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{
"NCT_ID" : "NCT02753712",
"Brief_Title" : "A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma",
"Official_title" : "A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma",
"Conditions" : ["Asthma"],
"Interventions" : ["Drug: Fluticasone/Formoterol BAI", "Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)"],
"Location_Countries" : ["Sweden", "Australia", "United Kingdom", "Slovakia", "New Zealand"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-08-14",
"Study_Completion_Date(Actual)" : "2017-08-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-04-11",
"First_Posted(Estimated)" : 2016-04-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-27",
"Last_Update_Posted(Estimated)" : 2018-10-23",
"Last_Verified" : 2018-10"
}
}} | #Study Description
Brief Summary
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
#Intervention
- DRUG : Fluticasone/Formoterol BAI
- DRUG : Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) | #Eligibility Criteria:
Inclusion Criteria for subjects on Seretide Accuhaler 250/50 µg at screening:
* Male and female subjects >=18 years.
* Adequate contraception
* Documented clinical history of asthma for >=6 months prior to screening visit
* Using Seretide Accuhaler at a stable dose of 250/50 μg BID at screening for >= 8 weeks.
* uncontrolled asthma as defined by Asthma Control Questionnaire (ACQ-6) score >= 1.0
* R5-R20 >= 0.10 kPa/L/s as measured on impulse oscillometry during the screening visit.
* Historical evidence (within 24 months) of eosinophilic airways disease evidenced by sputum eosinophil count >= 3% and/or FeNO 35 ppb.
Inclusion criteria for subjects on equivalent /higher dose or other ICS-LABAs or higher dose of Seretide at screening:
* Male and female subjects >=18 years.
* Adequate contraception
* Documented clinical history of asthma for >=6 months prior to screening visit
* R5-R20 >=0.07 kPa/L/s as measured on impulse oscillometry during the screening visit.
* 5. Historical evidence (within past 24 months) of eosinophilic airways disease, evidenced by sputum eosinophil count >=3% and/or FeNo >=35 ppb.
Exclusion Criteria for all subjects:
* Any severe chronic respiratory disease other than asthma.
* Subject has a smoking history >=10 'pack years' (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.)
* Current smoking history within 12 months prior to the screening visit
* Near fatal or life-threatening (including intubation) asthma within the past year.
* Known history of systemic (injectable or oral) corticosteroid medication within 1 month of visit 1.
* Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the investigator's opinion, precludes entry into the study. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
* In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to visit 1.
* Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the screening visit.
* Subject has taken β-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to screening visit.
* Current use of bronchodilators / anti-inflammatory agents other than those specified in the protocol.
* Known or suspected sensitivity to study drug or excipients.
* Participation in a clinical drug study within 30 days of the screening visit.
* Current participation in a clinical study.
Exclusion Criteria for subset of subjects undergoing OR-MRI and HD-CT
* Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes, but is not limited to: presence of non-MRI compatible artificial heart valves, hydrocephalus shunts, intracranial aneurysm clips, joint replacements or metal implants, pacemakers or other cardiac rhythm management devices, claustrophobia, history of metal in the eye, presence of shrapnel from a war injury, callipers or braces, dentures, dental plates or hearing aids that include metal and cannot be removed, history of epilepsy or black-outs, ear implants, piercings cannot be removed, intrauterine contraceptive device or coil.
* Inability to stay in the supine position for the duration of the scanning procedure
* Obesity (body weight >140kg).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT02753712 | 78,096 |
{
"NCT_ID" : "NCT00857272",
"Brief_Title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects",
"Official_title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects",
"Conditions" : ["Colonoscopy"],
"Interventions" : ["Drug: PEG electrolyte lavage solution + bisacodyl", "Drug: PEG electrolyte lavage solution + bisacodyl - reformulation"],
"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)" : "2009-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-05",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-03-05",
"First_Submitted_that_Met_QC_Criteria" : 2010-09-08",
"First_Posted(Estimated)" : 2009-03-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-03-05",
"Last_Update_Posted(Estimated)" : 2010-10-05",
"Last_Verified" : 2010-09"
}
}} | #Study Description
Brief Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
#Intervention
- DRUG : PEG electrolyte lavage solution + bisacodyl - reformulation
- multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
- DRUG : PEG electrolyte lavage solution + bisacodyl
- multi dose preparation (tablet/solution) for oral administration prior to colonoscopy | #Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
* At least 18 years
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria:
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
* Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
* Subjects who are pregnant or lactating, or intending to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT00857272 | 114,683 |
{
"NCT_ID" : "NCT03789968",
"Brief_Title" : "The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients",
"Official_title" : "The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients",
"Conditions" : ["HIV/AIDS"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-05",
"Study_Completion_Date(Actual)" : "2020-10-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-12-26",
"First_Posted(Estimated)" : 2018-12-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-12-26",
"Last_Update_Posted(Estimated)" : 2020-10-08",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
This study will assess changes in the incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide-based regimens in treatment experienced patients living with HIV infection.
Detailed Description
Simple, safe and effective antiretroviral therapy (ART) can provide optimal treatment outcomes for people living with HIV infection (PLWH) \[1\]. Increasingly complex and poorly tolerated regimens, on the other hand often limit ART adherence, while drug-drug interactions (DDIs) and safety concerns with individual ART agents can limit treatment selection \[2-4\]. Fortunately, recent advances in ART have included the emergence of several highly effective, safe and well tolerated regimens with limited DDIs. In clinical trials, integrase strand transfer inhibitors (INSTIs) such as raltegravir, elvitegravir, dolutegravir and bictegravir are consistently as effective or more effective than comparator agents and often superior in terms of tolerability \[5-10\]. Due to their efficacy, safety, and tolerability, INSTI-based regimens are now routinely used in treatment naïve patients and emerging data suggests that several may be used to simplify therapy for selected patients with treatment experience \[11, 12\].
Among the INSTIs, bictegravir is the newest agent in the class \[13\]. Similar to dolutegravir and raltegravir and in contrast to elvitegravir, it has few significant drug-drug interactions. Unlike dolutegravir and raltegravir, bictegravir is available as part of a single-tablet, once-daily regimen that includes tenofovir alafenamide and emtricitabine (BIC/TAF/FTC). Raltegravir is not available within a single tablet regimen, while dolutegravir is available as part of a single-tablet regimen, but it includes abacavir, which has been linked to an increased cardiovascular disease risk. As a result, BIC/TAF/FTC is currently among the most effective, safe, well-tolerated treatment options with limited drug-drug interactions.
With several new treatment options available, particularly in the INSTI class, current guidelines advocate switching ART when possible in virologically suppressed, ART experienced patients \[1\]. Switching ART can simplify treatment, improve tolerability, eliminate toxicity, and mitigate drug-drug interactions. When switching ART for any reason, it is critical to review a patient's full HIV treatment history, including virologic responses, past ART-associated toxicities, and cumulative resistance before selecting a new regimen \[1\].
Drug-drug interaction assessments with a patient's concomitant medications should also be performed prior to switching ART. More than 70% of the HIV population will be above the age of 50 by the year 2020 and many are receiving 5 or more medications for common chronic conditions in addition to being ART experienced \[14, 15\]. Cardiovascular disease, hepatic and renal disease, osteoporosis, insulin resistance, metabolic disorders, and cancers are among the conditions that can occur more commonly in PLWH and at times earlier in life in comparison to their HIV negative counterparts \[16\]. Drug-drug interactions between medications needed to treat or prevent these comorbid conditions can often interact with ART. Switching ART, in many circumstances can reduce the number drug interactions with medications for comorbid conditions. Conversely, switching can also lead to new interactions requiring intervention to avoid toxicities or prevent ineffective treatment.
Multiple studies have confirmed that switching HIV treatment can improve patient adherence and quality of life \[17\]. Several studies have also confirmed that clinically significant drug-drug interactions are common in patients living with HIV, but none have assessed changes in the incidence and severity of drug-drug interactions in the setting of ART switches \[18-20\]. The primary objective of this study is to assess changes in the incidence and severity of drug interactions before and after switching ART to BIC/TAF/FTC -based regimens in treatment experienced patients.
Null Hypothesis:
There is no difference in the incidence and severity of drug-drug interactions between ART and concomitant medications before and after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced patients.
Alternative Hypothesis:
The incidence and severity of drug-drug interactions between ART and concomitant medications is reduced after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced patients.
Data Collection Subjects from the Jefferson Infectious Diseases Associates outpatient HIV Clinic will be evaluated for study inclusion. Co-investigators at six partner institutions will also evaluate patients at their HIV clinics for study inclusion. The following information will be collected for patients meeting the study criteria: age, gender, race, duration of HIV infection, duration of ART treatment, number of previous ART regimens, CD4+ cell count and HIV RNA directly prior to switching to a BIC/TAF/FTC-based ART regimen, and the reason for switching ART to a BIC/TAF/FTC-based regimen. Additionally, all concomitant medication names at the time of the ART switch will be collected.
Scoring System To assess the combined incidence and severity of drug interactions with concomitant medications (CM) prior to and following each patient's ART switch, a DDI incidence and severity score was developed. The score is based upon results obtained when entering medications into the University of Liverpool's HIV Drug Interaction Checker (ULHDIC) database \[21\]. Each ART-CM pair is given one of the following scores: 'do not co-administer' is assigned a score of 2, 'potential interaction' a score of 1, and 'potential weak interaction' or 'no interaction' a score of 0. For those interactions that have 'no clear data,' or for those medications that are not listed in the drug database, the Department of Health and Human Services HIV treatment guidelines will be consulted along with the FDA product labeling.
Score Validation A separate analysis (data not provided here) was completed by study investigators to validate the use of the ULDIC severity ranking. The medication profiles of a random, representative sample of the study's population were selected for analysis. Drug interaction scores using the aforementioned ULHDIC were compared with drug interaction scores determined manually using the Department of Health and Human Services HIV treatment guidelines and FDA product labeling. No statistical difference in drug interaction scores between methods was observed.
Primary Endpoint The primary endpoint of the study will be to measure the change in mean total drug interaction scores pre and post ART switch to a BIC/TAF/FTC-based ART regimen. The total drug interaction scores for each patient pre- and post-switch will be calculated. The average pre-switch and post-switch scores will then be determined and analyzed for statistical differences using a two-sided paired t-test (normal distribution) with an alpha level of 0.05 or a Wilcoxon Ranked Sum test (non-normal distribution).
Secondary Endpoints The secondary endpoint of the study will be to identify predictors of achieving drug interaction score reductions after switching to a BIC/TAF/FTC-based ART regimen. Predictors for achieving drug interaction score reductions will be examined using a multivariable linear regression model. Initial models will include all a priori determined variables and all variables will be examined for multi-collinearity. Models will be fit using a backwards selection procedure. Candidate predictors will be eliminated individually by comparing the log likelihood ratio test for each model step and using the 5% significance level.
#Intervention
- DRUG : bictegravir/emtricitabine/tenofovir alafenamide
- Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen | #Eligibility Criteria:
Inclusion Criteria:
* HIV diagnosis
* 18 years or older
* Receiving ART for at least 3 months
* ART is switched to bictegravir/emtricitabine/tenofovir alafenamide between 2/7/2018 and 3/30/2019
* Patient is receiving at least one chronic or as needed non-ART medication at the time of the switch
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT03789968 | 113,099 |
{
"NCT_ID" : "NCT03684798",
"Brief_Title" : "Mental Contrasting With Implementation Intentions for Alcohol Use Disorders",
"Official_title" : "Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders",
"Conditions" : ["Alcohol Use Disorder"],
"Interventions" : ["Other: Treatment as usual", "Other: MCII"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-08-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-04",
"Study_Completion_Date(Actual)" : "2019-03-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-08-31",
"First_Posted(Estimated)" : 2018-09-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-09-24",
"Last_Update_Posted(Estimated)" : 2020-02-05",
"Last_Verified" : 2020-02"
}
}} | #Study Description
Brief Summary
Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high. The study aims to investigate the effects of a motivational training (Mental Contrasting with Implementation Interventions; MCII) as a therapeutic add-on to standard treatment in inpatients with Alcohol Use Disorders.
