data
stringlengths 62
36k
| criteria
stringlengths 174
19.2k
| NCT_ID
stringlengths 11
11
| metadata
dict |
|---|---|---|---|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of escitalopram in treating self-injurious skin picking.
Detailed Description
Purpose: Self-injurious skin picking is a problem documented to occur in 2 % of dermatology patients (Gupta, Gupta and Haberman, 1986) , and approximately 4% of the general population (Keuthen et al., 2000). It is widely under recognized, with medical sequelae that can include scarring, infections, lesions, and potentially life-threatening outcomes (O'Sullivan et al., 1999). In a prior study, fluoxetine was shown to be superior to placebo in treating self-injurious skin picking in a modest-sized double blind trial (Simeon et al., 1997). Similarly, open-label trials of other SSRIs, including sertraline (Kalivas, Kalivas and Gilman, 1996) and fluvoxamine (Arnold et al., 1999) resulted in reductions in skin-picking behavior. Escitalopram is a new SSRI that may have superior efficacy for the treatment of major depression and fewer side effects than other SSRIs. This study aims to assess the efficacy of escitalopram in patients who suffer from self-injurious skin-picking.
Comparisons: Subjects' initial scores on the CGI, HAM-D, SPTS, SPS, SPIS, BDI, BAI, QLESQ, \& BDDQ will be compared to subjects' final scores.
#Intervention
- DRUG : Escitalopram
|
#Eligibility Criteria:
Inclusion Criteria:
* Repetitive skin picking resulting in noticeable tissue damage and associated emotional distress and/or functional impairment.
* Age 18 <= age <= 65 years.
* Duration of skin picking symptoms >= 6 months.
* MGH Skin Picking Scale score >= 10.
* Written informed consent.
* Females of childbearing potential must have a negative serum or urinary beta-HCG test and be willing to use acceptable methods of birth control during study tenure.
Exclusion Criteria:
* Pregnant women or females of childbearing potential who do not consent to use of a medically acceptable method of contraception.
* Women who are breastfeeding.
* Subjects who pose a serious suicidal or homicidal risk in the judgment of study investigators.
* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
* Subjects with a dermatologic disorder that causes pruritis.
* Patients on anticoagulant therapy.
* History of seizure disorder.
* Comorbid bipolar disorder, psychosis, organic mental disorder, borderline personality disorder or developmental disorder. Subjects with obsessive compulsive disorder (with primary symptoms other than compulsive skin picking).
* History of substance dependence. If there is a history of substance abuse, subjects should be in remission for >= 6 months.
* Current treatment with cognitive behavioral therapy for skin picking.
* Current use of another SSRI medication.
* Other medications for medical disorders that might interfere with escitalopram.
* Current major depression or prescribed an antidepressant for major depression within the past 12 months.
* More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another prior SSRI.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00115011
|
{
"brief_title": "Escitalopram for the Treatment of Self-Injurious Skin Picking",
"conditions": [
"Impulse Control Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00115011",
"official_title": "Escitalopram for the Treatment of Self-Injurious Skin Picking",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-11",
"study_start_date(actual)": "2002-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-05-20",
"last_updated_that_met_qc_criteria": "2005-06-20",
"last_verified": "2008-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-06-21",
"first_submitted": "2005-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT) obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection and administered to patients who are infected with the new coronavirus and present dyspnea or a poor prognosis
Detailed Description
The outbreak of a new highly contagious and life-threatening infective disease was first reported in China in December 2019. Regardless of the undertaken containing measures, its spreading could not be effectively stopped and currently we are confronting the pandemic diffusion of a newly identified Coronavirus (SARS-CoV-2) (1). This causes a systemic disease, known as (Coronavirus Disease-19) COVID-19, characterised by a broad spectrum of clinical manifestations, including ineffective hyper-inflammation and severe pneumonia, with provisional epidemiologic data indicating a mortality rate of 0.1-15% (2). Do to the lack of vaccination, specific anti-virus sera or monoclonal antibodies, the therapeutic efforts to limit COVID-19 mostly rely on the empirical use of anti-viral drugs. Therefore, being the option of an active immunisation not available and because of the controversial efficacy of the available anti-viral therapies (3), we suggest the option of a passive immunisation for those patients who are infected with the new coronavirus and present dyspnea or a poor prognosis. The use of convalescent plasma, i.e. plasma obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection, could provide a rapid protection, limiting the observed evolution of COVID-19 towards life-threating manifestations (7-9).
When carried on according to standardised measures, the transfusion of plasma is highly safe (10-11) and we assume that products containing anti- SARS-CoV- 2 antibodies will provide the recipients a passive immunity through different mechanisms, including viral neutralisation, antibody-dependent cellular cytotoxicity and/or phagocytosis.
#Intervention
- DRUG : Convalescent plasma
- Convalescent plasma will be delivered as FFP. Three units of 200ml CP/FFP harvested from one donor will be transfused to one recipient, i.e. there will be a match between donor and recipient and each recipient will receive CP/FFP only from one donor.
CP/FFP will be administered intravenously at the infusion rate of 100ml/hour, starting from day 0, with a new transfusion every 24 hours, for a total of 3 transfusions (see scheme).
- Other Names :
- Fresh Frozen Plasma (FFP)
|
#Eligibility Criteria:
Inclusion Criteria:
A) Proven Sars-CoV-2 by PCR and hospitalization for COVID-19 in combination with either (1) or (2):
* Age >=50
AND (at least one):
* Pre-existing cardiovascular disease
* Diabetic disease
* Immunodeficiency/immunosuppression
* Neoplastic disease
* COPD or chronic liver disease or chronic renal failure
* Age >=18
AND (at least one):
* SpO2 <= 94% on room air or requiring supplemental oxygen at screening
* Typical changes on chest x-ray and/or lung-CT scan
* Immunosuppression or neoplastic disease
B) Informed Consent as documented by signature (Appendix Informed Consent Form) of the patient or, in case of inability, of the next relative/care-taking person. In the latter case, an independent doctor will also be involved and her/his signature will be required in order to enrol the patient.
Exclusion Criteria:
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product (FFP)
* Known IgA deficiency
* Cytokine Release Syndrome grade >=3 (see score)*
* ARDS
* Patients already hospitalized in intensive care unit and/or already receiving mechanical ventilation
* Known or suspected non-compliance, drug or alcohol abuse
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04869072
|
{
"brief_title": "Convalescent Plasma Therapy - Zurich Protocol",
"conditions": [
"COVID-19"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04869072",
"official_title": "A Phase i, Open-label, Single-centre Clinical Study to Evaluate Safety and Efficacy of Passive Immunization of High-risk SARS-CoV-2 Positive Patients With Convalescent Plasma Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-30",
"study_completion_date(actual)": "2021-03-30",
"study_start_date(actual)": "2020-04-29"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-03",
"last_updated_that_met_qc_criteria": "2021-04-27",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-03",
"first_submitted": "2021-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.
Detailed Description
From the day the very low birth weight infant was admitted to hospital, monitoring was recorded once a day, and continuous monitoring was recorded for 1 month. Before collection, the infant was confirmed to be in supine position with neutral temperature, and at the same time, the infant was in a quiet state, without the contact and operation of medical personnel. This study will first use LMS curve to fit the trend of perfusion index in very low birth weight infants within one month after birth.The perfusion index threshold of the outcome index was determined by ROC curve.
#Intervention
- OTHER : Not applicable (cohort study)
- This is a prospective observational study and does not include interventions. The exposure is peripheral perfusion index and the outcome is the incidence of late onset sepsis. From the day when the very low birth weight infant is admitted into hospital, PPI monitoring should be recorded once a day, and continuous monitoring would be recorded until 1 month after birth. Before collection, the infant will be confirmed to be in supine position with neutral temperature, and at the same time, the infant will be in a quiet state, without the contact and operation of medical personnel.
|
#Eligibility Criteria:
Inclusion Criteria:
* Infants weighting <1500g
* Infants admitted to Children's Hospital of Fudan University
Sex :
ALL
Ages :
- Minimum Age : 0 Hours
- Maximum Age : 3 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05224921
|
{
"brief_title": "Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants",
"conditions": [
"VLBW - Very Low Birth Weight Infant"
],
"interventions": [
"Other: Not applicable (cohort study)"
],
"location_countries": [
"China"
],
"nct_id": "NCT05224921",
"official_title": "Study of Peripherel Perfusion Index to Predict Late Onset Sepsis in Very Low Birth Weight Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-12-31",
"study_start_date(actual)": "2022-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-06",
"last_updated_that_met_qc_criteria": "2022-01-25",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-04",
"first_submitted": "2022-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve progression free survival and overall survival. However, it is a challenging treatment process both physically and psychologically. It is a procedure with many side effects that can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies, such as music therapy, have potential to be an important adjunct in palliation of symptoms in patients undergoing chemotherapy.
Detailed Description
Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room. This will occur between days -1 and +5, with the first music therapy session being as close to day +1 as possible and the second session being at least 48 hours later (but no more than 96 hours later).
Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist. Following day +7, music therapy will be offered to all patients who are interested in participating.
No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy sessions or to assessments. Patients will rate nausea and pain at the beginning and end of the first music therapy session on a validated visual analog scale.12-14 The scale will be 10cm with the least nausea or pain at point 0 and the greatest nausea or pain at point 10. Patients will be asked to rate their nausea and pain on day +5 and day +7.
#Intervention
- OTHER : Music Therapy
- Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room
- OTHER : No music therapy
- Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.
|
#Eligibility Criteria:
Inclusion Criteria:
* Be older than 18 years
* Have a diagnosis of multiple myeloma, non-Hodgkin, or Hodgkin lymphoma
* Be undergoing ASCT (Autologous Stem Cell Transplantation)
Exclusion Criteria:
* Have had previous ASCT
* Have a diagnosis of leukemia
* History of prior music therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01487031
|
{
"brief_title": "Music Therapy on Nausea and Pain for Autologous Stem Cell",
"conditions": [
"Multiple Myeloma",
"Non-Hodgkin Lymphoma",
"Hodgkin Lymphoma"
],
"interventions": [
"Other: Music Therapy",
"Other: No music therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01487031",
"official_title": "Assessment of the Use of Music Therapy on Nausea and Pain During Hospitalization for Autologous Stem Cell Transplantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2011-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-08-02",
"last_updated_that_met_qc_criteria": "2011-12-06",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-07",
"first_submitted": "2011-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Neonates undergo several painful procedures and these pain experiences can alter clinical outcome and behavior. The investigators aim to investigate the analgesic effect of low level laser for procedural pain during heel lancing of term neonates.
Detailed Description
This open-label, randomized controlled trial involves 130 term newborn infants (gestational ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are randomly assigned to low level laser group or breast milk group. Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. Then heel lancing is performed and two observers who are blinded to the intervention record the physiological (heart rate and oxygen saturation) and behavioral parameters (duration of crying and modified neonatal facial coding scores) following the procedure. Heart rate variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is used to detect the infant's salivary cortisol and amylase level as biomarker for stress evaluation. During the study course, digital cameras continuously record participants' behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical analysis.
#Intervention
- DEVICE : LaserPen
- low level laser is used before heel-lancing for newborn screening
- Other Names :
- power 150mW, wavelength 810nm, RJ-laser
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy fullterm neonates (37 <= age <= 42 gestational age)
* Apgar score >= 7
* will receive newborn screening
Exclusion Criteria:
* >42 or < 37 gestational age
* perinatal asphyxia
* major malformations or any other disease that need intensive care
* drug withdrawal received previous treatment
Sex :
ALL
Ages :
- Minimum Age : 2 Days
- Maximum Age : 4 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03268148
|
{
"brief_title": "Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants",
"conditions": [
"Procedural Pain"
],
"interventions": [
"Device: LaserPen"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03268148",
"official_title": "Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-30",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2017-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-27",
"last_updated_that_met_qc_criteria": "2017-08-29",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-31",
"first_submitted": "2017-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Detailed Description
Hemostatic, biomarker, and inflammatory changes are common in severe manifestations of coronavirus disease 2019 (COVID-19).Such factors, as well as the bedridden status and critical illness may constitute a prothrombotic milieu, predisposing to venous and arterial thrombosis. However, the optimal antithrombotic regimen for patients with COVID-19, especially those with severe disease, remains uncertain and is currently an area of active clinical interest. Prophylactic-dose anticoagulation is generally recommended for acutely ill hospitalized patients. However, given the hemostatic abnormalities of severe COVID-19 illness, it is unknown whether more intensive anticoagulation is preferred to reduce the risk of thrombotic events, potentially mitigating microvascular and macrovascular thrombi and even disseminated intravascular coagulation (DIC). Further, the risks of therapeutic dose anticoagulation must be weighed against the bleeding risks inherent to this approach. To address this critical gap in knowledge in an area of clinical equipoise, the investigators plan to conduct a cluster-randomized trial in patients admitted to intensive care units (ICUs) in a large volume academic medical center to select the best anticoagulation intervention.
#Intervention
- DRUG : Enoxaparin Prophylactic Dose
- Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI \< 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI \> 50 kg/m2: Enoxaparin 60 mg SC q12h
- Other Names :
- Lovenox
- DRUG : Heparin Infusion
- Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
- Other Names :
- Heparin
- DRUG : Heparin SC
- Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
- Other Names :
- Heparin
- DRUG : Enoxaparin/Lovenox Intermediate Dose
- If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
- Other Names :
- Lovenox
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)
* New admission to eligible CUIMC ICUs within 5 days
* Transfer from nonparticipating to participating ICU is eligible if otherwise meets eligibility criteria.
* Patients transferred between participating ICUs will maintain initial treatment assignment.
* Patients not on therapeutic anticoagulation and who were already admitted to participating ICU within 5 days of trial initiation are additionally eligible.
Exclusion Criteria:
* Weight under 50kg
* Contraindication to anticoagulation in the opinion of the treating clinician including
* overt bleeding
* platelet count <50,000
* Bleeding Academic Research Consortium (BARC) major bleeding in the past 30 days
* Gastrointestinal (GI) bleeding within 3 months
* history of intracranial hemorrhage
* Ischemic stroke within the past 2 weeks
* craniotomy/major neurosurgery within the past 30 days
* cardiothoracic surgery within the past 30 days
* intra-abdominal surgery within 30 days prior to enrollment
* Head or spinal trauma in the last months
* History of uncorrected cerebral aneurysm or arteriovenous malformation (AVM)
* Intracranial malignancy
* Presence of an epidural or spinal catheter
* Recent major surgery within the last 14 days
* Decrease in hemoglobin >3 g/dL over the last 24 hours
* Allergic reaction to anticoagulants (e.g. Heparin Induced Thrombocytopenia) as documented in the electronic health records. Extracorporeal membrane oxygenation (ECMO) support or other mechanical circulatory support.
* Severe chronic liver dysfunction (history of portosystemic hypertension (HTN), esophageal varices, or Child-Pugh class C or above or similar Model For End-Stage Liver Disease (MELD) scores), abnormality in liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin) 5 times greater than upper normal limit.
* A history of congenital bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia)
* Treating physician preference for therapeutic anticoagulation
* Enrollment in other concurrent trials related to anticoagulant or antiplatelet therapy
* Existing treatment with therapeutic anticoagulation during the previous 7 days of hospitalization prior to ICU admission (e.g. for venous thromboembolism (VTE), atrial fibrillation, mechanical valve, etc).
* Do-not-resuscitate (DNR) /do-not-intubate (DNI) or comfort measures only (CMO) orders prior to randomization.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04367831
|
{
"brief_title": "Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19",
"conditions": [
"COVID-19",
"Venous Thromboses",
"Arterial Thrombosis"
],
"interventions": [
"Drug: Enoxaparin/Lovenox Intermediate Dose",
"Drug: Heparin Infusion",
"Drug: Heparin SC",
"Drug: Enoxaparin Prophylactic Dose"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04367831",
"official_title": "Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-12",
"study_completion_date(actual)": "2021-05-12",
"study_start_date(actual)": "2020-05-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-10",
"last_updated_that_met_qc_criteria": "2020-04-27",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-29",
"first_submitted": "2020-04-27",
"first_submitted_that_met_qc_criteria": "2024-11-15"
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to better understand the experiences of adolescents with physical disabilities and assess the effectiveness of a Character Strengths Intervention (CSI) in improving their self-esteem, character strengths, and mental health. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Main Research Questions:
How do adolescents with physical disabilities perceive their self-esteem, character strengths, and mental health, including psychological adjustment, psychological distress, psychological wellbeing, life satisfaction, and resilience? Can the Character Strengths Intervention (CSI) enhance the self-esteem, character strengths, and mental health (psychological adjustment and distress) of adolescents with physical disabilities?
Study Tasks:
Participants, who are adolescents aged 12-18 years, will be asked to provide informed consent to participate in the study.
They will complete questionnaires to assess their self-esteem, character strengths, and mental health as a pre-assessment.
Participants in the intervention group will undergo the Character Strengths Intervention (CSI), which includes activities like exploring character strengths, writing gratitude letters, and practicing fresh look meditation, among others.
After the intervention, participants will complete post-assessment questionnaires to measure changes in self-esteem, character strengths, and mental health.
There will be a control group that does not receive any treatment.
Comparison Group:
Researchers will compare the outcomes between the intervention group, who received the Character Strengths Intervention (CSI), and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on self-esteem, character strengths, and mental health outcomes for adolescents with physical disabilities.
#Intervention
- BEHAVIORAL : Character Strengths Intervention
- Session 1. Getting Started: Introducing and Exploring Character Strengths Session 2. Boost a Lower Strength Session 3. Cultivate your inner self + Loving-Kindness Meditation Session 4. Gratitude Letter + Three Good things Session 5. Conclusion Each session will consist of 1-hour, which will be delivered once a week for 5 weeks. Moreover, participants will be given homework which they will practice the rest of the week.
- Other Names :
- Positive Psychology Interventions
|
#Eligibility Criteria:
Inclusion Criteria:
* Adolescents with physical disability
* Adolescents with physical disability in the age range 11 <= age <= 18
* Rural and urban residences
* Urdu, Englishspeaking
* Rawalpindi and Islamabad special education schools
Exclusion Criteria:
* Adolescents under age 11 and above 18
* Adolescents whose parents, teachers, or themselves would not be agreed and signed informed consent to participate in the study would be excluded
* Adolescents with physical disability such as:
* Sensory disability (mute and Fully/partial-visual impairment) impairment
* Hearing impairment
* Deaf-blindness
* And intellectual and cognitive impairment
* Adolescents with severe psychiatric and major medical issues -
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06080685
|
{
"brief_title": "Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents",
"conditions": [
"Mental Health Issue",
"Mutism",
"Orthopedic Disorder"
],
"interventions": [
"Behavioral: Character Strengths Intervention"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06080685",
"official_title": "Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-15",
"study_completion_date(actual)": "2023-12-15",
"study_start_date(actual)": "2023-09-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-01",
"last_updated_that_met_qc_criteria": "2023-10-06",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-12",
"first_submitted": "2023-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-viral drugs may, in fact, may lead to the development of resistant virus. We hypothesize that extended use (12 months) of valganciclovir (Valcyte™)will not only be efficacious but will not be associated with the development of resistant CMV.
Sample Size: 100 patients at 3 sites have been enrolled
Patient Selection: Adult (\>18 years) recipients of cadaveric or living donor kidneys, pancreas, or combine kidney-pancreas transplants.
Immunosuppression: To be determined according to each center's standard protocol (s).
Study Drug: Valcyte™ Days 0 - 90: All Patients, 900 mg QD
Days 91 - 365:
Group 1: 900 mg QD Group 2: 450 mg QD
Assessment of Valgancicovir (Valcyte™)Resistant CMV : Serial serum samples (at transplant, 6 weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54 genes.
Other Analyses:
Additional information will be evaluated relating to the development of CMV disease, development of ganciclovir toxicity, graft rejection or graft loss and patient death. Preliminary information regarding the predictive value of DNA assays for the development of CMV disease will be evaluated.
Detailed Description
CMV infection occurs most frequently in the first three months following transplantation and following treatment for acute rejection; both instances can be related to relatively high levels of immunosuppression relative to stable long-term allograft recipients. Disease then can occur and is manifest as fever, low white blood cell count, pneumonitis, gastroenteritis, hepatitis, retinitis, and a multitude of other symptoms.
Ganciclovir, a potent inhibitor of the herpesviridae DNA polymerase encoded for on the unique long (UL54) region of the CMV genome, has had a significant impact on both the prophylaxis and treatment of CMV infection in transplant patients. CMV-infected cells produce a phosphotransferase, or kinase (UL97 region) that phosphorylates ganciclovir to ganciclovir-triphosphate. The triphosphate product inhibits CMV replication by competitively inhibiting the incorporation of deoxyguanine triphosphate (dGTP) into the DNA region encoding the polymerase (UL54 region), thus resulting in the premature termination of viral DNA synthesis. Resistance to ganciclovir is conferred when mutations occur on the UL97 region of the CMV genome.
Ganciclovir is available in either an oral or an intravenous formulation. The obvious advantages of the oral formulation are somewhat offset by the fact that its bioavailability is only 8 to 10%. The product has been reformulated with the addition of an L-valyl ester; the resulting compound, valganciclovir (Valcyte™) is metabolized to ganciclovir and has a 3 to 7 fold increase in bioavailability and is able to maintain serum concentrations equivalent to the intravenous formulation. This provides a convenient method for obtaining therapeutic concentrations of ganciclovir for extended periods of time without the need for in-dwelling intravenous lines.
The optimal length of treatment has not been established and relapse rates as high as 25% are common upon cessation of the antiviral agent.6 Patients with CMV disease are initially treated with intravenous ganciclovir for two or more weeks, and then with an oral agent for many weeks thereafter. Current laboratory technology allows detection of active viral replication, either through the detection of the pp65 antigen on the surface of infected leukocytes or through the use PCR amplification for the detection of viral DNA. It is however, still unclear whether the best therapeutic option is to treat until symptoms disappear or to treat until evidence of active viral replication ceases.
The question of whether or not prolonged exposure to ganciclovir will result in an increase in the incidence of resistant CMV strains has not been answered. There is also a theoretical increase in the risk of selection pressure for resistant CMV when the lower dose of valganciclovir (450 mg) is used. This proposal will document the emergence of ganciclovir-resistant strains of CMV in high-risk kidney, pancreas, or combined kidney/pancreas transplant patients receiving long-term suppressive therapy with Valcyte™ and will also address the issue of selection pressure by randomizing for low and high dose valganciclovir prophylaxis. Emergence of resistance will be defined as detection of a resistance-conferring mutation in the UL97 (phosphotransferase) or UL54 (DNA polymerase) open reading frame of detectable CMV.
Objectives
Primary
To document:
1. The emergence of ganciclovir-resistant CMV by PCR amplification and DNA sequence analysis for detecting resistance-conferring mutations of UL97 and/or UL54 open reading frames.
2. The development and time-to-onset of CMV disease
Secondary
To document:
1. The development of ganciclovir toxicity
2. Loss of kidney and/or pancreas graft function
3. Patient death
Tertiary
To attempt to determine the predictive value of DNA assays for the development of CMV disease.
Study Design
This will be a phase 4, 4 center, and randomized pilot study. Kidney, pancreas or combined kidney/pancreas transplant patients that receive induction anti-thymocyte globulin or OKT3 and/or are either seropositive for CMV or receive a graft from a CMV seropositive donor will receive Valcyte™ 900 mg daily for 90 days. Patients will then be randomized to either 450 mg or 900 mg Valcyte™ each day for days 91 to 365. Patients will be serially monitored for the development of ganciclovir-resistant CMV. Patients will receive standard immunosuppression, antibacterial and antifungal prophylaxis, and other necessary medications as determined by their physicians.
Statistical Analysis
Primary Endpoints: Time to development of any CMV disease or emergence of ganciclovir-resistant CMV.
Methods: Kaplan-Meier product limit estimates for median time to CMV disease for both treatment groups will be used, and a Kaplan-Meier survival curve will be plotted to compare treatment difference. Kaplan-Meier product limit estimates for median time to CMV resistance for both treatment groups will be used, and a Kaplan-Meier survival curve will be plotted to compare treatment difference. In addition, the Cox regression will be performed to compare treatment groups using treatment as a covariate in the model.
Secondary Endpoints: Incidence of ganciclovir toxicity, loss of kidney and/or pancreas, and patient death.
Methods: Cox regression will be performed to compare treatment groups using treatment and incidence of resistance as covariates in the model. Fisher's exact test will be used to analyze the loss of kidney and/or pancreas allograft function, and patient mortality. Toxicity within the two prophylaxis cohorts will be compared using Fisher's exact test, also.
Tertiary Endpoint: Efficacy of DNA assay to predict CMV disease. Method: A two-tailed t test comparison will be used to test the hypothesis that high copy numbers of CMV DNA correlate with the development of CMV disease. Additionally, a test based on a Cox proportional hazard model will be used to assess other variables and their impact on the development of CMV resistance and their relationship to copy numbers of DNA.
The above parameters will be assessed at three time points...6 months from the initiation of the trial, at 12 months post enrollment for each patient, and again at 24 months post-enrollment.
Materials and Methods
Definitions of CMV CMV Infection
CMV infection is defined as the isolation or identification of CMV from any site (blood, urine, sputum, stool), positive seroconversion (presence of positive CMV IgM or a four-fold increase in the titer of CMV IgG), or evidence of CMV viral replication (pp65 antigenemia or positive CMV by PCR amplification techniques) in the absence of clinical symptoms.
CMV Syndrome
CMV syndrome is defined as a virologically confirmed illness with any of the following: fever, pneumonia, leukopenia, lymphocytosis, thrombocytopenia, serum alanine aminotranferase levels \> 2.5 x normal, with or without 'flu-like' manifestations of viral immunity (malaise, myalgias, arthralgias, anorexia, nausea, vomiting). Any patient presenting with any of these signs or symptoms at any time during this study will have blood, body fluid, and/or biopsy specimen sent for viral confirmation which may include any of the following studies: histology for the presence of inclusion bodies, immunofluorescence of antibody to pp65 antigen or qualitative presence of CMV genome by PCR amplification.
CMV Disease
CMV disease will be defined as CMV infection and syndrome with any of the following: evidence of host cellular viral inclusions on biopsy or body fluid for cytology, a positive conventional viral culture for CMV, a positive 'rapid antigen' test for the presence of pp65 antigen on the cell surface of buffy coat leukocytes, or the qualitative presence of CMV DNA as analyzed by PCR amplified virus. Specimens used for the above diagnostic procedures may include blood, liver or lung biopsy, endoscopic mucosal biopsy or brushing, bronchoalveolar lavage, or cerebrospinal fluid.
Severe CMV Disease
Severe CMV disease is defined as CMV disease in two or more organs or one or more of the following: CMV pneumonia, CMV retinitis, CMV CNS involvement, and invasive fungal or parasitic disease in association with CMV infection of any sort.
CMV Mortality
CMV mortality is defined as any death due to symptomatic CMV disease or death from any opportunistic infection while there is evidence of CMV disease or ongoing CMV viral replication.
Ganciclovir Resistant CMV
Ganciclovir resistant CMV is defined as the detection of a resistance-conferring mutation of the UL97 and/or the UL54 open reading frame by DNA sequence analysis of PCR amplified CMV genome.
Valganciclovir (Valcyte™)
Valcyte™ is a product of Roche Laboratories, Nutley, New Jersey. Patients will receive 450 or 900 mg per day depending on the stage of the study and the individual's randomization. Dosage will be adjusted for renal insufficiency as per package insert. If creatinine clearance (crcl) is \>60 (ml/min), no adjustment is needed. If crcl is 40-59, patients can only receive up to 450 mg once daily. Therefore, those randomized to the 900mg/day cohort will receive 450 mg and those randomized to receive 450 mg/day will receive 450 mg every other day (QOD). If creatinine clearance is less than 40 and will never improve, patients will be excluded or terminated from the study.
Immunosuppression
Immunosuppressive medications will be administered according to the protocols in place at each participating center. The choice of maintenance immunosuppression and treatment for rejection will be at the discretion of the center's principal investigator.
Concomitant Anti-infectives
Patients enrolled in the study will receive anti-bacterial and anti-fungal prophylaxis as determined by the protocol in place for their transplanted organ at their transplant center. The use of antibiotics and anti-fungals for the treatment of disease will be at the discretion of the individual patient's physician.
Hematopoietic Growth Factors
Regrastim (GM-CSF) (Prokine® Hoechst-Roussel, and Leukine®, Immunex) and filgrastim (G-CSF) (Neupogen®, Amgen) may be used at the discretion of the physician for the treatment of leukopenia, including ganciclovir-related leukopenia.
|
#Eligibility Criteria:
Inclusion Criteria:
1) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported.
*
Exclusion Criteria:
* Patients receiving systemic therapy for acute opportunistic infection at time of enrollment
* Patients receiving investigational drugs
* Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers
* Patients with active substance abuse or other condition that would impair compliance
* Patients who are unable to give informed consent
* Any patient with a creatinine clearance < 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (>40) as would occur with resolving ATN.
* Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF
* Any female patient who plans to become pregnant within one year
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00225394
|
{
"brief_title": "Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients",
"conditions": [
"CMV Disease",
"Viral Resistance",
"Rejection",
"Death"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00225394",
"official_title": "Long-Term Valcyte Therapy in Transplant Patients and the Development of Ganciclovir Resistant CMV",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-09-23",
"last_updated_that_met_qc_criteria": "2005-09-21",
"last_verified": "2005-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-23",
"first_submitted": "2005-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.
