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#Study Description
Brief Summary
This randomized phase II trial studies how well cytarabine with or without SCH 900776 works in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the rates of complete remission (CR) plus CR with incomplete recovery (CRi) achieved with cytosine arabinoside (ara-C) (cytarabine) plus the checkpoint kinase 1 (CHK1) inhibitor MK-8776 (Chk1 inhibitor SCH 900776) vs. ara-C alone for adults (ages 18-75) with relapsed acute myelogenous leukemia (AML).
SECONDARY OBJECTIVES:
I. To evaluate and compare the toxicities of ara-C + MK-8776 vs. ara-C alone. II. To determine the disease free and overall survival of those achieving response to treatment.
III. To determine the impact of MK-8776 on AML blast cell deoxyribonucleic acid (DNA) repair protein expression profiles and correlate the expression profiles with CR/CRi in response to ara-C + MK-8776 vs. ara-C alone.
IV. To evaluate and compare the amount of DNA damage induced in AML blasts by ara-C + MK-8776 vs. ara-C.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cytarabine intravenously (IV) continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
ARM B: Patients receive cytarabine as in Arm A.
In both arms, courses may repeat every 28 days.
After completion of study treatment, patients are followed up periodically.
#Intervention
- DRUG : Cytarabine
- Given IV
- Other Names :
- CHX-3311, U-19920
- DRUG : CHK1 Inhibitor SCH 900776
- Given IV
- Other Names :
- SCH 900776
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults with the established, pathologically confirmed diagnosis of relapsed AML
* AML that has relapsed at least once or is primary induction failure
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Patients must be able to give informed consent
* Female patients of childbearing age must have negative pregnancy test
* Serum creatinine =< 2.0 mg/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 x upper limit normal (ULN), unless due to Gilbert's, hemolysis or leukemic infiltration
* Alkaline phosphatase =< 5 x ULN, unless due to Gilbert's, hemolysis or leukemic infiltration
* Bilirubin =< 2.0 mg/dl, unless due to Gilbert's, hemolysis or leukemic infiltration
* Left ventricular ejection fraction >= 45% by multi gated acquisition scan (MUGA) or echocardiogram
* Baseline Fridericia corrected QT (QTcF) < 480 msec
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are eligible provided that they are >= 4 weeks from stem cell infusion, have no active graft-vs-host disease (GVHD), and meet other eligibility criteria
* Patients who fail primary induction therapy or relapse after achieving complete remission (CR) are eligible if they have undergone no more than 2 prior cytotoxic regimens (a regimen is described as a distinctive planned collection of agent[s] and/or modalities to be utilized together during a cycle or course of therapy; i.e., induction+consolidation with or without stem cell transplant [SCT]), >= 2 weeks off cytotoxic chemotherapy, and >= 2 weeks off radiation therapy; patients must be off biologic therapies including hematopoietic growth factors >= 2 weeks; if using hydroxyurea (HU), steroids, imatinib or other tyrosine kinase inhibitors (TKIs), interferon, or other non-cytotoxics for blast count control, patient must be off for >= 24 hours (hrs) before starting MK-8776
* Fluvoxamine and ciprofloxacin must be stopped 7 days prior to day 1 of therapy, and be excluded during administration of study therapy; if the subject is using any of the other drugs that are cytochrome P4501A2 (CYP1A2) or P-glycoprotein (PgP) inhibitors, substitution should be considered and administration of these drugs should be avoided on the days of administration of MK-8776; in addition, smoking should be avoided and cytochrome P450 3A4 (CYP3A4) substrates with a narrow therapeutic index should be avoided: alfentanil, astemizole, cisapride, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine
Exclusion Criteria:
* Any previous treatment with MK-8776
* Considered refractory or treatment failure to most recent treatment regimen, unless primary refractory
* Concomitant chemotherapy, radiation therapy, or immunotherapy
* Hyperleukocytosis with >= 50,000 blasts/uL (if using HU, steroids, tyrosine kinase/src inhibitors (including fms-related tyrosine kinase 3 [FLT3] inhibitors), arsenic, interferon or leukapheresis for blast count control, patient must be off those agents for 24 hours prior to beginning ara-C +/- MK-8776)
* Acute progranulocytic leukemia (APL, M3)
* Active disseminated intravascular coagulation (DIC)
* Active central nervous system (CNS) leukemia
* Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
* Presence of other life-threatening illness
* Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-8776
* History of Fridericia corrected QT (QTcF) prolongation greater than grade 1 or 480 msec
* Subjects with the following cardiac risk factors must be excluded: transmural myocardial infarction (MI) within prior 6 months, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack (TIA) or seizure disorder within 6 months prior to study drug administration