Detailed Description
Today's elaborated therapeutic interventions do not ensure sustainability of therapeutic success in alcohol-dependent patients. Thus, it is to develop and implement new therapeutic methods in order to increase regular treatment termination and continuous abstinence during treatment. Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high.
In the study, MCII is implemented as an add-on intervention in order to reduce the risk of a relapse during treatment and to decrease drop-outs from treatment in alcohol-dependent inpatients. Therefore, inpatients with alcohol use disorder (AUD) are randomly assigned to one of two groups. The experimental group does receive MCII, the control group an exercise from treatment as usual. In addition, patients undergo brief motivational screenings in form of self-report questionnaires at the beginning and during treatment in order to assess motivational mediation of treatment effects and drinking events. The effect of the MCII training will be examined on primary (drinking during treatment) and secondary outcome variables (early treatment termination, motivational changes after drinking events).
The Primary Outcome is return to drinking during treatment defined as any violation of total abstinence. Drinking is assumed if either a drinking event is reported by the patient or a Breathalyzer tests is positive.
Participants are allocated to the groups using randomisation with emphasis on equal group sizes in control and experimental group. The list of randomisation was generated with the online tool 'Research Randomizer'.
The investigator's a priori calculation of the required sample size is based on the primary outcome, i.e. return to any drinking during treatment. Given α=0.05 and 1-β=0.80 a one-sided z-test then yields a required sample size of 122 participants, i.e. 61 subjects in the intervention group and 61 subjects in the control group.
All randomized subjects will be included in the analyses, regardless of whether they terminate the study regularly or not. Analyses will be done according to the intention-to-treat method (ITT).
#Intervention
- OTHER : MCII
- In this study, the research staff will work through the MCII approach with the participant as an interactive, face-to-face training. The desired future consists of imaging an abstinent life and comparing it with personally relevant obstacles. Afterwards, the most relevant obstacle will be chosen and an if-then-plan will be formed, that refers to this obstacle.
- OTHER : Treatment as usual
- The patients in the control group will receive a 2 x 2 contingency table about the disadvantages and advantages of being abstinent and of drinking. In addition, abstinence intentions of patients in the control group will also be supported and risk situations and relapse events since the last trainings will be reappraised, but without the use of MCII. | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
* Age: >=18 years
Exclusion Criteria:
* Cognitive deficits that limit the patients' ability to provide informed consent
* Inability to follow the procedures of the study
* Acute suicidality
* Acute psychosis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT03684798 | 268,882 |
{
"NCT_ID" : "NCT00866502",
"Brief_Title" : "A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease",
"Official_title" : "A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump.",
"Conditions" : ["Parkinson's Disease"],
"Interventions" : ["Drug: Placebo", "Drug: sNN0031"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03",
"Study_Completion_Date(Actual)" : "2011-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-03-18",
"First_Posted(Estimated)" : 2009-03-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-03-18",
"Last_Update_Posted(Estimated)" : 2015-01-12",
"Last_Verified" : 2015-01"
}
}} | #Study Description
Brief Summary
This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.
Detailed Description
Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic symptoms of Parkinson's disease (PD) that are associated with degeneration of dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate neuronal stem and progenitor cells is one possible approach to restore the dopaminergic activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been demonstrated to reduce the typical symptoms in animal models of PD.
NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in the form of the drug product sNN0031 can improve motor function in patients with PD. In this first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks follow-up will be evaluated.
#Intervention
- DRUG : sNN0031
- Continuous ICV infusion for two weeks
- Other Names :
- PDGF
- DRUG : Placebo
- Continous ICV infusion
- Other Names :
- Artificial CSF | #Eligibility Criteria:
Inclusion Criteria:
* Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels >40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.) during the duration of the study.
* Diagnosis of idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb-III).
* Effect duration of oral L-dopa dose intake <=4 hours
* Score >=30 on motor part (part III) of UPDRS at defined off (>12 hours after last dose intake)
* Dopaminergic responsiveness with at least 33% decrease in the UPDRS part III score after administration of L-dopa
* Disease duration at least 5 years
* Age 30 <= age <= 75
* Stable anti-Parkinson treatment for at least 3 months
* Ophthalmologic examination with normal findings regarding vascular structure and function
* MRI examination of the brain and cervical spinal cord within 3 months before anticipated implantation of the device with no findings of tumors or potential sources of pathological bleedings, or abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, represent a surgical risk to the subject.
* Values of coagulation parameters including platelet count, normalized prothrombin complex (PK-INR), activated partial thromboplastin time (APTT) within normal ranges.
* The subject is medically able to undergo the surgery required for stereotactic implantation of the catheter and infusion pump.
* Has been given written and verbal information, has had opportunity to ask questions about the study, and understands time and procedural commitments
* Signed consent (written) to participate in the study
Exclusion Criteria:
* Atypical form of PD including repeated head trauma, drug- or toxin-induced PD, and other neurological conditions including Shy-Drager syndrome (multiple system atrophy), progressive supranuclear palsy, Wilson's disease, Huntington's disease, Hallervorden-Spatz syndrome, Alzheimer's disease, Creutzfeldt-Jakob disease, olivopontocerebellar atrophy, and post-traumatic encephalopathy
* Concurrent dementia with a score of 20 or lower on the MMT rating scale
* Concurrent clinically significant depression with a score of 16 or higher on the MADRS rating scale, equivalent to moderate or severe depression.
* Exposure to neuroleptic drugs blocking dopamine receptors within 6 months
* History of structural brain disease including tumors and hyperplasia
* History of increased intracranial pressure
* Prior surgical procedures or implantation of device for the treatment of PD
* Prior exposure to any formulation of PDGF-BB (including topical)
* Uncontrolled hypertension with blood pressure >160 mmHg systolic or >90 mmHg diastolic.
* Any disorder that precludes a surgical procedure (eg, signs of sepsis or inadequately treated infection), alters wound healing (e.g. including bleeding disorders), or renders chronic ICV delivery or device implants medically unsuitable.
* Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally. Physicians should specifically investigate anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities), underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease, or other medical conditions), and the administration of any antiplatelet or anticoagulant medication (e.g., aspirin, Plavix, NSAIDs) in the pre- or perioperative period. Any of those conditions or drugs could place a patient at an increased risk for intraoperative or postoperative bleeding.
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central nervous system (CNS) catheter.
* Presence of cardiac pacemakers, spinal cord stimulators, implantable programmable intraspinal drug pumps, or any other device that may interfere or interact with the programmer, without prior approval by Medtronic.
* Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the investigator
* Ongoing medical condition that according to the investigator would interfere with the conduct and assessments in the study. Examples are medical disability (eg, severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of investigational product or device performance, or would compromise the ability of the subject to undergo study procedures (eg, MRI, PET), or to give informed consent.
* Participation in another clinical trial with an investigational drug or device within 3 months prior to Screening visit.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT00866502 | 175,008 |
{
"NCT_ID" : "NCT01690676",
"Brief_Title" : "Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function",
"Official_title" : "The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects",
"Conditions" : ["Borderline Hypertension"],
"Interventions" : ["Dietary Supplement: Microcrystalline cellulose", "Dietary Supplement: Epicatechin"],
"Location_Countries" : ["Finland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-05",
"Study_Completion_Date(Actual)" : "2013-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-14",
"First_Posted(Estimated)" : 2012-09-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-19",
"Last_Update_Posted(Estimated)" : 2014-04-08",
"Last_Verified" : 2014-04"
}
}} | #Study Description
Brief Summary
Effect of apple polyphenols on FMD.
Detailed Description
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
#Intervention
- DIETARY_SUPPLEMENT : Epicatechin
- DIETARY_SUPPLEMENT : Microcrystalline cellulose | #Eligibility Criteria:
Inclusion Criteria:
* Borderline hypertension
* Otherwise healthy
* Aged 40 <= age <= 65 years (inclusive)
* Not consuming high amounts (over 20 mg daily) of flavonoids
Exclusion Criteria:
* BMI >32 kg/m2
* Total serum cholesterol >= 8 mmol/l
* Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
* Coronary artery disease
* Pregnancy or lactating
* Alcohol abuse as evaluated by medical history
* Regular smoking/using nicotine products
* Diabetes mellitus
* Apple allergy
* Use of lipid lowering medications
* Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
* Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
* High consumption of vitamin products, herbal remedies or products containing flavonoids
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT01690676 | 2,672 |
{
"NCT_ID" : "NCT00643734",
"Brief_Title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients",
"Official_title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults",
"Conditions" : ["Pneumonia"],
"Interventions" : ["Drug: levofloxacin", "Other: placebo", "Drug: azithromycin sustained release"],
"Location_Countries" : ["India", "Lithuania", "United States", "Mexico", "Chile", "Canada", "Peru", "Russian Federation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-04",
"Study_Completion_Date(Actual)" : "2004-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-19",
"First_Posted(Estimated)" : 2008-03-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-19",
"Last_Update_Posted(Estimated)" : 2008-03-26",
"Last_Verified" : 2008-03"
}
}} | #Study Description
Brief Summary
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
#Intervention
- DRUG : azithromycin sustained release
- azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
- OTHER : placebo
- placebo
- DRUG : levofloxacin
- 500 mg (two 250 mg capsules) by mouth once daily for 7 days
- OTHER : placebo
- placebo | #Eligibility Criteria:
Inclusion Criteria:
Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Exclusion Criteria:
Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT00643734 | 100,607 |
{
"NCT_ID" : "NCT03956186",
"Brief_Title" : "Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?",
"Official_title" : "Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?",
"Conditions" : ["Cesarean Section Complications", "Hypotension", "Spinal Anesthesia", "Perfusion Index", "Pleth Variability Index"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-11",
"Study_Completion_Date(Actual)" : "2019-07-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-16",
"First_Posted(Estimated)" : 2019-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-05-17",
"Last_Update_Posted(Estimated)" : 2019-07-24",
"Last_Verified" : 2019-07"
}
}} | #Study Description
Brief Summary
Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.
| #Eligibility Criteria:
Inclusion Criteria:
* singleton parturient
* planned for elective LSCS under spinal anesthesia
Exclusion Criteria:
* gestational age < 36 weeks
* emergency cases
* placenta previa, pre-eclampsia
* BMI>40
* Reynauld disease
* patient refusal
* cardiovascular disease
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:
No
| NCT03956186 | 81,008 |
{
"NCT_ID" : "NCT01448317",
"Brief_Title" : "Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects",
"Conditions" : ["Hypercholesterolemia"],
"Interventions" : ["Drug: Alirocumab (Solution)", "Drug: Placebo (Lyophilized formulation)", "Drug: Alirocumab (Lyophilized formulation)", "Drug: Placebo (Solution)"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01",
"Study_Completion_Date(Actual)" : "2012-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-21",
"First_Posted(Estimated)" : 2011-10-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-10-05",
"Last_Update_Posted(Estimated)" : 2016-09-28",
"Last_Verified" : 2016-09"
}
}} | #Study Description
Brief Summary
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
* To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
* To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the immunogenicity of a single SC dose of alirocumab.
Detailed Description
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
#Intervention
- DRUG : Alirocumab (Solution)
- Pharmaceutical form: solution
Route of administration: subcutaneous
- Other Names :
- SAR236553, REGN727
- DRUG : Alirocumab (Lyophilized formulation)
- Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
- Other Names :
- SAR236553, REGN727
- DRUG : Placebo (Solution)
- Pharmaceutical form: solution
Route of administration: subcutaneous
- DRUG : Placebo (Lyophilized formulation)
- Pharmaceutical form: lyophilized formulation
Route of administration: Subcutaneous | #Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject, between 20 and 65 years inclusive.
* Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
* Serum LDL-C levels >100 mg/dL
Exclusion Criteria:
* Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* History or presence of drug or alcohol abuse
* Smoking more than 5 cigarettes or equivalent in any 24 hour period.
* Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
* Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
* Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
* Presence or history of drug hypersensitivity
* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT01448317 | 260,869 |
{
"NCT_ID" : "NCT04490616",
"Brief_Title" : "TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment",
"Official_title" : "EFFECTS of RTMS TREATMENT on SOCIAL COGNITION DYSFUNCTIONS in MILD COGNITIVE IMPAIRMENT: an PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY",
"Conditions" : ["Mild Cognitive Impairment"],
"Interventions" : ["Other: rTMS treatment"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-02-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-28",
"Study_Completion_Date(Actual)" : "2024-03-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-10",
"First_Posted(Estimated)" : 2020-07-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-24",
"Last_Update_Posted(Estimated)" : 2025-03-20",
"Last_Verified" : 2023-10"
}
}} | #Study Description
Brief Summary
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
Detailed Description
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI subjects at 2 and 4 weeks, and after 8 weeks from baseline.
All patients will be recruited at Clinical Neuroscience Institute, Department of Neurology, Regional Civic Hospital, Lugan; Department of Geriatric Italian Hospital Viganello; and Department of Geriatric, Beata Vergine Hospital Mendrisio; Southern Switzerland, Switzerland.
Primary objective:
1. To investigate whether the application of high-frequency rTMS, for 2 or 4 weeks, to the RPTJ and MPFC resulted in social cognitive improvements.
Secondary objectives:
1. To verify whether the social cognition benefits previously recorded might persist after 8 weeks the end of the stimulation, with a major benefit with a longer rTMS application (4 weeks).
2. To investigate whether the application of high-frequency rTMS, at 2 weeks or 4 weeks, to the RPTJ and MPFC contributes to improve cognitive functions as well as neuropsychiatric (depression) and functional aspects.
3. To verify whether the cognitive functions, neuropsychiatric aspect, and functional benefits previously recorded persist after the end of the rTMS stimulation.
Primary analysis: To investigate the behavioral effects induced by the rTMS protocol after 2 and 4 weeks of daily stimulation on social cognition skills, executive/attentive functions, neuropsychiatric and functional aspects will be used a mixed-model ANOVA, considering the group as a between-subjects factor, and time as a within-subject factor.
Secondary Analyses: To investigate the direct or mediated rTMS effect on social cognition skills, a multivariate linear regression analysis will be done for each social cognition measure (ToM, empathy, social perception, social behavior) changes after rTMS treatment at 2 and 4 weeks as the dependent factor, separately, and appropriate screening/baseline dependent variables and rTMS groups as independent factors.
The evaluation and treatment of social cognition alterations in subjects with MCI can be useful for two main aspects: first, the mild cognitive and behavior impairment of these subjects favor a better answer at the treatment, both at the behavioral level and in terms of brain structural and functional response; second, treatment of these abilities in MCI population might retard the conversion to dementia. More importantly, the detection of predominant social cognition alteration in early phases of cognitive decline might be potentially helpful to differentiate individuals who will develop frontotemporal dementia. Therefore, it is important to investigate and define a treatment protocol to limit social cognition disturbances in MCI.
#Intervention
- OTHER : rTMS treatment
- A two-site rTMS stimulation delivered by a Magstim unit featuring a double 70 mm cooled coil will be applied.
MCI patients will be randomly assigned to one of the two study groups:
1. RR-Gr will receive 4 weeks of rTMS stimulation of the right temporo-parietal junction (RTPJ) and medial prefrontal cortex (MPFC);
2. PL-Gr will receive sham stimulation of the RTPJ and MPFC during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment will consist of five sessions (50 min, one per day).
For each area target, a total of 2000 pulses at 20Hz, 3-s train duration, and 28-s inter-train interval at 100% motor threshold (MT) will be delivered per session. A fixed intensity of MT will ensure a more consistent spatial spread of TMS effects in subjects' brains not influenced by differences in individual MT. In the sham condition, a sham coil will be used.
Each session lasted for about 60 min including time for set up and 50 min of stimulation. | #Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 50 <= age <= 85 old, inclusive, at the time of informed consent;
* Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
* Must meet Petersen's criteria for mild cognitive impairment, and must have:
* Clinical dementia rating global score of 0.5;
* Mini-Mental State Examination score between 24 and 30;
* Must have a score >= 26.5 at Token test to ensure that subjects have the ability to understand the instructions and procedures;
* Must have a score < 29 at Beck Depression Inventory to exclude major depression that could compromise the patient's ability to engage in the study;
* Apart from a clinical diagnosis of MCI, the subject must be in good health;
* Must be on stable dose of antidepressant (if applicable) for at least 2 months prior to the enrolment.
Exclusion Criteria:
* Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
* Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
* Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
* History of seizure within10 years prior to screening;
* Recent history of alcohol or substance abuse or use of cannabinoids;
* Any other medical conditions that are not stable or controlled, or could affect the subject's safety or interfere with the study assessments and treatment;
* Contraindication to having TMS treatment;
* Inability to understand the purpose of the study or to comply with study requirements.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT04490616 | 95,986 |
{
"NCT_ID" : "NCT01711034",
"Brief_Title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer",
"Official_title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer",
"Conditions" : ["Solid Tumors"],
"Interventions" : ["Drug: OPB-111077"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-06",
"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" : 2012-10-12",
"First_Posted(Estimated)" : 2012-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-10-17",
"Last_Update_Posted(Estimated)" : 2016-04-05",
"Last_Verified" : 2016-04"
}
}} | #Study Description
Brief Summary
The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.
Detailed Description
The secondary objective of this study is to investigate the pharmacokinetic properties of OPB-111077; the pharmacodynamic effects of OPB-111077; the antitumor activity of OPB-111077 as assessed by RECIST or IMWG Uniform Response Criteria; and to explore whether PET responses correlate with other measures of clinical response.
#Intervention
- DRUG : OPB-111077
- Dose escalation phase starting with dose of 100mg tablets on Day 1 and 4, and all remaining days of each 28 day cycle until disease progression or toxicity develops.
Dose expansion phase starting with daily dosing of 250mg for 28 day consecutive day cycles. | #Eligibility Criteria:
Inclusion Criteria:
* Pathologically and/or cytologically confirmed advanced malignancy that is refractory to standard therapy or for which there are no standard treatment options available
* For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives, whichever is shorter, need to have elapsed since the last dose
* Recovery from adverse effects of prior therapy at time of enrollment to
o <= Grade 1 (excluding alopecia)
* Agreement to forego any other chemotherapy, immunotherapy, radiotherapy, or investigational drug while enrolled on this trial except hormonal therapy for prostate cancer or radiotherapy for symptomatic bone metastases known to be present at Screening
* Male or female subjects aged >= 18 years
* ECOG performance status <= 2
* Adequate organ function
* Life expectancy of >= 3 months following trial entry
* For women of childbearing potential, a negative serum pregnancy test result at Screening
* For women of childbearing potential or men whose sexual partners are women of childbearing potential, agreement to use 2 methods of adequate contraception prior to trial entry, for the duration of the trial, and for 90 days after the last dose of trial medication
* Signed and dated IRB-approved informed consent prior to any performance of protocol-specific screening procedures
Exclusion Criteria:
* Uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled heart, liver, kidney, or endocrine disorder
* Altered mental status, psychiatric illness, or social situation that would limit compliance with trial requirements and/or obscure trial results
* Immunocompromised state
* Known or evidence of chronic viral hepatitis (hepatitis B or C virus)
* Untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease
* Inability to swallow oral meds or gastrointestinal disorder that might interfere with absorption of oral drugs
* Major surgery within 28 days of first receipt of trial drug
* Nursing or pregnant women
* >= Grade 1 neuropathy with pain or > Grade 2 neuropathy without pain (subjects with neuropathy caused by a previous regimen that is recovered to <= Grade 2 and stable without pain may be included)
* Food-effect sub-study (Part B) only: Pathologies or medical histories that might impair absorption and elimination.
* PET scan sub-study (Part C) only: Uncontrollable blood glucose or intolerance to PET scan procedures.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT01711034 | 101,028 |
{
"NCT_ID" : "NCT00304239",
"Brief_Title" : "Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp",
"Official_title" : "A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp",
"Conditions" : ["Actinic Keratosis"],
"Interventions" : ["Combination Product: Vehicle-PDT", "Combination Product: Metvix-PDT"],
"Location_Countries" : ["Germany", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-03-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-01-23",
"Study_Completion_Date(Actual)" : "2007-01-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-03-16",
"First_Submitted_that_Met_QC_Criteria" : 2022-08-03",
"First_Posted(Estimated)" : 2006-03-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-03-16",
"Last_Update_Posted(Estimated)" : 2023-07-03",
"Last_Verified" : 2022-08"
}
}} | #Study Description
Brief Summary
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp.
Detailed Description
Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple.
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.
Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) had been used for the activation of PAP, which absorbs light in the range of 400-700 nanometer (nm). The present study used the Aktilite CL 128 lamp. Aktilite 128 was based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study was similar to two other studies performed, on which the U.S. approval of Metvixia cream was based except for the light source used. This study was one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia cream.
Previous studies have shown that the risks attributed to Metvixia PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.
#Intervention
- COMBINATION_PRODUCT : Metvix-PDT
- Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.
- COMBINATION_PRODUCT : Vehicle-PDT
- Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments. | #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of 4 <= age <= 10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
* Males or females above 18 years.
* Written informed consent.
Exclusion Criteria:
* Participants with porphyria.
* Participants immunosuppressed for idiopathic, disease specific or therapeutic reasons.
* Known allergy to MAL, a similar PDT compound or excipients of the cream.
* Participants with history of hypersensitivity to nut products or other known protein antigens.
* Participation in other clinical studies either currently or within the last 30 days.
* Participants receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
* Participants receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months.
* Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
* Any conditions that may be associated with a risk of poor protocol compliance.
* Participants currently receiving regular ultraviolet radiation therapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT00304239 | 102,603 |
{
"NCT_ID" : "NCT03249038",
"Brief_Title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.",
"Official_title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.",
"Conditions" : ["Blood Loss, Surgical", "Blood Loss", "Blood Loss, Postoperative"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-08-01",
"Study_Completion_Date(Actual)" : "2017-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-08-10",
"First_Posted(Estimated)" : 2017-08-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-08-10",
"Last_Update_Posted(Estimated)" : 2024-10-29",
"Last_Verified" : 2024-10"
}
}} | #Study Description
Brief Summary
Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.
#Intervention
- OTHER : Measurement of external blood loss
- DIAGNOSTIC_TEST : Serum Hemoglobin concentration | #Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for elective urologic laparoscopy surgery.
Exclusion Criteria:
* Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
* Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
* Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT03249038 | 188,427 |
{
"NCT_ID" : "NCT01393340",
"Brief_Title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma",
"Official_title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma",
"Conditions" : ["Nasal Polyposis", "Asthma"],
"Interventions" : ["Drug: Placebo", "Drug: Omalizumab"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-10",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-07-07",
"First_Posted(Estimated)" : 2011-07-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-11",
"Last_Update_Posted(Estimated)" : 2011-07-13",
"Last_Verified" : 2011-07"
}
}} | #Study Description
Brief Summary
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation.
Study hypothesis
1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma.
2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis
3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps
#Intervention
- DRUG : Omalizumab
- Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection.
Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab.
- DRUG : Placebo
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Subjects must be at least 18 years, of either gender and any race.
* Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. Bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on CT-scan imaging and visible nasal polyps at endoscopy.
Subjects must have a diagnosis of asthma for more than 2 years. Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
* Clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
* Non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed Intra-Uterine Device (IUD); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. A monthly-control pregnancy test is requested.