#Intervention
- OTHER : Volume expansion with gelofusine
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent by patient or relative
* Time in ICU < 48 hours
* Septic shock
* Pulmonary artery catheter and radial arterial catheter
* Age 18 - 75 years
* Sinus rhythm
* Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study
* Mechanical ventilation with sedation
* Pwcp <18 mmHg
Exclusion Criteria:
* Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
* Contraindication to fluid challenge
* Contraindication to TEE
* Previous heart failure, heart valve stenosis of insufficiency
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01827007
|
{
"brief_title": "Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock",
"conditions": [
"Septic Shock"
],
"interventions": [
"Other: Volume expansion with gelofusine"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT01827007",
"official_title": "Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-02",
"study_start_date(actual)": "2008-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-09",
"last_updated_that_met_qc_criteria": "2013-04-04",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-09",
"first_submitted": "2013-04-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators aimed to investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management.
Detailed Description
Female Community Health Volunteers (FCHVs) in Nepal could play a role in preventing and managing hypertension. Limited studies have been conducted on Nepal's FCHV knowledge and capacity to deliver hypertension-related counseling and services. The investigators investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. The investigators used the Hypertension Knowledge Level Scale (HK-LS) to assess the knowledge through face-to-face interviews and observed BP measurement skills using an observation checklist. The investigators used paired t-tests to see the mean difference before and after the training. The investigators performed linear regression to assess the hypertension knowledge and BP measurement skills scores with socio-demographic and FCHV's general performance. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management. The investigators transcribed the recorded discussion verbatim and analyzed it using the framework analysis method
#Intervention
- OTHER : Training
- We conducted one day of training for FCHVs and four different groups of FCHVs from two municipalities. We conducted training on hypertension knowledge and blood pressure measurement skills for FCHVs. Studies from Nepal show that with appropriate training, FCHV has the potential to promote hypertension education and conduct hypertension screening. Access to essential equipment such as digital blood pressure monitors, would improve FCHV performance on measuring blood pressure. Therefore, our training was to provide hypertension knowledge and to train FCHVs to measure blood pressure.
The training had two objectives referring to enhancing knowledge and building skills.
|
#Eligibility Criteria:
Inclusion Criteria:
* Appointed as FCHV
* Age 18 years and older
Exclusion Criteria:
* Not able to respond during the data collection period
* Out of municipality during the data collection period
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06529289
|
{
"brief_title": "Effectiveness of Female Community Health Volunteers Training on Hypertension Knowledge and Blood Pressure Measurement Skills in Nepal",
"conditions": [
"Female Community Health Volunteers"
],
"interventions": [
"Other: Training"
],
"location_countries": [
"Nepal"
],
"nct_id": "NCT06529289",
"official_title": "Effectiveness of Female Community Health Volunteers Training Program on Hypertension Knowledge and Blood Pressure Measurement Skills in Kavrepalanchowk, Nepal",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-20",
"study_completion_date(actual)": "2024-06-01",
"study_start_date(actual)": "2023-04-20"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-31",
"last_updated_that_met_qc_criteria": "2024-07-28",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-07-31",
"first_submitted": "2024-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia
Detailed Description
This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.
.
#Intervention
- PROCEDURE : Laparoscopic Trans-Abdominal Pre-Peritoneal
- Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
- PROCEDURE : Open pre-peritoneal repair
- Open pre-peritoneal single mesh repair with suture fixation
- PROCEDURE : Bilateral Lichtenstein repair
- Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with painless uncomplicated primary bilateral inguinal hernias
Exclusion Criteria:
* Immune compromised patients
* Coagulopathy
* Chronic liver or renal disease
* High-risk patients unfit for major surgery (ASA III or IV),
* Massive scrotal hernias, Recurrent or Complicated hernias
* Groin pain due to any other pathology
* Previous infra-umbilical surgery
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04437784
|
{
"brief_title": "Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia",
"conditions": [
"Bilateral Inguinal Hernia"
],
"interventions": [
"Procedure: Open pre-peritoneal repair",
"Procedure: Laparoscopic Trans-Abdominal Pre-Peritoneal",
"Procedure: Bilateral Lichtenstein repair"
],
"location_countries": null,
"nct_id": "NCT04437784",
"official_title": "Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2020-06",
"study_start_date(actual)": "2014-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-18",
"last_updated_that_met_qc_criteria": "2020-06-17",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-18",
"first_submitted": "2020-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery
Detailed Description
Abdominoplasty is considered one of the most commonly performed cosmetic procedures. According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 758,590 abdominoplasties were performed in the world in 2016. This is an increase of 72.95% in comparison with 2011, making it the fourth most common cosmetic procedure. Given the increasing number of abdominoplasties performed, the importance of understanding the possible complications and morbidity associated with the procedure is critical. One of these complications is the postoperative pain. With adequate postoperative pain control, the patients met discharge criteria sooner and this helps in shortening the hospital stay, better overall patient satisfaction, and decreased hospital costs. Therefore, the severity of this problem and the all drug agent used to prevent and treat postoperative pain best interest to be aware in the anesthesiologists. Traditionally, analgesia for abdominal wall surgery is provided either by systemic drugs such as opioids, nonsteroidal anti-inflammatories, alpha 2 agonists and paracetamol or by epidural analgesia. However, Opioids, such as morphine or fentanyl, remain the mainstay of postoperative analgesic regimens for patients after abdominal wall surgery. The pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. (5) For this Alternative approaches, which reduce the requirement for strong opioids post-operative, are required. Recently, interest has focused on the use of N-methyl-D-aspartate (NMDA) receptor antagonists for the management of postoperative pain. Ketamine exerts its main analgesic effect by antagonism of NMDA receptors that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with the excellent analgesic property even in subanesthetic doses. (6) Various recently published studies have talked about the analgesic effect of low-dose ketamine (7,8) however, all of this study are relatively short procedure time, reduced surgical stimulation and small sample size. The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery
#Intervention
- DRUG : Ketamine
- Ketamine group to whom intravenous ketamine was administered in a loading dose of 0.15 mg/kg over 5 min, 10 minutes pre incision, followed-by an infusion at 2 micg/kg/min until the end of surgery.
- Other Names :
- Ketamine infusion
- DRUG : Morphine
- a loading dose of 0.1 mg/kg over 20 min intravenously, 10 minutes pre incision, then infused with morphine an infusion rate of 5 - 40 microgram/kg/hour till the end of surgery.
- Other Names :
- Morphine infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I or II
* patients aged between 18 <= age <= 50 years. -
Exclusion Criteria:
* those who refused to participate
* ASA physical status III, IV, patients younger than >= 18 years than 50 years
* super morbid obesity with BMI 50, history of epilepsy
* patients having a history of parenteral or oral analgesics within the last 24 hours before
* initiation of operation
* those having an allergy to study agents.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03664622
|
{
"brief_title": "Ketamine Versus Morphine Change Pain Profile",
"conditions": [
"Acute Pain"
],
"interventions": [
"Drug: Morphine",
"Drug: Ketamine"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03664622",
"official_title": "Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-01-20",
"study_start_date(actual)": "2018-09-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-29",
"last_updated_that_met_qc_criteria": "2018-09-07",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-10",
"first_submitted": "2018-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.
Detailed Description
This study includes up to a 3-week Screening Period, followed by a 52-week treatment period. Participants with CIC meeting the entry criteria received linaclotide 145 μg capsules, orally, once daily and participants with IBS-C meeting the entry criteria received linaclotide 290 μg capsules, orally, once daily. Participants with intolerable Adverse Events (AEs), following resolution of the AEs, could be randomized to receive 290 μg, 145 μg, or the lower dose of 72 μg linaclotide oral capsules for IBS-C; and 145 μg or 72 μg for CIC. Participants who experienced further intolerable AEs after the randomization could be transitioned to open-label 72 μg linaclotide.
#Intervention
- DRUG : Linaclotide
- Linaclotide capsules, orally, once daily.
- Other Names :
- LINZESS®
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants meet the Rome III criteria for IBS-C or CIC:
* IBS-C Criteria: the participant must meet the following 2 criteria (A and B).
A. IBS Criteria: The participant must have abdominal pain or discomfort at least 3 days per month in the 3 months before diagnosis (with symptom onset at least 6 months before diagnosis) associated with 2 or more of the following:
* Improvement with defecation.
* Onset associated with a change in frequency of stool.
* Onset associated with a change in form (appearance) of stool. B. Stool Consistency Requirement: During the 3 months before diagnosis in the absence of laxative or enema use, the patient has hard or lumpy stools (Bristol Stool Form Scale [BSFS] score 1 or 2) with at least 25% of bowel movements (BMs) and has loose or mushy stools (BSFS 5 or 6) with <25% of BMs.
* CIC Criteria: the participant must meet the following 3 criteria (A, B, and C):
A. Participant meets 2 or more of the following criteria for 3 months before the diagnosis with symptom onset at least 6 months before diagnosis:
* Straining during at least 25% of defecations.
* Lumpy or hard stools in at least 25% of defecations.
* Sensation of incomplete evacuation for at least 25% of defecations.
* Sensation of anorectal obstruction/blockage for at least 25% of defecations.
* Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor).
* Fewer than 3 defecations per week. B. Loose stools are rarely present without the use of laxatives. C. Insufficient criteria for irritable bowel syndrome. (The criteria for IBS are provided in Point A under IBS Criteria, above).
* Participant meets the colonoscopy requirements, which are modified from the Summary of the US-Multi-Society Task Force on Colorectal Cancer and other Colonoscopy Requirements.
* Participant has successfully completed protocol procedures (with no clinically significant findings).
Exclusion Criteria:
* At Day 1 visit, the participant reports having 6 or more spontaneous bowel movements (SBMs) in the week prior to screening.
* At Day 1 visit, the participant reports having any SBMs that were watery (BSFS=7) or more than 1 SBM that was mushy (BSFS=6) in the week prior to screening.
* Participant has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility.
* Participant has any protocol excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments.
* Participant has ever received linaclotide as a treatment (including commercially-available product) or has been randomized into any clinical study in which linaclotide was a treatment. (participant who enrolled into linaclotide clinical studies conducted prior or during this study but failed to be randomized are eligible for the current study).
* Participant has ever received plecanatide, SP-333, or has participated in a plecanatide clinical study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02590432
|
{
"brief_title": "An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation",
"conditions": [
"Irritable Bowel Syndrome With Constipation",
"Chronic Idiopathic Constipation"
],
"interventions": [
"Drug: Linaclotide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02590432",
"official_title": "An Open-label, Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-05",
"study_completion_date(actual)": "2018-02-05",
"study_start_date(actual)": "2015-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-22",
"last_updated_that_met_qc_criteria": "2015-10-27",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-29",
"first_submitted": "2015-10-27",
"first_submitted_that_met_qc_criteria": "2019-08-08"
}
}
}
|
#Study Description
Brief Summary
Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment.
In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman \& Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement.
The current project seeks to build on past progress by further developing and refining the booster. In particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
Detailed Description
Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from frequent or heavy alcohol use can be mild (e.g., hangovers, missed classes), moderate (e.g., poor grades, damaged relationships), or severe (e.g., assault, even death). Given the potentially dangerous consequences, reducing alcohol use and associated problems is a major health priority. Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. The benefits of online interventions include cost-effectiveness and ease of administration, plus they offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment.
Although post-intervention boosters have been shown to be effective for individuals seeking treatment for alcohol-related injuries in emergency medical settings, limited studies have investigated the efficacy of boosters for college students who have received alcohol interventions. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention, while at the same time maintaining low cost and easy dissemination (Braitman \& Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement.
The current project seeks to build on past progress reducing the gap between online and more efficacious in-person interventions. The current study further develops and refines the booster to identify optimal administration for maximum efficacy. In particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
Hypothesis 1a: Both groups receiving emailed feedback will reduce drinking and alcohol-related problems as compared to the intervention-only control condition.
Hypothesis 1b: Reductions in drinking and problems will be stronger for those who receive emails from an individual rather than automatically generated.
#Intervention
- BEHAVIORAL : e-checkup to go
- The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
- BEHAVIORAL : Feedback-only booster
- Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm. The content is clearly automatically generated.
- BEHAVIORAL : Feedback-plus-personal-contact booster
- Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm. The email is sent from an individual on the research staff.
|
#Eligibility Criteria:
Inclusion Criteria:
* Current college students at the sponsor institution at the time of enrollment
* Between the ages of 18 and 24
* Consumed at least standard drink of alcohol in the past 2 weeks
Exclusion Criteria:
* Under age of 18
* Over age of 24
* Not a college student
* Did not drink alcohol in the past 2 weeks
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 24 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03440476
|
{
"brief_title": "Personalized Booster Feedback After Alcohol Health Education",
"conditions": [
"College Student Drinking"
],
"interventions": [
"Behavioral: e-checkup to go",
"Behavioral: Feedback-only booster",
"Behavioral: Feedback-plus-personal-contact booster"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03440476",
"official_title": "Personalized Booster Feedback After Alcohol Health Education",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-30",
"study_completion_date(actual)": "2019-03-30",
"study_start_date(actual)": "2018-02-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-30",
"last_updated_that_met_qc_criteria": "2018-02-14",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-22",
"first_submitted": "2018-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Detailed Description
The Study Drugs:
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease or prevent the growth of cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients needed for tumor growth. This may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Sorafenib is designed to block the function of important proteins in cancer cells. These proteins, when active, are in part responsible for the abnormal growth and behavior of cancer cells.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) is a drug combination designed to kill rapidly dividing cells by stopping DNA (the genetic material of cells) from duplicating. Because of a pharmacy shortage of IV leucovorin, patients will continue treatment without leucovorin until it becomes available.
Study Groups (Arms):
If you are found to be eligible to take part in this study, you will be assigned to 1 of 4 study arms. Each study arm will receive lenalidomide in combination with 1 of the 4 drugs/drug combinations described in the 'Study Drugs' section above. The arm you are assigned to will depend on what arms are still open and what your doctor thinks is appropriate for you. Your doctor will consider the type of disease you have, other drugs you have received for the disease, and any side effects you may have seen with other drugs when deciding which arm you should be assigned to:
* If you are in Arm 1, you will receive lenalidomide and bevacizumab.
* If you are in Arm 2, you will receive lenalidomide and sorafenib.
* If you are in Arm 3, you will receive lenalidomide and temsirolimus.
* If you are in Arm 4, you will receive lenalidomide and FOLFOX.
Up to 4 dose levels of the drug combination will be tested for each arm. Up to 6 participants will be enrolled at each dose level in each arm. For each arm, the first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose for the drug combination is found for each arm. After the highest tolerable dose of the drug combination is found, an additional 20 patients will be able to receive this combination dose in each arm.
Study Drug Administration:
If you are in Arm 1, 2, or 3, each study 'cycle' will be 28 days. If you are in Arm 4, each study cycle will be 21 days.
If you are in Arms 1, 2, or 3, you will take lenalidomide by mouth 1 time each day during Days 1-21 of each study cycle. If you are in Arm 4, you will take lenalidomide by mouth 1 time each day during Days 1-14 of each study cycle. Swallow lenalidomide capsules whole with 1 cup (about 8 ounces) of water. Do not break, chew, or open the capsules.
If you miss a dose of lenalidomide, take is as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose). If you take more than the prescribed dose of lenalidomide, you should seek emergency medical care if needed and contact the study staff right away. Women who are able to become pregnant that might be caring for you should not touch the lenalidomide capsules or bottles unless they are wearing gloves. Any unused Revlimid® (lenalidomide) should be returned as instructed through the RevAssist® program.
Arm 1:
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
Arm 2:
You will take sorafenib by mouth 1 time each day of every cycle (Days 1-28). You should take it with a cup (8 ounces) of water, after taking lenalidomide. You should not eat or drink anything other than water for at least 1 hour before or after taking sorafenib.
Arm 3:
You will receive temsirolimus by vein over 30-60 minutes on Days 1, 8, 15, and 22 of each cycle.
Arm 4:
You will receive oxaliplatin and leucovorin by vein over 2 hours on Day 1 of each cycle. You will also receive 5-FU by vein over 22 hours at home on Days 1-2. The drug will be given through a pump that you carry with you.
Study Visits:
At all study visits, you will be asked about any side effects you may be having and about any other drugs you may be receiving.
On Day 1 of Cycle 1, the following tests and procedures will be performed if they were not performed within 7 days before Day 1 of Cycle 1:
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
On Day 15 of Cycle 1, blood (about 1 tablespoon ) will be drawn for routine tests.
On Day 1 of every even numbered cycle (Cycles 2, 4, 6, and so on):
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
At the end of every even numbered cycle (Day 28 for Arms 1, 2, and 3; Day 21 for Arm 4):
* You will have a CT scan, MRI scan, positron emission computed tomograph (PET) scan, or a PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed. The study doctor will explain these other types of scans to you in more detail, and you may be asked to sign a separate consent form that describes the scans and their risks in more detail.
* If your study doctor thinks it is needed, you will have either a CT or MRI scan of the brain to check the status of the disease.
* Blood (about 1 tablespoon) will be drawn for tumor markers.
On Day 1 of every odd numbered cycle (Cycles 3, 5, 7, and so on):
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
Pregnancy Testing:
If you are a woman who is able to become pregnant, you will have blood (about 1 teaspoon) or urine pregnancy tests on Day 1 of every cycle, 1 time each week during the first cycle, when you stop taking the study drugs, and 30 days after you stop taking the study drugs.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
Follow-Up Visit:
Thirty (30) days after you stop taking the study drugs for any reason, the following tests and procedures will be performed:
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 2 tablespoons) will be drawn for routine tests and tumor marker testing.
* You will have an ECG.
* You will have a CT scan, MRI scan, PET scan, or PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans that have not been listed here may also be performed. The study doctor will explain these other types of scans to you in more detail, and you may be asked to sign a separate consent form that describes the scans and their risks in more detail.
* If your study doctor thinks it is needed, you will have either a CT or MRI scan of the brain to check the status of the disease.
This is an investigational study. All of the study drugs are FDA-approved and commercially available for use in various types of cancer:
* Lenalidomide: multiple myeloma and myelodysplastic syndrome
* Bevacizumab: colorectal and lung cancers
* Sorafenib: liver carcinoma and renal cell carcinoma
* Temsirolimus: renal cell carcinoma
* 5-FU: cancers of the breast, pancreas, colon/rectum, stomach, and a type of skin cancer (superficial basal cell carcinoma)
* Oxaliplatin and leucovorin: colorectal cancer
It is investigational to give lenalidomide in combination with each of the other drugs to patients with advanced cancer.
Up to 180 participants will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- DRUG : Lenalidomide
- Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
- Other Names :
- CC-5013, Revlimid
- DRUG : Bevacizumab
- Starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
- Other Names :
- Avastin, Anti-VEGF monoclonal antibody, rhuMAB-VEGF
- DRUG : Sorafenib
- Starting dose: 200 mg by mouth daily for 28 a day cycle.
- Other Names :
- Nexavar, BAY 43-90006
- DRUG : Temsirolimus
- Starting dose: 15 mg by vein every week for a 28 day cycle.
- Other Names :
- CC-779, Torisel
- DRUG : Lenalidomide
- Starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle.
- Other Names :
- CC-5013, Revlimid
- DRUG : Oxaliplatin
- Starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle.
- Other Names :
- Eloxatin
- DRUG : Leucovorin
- 400 mg/m2 by vein on day 1 of a 21 day cycle.
- Other Names :
- Citrovorum, Wellcovorin
- DRUG : 5-fluorouracil
- 400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.
- Other Names :
- 5-FU, Adrucil, Efudex
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with advanced or metastatic cancer that is refractory to standard therapy, has relapsed after standard therapy, or for which there is no standard therapy available.
* Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, therapeutic radiation, or major surgery. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. Patients may have received palliative localized radiation immediately before or during treatment, providing radiation is not delivered only to the site of disease being treated under this protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2
* Patients must have normal organ and marrow function, defined as absolute neutrophil count >= 1,000/mL; platelets >=50,000/mL (unless these abnormalities are due to bone marrow involvement); creatinine clearance >= 50 ml/min by Cockcroft-Gault formula; total bilirubin <= 2.0; and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase(SGPT) <= 5 X upper limit of normal (ULN) (unless patient has liver metastases).
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
* Patients must be able to understand and be willing to sign a written informed consent document.
* Must be >= 18 years.
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
* Use of any other experimental drug or therapy within 21 days of baseline.
* Known hypersensitivity to thalidomide.
* History of hypersensitivity to any component of the formulation.
* The development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Patients unwilling or unable to sign informed consent document.
* Uncontrolled systemic vascular hypertension (Systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg on medication) for patients treated in the bevacizumab or sorafenib arms.
* Patients with active deep venous thrombosis or pulmonary embolism or patients receiving anti-coagulation.
* Patients with clinically significant cardiovascular disease: History of cerebro-vascular accident (CVA) within 6 months; Myocardial infarction or unstable angina within 6 months; Unstable angina pectoris.
* Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 of protocol treatment.
* Patients that are taking CYP3A4 inducers and/or inhibitors, being considered for the temsirolimus arm: If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the temsirolimus arm, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on the temsirolimus arm.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01183663
|
{
"brief_title": "Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)",
"conditions": [
"Advanced Cancers"
],
"interventions": [
"Drug: 5-fluorouracil",
"Drug: Oxaliplatin",
"Drug: Sorafenib",
"Drug: Lenalidomide",
"Drug: Temsirolimus",
"Drug: Bevacizumab",
"Drug: Leucovorin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01183663",
"official_title": "A Phase I Study of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) in Patients With Advanced Cancers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2010-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-03",
"last_updated_that_met_qc_criteria": "2010-08-16",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-17",
"first_submitted": "2010-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Research shows that older people need reminders to increase fluid consumption. The aim of the research was to investigate the effect of an audible alarm on the fluid consumption of old people living in a nursing home. The research was conducted as a single-blind, randomized controlled, prospective experimental study on the pre-test post-test model.
The study was performed between 27 July 2017 and 1 February 2018 at a nursing home in the west of Turkey. Out of 979 in nursing home who conformed to the inclusion criteria of the study, 100 (intervention group (n: 50) and control group (n: 50) were voluntarily included in the sample. The intervention group was given education and a wristwatch which gave an audible alarm to remind them to drink liquid, the control group was given only education. The old people in both groups were monitored before the education, after the education, after the audible alarm and 15 days after the audible alarm every three days on total of 12 days. The amount of liquid that the elderly should drink daily was determined according to Gaspar formula.
#Intervention
- BEHAVIORAL : Intervention group
- The elderly in this group were trained using the 'For Your Health For Fluid' training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes.
A Beyid wristwatch was used. This spoke the time in Turkish, every hour on the hour. In this way, the old people were reminded to drink a glass of liquid each hour. The watch had an alarm capability, and could be taken on to sleep mode at night in order not to wake the old people.
- BEHAVIORAL : Control group
- The elderly in this group were trained using the 'For Your Health For Fluid' training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Criteria for inclusion in the study were being aged 65 or over, not having a fluid deficiency and living in nursing home.
Exclusion Criteria:
* Exclusion criteria were having an education level of less than primary education
* Being visually or aurally impaired,
* Being bedridden,
* Not being able to take liquids orally, Having health problems such as fever,
* Vomiting, diarrhea or kidney disease causing fluid loss,
* Taking diuretic medication and using more than more than five doses per day,
* Having a diagnosis of a disease such as kidney failure or cardiac insufficiency requiring restriction of fluids, or having a diagnosis of neurological or psychiatric dysfunction, or dementia or Alzheimer's.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04242745
|
{
"brief_title": "The Effect of Audible Alarm on the Fluid Consumption of the Elderly",
"conditions": [
"The Elderly"
],
"interventions": [
"Behavioral: Control group",
"Behavioral: Intervention group"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04242745",
"official_title": "The Effect of an Audible Alarm on the Fluid Consumption of The Elderly Living in a Nursing Home: A Randomized, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-01",
"study_completion_date(actual)": "2019-12-20",
"study_start_date(actual)": "2017-07-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-27",
"last_updated_that_met_qc_criteria": "2020-01-24",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-27",
"first_submitted": "2020-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years).
The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.
#Intervention
- DRUG : alfuzosin (SL770499)
|
#Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents of either gender 2 <= age <= 16 years with elevated detrusor LPP of neuropathic etiology.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00629720
|
{
"brief_title": "Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology",
"conditions": [
"Urinary Bladder Neurogenic"
],
"interventions": null,
"location_countries": [
"Serbia",
"United States"
],
"nct_id": "NCT00629720",
"official_title": "Four-week, Open-label, Multicenter, Randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-02",
"study_completion_date(actual)": "2007-02",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-12-15",
"last_updated_that_met_qc_criteria": "2008-02-26",
"last_verified": "2009-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-06",
"first_submitted": "2008-02-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.
Detailed Description
This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 0 to 6 months;
* Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
* Unable to breastfeed;
* Vital signs are stable;
* Legal guardian has signed the informed consent.
Exclusion Criteria:
* Subject with congenital and hereditary metabolic diseases;
* Digestive tract obstruction;
* Subject with immunodeficiency diseases;
* Subject who is allergic to known components of amino acid formula powder;
* The investigator judges it is not suitable for the subject to participate in this study.
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03769051
|
{
"brief_title": "Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula",
"conditions": [
"Cow's Milk Protein Allergy"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03769051",
"official_title": "Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-28",
"study_completion_date(actual)": "2019-04",
"study_start_date(actual)": "2015-06-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-06",
"last_updated_that_met_qc_criteria": "2018-12-06",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-07",
"first_submitted": "2018-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.
Detailed Description
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner.
The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.
#Intervention
- DEVICE : Auto-titrating mandibular positioner test
- Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
|
#Eligibility Criteria:
Inclusion Criteria:
* Minimum 18 years
* Participant has been deemed suitable for oral appliance therapy
* Prescription for oral appliance
* Adequate range of motion
* Adequate dentition
* Ability to understand and provide informed consent
* Ability and willingness to meet the required schedule
Exclusion Criteria:
* Loose teeth or advanced periodontal disease
* Full dentures
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03049982
|
{
"brief_title": "A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test",
"conditions": [
"Obstructive Sleep Apnea"
],
"interventions": [
"Device: Auto-titrating mandibular positioner test"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03049982",
"official_title": "A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-17",
"study_completion_date(actual)": "2018-10-17",
"study_start_date(actual)": "2017-02-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-07",
"last_updated_that_met_qc_criteria": "2017-02-07",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-10",
"first_submitted": "2017-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
#Intervention
- BIOLOGICAL : GSK Biologicals' FluLaval®
- Intramuscular injection
- BIOLOGICAL : Placebo (saline)
- Intramuscular injection
- BIOLOGICAL : GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
- Intramuscular injections
- BIOLOGICAL : GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
- Intramuscular injections
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
* Written informed consent obtained from the subject.
* Male or female adults, 19 <= age <= 40 years at the time of the first vaccination.
* Body weight of at least 110 pounds (49.9 kg).
* Safety laboratory tests results within the parameters specified by protocol.
* Satisfactory baseline medical assessment by physical examination (stable health status with no exclusionary conditions). Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
* Female subjects of non-childbearing potential may be enrolled in the study.
* Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy, or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Exclusion Criteria:
* Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine
* A medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
* Prior receipt at any time of any seasonal influenza vaccine.
* Planned administration of any vaccine not foreseen by the study protocol (including any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.
* Administration of any licensed vaccine within 30 days before the first study vaccine dose.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Receipt of systemic glucocorticoids (e.g., prednisone >= 0.5 mg/kg/day, or >= 10 mg/day [whichever is less] for more than 14 consecutive days) within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
* Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* History of anemia.
* Presence of a temperature >= 38.0ºC (>=100.4ºF), (oral temperature assessment preferred), or acute symptoms greater than 'mild' severity on the scheduled date of first vaccination
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (No laboratory testing is required.)
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of any vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to any vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-HCG) test result prior to first vaccination.
* Lactating or nursing women.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01059617
|
{
"brief_title": "Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A",
"Biological: GSK Biologicals' FluLaval®",
"Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A",
"Biological: Placebo (saline)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01059617",
"official_title": "A Study to Evaluate Immune Responses Following A/California/7/2009 (H1N1)V-like Virus Vaccination Given 4 Months Following Seasonal Influenza Vaccination in Adults 19 to 40 Years of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01-14",
"study_completion_date(actual)": "2011-10-21",
"study_start_date(actual)": "2010-02-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-20",
"last_updated_that_met_qc_criteria": "2010-01-28",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-01",
"first_submitted": "2010-01-28",
"first_submitted_that_met_qc_criteria": "2012-05-03"
}
}
}
|
#Study Description
Brief Summary
Background: It is not often written in medical journals that preduodenal portal vein, biliary atresia, intestinal malrotation, and situs inversus totalis are all related.
Case reports: A two-month-old female infant had biliary atresia type III, situs inversus totalis, midgut malrotation, and preduodenal portal vein. She had been operated on by the Kasai procedure (hepato-portoenterostomy).
Discussion: It is important to carefully look into the relationship between preduodenal portal vein and biliary atresia because the patient at a risk of injury from this aberrant vein at operative intervention.
Detailed Description
A full-term female infant, G1P1, weighing 3450 g at birth, was referred to our department at the age of 2 months old with severe jaundice and poor feeding. The mother reported yellow sclera and skin, lightning-colored stool, and dark colored urine a few days after birth, which were progressively aggravated.
On physical examination, the infant had an olive-green colored sclera and skin with an itching mark, a pale clay stool in the diaper, a law grade fever of 37.8°C, a weight of 3870 g, a pulse rate of 138 b/m, and a respiratory rate of 38 b/m. The heart sounds and breath sounds were normal. The abdomen was soft and lax on examination. The liver was two fingers below the costal margin. The intestinal sound was normal.
The laboratory investigation revealed that total bilirubin was elevated at 7 mg/dl, direct bilirubin was elevated at 4 mg/dl, GGT was elevated at 157,1 U/L, alkaline phosphatase was elevated at 279 U/L, and albumin was decreased at 3.4 g/dL.