* Subjects with history of risk factors for torsades de pointes: clinical history of heart failure (New York Heart Association [NYHA] class III or IV), hypo- or hyper-kalemia or hypomagnesemia (supplementation to bring levels within normal limits prior to administration of MK-8776 is acceptable) or family history of Long QT Syndrome
* Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy or who have a prior history of acquired immunodeficiency syndrome (AIDS) indicator conditions, other than history of lymphoma more than 3 years remote
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
|
NCT01870596
|
{
"brief_title": "Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia",
"conditions": [
"Adult Acute Megakaryoblastic Leukemia",
"Adult Acute Monoblastic Leukemia",
"Adult Acute Monocytic Leukemia",
"Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11",
"Adult Acute Myeloid Leukemia With Maturation",
"Adult Acute Myeloid Leukemia With Minimal Differentiation",
"Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11",
"Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1",
"Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL",
"Adult Acute Myeloid Leukemia Without Maturation",
"Adult Acute Myelomonocytic Leukemia",
"Adult Erythroleukemia",
"Adult Pure Erythroid Leukemia",
"Alkylating Agent-Related Acute Myeloid Leukemia",
"Recurrent Adult Acute Myeloid Leukemia"
],
"interventions": [
"Drug: CHK1 Inhibitor SCH 900776",
"Drug: Cytarabine",
"Other: Laboratory Biomarker Analysis"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01870596",
"official_title": "Randomized Phase II Trial of Timed Sequential Cytosine Arabinoside (Ara-C) With and Without the Checkpoint Kinase 1 (CHK1) Inhibitor MK-8776 in Adults With Relapsed AML",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-01",
"last_updated_that_met_qc_criteria": "2013-06-03",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-06",
"first_submitted": "2013-06-03",
"first_submitted_that_met_qc_criteria": "2016-07-20"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the feasibility of a stigma reduction intervention in Human Immunodeficiency Virus(HIV)-positive women using a video of first-person narratives delivered via personal Ipod Touch.
Detailed Description
Nearly 30 years into the Acquired Immune Deficiency Syndrome (AIDS) epidemic, stigma is still hampering efforts to stop its spread. Human Immunodeficiency Virus(HIV)-infected women are particularly vulnerable to both perceived and enacted stigma, which together are referred to as internalized stigma. As the demographic face of HIV infection in the US has changed from being largely a disease of gay white men to one of poor minority women, the debilitating effects of stigma have worsened. It has a profound impact on prevention and treatment efforts; women with HIV infection may be fearful of insisting that their sexual partners wear condoms because of the possibility that this may signal their serostatus, and they may not want to take antiretroviral medications in front of others, fearing that people may ask questions about their pills and the reasons for taking them. The effects of stigma include a cascade of other negative outcomes as well, including poor self-esteem and self-efficacy, especially self-efficacy for disclosure and for coping. Yet it is nearly impossible to intervene with those who stigmatize others because this group is often as broad as the general public, and they may not be interested in an intervention. Therefore, the best approach may be to work with women who are experiencing stigma, in an effort to decrease stigma, improve self-esteem and coping self-efficacy, and facilitate safe disclosure. To date, there have been few interventions to help HIV-infected women deal with stigma. One option would be a video converted to an Moving Picture 4 (MP4) file that can be viewed on an iPod Touch, a small portable viewing device, allowing the woman privacy and safety in viewing. Barroso (primary investigator on the proposed study) assisted in the creation of a video on stigma for women with HIV infection, based on the results of a qualitative metasynthesis. The 45-minute video presents vignettes about five seropositive women and the ways in which stigma has impacted their lives. The primary aim of the proposed study is to assess the feasibility, acceptability and utility of implementing this low-cost, technologically delivered intervention to mitigate the negative effects of HIV-related stigma on seropositive women. The secondary aim is to compare outcomes across time in women who receive the stigma intervention with those of a control group receiving usual care at baseline, 30, and 90 days, and to determine effect sizes for a larger definitive study to test the efficacy of this intervention in reducing internalized stigma, improving coping self-efficacy and self-esteem, and facilitating safe disclosure in HIV-infected women. The investigators believe that this intervention is innovative because they are the first investigators to propose using a video, developed from the findings of a metasynthesis of studies about stigma as it is experienced by HIV-infected women, for this purpose. It is also innovative in the use of a portable viewing device which will allow the women to safely and privately view the video. The investigators further believe that this intervention has the potential to make a significant impact, at a low cost in terms of money and personnel time, in mitigating stigma.