* Male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
Exclusion Criteria:
* Women must not be pregnant, breast feeding, or premenarcheal.
* Patients younger than 18 years.
* Subjects with history of systemic reactions to the study medication.
* Subjects with prohibited medication at screening without full wash-out period.
* Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
* Subjects with cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome by history are excluded.
* Subjects must not have ever been diagnosed with a parasitic infection.
* Subjects must not have ever been diagnosed with cancer
* Subjects must not have a medical history of Human Immunodeficiency Virus (HIV) or hepatitis B or C. Testing will not be done at screening.
* Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
* Subjects must not have received specific immunotherapy within the previous three months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT01393340 | 65,078 |
{
"NCT_ID" : "NCT02184091",
"Brief_Title" : "Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine",
"Official_title" : "An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)",
"Conditions" : ["Renal Insufficiency", "Hepatic Insufficiency"],
"Interventions" : ["Drug: Nevirapine"],
"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)" : "1999-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "1999-07",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-07-08",
"First_Posted(Estimated)" : 2014-07-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-07-08",
"Last_Update_Posted(Estimated)" : 2014-07-14",
"Last_Verified" : 2014-07"
}
}} | #Study Description
Brief Summary
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients
#Intervention
- DRUG : Nevirapine | #Eligibility Criteria:
Inclusion Criteria:
* Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table
* For patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups:
* Group 1 (mild dysfunction) = 50 ml/min <= Creatinine Clearance (CLcr) < 80 ml/min
* Group 2 (moderate dysfunction) = 30 ml/min <= CLcr < 50 ml/min
* Group 3 (severe dysfunction) = CLcr < 30 ml/min and
* Group 4 = end-stage renal disease (ESRD) requiring dialysis
* For patients in the hepatic group
* Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
* clinically diagnosed with hepatic insufficiency and Class A or B liver disease according to Child-Pugh's Classification; subjects must have a Child-Pugh score of 5 <= age <= 9 points
* For patients in the normal group, i.e. normal with respect to hepatic and renal function
* matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history
* Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
* No abnormalities on clinical or laboratory evaluations
* Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception
* Patients who are able to provide written consent and comply with study requirements
Exclusion Criteria:
* Female patients who are pregnant or breast-feeding
* Seated systolic blood pressure either < 100 mmHg or > 150 mmHg and/or heart rate either < 50 beats/min or > 90 beats/min
* History of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject
* Patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation
* Patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug
* Significant electrocardiogram (ECG) abnormalities
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT02184091 | 46,930 |
{
"NCT_ID" : "NCT05575687",
"Brief_Title" : "Brain and Glycemic Responses to Sweet Soft Drinks",
"Official_title" : "Brain and Glycemic Responses to Soft Drinks With Different Sweeteners",
"Conditions" : ["Normal Physiological Response to Sweet Drinks"],
"Interventions" : ["Other: Monk fruit", "Other: Allulose + stevia", "Other: Sucrose", "Other: Water (reference)", "Other: Sucralose", "Other: Stevia"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-01-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-15",
"Study_Completion_Date(Actual)" : "2024-03-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-10-04",
"First_Posted(Estimated)" : 2022-10-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-10-07",
"Last_Update_Posted(Estimated)" : 2024-04-01",
"Last_Verified" : 2024-03"
}
}} | #Study Description
Brief Summary
The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years.
The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners.
Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).
Detailed Description
Rationale: The brain is crucial in the regulation of energy intake and maintaining homeostasis which is subserved by an interaction of homeostatic and reward-related brain areas. These brain areas integrate multiple neural and hormonal signals related to energy content such as sweet taste and food reward in the form of ingested energy. Sugar-sweetened soft drinks have been shown to contribute to overconsumption and obesity. Therefore, there is great consumer interest in drinks with low-caloric sweeteners because they do not contribute to energy intake while still providing the hedonic experience of sweet taste. However, different low-caloric sweeteners may have differential effects on the brain because of (subliminal) taste difference and their different metabolic fate. We hypothesize that the brain and glycemic responses to drinks sweetened with sugar and different low-caloric sweeteners will be different. This may have implications for their reward value.
Objective: To determine changes in brain activity in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners.
Study design: Randomized crossover design with six treatments. Study population: 30 healthy, non-smoking, normal-weight individuals, aged between 18 and 30 years.
Intervention: Participants will be scanned using MRI before and after consumption of six 500-ml drinks: water; water + sucrose; water + sucralose; water + stevia extract; water + allulose + stevia; water + monk fruit extract. Regional cerebral blood flow (rCBF) and resting state functional MRI (rsfMRI) scans will be made at baseline and at t=5 and t=30 min. Additionally, gastric emptying of the drinks will be examined through gastric MRI at t=15, 25 and 45 min. Blood samples will be collected to measure changes in insulin and glucose levels at baseline and at t=5, 15, 30, 45 and 60 min for all sweet treatments. Participants will rate their appetite and thirst at baseline and at t=15, 25, 30, 45 and 60 min.
#Intervention
- OTHER : Water (reference)
- Ingestion of 500 ml mineral water
- OTHER : Sucrose
- Ingestion of 500 ml of a flavored mineral water sweetened with sucrose
- OTHER : Sucralose
- Ingestion of 500 ml of a flavored mineral water sweetened with sucralose
- OTHER : Stevia
- Ingestion of 500 ml of a flavored mineral water sweetened with stevia extract
- OTHER : Monk fruit
- Ingestion of 500 ml of a flavored mineral water sweetened with monk fruit extract
- OTHER : Allulose + stevia
- Ingestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract | #Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 30 years
* BMI between 18.5 and 25 kg/m2
* Apparently healthy (self-reported)
* Right-handed (because brain responses may differ between right- and left handed individuals)
* Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having antecubital veins suitable for blood sampling via a catheter
* Willing to comply with the study procedures
* Willing to be informed about incidental findings of pathology and consenting to informing their general practitioner about this.
Exclusion Criteria:
* Having disturbances of glucose metabolism such as being prediabetic or diabetic
* Use of medication that could influence study results including insulin/metformin/proton pump inhibitors, antacids, anti-depressants
* Allergy or intolerance for any of the study products/compounds (sucrose, sucralose, stevia extract, allulose, monk fruit extract)
* Being a regular smoker (smoking more than one cigarette or e-cigarette with nicotin per day)
* Drinking more than 14 glasses of alcohol a week
* Having genetic, psychiatric or neurological diseases affecting the brain
* Gastric disorders or regular gastric complaints (more than once per week), for example heart burn
* Having renal or hepatic disease
* Using recreational drugs more than once per week (e.g. marihuana, XTC, GHB, laughing gas)
* Having given a blood donation in the past two months
* Being pregnant, lactating or planning on becoming pregnant during the study
* Currently following or having followed calorie-restricted diet in the past two months
* Participating in other research during the study period
* Not having a general practitioner
* Being an employee or student of the Division of Human Nutrition and Health
* Having a contra-indication to MRI scanning
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
| NCT05575687 | 217,327 |
{
"NCT_ID" : "NCT00781092",
"Brief_Title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes",
"Official_title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes",
"Conditions" : ["Dry Eye"],
"Interventions" : ["Other: Bausch and Lomb Sensitive Eyes", "Other: Systane Ultra"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-10",
"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" : 2008-10-27",
"First_Posted(Estimated)" : 2008-10-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-10-27",
"Last_Update_Posted(Estimated)" : 2012-09-20",
"Last_Verified" : 2012-09"
}
}} | #Study Description
Brief Summary
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Detailed Description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
#Intervention
- OTHER : Systane Ultra
- Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
- Other Names :
- Natural Tears
- OTHER : Bausch and Lomb Sensitive Eyes
- Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
- Other Names :
- Saline Solution | #Eligibility Criteria:
Inclusion Criteria:
* Subjects must be a suitable candidate for FDA Approved LASIK.
* Subjects must have a stable refraction as documented by previous clinical records.
* Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
* Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
* Subjects must be at least 18 years.
* Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
* Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
* Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
* Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
* Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
* Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
* Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>25 mm Hg in either eye.
* Subjects with macular pathology in either eye.
* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT00781092 | 74,892 |
{
"NCT_ID" : "NCT02700009",
"Brief_Title" : "Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care",
"Official_title" : "Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care",
"Conditions" : ["Depression"],
"Interventions" : ["Other: Treatment as Usual (TAU)", "Behavioral: Computer-assisted CBT (CCBT)"],
"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)" : "2016-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12",
"Study_Completion_Date(Actual)" : "2020-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-02-25",
"First_Posted(Estimated)" : 2016-03-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-01",
"Last_Update_Posted(Estimated)" : 2025-03-17",
"Last_Verified" : 2025-03"
}
}} | #Study Description
Brief Summary
Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of delivering therapy designed to be replicated and sustained in other primary care settings. Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients with depression to receive either computer-assisted cognitive-behavior therapy or treatment as usual.
Detailed Description
Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.
In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.
Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.
#Intervention
- BEHAVIORAL : Computer-assisted CBT (CCBT)
- Computer-assisted psychotherapy for depression using a computer program plus clinician support
- OTHER : Treatment as Usual (TAU)
- Ordinary treatment for depression in primary care setting | #Eligibility Criteria:
Inclusion Criteria:
* Patient Health Questionnaire score of 10 or above
* Age 18 or above
Exclusion Criteria:
* Refusal to provide informed consent
* Inability to read English text on computer screen
* Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
* Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
* Dementia or other organic brain disorders that would prevent participation in CCBT
* Diagnosis of any psychotic disorder or bipolar disorder.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT02700009 | 211,106 |
{
"NCT_ID" : "NCT04139811",
"Brief_Title" : "Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD",
"Official_title" : "Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment",
"Conditions" : ["Retinal Detachment"],
"Interventions" : ["Other: Pars Plana Vitrectomy"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-15",
"Study_Completion_Date(Actual)" : "2019-08-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-24",
"First_Posted(Estimated)" : 2019-10-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-10-23",
"Last_Update_Posted(Estimated)" : 2019-10-25",
"Last_Verified" : 2019-10"
}
}} | #Study Description
Brief Summary
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Detailed Description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
#Intervention
- OTHER : Pars Plana Vitrectomy
- vitrectomy with and without ILM peeling | #Eligibility Criteria:
Inclusion Criteria:
* All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
Exclusion Criteria:
* Complicated cases with advanced proliferative vitreoretinopathy (PVR).
* Patients with retinal vascular disorders and other macular disorders.
* Combined tractional and rhegmatogenous detachment.
* Previous retinal reattachment surgery or Intravitreal injections.
* Glaucomatous patients.
* Patients with corneal opacity which impairs good visualization.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT04139811 | 257,686 |
{
"NCT_ID" : "NCT04593095",
"Brief_Title" : "Nurturing and Quiet Intervention: NeuroN-QI",
"Official_title" : "Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial",
"Conditions" : ["Neurodevelopment"],
"Interventions" : ["Other: NeuroN-QI"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-01",
"Study_Completion_Date(Actual)" : "2024-06-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-08-25",
"First_Posted(Estimated)" : 2020-10-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-10-13",
"Last_Update_Posted(Estimated)" : 2025-03-20",
"Last_Verified" : 2023-11"
}
}} | #Study Description
Brief Summary
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.
#Intervention
- OTHER : NeuroN-QI
- SSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued. | #Eligibility Criteria:
Inclusion Criteria:
Infants:
* born between 26 and 316/7 WGA.
Mothers
* agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
* express breast milk for their infant;
* speak, read, or write French or English.
Nurses:
* have at least 6 months of work experience in a NICU;
* speak and read French or English.
Exclusion Criteria:
Infants:
* have birth defects or genetic disorders;
* have an intraventricular hemorrhage > grade II;
* receive nasal respiratory support;
* have been transferred from another hospital.
Mothers:
* are <18 years;
* had a multiparous birth;
* have a physical condition that does not allow SSC;
* abuse substances or alcohol;
* do not intend to breastfeed or give breastmilk.