Abdominal ultrasonography revealed a triangular cord sign in the liver hilum, an absent gall bladder, and a normal-sized spleen on the right side behind the liver. A chest x-ray revealed dextrocardia. The HIDA scan revealed failure of radioisotope excretion in the duodenum . Non-contrast magnetic resonance cholangiopancreatography (MRCP) showed that the common hepatic duct and the common bile duct could not be seen. Preoperative percutaneous liver biopsy reported liver fibrosis, bile ductules proliferation and cholestasis.
An experienced pediatric surgeon obtained the decision for exploratory laparotomy by right subcostal abdominal incision. The spleen is located in the right upper quadrant behind the liver. Extracorporealization of the liver is done . The gall bladder was rudimentary. On further exploration, the principle investigator also found intestinal malrotation (IM) and PDPV. All extrahepatic bile ducts were absent; type III portal atresia. The portal palate was dissected easily and the rudimentary gall bladder was removed.
Widening of the narrow base of the intestinal mesentery, then reconstruction of the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation) was done . A wedge liver biopsy obtained reported ductular proliferation, hepatic fibrosis, and bile plugs; a feature suggestive of biliary obstruction.
The post-operative follow-up of the patient revealed features of bile drainage in the intestine; the stool returned to its normal brawn color; and the yellow skin color was slightly improved. Total bilirubin was 4 mg/dl and direct bilirubin was 2 mg/dl. The patient was discharged on the tenth post-operative day.
#Intervention
- PROCEDURE : hepato-portoentostomy
- the retro-colic Roux-en-Y limb of the jejunum, and finally hepato-portoentostomy (Kasai operation)
- Other Names :
- (Kasai operation)
|
#Eligibility Criteria:
Inclusion Criteria:
* Biliary atresia with another syndrome
Exclusion Criteria:
* Biliary atresia alone
Sex :
FEMALE
Ages :
- Minimum Age : 2 Months
- Maximum Age : 3 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05917236
|
{
"brief_title": "Biliary Atresia With Rare Associations, a Case Report",
"conditions": [
"BA - Biliary Atresia"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT05917236",
"official_title": "Biliary Atresia and Preduodenal Portal Vein",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-01",
"study_completion_date(actual)": "2022-09-01",
"study_start_date(actual)": "2021-09-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-23",
"last_updated_that_met_qc_criteria": "2023-06-22",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-23",
"first_submitted": "2022-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco Products Directive (TPD) within the context of FCTC ratification at an EU level. The investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany, Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.
EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation programme under grant agreement No 681109
Detailed Description
Smoking and other forms of tobacco consumption are considered the single most important cause of preventable morbidity and premature mortality worldwide, with tobacco the major single cause for premature deaths in the European Union (EU).Efforts to reduce the devastation of tobacco-related deaths and illness in the EU consist of its newly adopted binding legislation, the Tobacco Products Directive (TPD), and the ongoing implementation of the WHO Framework Convention on Tobacco Control (FCTC).
Objective:
The main objective of EUREST-PLUS is to monitor and evaluate the psychosocial and behavioral impact of the TPD within the context of FCTC ratification at a European level, through the creation of a cohort study of adult smokers in 6 EU MS (Germany, Greece, Hungary, Poland, Romania, Spain; total n=6000) in a pre- vs. post-TPD study design. The baseline recruitment will take place in WP2 and the follow up in WP3.
Sampling frames:
* The sampling frame will be determined through a national probability sampling design within each country.
* Sample stratification will be geographic and comprise the major regions of each country (Nomenclature of Territorial Units for Statistics - NUTS) NUTS2 (Basic regions for the application of regional policies) will be used for all countries except Germany - where NUTS1 (Major socio-economic regions) will be used, as well as degrees of urbanization (city/town/rural.)
* Geographic areas excluded from the sampling design will be: In Greece, the islands in the Ionian Sea, the northern Aegean Sea and the southern Aegean Sea. In Spain the Canaries, Ceuta and Melilla
* Overall the design will be multistage within strata. The strata will be conceptually divided into clusters, each the size of an enumeration area, with the objective of sampling a total of 250 clusters - 4 adult smokers per cluster in every country.
* Clusters will be allocated based on population size and sampled via random sampling.
Sampling households within clusters:
* Interviewers will employ a random walk procedure within a particular cluster
* Once interviewers have arrived at an address, the household will be approached four times at different times of the day and week before being designated as 'unable to be contacted.'
* If an address corresponds to multiple households, a single household will be chosen at random.
* Households are approached until a total of 4 adult smokers have been reached within the cluster. A maximum of one male smoker and one female smoker will be selected for interview in each household.
* One male and one female from within the household that meet the criteria will be selected using the last birthday method
Respondents:
* The respondents for the Survey will be smokers aged 18 and older. The first part of the survey, which is the household screener, contains the questions that are used to determine whether the household has members that meet the criteria for inclusion.
* The household screener is asked of the most knowledgeable individual (MKI) within the household.
* One male and one female from within the household that meet the criteria will be selected using the last birthday method.
* The Individual screener follows the Household screener and confirms the information from the MKI is accurate. If the selected individual meets the eligibility criteria and consents to participate, they will be included in the sample
Survey (questionnaire):
The questionnaire will include questions not only about tobacco use, history of use, history of quitting, quit method(s) used, measures of dependence, and demographics (age, gender, education, income) but also extensive, theory-based measures of responsiveness to each policy domain of the FCTC. The survey questionnaire will consist of:
1. multiple measures of policy-specific variables for each of the domains of the TPD and FCTC (e.g., health warnings, additives, e-cigarettes for TPD, illicit trade; additional domains of the FCTC, including smoke-free laws, tax/price policies, cessation services, additional product regulation domains);
2. psychosocial mediators, identified by past research and theory to predict future health behaviours, including beliefs and attitudes, perceived risk, intentions to quit;
3. moderators such as demographic variables (sex, gender), and other variables that will allow analyses of whether TPD and FCTC policies vary in their impact as a function of socioeconomical status.
#Intervention
- OTHER : Questionnaire
- Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be 18 years or older.
* Must smoke at least monthly.
* Must have smoked 100 cigarettes in their lifetime.
* Must live in the household visited
Exclusion Criteria:
* Inability to complete the questionnaire due to health/mental incapability.
* Unable to provide consent to participate.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02773836
|
{
"brief_title": "European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)",
"conditions": [
"Tobacco Dependence"
],
"interventions": [
"Other: Questionnaire"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02773836",
"official_title": "European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09-12",
"study_completion_date(actual)": "2018-05-06",
"study_start_date(actual)": "2016-06-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-03",
"last_updated_that_met_qc_criteria": "2016-05-13",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-16",
"first_submitted": "2016-05-11",
"first_submitted_that_met_qc_criteria": "2019-02-19"
}
}
}
|
#Study Description
Brief Summary
200 patients took part in the questionnaire and were examined using the PSI. Thereafter the participants were divided into two groups, non-periodontitis persons (group 1; PSI 0-2) and periodontitis persons (group 2; PSI 3-4). The answers were evaluated using a point system ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of influence. Receiver-operating characteristic (ROC) curve analyses were applied to examine the overall discriminatory power, sensitivity and specificity, and corresponding cut-off points of the self-reported periodontal disease scale.
Detailed Description
Materials and Methods
This clinical investigation was approved by the Ethics Commission at the Medical Faculty in Leipzig (337-13-18112013). Before commencing the double-blind, controlled clinical trial (), all study participants were informed of its content and the use of personal data and confirmed their voluntary willingness to take part in writing.
Patients
A new questionnaire was used as part of a preliminary dental examination to interview a total of 200 patients concerning the clinical indications and periodontal risk factors. The clinical follow-up examination was conducted by the Periodontal Screening Index (PSI). To include representative periodontitis patients a consecutive sampling was applied. The participants were divided into two groups of non-periodontitis patients (group 1; PSI Code 0,1,2) and periodontitis persons (group 2; PSI Code 3 and 4) for the first PSI classification (Perio 1). The sampling was finished until each group reached a number of hundred patients. To reduce the so-called center effect \[25\] the patients were all unknown to the examiners. Patients were also required to be at least 18 years to take part in the study. Patients undergoing a periodontal treatment, pregnant and disabled persons were also excluded from the study.
Periodontal Situation (PSI, PSR®)
The Periodontal Screening Index (PSI in Germany) or Periodontal Screening and Recording (PSR®) \[12,13\] was registered based on a WHO probe (Morita, Kyoto, Japan). The set of teeth was divided into sextants for the purpose of the investigation. The PSI scores (0 to 4) were recorded: score 0=healthy, score 1=bleeding, score 2=supra-/subgingival calculus, score 3=probing depths from 3.5mm to max. 5.5mm, score 4=probing depths greater than 5.5mm. We noted only the highest findings for each sextant. Persons with findings of code 0 to code 2 were classified as non-periodontitis persons (group 1), whereby codes 3 and 4 were considered a probable periodontitis persons (group 2). Two additional PSI classifications were defined in order to review the robustness of the screening test with respect to the prevalent severity of periodontitis. Classification Perio 2 comprised persons with a PSI code 0,1,2 and once code 3, indicating non-periodontitis, while persons recording two codes 3 or 4 on one occasion were periodontitis persons. In the third classification (Perio 3), only such patients as exhibited at least one code 4 were considered as periodontitis persons, while all others were evaluated as non-periodontitis persons.
All clinical recordings were performed by the same calibrated examiners. Examiners calibration was performed as follows: five adults, not enrolled in the study, were evaluated by the examiners on two separate occasions, 48 hours apart. Calibration was accepted if the millimetre measurements at baseline and 48 hours later did not differ more than 10 percent.
Questionnaire
The questionnaire was initially prepared by a retrospective selection of suitable items reviewed in current literature on the subject of periodontal risk factors and indicators. Research was conducted using PubMed, whereby only articles written in English were included. Systematic reviews and randomised, controlled studies were preferred. Based on this 16 questions were developed. The individual response options were assigned point values extending from zero to eight, based on their assumed degree of influence on the periodontal disease. To determine the correct wording and phrasing the questionnaire was given as a pretest to 20 patients not included in the study.
Statistical analysis
Statistical evaluation was conducted using SPSS for Windows, Version 22.0 (SPSS Inc., NY, U.S.A.) and BiAS. for Windows, Version 10.12. (epsilon-Verlag GbR, Hochheim Darmstadt, Germany). The sample size (200 participants) was calculated with an expected standard deviation of four score points, minimal different score point delta between 1.6 and 2, p-value of 0.05 and a power of 0.8 \[24\]. The categorised data was evaluated based on the Chi-squared test (question 2-6, 8-12, 15, 16), the precise test according to Fisher (question 1, 7, 13, 14). A two-sided review of significance was applied to each of the tests, whereby a p-value of \<0.05 was assumed to be statistically significant for all statistical tests.
The distribution of total score was reviewed according to the Kolmogorov-Smirnov test in terms of normal distribution. The score did not exhibit a normal distribution (Kolmogorov-Smirnov test: p\<0.05). Furthermore the Mann-Whitney U-test was applied in the comparison of scores based on the variety of periodontitis classifications (differentiated consideration of periodontally diseased persons) and box plots were created to elucidate the data.
ROC curves (receiver operating characteristic) were produced to illustrate sensitivity and specificity. The area under the ROC curve (AUC), which in a test without forecast reliability will be 0.5 and not more than 1, is a benchmark to measure forecast reliability. The cut-off point was defined as beyond a sensitivity of at least 80% with the greatest possible specificity in order to meet the requirements of a screening test.
#Intervention
- OTHER : 16 Items
- Patients took part in the questionnaire and were examined using the PSI (periodontal screening index).
- Other Names :
- self-reported questionnaire
- OTHER : PSI
- The PSI scores (0 to 4) were recorded: score 0=healthy, score 1=bleeding, score 2=supra-/subgingival calculus, score 3=probing depths from 3.5mm to max. 5.5mm, score 4=probing depths greater than 5.5mm. Only the highest finding was noted for each sextant. Persons with findings of code 0 to code 2 were classified as non-periodontitis persons (group 1), whereby codes 3 and 4 were considered a probable periodontitis persons (group 2).
- Other Names :
- periodontal screening index
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients were all unknown to the examiners
* Patients were also required to be at least 18 years
* All study participants were informed of its content and the use of personal data and confirmed their voluntary willingness to take part in writing.
Exclusion Criteria:
Patients undergoing a periodontal treatment, antibiotic therapy, pregnant and disabled persons were also excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02754401
|
{
"brief_title": "Evaluation of a New Self-reported Tool for Periodontitis Screening",
"conditions": [
"Periodontitis and Treatment Need"
],
"interventions": [
"Other: 16 Items",
"Other: PSI"
],
"location_countries": null,
"nct_id": "NCT02754401",
"official_title": "Evaluation of a New Self-reported Tool for Periodontitis Screening.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-07",
"study_completion_date(actual)": "2014-07",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-29",
"last_updated_that_met_qc_criteria": "2016-04-25",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-28",
"first_submitted": "2016-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.
#Intervention
- DRUG : Clofarabine in combination with IV busulfan and ATG
- A conservative approach has been used for the determination of the dose due to the high risk studied population, e.g., decrease to 30 mg m²/day for a 4-day course of clofarabine. Clofarabine will be started at Day -8 to allow improvement of liver function tests, if any, by time of allo-HSCT. Clofarabine (C) 30 mg/m²/day for 4 days (day -8 to day-5). Busilvex (B): 3.2 mg/kg/day for 2 days (day -4 and day-3)Thymoglobuline (T): 2.5 mg/Kg/day for 2 days (day -2 and day-1). Graft (G) at day 0 GVHD prophylaxis: Cyclosporine 3 mg/kg/day starting day-1. Genzyme provided supplies of clofarabine for all patients included in the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 65
* For patients younger than 50 years, cons-indication for the use of a standard myeloablative conditioning (history of hematopoietic stem cell transplantation autologous or allogeneic, or the presence of co-morbidities or medical history making prohibitive in terms toxicity using chemotherapy and / or high dose radiotherapy as judged by the referring physician) - MDS, ALL or AML at high risk, WHO THE biphenotypic-Score <2
* Any primary diagnosis of high-risk MDS/AML or ALL eligible for a treatment by reduced intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (allo-SCT)
* Suitable donor available (related or matched unrelated)
* Cardiac: LV Ejection Fraction >= 50% by MUGA or Echocardiogram.
* Pulmonary: FEV1 and FVC >= 50% predicted, and DLCO (corrected for hemoglobin) >= 50% of predicted
* Adequate renal and hepatic function
* Performance status: Karnofsky >= 70%
* Informed consent signed by patient prior to enrolment
Exclusion Criteria:
* Age <18
* Age >65
* Known hypersensitivity to clofarabine or excipients- Other hematologic malignancies than ALL, AML and MDS
* Patients with prior standard allogeneic HSCT with grade > 2 aGvHD
* Prior standard allogeneic transplantation if < 2 months
* Contra-indication to one of the drug of the RIC regimen .
* Patient with > 3 treatment lines prior to inclusion
* Pregnant or lactating females
* Patient HIV+, Hep B+, Hep C+- Uncontrolled systemic infection
* Performance Status Score ECOG > 2- Known central nervous system involvement with AML or ALL- Uncontrolled active infection of any kind or bleeding
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.
* For patients younger than 50 years, possibly indicating a standard myeloablative conditioning
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00863148
|
{
"brief_title": "Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)",
"conditions": [
"MDS",
"AML",
"ALL",
"BAL"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00863148",
"official_title": "A Phase II Open-label, Multicenter, Non Randomized Study Evaluating the Efficacy and the Safety of Clofarabine in Combination With IV Busulfan and Thymoglobulin (CBT) as a Reduced Intensity Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Adult Patients With High-risk AML, MDS or ALL.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-19",
"last_updated_that_met_qc_criteria": "2009-03-16",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-17",
"first_submitted": "2009-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
upplementing general anaesthesia with caudal analgesia in sphincter sparing procedures might be useful as it will provide a satisfactory combination of sphincter muscle tone preservation, good intraoperative and postoperative analgesia along with a reduction in the consumption of opioids and anaesthetic drugs. To the best of our knowledge, this anaesthetic technique was not tested in sphincter sparing procedures before.
Detailed Description
Anal fistulae, defined as an abnormal connection between the distal alimentary tract and the integument, are among the common illnesses affecting the anal canal, with a prevalence rate of 8.6 cases per 100,000.1 Usually, anorectal fistulae are safely and reliably treated by fistulotomy. One of the common complications of fistulotomy is incontinence due to sphincter injury, with an incidence reaching up to 12%2. Moreover, this technique is not well suited for complex anal fistulae due to the prevalent risk of incontinence reaching up to 50%2. That created the need for sphincter sparing procedures to evolve which do not involve division of any portion of the sphincter complex, thus evolvement of an anaesthetic technique which spares the presence of muscle tone, and provides good postoperative analgesia.2,3 The choice of anaesthetic technique for sphincter sparing procedures is challenging. Regional anaesthetic techniques such as saddle, lumbar epidural, and caudal blocks are considered well tolerable and reliable for anorectal surgery. Lumbar epidural local anaesthesia does not produce a uniform anaesthetic effect across the spinal segments as the large size of the L5 and S1 nerve roots may be resistant to the local anaesthetic effect and The cranial spread of lumbar epidural anaesthesia is somewhat more extensive than the caudal spread which suggest that the onset of the block of the caudal sacral segments may be later than that of the lumbar segments. 4On the other hand, saddle anaesthesia is the preferred route for most of the anorectal surgeries as it abolishes the muscle tone5; however, loss of the muscle tone consequently increases the possibility of the external anal sphincter injury in complex anal fistulas. Thus; sphincter sparing procedures are usually performed under general anaesthesia omitting neuromuscular blocking agents in order to preserve sphincter tone intraoperatively.6 However, the choice of general anaesthesia for this procedure still lacks adequate postoperative analgesic plan.
Caudal block is not a commonly used route for analgesia in adults due to the evolution of lumbar epidural block5. The introduction of ultrasound for guiding different blocks, including caudal block had increased the use of caudal block7 especially when sacral nerve spread of anaesthetics is preferred over lumbar nerve spread8. Modern epidural dosing regimens (e.g. 0.0625% to 0.1 % bupivacaine with 2-4 mcg/ml fentanyl) 6,9 reduce the total local anaesthetic dose required and motor block experienced; potentially allowing the patient to be ambulatory.
Therefore, Supplementing general anaesthesia with caudal analgesia in sphincter sparing procedures might be useful as it will provide a satisfactory combination of sphincter muscle tone preservation, good intraoperative and postoperative analgesia along with a reduction in the consumption of opioids and anaesthetic drugs. To the best of our knowledge, this anaesthetic technique was not tested in sphincter sparing procedures before.
#Intervention
- PROCEDURE : Caudal block
- caudal block with low dose bupivicaine 0.25% to preserve tone
- DRUG : Morphine
- morphine to control pain and avoid using muscle relaxant
|
#Eligibility Criteria:
Inclusion Criteria:
* with complex anal fistula -
Exclusion Criteria:
* known hypersensitivity to amide type local anesthetics, contraindications to caudal block such as use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure, severe aortic and / or mitral valve stenosis, and ischemic hypertrophic sub aortic stenosis, along with BMI (Body mass index) > 35 kg/m2 , anatomical abnormalities or previous surgeries involving the sacrum.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04651595
|
{
"brief_title": "Efficacy of Caudal Block on Intra-operative Anal Sphincter Muscle Tone and Post-operative Analgesia During Anal Sphincter Sparing Procedures Under General Anaesthesia",
"conditions": [
"Efficacy of Caudal Block on Intra-operative Anal Sphincter Muscle Tone"
],
"interventions": [
"Procedure: Caudal block",
"Drug: Morphine"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04651595",
"official_title": "Efficacy of Caudal Block on Intra-operative Anal Sphincter Muscle Tone and Post-operative Analgesia During Anal Sphincter Sparing Procedures Under General Anaesthesia: A Randomized Control Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-01",
"study_completion_date(actual)": "2021-12-01",
"study_start_date(actual)": "2021-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-20",
"last_updated_that_met_qc_criteria": "2020-12-02",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-03",
"first_submitted": "2020-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans often present to their primary care providers with symptoms of PTS and related physical problems; however, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care.
In this study instigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training for primary care providers by taking the following steps: (1) partner with stakeholders to iteratively design the training which takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) perform a randomized control trial to compare the virtual world training with an online training, and (3) summarize the findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.
Detailed Description
The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans who have PTS symptoms after military service are often resistant to referrals to mental health care because of the warrior culture of stoicism coupled with the stigma of seeking mental health care. Also, Veterans living in rural or remote areas may not have access to trained mental health professionals. Thus, Veterans often present to their primary care providers with symptoms of PTS and related physical problems. Unfortunately, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care. This can result in missed opportunities to intervene to prevent what may become chronic mental and physical health problems in the future, which affect not only the warfighter, but also their families, partners and children.
In a prior project funded by the Department of Defense (DoD), study investigators created and tested a web-based training program to teach primary care providers about how to assess for and manage PTS which proved successful in a small pilot study. Nevertheless, primary care providers who participated in the training reported that the training was not interactive and engaging enough and about 30% did not complete it. Moreover, the pilot study did not use gold standard methods to measure study outcomes and because project stakeholders, namely the Veterans Administration (VA) and the DoD, did not participate in the development of the training, investigators were not able to easily implement and disseminate it to primary care clinicians who work in these healthcare systems.
Virtual World technology is a three-dimensional immersive and highly interactive online experience in which users enter virtual environments as self-styled representations of themselves, known as avatars. Virtual Worlds are used in some of the most popular and engaging commercially-available video games. Virtual World technology is also increasingly being used for educational activities, particularly in learning about mental health problems and communication techniques. This is because experiences like mental health symptoms such as re-experiencing or intrusive thoughts (flashbacks) can be simulated, and participants (as avatars) can practice and receive feedback on new communication skills without feeling self-conscious. Learners can also practice motivational interviewing techniques such as using a stylized virtual scale to literally weigh the pros and cons (represented as blocks) of a particular behavior change. These interactive activities afforded by Virtual World technology can be used to make the learning experience far more memorable and enduring.
In this study, investigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training by taking the following steps: (1) partner with stakeholders to iteratively design the training so that is responsive to stakeholder needs and takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) add a more robust evaluation component, including a randomized control trial with stronger provider and patient outcomes to achieve more valid results, and (3) summarize findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.
#Intervention
- OTHER : Virtual World
- Participants will complete a synchronous PTSD training in an immersive virtual world environment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary Care Providers (PCPs) currently practicing adult medicine (including licensed internists, family practitioners, nurse practitioners, physician assistants, allied health professionals and trainees working in Primary Care setting)
* English-speaking
Exclusion Criteria:
* Lack of sufficient time to participate in all required training sessions, homework and evaluations.
* Lack of a computer capable of running the Virtual World software
* Retired or retiring during the study period
* Vision or hearing impaired or other disability precluding the use of a computer or telephone*
* While this is an exclusionary criterion for this trial, prior to broader dissemination, at the conclusion of the study, we will make accommodations in the Virtual World training to make it Section 508-compliant for persons with disabilities.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03898271
|
{
"brief_title": "PTSD Training for PCPs in a Virtual World",
"conditions": [
"Post Traumatic Stress Disorder"
],
"interventions": [
"Other: Virtual World"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03898271",
"official_title": "Improving Access to Care for Warfighters: Virtual Worlds Technology to Enhance Primary Care Training in Posttraumatic Stress and Motivational Interviewing",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-30",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2015-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-23",
"last_updated_that_met_qc_criteria": "2019-03-29",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-01",
"first_submitted": "2019-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.
Detailed Description
* Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapy will be recruited 1:2 manner in two hospitals. Target numbers are 48 and 95, respectively.
* All the participants will be vaccinated for influenza during their chemotherapy when they meet inclusion criteria.
* All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination.
* Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-35 days after vaccination) will be examined in all participants to examine seroprotection rates, seroconversion rates, and changes in geometric mean titer.
* And they will be monitored for any vaccination-related adverse reaction or immune-related adverse events after 2-4 days(via phone call), and till 6 months after vaccination (when they visit oncology clinics).
#Intervention
- BIOLOGICAL : Influenza vaccination
- Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM
|
#Eligibility Criteria:
Inclusion Criteria:
* Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapeutic agent in Seoul National University Hospital or Seoul National University Bundang Hospital.
* Patients who was not vaccinated for influenza in 2018 <= age <= 2019 season
* ECOG performance status 0 or 1
* Patients who fulfilling following laboratory criteria Total bilirubin <= 1.5 x upper normal limit Aspartate transaminase, alanine transaminase <= 2.5 x upper normal limit Alkaline phosphatase <= 2.5 x upper normal limit Creatinine <= upper normal limit
* Patients who can understand and agreed with the informed consents.
Exclusion Criteria:
* Patients having contraindication for influenza vaccination (e.g. egg allergy)
* Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
* Patients with HIV infection
* Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
* Patients who have transplanted organ and receive immunosuppressants
* Patients who are suspected to have active infection (e.g. pneumonia)
* Patients who receive targeted chemotherapeutic agent alone for cancer treatment
* Patients who could not receive cancer chemotherapy due to hematologic abnormality at the date of the participation
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03590808
|
{
"brief_title": "Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor",
"conditions": [
"Influenza",
"Solid Carcinoma"
],
"interventions": [
"Biological: Influenza vaccination"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03590808",
"official_title": "Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-21",
"study_completion_date(actual)": "2019-05-30",
"study_start_date(actual)": "2018-09-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-19",
"last_updated_that_met_qc_criteria": "2018-07-10",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-18",
"first_submitted": "2018-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to compare selected CVD biomarker data between subjects who were long-term consumers of cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal endpoints related to CVD risk that differed among the three tobacco-use cohorts. The following assessments provided the primary study endpoints for comparative analyses between the cohorts:
1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired carbon monoxide (ECO).
2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect).
3. Biomarkers of tobacco exposure in urine and blood.
Detailed Description
This single site, observational study will provide an increased understanding of how consumption of different tobacco products (i.e., cigarettes and moist snuff compared to no tobacco use) affects 1) CVD-related physiological assessments and 2) CVD-related biomarkers of tobacco effect (i.e., proteins, lipids, and cellular components). A recent policy statement from the American Heart Association provides a review and analysis of the impact of smokeless (ST) use on cardiovascular disease (CVD) (Piano et al. 2010). The authors acknowledge that the evidence is consistent with the suggestion that the cardiovascular risks from ST products are markedly lower than those from cigarette smoking. Despite the potential risk reduction in transitioning from cigarettes to ST consumption, few studies have directly compared biomarkers of tobacco effect (BioEff) among smokers, moist snuff consumers (MSC) and non-tobacco consumers (NTC).
Furthermore, this study will measure biomarkers of tobacco exposure to assess their ability to differentiate the three tobacco consumer groups (smokers, moist snuff consumers, non-tobacco consumers) based on product use. Estimating exposures to combustion-related compounds found in tobacco smoke is best accomplished using biomarkers. A key advantage of human exposure biomarkers is that they are considered reliable metrics of the levels of exposure that consumers actually experience when using tobacco products (Hecht et al., 2010). Because combustion does not occur during ST use, ST products lack most of the combustion-related compounds found in tobacco smoke. Biomarker differences found between different tobacco use groups to harmful or potentially harmful constituents may indicate differences in subsequent health risks (Rodu and Godshall, 2006; Hatsukami et al., 2006).
Epidemiological data demonstrate that the health risks associated with cigarettes are significantly greater than those associated with the use of non-combustible tobacco and nicotine products (Surgeon General, 2010). On a relative risk continuum, cigarette smoking presents a significantly greater risk to tobacco users than use of non-combustible smokeless products. ST products, which are consumed orally, do no generate chemicals associated with the burning of tobacco, and thus, present a reduced toxicant profile compared to smoking.
To address the purpose and objectives of this study, the study was conducted as follows:
* Subjects were consented for the study prior to any procedures being performed and screened on study-specific inclusion/exclusion criteria to determine subject eligibility (within 28 days of study check-in).
* Eligible subjects were admitted to the clinical research unit between 12:00 noon and 5:00 p.m. on Day 1 and confined for one overnight stay (approximately 18-23 hours).
* After all study procedures were completed on Day 1 and Day 2, appropriate basic safety assessments were made and subjects were discharged approximately at 12:00 noon on Day 2.
A brief description of the study procedures performed is listed below.
* After check-in on Day 1, eligible subjects observed a 45-minute tobacco abstention period, followed by use of a single unit of their usual brand (UB) tobacco product, referred to as a 'Challenge.' For smokers, the 'challenge' was smoking one UB cigarette in their usual manner; for moist snuff consumers, a 30-minute use of one typical pinch of their UB moist snuff.
* Fifteen minutes after the end of UB use, the following procedures were performed sequentially: ECO; blood samples for biomarkers of exposure (serum nicotine and cotinine, percent carboxyhemoglobin in whole blood); and ABI.
* At 30 minutes post-UB use, FMD was measured followed by administration of health-related questionnaires. The non-tobacco consumers had no product 'Challenge'. The completion of study questionnaires served as the reference point for collection of ECO, ABI and FMD.
* Blood biomarkers of tobacco exposure were collected on Day 1 following product 'Challenge' and on Day 2 following an overnight tobacco abstention and fast.
* Urine biomarkers of tobacco exposure and effect were collected on both Day 1 post-'Challenge' and on Day 2 fasting.
* Blood biomarkers of tobacco effect were only collected on Day 2 fasting, followed by the re-assessment of the physiological measures (ECO, ABI, FMD) and assessment of CIMT.
