingly being explored to better understand online information from large, broad populations of patients. Twitter offers promise as a research tool due to its immense scale, its immediacy (for example, emergency departments in Boston learned about the tragic marathon bombings faster through Twitter than through news or established emergency service communication channels), and the systematic searchability of its content. Also of interest is that the site is not focused on health and so it draws people by their interest in communicating more generally, and yet includes public discourse on a broad array of health topics, from the perspective of patients, providers, policymakers, organizations and others. Although the Twitter user base is not a nationally-representative sample it has a surprisingly deep representation across age, geography, and social distributions. African-Americans, Latinos, and those in urban populations are in fact overrepresented on Twitter relative to the general population.
This proposal reflects early work, but work that is fundamental to developing a base for understanding the scientific uses and limitations of Twitter and related social media. This proposal aims to analyze CV health behaviors being discussed online and evaluate new approaches for improving access to CV health information and implementing behavior modification.
#Intervention
- BEHAVIORAL : Health System: HTN Intervention
- Interested participants can enroll online via a Twitter link. Patients will consent to having their electronic health records accessed to validate clinical data. Participants will complete short surveys. The project Twitter account would follow tweeters with high impact CV messages and tweet daily high impact and accurate CV health messages (identified in aim 3). Participants will follow the study team \& may receive daily private heart health messages via Twitter. This would allow participants to see CV health messages posted in the words and context of patients that may be similar to them, participate in online CV health discussions, and access CV health networks that they may not otherwise know about. Participants will also tweet heart health messages weekly. | #Eligibility Criteria:
Inclusion Criteria:
* Twitter users at least 21 years with diabetes and, or hypertension
Exclusion Criteria:
* Anyone below the age of 21
* no diagnosis of hypertension
* not pregnant
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02622256 | 203,196 |
{
"NCT_ID" : "NCT04356820",
"Brief_Title" : "The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination",
"Official_title" : "The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination",
"Conditions" : ["Pain, Acute", "Anxiety Acute"],
"Interventions" : ["Other: acupressure"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-15",
"Study_Completion_Date(Actual)" : "2019-09-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-04-16",
"First_Posted(Estimated)" : 2020-04-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-04-20",
"Last_Update_Posted(Estimated)" : 2020-04-22",
"Last_Verified" : 2020-04"
}
}} | #Study Description
Brief Summary
This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.
#Intervention
- OTHER : acupressure
- Data collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room
- Other Names :
- music | #Eligibility Criteria:
Inclusion Criteria:
* - not to be pregnant,
* no hearing problems
* Being between the ages of 19 and 65, Not having any psychiatric illness,
* No gynecological cancer, Not to have any deformity in her extremities
Exclusion Criteria:
*
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04356820 | 19,870 |
{
"NCT_ID" : "NCT01513187",
"Brief_Title" : "Pazopanib in Combination With Interferon Alfa 2-A, in Patients With Advanced Renal Cell Carcinoma",
"Official_title" : "Phase I/II Prospective, Open Label and Multicentric Clinical Trial to Determine the Recommended Dose (Phase I) and Efficacy of Pazopanib in Combination With Interferon Alfa 2-A (Phase II), in Patients With Advanced Renal Cell Carcinoma",
"Conditions" : ["Advanced Renal Cell Carcinoma"],
"Interventions" : ["Drug: Pazopanib + interferon alpha 2A"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-07-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2019-02-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-01-10",
"First_Posted(Estimated)" : 2012-01-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-01-16",
"Last_Update_Posted(Estimated)" : 2022-03-10",
"Last_Verified" : 2020-03"
}
}} | #Study Description
Brief Summary
Phase I / II, open, prospective, multicenter single-arm, Clinical Trial in two stages: in the first stage it will determine the optimal dose of the combination of pazopanib and interferon alfa-A2 in the treatment of patients with advanced renal carcinoma and a second stage that will determine the efficacy of this combination measured in terms of response rate.
#Intervention
- DRUG : Pazopanib + interferon alpha 2A
- Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days.
Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient | #Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age >= 18 years.
* Patients diagnosed histologically clear cell carcinoma of the kidney metastatic or unresectable locally advanced, previously untreated. However, in Phase I may include patients with primary tumors other than renal cell can benefit from these drugs and patients with renal cell carcinoma treated before.
* Performance status (ECOG) 0 <= age <= 1.