#Intervention
- BEHAVIORAL : Ipod video
- This group will be asked to watch the video on their Ipod Touch in its entirety at least once per week during the first four weeks of the study, and as often as desired in weeks 5-12. The participants will be asked to record the times viewed and their feelings/comments in a viewing log, and will be given surveys at 30 and 90 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* speaks, understands, and reads English
* Scores over 40 on Internalized Human Immunodeficiency Virus (HIV) Stigma Scale
* HIV positive
* mentally competent to give informed consent
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01385241
|
{
"brief_title": "Feasibility of a Stigma Reduction Intervention for Human Immunodeficiency Virus (HIV)-Infected Women",
"conditions": [
"Human Immunodeficiency Virus (HIV)",
"Self-efficacy",
"Self-esteem"
],
"interventions": [
"Behavioral: Ipod video"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01385241",
"official_title": "Feasibility of a Stigma Reduction Intervention for HIV-infected Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2011-07"
},
"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)": "2014-10-22",
"last_updated_that_met_qc_criteria": "2011-06-29",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-30",
"first_submitted": "2011-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Graded motor imagery (GMI) clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in chronic shoulder pain shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in chronic rotator cuff-related shoulder pain on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.
#Intervention
- OTHER : graded motor imagery
- The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.
- OTHER : traditional physiotherapy method
- This protocol included stretching and strengthening exercises. Self-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening.
|
#Eligibility Criteria:
Inclusion Criteria:
Age 18 <= age <= 65 years Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes Pain at rest maximum 2 out of 10 on verbal numerical rating scale Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test
Exclusion Criteria:
Bilateral shoulder pain Corticosteroid injections less than 6 weeks prior to the enrolment Participants who were pregnant, Mini Mental State Examination score >24 Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test) Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) Primary diagnosis of acromioclavicular pathology, shoulder instability Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication Participants performing overhead sport activities for more than 4hours/week
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06092489
|
{
"brief_title": "Chronic Rotator Cuff-related Shoulder Pain and Graded Motor Imagery",
"conditions": [
"Chronic Pain",
"Shoulder Pain"
],
"interventions": [
"Other: graded motor imagery",
"Other: traditional physiotherapy method"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06092489",
"official_title": "The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Chronic Rotator Cuff-related Shoulder Pain.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-13",
"study_completion_date(actual)": "2024-07-10",
"study_start_date(actual)": "2023-10-20"
},
"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)": "2024-07-11",
"last_updated_that_met_qc_criteria": "2023-10-18",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-23",
"first_submitted": "2023-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.
#Intervention
- DIETARY_SUPPLEMENT : Nitrate supplementation
- 7 days of supplementation with sodium nitrate solution
- DIETARY_SUPPLEMENT : Placebo supplementation
- 7 days of supplementation with sodium chloride solution
|
#Eligibility Criteria:
Inclusion Criteria:
* COPD
* Indication metabolic inefficiency
Exclusion Criteria:
* Sodium intake limitation
* Long-term oxygen therapy
* Severe renal impairment
* Use of medications that may interact with nitrate
* Contra-indications for performing (sub)maximal cycle ergometry
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
|
NCT02084758
|
{
"brief_title": "Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Dietary Supplement: Nitrate supplementation",
"Dietary Supplement: Placebo supplementation"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT02084758",
"official_title": "The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-06",
"last_updated_that_met_qc_criteria": "2014-03-10",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-12",
"first_submitted": "2014-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 years
* Under 45 years
* Having at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth defect with aneuploidy, history of GDM or known DM) for Case Group.