Sex :
ALL
Ages :
- Minimum Age : 26 Weeks
- Maximum Age : 32 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT04593095 | 125,683 |
{
"NCT_ID" : "NCT05977010",
"Brief_Title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count",
"Official_title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count",
"Conditions" : ["HIV"],
"Location_Countries" : ["Indonesia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-01-10",
"Study_Completion_Date(Actual)" : "2018-01-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-01-11",
"First_Posted(Estimated)" : 2023-08-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-07-27",
"Last_Update_Posted(Estimated)" : 2023-08-04",
"Last_Verified" : 2023-07"
}
}} | #Study Description
Brief Summary
This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital. The participant will be interviewed and retrieved for their demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1 viral load examination using Xpert® HIV-1 Viral Load \[Cepheid\], in-house qRT-PCR, and REALTIME HIV-1 VIRAL LOAD \[Abbott\]
Detailed Description
Participant candidate will be screened at Tangerang District Hospital's outpatient and inpatient units. The purpose is to get various VL values from participants with various clinical conditions (light-heavy). If a participant is willing to participate and has signed the Informed Consent Form (ICF), he/she will be interviewed for demographic data and case history (age, gender, first HIV diagnosis). After that, the participant will be physically examined (height, weight, and vital signs). Other information, such as current HIV clinical stage, current ART regimen, Viral Load value (final and highest), and CD4 (final and lowest) are collected from participant's medical records.
The participant's blood will be drawn as much as 9 ml and will be processed to obtain plasma. Plasma will be aliquoted into 3 vials for VL test using 3 devices: 1 ml using Xpert HIV-1, 1 ml using PCR (Abbott) at Dharmais Hospital, and 1 ml or leftover plasma using PCR (ABI7500) at INA-RESPOND's reference laboratory. The process follows the manufacturer's manual or the standard of sample preparation procedure and the operation of the devices at each hospital.
The result of viral load measurement will be informed to the participant via the attending physician during the participant's routine HIV treatment visit to the hospital.
| #Eligibility Criteria:
Inclusion Criteria:
* HIV positive patient by the HIV Diagnoses Guideline in the Tangerang District Hospital.
* Patient older than 18 years and above.
* Willing and signed the informed consent (ICF).
* Willing to comply with the study procedures.
Exclusion Criteria:
* Suffered from a disease or having condition that could complicated the blood drawing process or increasing the risk of disease complications.
* Currently imprisoned.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT05977010 | 8,125 |
{
"NCT_ID" : "NCT05433233",
"Brief_Title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension",
"Official_title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension",
"Conditions" : ["Hypertension", "Aging"],
"Interventions" : ["Behavioral: Walking", "Other: HAPA Behavior Change Counseling"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-09-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-22",
"Study_Completion_Date(Actual)" : "2021-03-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-06-21",
"First_Posted(Estimated)" : 2022-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-21",
"Last_Update_Posted(Estimated)" : 2022-06-30",
"Last_Verified" : 2022-06"
}
}} | #Study Description
Brief Summary
Eight out of ten older adults have hypertension in the US, which is a strong risk factor for cardiovascular events. To manage hypertension, regular and structured exercise is effective and strongly recommended regardless of drug therapy. However, structured exercise is often performed in a health club, could be difficult, and warrants caution in older adults with chronic conditions. In contrast, the most common lifestyle physical activity in older adults is walking, which is inexpensive, easy, and safe. Recent technological advancement in activity monitoring provides reliable step counts and promotes lifestyle walking. Although one of the most popular public health goals is walking 10,000 steps/day, recent studies found that it is unrealistic and difficult to achieve. Further, there is very little evidence whether walking 10,000 steps/day is effective, specifically in older adults with hypertension. Walking 3,000 extra steps/day 5 days/week is equivalent to meeting the current aerobic physical activity guidelines, as it takes about 30 minutes each day, and is more realistic and achievable. Steps/day is easy to understand and captures most physical activities in older adults. However, there are no specific guidelines about how many daily steps are needed for older adults in the current physical activity guidelines. Thus, this project is aimed to provide pilot data to answer a simple, but unknown, question about physical activity in older adults: 'Can increasing lifestyle walking in older adults with hypertension reduce blood pressure? And can older adults maintain a lifestyle walking intervention on their own?'. This project will significantly contribute to developing more effective and easy physical activity guidelines for older adults.
Detailed Description
All participants will be prescribed a step goal to increase their walking by 3,000 steps/day on 5 days/week for 20 weeks. During the first 10 weeks, support will be provided by research personnel to actively help obtain these goals. During weeks 11-20, participants will be in a self-maintenance phase where no research personnel assistance will be provided to help maintain the extra walking. Participants will log their steps every day during the 20-weeks from a pedometer that they will wear daily. Participants will assess blood pressure and weight at baseline, 10 and 20 weeks.
#Intervention
- BEHAVIORAL : Walking
- Participants will perform 3,000 additional steps/day on 5 days/week.
- OTHER : HAPA Behavior Change Counseling
- Structured dialogue for initiating behavior change. | #Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 65+
* Systolic/diastolic blood pressure of 130 <= age <= 159/80 <= age <= 99 mmHg. Participants will be allowed to be on blood pressure medication.
* Body mass index of 25 <= age <= 40 kg/m2
* Non-smokers
* Sedentary/inactive individuals: not meeting the current aerobic physical activity guidelines of 150 minutes per week over the past 3 months
* Baseline average daily step count <8,000 steps
Exclusion Criteria:
* Any significant mobility limitation because our intervention requires an increase in 3,000 steps per day, which needs to be achievable by the participant.
* A stroke, myocardial infarction (heart attack) or cancer diagnosis within the last 6 months.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT05433233 | 230,127 |
{
"NCT_ID" : "NCT00165542",
"Brief_Title" : "A-protein Levels in Adult and Pediatric Brain Tumor Patients",
"Official_title" : "Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients",
"Conditions" : ["Malignant Childhood Central Nervous System Neoplasm"],
"Interventions" : ["Other: A PROTEIN level"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1998-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-02",
"Study_Completion_Date(Actual)" : "2009-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-12",
"First_Posted(Estimated)" : 2005-09-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-12",
"Last_Update_Posted(Estimated)" : 2016-11-23",
"Last_Verified" : 2016-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to evaluate the sensitivity and specificity of 'A-PROTEIN' levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated with the underlying diagnosis and outcome.
Detailed Description
* Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist.
* Blood or cerebrospinal fluid will be collected for this study only when they are being collected for other reasons before and after each surgery. Samples will also be collected after any event such as significant change in symptoms or radiographic progression.
* Once the patients condition has been stabilized, samples will be take at regular intervals of \>= 1 month. The duration of this study is 24 months.
#Intervention
- OTHER : A PROTEIN level | #Eligibility Criteria:
Inclusion Criteria:
* All patients with possible malignant or benign lesions of the central nervous system will be included.
* There are no restrictions with respect to treatment protocols or prior therapy.
* Patients will be identified after presentation to the neurosurgical, neurological or oncologic services at participating centers. Any patient with evidence of a central nervous system tumor will be eligible. Individuals without evidence of CNS tumors are also eligible, in order to provide blinded controls.
* A signed informed consent will be requested and required for participation.
* There is no age, sex, or ethnic origin restrictions in this protocol. Patients who choose not to participate in the study will continue to have their regular care as defined by their treating team. Patients who speak foreign languages are eligible as long a translator can be found to ensure proper consent has been obtained.
Exclusion Criteria: There are no exclusion criteria for this study.
Sex :
ALL
Ages :
- Maximum Age : 77 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00165542 | 203,285 |
{
"NCT_ID" : "NCT05433519",
"Brief_Title" : "Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age",
"Official_title" : "Z 32104 - Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age",
"Conditions" : ["Gestational Age", "Machine Learning", "Pregnancy Related"],
"Location_Countries" : ["United States", "Zambia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-07-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-31",
"Study_Completion_Date(Actual)" : "2023-11-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-06-21",
"First_Posted(Estimated)" : 2022-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-21",
"Last_Update_Posted(Estimated)" : 2024-05-08",
"Last_Verified" : 2023-12"
}
}} | #Study Description
Brief Summary
This is a prospective cohort study of women enrolled early in pregnancy, with randomization to determine the timing of three follow-up visits in the second and third trimester. At each of these follow-up visits, investigators will assess gestational age with the FAMLI technology and compare that estimate to the known gestational age established early in pregnancy.
Detailed Description
The primary purpose of this research is to assess the diagnostic accuracy of the FAMLI Technology, a novel machine learning-based tool for gestational age assessment that can run on a smart phone or tablet. Study staff will enroll 400 pregnant volunteers prior to 14 completed gestational weeks and obtain accurate 'ground truth' gestational age dating with standard ultrasound biometry, using the crown-rump length. These participants will then be asked to return for three follow-up visits, which will include a routine sonogram performed by a trained sonographer and the collection of a set of blind sweep cineloop videos using a low-cost, battery-operated device. The research will be conducted in Chapel Hill, North Carolina (at the University of North Carolina Hospital and/or sites associated with UNC OBGYN) and in Lusaka, Zambia (at the University Teaching Hospital or Kamwala District Health Centre). Approximately equal numbers of participants will be enrolled from each country.
| #Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* viable intrauterine pregnancy at less than 14 0/7 weeks of gestation
* ability and willingness to provide written informed consent
* intent to remain in current geographical area of residence for the duration of study
* willingness to adhere to study procedures
Exclusion criteria:
* maternal body mass index = 40 kg/m^2
* multiple gestation (i.e., twins or higher order)
* major fetal malformation or anomaly
* any other condition (social or medical) that, in the opinion of the study staff, would make study participation unsafe or complicate data interpretation.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05433519 | 189,490 |
{
"NCT_ID" : "NCT04068961",
"Brief_Title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism",
"Official_title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism",
"Conditions" : ["Oculocutaneous Albinism", "Mutation"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-09-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-10-31",
"Study_Completion_Date(Actual)" : "2010-10-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-08-22",
"First_Posted(Estimated)" : 2019-08-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-08-22",
"Last_Update_Posted(Estimated)" : 2019-08-28",
"Last_Verified" : 2019-08"
}
}} | #Study Description
Brief Summary
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.
Detailed Description
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.
.
#Intervention
- OTHER : Genetic analyzes
- Analysis by CGH array, homozygotic cartography and candidate gene sequencing | #Eligibility Criteria:
Inclusion Criteria:
*Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes)
Exclusion Criteria:
None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04068961 | 235,973 |
{
"NCT_ID" : "NCT03714100",
"Brief_Title" : "Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia",
"Official_title" : "Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older Adults in West Virginia",
"Conditions" : ["Accidental Falls"],
"Interventions" : ["Behavioral: Tai Ji Quan: Moving for Better Balance"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-31",
"Study_Completion_Date(Actual)" : "2020-01-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-10-11",
"First_Posted(Estimated)" : 2018-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-10-18",
"Last_Update_Posted(Estimated)" : 2020-10-14",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
Detailed Description
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, CDC-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others. We recently completed a CDC-funded study which successfully translated a 16-week TJQMBB intervention into 20 faith-based organizations in 7 rural WV counties. In the maintenance phase of the study (i.e., post intervention), only 38% of classes continued despite the fact that 87% of participants expressed a desire to continue. The rate limiting factor for continuing classes in these rural areas was lack of instructors. Thus, there is a vital need to further translate TJQMBB into practice using alternative delivery channels to increase the reach and maintenance of the program, especially in rural areas where instructors are less available.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
The purpose of this translational study is to work with our injury control, technology, and wellness partners to: 1) implement a 16-week intervention of the tele-TJQMBB classes in 120 older adults at 12 community sites in 4 WV counties; 2) describe functional, self-reported, and fall/injury outcomes; and 3) evaluate the translation of tele-TJQMBB with respect to its Reach into the target population (number of participants), Effectiveness (participant outcomes), Adoption (number of sites, instructors, classes), Implementation (fidelity ratings), and Maintenance (satisfaction, continued participation) using the Re-aim Framework. Demonstrating that tele-TJQMBB is effective would provide an additional delivery channel for the program, help overcome the barrier of identifying instructors in rural areas, and in the future, allow for the number of classes to be expanded to reach more older adults, provide more community-based programs in which to refer older adults to, and enhance overall maintenance of the program. To our knowledge, this is the first study to translate an evidence-based, group, fall-prevention exercise program using an alternative delivery method in a priority population, and thus, may serve as a model for reaching other underserved older adults.