* Patients must have measurable disease by RECIST criteria V 1.1. Progression should be documented in the two months prior to study entry.
* Patients may not have received prior treatment with anti-VEGF agents, mTOR inhibitors or cytokines. However, in Phase I may include patients who have received any previous treatment.
* Paraffin tumor sample should be available and collection of serum from all subjects for biomarker analysis previously and / or during treatment with study medication.
* Adequate Hematologic, liver and kidney functions.
* Women of childbearing potential must be using an effective method of birth control (abstinence, any intrauterine device [IUD] published data showing that the expected minimum rate of failure is less than 1% per year, or any other method the published data show that the expected minimum rate of failure is less than 1% per year) before inclusion in the study and continue using it during the same six months after completion. Women of childbearing age should get a negative pregnancy test in urine or serum (minimum sensitivity 25 IU / L or equivalent units of beta fraction of human chorionic gonadotropin [β-HCG]) during the seven days prior to the randomization.
* Able to swallow oral compound.
* Willingness and ability to attend scheduled visits, to follow the treatment schedule and to undergo clinical trials and other study procedures
Exclusion Criteria:
* History of prior malignancies diagnosed or treated over the past 5 years except basal cell skin cancer or prostate cancer incidentally detected previously treated. However, patients with a history of malignancy but free of the disease over the past 5 years, or patients with a history of nonmelanoma skin carcinoma-completely-resected or carcinoma in situ treated successfully can participate in the study .
In Phase I, patients diagnosed with other previous or concomitant malignant diseases can be included.
* Presence of metastases in the central nervous system (CNS) or leptomeningeal carcinomatosis, except for patients with previously treated CNS metastases, asymptomatic and have not needed corticosteroids or anticonvulsant drugs in the 3 months prior to administering the first dose of the drug under study. Only is required CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) if clinically indicated or if the individual has a history of CNS metastases.
* Clinically significant gastrointestinal disorders may increase the risk of gastrointestinal bleeding including, but not limited to:
Active peptic ulcer disease Known metastatic lesions with probable intraluminal bleeding Inflammatory bowel disease (ulcerative colitis, Crohn's disease) or other gastrointestinal disorders with increased risk of perforation History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the start of study treatment.
* Clinically significant gastrointestinal abnormalities may affect the absorption of the investigational product such as but not limited to:
Malabsorption syndrome Major resection of the stomach or small intestine Grade 3 diarrhea
* Patients with active infection or other disease or serious medical condition.
* Prolongation of the corrected QT wave (QTc)> 480 ms on baseline ECG according to the Bazett formula.
* Subjects with a history of one or more of the following cardiovascular disease in the last 6 months prior to the inclusion in the study:
Angioplasty or stent placement Myocardial infarction Unstable Angina Coronary bypass surgery Symptomatic peripheral vascular disease Congestive heart failure Class II, III or IV New York Heart Association (NYHA)
* Poorly controlled hypertension [defined as systolic blood pressure (SBP) >= 140 mmHg or diastolic blood pressure stress (DBP) >= 90 mmHg] while the patient is on antihypertensive therapy.
Note: the commencement or adjustment of antihypertensive medication it is possible before the patient study start. In the baseline period measure blood pressure at least twice with a minimum interval of 24 hours. The mean values of SBP / DBP in each blood pressure reading should be <140/90 mmHg to include the subject in the study.
* Background, in the last six months prior to the inclusion of stroke (including transient ischemic attacks), pulmonary embolism or deep vein thrombosis (DVT) untreated.
Note: may be included subjects with recent DVT who received anticoagulants for at least 6 months.
* Surgery or trauma in the last 28 days, or minor surgery (eg., Removal of central venous catheter) in the last 7 days prior to inclusion or unhealed wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding diathesis.
* Hemoptysis within 6 weeks prior to inclusion.
* Pregnant or breastfeeding.
* Any medical condition (eg. Uncontrolled infection), psychiatric or other to be serious and / or unstable and may interfere with the safety of the patient, obtaining informed consent or compliance with study procedures.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01513187 | 220,411 |
{
"NCT_ID" : "NCT03596359",
"Brief_Title" : "Teach-Back Method on Quality of Life in Heart Failure Patients",
"Official_title" : "Effect of Self-care Education With Teach-Back Method on Quality of Life in Heart Failure Patients",
"Conditions" : ["Heart Failure"],
"Interventions" : ["Other: Received routine treatment", "Behavioral: Education with Teach-Back method"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-11-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03-02",
"Study_Completion_Date(Actual)" : "2017-05-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-25",
"First_Posted(Estimated)" : 2018-07-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-20",
"Last_Update_Posted(Estimated)" : 2018-07-23",
"Last_Verified" : 2018-07"
}
}} | #Study Description
Brief Summary
This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.