* Singleton pregnant women
Exclusion Criteria:
* under 18 years
* Above 45 years
* Multiple pregnancies
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
|
NCT06135883
|
{
"brief_title": "Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects",
"conditions": [
"Neural Tube Defects",
"Folic Acid"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT06135883",
"official_title": "Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-20",
"study_completion_date(actual)": "2023-08-20",
"study_start_date(actual)": "2023-02-20"
},
"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)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2023-11-13",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-18",
"first_submitted": "2023-11-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to determine the effects of nursing care provided based on the Watson's Theory of Human Caring to the relatives of palliative care patients on caregivers' spiritual well-being and hope. This research was conducted with 60 patient relatives (intervention group: 30, control group: 30) taking care of their patient in palliative care unit.
Detailed Description
Every year, millions of patients as well as millions of patients are primarily involved in the palliative care process. It is emphasized that from the very start of palliative care process until grievance stage, patient relatives require a myriad of physical, psychological, social and spiritual needs. It has been widely reported that among relatives of palliative care patients, there is a high incidence of mental distress, depression, anxiety, sleep disturbance, fear and despair. The maintain of hope and spiritual well-being are important in dealing with this difficult process. Accordingly, nursing care is important, which supports the hope and spiritual well-being of patients' relatives. Nursing care that supports hope and focuses on spiritual dimensions is important in Watson's Human Care Theory.
#Intervention
- OTHER : Nursing care based on the Theory of Human Caring
- Planned nursing care based on 10 caritas processes of Theory of Human Caring.
|
#Eligibility Criteria:
Inclusion Criteria:
* aged 18 and above
* willingness and motivation to participate in research
* literacy
* being the primary caregiver
* lack of mental or verbal deficiency to respond the questions
Exclusion Criteria:
* aged 18 below
* unwilling to participate in research
* illiterate
* non-primary caregiver
* mental or communicative disabilities
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
|
NCT04415411
|
{
"brief_title": "Effects of Nursing Care Provided to Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope",
"conditions": [
"Hope",
"Spirituality",
"Palliative Care"
],
"interventions": [
"Other: Nursing care based on the Theory of Human Caring"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04415411",
"official_title": "Effects of Nursing Care Provided to the Relatives of Palliative Care Patients on Caregivers' Spiritual Well-being and Hope: A Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-18",
"study_completion_date(actual)": "2019-03-18",
"study_start_date(actual)": "2018-10-05"
},
"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)": "2020-06-09",
"last_updated_that_met_qc_criteria": "2020-06-01",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-04",
"first_submitted": "2020-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Does the use of lidocaine jelly during Mohs surgery on the nose decrease the total amount of lidocaine used during surgery.
Does patient satisfaction improve when lidocaine jelly is used during Mohs surgery of the nose?
Detailed Description
Hypothesis: Supplementing lidocaine/epinephrine injections with intralesional lidocaine jelly will decrease the overall quantity of lidocaine/epinephrine injectable used, and will decrease patients' self-reported pain/anxiety associated with needle sticks.
Objectives: To assess how using lidocaine jelly in Mohs surgery impacts 1) the overall quantity of lidocaine/epinephrine injectable needed to maintain anesthesia, and 2) patients' pain/anxiety associated with anesthesia injections.
Background:
Mohs micrographic surgery is a procedure that removes cancerous lesions of the skin in a step-wise fashion. Patients are injected with local analgesia for tumor extirpation. The tumor is removed and the tissue is sent for histopathology while the patient waits. Tissue processing time can take up to 2 hours during which the effects of the local analgesia have waned. Once the tissue has been process and examined, patients are brought back to the surgical suite and either have another section of tissue removed (if the margins were positive) or have the wound reconstructed (if the margins were negative). Lidocaine Hydrochloride (Xylocaine) injection with Epinephrine is the traditionally method used to maintain local anesthesia throughout the procedure. The FDA has declared a shortage of this injectable Lidocaine/Epinephrine, stressing the need for a substitute drug. Additionally, multiple needle sticks can be uncomfortable and anxiety provoking for patients. Needle sticks on hypersensitive areas such as the nose can be particularly painful. Previous research has demonstrated that a different form of anesthetic, a topical lidocaine jelly, is efficient in prolonging anesthesia in Mohs surgery (Robins, 1991). No study has published the impact of supplemental lidocaine jelly use on the overall quantity of injection needed, nor on patient pain/anxiety associated with needle sticks.