#Intervention
- BEHAVIORAL : Tai Ji Quan: Moving for Better Balance
- Participants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
- Other Names :
- Tai Chi, Physical Activity, Exercise | #Eligibility Criteria:
Inclusion Criteria:
* Adults age 55 and older
* Community-dwelling
* Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks
* Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week after the classes end)
* Able to walk at least 2 city blocks with or without an assistive device
Exclusion Criteria:
* Lack reliable transportation
* Unable to speak English
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT03714100 | 256,806 |
{
"NCT_ID" : "NCT03583060",
"Brief_Title" : "Interoceptive Engagement",
"Official_title" : "Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison",
"Conditions" : ["Stress"],
"Interventions" : ["Behavioral: Mindful Awareness in body-oriented therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11-01",
"Study_Completion_Date(Actual)" : "2018-11-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-26",
"First_Posted(Estimated)" : 2018-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-09",
"Last_Update_Posted(Estimated)" : 2020-05-13",
"Last_Verified" : 2020-05"
}
}} | #Study Description
Brief Summary
The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.
#Intervention
- BEHAVIORAL : Mindful Awareness in body-oriented therapy
- teaches interoceptive awareness skills for self care | #Eligibility Criteria:
Inclusion Criteria:
* adult (over 18)
* Perceived Stress Scale scores indicating moderate stress levels
* naive to mindfulness-based approaches (no prior experience)
* agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)
* fluent in English
* can attend MABT and assessment sessions
* right-handed (for uniformity of neuroimaging results)
Exclusion Criteria:
* lifetime diagnosis of mental health disorder
* unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)
* cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent
* use of medications in the past 30 days that affect hemodynamic response
* lifetime head injuries or loss of consciousness longer than 5 min
* currently pregnant
* contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT03583060 | 79,240 |
{
"NCT_ID" : "NCT00210470",
"Brief_Title" : "A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer",
"Official_title" : "A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck",
"Conditions" : ["Squamous Cell Carcinoma of the Head and Neck"],
"Interventions" : ["Drug: Indomethacin", "Drug: Cyclophosphamide", "Biological: IRX-2", "Drug: Omeprazole", "Drug: Zinc"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-12",
"Study_Completion_Date(Actual)" : "2012-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Submitted_that_Met_QC_Criteria" : 2012-01-06",
"First_Posted(Estimated)" : 2005-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2020-12-11",
"Last_Verified" : 2020-12"
}
}} | #Study Description
Brief Summary
This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
Detailed Description
IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.
The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.
#Intervention
- BIOLOGICAL : IRX-2
- IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
- DRUG : Cyclophosphamide
- Single i.v. injection of low-dose (300 mg/m2) on Day 1
- Other Names :
- Cytoxan, cyclophosphane
- DRUG : Indomethacin
- 21 days of oral indomethacin, 25 mg. 3 times daily
- Other Names :
- Indocin, Indocid
- DRUG : Zinc
- 21 days of zinc gluconate (65 mg) as part of an oral multivitamin
- Other Names :
- zinc gluconate
- DRUG : Omeprazole
- 21 days of 20 mg. orally
- Other Names :
- Prilosec | #Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
* No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
* Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
* Life Expectancy of greater than 6 months
Exclusion Criteria:
* Stage IVB Squamous Cell Carcinoma
* Use of any investigational agent within the previous 30 days
* Uncontrolled cardiovascular disease
* Myocardial infarction within the last 3 months
* Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
* Positive for hepatitis B or C or HIV
* Evidence of distant metastases
* Clinical gastritis or peptic ulcer within the last 6 months
* Stroke within the last six months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT00210470 | 164,018 |
{
"NCT_ID" : "NCT01972711",
"Brief_Title" : "Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics",
"Official_title" : "A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and Female Volunteers With High or Low Schizotype Characteristics.",
"Conditions" : ["Schizophrenia"],
"Interventions" : ["Drug: Placebo", "Drug: Amisulpride", "Drug: SEP-363856"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07",
"Study_Completion_Date(Actual)" : "2015-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-10-24",
"First_Posted(Estimated)" : 2013-10-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-24",
"Last_Update_Posted(Estimated)" : 2024-06-26",
"Last_Verified" : 2024-06"
}
}} | #Study Description
Brief Summary
This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.
Detailed Description
The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low schizotype characteristics.
#Intervention
- DRUG : SEP-363856
- SEP-36385625 as a single oral dose of 50 mg
- DRUG : Amisulpride
- Amisulpride as a single oral dose of 400 mg
- DRUG : Placebo
- single oral dose placebo | #Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 <= age <= 45, inclusive, at Day 1.
* Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Subject must be normotensive with sitting (5 minutes) blood pressure between the range of 90 to 150 mm Hg systolic, inclusive, and 60 to 90 mm Hg diastolic, inclusive, at Screening.
* Subject must have sitting (5 minutes) heart rate >= 50 beats per minute at Screening.
* Subject must agree to use one of the following birth control/contraception methods from Screening until 90 days after receiving study drug.
* Female subject of child bearing potential (<= 65 years) should be surgically sterile or abstinent or, if sexually active, must use an adequate method of contraception in addition to their partner(s) using a barrier method.
* Male subject with female partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child and use barrier contraception, in addition to their female partner(s) using another method.
* Male subject must not donate sperm.
* Acceptable forms of contraception are as follows:
* Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or pessary.
* Non-hormone containing intrauterine methods: intrauterine devices or systems.
* Other: prescription oral contraceptives, contraceptive injections, contraceptive implant, contraceptive vaginal ring, hormonal intrauterine device, double-barrier method, contraceptive patch, or male partner sterilisation.
* Subject must have normal ECG results, including QTcF < 450msec (for men) or < 470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR0.33) at Screening.
* Subject must be a completely fluent English speaker who, in the opinion of the Investigator, is capable of completing the fMRI and behavioural tasks.
* Subject must be right-handed.
* Subject must have acceptable weight as defined by BMI (weight [kg]/height [m]²) range of 18 to 35 kg/m², inclusive at Screening.
* Subject must be a non-smoker or light smoker (<= 10 cigarettes per day).
* Subject must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Subject in the low schizotypy group must have an SPQ score < 10 at Screening.
* Subject in the high schizotypy group must have an SPQ score >43 at Screening
Exclusion Criteria:
* Subject with a history of alcohol or substance dependence within the last 12 months from Screening.
* Subject with a positive urine drug screen at Screening or Day 1. One re-test within 1 to 3 days is permitted if positive result is believed to be due to licenced opiate-based medication or ingestion of poppy seeds. In this event, re-test result will be used for assessing entry criterion and must be completed prior to randomisation.
* Subject with a positive alcohol breath test at Screening or Day 1.
* Female subject with a positive pregnancy test at Screening or Day 1.
* Female subject currently pregnant or trying to get pregnant or currently breast feeding.
* Subject who consumes large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks (tea, instant coffee) or 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day).
* Subject with a relevant history, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures.
* Subject with a history of cancer, except for basal cell or Stage 1 squamous cell carcinoma of the skin which has been in remission for at least 5 years prior to Day 1.
* Subject meets the diagnostic criteria for schizophrenia, or any other psychotic disorder, as determined by the SCID-I at Screening
* Subject with a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
* Subject with a history of positive HIV test.
* Subject with a history of, or current condition of, migraine headaches or has undergone operations to the head.
* Subject with a significant hearing impairment which, in the opinion of the Investigator, may interfere with the performance of the behavioural tasks or fMRI tasks.
* Subject with a significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which in the opinion of the Investigator may interfere with the performance of the behavioural tasks or fMRI tasks.
* Subject received prescribed medication within 28 days prior to Day 1 (apart from the contraceptive pill). Subjects who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
* Subject received non-prescription medication, including supplements such as vitamins and herbal supplements within 48 hours prior to Day 1 (apart from paracetamol). Subjects who have taken non-prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
* Subject received an experimental drug and / or used an experimental medical device within 30 days of randomisation or within a period less than 5 times the drug's half-life, whichever is longer.
* Subject with a known hypersensitivity to SEP-363856 or amisulpride or any of their excipients.
* Subject with a history of severe drug allergy or hypersensitivity.
* Subject who is unable or unwilling to comply with study procedures, including study prohibitions and restrictions (see Section 10.2, Concomitant Medications and Section 10.3, Restrictions).
* Subject with previous experience with the ETB.
* Subject with a diagnosis of dyslexia.
* Subject with a history of claustrophobia or inability to tolerate scanner environment.
* Subject who fulfills any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
* Subject with a clinically relevant structural brain abnormality as determined by prior MRI scan.
* Subject with planned medical treatment within the study period that might interfere with the study procedures.
* Subject who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
* Subject is a staff member or the relative of a staff member, or is in a subordinate relationship with the Investigator.
* Subject answers 'yes' to 'Suicidal Ideation' Items 4 or 5 on the C-SSRS.
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
| NCT01972711 | 228,836 |
{
"NCT_ID" : "NCT01447485",
"Brief_Title" : "Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients",
"Official_title" : "A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age",
"Conditions" : ["Hypertension", "Chronic Kidney Disease", "Nephrotic Syndrome"],
"Interventions" : ["Drug: Valsartan (VAL489)"],
"Location_Countries" : ["Japan"],
"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)" : "2011-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-10",
"Study_Completion_Date(Actual)" : "2011-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-08-31",
"First_Posted(Estimated)" : 2011-10-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-10-05",
"Last_Update_Posted(Estimated)" : 2020-12-21",
"Last_Verified" : 2012-05"
}
}} | #Study Description
Brief Summary
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
#Intervention
- DRUG : Valsartan (VAL489) | #Eligibility Criteria:
Inclusion Criteria:
* Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion Criteria:
* GFR < 30 mL/min/1.73 m2
* Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
* Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01447485 | 207,057 |
{
"NCT_ID" : "NCT02551341",
"Brief_Title" : "Lung Protective Ventilation During Robotic Assisted Prostatectomy",
"Official_title" : "Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Hormones, Biomarkers of Nephrotoxicity and Haemodynamics in Patients Undergoing Robot-assisted Radical Prostatectomy",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Procedure: higher PEEP ventilation"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01",
"Study_Completion_Date(Actual)" : "2017-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-09-13",
"First_Posted(Estimated)" : 2015-09-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-15",
"Last_Update_Posted(Estimated)" : 2018-11-16",
"Last_Verified" : 2018-11"
}
}} | #Study Description
Brief Summary
Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assisted robotic radical prostatectomy
Detailed Description
Protocol Summary
Purpose:
The project will investigate whether a suspected lung protective ventilator therapy in connection with surgery for cancer of the prostate (prostate) have a relevant beneficial effects on lung function, renal function and circulation associated with keyhole surgery performed with surgical robot.
Trial method:
The trial is a randomized study (randomized controlled trials), which are drawn between normal and a suspected lung protective ventilator treatment in connection with the surgical removal of the prostate due to Cancers. Before the operation, collected urine and blood samples and that a study of lung function and circulation as a starting point. During the operation, and in the following two days collected urine and blood samples. Prepare Furthermore, new studies of lung function and circulation. Blood tests and lung function studied also in outpatient control about 1 week after surgery.