#Intervention
- OTHER : Subject's usual brand (UB) tobacco product
- For SMK: UB of cigarettes; For MSC: UB of moist snuff
|
#Eligibility Criteria:
Inclusion Criteria:
* Smokers: exclusive FF (full flavor; > 13.0 mg FTC 'tar' ) or FFLT (full flavor, low 'tar' [6.0 to 13.0 mg FTC 'tar']) smokers who reported smoking at least 15 cigarettes daily for at least three years prior to Day 1 and whose ECO was 10 to 100 ppm (ranges of 2 to 9 ppm and 101 to 125 ppm were allowed upon joint review by the Sponsor and Investigator).
* Moist Snuff Consumers: exclusive oral smokeless tobacco users of any brand (Copenhagen, Skoal, Grizzly, Kodiak, Timber Wolf, Longhorn, Red Man, Levi Garrett, Beech-Nut, Chattanooga Chew, Kayak, etc.), any style (snuff cut, long cut, fine cut, pouch, loose, or plug) and any flavor (natural, straight, mint, wintergreen, etc.) who reported using at least two cans or packages per week for at least three years prior to Day 1 and whose ECO was 0 to 5 ppm (a range of 6 to 10 ppm was allowed upon joint review by the Sponsor and Investigator).
* Non-tobacco Consumers: never-smokers/never-ST users whose ECO was 0 to 5 ppm (a range of 6 to 10 ppm was allowed upon joint review by the Sponsor and Investigator).
* Male, between 26 and 49 years, inclusive (on Day 1 check-in).
* Free of clinically significant health problems in the opinion of the Investigator.
* Forced expiratory volume exhaled in one second (FEV1) >=70% of predicted at Screening.
* Willing to undergo all study procedures during confinement.
* Not taking medication on a daily basis for chronic medical disorders deemed clinically significant by the Investigator.
* Willing to suspend usage of daily aspirin or over-the-counter (OTC) medication seven days prior to Day 1.
* Not taking any creatine supplements.
* Negative tests for selected drugs of abuse and alcohol at Screening and at Day 1 check-in.
* Able to read and comprehend questionnaires in English.
* Able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
* At Screening, a BP that exceeds 140/90.
* <70% predicted FEV1 from three acceptable maneuvers.
* Unwilling to have the FMD procedure performed two or more times during confinement.
* Unwilling to have the ABI procedure performed two times during confinement.
* For the FMD determination, poor brachial artery visualization due to extremely deep position or severe artifacts (noise) due to overlying muscle that, in the sonographer(s)' opinion, would result in an inferior, unreadable or unobtainable brachial artery image.
* A donation of blood from 30 days prior to Screening through Day 1, inclusive, or of plasma from two weeks prior to Screening through Day 1, inclusive.
* Receipt of blood products within two months prior to Day 1 check-in.
* Evidence of visible oral cancer, as found in an oral health examination at Screening or based on oral health questions at Day 1 check-in.
* Subject who is an employee of the clinical site.
* Subject who has participated in any other investigational study drug or product trial in which receipt of an investigational study drug or product occurred within 30 days prior to Day 1 check-in, inclusive.
Sex :
MALE
Ages :
- Minimum Age : 26 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01692353
|
{
"brief_title": "Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers",
"conditions": [
"Cardiovascular Disease",
"Cigarette Smoking"
],
"interventions": [
"Other: Subject's usual brand (UB) tobacco product"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01692353",
"official_title": "Evaluation of Cardiovascular Disease Biomarkers in Exclusive Smokers and Exclusive Moist Snuff Consumers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-04",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-17",
"last_updated_that_met_qc_criteria": "2012-09-20",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-25",
"first_submitted": "2012-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries.
Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
Detailed Description
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
#Intervention
- BIOLOGICAL : Autologous Mesenchymal Stem Cells
- Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Complete spinal cord injury grade AIS-A or -B, or incomplete C
* At least 2 weeks since time of injury
* Cognitively unaffected
* Motivated for stem cell transplantation
Exclusion Criteria:
* Reduced cognition
* Age under 18 years of above 70 years
* Significant osteoporosis in spine and/or joints
* Pregnancy (Adequate contraceptive use is required for women in fertile age)
* Anoxic brain injury
* Neurodegenerative diseases
* Evidence of meningitis
* Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Syphilis.
* Medical Complications that contraindicate surgery, including major respiratory complications.
* Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate Magnetic resonance imaging (MRI).
* Other medical conditions which can interfere with stem cell transplantation
* Inability to provide informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02981576
|
{
"brief_title": "Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.",
"conditions": [
"Spinal Cord Injuries"
],
"interventions": [
"Biological: Autologous Mesenchymal Stem Cells"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT02981576",
"official_title": "Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-05",
"study_completion_date(actual)": "2019-01-20",
"study_start_date(actual)": "2016-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-24",
"last_updated_that_met_qc_criteria": "2016-12-01",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-05",
"first_submitted": "2016-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with \& without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.
#Intervention
- PROCEDURE : immediate implant placement without bone grafting
- After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done \& patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.
- PROCEDURE : immediate implant placement with socket bone grafting
- After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.
|
#Eligibility Criteria:
inclusion criteria:
* adult (>20 years) with non-restorable maxillary teeth in the esthetic zone,
* thick gingival phenotype,
* intact but thin labial plate of bone (<=1mm)
* intact palatal bone extending at least 6mm apically,
* sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
* labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part >=5mm.
* patients agreed to sign a written informed consent.
Exclusion criteria:
* smokers,
* pregnant women,
* patients with systemic disease,
* patients with parafunctional habits such as bruxism or clenching,
* infected socket,
* periapical pathosis
* history of radiotherapy or chemotherapy within the past 2 years.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05360693
|
{
"brief_title": "Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant",
"conditions": [
"Immediate Implants",
"Esthetic Zone",
"Labial Bone Dimensional Changes",
"Without Labial Bone Grafting",
"With Labial Grafting",
"Thin Labial Plate of Bone Pre-extraction"
],
"interventions": [
"Procedure: immediate implant placement without bone grafting",
"Procedure: immediate implant placement with socket bone grafting"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05360693",
"official_title": "Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-01",
"study_completion_date(actual)": "2022-04-29",
"study_start_date(actual)": "2020-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-08",
"last_updated_that_met_qc_criteria": "2022-04-30",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-04",
"first_submitted": "2022-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.
Detailed Description
A stepped wedge cluster randomized trial design will be employed in order to properly evaluate the impact of this intervention. Each of the 18 participating hospitals will be randomized one of the four wedges according to a random schedule; each wedge will consist of 4 to 5 hospitals. With this design, the implementation of the intervention will be rolled out sequentially to the participating hospitals over a 5 month period for each wedge. All hospitals will have received the intervention by the end of the study.
Note that the study design fields provided by ClinicalTrials.gov do not allow for describing this type of study design; therefore, the investigators have listed the study as a single arm. In reality, this study will have 4 wedges, each containing randomized clusters of 4-5 hospitals.
#Intervention
- BEHAVIORAL : Quality improvement
- The primary intervention in this project will be a multi-faceted quality improvement plan targeting improved predictions of neurological outcome and survival after cardiac arrest.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients =/> 18 years
* Non-traumatic out of hospital cardiac arrest
* Sustained return of spontaneous circulation (palpable pulse for > 20 minutes)
* Comatose (i.e. without full neurological recovery; non-responsive to verbal commands)
* Surviving to at least 6 hours after emergency department arrival
Exclusion Criteria:
* Patients who die within 6 hours of emergency department arrival
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01472458
|
{
"brief_title": "Premature Termination of Resuscitation in Survivors of Cardiac Arrest",
"conditions": [
"Cardiac Arrest"
],
"interventions": [
"Behavioral: Quality improvement"
],
"location_countries": null,
"nct_id": "NCT01472458",
"official_title": "Premature Termination of Resuscitation in Survivors of Cardiac Arrest",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2011-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-06",
"last_updated_that_met_qc_criteria": "2011-11-15",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-16",
"first_submitted": "2011-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
|
#Eligibility Criteria:
Inclusion Criteria:
* Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
* If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
* Patients must voluntarily sign and date Subject Information Form and Informed Consent Form prior to inclusion into the study.
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
* Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02636608
|
{
"brief_title": "Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary",
"conditions": [
"Chronic Hepatitis C"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02636608",
"official_title": "Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-23",
"study_completion_date(actual)": "2018-05-23",
"study_start_date(actual)": "2015-11-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-26",
"last_updated_that_met_qc_criteria": "2015-12-17",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-22",
"first_submitted": "2015-12-16",
"first_submitted_that_met_qc_criteria": "2019-05-23"
}
}
}
|
#Study Description
Brief Summary
The investigators will look for the presence of the fusion gene in all patients operated on for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter being sought in both routine and anomalies never co-existing.
The hypothesis is that the rate of progression-free survival in grade IV gliomas and III without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients relapse before 6 months of treatment), must be with this new treatment 35% (primary endpoint).
The main objective is the evaluation of disease-free survival at 6 months.
Detailed Description
3% of GBM and IDHwt gliomas have a highly oncogenic FGFR-TACC gene fusion that confers high sensitivity to FGFR inhibitors to tumor cells, in vitro and in vivo. Preclinical data shows that expression of FGFR-TACC fusions confers sensitivity to FGFR inhibitors (including AZD4547) to GBM models.AZD4547 (AstraZeneca) is a potent and selective inhibitor of FGFR-1, 2 and 3 receptor tyrosine kinases. Preclinical data have shown some CNS penetration. Some of the important adverse events are hyperphosphatemia, and ocular complications. The primary objective and assessment criterion is to assess the efficacy of AZD4547 by measuring the rate of Progression Free Survival at 6 months (PFS6) in recurrent malignant glioma patients with FGFR-TACC fusion.Secondary objectives and assessment criteria are: - To characterize the safety, tolerability and PK of AZD4547 in glioma patients
* To further assess the anti-tumor activity of AZD4547 for patients with recurrent glioma with FGFR-TACC fusion based on Overall Response Rate for patients with a measurable residue.
* To further assess the anti-tumor activity of AZD4547 for patients with recurrent glioma with FGFR-TACC fusion based on the duration of PFS
* To further assess the anti-tumor activity of AZD4547 for patients with recurrent glioma with a FGFR-TACC fusion based on Overall Survival AZD4547 Exploratory objectives - To elucidate the mechanism of response and resistance (primary and secondary) by exploratory biomarker analysis Experimental design: This is a phase II study in patients diagnosed with a FGFR3-TACC3 or FGFR1-TACC1 fusion positive glioma presenting with a recurrence of the disease after chemotherapy and radiotherapy. RNA will be systematically screened for the presence of FGFR-TACC in each of the 11 participating centers, and IHC for FGFR3 hyperexpression. The investigators also encourage a wide use of FGFR3 IHC in non participating centers in order to identify additional potential candidates who can be referred to one of the 11 centers for assessment of FGFR-TACC expression by RNA analysis..
Patients will receive AZD4547 at a dose of 80mg bd on a continuous schedule, until disease progression. With the following hypothesis: P0: PFS6=15%, P1: PFS6=35%, with alpha=5% and power=80%, an initial cohort of 12 patients will be treated. If objective anti-tumor effects are observed, the cohort will be expanded to include a total number of 38 subjects. Grade II gliomas are also eligible but they will constitute an extra small cohort.
#Intervention
- DRUG : AZD4547
- 80 mg bd (per os)
- Other Names :
- Potent and selective inhibitor of FGFR-1, 2 and 3 receptor tyrosine kinases (enzyme and cellular phosphorylation endpoints) with lower potency for inhibition of IGF1R and KDR
|
#Eligibility Criteria:
Inclusion criteria:
* Recurrent glioma after standard treatment, expressing the FGFR3-TACC3 or FGFR1-TACC1 fusion gene as confirmed by RT-PCR sequencing.
* First recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume.
* World Health Organisation performance status 0 <= age <= 2 (KPS>50) with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
If a patient declines to participate in any voluntary exploratory research component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study
* Aged at least 18 years.
* Patients should be using adequate contraceptive measures which should be maintained during the whole duration of AZD4547 treatment and at least 7 days after treatment suspension. Females should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
Exclusion criteria:
* Treatment with any of the following:
* Nitrosourea within 6 weeks before the first dose of study treatment
* Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment
* Any other chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks before the first dose of study treatment, except hormonal therapy.
* Potent inhibitors or inducers of CYP3A4 or 2D6 or substrates of CYP3A4 within the required washout period as specified in the section 7.3
* Prior treatment in this or another AZD4547 study, or prior randomisation in a study in which AZD4547 is/was under investigation. Prior treatment with any FGFR inhibitor.
* Major surgery (excluding placement of vascular access) within 14 days before the first dose of study treatment
* With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
* Any of the following cardiac criteria:
* Mean QT interval corrected for heart rate (QTc) >=470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's correction.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years or any concomitant medication known to prolong the QT interval
* History of myocardial infarction, unstable angina, stroke or transient ischemic attack within the last 6 months
* Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
* Absolute neutrophile count <1.5 x 109/L
* Platelet count <100 x 109/L
* Haemoglobin <90 g/L
* Alanine aminotransferase >2.5 times the upper limit of normal (ULN)
* Aspartate aminotransferase >2.5 times ULN Total bilirubin >1.5 times ULN
* Creatinine >1.5 times ULN concurrent with creatinine clearance <50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN
* Corrected calcium >ULN
* Phosphate >ULN
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD4547
* History of hypersensitivity to active or inactive excipients of AZD4547 or drugs with a similar chemical structure or class to AZD4547
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
* Any of the following ophthalmological criteria:
* Current evidence or previous history of retinal pigmented epithelium detachment (RPED)
* Previous laser treatment or intra-ocular injection for treatment of macular degeneration
* Current evidence or previous history of dry or wet age-related macular degeneration
* Current evidence or previous history of retinal vein occlusion (RVO)
* Current evidence or previous history of retinal degenerative diseases (eg, hereditary)
* Current evidence or previous history of any other clinically relevant chorioretinal defect
* Contraindications to MRI
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02824133
|
{
"brief_title": "Treatment With AZD4547 for Recurrent Malignant Glioma Expressing FGFR-TACC Gene Fusion'",
"conditions": [
"Recurrent IDHwt Gliomas With FGFR3-TACC3 Fusion",
"Recurrent IDHwt Gliomas With FGFR1-TACC1 Fusion"
],
"interventions": [
"Drug: AZD4547"
],
"location_countries": [
"France"
],
"nct_id": "NCT02824133",
"official_title": "A Phase I/II, Open-Label, Multicentre Study to Assess The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of AZD4547 in Patients With Relapsed/Refractory Glioma Positive for an FGFR Fusion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09",
"study_completion_date(actual)": "2018-10",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-29",
"last_updated_that_met_qc_criteria": "2016-07-01",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-06",
"first_submitted": "2015-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
#Intervention
- DEVICE : RebiSmart™
- Electronic self-injection device (RebiSmart™) to inject Rebif®
- Other Names :
- Rebif
- DEVICE : RebiSmart™
- Electronic self-injection device (RebiSmart™) to inject Rebif®
- Other Names :
- Rebif
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females between 18 and 65 years.
* Have RMS according to the revised McDonald Criteria.
* Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
* Be willing and able to comply with the protocol requirements for the duration of the study.
* Have given written informed consent prior to entering the screening period.
* Must register with the Rebif® Multiple Support Program.
* Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.
Exclusion Criteria:
* Have any disease other than MS that could better explain his/her signs and symptoms.
* Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
* Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
* Have a diagnosis of clinically isolated syndrome (CIS).
* Participation in any other investigational trial prior to 30 days of Study Day 1.
* Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
* Have received previous treatment with Rebif within 5 years prior to screening.
* Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01128075
|
{
"brief_title": "Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects",
"conditions": [
"Multiple Sclerosis",
"MS"
],
"interventions": [
"Device: RebiSmart™"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01128075",
"official_title": "Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2009-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-09",
"last_updated_that_met_qc_criteria": "2010-05-20",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-21",
"first_submitted": "2010-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the present study was to evaluate the efficacy of AAT intervention in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit, regardless of diagnosis, in terms of improving self-efficacy and reducing anxiety symptoms. To assess professional opinions on the effects of intervention on participants, and to determine participant satisfaction. These objectives were accomplished through a multicenter, non-randomized, open-label, two-arm controlled study of AAT for adolescents with mental disorders.
Detailed Description
The rationale of this study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit and regardless of diagnosis. The investigators conducted a multicenter, non-randomized, controlled, open-label, two-arm clinical trial in three hospitals. A total of 178 adolescents admitted to the Acute Child and Adolescent Psychiatry Unit were included in the study. Participants from the three hospitals were assigned to Experimental Group (n=114) and participants from one hospital were assigned to Control Group (n=64). Both the experimental group and the control group carried out a total of two one-hour group sessions at the hospitals' own facilities, on a weekly basis for two consecutive weeks; with the additional assistance of the therapy dog in the Experimental group. The investigators evaluated changes on self-efficacy and anxiety symptoms at pre-treatment and post-treatment; and they assessed professional opinions on the effects of intervention on participants at post-treatment, and determined participant satisfaction at post-treatment.
#Intervention
- BEHAVIORAL : Animal Assisted Therapy (AAT)
- A structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group.
- Other Names :
- Dog assisted Therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Be between 13 and 17 years.
* Willing to participate in the study on a voluntary basis.
* Delivery of the information sheet and signature of the informed consent (participant and legal guardian).
* Attendance at both group sessions from the intervention.
Exclusion Criteria:
* If in the initial interview they declared having allergy or fear of dogs.
* History of aggression towards animals.
* Re-admissions who had already participated in the study.
* If, when informed, the patient and/or his/her legal guardian did not wish to participate in the study.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06414850
|
{
"brief_title": "Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units.",
"conditions": [
"Mental Health Issue"
],
"interventions": [
"Behavioral: Animal Assisted Therapy (AAT)"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT06414850",
"official_title": "Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-07",
"study_completion_date(actual)": "2022-01-07",
"study_start_date(actual)": "2020-02-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-16",
"last_updated_that_met_qc_criteria": "2024-05-10",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-05-16",
"first_submitted": "2024-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the prevalence of vitamin D deficiency in patients with Heart Failure.
To investigate if vitamin D levels are correlated to the degree of Heart Failure.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient in the Heart Failure Clinic, Hvidovre Hospital
* Willing to participate and sign informed consent > 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00501553
|
{
"brief_title": "Vitamin D in Patients With Heart Failure",
"conditions": [
"Heart Failure"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00501553",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-05",
"study_start_date(actual)": "2005-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-27",
"last_updated_that_met_qc_criteria": "2007-07-13",
"last_verified": "2007-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-16",
"first_submitted": "2007-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.
Detailed Description
This study will specifically try:
1. To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.
2. To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit.
3. To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires.
Eligibility criteria includes:
* Adult patients 18 or older
* Single arch or double arch treatment
* Non-extraction treatment in the mandibular arch
* Presence of full complement dentition from first molar to first molar
* No spaces in the mandibular arch
* Mandibular anterior irregularity index greater than 5
* Patient with healthy periodontium and attachment loss of up to 2mm
* The amount of crowding should allow for bracket placement
* No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria includes:
* Failure to provide oral and written consent to participation
* Medical problems that affect tooth movement (Refer to Appendix I)
* Presence of primary teeth in the mandibular anterior area
* Missing permanent mandibular anterior teeth
* Inability to place brackets in the anterior mandibular teeth
* Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Outcome measures
1. Two outcome assessors will be calibrated in the assessment of the Little's irregularity index. The irregularity index will be measured twice by two blinded outcome assessors using a fine-tip digital caliper.
2. The subjects will be instructed to record their level of pain: immediately, 1 hour, 12 hours, and 7 days after the first wire placement \[76, 82\]. They will be also asked to report if they had taken any pain medications, their level of ease and satisfaction with the procedure, if they would undergo this procedure again, and if they would recommend it to a friend. A 100 mm Visual Analog Scale (VAS) will be used to evaluate the level of pain, ease, and satisfaction of all the subjects, with anchors at each end of the line that read 'no pain (easy, satisfied)' (0 mm) and 'most pain (complicated, not satisfied)' (100 mm).
#Intervention
- PROCEDURE : Piezotome-Corticision
- Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed.
- DEVICE : Orthodontics
- Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
#Eligibility Criteria:
Inclusion criteria:
* Adult patients >= 18 years
* Single arch or double arch treatment
* Non-extraction treatment in the mandibular arch
* Presence of full complement dentition from first molar to first molar
* No spaces in the mandibular arch
* Mandibular anterior irregularity index greater than 5
* Patient with healthy periodontium and attachment loss of up to 2mm
* The amount of crowding should allow for bracket placement
* No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria:
* Failure to provide oral and written consent to participation
* Medical problems that affect tooth movement (Refer to Appendix I)
* Presence of primary teeth in the mandibular anterior area
* Missing permanent mandibular anterior teeth
* Inability to place brackets in the anterior mandibular teeth
* Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02026258
|
{
"brief_title": "Efficiency of Piezotome-Corticision Assisted Orthodontics",
"conditions": [
"Mandibular Anterior Crowding",
"Piezocision",
"Pain Perception"
],
"interventions": [
"Device: Orthodontics",
"Procedure: Piezotome-Corticision"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02026258",
"official_title": "Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-07",
"last_updated_that_met_qc_criteria": "2013-12-30",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-01",
"first_submitted": "2013-12-23",
"first_submitted_that_met_qc_criteria": "2017-07-31"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
Detailed Description
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.
#Intervention
- DRUG : Placebo
- Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
- DRUG : Fulranumab 1 mg
- Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
- DRUG : Fulranumab 3 mg
- Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class >=2) of the study joint
* Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
* Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)
* Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
* During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child
Exclusion Criteria:
* Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
* Unstable or progressive neurologic disorders
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02289716
|
{
"brief_title": "Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003",
"conditions": [
"Osteoarthritis",
"Pain"
],
"interventions": [
"Drug: Fulranumab 3 mg",
"Drug: Placebo",
"Drug: Fulranumab 1 mg"
],
"location_countries": [
"Netherlands",
"United States",
"Poland",
"Canada",
"Spain",
"Belgium",
"Czechia",
"United Kingdom"
],
"nct_id": "NCT02289716",
"official_title": "Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10-10",
"study_completion_date(actual)": "2016-10-10",
"study_start_date(actual)": "2015-07-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-14",
"last_updated_that_met_qc_criteria": "2014-11-10",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-13",
"first_submitted": "2014-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.
Detailed Description
This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.
#Intervention
- OTHER : lopinavir/ritonavir
- standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV infection
* Age < 18 years
* BW > 25 kg
* HIV RNA viral load < 50 copies within 6 months
* Written informed consent
Exclusion Criteria:
* Active opportunistic infection
* Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01139905
|
{
"brief_title": "Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children",
"conditions": [
"HIV-1 Infections"
],
"interventions": [
"Other: lopinavir/ritonavir"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT01139905",
"official_title": "Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-26",
"last_updated_that_met_qc_criteria": "2010-06-08",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-09",
"first_submitted": "2010-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited.
The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.
Detailed Description
The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. A possible relapse after neuraxial anesthesia, it is believed to be associated with local anesthetic's toxicity and concentration.
The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.
#Intervention
- PROCEDURE : General anaesthesia
- Intravenous or volatile general anesthesia was preformed with different type of airway management (endotracheal tube, laryngeal mask and bag mask ventilation)
- PROCEDURE : Neuraxial anaesthesia
- spinal or epidural injections of local anesthetic with or without opioid
|
#Eligibility Criteria:
Inclusion Criteria:
* multiple sclerosis
* surgical procedure under general anaesthesia
* surgical procedure under neuraxial anaesthesia
Exclusion Criteria:
* patients (medical records) with incomplete data
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06526130
|
{
"brief_title": "Influence of Anaesthesia Type on Multiple Sclerosis Relapse",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Procedure: Neuraxial anaesthesia",
"Procedure: General anaesthesia"
],
"location_countries": null,
"nct_id": "NCT06526130",
"official_title": "Multiple Sclerosis Comparison of Relapse Incidence After General and Neuraxial Anesthesia: a Retrospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2024-05-16",
"study_start_date(actual)": "2012-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-30",
"last_updated_that_met_qc_criteria": "2024-07-23",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-07-29",
"first_submitted": "2024-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Type 2 Diabetes Mellitus (T2DM) is a group of metabolic disorders characterized by hyperglycemia in the absence of treatment, positioned in the first places of prevalence and mortality in the Mexican population. Adherence to treatment is a central element to prevent complications of the disease, where the active participation of the patient in his or her treatment is fundamental. Despite institutional healthcare efforts to promote this element, there is no clarity in the Clinical Practice Guidelines aimed at the attention of people with T2DM on how to achieve it.
The aim of this project will be to evaluate the effect of an intervention based on Contingency Behavior Analysis on treatment adherence, quality of life and glycemic level in people with newly diagnosed T2DM.
Pre-experimental design with pretest and posttest measurements. The Dependent Variable will be an intervention based on Contingency Behavior Analysis.
The Independent Variables will be adherence to treatment, quality of life and glycemic level.
The power calculation suggests an n = 38, using sequential non-probability sampling.
People older than 18 years with less than 5 years of T2DM diagnosis will be included.
Pretest and posttest differences, effect size and correlations between measurement variables will be analyzed.
It is expected that the intervention based on Contingency Behavior Analysis will encourage the active participation of people with T2DM, improving their adherence to treatment, glycemic level and quality of life.
Considering that the Clinical Practice Guidelines emphasize the importance of therapeutic adherence through the active participation of the patient and his/her environment, it is expected that this project will provide the tools for behavioral change that so far are not included in public health in Mexico.
Detailed Description
Currently, Type 2 Diabetes Mellitus (T2DM) in Mexico is the third leading cause of mortality in men and the second leading cause in women. Furthermore, due to the inadequate management of T2DM during the Covid-19 pandemic, an excess mortality of 35.6% was observed in the January-August 2020 period. The impact of the disease on people's health is also reflected in morbidity through diabetic complications and comorbidities related to T2DM such as cardiovascular diseases, dyslipidemias, overweight and obesity. In the case of diabetic comorbidities and complications it must be considered that sometimes they are not really due to inadequate self-care on the part of the patient, but are part of the natural progression of the disease as each person ages. However, whether the origin of diabetic complications is due to the patient's inadequate self-care behaviors or to the natural progression of the disease, the person with T2DM needs to receive comprehensive guidance to cope with disease conditions, treatment and self-care through prevention strategies and diabetes education.
In this regard, over the last decade, the Mexican health system has made various efforts to address this issue. Either through national health care programs at the federal and state levels, or through the implementation of mexican Clinical Practice Guidelines (mCPG) for the management of patients with T2DM. However, despite these implementations, in a period of 9 years (2011-2020) an increase in the registered death rate due to T2DM has been observed from 7.0 per ten thousand inhabitants in 2011 to 8.2 in 2020, which suggests that a change in the practice of care directed to this population is necessary. Perhaps one of the main problems that prevents a change in practice is the belief that it is enough to simply provide people with information on health care so that they are able to implement it in their daily lives. However, for years it has been pointed out and demonstrated that this was not enough, but that it was also necessary to provide people with the appropriate strategies for the development of new care behaviors. To achieve this, the Latin American Diabetes Association has recommended that programs encourage the active participation of people with T2DM, a recommendation that is even reflected in some health programs in Mexico . This leads to the second problem that is hindering the development of true health care that fosters the active participation of its users: professional training. In Mexico, the psychology professional is considered as a healthcare provider only on the rehabilitation of the adult lower extremity amputee patient due to T2DM, in the follow-up of physical exercise prescription, as part of nursing interventions for the control of T2DM in adult population, and in the prevention and diagnosis of T2DM in pediatric patients. This occurs despite the fact that most programs and mCPGs emphasize the importance of psychological assessment and intervention for the modification of risk behaviors and the development of healthy habits. However, by not considering psychology professionals formally to carry out education strategies, these tasks are relegated to other professionals such as physicians, nurses, nutritionists and social workers who, although they have the training to provide information about diabetes, do not have adequate training to promote the necessary behavioral modification in the development of healthy habits and promote the active participation of patients with T2DM in the search for solutions to contextual barriers, promoting health care in their daily lives through deprofessionalization work.
It would be expected that this intervention model, by improving the TA of people with Type 2 Diabetes Mellitus, would improve the participants' evaluation of their quality of life in areas such as diabetes control, anxiety related to the disease, social burden, sexual function and energy, as well as in glycemic level, mainly. In addition, this type of intervention proposals can offer a double benefit in terms of Effectiveness by modifying those situational aspects that hinder an adequate adherence to treatment in people with T2DM; and in terms of Efficiency, by allowing to carry out a work where participants can be trained as health promoters, and thus increase the dissemination of health services through the mediation of participants in the sectors close to them and that, due to institutional limitations, this population does not have direct access to them.
#Intervention
- BEHAVIORAL : Intervention
- The general outline of the intervention is divided into three phases:
1. Dispositional alteration, where the aim will be to obtain precise information on the barriers that patients encounter in carrying out their treatment and thus focus the issues to achieve an awareness of the disease by altering some of the factors that give rise to the realization of behaviors that interfere with treatment adherence.
2. Alteration of one's own behavior, focused on the development of healthy habits that are consistent with the indications of the health team for the proper management of the disease.
3. Alteration of the behavior of others, focused on the development of skills in the participants so that they are able to modify the behavior of other people close to them through health promotion strategies.
- Other Names :
- Contingency Behavioral Analysis
|
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years.
* Have less than 5 years with the diagnosis of Diabetes Mellitus Type 2.
* Ability to be present for 60 <= age <= 90 minutes in face-to-face sessions.
* Additionally, since it is common for people with T2DM to have several comorbidities, this study will include people who also have hypertension, overweight/obesity or dyslipidemia, since in the National Health Survey (INSP, 2021) these were considered to be the comorbidities with the greatest impact at the national level.