Methods:
We will conduct a prospective, randomized trial of 250 patients receiving Mohs micrographic surgery to lesions on the nose. Annually Mohs micrographic surgery is performed on approximately 900 patients with 30% of these procedures being performed on lesions on the nose. Patients receiving Mohs treatment for lesions on the nose will be randomly assigned to one of two groups: (1) those whose wounds will be dressed with lidocaine jelly (treatment group), and (2) those whose wounds will be dressed with surgical lubricant (control/placebo group).
All patients will receive a pre-treatment baseline pain/anxiety survey followed by an initial lidocaine injection. The amount of lidocaine/epinephrine injection each patient receives throughout remaining stages of surgery will be recorded, as per the current workflow. All patients will complete a second pain/anxiety survey immediately after numbing but prior to the first stage of surgery.
After the first stage of surgery, either lidocaine jelly or surgical lubricant will be applied to the wound followed by a pressure bandage as per standard practice. Dressing are removed immediately prior to the next stage of surgery. After each subsequent stage of surgery, an identical wound dressing will be placed on the operative site.
Immediately prior to each subsequent stage of surgery, we will assess patients' pain sensation, and additional lidocaine/epinephrine will be injected if needed. After the surgical site is re-anesthetized, vital signs will be recorded and the Pain/Anxiety survey administered immediately prior to the first incision of that stage.
#Intervention
- DRUG : Lidocaine jelly
- lidocaine 2% jelly applied during Mohs surgery
- Other Names :
- lidocaine
- DRUG : Surgilube
- surgilube (placebo) applied during Mohs surgery
|
#Eligibility Criteria:
Inclusion criteria:
Patients having Mohs surgery on the nose who are able to consent to the study >18 years
Exclusion criteria:
unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other than the nose
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
|
NCT03595449
|
{
"brief_title": "Lidocaine Jelly for Pain Control During Mohs Surgery",
"conditions": [
"Pain",
"Satisfaction, Consumer"
],
"interventions": [
"Drug: Surgilube",
"Drug: Lidocaine jelly"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03595449",
"official_title": "Patient Satisfaction in Mohs Micrographic Surgery With Supplemental Lidocaine Jelly",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-31",
"study_completion_date(actual)": "2020-08-31",
"study_start_date(actual)": "2018-08-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-13",
"last_updated_that_met_qc_criteria": "2018-07-12",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-23",
"first_submitted": "2018-04-06",
"first_submitted_that_met_qc_criteria": "2021-05-28"
}
}
}
|
#Study Description
Brief Summary
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.
Detailed Description
This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.
Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.
Preparation of I-PRF:
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.
#Intervention
- PROCEDURE : Conventional arthrocentesis followed by I-PRF injection
- An auriculotemporal nerve block using Mebacaine 0.5% was administered near the mandible's neck. The patient sat at a 45° angle with their head turned. The posterior entry point was 10 mm from the midtragus and 2 mm below the line, while the anterior entry point was marked 20 mm from the midtragus and 10 mm below the line. A biting block kept the mouth open. 2-3 ml of Ringer lactate was injected with an 18-gauge needle to enlarge the joint space. A second needle allowed the solution to flow freely. After lavaging the joint, 1 ml of I-PRF was injected into the upper joint space. Jaw manipulation was done to address adhesions and improve disc mobility.