#Intervention
- BEHAVIORAL : Education with Teach-Back method
- OTHER : Received routine treatment | #Eligibility Criteria:
Inclusion Criteria:
* Age from 45 to 85
* Heart failure diagnosed six months ago
* The Ejection Fraction less than 45
* Have reading and writing skills
* Have perfect consciousness
* Fluency in Persian
Exclusion Criteria:
* Patient do not cooperate with researchers
* The inability of each sample to continue cooperation during the study because of the problem or acute disease.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03596359 | 166,981 |
{
"NCT_ID" : "NCT01911052",
"Brief_Title" : "The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy",
"Official_title" : "The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy in Health Screened Population",
"Conditions" : ["Bowel Preparation"],
"Interventions" : ["Other: Short message system based re-education", "Other: Telephone based re-education"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-02",
"Study_Completion_Date(Actual)" : "2014-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-07-22",
"First_Posted(Estimated)" : 2013-07-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-07-26",
"Last_Update_Posted(Estimated)" : 2014-07-17",
"Last_Verified" : 2014-07"
}
}} | #Study Description
Brief Summary
Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Recent study reported that Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the quality of bowel preparation and polyp detection rate. However, there is no study to compare the effect of telephone with short message system (SMS) based re-education on the quality of bowel preparation in health screened population. Our goal is to improve the quality of bowel preparation with telephone or SMS based re-education for outpatients undergoing screening colonoscopies. The investigators hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.
#Intervention
- OTHER : Telephone based re-education
- The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.
- OTHER : Short message system based re-education
- The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy. | #Eligibility Criteria:
Inclusion Criteria:
* All health screened populations
* age >18
* scheduled for an elective screening colonoscopy
Exclusion Criteria:
* inpatients
* pregnancy
* breast feeding
* prior history of surgical large bowel resection
* patients allergic to PEG-ELS based laxatives
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01911052 | 168,152 |
{
"NCT_ID" : "NCT00449293",
"Brief_Title" : "Behavioral Therapy for Reduction in Smoking Craving",
"Official_title" : "Behavioral Therapy for Reduction in Smoking Craving",
"Conditions" : ["Smoking Cessation", "Tobacco Dependence"],
"Interventions" : ["Behavioral: standard cognitive behavioral therapy", "Behavioral: Mindfulness Based Cognitive Therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-06",
"Study_Completion_Date(Actual)" : "2008-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-03-16",
"First_Posted(Estimated)" : 2007-03-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-03-16",
"Last_Update_Posted(Estimated)" : 2017-05-31",
"Last_Verified" : 2008-01"
}
}} | #Study Description
Brief Summary
The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.
Detailed Description
The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.
#Intervention
- BEHAVIORAL : standard cognitive behavioral therapy
- Standard therapy to help participants with smoking cessation.
- BEHAVIORAL : Mindfulness Based Cognitive Therapy
- A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving. | #Eligibility Criteria:
Inclusion Criteria:
* Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
* Subjects must smoke at least 10 cigarettes per day
* Must be at least 18 years
* English speaking
* Able to read, understand, and complete a written questionnaire
* Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
* Must not currently be using pharmacologic therapy to quit
* Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
* Only strongly right-handed subjects will be included
Exclusion Criteria:
* Pregnant women
* Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
* Weigh over 300 pounds
* Known problem of claustrophobia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00449293 | 238,067 |
{
"NCT_ID" : "NCT00968019",
"Brief_Title" : "Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent",
"Official_title" : "A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry",
"Conditions" : ["Coronary Arteriosclerosis"],
"Interventions" : ["Device: Presillion stent"],
"Location_Countries" : ["Portugal", "Spain"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-04",
"Study_Completion_Date(Actual)" : "2011-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-08-27",
"First_Submitted_that_Met_QC_Criteria" : 2013-01-24",
"First_Posted(Estimated)" : 2009-08-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-08-27",
"Last_Update_Posted(Estimated)" : 2013-03-13",
"Last_Verified" : 2013-03"
}
}} | #Study Description
Brief Summary
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Detailed Description
Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.
Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions
Study design: multicenter, prospective, observational
#Intervention
- DEVICE : Presillion stent
- Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU). | #Eligibility Criteria:
Inclusion Criteria:
* All subjects treated with Presillion stent up to two de novo coronary artery lesions
Exclusion Criteria:
* No specified
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00968019 | 157,504 |
{
"NCT_ID" : "NCT01395160",
"Brief_Title" : "Female Experiences and Brain Activity",
"Official_title" : "Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders",
"Conditions" : ["Attention Deficit Hyperactivity Disorder", "ADHD", "Bipolar Disorder"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-11",
"Study_Completion_Date(Actual)" : "2012-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-05-20",
"First_Posted(Estimated)" : 2011-07-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-14",
"Last_Update_Posted(Estimated)" : 2013-09-02",
"Last_Verified" : 2013-08"
}
}} | #Study Description
Brief Summary
The Female Experiences and Brain Activity study will investigate how different groups of people process information in different ways. Using electro-physiological methods it will investigate differences in brain activity between women with ADHD, women with bipolar disorder and those without a psychiatric illness. It will also investigate the relationship between patterns of brain activity, mood and functioning.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) and bipolar disorder (BD) affect approximately 2.5% and 1%, respectively, of the adult population in the UK. They represent a major clinical and economic burden on society. Genetic and environmental risk factors (such as life events for BD); have been identified for each disorder. Despite the highly different symptom presentations for ADHD and BD, it has recently become clear that they share a cognitive characteristic, observed in high response time variability (RTV). This has led to the question of whether the increased RTV, which reflects short-term fluctuations in performance, is a non-specific marker for psychopathology or whether the causes for the higher RTV could differ across disorders. RTV has been identified as a possible early marker of psychopathology; therefore a better understanding of the underlying mechanisms could lead to improved diagnosis and prevention of negative consequences. Further, it will give insight into the comorbidity observed between ADHD and BD. This study will use cognitive-electrophysiological methods to investigate the causes for RTV and its association with other cognitive and neurophysiological impairments observed in each disorder (aim 1). The second question will address whether, within each disorder, current cognitive functioning relates to the patients' current social functioning (aim 2). Adverse life events and other psychosocial risk factors can contribute to high variability in the level of social functioning observed, within and between individuals, in each disorder; yet our understanding of the association between current social functioning and cognitive functioning is limited. Finally the study will explore if any cognitive differences detected by electrophysiological investigation are associated with any candidate gene markers for either disorder (aim 3).
| #Eligibility Criteria:
Inclusion Criteria:
* current clinical diagnosis of adult ADHD
* or current clinical diagnosis of Bipolar Disorder
* or no history of psychiatric illness
* white European descent
Exclusion Criteria:
* presence of a neurodevelopmental disorder
* epilepsy
* brain injury
* dyslexia
* limited proficiency in English language
* IQ<70
* any current psychiatric medication use (with the exception of mood stabilisers or stimulant medication in the clinical groups)
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01395160 | 13,807 |
{
"NCT_ID" : "NCT00913874",
"Brief_Title" : "To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions",
"Official_title" : "A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions",
"Conditions" : ["Epilepsy", "Bipolar Disorder"],
"Interventions" : ["Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)", "Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-10",
"Study_Completion_Date(Actual)" : "2005-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-06-02",
"First_Posted(Estimated)" : 2009-06-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-06-03",
"Last_Update_Posted(Estimated)" : 2017-03-28",
"Last_Verified" : 2009-06"
}
}} | #Study Description
Brief Summary
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.
#Intervention
- DRUG : Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
- DRUG : Depakote 500 mg DR Tablets (Abbott Laboratories, USA) | #Eligibility Criteria:
Inclusion Criteria:
* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00913874 | 28,295 |
{
"NCT_ID" : "NCT00371696",
"Brief_Title" : "Feasibility of n-of-1 Trials - a Pilot Study",
"Official_title" : "Pilot Study of the Feasibility of n-of-1 Trials: the Individualisation of Treatments for Osteoarthritis",
"Conditions" : ["Osteoarthritis"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-12",
"Study_Completion_Date(Actual)" : "2003-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-09-01",
"First_Posted(Estimated)" : 2006-09-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-09-01",
"Last_Update_Posted(Estimated)" : 2006-09-04",
"Last_Verified" : 2003-01"
}
}} | #Study Description
Brief Summary
The aim of this study was to provide essential pilot data on the feasibility of conducting n-of-1 trials within secondary care within the UK, notably to: test the process of recruitment and design aspects of such trials; assess the acceptability of this research method to patients, explore the experiences of patients involved; determine the most appropriate treatment for individual patients.