Exclusion Criteria:
* Having any present complication derived from poor diabetes control such as neuropathy, retinopathy, nephropathy or lower limb amputations due to poor control of the disease. This is due to the fact that the intervention is inserted within a secondary prevention scheme, where the aim is for people with T2DM to reduce the risk of developing complications (Seguí et al., 2011).
* Refusal by the participant to attend the intervention sessions.
* Having a psychological or psychiatric disorder diagnosed by a health professional that prevents active participation in the workshops.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05719675
|
{
"brief_title": "Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.",
"conditions": [
"Treatment Adherence",
"Quality of Life",
"Glucose Metabolism Disorders (Including Diabetes Mellitus)"
],
"interventions": [
"Behavioral: Intervention"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT05719675",
"official_title": "Efecto de un Programa de atención Para la Salud Sobre la Adherencia al Tratamiento en Personas Con Diabetes Mellitus Tipo 2 de Reciente diagnóstico",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-03",
"study_completion_date(actual)": "2023-05-17",
"study_start_date(actual)": "2023-03-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-29",
"last_updated_that_met_qc_criteria": "2023-01-30",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-09",
"first_submitted": "2023-01-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.
Detailed Description
Diabetes is a chronic and a progressive metabolic disorder which necessitates active patient involvement to effectively manage nutrition, physical activity, and medication for optimal outcomes. Self-management is a critical aspect of diabetes care and a variety of studies have established the need for people with diabetes to be knowledgeable about their condition and be actively involved in its management to effectively reduce the risk of future health complications and improve other outcomes. Diabetes self-management education and support (DSMES) can help patients effectively engage in and perform their diabetes-related self-care activities. However, only a small number of patients with diabetes participate in DSMES. A few studies in this area have highlighted both physician and patient-related factors that could affect the receipt of DSMES. Patients' involvement in a DSMES program continues to be largely prompted by a physician referral and it has been suggested that improving physician involvement in the DSMES process could enhance overall patient engagement and adherence to such programs.
As part of the proposed mixed methods study, in Phase 1, in-depth surveys (or interviews) will be undertaken with: (a) physicians caring for people with type 2 diabetes, (b) DSMES providers (e.g., certified diabetes educators, diabetes nurses, dietitians), and (b) patients with type 2 diabetes regarding their perception of diabetes education programs, barriers, and facilitators to engagement. Findings from Phase 1 will be shared with the education team at a diabetes center in a community hospital in Orange County, California to inform changes to their currently existing diabetes education curriculum to make it more patient-centered and improve physician engagement and support. As part of Phase 2, the newly developed program will be implemented with a diverse cohort of 90 patients with type 2 diabetes. Patient participation (attendance) in the DSMES process will be documented as a primary marker of patient engagement while their clinical and psycho-social outcomes will serve as secondary indicators. Among other outcomes, physician, educator, and patient satisfaction with the newly developed referral process will also be assessed as a measure of intervention acceptability and success.
#Intervention
- BEHAVIORAL : DSMES
- It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients of White, Asian, or Hispanic origin (30 in each group) Fluent in English (for the White and Asian group) Fluent in Spanish (for the Hispanic group) Age > 18 years Physician referral for DSME/S Formal diagnosis of type 2 diabetes
Exclusion Criteria:
Current or planned pregnancy. Any medical or other condition that the investigator feels would interfere with study participation.
Mental incapacity precluding adequate understanding or cooperation. Potential participants who are imprisoned or hospitalized
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03464812
|
{
"brief_title": "Evaluating Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Diabetes Education Program",
"conditions": [
"Type2 Diabetes"
],
"interventions": [
"Behavioral: DSMES"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03464812",
"official_title": "Evaluating Patient Engagement and Other Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Structured, Physician Supported, Patient-centered Diabetes Education Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-05",
"study_completion_date(actual)": "2019-08-05",
"study_start_date(actual)": "2017-08-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-14",
"last_updated_that_met_qc_criteria": "2018-03-07",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-14",
"first_submitted": "2018-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.
Detailed Description
The objective of this study is to validate the STN signal for slow-wave detection during auditory stimulation. To test this, the electrophysiological activity within the STN will be measured as local field potentials (LFP) using standard STN-DBS electrodes. To assess whether the recorded STN activity can be used for AS, the coherence analysis of cortical and STN slow waves will be performed.
At the screening consultation, the study physician will obtain written informed consent, confirm inclusion and exclusion criteria, and obtain entry questionnaires including demographics, medical history, and concomitant therapy. Following a successful screening consultation, the study physician will schedule a screening night at the sleep laboratory in the department of Neurology, University Hospital Zurich (USZ), during which clinical surface EEG (12-channel system, including EMG, ECG, and EOG) will be recorded and AS will be applied. To test the individual susceptibility to AS, ERPs to auditory stimuli and SWA change will be assessed.
If the screening night was successful, each patient will undergo a baseline consultation and 3 recording sessions.
During all 3 recording sessions, the patients will be asked about their subjective sleep quality and current mood, concomitant therapy (including LED), and MDS-UPDRS III will be performed by the study physician. The surgical implantation (which is not part of the current proposal) follows standardized clinical protocol and is applied in 2 steps. Sleep will be recorded simultaneously with clinical surface EEG and STN LFP in all 3 recording sessions (combined LFP-EEG recording) and AS will be performed based on slow-wave detected in the surface EEG.
In detail: In the first step, DBS leads are implanted in the STN, keeping the wires externalized. Following one night in the intensive or intermediate care unit for monitoring, patients will undergo a full-night combined LFP-EEG recording and AS (Recording Session 1), with LFP data collected from the externalized wires (DBS off). Next, the surgery will be completed by implantation of the neuromodulator and its connection to the DBS leads. Following the completion of the surgery, rehabilitation will start. The rehabilitation period will last for 2-5 weeks. At the end of the rehabilitation Recording Session 2 and 3 will take place. These recording session will be separated by 2-3 days and their order will be randomized and counterbalanced across participants. During Recording Session 2, combined LFP-EEG recording and AS will be performed during first 4 hours of the night sleep; STN LFP will be recorded with the implanted neurostimulator (DBS off). Recording Session 3 will be similar to Recording Session 2, but with DBS on (i.e. using DBS settings that were adjusted during rehabilitation). Because stable LFP recordings by PERCEPT™ PC neurostimulator is only possible for 4 hours, LFP sleep recordings during Recording Session 2 and 3 are limited to the first 4h of sleep. Surface EEG and AS, however, will be performed for the whole night after the LFP recoding end. Recording Sessions 2 and 3 will take place either at Clinic Lengg or in the USZ sleep laboratory (if the patient will be at a different rehabilitation center than Clinic Lengg).
Additionally, circadian rhythm will be assessed continuously throughout the interventions using actigraphy.
#Intervention
- DEVICE : Acoustic stimulation
- In this project, the intervention is a presentation of low-volume non-arousing auditory stimuli during deep NREM sleep via attached headphones. Stimuli will be applied targeting the up-phase of slow waves to enhance sleep slow-wave activity.
Previous studies showed that this procedure does not lead to reduced sleep quality nor result in changed sleep architecture. Therefore, no negative consequences as a result of our intervention are to be expected. In fact, it is currently applied in several other studies including children, adults, and the elderly. Importantly, stimulation is not arousing, as the sounds presented during deep sleep are brief (50 ms) and at low volume (around 50 dB). In case of arousal during sleep (detected using the surface EEG signal), the volume will be adjusted.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Diagnosis of PD along with international criteria with mild to moderate disease severity (Hoehn-Yahr (HY) stages ll-lll), selected for receiving STN-DBS therapy with the neurostimulator PERCEPT™
* Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
* Age above 18 years
* Negative pregnancy test during screening in female patients of childbearing potential (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year)
Exclusion Criteria:
* Failure to give informed consent
* Known presence of neurologic (other than PD), psychiatric, or systemic diseases (others than associated with PD)
* Clinical moderate to severe sleep-wake disorders (e.g. RLS-Index>=20, sleep apnea index >= 15 or, PLM-Index >= 15 if associated with arousals assessed during clinical PSG (in the framework of the pre-DBS work-up) and the clinical presentation of a RLS)
* Atypical or secondary Parkinsonism
* Severe medical conditions as renal insufficiency, liver failure, or congestive heart failure
* Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
* Regular use of benzodiazepines other long-acting central nervous system (CNS)-depressant substances or long-acting antidepressants
* Use of melatonin less than 1 day prior to recording session
* Substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day)
* High caffeine consumption (> 5 servings/day; including coffee, energy drink)
* Known or suspected drug- or medication abuse
* Hearing deficiency resulting in inability to hear the auditory stimuli during sleep (based on results of standard pure-tone threshold audiometry)
* Not tolerating AS during screening night
* Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
* Participation in another study with the intervention within the 30 days preceding, and during the present study
* Previous enrolment in the current study
* Enrolment of the investigator, his/her family members, employees, and other dependent persons
* Shift work (work during the night)
* Travelling more than 2 time zones in the last month before the intervention starts or during the intervention (start of intervention will be adapted to fit with this criteria)
* Lack of safe contraception, defined as: Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
* During DBS implantation/ICU:
* Use of long-acting substances (i.e. long-lasting benzodiazepines, anti-depressants)
* Use of full anesthesia
* Atypical STN electrophysiology
* Miss-location of the DBS leads (location will be checked after surgery using SureTune™ Medtronic software based on CT and MRI)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05184270
|
{
"brief_title": "Integration of Auditory, and Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease",
"conditions": [
"Parkinson Disease"
],
"interventions": [
"Device: Acoustic stimulation"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT05184270",
"official_title": "Integration of Auditory Slow-Wave Stimulation Into Subthalamic Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease: A Proof-of-Concept Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-07",
"study_completion_date(actual)": "2023-03-07",
"study_start_date(actual)": "2021-11-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-21",
"last_updated_that_met_qc_criteria": "2021-12-21",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-11",
"first_submitted": "2021-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study.
Primary Objective:
* To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV
Detailed Description
Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.
#Intervention
- OTHER : Blood sample
- Blood sample for immunogenicity assessment
- BIOLOGICAL : JE-CV administered in Study JEC02
- Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05
|
#Eligibility Criteria:
Inclusion Criteria :
* Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
* Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
* Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria :
* Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
* Planned participation in another clinical trial up to the first year of the follow-up in the present trial.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01001988
|
{
"brief_title": "Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers",
"conditions": [
"Encephalitis",
"Japanese Encephalitis"
],
"interventions": [
"Other: Blood sample",
"Biological: JE-CV administered in Study JEC02"
],
"location_countries": [
"Philippines",
"Thailand"
],
"nct_id": "NCT01001988",
"official_title": "Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10-16",
"study_completion_date(actual)": "2013-10-16",
"study_start_date(actual)": "2009-08-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-29",
"last_updated_that_met_qc_criteria": "2009-10-23",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-27",
"first_submitted": "2009-10-23",
"first_submitted_that_met_qc_criteria": "2017-10-23"
}
}
}
|
#Study Description
Brief Summary
Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection
Detailed Description
Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.
#Intervention
- DEVICE : soft tissue laser
- Surgical laser used in excision purpose
|
#Eligibility Criteria:
Inclusion Criteria:
* patients suffering from the plasma cell gingivitis
Exclusion Criteria:
* Patient not eligible for maxillofacial surgery
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05236322
|
{
"brief_title": "Management of Plasma Cell Gingivitis by Two Surgical Techniques",
"conditions": [
"Plasma Cell Gingivitis"
],
"interventions": [
"Device: soft tissue laser"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05236322",
"official_title": "Management of Plasma Cell Gingivitis by En-block Removal",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-10",
"study_completion_date(actual)": "2022-01-20",
"study_start_date(actual)": "2022-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-11",
"last_updated_that_met_qc_criteria": "2022-02-02",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-11",
"first_submitted": "2022-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection.
Detailed Description
This is a Phase I, double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial. This means the study doctor nor yourself know in which treatment session you will receive which active medication or matching placebo. Every participant will receive each treatment in turn. The order in which you receive the treatment sessions is determined by chance, like tossing a coin. The purpose of the study is to evaluate the effect of telaprevir (TVR) on the results of electrocardiograms (electric recording of the heart). Two dose regimens of TVR will be tested, i.e. 750 mg every 8 hours (the dose that will be given to patients) and 1875 mg every 8 hours (a dose higher than the one that will be given to patients), administered for 4 days, with an additional morning dose on Day 5. A single dose of 400 mg moxifloxacin will be used as a positive control to assess trial sensitivity. The trial population will consist of 44 healthy volunteers. Treatment A will consist of TVR 750 mg every 8 hours on Days 1-4 + single 750 mg morning dose on Day 5 (2 active TVR tablets + 3 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment B will consist of TVR 1875 mg every 8 hours on Days 1 to 4 + single 1875 mg morning dose on Day 5 (5 active TVR tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment C will consist of a single dose of 400 mg moxifloxacin (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of active moxifloxacin on Day 5). Treatment D will consist of placebo (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5).There will be a washout period of 8 days between subsequent treatment sessions. Electrocardiograms (ECGs) will be recorded continuously for 24 hours by Holter monitoring (small electrodes will be attached to your chest and connected to a small device to record your heart rhythm over a 24-hour period) on the day before intake of study medication starts and on Day 5 of all treatment sessions. In addition, for safety monitoring, separate ECGs will be performed at predefined time points. Samples to access pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of TVR and moxifloxacin will be collected on the day before intake of medication starts and day 5 of all treatment sessions, as well as predose on Days 2, 3 and 4 of all treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood- and urine analysis, vital signs, physical examinations, alcohol breath tests and by assessing how you are feeling. In every treatment session, participants will receive 5 oral tablets of 375 mg TVR or placebo every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single oral morning dose of 400 mg moxifloxacin or placebo on Day 5. In between treatment sessions, there will be a wash-out period of 8 days.
#Intervention
- DRUG : Telaprevir; Moxifloxacin; Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Non-smoking for at least 6 months prior to screening
* A body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to30 kg/m2, extremes included
* Otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of laboratory tests and a urinalysis carried out at screening
Exclusion Criteria:
* Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week from 14 days before the first intake of study medication and of an average of more than five 240-mL servings of coffee or other caffeinated beverage (e.g. tea, cola) per day from screening onwards
* A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs during the screening period
* Participation in a clinical study involving administration of an investigational drug within 2 months or 5 half lives (whichever is longer) prior to the screening visit
* Donation of any blood or having had a significant loss of blood within 3 months, or donation of more than 1 unit of plasma within 7 days before the first dose of study drug
* Male patients with female partners who are planning to become pregnant during the study or within 90 days of the last dose of study medication and female patients of childbearing potential who are pregnant or planning to become pregnant within 90 days of the completion of the study, who are not using adequate contraception, or who are breastfeeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00973388
|
{
"brief_title": "VX-950-TiDP24-C136 - A Trial to Evaluate the Effect of Telaprevir (TVR) on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers",
"conditions": [
"Hepatitis C"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00973388",
"official_title": "A Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled, Four-period Crossover Trial to Evaluate the Effect of Telaprevir (TVR) on the QT/QTc Interval in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01",
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-12-17",
"last_updated_that_met_qc_criteria": "2009-09-04",
"last_verified": "2010-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-09",
"first_submitted": "2009-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Fats and oils are made up of \>90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the 'sn-2 hypothesis'. New evidence have also emerged to show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats \[namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)\], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated
Detailed Description
To investigate the effects of different dietary fats with primarily oleic acid in the sn-2 position on the cardiovascular risk profile in healthy Malaysian volunteers
#Intervention
- OTHER : Diet: Palm olein IV64
- Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.
- OTHER : Diet: Cocoa butter
- Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.
- OTHER : Diet: Virgin olive oil
- Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (\~50g of test fats, brownies (\~15g test fat each) for breakfast and 4 pieces cookies (\~5g test fat each) with low fat palm olein based background diet daily.
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy adult male or female, aged 20 <= age <= 50 years
* BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998)
Exclusion criteria:
* Hyperlipidemia (TC>6.2 mmol/L, TAG >2.0 mmol/L)
* History of chronic disease- type 2 DM, heart disease, cancer
* Habitual smokers (>2 sticks a day)
* Hypertensives: >140/90 mmHg
* On medication/nutraceuticals to reduce blood lipids, blood pressure
* Pregnant or lactating women
* Planned trip abroad/overseas during period of study
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02802904
|
{
"brief_title": "Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers",
"conditions": [
"Cardiovascular Risk Factor"
],
"interventions": [
"Other: Diet: Cocoa butter",
"Other: Diet: Virgin olive oil",
"Other: Diet: Palm olein IV64"
],
"location_countries": null,
"nct_id": "NCT02802904",
"official_title": "Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-17",
"last_updated_that_met_qc_criteria": "2016-06-13",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-16",
"first_submitted": "2016-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
Detailed Description
The protective capacity of thio-containing compounds against normal tissue damage from radiation have been recognized for over 40 years..
Although intravenous administration is the approved standard route, because of practical advantages there has been increasing interest in the subcutaneous administration of Ethyol, which presents multiple advantages when used for radioprotection.
Based on the data that has been presented, as well as the personal experience of this and other physicians/centers with subcutaneous administration of amifostine, the researchers are proposing an open-label study evaluating the rate and severity of toxicities associated with this route of administration. Toxicities to be assessed include nausea/vomiting, hypotension, and skin/fever reactions.
#Intervention
- DRUG : Ethyol (Amifostine)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection.
* Eastern Cooperative Oncology Group (ECOG) performance status < 2
* Age > 18
* Patient receiving radiation therapy or combined modality therapy to treat malignancy.
* No evidence of distant metastatic disease.
* Granulocyte count (segs & bands) > 2000/mm3 and platelet count > 100,000/mm3
* Serum creatinine <2.0mg/dL
* Total bilirubin <2.0mg%, SGOT < times the upper limit of normal.
* Patients may not be entered on investigational therapeutic trials.
* Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.
Exclusion Criteria:
* Life expectancy of <6 months
* Patients receiving only chemotherapy to treat malignancy.
* Patients who have been treated with any investigational drugs <4 weeks prior to study entry.
* General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
* Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
* Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00130143
|
{
"brief_title": "Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities",
"conditions": [
"Head and Neck Cancer",
"Lung Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00130143",
"official_title": "Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-09",
"study_start_date(actual)": "2003-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-09-27",
"last_updated_that_met_qc_criteria": "2005-08-12",
"last_verified": "2005-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-08-15",
"first_submitted": "2005-08-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: Despite being an important treatment intervention, chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity.
Objectives: This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during chest tube removal.
Design: Prospective, parallel three armed, randomized controlled trial. Settings: The study was conducted in athoracic surgery unit of a university hospital.
Methods: The sample of this study consisted of 180 patients in two experimental groups and one control group.The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group.One experimental group received cold application using ice pack and the other received cold application using gel pad until the skin temperature of all the patients fell to 13.6°C. The control group did not receive any intervention. Pain severity was assessed with Numerical Rating Scale (NRS) before chest tube removal, at the end of the procedure and 15 minutes after the procedure. Data was analyzed using descriptive statistics, chi-square, student t-test in independent groups, one-way analysis of variance (ANOVA), and repeated measures ANOVA.
Detailed Description
This study was aimed to determine which cold application material is more effective in pain control of patients during chest tube removal process.
The primary outcomes measures of this study were the effect of cold application materials on severity of pain.The secondary outcome measures of this study were duration of cold application and analgesic requirements of the patients.
Procedure Before removal of chest tube, nurse researcher (DS) who is working in the thoracic surgery clinic as a nurse, explained aim of study and take informed consent all patients. Data were collected with Patient Information Form and NRS.
Patient Information Form was filled out for each using the information obtained from patients/patients' relatives, patient files and health professionals of the clinic and the patients' pain severity was measured with NRS.
The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group. Before the chest tube was removed, nurse researcher (DS) made cold application with ice pack the first experimental group and cold application with gel pad the second experimental group. The control group did not receive any intervention. Since the cold application temperature should be reduced to 13.6 °C in order to have local analgesic effect in both of the experimental groups the patient's skin temperature was measured at one-minute intervals by using an infrared non-contact thermometer (Microlife Non-Contact, Switzerland) with a wide measurement range (0-100 °C) and a measurement time of three seconds. This application was terminated when the temperature was 13.6 °C and the chest tube was removed by the physician.
Pain severity of all the patients was measured with NRS immediately after and 15 minutes after chest tube removal.
#Intervention
- OTHER : Cold application
- cold application using ice pack/gel pad in the control of pain experienced during chest tube removal
|
#Eligibility Criteria:
Inclusion Criteria:
* had chest tube
* Must be conscious, orientated and cooperated
* Must be able to speak and understand Turkish
Exclusion Criteria:
* Psychiatric disease
* Language problems
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04200859
|
{
"brief_title": "Effect of Cold Application Materials on Pain During Chest Tube Removal",
"conditions": [
"Local Application / Packing Too Cold"
],
"interventions": [
"Other: Cold application"
],
"location_countries": null,
"nct_id": "NCT04200859",
"official_title": "The Effect of Different Cold Application Materials on Pain During Chest Tube Removal: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11",
"study_completion_date(actual)": "2017-11",
"study_start_date(actual)": "2016-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-16",
"last_updated_that_met_qc_criteria": "2019-12-13",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-16",
"first_submitted": "2019-12-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
STA-9090, a synthetic small molecule, demonstrates significant activity for down-regulating Heat Shock Protein 90 or Hsp90 levels. Hsp90 belongs to a class of molecular chaperone proteins known to be critical regulators of cancer cell proliferation and survival. Preclinical laboratory experiments have shown STA-9090, an Hsp90 inhibitor, could inhibit ocular melanoma cell lines. The primary objective of this trial is to obtain evaluations of STA-9090 efficacy to metastatic ocular melanoma.
Detailed Description
Patients with metastatic ocular melanoma have a poor prognosis and very limited standard therapeutic options. The recent discoveries of GNAQ and GNA11 mutations leading to MAPK pathway activation and the over-expression of c-Met generate the hypothesis that inhibition of hsp90 client proteins will provide clinical benefit. This study tests the feasibility and efficacy of hsp90 inhibition in patients with metastatic ocular melanoma. Multiple components of the MAPK pathway (B-Raf, C-Raf, cdk4) in addition to c-Met are client proteins of hsp90 and dependent of active hsp90 for stability. Inhibition of hsp90 should lead to decreased expression of these client proteins.
#Intervention
- DRUG : STA-9090
- Other Names :
- Ganetespib
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed stage IV ocular melanoma
* ECOG Performance status 0, 1, or 2
* 18 years or older
* Laboratory values as indicated in the protocol
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
* Presence of metastatic disease that would be amenable to the required biopsies
* At least one site of measurable disease as defined by at least 1cm in greatest dimension. This site must be different from the sites to be used for biopsy. No prior radiation therapy or directed ablation to the site of measurable disease
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Major surgery within 4 weeks prior to first dose of STA-9090
* Minor surgery within 7 days of first dose of STA-9090
* Embolization procedure or ablation procedure to treat tumor within 4 weeks of first dose
* Participants may not be receiving any other investigational agents
* Poor venous access for study drug administration unless patient can use silicone based catheters
* History of brain metastases or of leptomeningeal involvement
* History of allergic reactions or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to STA-9090
* Baseline QTc > 450 msec or previous history of QT prolongation while taking other medications
* Ventricular ejection fraction (EF) of 55% or less at baseline
* Treatment with chronic immunosuppressants
* Melanoma of cutaneous, mucosal or acral-lentiginous origin or of unknown primary
* Prior treatment with HSP90 inhibitor
* Not willing to undergo biopsy before and after treatment
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Other medications, or severe acute/chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into the study
* Pregnant or breastfeeding women
* Individual with a history of a different malignancy are ineligible except for circumstances outlined in the protocol
* HIV-positive individuals on combination antiretroviral therapy
* History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
* History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medication, or Grade 2 or greater left bundle branch block
* NYHA class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
* Current or prior radiation therapy to the left hemithorax
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01200238
|
{
"brief_title": "STA-9090(Ganetespib) in Metastatic Ocular Melanoma",
"conditions": [
"Ocular Melanoma"
],
"interventions": [
"Drug: STA-9090"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01200238",
"official_title": "A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10-12",
"study_completion_date(actual)": "2016-11-11",
"study_start_date(actual)": "2010-09-17"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-18",
"last_updated_that_met_qc_criteria": "2010-09-10",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-13",
"first_submitted": "2010-09-10",
"first_submitted_that_met_qc_criteria": "2018-06-25"
}
}
}
|
#Study Description
Brief Summary
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.
#Intervention
- DRUG : levothyroxine
- To compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy.
- Other Names :
- Synthroid, Levoxyl
|
#Eligibility Criteria:
Inclusion Criteria:
* Female between ages of 18 <= age <= 45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.
Exclusion Criteria:
* Males
* Younger than >= 18 years than 45 years
* More than 10 weeks pregnant at enrollment
* Iodine deficient
* Pregnant with more than one baby (i.e., twins, triplets, etc.)
* NOT taking thyroid hormone medicine before becoming pregnant
* Levels of thyroid hormone in blood have been too low or too high in the past 6 months
* Treated with radioactive iodine in the past year.
Sex :
FEMALE
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
|
NCT03115515
|
{
"brief_title": "Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy",
"conditions": [
"Pregnancy Related",
"Thyroid"
],
"interventions": [
"Drug: levothyroxine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03115515",
"official_title": "Randomized, Prospective Trial Comparing the Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2018-02",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-29",
"last_updated_that_met_qc_criteria": "2017-04-11",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-14",
"first_submitted": "2017-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.
The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).
This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.
Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.
#Intervention
- DEVICE : Novae E®
- DEVICE : Sunfit®
- DEVICE : Quartz®
|
#Eligibility Criteria:
Inclusion Criteria:
* patients older men or women 60 <= age <= 75 years
* with a primary or secondary osteoarthritis or osteonecrosis
* having a functional disorder requiring the installation of a total hip prosthesis of primary
Exclusion Criteria:
* patients aged 76 years or more
* protected adults
* resumption of PTH
* cephalic prosthesis recovery or intermediate
* resumption of cupules
* primary or secondary malignant tumor of the hip
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02525809
|
{
"brief_title": "Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.",
"conditions": [
"Total Hip Replacement"
],
"interventions": [
"Device: Quartz®",
"Device: Sunfit®",
"Device: Novae E®"
],
"location_countries": null,
"nct_id": "NCT02525809",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-01",
"last_updated_that_met_qc_criteria": "2015-08-14",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-17",
"first_submitted": "2015-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.
Detailed Description
100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. Prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. Subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.
#Intervention
- DEVICE : bracket removal pliers, LODI
- Brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.
- Other Names :
- adhesive removal pliers, tungsten bur
|
#Eligibility Criteria:
Inclusion Criteria:
* fixed appliance in both dental arches
* brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions
Exclusion Criteria:
* periodontal disease
* restorations or caries on buccal surfaces of the teeth,
* consumption of analgesics within eight hours preceding the debonding appointment
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06324162
|
{
"brief_title": "Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?",
"conditions": [
"Debonding",
"Orthodontic Brackets"
],
"interventions": [
"Device: bracket removal pliers, LODI"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT06324162",
"official_title": "Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? A Comparative Study of Two Bracket Systems and Two Debonding Methods",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-01",
"study_completion_date(actual)": "2023-05-01",
"study_start_date(actual)": "2021-10-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-21",
"last_updated_that_met_qc_criteria": "2024-03-15",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-21",
"first_submitted": "2024-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Among the well-known factors that contribute to the development of obesity, childbearing has been reported as an important influential factor. Physical activity is strongly recommended as one of the main tools to reduce any excessive weight gain during pregnancy and also to reduce weight retention in the postpartum period. During the postpartum period, exercise training coupled with a well-balanced nutritional plan, offers an effective intervention to help mothers lose weight safely. International guidelines for physical activity after pregnancy include strengthening routines. Worth noting, most of the above cited studies focused on the benefits of aerobic activities. Strength training interventions are virtually unexplored in postpartum women despite its potential benefits. Compared to the pregnancy period, postpartum barriers to physical activity seem to focus less on health-related barriers. In postpartum, time limitations for childcare become a more common barrier. For this reason, a postpartum exercise program that incorporates the babies in a specific exercise session has a better chance to succeed. The aim of this project is to determine the benefits of strength training in a group class setting in postpartum healthy women with their babies. Whereas mother's participation in regular physical activity may encourage regular physical activity habits in her offspring, a second aim of this project is to also quantify the infant's physical activity. The main measured outcomes are: maternal muscular strength; body composition; aerobic capacity; exercise self efficacy; depressive symptoms; physical activity level and food habits and baby's physical activity level.
Detailed Description
Research Questions:
Maternal:
Is a strength training group class (with babies) in postpartum women associated with (I) strength and lean body mass improvement, (II) improvement aerobic capacity, (III) more spontaneous physical activity, (IV) better self efficacy and (V) better mood?
Baby:
Does maternal lifestyle affect the baby's (0-12 months) physical activity level?
Hypothesis:
It is hypothesized that women who complete the 10 week exercise program will have improved strength from pre-intervention to post intervention. It is also hypothesized that women who are adherent to the exercise program will have more active babies.
Methods:
Participants train 60 min per session for 10 weeks on non consecutive days (Tues and Thurs). All training sessions will be supervised by a qualified exercise instructor (graduate in kinesiology) to ensure proper technique and to minimize the risk of injury. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. The strength training protocol is based on the American College of Sports Medicine (ACSM) guidelines. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies will also be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. The principle of progressive overload will follow a linear increase as described in ACSM position stand.
All participants will be tested at time points t0 , t1 ( after 5 weeks) and t2 (after 10 weeks; at the and of the study) on: i) strength and body composition; ii) aerobic capacity; iii) objective and subjective physical activity level; vi) exercise self efficacy; v) depressive symptoms and vi) dietary habits.