- PROCEDURE : 3d surgical guided Arthrocentesis followed by I-PRF injection
- Patients underwent arthrocentesis with Ringer lactate, followed by I-PRF injection in the TMJ's superior space using a CT-planned 3D-printed guide. Positioned at a 45° angle, patients were comfortably seated, and disinfection was performed. The patient-specific guide, fitting over maxillary teeth and the face, was employed unilaterally or bilaterally with a biting block for mouth opening maintenance. An 18-gauge needle administered 2-3 ml of Ringer lactate, widening the joint space, followed by a second needle allowing free solution flow (80-90 ml) to flush the superior joint space. Post-arthrocentesis, 1 ml of I-PRF was injected. To enhance joint mobility and free the disc, gentle manipulation of the lower jaw was performed after removing the needles and guide.
|
#Eligibility Criteria:
Inclusion Criteria:
* Bilateral or unilateral TMJ internal derangement.
* No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
* Ability to undergo MRI or CT scans without contraindications.
Exclusion Criteria:
* Those with systemic diseases (polyarthritis or rheumatoid diseases).
* Individuals with neurologic disorders.
* Patients with a history of condylar fracture or previous TMJ injections.
* Those with head and neck cancer.
* Completely edentulous patients (lacking teeth).
* Individuals with implanted metal or medical devices.
* Patients with developmental and congenital disorders of the TMJ.
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
|
NCT06132594
|
{
"brief_title": "Computed Guided Prolotherapy Versus Conventional Prolotherapy",
"conditions": [
"Temporomandibular Joint Disorders",
"Orofacial Pain"
],
"interventions": [
"Procedure: 3d surgical guided Arthrocentesis followed by I-PRF injection",
"Procedure: Conventional arthrocentesis followed by I-PRF injection"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06132594",
"official_title": "Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-14",
"study_completion_date(actual)": "2022-10-14",
"study_start_date(actual)": "2021-10-02"
},
"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)": "2023-11-15",
"last_updated_that_met_qc_criteria": "2023-11-09",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-15",
"first_submitted": "2023-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients.
The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count.
This study is a phase II, randomised, double-blind, placebo-controlled, single-centre.
24 patients will be included in the study.
Detailed Description
A key secondary objective is to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy.
Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters:
* Overall incidence of side effects (any type any grade)
* Progression-free survival (PFS)
* Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles).
* CD4 lymphopenia over the study period
Exploratory biological markers
A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will:
* selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations)
* selectively improve the functional response of T cells, DC subsets and NK cells.
* is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels)
* enable to increase TCR diversity (analysis of combinatorial diversity).
#Intervention
- DRUG : placebo
- Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)
- DRUG : interleukin 7
- patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)
- DRUG : interleukin 7
- patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
- DRUG : interleukin 7
- patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
|
#Eligibility Criteria:
Inclusion Criteria:
* Female aged more than 18 years
* Histologic diagnosis of metastatic breast cancer to be treated with capecitabine at study entry. NB: Patients previously treated with capecitabine are eligible only if more than 6 months have elapsed since the last capecitabine intake.
* Lymphopenic (i.e. with at least one value of lymphocyte count 1500/µL within 15 days before Day 0).
* Performance status ECOG of 0, 1,2 or 3
* Life expectancy >= 6months
* Adequate bone marrow, hepatic and renal function as follows:
* Neutrophils >= 1,000/µL
* Platelets >= 100 109/µL
* ASAT, ALAT, or Alkaline Phosphatase <= 2.5 x ULN
* Total Bilirubin <= 1.5 x ULN
* INR <= 1.5
* Calculated creatinin clearance >= 60mL/min (Cockcroft formula or MDRD formula for patients older than 65 years)- Ability to understand and sign informed consent
* Covered by a medical insurance.
Exclusion Criteria:
* Prior history of other malignancies other than breast cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years.
* No resolution of specific toxicities related to any prior anti-cancer therapy to Grade <=2 according to the NCI CTCAE v.4.0 (except lymphopenia, alopecia and neuropathy)
* Wash out period of less than 5 times the half-life of previous anti-cancer treatment before study entry, except if previous chemotherapy treatment before study entry. NB: For patient previously treated by hormonotherapy, a wash out period of 1 week will be sufficient
* Uncontrolled hypertension (i.e., resting systolic blood pressure greater than140 mmHg or resting diastolic blood pressure greater than 90 mmHg), despite pharmacologic antihypertensive treatment, confirmed with a second blood pressure measurement done later in the same day
* History of lymphoid malignancy (e.g. Hodgkin disease, non Hodgkin lymphoma, Leukemia).