The two groups of patients (for respectively normal respiratory therapy and suspected lung protective) compared subsequent terms. Impact on lung function, renal function and circulation as well as the number and severity of any complications compared to assess whether the suspected lung protective ventilator therapy is safe and provides adequate beneficial effect to introduce as standard in the future.
Tissue sampling used in the form of blood tests or urine tests MHP research biobank in the experiment. This tissue will be used for analyzes in the specific project and the tissue will be destroyed after current guidelines for project completion.
Side effects and risks:
There are at every blood sampling a small risk of infection and bleeding. Using standard sterile technique. Blood volume removed by blood tests is max of 250 ml in total. Removing this amount of blood does not entail health risks in patients. There may be discomfort around the injection site, the needle drop is wrong in the arm, but using standard sterile technique and dropped down by experienced personnel. Blood samples for the experiment performed during routine blood sampling equipment as specified in the department's instructions.
For lung studies will in some cases could be detected a certain constriction of the small branches of the airways (bronchi). To determine whether this is a condition may require treatment given ally a spray to suck, which aims to expand the branches in order to improve lung function. This medication can cause slight transient dizziness and palpitations.
Disadvantages:
The additional lung examinations in the study will attempt established in connection with the patient's usual attendance and stay at the hospital to avoid extra visits. There must be calculated some extra time spent for outpatient visits in connection with participation in the trial. There is no economic disadvantages associated with the trial for the patient.
Economic conditions:
There is no economic disadvantages associated with the trial for the patient. Funding for the project will be done through a joint financing by the Urology Department D, Department of Anesthesiology and University Clinic for Kidney disease and high blood pressure, Hospital West and Aarhus University. Research funds will be sought from public and private funds.
Publication of trial results:
The results, both positive and negative findings, will be made published in internationally recognized scientific journal anonymously with no personally identifiable data.
Research Ethics statement:
The project reported to the Ethical Science Council at the Central Denmark Region. Database for the project must be approved by the Data Protection Agency by Region of Central. The project is started only after the approval of these two bodies. The project will comply with applicable GCP rules.
Recruitment of participants:
First contacting the patient about the project via the operator, Urology Department, at the information interview on operation. If the patient wants to get further information about the project handed out written information and project manager contacted.
The written information consists of: Participant Information, consent form, 'Information for subjects' and 'Your Rights as a test subject in a biomedical research.' The patient is informed both in writing and orally on the right and the opportunity to bring legal counsel to informed consent.
The project manager or his representative hold subsequent information interview about 7 days before surgery. This will last approximately 30 minutes. Information being conducted in consultation room at the clinic, where there is no other activity in the allocated room during the interview.
The anesthesia controller or his deputy hold right now usual anesthesia monitoring and ensuring written consent.
At the oral information, patients will be informed that there is a request to participate in a biomedical research. Patients are informed acc. the guidelines in 'Guidelines for review, etc. of a biomedical research for the ethics committee system 'from the Central Scientific Ethical Committee. Information is provided for the experiment, as listed in Annex 1 'Information for volunteers.' The subjects, who wish to participate are advised that, if they wish, can get consideration before submitting their written consent to participate in research is voluntary, and that they will always be able to draw a committed participation back .
The subjects were informed that they will receive information on the results achieved by research reporting on the project if they are interested in this.
Written informed consent given to the project manager or the anesthetic consultant or his deputy in the project in connection with the information interview, journal recording and anesthesia monitoring. The subjects signed concent- and proxy statement, which is kept by the Data Protection Agency guidelines. A copy provided to the subject.
#Intervention
- PROCEDURE : higher PEEP ventilation | #Eligibility Criteria:
Inclusion Criteria:
* Age> 18 years
* Men
* Indication for robot-assisted radical prostatectomy acc. the department's instructions
Exclusion Criteria:
* Lack of desire to participate
* EGFR <15 ml / min
* BMI> 35 kg / m2
* Former lung surgery
* Known requiring treatment lung disease
* Known heart disease svt NYHA Class III or higher
* Recent AMI within 12 months
* Known neuromuscular disease
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT02551341 | 131,313 |
{
"NCT_ID" : "NCT02579954",
"Brief_Title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension",
"Official_title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Interventions" : ["Behavioral: Rehabilitation"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-08-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-05",
"Study_Completion_Date(Actual)" : "2024-01-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-15",
"First_Posted(Estimated)" : 2015-10-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-19",
"Last_Update_Posted(Estimated)" : 2024-06-25",
"Last_Verified" : 2024-06"
}
}} | #Study Description
Brief Summary
Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.
#Intervention
- BEHAVIORAL : Rehabilitation
- Other Names :
- Supervised rehabilitation | #Eligibility Criteria:
Inclusion Criteria:
* Adult patients
* Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
* Prevalent cases of pulmonary artery hypertension (>= 6 months) confirmed by right heart catheterism,
* Stable for at least 3 months,
* Written consent.
Exclusion Criteria:
* Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
* Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT02579954 | 276,317 |
{
"NCT_ID" : "NCT03154957",
"Brief_Title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path",
"Official_title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path",
"Conditions" : ["Shoulder Dislocation"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-07",
"Study_Completion_Date(Actual)" : "2017-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-05-11",
"First_Posted(Estimated)" : 2017-05-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-14",
"Last_Update_Posted(Estimated)" : 2020-01-30",
"Last_Verified" : 2017-05"
}
}} | #Study Description
Brief Summary
The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients
| #Eligibility Criteria:
Inclusion Criteria:
* Adult patient consulting for acute shoulder dislocation
Exclusion Criteria:
* Patient refusing to participate in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT03154957 | 57,856 |
{
"NCT_ID" : "NCT04633668",
"Brief_Title" : "Impact of Cognitive Behavioral Therapy on Parasomnias",
"Official_title" : "Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias",
"Conditions" : ["Parasomnia"],
"Interventions" : ["Behavioral: Self-Monitoring", "Behavioral: CBT for parasomnias (CBT-p)"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-30",
"Study_Completion_Date(Actual)" : "2022-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-06",
"First_Posted(Estimated)" : 2020-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-11-12",
"Last_Update_Posted(Estimated)" : 2022-05-17",
"Last_Verified" : 2022-05"
}
}} | #Study Description
Brief Summary
This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities).
Detailed Description
Sleep wake disorders are prevalent and impactful conditions often poorly assessed and sub-optimally treated in the clinical setting. Undiagnosed sleep disorders can masquerade as mental health conditions and worsen the outcomes associated with these conditions. Further, sleep disorders can develop from mental health conditions and the reverse is also true (particularly for mood disorders). Successful treatment of sleep disorders requires a targeted approach.
Parasomnias are unwanted physical or mental events that occur during sleep or during arousal from sleep. The states of wakefulness, NREM, and REM are normally distinct and occur in an organized and predictable pattern over the 24-hour period. However, in parasomnias, aspects of more than one state co-occur and intermix. There are four types of parasomnias identified by the Diagnostic and Statistical Manual of Mental Disorders ( DSM 5). These include two NREM parasomnias: sleepwalking and sleep terrors, and two REM parasomnias: nightmare disorder and REM sleep behaviour disorder (RSBD). Lifetime prevalence of these conditions ranges from 6.9% (sleepwalking) to 67% (nightmare disorder).
In general, NREM parasomnia events are primed by conditions that increase sleep pressure and triggered by sleep-disrupting factors. They are more likely to occur following sleep restriction or deprivation, when SWS rebounds. Immediate triggers of sleepwalking in adults are sleep disruptions associated with sleep-disordered breathing, periodic limb movements, noises and touch. Pilon et al. induced episodes in adult sleepwalkers, but not in non-sleepwalkers, with specific auditory stimuli and this effect was accentuated under conditions of prior sleep deprivation.
Currently accepted interventions for parasomnias include pharmacological and psychological treatments. Pharmacological interventions involve the use of sedating medications (benzodiazepines, tricyclic antidepressants) or alpha-1 blocker (Prazosin).
Cognitive Behavioral Therapy. Psychological treatments primarily rely on cognitive behavioral therapy to achieve better sleep hygiene, reduced hyperarousal, and to teach the ability to practice with reducing cognitive arousal during the sleep period through planned rehearsal and scheduled awakenings. There are no well elaborated and systematic treatment packages for Non-REM parasomnias and so this protocol will represent an innovation in this area. Therefore, the purpose of the study is to develop and test such a package.
Self-Monitoring of Sleep. Self-monitoring of disturbed sleep has been shown to produce small but significant positive impacts on some aspects of sleep (e.g., insomnia). As there is no widely accepted placebo for parasomnia treatment, this is viewed as an adequate control condition.
Objectives This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities). The hypotheses of the study are that participants who receive a 6-week program CBT-p therapy will report fewer episodes of parasomnia than those who self-monitor their sleep for 6 weeks, and will have objectively better sleep as measured by the prodigy and actigraphy at one-week (T2) post treatment and at two months post treatment (T3).
METHODS Trial Design This will be a single-blind randomized controlled trial with two conditions.
#Intervention
- BEHAVIORAL : CBT for parasomnias (CBT-p)
- Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks
- BEHAVIORAL : Self-Monitoring
- Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks | #Eligibility Criteria:
Inclusion Criteria:
* DSM 5 Parasomnia Disorder
* at least one parasomnia event per week
* daytime fatigue or sleepiness
* 6 months in duration
Exclusion Criteria:
* current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
* for participants taking benzodiazepines or Prazosin, a stable dose regime for the past 4 weeks,
* excessive alcohol consumption defined as the consumption of > 10 alcoholic beverages per week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT04633668 | 62,733 |
{
"NCT_ID" : "NCT04016480",
"Brief_Title" : "HFNC During Bronchoscopy for Bronchoalveolar Lavage",
"Official_title" : "High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage",
"Conditions" : ["Acute Respiratory Failure", "Bronchoscopy", "Bronchoalveolar Lavage"],
"Interventions" : ["Device: High Flow Nasal Cannula", "Device: Conventional Oxygen Therapy"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-09-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02-28",
"Study_Completion_Date(Actual)" : "2020-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-07-02",
"First_Posted(Estimated)" : 2019-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-07-09",
"Last_Update_Posted(Estimated)" : 2020-12-04",
"Last_Verified" : 2020-12"
}
}} | #Study Description
Brief Summary
The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia.
Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography).
Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.
Detailed Description
Patients with Acute Respiratory Failure may sometimes require a bronchial endoscopy for broncho-alveolar lavage (BAL).
During the procedure, hypoxemia may worsen and oxygen may be require to avoid desaturation.
In the recent years, High-Flow through Nasal Cannula (HFNC) has been introduced in the clinical practice. HFNC delivers to the patient heated humidified air-oxygen mixture, with an inspiratory fraction of oxygen (FiO2) ranging from 21 to 100% and a flow up to 60 L/min through a large bore nasal cannula.
HFNC has some potential advantages. First of all, HFNC provides heated (37°C) and humidified (44 mg/L) air-oxygen admixture to the patient, which avoids injuries to ciliary motion, reduces the inflammatory responses associated to dry and cold gases, epithelial cell cilia damage, and airway water loss, and keeps unmodified the water content of the bronchial secretions. Second, HFNC determines a wash out from carbon dioxide of the pharyngeal dead space. Third, HFNC generates small amount (up to 8 cmH2O) of pharyngeal pressure during expiration, which drops to zero during inspiration. Fourth, HFNC guarantees a more stable FiO2, as compared to conventional oxygen therapy. Whenever the inspiratory peak flow of a patient exceeds the flow provided by a Venturi mask, the patient inhaled also part of atmospheric air.
Electrical impedance tomography (EIT) is a noninvasive imaging technique providing instantaneous monitoring of variations in overall lung volume and regional distribution of ventilation, as determined by variations over time in intrathoracic impedance, which is increased by air and reduced by fluids and cells. EIT allows determining changes in end-expiratory lung impedance (EELI), a surrogate estimate of end-expiratory lung volume, assessing global and regional distribution of Vt, and obtaining indexes of spatial distribution of ventilation.