I. Strength/Body composition assessment At each time point, strength will be assessed for the upper body (push-ups), lower body (squats), and trunk (abdominal curl-up test). The participants will perform push-ups (as many as possible using a fixed pattern of 40 beats per minute - time and number will be recorded up to a maximum of 1 minute). This will be repeated for the number of lower body squat position performed (as many squats as possible using a fixed pattern of 40 beats per minute -time and number will be recorded up to a maximum of 1 minute); these methods have been chosen to reduce the likelihood of any adverse events. The participant will also complete the ACSM-recommended partial curl-up test to assess abdominal strength and endurance. Briefly, as many abdominal curl-ups as possible has to be performed until the participant either stops, or cannot stay in rhythm with a fixed cadence (40 beats/min) up to 1 minute as per ACSM guidelines.
Body composition assessment will include body mass, height, BMI and body fat (sum of five skinfolds: triceps, biceps, subscapular, suprailiac, thigh) measures.
II. Aerobic capacity Briefly, participants perform a 5- min. bout of exercise, stepping up and down from a standard step (height 30 cm) following a specific cadence. During the step test, heart rate (HR) is measured continuously using a heart-rate monitor. Then, VO2max is estimated based on HR and a target exercise intensity (estimated VO2).
III. Physical activity assessment At each time point, participants will to complete two self- reported questionnaires regarding physical activity level, the International Physical Activity Questionnaire (IPAQ; and the Physical Activity Readiness Questionnaire (PAR-Q+).The IPAQ asks participants to recall their levels of physical activity within five domains (leisure, work, transportation, household, recreation) and three intensity categories over a 7-day recall period. The PAR-Q+ determines if it is safe to start an exercise program. Additionally, at t0, t1 and t2 each participant will complete an individual physical activity diary for 7 days. Moreover, during this period participants will continuously wear a pedometer .
IV. Exercise self efficacy Exercise self-efficacy will be measured at each time point (t0,t1 and t2). This survey includes five separate items targeting self-efficacy.
V. Depressive symptoms Levels of postpartum mood will be assessed through the Edinburgh Postnatal Depression Scale (EPDS).
VI. Eating Habits Mother's eating habits will be measured through the Short-Form Frequency Questionnaire (SFFFQ).
VII. Breastfeeding habits will be measured through a Breastfeeding and Infant Feeding Questionnaire.
Baby At each time point, a Rothbart Infant Behavior Questionnaire- Revised (IBQ-R) will be completed by the participants to measure temperament and gross motor activity in infants between the ages of 3 and 12 months.
This study will take place at the Canadian Centre for Activity and Aging gymnasium on Tuesday and Thursday afternoons (time to be determined). Women who contact us will be asked when their baby was born. Those women whose babies are less than 20 weeks of age will be placed in Group A and those women whose babies are older than 20 weeks will be placed in Group B. These groups were divided by baby age because early postpartum women and babies are a different group than those women with babies 6 months and older.
#Intervention
- BEHAVIORAL : Group A
- Muscle conditioning exercise for postpartum women and infants less than 20 weeks of age.
- BEHAVIORAL : Group B
- Muscle conditioning exercise for postpartum women and infants more than 20 weeks of age.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy (free from chronic diseases) women between 8 weeks and 50 weeks after delivery.
Exclusion Criteria:
* Inability to perform strength training or moderate-intensity exercise, athletes/well trained mothers (i.e. mothers undergoing regular strength training), smokers and women who are planning to become pregnant over the subsequent year. Women who cannot read, write and understand English will not be included.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03405649
|
{
"brief_title": "Active Mother May Lead to an Active Baby.",
"conditions": [
"Postpartum",
"Exercise",
"Intervention"
],
"interventions": [
"Behavioral: Group B",
"Behavioral: Group A"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03405649",
"official_title": "Active Mother- Active Baby: Resistance Training in Postpartum Women as a Group Class Exercise Intervention With Their Babies.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-01",
"study_completion_date(actual)": "2021-01-01",
"study_start_date(actual)": "2018-08-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-06",
"last_updated_that_met_qc_criteria": "2018-01-14",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-23",
"first_submitted": "2018-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.
Detailed Description
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.
#Intervention
- BIOLOGICAL : ONO-4685
- Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
- BIOLOGICAL : Placebo
- Placebo will be administered by intravenous continuous infusion at the designated speed.
- BIOLOGICAL : KLH
- KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
- BIOLOGICAL : KLH, ONO-4685
- Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.
- BIOLOGICAL : KLH, placebo
- Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.
|
#Eligibility Criteria:
Inclusion Criteria:
* Japanese healthy adult male subjects (PartA, B, and C)
* Caucasian healthy adult male subjects (Part D)
* Age (at the time of informed consent): >=20 yeas, <= 45 yeas
* Body weight (at the time of screening test): >=50 kg
Exclusion Criteria:
* Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
* Subjects with current or with a history of severe allergy to drugs or foods
* Subjects with current or with a history of drug or alcohol abuse
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04079062
|
{
"brief_title": "Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Biological: KLH",
"Biological: KLH, ONO-4685",
"Biological: Placebo",
"Biological: KLH, placebo",
"Biological: ONO-4685"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT04079062",
"official_title": "Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-25",
"study_completion_date(actual)": "2021-05-25",
"study_start_date(actual)": "2019-09-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-03",
"last_updated_that_met_qc_criteria": "2019-09-02",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-06",
"first_submitted": "2019-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
#Intervention
- DRUG : AEE788
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed GBM in first or second recurrence or relapse
* Adequate hematologic, hepatic and renal function
* Age >= 18 years
* Karnofsky performance status score >= 70%
* Life expectancy >= 12 weeks
Exclusion Criteria:
* Peripheral neuropathy > grade 1
* Diarrhea > grade 1
* Gastrointestinal dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00116376
|
{
"brief_title": "Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)",
"conditions": [
"Glioblastoma Multiforme"
],
"interventions": [
"Drug: AEE788"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00116376",
"official_title": "A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-11",
"study_completion_date(actual)": "2005-11",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-10",
"last_updated_that_met_qc_criteria": "2005-06-28",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-06-29",
"first_submitted": "2005-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.
Detailed Description
Experimental Drug Profile. The active substance of Fortelyzin is Forteplase. It's recombinant protein which contains aminoacid sequence of staphylokinase. It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.
Main goals of the study are to prove an efficacy of the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase(Actilyse) in patients with ischemic stroke.
To prove a safety and to assess possible adverse events in the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase (Actilyse) in patients with ischemic stroke.
Study Design. All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilyse) by using 'envelope method' of randomization. It is an open-lable study. Each of agents will be administered no longer then 4,5 hours from symptoms onset. Comparative agent will be administered as prescribed in its instructions. All patients will be examination for 90 days
#Intervention
- DRUG : Recombinant staphylokinase
- 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
- Other Names :
- Fortelyzin
- DRUG : Alteplase
- Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
- Other Names :
- Actilyse
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women between the ages of 18 and 80 (Version 1.0)
* Men and women aged 18 years and older, after 80 years with caution (Version 2.0)
* Verified diagnosis of ischemic stroke (from 5 to 25 points on the NIHSS scale). (Version 1.0)
* Verified diagnosis of ischemic stroke (Version 2.0)
* The time from the onset of the disease is no more than 4.5 hours.
* Informed consent received
Exclusion Criteria:
* The time of the onset of the first symptoms is more than 4.5 hours from the onset of the disease or the time of the onset of the first symptoms of a stroke is not known (for example, the development of a stroke during sleep - the so-called 'night stroke').
* Increased sensitivity to alteplase, gentamicin (residual traces from the production process).
* Systolic blood pressure above 185 mm Hg. Art. Or diastolic blood pressure above 110 mm Hg. Art. Or the need for / in the administration of drugs to reduce blood pressure to these boundaries.
* Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumors, arteriovenous malformation, brain abscess, aneurysm of cerebral vessels.
* Surgery on the brain or spinal cord.
* Suspicion of subarachnoid hemorrhage.
* Signs of severe stroke: clinical signs (stroke scale NIH> 25), neuroimaging (according to CT of the brain and / or MRI of the brain in the DWI, the ischemia focuses on the territory of more than 1/3 of the CMA pool).
* Simultaneous reception of oral anticoagulants, for example, warfarin with INR> 1.3.
* The use of direct anticoagulants (heparin, heparinoids) in the preceding stroke of 48 h with APTT values above the norm.
* Prior stroke or severe head injury within 3 months.
* Significant regression of neurological symptoms during the observation of the patient.(Version 1.0)
* Light neurological symptoms (NIH <4 points). (Version 1.0)
* Significant regression of neurological symptoms during the observation of the patient before thrombolisis (Version 2.0)
* Hemorrhagic stroke or stroke, unspecified in history.
* Strokes of any genesis in the history of a patient with diabetes mellitus.
* Gastrointestinal bleeding or bleeding from the genitourinary system in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer during the last 3 months.
* Extensive bleeding now or within the previous 6 months.
* Severe liver disease, including liver failure, cirrhosis, portal hypertension (with varicose veins of the esophagus), active hepatitis.
* Acute pancreatitis.
* Bacterial endocarditis, pericarditis.
* Aneurysms of arteries, malformations of arteries and veins. Suspicion of exfoliating aortic aneurysm.
* Neoplasms with an increased risk of bleeding.
* Large operations or severe injuries within the last 14 days, minor surgery or invasive manipulation in the last 10 days.
* Puncture of uncompensated arteries and veins during the last 7 days.
* Prolonged or traumatic cardiopulmonary resuscitation (more than 2 min).
* Pregnancy, obstetrics, 10 days after birth.
* The number of platelets is less than 100,000 / μL.
* Blood glucose less than 2.7 mmol / l or more than 22.0 mmol / l.
* Hemorrhagic diathesis, including renal and hepatic insufficiency.
* Data on bleeding or acute trauma (fracture) at the time of examination.
* Seizures in the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of ischemic stroke with a postictal residual deficiency.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03151993
|
{
"brief_title": "Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS",
"conditions": [
"Ischemic Stroke"
],
"interventions": [
"Drug: Alteplase",
"Drug: Recombinant staphylokinase"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT03151993",
"official_title": "Multicenter Open Label Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actilyse) in Patients With Acute Ischemic Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-23",
"study_completion_date(actual)": "2019-06-20",
"study_start_date(actual)": "2017-03-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-14",
"last_updated_that_met_qc_criteria": "2017-05-11",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-12",
"first_submitted": "2017-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk
Detailed Description
2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk.
The sonographer was not involved in the patient's care and the managing obstetrician was blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency, position and station ) and the mode of delivery were assessed retrospectively.
#Intervention
- DEVICE : transabdominal ultrasound
- 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 & 35 years.
* BMI is less than 30
* The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)
* Singleton pregnancy.
* History of one vaginal delivery.
* Occiputo anterior position.
* Active phase of first stage of labor.
Exclusion Criteria:
* Age (below18 or above 35).
* Primigravida.
* Occiputo posterior position.
* Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section .
* Multiple gestation.
* Medical disorders like hypertension, DM, liver or renal diseases
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03264599
|
{
"brief_title": "Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Outcome of Labor",
"conditions": [
"Vaginal Delivery"
],
"interventions": [
"Device: transabdominal ultrasound"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03264599",
"official_title": "Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Maternal and Fetal Outcome of Labor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-21",
"study_completion_date(actual)": "2017-08-20",
"study_start_date(actual)": "2016-07-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-29",
"last_updated_that_met_qc_criteria": "2017-08-25",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-29",
"first_submitted": "2017-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The principal objective of this research is the evaluation of the effect of mineralized water consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low mineralized water consumption.
#Intervention
- OTHER : Mineralized water
- OTHER : Low mineralized water
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI included between 18.5 and 25 kg/m²
* non smoking
* moderated hypercholesterolemia
Exclusion Criteria:
* food allergy
* diabetes
* high blood pressure
* kidney deficiency
* thyroid deficiency
* metabolism deficiency
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00742703
|
{
"brief_title": "Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms",
"conditions": [
"Moderated Cholesterolemia"
],
"interventions": [
"Other: Low mineralized water",
"Other: Mineralized water"
],
"location_countries": [
"France"
],
"nct_id": "NCT00742703",
"official_title": "Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-03-09",
"last_updated_that_met_qc_criteria": "2008-08-27",
"last_verified": "2009-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-28",
"first_submitted": "2008-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
the study aimed to evaluate the diagnostic performance of cardiac output (CO) change after the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.
Detailed Description
Acute heart failure (AHF) is a frequent condition in emergency department and is responsible of high number of admissions, complications, and deaths.
despite advances in diagnostic techniques, AHF diagnosis still be challenging .
Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of patient.
the gold standard of measuring CO is thermodilution catheterization, however it is an invasive technique with high risks.
Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest through electrodes placed on the neck and sides.
the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO from the impedance waveform.
In practice, the investigators connect the device 'BIOPAC' by using four electrodes which the investigators place on the base of the neck (posterior face) and on the base of the thorax (posterior face).
The ECG recording is taken simultaneously with two other electrodes placed at the right upper limb and left lower limb.
In addition to detecting the electric current and the ECG, heart sounds are recorded using a sensor that is placed at the mitral site.
Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO measurement was repeated. CO is calculated by averaging three measurements at one minute intervals at baseline and after NTG administration. DeltaCO was defined as the percent of change of baseline CO after NTG test.
#Intervention
- DIAGNOSTIC_TEST : Reference position patient is put in a 30 degree supine position during 5 minutes
- Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)
- DIAGNOSTIC_TEST : nitroglucerin
- 0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 year old or above non traumatic acute dyspnea
Exclusion Criteria:
* ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours,
* pericardial effusion ,
* chest wall deformity suspected of causing dyspnea,
* coma,
* need for mechanical ventilation or vasopressor drugs,
* serious and sustained arrhythmia,
* pace maker,
* severe mitral valve disease, severe pulmonary arterial hypertension,
* renal failure (creatinine >350µmol/l.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04484298
|
{
"brief_title": "Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)",
"conditions": [
"Heart Failure"
],
"interventions": [
"Diagnostic Test: nitroglucerin",
"Diagnostic Test: Reference position patient is put in a 30 degree supine position during 5 minutes"
],
"location_countries": [
"Tunisia"
],
"nct_id": "NCT04484298",
"official_title": "Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-29",
"study_completion_date(actual)": "2020-03-01",
"study_start_date(actual)": "2019-01-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-29",
"last_updated_that_met_qc_criteria": "2020-07-20",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-23",
"first_submitted": "2020-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
Detailed Description
All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are 'Improved' using the definition outlined in the CCS will be grouped together as Responders. All subjects that are 'Worsened' or 'Unchanged' using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with 'equal or better' echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.
#Intervention
- DEVICE : MultiPoint Pacing
- Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
- DEVICE : Traditional Biventricular Pacing
- Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
|
#Eligibility Criteria:
Inclusion Criteria:
* Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
* Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
* Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
* Have an existing Class I recalled lead
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
* Have permanent atrial fibrillation (AF)
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 9 months due to any condition
* Are less than 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01786993
|
{
"brief_title": "MultiPoint Pacing IDE Study",
"conditions": [
"Heart Failure"
],
"interventions": [
"Device: MultiPoint Pacing",
"Device: Traditional Biventricular Pacing"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01786993",
"official_title": "MultiPoint Pacing IDE Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-04",
"last_updated_that_met_qc_criteria": "2013-02-06",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-08",
"first_submitted": "2013-02-06",
"first_submitted_that_met_qc_criteria": "2016-08-08"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine the variation between individuals in blood lipid metabolites, and the changes in these metabolites in response to omega-3 fatty acids in patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is that measuring variation among individuals and changes in response to omega-3 fatty acids comprehensively by using metabolomics will help to identify those individuals who are responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory intervention.
Detailed Description
It is unclear how metabolomic profiles of individuals change in response to short-term intervention with omega-3 fatty acids. It is necessary to establish the means and standard deviations in the levels of omega-3 fatty acids and their related metabolites in healthy subjects and in different disease states in order to better understand the mechanisms related to lipid metabolism of metabolic diseases that are modified by omega-3 fatty acids. Specifically, the project will examine the metabolomic profiles of healthy controls and patients with immunoglobulin A nephropathy (IgAN) before and after an omega-3 fatty acid intervention. The IgAN patient samples were obtained from collaborators from a previously completed project. The healthy subjects were tested in a small pilot trial conducted at UC Davis as described below.
* Twelve healthy volunteers willing and able to take 6 g of fish oil for 6 weeks were recruited from the general UC Davis population including students, faculty, and staff. The volunteers were recruited by personal communication at seminars and other school-related activities as well as flyers posted on campus.
* The volunteers were contacted and scheduled for a screening and consent visit. Subjects who met all eligibility criteria and signed a consent form were then scheduled for a baseline blood draw and to collect a first morning urine sample. A research team member contacted each subject the day before their first scheduled study date to confirm and remind the subject about fasting, about collecting the first morning urine void, and the time and location of the study.
* On each study visit, the participants came to the Ragle Human Nutrition Center (1283 Academic Surge) between 7 and 9 am after an overnight fast, at which point they were weighed (clothed but with no shoes) on a digital scale and their height was measured. A registered phlebotomist drew 20 mL of blood by venipuncture for their baseline blood draw. Subjects also brought in their first morning urine sample at this time. Subjects were then given their fish oil capsules that were separated in a Ziploc bag for each week of the intervention. Subjects took the fish oil capsules at home at their own discretion but study personnel suggested they take the capsules after their last meal of the day and before bed each evening. Study personnel contacted subjects throughout the course of the study by phone and/or e-mail to make sure that there were no adverse effects from the fish oil and to ensure compliance. Subjects were instructed to record their diets through 24-hour dietary recalls before the baseline blood draw, and at 3 additional time points throughout the study.
* Immediately after blood collection, the researchers separated the red blood cells and peripheral blood mononuclear cells (PBMC) from the plasma, aliquoted the samples, and then stored them in a -70°C freezer for future analysis.
#Intervention
- DIETARY_SUPPLEMENT : Fish Oil
- Ocean Nutrition Fish Oil Capsules containing 1.9 g eicosapentaenoic acid (EPA) and 1.5 g docosahexaenoic acid (DHA)
|
#Eligibility Criteria:
Inclusion Criteria:
* Weight at least 110 pounds or BMI at least 19
* Adult (aged 18 <= age <= 65 years)
* Disclose which medications currently taking
* Able to come to the Ragle Center at the designated times
* Able to give blood
* Able to take 6 g fish oil per day for 6 weeks
* Able to carry out first morning urine collection
* Able to stop or avoid taking NSAIDS and allergy medications for 6 weeks
* Able to stop or avoid eating seafood and seaweed for 6 weeks
Exclusion Criteria:
* Pregnant or nursing (or unsure if pregnant)
* Diagnosed with a disease by their physician
* Currently taking prescription medications that alter lipid metabolism (such as HMG CoA reductase inhibitors, PPAR agonists, steroids) and/or anti-coagulants
* Currently has some form of anemia (or unsure)
* Has an existing health condition or concern
* Unable to stop or avoid taking NSAIDS and allergy medications for 6 weeks
* Unable to stop or avoid eating seafood or seaweed for 6 weeks
* Unable to give blood or do first morning urine collection
* Recently recovering from a major injury, infection, or illness (in the last 2 <= age <= 4 weeks)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01838239
|
{
"brief_title": "Development of a Metabolic Assessment Tool for Chronic Kidney Disease",
"conditions": [
"Immunoglobulin A Nephropathy",
"Healthy Subjects"
],
"interventions": [
"Dietary Supplement: Fish Oil"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01838239",
"official_title": "Development of a Metabolic Assessment Tool for Chronic Kidney Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-30",
"last_updated_that_met_qc_criteria": "2013-04-23",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-24",
"first_submitted": "2013-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.
#Intervention
- DRUG : Dabigatran etexilate
- DRUG : Warfarin
|
#Eligibility Criteria:
Inclusion criteria:
* Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
* Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
* Completion of anticoagulation therapy for 5 <= age <= 15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
* Eligibility for treatment with an oral anticoagulant
* Further inclusion criteria apply
Exclusion criteria:
* Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
* Planned surgical treatment for CVT
* Conditions associated with increased risk of bleeding
* History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
* Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
* Severe renal impairment
* Active liver disease
* Pregnancy, nursing or planning to become pregnant while in the trial
* Further exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02913326
|
{
"brief_title": "A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)",
"conditions": [
"Thromboembolism"
],
"interventions": [
"Drug: Warfarin",
"Drug: Dabigatran etexilate"
],
"location_countries": [
"France",
"India",
"Netherlands",
"Poland",
"Portugal",
"Germany",
"Russian Federation",
"Spain",
"Italy"
],
"nct_id": "NCT02913326",
"official_title": "RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-22",
"study_completion_date(actual)": "2018-06-22",
"study_start_date(actual)": "2016-12-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-15",
"last_updated_that_met_qc_criteria": "2016-09-21",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-23",
"first_submitted": "2016-09-21",
"first_submitted_that_met_qc_criteria": "2019-08-09"
}
}
}
|
#Study Description
Brief Summary
Knee osteoarthritis (KOA) is a chronic progressive disease that imparts substantial socioeconomic burden to society and healthcare systems. The prevalence of KOA has dramatically risen in recent decades due to consistent increases in life expectancy, and demand for joint replacement continues to rise. Total knee replacement is indicated for end-stage KOA, as it is very effective in terms of pain relief, improvement of function, and quality of life. However, the investigators will be facing an unsustainable joint replacement burden, with significant healthcare budget and health workforce implications. To alleviate this problem, different strategies including reinforce the importance of education and exercise are included; as previous studies showed that less than 40% of patients with KOA received non-pharmacological treatment, indicating that the uptake of evidence-based guidelines in clinical practice and rehabilitation is still suboptimal. Several literatures revealed that quadriceps and hamstrings strength exercise could effectively reduce pain. It has widely accepted that patients with end stage KOA will eventually pursue total knee replacement as the only viable option, and exercise has low efficacy in reduction of pain and disability in this group of patients. So, the investigators would like to know whether exercise therapy can help severe KOA patients
#Intervention
- OTHER : Whole-Body Vibration
- 10 minutes of whole-body vibration when performing semi-squatting or forward lunges (12-16 Hz, varying intensity from low to high depending on patients' tolerance
- OTHER : Exercise
- Four to five sessions of a physiotherapist-led exercise program with education talk (20 minutes), group exercises (30 minutes) and individual exercises (30 minutes) per week supplemented with home exercises
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement
* Completed 8-week course of physiotherapy program
Exclusion Criteria:
* TKR during the last 12 months
* Severe heart failure or neurological diseases affecting physical functions
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06183177
|
{
"brief_title": "Pain Function and QOL Undergoing Whole-Body Vibration and Exercise in End-Stage Knee Osteoarthritis",
"conditions": [
"Knee Osteoarthritis",
"Pain, Joint"
],
"interventions": [
"Other: Exercise",
"Other: Whole-Body Vibration"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT06183177",
"official_title": "Improving Pain, Function and Quality of Life in End-Stage Knee Osteoarthritis: A Prospective Cohort Study of Whole-Body Vibration and Exercise as Bridging Therapies for Total Knee Replacement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-01",
"study_completion_date(actual)": "2023-01-26",
"study_start_date(actual)": "2021-10-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-02",
"last_updated_that_met_qc_criteria": "2023-12-26",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-27",
"first_submitted": "2023-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).
Detailed Description
There are two parts in the study. A Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer. There will be a 7-day run-in period with ipatasertib alone prior to Cycle 1, Day 1. After the completion of the ipatasertib run-in period, participants will begin Cycle 1, Day 1 of the ipatasertib and rucaparib combination treatment. Each cycle has 28 days. Participants will be split into 4 cohorts: Dose Level 1 group - 300 mg ipatasertib once daily (QD) + 400 mg rucaparib twice daily (BID), Dose Level 2a: 300 mg ipatasertib QD + 600 mg rucaparib BID, Dose Level 2b: 400 mg ipatasertib QD + 400 mg rucaparib BID, Dose Level 3: 400 mg ipatasertib QD + 600 mg rucaparib BID
A Dose-Expansion Phase (Part 2) - The recommended dose identified in Part 1 (highest dose level of ipatasertib and rucaparib with an acceptable safety profile and less than one-third of participants experience a dose limiting toxicity) will be evaluated in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).
Enrollment in Cohort 3 in dose escalation phase was not opened as one-third of Dose Limiting Toxicity (DLT) evaluable participants receiving the highest dose of rucaparib in Cohort 2a experienced a DLT.
#Intervention
- DRUG : Ipatasertib
- Ipatasertib will be administered orally.
- Other Names :
- RO5532961, GDC-0068
- DRUG : Rucaparib
- Rucaparib will be administered orally.
- Other Names :
- CO-338
|
#Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* A life expectancy of at least 3 months
* Ability to swallow oral study drug
* Have adequate organ and marrow function as confirmed by the laboratory values listed below, obtained within 28 days prior to the first dose of study treatment:
* Bone marrow function assessments (without transfusion within 28 days prior to receipt of study treatment):
1. ANC >= 1500 cells/uL (1.5 x 10^9/L) without granulocyte-colony stimulating factor support
2. Platelet count >= 100.0 x 10^9/L
3. Hemoglobin >= 9 g/dL (or 5.6 mmol/L)
* Chemistry panel assessments:
1. AST and ALT <= 1.5 x upper limit of normal (ULN); if liver metastases, <= 2.5 x ULN
2. Bilirubin <= 1.5 x ULN (<= 3 x ULN if hyperbilirubinemia is due to Gilbert's syndrome)
3. Serum albumin >= 3.0 g/dL
4. Serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min
5. Fasting glucose <= 150 mg/dL and hemoglobin A1c <= 7.5%
* Resolved or stabilized toxicities resulting from previous therapy to Grade 1 (except for alopecia and neuropathy).
Cancer-Related Inclusion Criteria
* Have a histologically confirmed diagnosis of ovarian (Part 1 only), breast (Part 1 only) or prostate cancer (Part 1 and Part 2)
* Disease must be either metastatic or locally advanced disease that cannot be treated with curative intent
* For patients with ovarian cancer (Part 1 only):
1. High-grade (2 or 3) serous or endometrioid or clear cell epithelial ovarian, fallopian tube, or primary peritoneal cancer (PPC)
2. Must have received at least one prior platinum-based therapy and may have platinumsensitive disease (i.e., documented radiologic disease progression >= 6 months following the last dose of the platinum treatment administered) or platinum-resistant disease
3. Have a CA-125 level that is > 2 x ULN
4. Must have measurable disease by RECIST v1.1
* For patients with breast cancer (Part 1 only): must be human epidermal growth factor receptor 2 negative (HER2-) (estrogen receptor [ER]/progesterone positive or negative):
1. ER/progesterone-positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic)
2. ER/progesterone-negative/HER2- (triple-negative breast cancer [TNBC]) patients must have received at least one prior line of chemotherapy for metastatic breast cancer
3. Must not have received more than two prior lines of chemotherapy for metastatic breast cancer
4. Must have measurable disease by RECIST v1.1
For patients with prostate cancer:
* Adenocarcinoma of the prostate without small cell or neuroendocrine features
* Surgical or medical castration with testosterone < 50 ng/dL (1.7 nM)
* Patients treated with luteinizing hormone-releasing hormone analogs must have initiated therapy at least 4 weeks prior to the first dose of study treatment and continue throughout the study treatment
* Progression of prostate cancer either via PSA progression (two rising PSA levels measured >= 1 week apart, with second result >= 1 ng/mL) or radiographic progression with or without PSA progression
* Must have received at least one prior line of second-generation androgen receptor targeted therapy (e.g., abiraterone, enzalutamide, apalutamide)
* Patients with prostate cancer must have either measurable disease by RECIST v1.1 or bone lesions by bone scan, or both.
* Submission of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 12 freshly cut, unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis (retrospective NGS testing for HR and PI3K-AKT pathway status and for other protocol-mandated secondary and exploratory assessments). Cytologic or fine needle aspirate samples are not acceptable. Tumor tissue from bone metastases is not acceptable.
* For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib,or 6 months after the last dose of rucaparib, whichever occurs later
Exclusion Criteria:
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose of ipatasertib or 6 months after the final dose of rucaparib
* Prior treatment with a PARP inhibitor, AKT inhibitor, or PI3K inhibitor
* Treatment with investigational therapy within 14 days prior to initiation of study drug
* Symptomatic and/or untreated CNS metastases
* Uncontrolled tumor-related pain
* Non-study-related minor surgical procedures <= 5 days or major (invasive) surgical procedure <=14 days prior to first dose of study treatment
* Patients with active hepatitis C virus (HCV)
* Hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test or a positive quantitative HBV DNA test
* Known HIV infection
* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Serious infection requiring antibiotics within 14 days of first dose of study treatment
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Need for chronic corticosteroid therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
* History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low-grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of < 5% at 5 years.
* History of clinically significant cardiovascular dysfunction
* Presence of any other condition that may have increased the risk associated with study participation or may have interfered with the interpretation of study results, and, in the opinion of the investigator, would have made the patient inappropriate for entry into the study
Ipatasertib-Specific Exclusion Criteria:
* Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
* History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)
* Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or five elimination half-live of the inhibitors, whichever is longer, prior to initiation of study drug
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03840200
|
{
"brief_title": "A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.",
"conditions": [
"Breast Cancer",
"Prostate Cancer",
"Ovarian Cancer"
],
"interventions": [
"Drug: Ipatasertib",
"Drug: Rucaparib"
],
"location_countries": [
"United States",
"Spain",
"Australia",
"Italy",
"Korea, Republic of"
],
"nct_id": "NCT03840200",
"official_title": "A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Rucaparib in Patients With Advanced Breast, Ovarian, or Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-07",
"study_completion_date(actual)": "2022-01-04",
"study_start_date(actual)": "2019-06-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-30",
"last_updated_that_met_qc_criteria": "2019-02-11",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-15",
"first_submitted": "2019-02-11",
"first_submitted_that_met_qc_criteria": "2023-10-26"
}
}
}
|
#Study Description
Brief Summary
The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.