Detailed Description
Whilst the large scale randomised controlled trial (RCT) remains the scientific 'gold standard' for evaluating therapies in clinical medicine, the assumption made, that the treatment effect demonstrated is generalisable and applicable to all patients, is unlikely to be true. There will inevitably be some patients who benefit from a particular treatment more than others. N-of-1 trials are a means of conducting RCTs in individual patients with the added opportunity to use patient generated outcome measures. Patients act as their own control and receive all treatments under comparison, more than once, in a random sequence. While n-of-1 trial methodology is reasonably well specified they remain under-exploited and little is known about the process aspects of conducting such trials or the experiences and views of those who participate in them. The time commitment by patients and health professionals is not inconsiderable and there may well be particular problems with recruitment and drop out. N-of-1 trials rely on co-operation between individual clinicians and patients, however, no work has been undertaken to explore the ways in which patient-practitioner relationships and their experiences and views influence the progress and outcome of n-of-1 trials.
Patients with confirmed osteoarthritis (OA) of the knee, selected for a mix of gender, age, weight, will be recruited to the n-of-1 trials to compare either, an NSAID (diclofenac) with simple analgesic (paracetamol) or a standard knee support with a heat retaining support. Patients will undergo a (1 hour) semi-structured interview before the trial commences and once the trial is completed or terminated. Patients treated with supports/drugs will receive each treatment for a period of one/two weeks respectively, for 3 cycles (order determined at random). Patients will complete daily diaries including standard patient questionnaires and a patient generated outcome measure. Qualitative interviews and observational methods will be employed to study practitioner/ patient relationships; decision to participate; expectations and experience; appropriateness and acceptability of research design and measures. Patients declining to take part will be approached to explore reasons for not participating.
#Intervention
- DRUG : diclofenac
- DRUG : paracetamol
- DEVICE : heat retaining knee support
- DEVICE : standard knee support | #Eligibility Criteria:
Inclusion Criteria:
* Patients attending clinics in the North Bristol Health Care Trust, with confirmed OA of the knee (Kellgren-Lawrence radiographic score of 2 <= age <= 4 within the previous 12 months) and use-related pain.
Exclusion Criteria:
* Patients who had received corticosteroid injections or operations on their knee in the previous six months were excluded. Those with known contraindications to paracetamol or any NSAID, and those taking steroids, warfarin or aspirin for another medical condition were excluded from the drug trials.
Sex :
ALL
Ages :
- Minimum Age : 0 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00371696 | 88,092 |
{
"NCT_ID" : "NCT03800537",
"Brief_Title" : "MR Fingerprinting: A Novel Sequence Applied to Neuroimaging",
"Official_title" : "MR Fingerprinting: A Novel Sequence Applied to Neuroimaging",
"Conditions" : ["Disease;Neurological"],
"Interventions" : ["Device: MR Fingerprinting"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-03-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-18",
"Study_Completion_Date(Actual)" : "2022-08-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-08",
"First_Submitted_that_Met_QC_Criteria" : 2023-05-19",
"First_Posted(Estimated)" : 2019-01-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-08",
"Last_Update_Posted(Estimated)" : 2023-06-12",
"Last_Verified" : 2022-08"
}
}} | #Study Description
Brief Summary
Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over the past 30 years because it is non-invasive, requires no ionizing radiation, and provides exquisite images of soft tissues and anatomic structures with many tissue/disease specific contrasts. While MRI has served the community well for many years, it is increasingly clear that it also has significant limitations.
One of the principle limitations is the lack of quantitative information for tissue/structure characterization. The current paradigm of MRI is to use a set of scanner settings to generate an image 'weighted' by a specific MR contrast mechanism (physical parameter), where it is hoped that variations in the parameter will be accentuated. However, without quantitative knowledge of the parameters, the final image contrast may depend on many factors, which complicates image interpretation and diagnostic performance. Quantitative measurement can provide a great deal of information about tissue properties and pathological conditions, since these parameters ultimately determine the contrast that is observed in conventional images.