Diaphragm ultrasound is a bedside, radiation free technique to assess the contractility of the diaphragm and the respiratory effort.
In this study investigators aim to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula in terms of respiratory effort (as assessed through diaphragm ultrasound), lung aeration and ventilation distribution (as assessed with EIT) and arterial blood gases.
#Intervention
- DEVICE : High Flow Nasal Cannula
- High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
- DEVICE : Conventional Oxygen Therapy
- Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94% | #Eligibility Criteria:
Inclusion Criteria:
* need for bronchial endoscopy for bronchoalveolar lavage
Exclusion Criteria:
* life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
* need for invasive or non invasive ventilation
* presence of pneumothorax or pulmonary enphisema or bullae
* recent (within 1 week) thoracic surgery
* presence of chest burns
* presence of tracheostomy
* pregnancy
* nasal or nasopharyngeal diseases
* dementia
* lack of consent or its withdrawal
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT04016480 | 50,905 |
{
"NCT_ID" : "NCT06478654",
"Brief_Title" : "Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries",
"Official_title" : "Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperative Analgesia for Aesthetic Breast Surgeries",
"Conditions" : ["Postoperative Pain"],
"Interventions" : ["Procedure: Bilateral Modified Pectoral Nerve Block (PECS II).", "Procedure: Bilateral Thoracic Erector spinae plane block (ESPB)."],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-09-01",
"Study_Completion_Date(Actual)" : "2024-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-06-23",
"First_Posted(Estimated)" : 2024-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-06-26",
"Last_Update_Posted(Estimated)" : 2024-12-03",
"Last_Verified" : 2024-02"
}
}} | #Study Description
Brief Summary
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.
Detailed Description
Preoperative settings:
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale (NRS) and its interpretation.
Intravenous access will be inserted, premedication with midazolam 3 mg will be done. On arrival to operating room, routine monitoring including electrocardiography (ECG), non-invasive arterial blood pressure(NIBP) and pulse oximetry will be used. The mean arterial blood pressure (MAP)and heart rate (HR) will be recorded before induction of general anaesthesia (baseline).
Intraoperative \& postoperative settings :
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done. Patient inductions by Propofol (2 mg/kg), Atracurium 0.5 mg/kg and Fentanyl 1 µg/kg. Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram. Anaesthesia will be maintained with Isoflurane 1,5 to 2 vol%. Patient will be given 50% oxygen/air mixture, and Incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. The depth of anaesthesia will be adjusted to keep changes of hemodynamics; (MAP) and (HR); within the range of ±20% of the baseline.
Under complete aseptic conditions, The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks.
The blocks will be performed with a 20gauge, echogenic needle (Pajunk, 120mm, Germany).
The patients will be randomly divided into two groups,then the desired block will be done.
Surgical procedure will be started after performing the desired block.
At the end of surgery, Patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. Patients will be transported to Post Anaesthesia care unit (PACU). HR, systolic, diastolic and mean pressures will be observed.
#Intervention
- PROCEDURE : Bilateral Modified Pectoral Nerve Block (PECS II).
- The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°.
The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
- PROCEDURE : Bilateral Thoracic Erector spinae plane block (ESPB).
- Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine. | #Eligibility Criteria:
Inclusion Criteria:
* Females aged >=21 years' old.
* BMI <=35.
* Patients with ASA I & II.
* Scheduled for one of the aesthetic breast surgeries.
Exclusion Criteria:
* Patients refusal.
* Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection.
* Patients with unstable cardiovascular disease.
* Emergency surgery.
* Patients with chronic pain.
* History of allergy to the medications used in the study.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT06478654 | 276,084 |
{
"NCT_ID" : "NCT00638079",
"Brief_Title" : "Evaluating the Effect of Food on Absorption of Megace ES",
"Official_title" : "Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects",
"Conditions" : ["Pharmacokinetics", "Bioavailability", "Absorption"],
"Interventions" : ["Drug: Megestrol acetate oral suspension 625 mg/5 mL"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-07",
"Study_Completion_Date(Actual)" : "2006-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-11",
"First_Posted(Estimated)" : 2008-03-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-11",
"Last_Update_Posted(Estimated)" : 2016-04-19",
"Last_Verified" : 2015-08"
}
}} | #Study Description
Brief Summary
To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.
#Intervention
- DRUG : Megestrol acetate oral suspension 625 mg/5 mL
- Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
- Other Names :
- Megace ES
- DRUG : Megestrol acetate oral suspension 625 mg/5 mL
- Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
- Other Names :
- Megace ES | #Eligibility Criteria:
Inclusion Criteria:
* Body weight ranging from 60 <= age <= 100 kg (132 <= age <= 220 lbs) and body mass index >=18 and <=32
* Healthy
Exclusion Criteria:
* History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
* History of or any current medical conditions that could affect subject safety
* History of frequent nausea or emesis, regardless of etiology
* Participation in a clinical drug study during the 30 days preceding the initial dose
* Significant illness during the 4 weeks preceding study entry
* Use of any medication, including vitamins/herbal/mineral supplements, during the 7 days preceding the initial dose
* Refusal or inability to abstain from food 10 hours proceeding and 4 hours following study drug administration, to consume the FDA high fat meal as directed, and to abstain from caffeine- or xanthine-containing beverages entirely during each confinement
* Any history of or current drug or alcohol abuse
* Prior alcohol intake exceeding the equivalent of 14 units/week (12 oz beer = 4 oz wine = 1.5 oz shot = 1 unit) on average, or consumption of any alcoholic beverages within 48 hours of study drug administration
* History of smoking>25 cigarettes/day within 45 days of study drug administration
* Blood or blood products donated within 30 days prior to study drug administration, or anytime during the study, except as required by this protocol
* Positive results of urine drug screen, blood alcohol by a Breathalyzer test, hepatitis B surface antigen, hepatitis B surface antibody (unless immunized), or anti-HCV
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
| NCT00638079 | 160,240 |
{
"NCT_ID" : "NCT00122447",
"Brief_Title" : "Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance",
"Official_title" : "CVD Risk and Prevention in Early Glucose Intolerance",
"Conditions" : ["Impaired Glucose Tolerance", "Prediabetic State"],
"Interventions" : ["Drug: Placebo", "Drug: Aspirin", "Drug: Olmesartan", "Drug: Alpha lipoic acid"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-05",
"Study_Completion_Date(Actual)" : "2011-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-07-21",
"First_Submitted_that_Met_QC_Criteria" : 2012-05-18",
"First_Posted(Estimated)" : 2005-07-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-07-21",
"Last_Update_Posted(Estimated)" : 2013-12-05",
"Last_Verified" : 2013-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers, β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an anti-inflammatory agent - in patients with impaired glucose tolerance (IGT) in a randomized, controlled trial.
Detailed Description
Diabetes is a common, major health problem in the United States, and it significantly increases the risk of developing heart disease, which is the leading cause of death. Research studies have shown that the risk of heart disease is increased, even in the 'pre-diabetes' or impaired glucose tolerance (IGT) stage, before the onset of true diabetes. While many studies have shown that aggressive management of diabetes lowers the risk of heart disease, at the present time, it is not known how best to treat patients with impaired glucose tolerance (pre-diabetes) to prevent the development of heart disease. It is also not known where in the range of blood sugar levels risk begins to increase. The purpose of this study is to determine:
* whether medications, which target pathways involved in the development of heart disease, can decrease the risk of heart disease in individuals with impaired glucose tolerance; and
* whether a 'high' blood sugar level measured one hour after drinking a standard high-sugar drink is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes.
The purpose of Aim 1 of this study is to determine whether medications, which target pathways involved in the development of heart disease, can decrease the risk of heart disease in individuals with impaired glucose tolerance. One hundred-twenty volunteers with impaired glucose tolerance and 30 volunteers with normal glucose tolerance (normal blood sugars after ingesting a standard high-sugar drink) will be recruited from the 'Screening for Impaired Glucose Tolerance' (SIGT) study. The 30 volunteers with normal glucose tolerance will not take any study medication, but will undergo medical testing to determine their risk of heart disease at the beginning of the study, after which their participation in the study will be complete. The 120 volunteers with impaired glucose tolerance will be randomly assigned to one of four medications to be taken over a one-year period:
* alpha lipoic acid (an antioxidant, dietary supplement);
* olmesartan (a drug used to treat high blood pressure);
* aspirin (an anti-inflammatory drug); and
* placebo (an inactive, 'dummy' pill).
Subjects with impaired glucose tolerance will undergo medical testing to determine their risk of heart disease at the beginning of the study (before beginning study medications), after 3 months of intervention, and again at the end of the study (12 months after enrollment). Test results will be compared between the subjects taking each of the active medications and those taking placebo, to determine if the medications lead to a significant reduction in the risk for the development of heart disease. The medical tests used in this study are currently used in medical practice, and include blood and urine specimens, ultrasound testing of the artery at the arm, and an insulin sensitivity test (test of how effectively the body uses sugar). All visits and tests will be conducted in the General Clinical Research Centers of Emory University Hospital and Grady Memorial Hospital.
The purpose of Aim 2 of this study is to determine whether a 'high' blood sugar level measured one hour after drinking a standard high-sugar drink (1-hour blood sugar level) is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes. Seventy-five volunteers with normal glucose tolerance (normal blood sugars after ingesting a standard high-sugar drink) will be recruited from the SIGT study, as well as 15 subjects with impaired glucose tolerance and 15 with diabetes. The subjects with normal glucose tolerance will be grouped into those with 'low', 'middle', and 'high' 1-hour blood sugar levels. All subjects will undergo medical testing (as in Aim 1 above) to determine their risk of heart disease. Test results of subjects with 'low', 'middle', and 'high' 1-hour blood sugar levels will be compared against one another, as well as against those of subjects with IGT and diabetes. If subjects with normal glucose tolerance but 'high' 1-hour blood sugar levels are found to have increased risk for heart disease compared to those with 'low' 1-hour blood sugar levels, then the 1-hour blood sugar levels may provide important information regarding an increased risk of heart disease even in individuals with normal glucose tolerance but 'high' 1-hour blood sugar levels - a population which otherwise would not be identified with the current standard tests used for the diagnosis of diabetes and pre-diabetes.
Over 40 million Americans have pre-diabetes (impaired glucose tolerance), which is associated with an increased risk of the development of both diabetes and heart disease. Findings from these studies will provide important insights into the pathways that lead to the development of heart disease related to pre-diabetes, prevention of heart disease in the pre-diabetic population, and identification of individuals at high risk for heart disease earlier in their natural history - even before the onset of pre-diabetes.
#Intervention
- DRUG : Aspirin
- 325 mg PO QD
- Other Names :
- Bayer aspirin
- DRUG : Alpha lipoic acid
- 600 mg PO BID
- DRUG : Olmesartan
- 40 mg PO QD
- Other Names :
- Benicar
- DRUG : Placebo
- Identical placebo for each active comparator:
placebo aspirin 325 mg PO QD; placebo for alpha lipoic acid 600 mg PO BID; placebo for olmesartan 40 mg PO QD | #Eligibility Criteria:
Inclusion Criteria:
* Impaired glucose tolerance
Exclusion Criteria:
* Diagnosis of diabetes
* Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
* Have systolic blood pressure >140 mm Hg
* Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
* Vascular disease (cardiac, peripheral, cerebral)
* Renal insufficiency or hepatic abnormalities
* Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
* Anemia or a history of bleeding disorder
* Have a history of ARB or aspirin allergy
* Have the syndrome of asthma, rhinitis, and nasal polyps
* Have other medical problems which would preclude taking potential study medications for 12 months
* Are pregnant or have a positive pregnancy test
* Are breast feeding
* Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
* Have health status such that the envisioned blood sampling would confer a physiologic risk
* Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
* Do not appear capable of giving informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT00122447 | 264,247 |
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