#Intervention
- DRUG : Symbicort
- Participants are administered 54 μg Formoterol and 1920 μg Budesonide
- DRUG : Formoterol
- Participants are administered 54 μg Formoterol from an inhaler device
- DRUG : Formoterol
- Participants are administered 120 μg Formoterol in a capsule, which is taken orally
- DRUG : Placebo
- Participants are administered placebo
- DRUG : Mannitol
- Participants are administered 600 mg Bronchitol
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 45
* Physically active >5 hours a week
* Maximum oxygen uptake classified as high or very high
Exclusion Criteria:
* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* FEV1/FVC ratio < 0,7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during the study
* In chronic treatments with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months
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
|
NCT06105671
|
{
"brief_title": "U-LABA/ICS Effects on Exercise Performance, Formoterol",
"conditions": [
"Exercise Performance"
],
"interventions": [
"Drug: Formoterol",
"Drug: Mannitol",
"Drug: Symbicort",
"Drug: Placebo"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT06105671",
"official_title": "Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-04",
"study_completion_date(actual)": "2024-07-04",
"study_start_date(actual)": "2024-01-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-13",
"last_updated_that_met_qc_criteria": "2023-10-23",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-30",
"first_submitted": "2023-10-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
Detailed Description
The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.
#Intervention
- DRUG : alendronate
- several duration of treatment
- Other Names :
- fosamax
|
#Eligibility Criteria:
Inclusion Criteria:
* postmenopausal osteoporosis under densitometric criteria of the World Health Organization
Exclusion Criteria:
* secondary osteoporosis
* alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00936260
|
{
"brief_title": "Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis",
"conditions": [
"Osteoporosis"
],
"interventions": [
"Drug: alendronate"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT00936260",
"official_title": "Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-12",
"study_completion_date(actual)": "2004-12",
"study_start_date(actual)": "1998-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-07-10",
"last_updated_that_met_qc_criteria": "2009-07-09",
"last_verified": "1998-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-10",
"first_submitted": "2009-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.
OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).
Detailed Description
DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24 months. After the 24-month visit, a sub-population (138 patients) accepted to continue the intervention until 36 months, thus generating a follow-up study.
SETTING: 3 Italian university medical centers. INTERVENTIONS: Participants received 54 mg of genistein, daily, (n=71) or placebo (n=67). Both intervention and placebo contained calcium and vitamin D3. All patients also received dietary instruction in an isocaloric fat-reduced diet.
MEASUREMENTS: Mammographic breast density at baseline and after 24 and 36 months was assessed by visual classification scale and by digitized quantification. BRCA1 and BRCA2 molecular message, sister chromatid exchanges and endometrial thickness were also evaluated at the same time points. Measurements of lumbar spine and femoral neck BMD and QUS t-score were assayed in our patients. Secondary outcomes were serum levels of B-ALP, IGF-I, sRANKL, osteoprotegerin and urinary excretion of CTX, pyridinoline and deoxypyridinoline. Furthermore insulin resistance (HOMA-IR), glucose levels, homocysteine and hot flushes were also evaluated. In addition for thyroid safety TSH, fT3, fT4, thyroid autoantibodies, and mRNA for thyroid and retinoid receptors were evaluated.
#Intervention
- DIETARY_SUPPLEMENT : aglycone genistein
- 2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
- Other Names :
- Genivis, Fosteum
- DIETARY_SUPPLEMENT : placebo
- 2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
|
#Eligibility Criteria:
Inclusion Criteria:
* Good general health
* Have not had a menstrual period in the preceding year
* Had not undergone surgically induced menopause
* Had a follicle-stimulating hormone level > 50 IU/liter and a serum 17 beta-estradiol level <= 100 pmol/liter
* Established osteopenia (-1<T-score<-2.5 SD)
Exclusion Criteria:
* Clinical or laboratory evidence of confounding systemic diseases, such as cardiovascular, hepatic, or renal disorders
* Coagulopathy, use of oral or transdermal estrogen, progestin, androgen or other steroids
* Biphosphonates, cholesterol-lowering therapy or cardiovascular medications in the preceding six months
* Smoking habit of more than two cigarettes per day
* Previous treatment with any drug that could affect the skeleton in the preceding year
* A family history of estrogen-dependent cancer
* BMD at femoral neck > 0.795 g/cm2; this BMD value corresponds to a T score of -1 standard deviation
Sex :
FEMALE
Ages :
- Minimum Age : 49 Years
- Maximum Age : 67 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00626769
|
{
"brief_title": "Third Year Evaluation on Genistein Efficacy and Safety",
"conditions": [
"Menopause",
"Osteopenia"
],
"interventions": [
"Dietary Supplement: aglycone genistein",
"Dietary Supplement: placebo"
],
"location_countries": null,
"nct_id": "NCT00626769",
"official_title": "Safety Profile and Bone Efficacy of the Phytoestrogen Genistein in a Cohort of Osteopenic, Postmenopausal Women After Three Years of Treatment: a Follow-up Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2005-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-05-19",
"last_updated_that_met_qc_criteria": "2008-02-28",
"last_verified": "2009-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-29",
"first_submitted": "2008-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.
#Intervention
- BIOLOGICAL : Platelet rich fibrin matrix
- 0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy adults
* aged 25- 75 years
* with moderate to severe nasolabial folds
Exclusion Criteria:
* pregnant
* allergy to local anesthetics
* history of bleeding disorder
* active infection at the treatment site
* injectable filler in the nasolabial folds within past year
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00874094
|
{
"brief_title": "Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds",
"conditions": [
"Nasolabial Folds"
],
"interventions": [
"Biological: Platelet rich fibrin matrix"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00874094",
"official_title": "Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-07-12",
"last_updated_that_met_qc_criteria": "2009-04-01",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-02",
"first_submitted": "2009-04-01",
"first_submitted_that_met_qc_criteria": "2013-07-10"
}
}
}
|
#Study Description
Brief Summary
Adolescent suicide is the 2nd leading cause of death in this age group. There are no validated treatments to decrease the risk of adolescent suicidal behavior, and there are especially no interventions to target the highest risk period for adolescent suicide and suicidal behavior, namely during the time of transition from inpatient to outpatient care. This purpose of this project was to develop a novel, brief intervention that can be delivered on an inpatient unit prior to the transition to outpatient care, and augment known factors to protect adolescents from suicidal behavior, and extend the impact of treatment by liaison with the outpatient therapist and the development of a personalized safety plan phone application. This treatment, ASAP, focuses on augmenting adherence to the components of ASAP and outpatient aftercare, development of a personalized Safety Plan, and Affect Protection, through helping the teen and family promote a positive mood, tolerate distress, engage in healthy emotion regulation and access social support.
Detailed Description
This 2-site R34 project developed a brief, flexible, manualized intervention with supporting phone app with the purpose of reducing the risk of suicidal behavior in adolescents with high suicidal ideation or a recent suicide attempt, during the transition from inpatient to outpatient care. This transition period is the highest risk period for attempted and completed suicide. Suicide is the 2nd leading cause of adolescent mortality, and there are currently no established interventions for suicidal teens. By developing a treatment that can be delivered on an inpatient unit prior to the transition to outpatient treatment, we anticipated being able to lower suicidal risk and increase the likelihood that participants will attend subsequent outpatient treatment. In keeping with the priorities of NIMH, this intervention aimed at reducing the risk of suicide and suicidal behavior was trans-diagnostic. We term the intervention ASAP, with anticipated components: (1) Adherence-promoting engagement and adherence to treatment through motivational interviewing; (2) Safety planning; and (3) Affect Protection- selecting from a menu of techniques for maintaining positive affect (e.g. savoring and switching strategies, mobilizing social support, engaging in emotion regulation and distress tolerance skills). Each of these components was delivered within a Motivational Interviewing framework for enhancing intrinsic motivation for change. Treatment was brief (3-5 hours), and flexibly delivered on inpatient units prior to initiation of outpatient treatment.
ASAP included the family in the treatment, and a safety plan phone app to extend the impact of treatment was also developed. Innovative features included: (1) delivery of an intervention at a time and place when suicidal risk is highest; (2) augmentation of protective factors against recurrent suicidal behavior, specifically by promoting development of positive affect, emotion regulation, distress tolerance, and social support; (3) a Safety plan phone app to extend the impact of treatment; and (4) liaison with the outpatient therapist to ensure continuity of care.
This project conducted an RCT of ASAP followed by Aftercare (AC) vs. AC alone to determine ASAP's feasibility, acceptability, impact on proximal targets (e.g., adherence to outpatient care, sleep, positive affect, substance use), suicidal ideation and behavior. In total 68 suicidal adolescents were enrolled, 2 of whom were withdrawn following baseline assessment and were excluded from analyses, resulting in the final study sample size of 66. ASAP, developed with and intended for community clinicians, has the potential to be a sustainable intervention to reduce the burden of adolescent suicidality. Data analyses have been completed and results are being finalized.
#Intervention
- BEHAVIORAL : As Safe As Possible
- The ASAP (As Safe As Possible) treatment is a brief, intensive intervention initiated during inpatient care and transitioning to outpatient care. The intervention focuses on 1) using motivational interviewing (MI) strategies throughout care; 2) developing a safety plan, including adapting the plan to an interactive safety plan phone app, Brite); and 3) using treatment modules to target specific risk factors that are selected based on individual need.
- Other Names :
- ASAP
- BEHAVIORAL : Brite
- Brite is a HIPAA-compliant mobile application designed to provide the participants with emotion regulation and distress tolerance skills, social support, and convenient access to safety plan resources via the patients' phone.
- BEHAVIORAL : Treatment as Usual
- Participants received usual treatment for suicidal adolescents as they transition from inpatient hospitalization to outpatient therapy, which included a paper safety plan.
|
#Eligibility Criteria:
Inclusion Criteria:
* Child participants will be adolescents (aged 12 <= age <= 17.11 years) admitted to an inpatient unit for a recent suicide attempt or significant suicidal ideation with a plan or intent. We define a suicide attempt, as per the Columbia Clinical Algorithm for Suicide Assessment (C-CASA), as 'self-destructive behavior with inferred or stated intent to die.'
* Participants must be English-speaking.
* Participants can have unipolar or bipolar disorder, conduct or oppositional disorder, eating disorder, or alcohol or substance use or abuse or dependence.
Exclusion Criteria:
* Child participants to be excluded will be those with current psychosis, mania, <90% of ideal body weight, or IQ<70 (based on the age-appropriate Wechsler Intelligence Scale if concerns about intellectual capabilities are evident at assessment), as these conditions may require more intensive interventions or limit comprehension of the intervention components.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02272179
|
{
"brief_title": "Brief Intervention for Suicide Risk Reduction in High Risk Adolescents",
"conditions": [
"Adolescent Behavior"
],
"interventions": [
"Behavioral: As Safe As Possible",
"Behavioral: Treatment as Usual",
"Behavioral: Brite"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02272179",
"official_title": "Brief Intervention for Suicide Risk Reduction in High Risk Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-11",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-20",
"last_updated_that_met_qc_criteria": "2014-10-21",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-22",
"first_submitted": "2014-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).
#Intervention
- DRUG : AGN-199201
- 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
- DRUG : AGN-190584
- 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
- DRUG : AGN-199201 Vehicle
- 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
*Presbyopia in each eye that impacts daily activities.
Exclusion Criteria:
* Use of any topical ophthalmic medications, including artificial tears
* Contact lens use in either eye within 14 days or planned use during the study
* History of eye surgery
* Diagnosis of any type of glaucoma or ocular hypertension
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02197806
|
{
"brief_title": "Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia",
"conditions": [
"Presbyopia"
],
"interventions": [
"Drug: AGN-190584",
"Drug: AGN-199201 Vehicle",
"Drug: AGN-199201"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02197806",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-03",
"last_updated_that_met_qc_criteria": "2014-07-21",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-23",
"first_submitted": "2014-07-21",
"first_submitted_that_met_qc_criteria": "2015-10-30"
}
}
}
|
#Study Description
Brief Summary
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.
Detailed Description
Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.
#Intervention
- DEVICE : noninvasive ventilation
- noninvasive ventilation to support the COVID-19 patients with respiratory failure
|
#Eligibility Criteria:
Inclusion Criteria:
* Shortness of breath, RR>30 times per minute;
* At room air, SpO2 lower than 93%;
* The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) <= 300mmHg;
* CT（computed tomography） chest imaging shows that lung damage develops significantly within 24 to 48 hours.
Exclusion Criteria:
* Severe cardiovascular disease,
* respiratory arrest,
* cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
* change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
* secretions,
* recent facial or gastroesophageal surgery,
* craniofacial trauma, 8)fixed nasopharyngeal abnormalities,
9）burns, 10) extreme obesity.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04568655
|
{
"brief_title": "The Noninvasive Ventilation to COVID-19 Patients",
"conditions": [
"Noninvavie Ventilation to Patients With COVID-19"
],
"interventions": [
"Device: noninvasive ventilation"
],
"location_countries": [
"China"
],
"nct_id": "NCT04568655",
"official_title": "The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-01",
"study_completion_date(actual)": "2020-07-01",
"study_start_date(actual)": "2020-02-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-29",
"last_updated_that_met_qc_criteria": "2020-09-28",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-29",
"first_submitted": "2020-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.
#Intervention
- BEHAVIORAL : Psychological evaluation
- Patients will be answer to validated test about how they feel. Psychological interview is also possible depending on patients availability. The different answers will be compared between the four groups
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is older than 18 years
* With a good understanding and practice of the French language
* And depending on the group, experimental or control, presenting:
* pancreatic cancer expected to be treated with pancreatectomy or planned to be treated with pancreatectomy excluding cancer or breast cancer scheduled to be treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).
* No patient's opposition to the information provided
* Affiliated to the social security plan or beneficiary
Exclusion Criteria:
* Other medical or psychiatric condition,
* Level of cognitive efficiency incompatible with response to questions about himself,
* A person in an emergency situation, a person under legal protection or unable to express the non opposition to their participation to research.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04422730
|
{
"brief_title": "Evolution of Body Connection After Surgery",
"conditions": [
"Pancreas Cancer"
],
"interventions": [
"Behavioral: Psychological evaluation"
],
"location_countries": [
"France"
],
"nct_id": "NCT04422730",
"official_title": "Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-05",
"study_completion_date(actual)": "2024-03-05",
"study_start_date(actual)": "2020-06-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-04",
"last_updated_that_met_qc_criteria": "2020-06-05",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-09",
"first_submitted": "2019-12-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.
Detailed Description
These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the 'Instructions for Use'.
#Intervention
- DIAGNOSTIC_TEST : iMOST X-1 Hematology Analyzer
- The X-1 is a point of care automated hematology analyzer
|
#Eligibility Criteria:
Inclusion Criteria:
* all clinic attendees
Exclusion Criteria:
* unable to provide a venous and fingerstick blood specimen
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04778553
|
{
"brief_title": "Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study",
"conditions": [
"Hematologic Tests"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04778553",
"official_title": "Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-09",
"study_completion_date(actual)": "2021-01-21",
"study_start_date(actual)": "2020-10-19"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-03",
"last_updated_that_met_qc_criteria": "2021-02-26",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-03",
"first_submitted": "2021-02-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.
Detailed Description
A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.
#Intervention
- DIETARY_SUPPLEMENT : Ginger drink
- 300 ml ginger drink
- DIETARY_SUPPLEMENT : Placebo: Super pure water
- Placebo: Super pure water
|
#Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy males,
* Age (30 - 65) years,
* Not diabetic or plasma glucose > 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
* Subjects < 10% risk of cardiovascular disease
Exclusion Criteria:
* Women,
* Men younger than 30 years and older that 65 years,
* Men who are sick or on anti-diabetic and anti-hypertensive drugs.
* Men who have history of heart attack or stroke within the last 12 months
* Men who are on lipids lowering drugs
Sex :
MALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02735486
|
{
"brief_title": "Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease",
"conditions": [
"Cardiovascular Disease"
],
"interventions": [
"Dietary Supplement: Placebo: Super pure water",
"Dietary Supplement: Ginger drink"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02735486",
"official_title": "Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-12",
"last_updated_that_met_qc_criteria": "2016-04-06",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-12",
"first_submitted": "2015-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the use of home blood pressure monitors plus nurse telephone monitoring is more effective than the use of blood pressure monitors alone in improving control of high blood pressure in an urban medical clinic.
Detailed Description
Participants will all have home blood pressure monitors, education session on controlling their blood pressure and will be randomized to recieve 6 months of intensive telephonic on a set monitoring schedule or no telephonic follow up. Phone calls will be weekly for 4 weeks, then every 2 weeks for 8 weeks then monthly for 3 months.
#Intervention
- DEVICE : Home monitoring
- Participants will receive a home blood pressure monitor and be taught how to use it. They will have an education session to review treatment goals, medications, diet and exercise. They will be asked to see their primary care provider at least every 3 months and the research nurse at 3, 6 and 12 months.
- OTHER : monitor & phone call
- Participants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosed with essential hypertension
* systolic blood pressure >140 mm Hg (130 if diabetic) OR diastolic blood pressure > 90 mm Hg (80 if diabetic)on at least 2 clinic visits prior to randomization
* BP at time of screening is > than systolic 140 (130 if diabetic) or diastolic 90 (80 if diabetic)
* patient is prescribed at least 1 antihypertensive medication
* Patient is fluent in English
* Patient is easily accessible by telephone
Exclusion Criteria:
* persons with stage 4 or 5 chronic kidney disease or end stage renal disease on dialysis
* Patients with a terminal illness
* Patients with severe dementia or serious mental illness
* Inability to preform self blood pressure monitoring
* Patient lacks a functioning home phone or personal cellular phone
* Pregnant or planning to get pregnant
* Arm circumference exceeds the allowable limit on the largest home BP monitor cuff
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00662753
|
{
"brief_title": "A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure",
"conditions": [
"Hypertension"
],
"interventions": [
"Other: monitor & phone call",
"Device: Home monitoring"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00662753",
"official_title": "A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-25",
"last_updated_that_met_qc_criteria": "2008-04-17",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-21",
"first_submitted": "2008-04-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of this study is to better understand the clinical and demographic correlates of asthma and atopic disorders in children (through the age of 6 years) with a history of severe RSV-induced bronchiolitis.
|
#Eligibility Criteria:
Inclusion Criteria:
* successfully completed MK-0476 Protocol 272
* had RSV-induced bronchiolitis at entry into Protocol 272
Exclusion Criteria:
* had developed or had been diagnosed with any illness or congenital disorder that could be immediately life threatening
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01140048
|
{
"brief_title": "Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)",
"conditions": [
"Respiratory Syncytial Virus Bronchiolitis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01140048",
"official_title": "An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2007-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-02",
"last_updated_that_met_qc_criteria": "2010-06-07",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-09",
"first_submitted": "2010-06-07",
"first_submitted_that_met_qc_criteria": "2012-08-31"
}
}
}
|
#Study Description
Brief Summary
The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.
Detailed Description
Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all patients will be followed at every 3 months for the first 12 months from the implant. The responder/non-responder evaluation will occur at 6 months from the implant date. The criteria used for determining the response to CRT will be captured.
During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.
#Intervention
- DEVICE : CRT Patients
- This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
- Other Names :
- St Jude Medical, Any approved CRT device
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient willing and able to sign informed consent
* Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no prior LV lead placement
Exclusion Criteria:
* Are likely to undergo heart transplantation within the next 12 months
* Are less than 18 years
* Are pregnant or planning to become pregnant during the duration of the study
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01805154
|
{
"brief_title": "Advance Cardiac Resynchronization Therapy (CRT) Registry",
"conditions": [
"Heart Failure"
],
"interventions": [
"Device: CRT Patients"
],
"location_countries": [
"Japan",
"India",
"Colombia",
"China",
"United States",
"Puerto Rico",
"Brazil",
"Argentina",
"Korea, Republic of"
],
"nct_id": "NCT01805154",
"official_title": "Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-12",
"last_updated_that_met_qc_criteria": "2013-03-04",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-06",
"first_submitted": "2013-02-14",
"first_submitted_that_met_qc_criteria": "2019-07-01"
}
}
}
|
#Study Description
Brief Summary
Drugs used in chemotherapy work different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Flavopiridol may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine hydrochloride in treating patients who have locally advanced, unresectable pancreatic cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of flavopiridol in combination with radiotherapy followed by gemcitabine in patients with locally advanced, unresectable pancreatic cancer.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of flavopiridol in these patients. II. Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive flavopiridol IV over 1 hour twice weekly (on days 1 and 4 or days 2 and 5) for 6 weeks. Concurrently, patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Four weeks after the completion of radiotherapy, patients are re-evaluated\*. Beginning within 4-7 weeks after the completion of chemotherapy and radiotherapy, patients receive gemcitabine hydrochloride alone or in combination with another cytotoxic agent or gemcitabine hydrochloride combined with a targeted drug (e.g., erlotinib or bevacizumab) at the discretion of the oncologist. NOTE: \*Patients whose imaging studies suggest potential curative resection are referred for a surgical evaluation before initiating gemcitabine hydrochloride therapy. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at the recommended phase II dose.
Patients are followed at 4 weeks and then every 8 weeks thereafter.
PROJECTED ACCRUAL: Approximately 3-46 patients will be accrued for this study within 2 years.
#Intervention
- DRUG : alvocidib
- Given IV
- Other Names :
- FLAVO, flavopiridol, HMR 1275, L-868275
- DRUG : gemcitabine hydrochloride
- Given IV
- Other Names :
- dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
- RADIATION : 3-dimensional conformal radiation therapy
- Undergo 3-dimensional conformal radiation therapy
- Other Names :
- 3D conformal radiation therapy, 3D-CRT
- OTHER : laboratory biomarker analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* No non-adenocarcinoma of the pancreas (i.e., islet cell, lymphoma, or sarcoma)
* Locally advanced and unresectable disease defined as the following:
* Obvious encasement of the celiac, hepatic, or superior mesenteric artery
* Encasement of the portal or superior mesenteric vein not amenable to resection
* Extrapancreatic extension with or without regional lymph node involvement
* No distant metastases
* Measurable or evaluable disease
* Primary pancreatic tumor is considered evaluable, not measurable
* A lymph node mass is considered measurable
* Performance status - ECOG 0 <= age <= 2
* Performance status - Karnofsky 60 <= age <= 100%
* More than 12 weeks
* WBC at least 3,000/mm^3
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No Crohn's disease or inflammatory bowel disease that would preclude study participation
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
* No other uncontrolled concurrent illness that would preclude study participation
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy for this disease except gemcitabine hydrochloride-based therapy for which no radiologic evidence of distant metastatic disease exists
* No prior flavopiridol or other cyclin-dependent kinase therapies
* No prior radiotherapy for this disease
* Prior curative surgery with local recurrence allowed
* No other concurrent investigational therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00047307
|
{
"brief_title": "Flavopiridol Plus Radiation Therapy Followed By Gemcitabine Hydrochloride in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer",
"conditions": [
"Adenocarcinoma of the Pancreas",
"Recurrent Pancreatic Cancer",
"Stage II Pancreatic Cancer",
"Stage III Pancreatic Cancer",
"Stage IV Pancreatic Cancer"
],
"interventions": [
"Drug: gemcitabine hydrochloride",
"Other: laboratory biomarker analysis",
"Drug: alvocidib",
"Radiation: 3-dimensional conformal radiation therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00047307",
"official_title": "A Phase 1 Study of Alvocidib (Flavopiridol) in Combination With Radiation in Locally Advanced, Non-Operable Pancreatic and Extrahepatic Bile Duct Cancers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2002-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-04",
"last_updated_that_met_qc_criteria": "2003-01-26",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-01-27",
"first_submitted": "2002-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to prospectively explore the impact from the different cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients with type 2 diabetes.
Detailed Description
CARDIPP (Cardiovascular Risk factors in Patients with Diabetes - a Prospective study in Primary care) was launched in 2005 with the aim of identifying markers for cardiovascular disease to facilitate earlier and individually adjusted intervention in middle aged patients with type 2 diabetes. The patients in CARDIPP were consecutively recruited from primary health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005 through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the participation in the study was performed as an extended annual follow up. Blood pressure was measured as the average of three seated measurements taken 1 minute apart and standard anthropometric and clinic evaluations were performed including measurement of waist circumference and sagittal abdominal diameter which is a new and promising measurement of abdominal obesity that may serve as a surrogate marker of insulin sensitivity. We also obtained a recording of 24-hour ambulatory blood pressure. The patients filled out a detailed questionnaire for evaluation of life style factors and exercise habits. Pedometer-determined ambulatory activity for three consecutive days in combination with the questionnaires was used for quantification of daily physical activity.
The cardiovascular investigations were performed at the Department of Physiology, Linköping University Hospital and at County Hospital Ryhov, Jönköping, Sweden. The patients were subjected to cardiac ultrasonography for calculation of left ventricular mass and ejection fraction as well as diastolic cardiac function. Measurement of the carotid, femoral and radial pulse pressure wave form is performed by aid of tonometry, with pressure wave analysis and calculation of central blood pressure. Furthermore, pulse wave velocity in both central elastic and muscular peripheral arteries is defined as an index of arterial wall stiffness. The intima-media thickness (IMT) and the lumen diameter (LD) of the carotid arteries were evaluated using a B-mode ultrasound.
CARDIPP-R comprises a re-investigation of the cohort four years after the completion of the baseline examination and will thus start in November 2009 and will be completed by 2012. In CARDIPP-R, all participants from the baseline study will be invited to the re-investigation. The CARDIPP-R study protocol for the cardiac ultrasonography, the carotid ultrasonographic investigations and tonometry for measurements of the carotid, femoral and radial pulse pressure wave form and pulse wave velocity will follow the CARDIPP baseline protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes
Exclusion Criteria:
* Not able to understand Swedish
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01049737
|
{
"brief_title": "Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care",
"conditions": [
"Diabetes Mellitus Type 2",
"Cardiovascular Diseases"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT01049737",
"official_title": "Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2005-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-08",
"last_updated_that_met_qc_criteria": "2010-01-13",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-14",
"first_submitted": "2010-01-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present study aims to investigate the effect of the physical activity program developed according to the Precede-Proceed Model on children\'s physical activity level and physical activity self-efficacy, attitude, enjoyment level, and exercise change behaviors. This study was conducted in an experimental design with a pretest-posttest control group. Considering the possibility of data loss during the research, 178 students between the ages of 9 and 11 were included in the study, 89 in the intervention group and 89 in the control group. The exercises were carried out three days a week for 30 minutes in the school garden and gym, and the training was carried out in the classrooms one day a week.
#Intervention
- BEHAVIORAL : Experimental: Physical activity program
- In consultation with school administrators and classroom teachers, a physical activity program was implemented so that students\&#39; classes would not be disrupted.
The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week.
During the program, students did a total of 180 hours of physical activity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the fourth grade at the designated schools
* Could read and write
* Families agreed to participate and gave their consent
Exclusion Criteria:
* Have chronic and metabolic diseases or disabilities
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06623604
|
{
"brief_title": "The Effect of the Physical Activity Program Developed According to the Precede-Proceed Model on the Physical Activity Level and Physical Activity Behavior of Elementary School Students",
"conditions": [
"Physical Activity",
"Physical Activity Levels",
"Physical Activity Behavior"
],
"interventions": [
"Behavioral: Experimental: Physical activity program"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06623604",
"official_title": "The Effect of the Physical Activity Program Developed According to the Precede-Proceed Model on the Physical Activity Level and Physical Activity Behavior of Elementary School Students",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-30",
"study_completion_date(actual)": "2022-06-30",
"study_start_date(actual)": "2021-10-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-02",
"last_updated_that_met_qc_criteria": "2024-10-01",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-02",
"first_submitted": "2024-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy.
The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.
Detailed Description
This is a prospective, randomized clinical trial involving patients who present to the hospital with non-perforated appendicitis. We will offer enrollment to several institutions provided they receive institutional approval.
There are likely several parameters that will show small differences between groups, and this study will precisely quantify them to allow for adequate consultation from surgeons to families dealing with acute appendicitis. One theoretical concern over the SILS approach is that the exposure of the appendix to the wound could increase the rate of infectious complications; therefore, this is the primary outcome variable. The documented rate of infectious complications at our institution in patients with non-perforated appendicitis is 0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or 180 in each arm.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.
#Intervention
- PROCEDURE : Single Incision Laparoscopic Appendectomy
- A single incision through the umbilicus to remove the appendix
- Other Names :
- SILS
- PROCEDURE : 3 port laparoscopic appendectomy
- Standard 3 port laparoscopic appendectomy with intracorporeal stapling
- Other Names :
- Laparoscopic Appendectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* Children under 18 years
* Non-perforated appendicitis
Exclusion Criteria:
* Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00981136
|
{
"brief_title": "Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Appendectomy",
"conditions": [
"Appendicitis"
],
"interventions": [
"Procedure: 3 port laparoscopic appendectomy",
"Procedure: Single Incision Laparoscopic Appendectomy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00981136",
"official_title": "Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2009-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-15",
"last_updated_that_met_qc_criteria": "2009-09-21",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-22",
"first_submitted": "2009-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Detailed Description
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
#Intervention
- DEVICE : BiPAP autoSV Advanced
- The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females, ages 21 <= age <= 75.
* Able and willing to provide written informed consent.
* Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
1. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) >= 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
2. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) >= 15 and CAI > 5 from an attended Diagnostic PSG.
3. For participants diagnosed with Complex Sleep Apnea, an AHI >= 15 and CAI > 5 from a CPAP titration.
* Systolic blood pressure > 80 mm Hg at Visit 1.
* Agreement to undergo a full-night, attended Diagnostic PSG.