Detailed Description
The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. Quantitative MRI has been a continuous interest in the MRI community, but extremely challenging due to long acquisition times and sensitivity to motion. Recently, the investigators have introduced a novel MRI data acquisition approach, namely MR Fingerprinting (MRF), for simultaneous measurement of several important parameters in a single MRI scan.
In this study, the investigators propose to apply MR Fingerprinting at UNC and evaluate its performance for different neurological diseases. The investigators hypothesize that the quantitative MR imaging technique will lead to improved tissue characterization and diagnosis.
#Intervention
- DEVICE : MR Fingerprinting
- The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence. | #Eligibility Criteria:
Inclusion Criteria:
* The study will include English-speaking patients that are already scheduled to undergo a clinical neurological MRI for diagnostic purposes.
Exclusion Criteria:
* Pregnant women will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03800537 | 214,532 |
{
"NCT_ID" : "NCT00397254",
"Brief_Title" : "Two Rizatriptan Prescribing Portions for Treatment of Migraine",
"Official_title" : "An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine",
"Conditions" : ["Migraine"],
"Interventions" : ["Drug: rizatriptan"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-01",
"Study_Completion_Date(Actual)" : "2008-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-11-07",
"First_Submitted_that_Met_QC_Criteria" : 2009-09-17",
"First_Posted(Estimated)" : 2006-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-11-08",
"Last_Update_Posted(Estimated)" : 2010-06-08",
"Last_Verified" : 2009-09"
}
}} | #Study Description
Brief Summary
The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.
Detailed Description
A common clinical perception exists that less effective treatment of attacks increases the burden of disease across attacks in the form of increased attack frequency, severity, duration, and/or treatability. If this perception is true, more effective treatment decreases the burden of disease across attacks. There are multiple barriers to effective treatment. The triptan class of migraine medications is frequently dispensed in the context of health benefit plan formulary limitations. Because of limited supply, medications must be used very cautiously. Patients may hoard medication in reaction to fear of running out. Overly cautious use and hoarding may lead to greater disease burden.
The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation ('Formulary Limit') vs. a less limited allocation ('Clinical Limit') on disease burden.
#Intervention
- DRUG : rizatriptan
- 10mg ODT 27 tablets
- Other Names :
- Maxalt
- DRUG : rizatriptan
- 10mg ODT 9 tablets
- Other Names :
- Maxalt | #Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years
* Patient has at least a 1-year history of migraine with or without aura by International Headache Society (IHS) criteria 1.1 and 1.2
* Patient typically has 3 <= age <= 8 migraine attacks/month
* Patient has less than 10 headache days/month with no evidence of IHS 8.2 Medication Overuse Headache
* Patient receives their triptan medication under a pre-determined prescribing allocation ranging from 6 <= age <= 12 tablets per month for the last 3 months preceding Visit 1.
* Patient and investigator agree that multiple doses of rizatriptan described in the package circular are appropriate for non-responsive or recurring headache.
* Patient uses a triptan as mainstay of acute therapy at Visit 1.
* Patient of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of rizatriptan outside the study.
* Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria:
* Patient has headache disorders beyond migraine or episodic tension-type headache IHS 2.1
* Patient is receiving prophylactic therapy for migraine
* Patient is currently taking:
Daily or nearly daily (typically >3 days out of 7 days) use of non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or other analgesics. Aspirin less than or equal to 325mg daily is allowed for cardioprotection.
Monoamine oxidase inhibitors (MAOIs) Propranolol Patient taking either an MAOI ro propranolol may be enrolled in the study, if in the clinical judgement of the investigator, either of these medications can be discontinued 2 weeks prior to study entry. Otherwise the use of MAOIs and propranolol are prohibited during the study.
* Patient has basilar or hemiplegic migraine headache.
* Patient has history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or finding consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease.
* Patient has uncontrolled hypertension.
* Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients.
* Patient is pregnant or a nursing mother.
* Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
* Patient has received treatment with an investigational device or compound within 30 days of the study (Visit 1).
* Patient had clinical evidence of significant pulmonary, renal, hepatic, endocrine, neurologic (apart from migraine), psychiatric or any other condition that, in the opinion of the investigator may confound the results of the study, pose an additional risk, or interfere with optimal participation in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00397254 | 219,930 |
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