* Agreement to undergo a full-night, attended CPAP titration PSG.
* Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
Exclusion Criteria:
* Active participation in another interventional research study.
* Diagnosis of acute decompensated heart failure.
* Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
* Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
* Qualifying for or awaiting heart transplantation.
* Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
* At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
* Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
* Participants in whom PAP therapy is medically contraindicated.
* Uncontrolled hypertension (systolic >= 200 mm Hg/diastolic >= 120 mm Hg).
* Narcolepsy.
* Untreated Restless Legs Syndrome.
* Periodic Limb Movement arousal index > 20/hr.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01199042
|
{
"brief_title": "Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients",
"conditions": [
"Cheyne-Stokes Respiration",
"Sleep Apnea, Central"
],
"interventions": [
"Device: BiPAP autoSV Advanced"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01199042",
"official_title": "BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-28",
"last_updated_that_met_qc_criteria": "2010-09-09",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-10",
"first_submitted": "2010-09-09",
"first_submitted_that_met_qc_criteria": "2016-03-28"
}
}
}
|
#Study Description
Brief Summary
This is a health system-level research study of physicians and care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and other) of a subset of common patient care indications.
Detailed Description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. The time to review educational materials is estimated to be approximately 15 minutes.
Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.
#Intervention
- OTHER : Educational Materials for Chronic Disease Management Test (CDMT)
- These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.
|
#Eligibility Criteria:
Inclusion Criteria:
* Licensed primary care provider (PCP) (MD, DO, NP, PA) currently practicing in the following areas: a) Internal medicine b) Family medicine
* Have practiced as a PCP in internal or family medicine for greater than 2 but less than 30 years
* practicing in a community / non-academic based practice setting
* >= 40 patients under care weekly
* Commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and COPD
* Practicing in the United States
* English-speaking
* Access to the internet
* Informed and voluntarily consented to be in the study
Exclusion Criteria:
* Non-English speaking
* Not a licensed primary care provider
* Unable to access the internet
* Not practicing in the U.S.
* Do not voluntarily consent to be in the study
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05658653
|
{
"brief_title": "Clinical Utility of CDMT Among VillageMD Providers",
"conditions": [
"Chronic Disease",
"Drug Drug Interaction",
"Medication Adherence"
],
"interventions": [
"Other: Educational Materials for Chronic Disease Management Test (CDMT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05658653",
"official_title": "Measuring the Clinical Utility of Aegis's Chronic Disease Management Test Among VillageMD Providers: A CPV Randomized Control Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-10",
"study_completion_date(actual)": "2023-01-10",
"study_start_date(actual)": "2022-08-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-29",
"last_updated_that_met_qc_criteria": "2022-12-13",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-21",
"first_submitted": "2022-12-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
Detailed Description
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants. Participants will receive study medication under fed state first and later under fasted state or vice versa. The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study. Total duration of study for each participant will be approximately 48 days.
#Intervention
- DRUG : Mebendazole - fasted state (Treatment A)
- Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
- Other Names :
- VERMOX
- DRUG : Mebendazole - fed state (Treatment B)
- Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
- Other Names :
- VERMOX
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have signed an informed consent document
* Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
* Woman must have a negative serum human chorionic gonadotropin pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
* Man must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
* Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before dosing in each treatment period
* Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and Day 1 of the each treatment period
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02051738
|
{
"brief_title": "A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Mebendazole - fasted state (Treatment A)",
"Drug: Mebendazole - fed state (Treatment B)"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02051738",
"official_title": "A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-27",
"last_updated_that_met_qc_criteria": "2014-01-30",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-31",
"first_submitted": "2014-01-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \[14C\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \[14C\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.
#Intervention
- DRUG : Period 1 treatment
- 200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \[14C\]-ipatasertib on Day 1 of study
- DRUG : Period 2 treatment
- 200-mg/100-mcCi oral \[14C\]-ipatasertib on Day 15 of study
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers 18 <= age <= 55 of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m2, inclusive
Exclusion Criteria:
* Females
* Clinically significant findings from medical history or screening evaluations
* Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in
* Significant radiation exposure within 12 months prior to check-in
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
|
NCT02390492
|
{
"brief_title": "A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: Period 2 treatment",
"Drug: Period 1 treatment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02390492",
"official_title": "A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute Bioavailability Following Single Oral and Intravenous Doses in a Single Cohort of Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2015-03-16",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-17",
"first_submitted": "2015-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.
Detailed Description
Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Continuous health plan enrollment for 12 months before and after index Rx
* At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
* COPD diagnosis, and aged 40 years at time of first prescription
* At risk population for COPD exacerbations
Exclusion Criteria:
* ICS/LABA combination or LAMA therapy during pre-index period
* Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
* Patients diagnosed with cancer
* Patients with long-term OCS medication use during pre-index period
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01917643
|
{
"brief_title": "Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients",
"conditions": [
"COPD Exacerbation"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01917643",
"official_title": "A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2013-11",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-03",
"last_updated_that_met_qc_criteria": "2013-08-05",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-07",
"first_submitted": "2013-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.
The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.
Detailed Description
Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.
During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.
Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.
The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.
Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.
#Intervention
- PROCEDURE : Off-Pump Coronary Artery Bypass Grafting
|
#Eligibility Criteria:
Inclusion Criteria:
* Age seventy years or above
* Admitted for first time coronary artery bypass operation
Exclusion Criteria:
* Given information cannot be understood
* Aortic crossclamping not safe due to calcification
* Preoperative cardiac conditions demanding cardiopulmonary bypass
* Re-do cardiac surgery
* Patients requiring operation within the same day after conference
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00123981
|
{
"brief_title": "The Danish On-pump, Off-pump Randomization Study (DOORS)",
"conditions": [
"Ischemic Heart Disease"
],
"interventions": [
"Procedure: Off-Pump Coronary Artery Bypass Grafting"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT00123981",
"official_title": "The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-11",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2005-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-06",
"last_updated_that_met_qc_criteria": "2005-07-25",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-07-26",
"first_submitted": "2005-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.
Detailed Description
The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.
Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.
Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.
Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject has solid cancer
* Subject is expected to start chemotherapy
Exclusion Criteria:
* Pregnancy and lactation
* Severe impaired kidney function
* Severe hepatic impairment
* Mental disease
* Acute myocardial infarction 28 days ago or earlier
* Acute Cerebrovascular Event 1 month ago or earlier
* Rhythm disturbance that complicate pulse wave velocity evaluation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04681560
|
{
"brief_title": "Impact of Platinum-based Cancer Treatment on Endothelial Function",
"conditions": [
"High Blood Pressure",
"Cardiovascular Complication"
],
"interventions": null,
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT04681560",
"official_title": "The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-09",
"study_completion_date(actual)": "2020-01-20",
"study_start_date(actual)": "2018-01-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-23",
"last_updated_that_met_qc_criteria": "2020-12-18",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-23",
"first_submitted": "2020-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.
#Intervention
- DRUG : AGS-16M8F
- IV
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
* Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
* Eastern Cooperative Group (ECOG) performance status of 0 <= age <= 1
* Negative pregnancy test (women of childbearing potential)
* Hematologic function, as follows:
* Absolute neutrophil count (ANC) >= 1.5 x 109/L
* Platelet count >= 100 x 109/L
* Hemoglobin >= 9 g/dL (transfusions are allowed)
* Renal function, as follows:
* creatinine <= 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
* Hepatic function, as follows:
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 x ULN or <= 5x ULN if known liver metastases
* Total bilirubin <= 1.5 x ULN
* International Normalized Ratio (INR) < 1.3 (or <= 3.0 if on therapeutic anticoagulation)
* Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration
Exclusion Criteria:
* Past or present documented central nervous system (CNS) tumor or CNS metastasis
* Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
* History of thromboembolic events and bleeding disorders <= 3 months (e.g., DVT or PE)
* Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
* Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
* Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01114230
|
{
"brief_title": "A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer",
"conditions": [
"Renal Cell Carcinoma",
"Pharmacokinetics of AGS-16M8F"
],
"interventions": [
"Drug: AGS-16M8F"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01114230",
"official_title": "A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2010-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-12-12",
"last_updated_that_met_qc_criteria": "2010-04-30",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-03",
"first_submitted": "2010-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
#Intervention
- BIOLOGICAL : Comparator: V710
- Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
- BIOLOGICAL : Comparator: placebo
- Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 80 of age
* Good physical health based upon medical history and physical examination
* Willing and able to participate in the entire study duration
* Female subject with a negative urine pregnancy test immediately prior to study vaccination
Exclusion Criteria:
* Chronic skin infections or a chronic skin condition (e.g. psoriasis)
* Serious S. aureus infection in the last 12 months
* Allergy to aluminum-containing substance taken in the body or to any other vaccine component
* Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
* Participation in a prior V710 vaccine clinical study
* Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00822757
|
{
"brief_title": "Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)",
"conditions": [
"Healthy"
],
"interventions": [
"Biological: Comparator: placebo",
"Biological: Comparator: V710"
],
"location_countries": null,
"nct_id": "NCT00822757",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-10",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-10-02",
"last_updated_that_met_qc_criteria": "2009-01-13",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-14",
"first_submitted": "2009-01-13",
"first_submitted_that_met_qc_criteria": "2011-10-13"
}
}
}
|
#Study Description
Brief Summary
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects
To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects
To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy male subjects
Detailed Description
This clinical trial is a dose block-randomized, double-blinded, placebo controlled, single ascending dose, food interaction study. AEs, PE, Vital signs, ECGs and clinical lab tests will be assessed to evaluate the safety and tolerability, and blood and urine will be collected to evaluate the pharmacokinetic parameters.
This single ascending dose, food interaction study will be conducted with the KD101 dose of 200, 600, 1000 and 1400 mg. After evaluating the safety and pharmacokinetic parameters in the single dose KD101 group of 200mg, next higher dose of KD101 will be administered and evaluated and food interaction will be evaluated in the KD101 group of 600mg.
#Intervention
- DRUG : KD101
- 200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning
- Other Names :
- KD101 soft capsule 200mg
- DRUG : placebo
- PO, once in the morning
- Other Names :
- KD101 placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who listened the properties of this clinical trial and signed IRB approved-ICF by voluntary consent
* Male adults aged 20 <= age <= 55 at screening
* Healthy volunteer whose BMI >= 18
* Subjects who are adequate to this trial by physical examination, lab examination, diagnosis from physician
Exclusion Criteria:
* Subjects who had clinically significant disease history (liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,mental system,blood,tumor) or diagnosed within 1 month from screening
* Subjects who had gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) that affect the absorption of test drug or gastrointestinal operation (However, appendectomy, herniotomy induced by acute appendicitis are excluded)
* Subjects who had / or were suspected to had following history. [myocardial infarction (diagnosed by cardiac enzyme and/or diagnostic ECG), cerebral infarction/stroke , arrhythmia needed to medical treatment, unstable angina, pulmonary hypertension]
* Subjects who had positive result to Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus during screening
* Subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had clinically-significant allergy
* Subjects whose systolic BP was <85mmHg or >145mmHg, or diastolic BP was <50mmHg or >95mmHg, or pulse was >100/min after 3 minute-seating position. (BP can be re-measured twice at leat 5 minute-interval)
* Subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing day) or OTC drug or vitamines (within 1 weeks from the first dosing day)
* Subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit drinking alcohol during clinical trial period
* Subjects who ate following food within 2 days from the first dosing day or cannot quit following food [grapefruit-contain food, caffein-contain food(coffee, green tea, black tea, soft drink, coffee milk, energy drink)]
* Subjects who didn't agree contraception
* Subjects who didn't agree to quit smoke
* Subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis) or who took transfusion within 1 month
* Subjects who participated another clinical trials within 3 months from first dosing day. (The clinical trial completion day is defined as the last dosing day of past clinical trial)
* Subjects who are not adequate to this trial by lab examination and another reason
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01979380
|
{
"brief_title": "Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects",
"conditions": [
"Drug Toxicity"
],
"interventions": [
"Drug: KD101",
"Drug: placebo"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01979380",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Ascending Single Oral Dose, Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2013-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-12",
"last_updated_that_met_qc_criteria": "2013-11-04",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-08",
"first_submitted": "2013-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
Detailed Description
The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
#Intervention
- DEVICE : ION™ Coronary Stent System
- This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.
|
#Eligibility Criteria:
Inclusion Criteria:
Consented subjects receiving one or more ION(TM)Coronary Stents
Exclusion Criteria:
Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01422889
|
{
"brief_title": "ION US Post-Approval Study",
"conditions": [
"Atherosclerosis",
"Coronary Artery Disease"
],
"interventions": [
"Device: ION™ Coronary Stent System"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01422889",
"official_title": "A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2011-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-04",
"last_updated_that_met_qc_criteria": "2011-08-23",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-25",
"first_submitted": "2011-08-22",
"first_submitted_that_met_qc_criteria": "2015-03-09"
}
}
}
|
#Study Description
Brief Summary
The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis
#Intervention
- DRUG : Meloxicam
- DRUG : Diclofenac
- DRUG : Nimesulide
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders between 2 and 8 years
* Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria:
* Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended
Exclusion Criteria:
* Known or suspected hypersensitivity to study medications or NSAID's
* Pharyngeal smear positive for ß-hemolytic Streptococcus
* treatment with antimicrobials prior to enrolment in the study
* Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months
* Asthma
* nasal polyps
* angioneurotic edema or urticaria after the administration of aspirin or NSAID's
* Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate
* Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs
* Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose
* Treatment with corticosteroids at the time of enrollment or within the two previous months
* Known liver, renal or hematological disease
* Participation in another clinical trial during the study period or during the previous month
* Previous enrollment in this study
* Inability to comply with the protocol
* Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria):
* Clinical presentation characterized by a rapid onset, very high fever (>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02229747
|
{
"brief_title": "Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis",
"conditions": [
"Pharyngitis"
],
"interventions": [
"Drug: Diclofenac",
"Drug: Meloxicam",
"Drug: Nimesulide"
],
"location_countries": null,
"nct_id": "NCT02229747",
"official_title": "Randomized, Open-label, Controlled Trial to Assess the Clinical Efficacy and Safety of Meloxicam Suspension 0.25 mg/kg/Day Once a Day, Versus Diclofenac 1 mg/kg/Day Twice a Day or Nimesulide 4 mg/kg/Day Twice a Day, for Five Days in the Treatment of Patients With Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-02",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2001-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-09-01",
"last_updated_that_met_qc_criteria": "2014-08-29",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-01",
"first_submitted": "2014-08-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.
Detailed Description
The overall objective was to design and implement an intervention program to promote changes in diet and physical activity that promotes, through the focus of the motivational interview, the increase in the consumption of fruits and vegetables, the decrease in the consumption of fats and the increase in physical activity, to achieve an impact in the reduction of weight and body fat, the improvement in the biomarkers of the disease and in the quality of life in women survivors of BC.
Specific objectives
1. Determine the adherence of participants to a healthy lifestyle intervention by analyzing biological markers of dietary intake (alpha and beta carotene, as well as lipid profile) at the beginning of the study and at 4 and 8 months after initiation of the intervention.
2. Investigate the impact of the intervention on changes in weight, body mass index, body fat, muscle mass and bone mineral density of women by measuring these variables at the beginning of the study and at 4 and 8 months after intervention.
3. Examine the effect of the intervention on biomarkers of the disease: mammographic density, telomere length and telomerase activity, VEGF, DNA methylation and CPTP at baseline and 8 months.
4. To evaluate the impact of the intervention program on inflammatory markers: leptin and adiponectin, IL6, IL8, CRP and TNF-α at the beginning, 4 and 8 months after the intervention started.
5. Analyze the effect of the intervention on the alterations in sleep quality and quality of life of the women survivors of breast cancer at the beginning, 4 and 8 months after the intervention.
Study Design and Participants
This was a randomized controlled clinical trial with two groups of breast cancer survivors. In the intervention group, we used the strategy of Motivational Interviewing to promote changes in diet and physical activity; the comparison group received an orientation with a traditional educational approach. The intervention program lasted eight months. A total of 60 women from Sonora, Mexico, participated in the study. The women were selected from the State Oncology Center and through social networks. The research protocol was sent to the ethics committee of the Center for Research in Food and Development, A.C. and women signed an informed consent letter to participate in the study.
Visits and monitoring
After the recruitment, application of questionnaires and blood sampling at the first visit (baseline), the participants were randomly assigned to the intervention (n = 30) or the comparison group (n = 30). The orientation was similar in both groups and was carried out in two modalities: in person at the participant's house and by telephone. The first orientation was made within the first 15 days after the first visit (baseline) and was at the participant's home. Within a week of the first initial orientation, the participants were called by phone to continue the monitoring and orientation process. During the first four months, the orientation was every fifteen days, and combined the visits to the participant's house with phone calls. During the next four months, the orientation took place once a month and at the participant's house.
Intervention program for changes in lifestyle
Guidance on lifestyle changes in the intervention group was carried out using the motivational interviewing approach and was conducted by trained personnel for that purpose. The dietary intervention was designed to promote the increase in plasma carotene levels, due to the increase in the consumption of fruits and vegetables. The intervention also promoted the improvement of the lipid profile (due to the decrease in fat consumption) and the control or reduction of body weight.
The diet and physical activity components of the lifestyle change program were progressive, and we managed individualized interventions. Both the diet and the physical activity regimen could be adjusted to any unexpected situation (e.g., Decrease in the number of steps due to stomach problems or ankle sprains) during the entire participation period.
The dietary goals contemplated to reach a consumption of 20% of the total energy coming from fats, the consumption of 6 or more servings of fruits / vegetables a day and the promotion of a healthy body weight, to increase fiber consumption to a greater than 30 grams daily, decrease the consumption of sugary drinks and increase the consumption of protein. The emphasis on dietary fat restriction helped to achieve other dietary goals, such as increased consumption of vegetables and fruits, increased fiber consumption, and mild to moderate body weight loss. To reach the goal of having a fat intake in the diet of 20% of the total energy consumed, a goal of grams of fat was established for each participant.
The component of physical activity consisted of a moderately low aerobic regime with the aim of gradually increasing the number of steps per week, in order to be able to walk at least 4000 steps (in addition to those that are already routine) per day or 28,000 steps per week. In addition, participants were encouraged to reduce sedentary time, by performing simple exercises while sitting and stretching exercises, among others.
The educational materials covered different topics such as knowing how to read and interpret the labels on food, recommendations for buying food, recommendations for eating out and others. The visits and orientation calls included a brief assessment of the food consumed and the physical activity performed the previous day, as well as a review of the list of weekly behavior goals and lifestyle journals, which helped the counselor to assess adherence to lifestyle goals and provide specific encouragement and feedback to the participant. Lifestyle journals were used to assess the intake of fat grams as well as daily steps to assess adherence and identify specific barriers to compliance with behavioral goals.
Comparison group
This group received a notebook that included general health information. As with the intervention group, they were provided with a pedometer and common literature on recommendations to stay physically active. Participants in this group were not asked to record their diet or physical activity, and guidance was provided monthly during the 8-month intervention.
Collection of information
The collection of the information was carried out in the two groups. The sociodemographic and health data of the participants were obtained in the first visit. The anthropometric and body composition measurements, as well as the application of questionnaires on sleep quality and quality of life were carried out at the first visit (day 1), 4 and 8 months after the intervention as well the dietary evaluation. The blood samples for the analysis of carotenoids, lipid profile, , VEGF, DNA methylation, and proinflammatory markers were taken on the first day, at 4 and 8 months. The mammographic density analysis, telomere length, and telomerase activity were carried out at the beginning of the study and at 8 months.
#Intervention
- BEHAVIORAL : Motivational Interviewing
- The motivational interviewing strengthens the motivation and commitment to achieve a specific change through the induction and exploration of the reasons for modifying behavior. All this within an atmosphere of acceptance and compassion. It is about extracting the possible solutions to the change that is faced from the individual and his environment and not from the professional. This strategy is achieved by looking for the patient to feel motivated, and to express their problem and thus create discrepancy so that they evaluate their actions and reflect on the changes they should make.
- Other Names :
- Intervention group
- BEHAVIORAL : Traditional Education
- Traditional education refers to the normal care given to breast cancer survivors. That is, they receive recommendations about their physical activity and diet but without any motivational approach.
- Other Names :
- Comparison group
|
#Eligibility Criteria:
Inclusion Criteria:
* Women over 18 with a diagnosis of stage II-IV invasive breast cancer
* Have at least 6 weeks and no more than 2 years of completing your therapy at the time of recruitment
* Do not present metastasis
* Not having a special diet or rigorous physical activity
* Not suffer any chronic illness or physical limitation
* Not have depression problems
* Sign the informed consent letter
Exclusion Criteria
* Have restrictions for physical activity
* Strict diet or be a vegetarian
* Body mass index below 18
* Having undergone surgery to lose weight
* Having excision in both breasts or having implants
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04096469
|
{
"brief_title": "Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors",
"conditions": [
"Body Weight Changes",
"Mammographic Density",
"Quality of Life"
],
"interventions": [
"Behavioral: Traditional Education",
"Behavioral: Motivational Interviewing"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT04096469",
"official_title": "Intervention Program to Promote Changes in Diet and Physical Activity and to Evaluate Its Impact on Body Weight, Biomarkers of Disease and Quality of Life in Breast Cancer Survivors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-01",
"study_completion_date(actual)": "2019-09-01",
"study_start_date(actual)": "2016-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-29",
"last_updated_that_met_qc_criteria": "2019-09-18",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-19",
"first_submitted": "2019-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objectives of this scientific expedition are: a/ Evaluation of temporal cognitive perception and collective synchronization in a temporally anomalous universe (underground environment), b/ Influence of group living on the endogenous circadian rhythmicity of the central biological clock and peripheral clocks in a 'free-running' situation (absence of light/natural darkness), c/Evaluation of cognitive and physiological performance in response to exposure to an extreme environment in a natural underground cavity (cave) without access to a time indicator for 40 days, d/Correlation of cognitive, behavioral, psychological, social, neurophysiological and physiological parameters, e/ Determination of adaptation or maladaptation criteria (biological, genetic, physiological, neurophysiological, psychological and cognitive) in an isolation environment (underground) f/ Study of the evolution of collective organization, decision making and leadership in an extreme isolation and management situation.
Detailed Description
This exceptional period has shown a significant desynchronization and loss of notion of time in a large number of people as well as important questions about human abilities to live in confined conditions. It is partly for this reason, but also to answer more fundamental questions on the perception of time that the extraordinary research expedition Deep Time was conceived: 40 days underground to know the links of our brain to time and synchronization within a group. A fundamental need for our future. This scientific expedition will take place entirely in France to ensure the feasibility and safety of the subjects and experimenters, under the direction of Christian Clot and the Institute of Human Adaptation, placed under the high patronage of the Ministry of Education, Research and Innovation.
The project addresses the fundamental question of human adaptation to the physical environment and the crucial role of the brain's neuroplasticity properties.
The present 'Deep-Time' protocol naturally echoes the 'out-of-time' isolation experiments conducted by the speleologist Michel Siffre starting in 1962 and its various components in the years that followed.
These 'out of time' experiments led to certain conclusions. As curious as it may seem, in the absence of the time givers (synchronizers or Zeitgebers in German) that are the social rhythms and the day-night alternations, the spontaneous rhythm would settle on a rhythm of about 25 hours.
However, these experiments remained limited to isolated individuals, in conditions of spatial unity (no displacement outside of the work camps), leaving a whole field of research and questioning that the year 2021 has strongly emphasized.
The objectives of this scientific expedition are: a/ Evaluation of temporal cognitive perception and collective synchronization in a temporally anomalous universe (underground environment), b/ Influence of group living on the endogenous circadian rhythmicity of the central biological clock and peripheral clocks in a 'free-running' situation (absence of light/natural darkness), c/Evaluation of cognitive and physiological performance in response to exposure to an extreme environment in a natural underground cavity (cave) without access to a time indicator for 40 days, d/Correlation of cognitive, behavioral, psychological, social, neurophysiological and physiological parameters, e/ Determination of adaptation or maladaptation criteria (biological, genetic, physiological, neurophysiological, psychological and cognitive) in an isolation environment (underground) f/ Study of the evolution of collective organization, decision making and leadership in an extreme isolation and management situation.
#Intervention
- BEHAVIORAL : exploratory protocol
- physiological and cognitive evaluations
|
#Eligibility Criteria:
Inclusion Criteria:
Strictly right-handed Good health without any medical and psychiatric diseases No contraindications to MRI French or European nationality Not to be included in another biomedical protocol
Exclusion Criteria:
Being pregnant Minor, under guardianship or curatorship
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05603780
|
{
"brief_title": "DEEPTIME: Human Adaptation in Time Underground Isolation",
"conditions": [
"Physiological Stress",
"Cognitive Dysfunction",
"Sleep"
],
"interventions": [
"Behavioral: exploratory protocol"
],
"location_countries": [
"France"
],
"nct_id": "NCT05603780",
"official_title": "Cognitive, Emotional, Physiological, Chronobiological and Genetic Effects of a Time Underground Isolation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-11",
"study_completion_date(actual)": "2022-03-11",
"study_start_date(actual)": "2021-03-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-03",
"last_updated_that_met_qc_criteria": "2022-10-27",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-03",
"first_submitted": "2021-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
#Intervention
- DRUG : biphasic insulin aspart 30
- Single dose administrated subcutaneously (s.c., under the skin)
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI (body mass index) between 18 and 28 kg/m^2, both inclusive
* Subject is a nonsmoker for at least 3 months
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
* Fasting plasma glucose between 80 and 110 mg/dl
Exclusion Criteria:
*
*Any clinically significant disease history of systemic or organ disease
*
*Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
*
*In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
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
|
NCT01487811
|
{
"brief_title": "Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers",
"conditions": [
"Diabetes",
"Healthy"
],
"interventions": [
"Drug: biphasic insulin aspart 30"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01487811",
"official_title": "Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-11",
"study_completion_date(actual)": "2005-11",
"study_start_date(actual)": "2005-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-06",
"last_updated_that_met_qc_criteria": "2011-12-06",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-07",
"first_submitted": "2011-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
Detailed Description
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of \>30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
#Intervention
- PROCEDURE : upgraded '2C3L'
- Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.
- Other Names :
- EI-VOM+2C3L
- PROCEDURE : pulmonary vein antral isolation
- After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.
- Other Names :
- PVI
|
#Eligibility Criteria:
Inclusion criteria
Patients must meet all the following criteria to be included in the study:
* age between 18 and 80,
* patients undergoing a first-time ablation procedure for non-valvular AF,
* patients with defined as a sustained episode more than 3 months
* PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
* patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
* AF refractory to at least one AAD,
* willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.
Exclusion criteria Patients are to be excluded if any of the following criteria is met：
* patients with paroxysmal AF,
* patients with AF secondary to an obvious reversible cause,
* patients with left atrial diameter >= 60 mm in the parasternal long axis view,
* left ventricular ejection fraction (LVEF) < 30%,
* patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
* patients with contraindication to anticoagulation,
* patients with contraindication to right or left sided heart catheterization,
* pregnancy,
* life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
* patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04497376
|
{
"brief_title": "Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation",
"conditions": [
"Persistent Atrial Fibrillation",
"Catheter Ablation"
],
"interventions": [
"Procedure: upgraded '2C3L'",
"Procedure: pulmonary vein antral isolation"
],
"location_countries": [
"China"
],
"nct_id": "NCT04497376",
"official_title": "Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-18",
"study_completion_date(actual)": "2024-07-18",
"study_start_date(actual)": "2021-08-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-19",
"last_updated_that_met_qc_criteria": "2020-07-30",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-04",
"first_submitted": "2020-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe
Detailed Description
This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.
#Intervention
- PROCEDURE : Forceps biopsy and cryobiopsy
- Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.
|
#Eligibility Criteria:
Inclusion Criteria:
* Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
* Age between 18 and 90 years
* Written informed consent after participant's information
Exclusion Criteria:
* Age < 18 and > 90 years
* Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)
* Contraindication against bronchoscopy (e.g. co-morbidities)
* INR > 2 or Thrombocytes < 50000
* Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
* Anticoagulation with NOAK within 48 hours before biopsy
* Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
* Tumors suspicious of endobronchial growth
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04885595
|
{
"brief_title": "Diagnosis of Peripheral Lung Nodules Using Cryobiopsy",
"conditions": [
"Lung; Node"
],
"interventions": [
"Procedure: Forceps biopsy and cryobiopsy"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04885595",
"official_title": "Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-15",
"study_completion_date(actual)": "2023-05-30",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-28",
"last_updated_that_met_qc_criteria": "2021-05-08",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-13",
"first_submitted": "2021-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
#Intervention
- BIOLOGICAL : rLP2086 vaccine
- 120 mcg, 3 doses, at month 0, 2, and 6.
- BIOLOGICAL : control
- HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects aged 10 <= age <= 25.
Exclusion Criteria:
* Previous vaccination with Hepatitis A virus vaccine
* Previous vaccination with investigational meningococcal B vaccine
* History of culture-proven N. meningitidis serogroup B disease
* Any neuroinflammatory or autoimmune condition
* Any immune defect that would prevent an effective response to the study vaccine
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01352793
|
{
"brief_title": "A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years",
"conditions": [
"Meningitis, Meningococcal"
],
"interventions": [
"Biological: control",
"Biological: rLP2086 vaccine"
],
"location_countries": [
"Lithuania",
"Sweden",
"United States",
"Chile",
"Germany",
"Poland",
"Spain",
"Australia",
"Estonia",
"Finland",
"Czech Republic",
"Denmark"
],
"nct_id": "NCT01352793",
"official_title": "A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2012-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-11",
"last_updated_that_met_qc_criteria": "2011-05-11",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-12",
"first_submitted": "2011-05-11",
"first_submitted_that_met_qc_criteria": "2015-02-25"
}
}
}
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.