* History of splenectomy or hematologic disease associated with hypersplenism, such as gamma or beta-thalassemia, hereditary spherocytosis, Gaucher's disease, or autoimmune hemolytic anemia.
* Any cardiac, pulmonary, thyroid, renal, hepatic, neurological severe/uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
* Any history of severe auto-immune disease
* Hepatitis B antigen (HBs Ag) positive, Hepatitis C (HCV Ab) antibody positive or HCV RNA detectable
* Documented HIV-1 positivity
* History of cardiovascular disorders grade >2 (NYHA) within 6 months preceding the inclusion
* Active uncontrolled viral, fungal or bacterial infection
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements (participants must agree to refrain from substance abuse use during the entire course of the study)
* Pregnant or breast-feeding women
* No use of effective birth control methods for women of childbearing potential
* Any contraindications to capecitabine treatment (refer to Xeloda SPC Appendix 11) and to any other anti-cancer treatment authorized as per protocol (refer to respective SPC for specific contraindications)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01368107
|
{
"brief_title": "Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients",
"conditions": [
"Metastatic Breast Cancer"
],
"interventions": [
"Drug: placebo",
"Drug: interleukin 7"
],
"location_countries": [
"France"
],
"nct_id": "NCT01368107",
"official_title": "A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2011-06"
},
"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)": "2015-02-09",
"last_updated_that_met_qc_criteria": "2011-06-06",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-07",
"first_submitted": "2011-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will measure resting state network central nervous system activity by functional magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.
Hypothesis 1. Because they are different sensory systems, there will be different patterns of Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS) activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).
Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ for LKM+ vs. LKM- stimulation for both visual and tactile interventions.
Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be greater for combined visual + tactile than for either visual or tactile stimulation alone.
Detailed Description
This project builds on our previous research to build a platform for a successful NIH proposal to address a key gap in our understanding of the mechanism of non-verbal clinician-patient communication on physiology and behavior. Social neuroscience is a rapidly growing area of research that offers unique opportunities to better understand the mechanisms underlying common observations about clinician-patient interactions.The purpose of this study is to better understand the CNS mechanisms underlying the observed changes in self-reported well-being and ANS activity by evaluating resting fMRI activity under controlled conditions. The specific aims are to compare resting fMRI activity in the mirror neuron system (MNS) and resting state networks (RSN), reflected specifically in the Insula, Anterior Cingulate Cortex (ACC), Precuneus, Posterior Cingulate Cortex (PCC), Amygdala, Bilateral Inferior Parietal Cortex, Primary Motor-Visual System, and Dorsal Medulla while viewing touch with lovingkindness meditation lovingkindness meditation vs no lovingkindness meditation, receiving touch with lovingkindness meditation vs no lovingkindness meditation and both viewing and receiving touch with lovingkindness meditation vs no lovingkindness meditation. This is a descriptive study to generate sample size estimates for an NIH RO1 proposal.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 40 years
* healthy
* can understand and respond to verbal directions while in an MRI
Exclusion Criteria:
* blind
* undergone treatment for brain tumor, stroke, intracranial hemorrhage
* diabetes or any other form of peripheral neuropathy
* require a pacemaker, insulin pump or other electronic equipment
* taking beta blocking medications, systemic steroid medications or other medications likely to affect autonomic or central nervous system function
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01432288
|
{
"brief_title": "Touch and Attention MRI Study",
"conditions": [
"Central Nervous System"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01432288",
"official_title": "Effects of Touch and Attention on Central Nervous System Resting State Network (RSN) Activity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2011-08"
},
"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)": "2017-08-10",
"last_updated_that_met_qc_criteria": "2011-09-09",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-12",
"first_submitted": "2011-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.
Detailed Description
age group between 18-65 years, intubated and ventilated patients due to respiratory failure from severe lung infection and/or traumatic lung contusion \[respiratory failure was diagnosed by arterial blood gases (ABG) with partial pressure of oxygen (PaO2) ≤60 mmHg, partial pressure of carbon dioxide (PaCO2)≥60 mmHg, PH \> 7.30, respiratory rate \>25 min\]. All patients ventilated for 4 days with CMV with respiratory rate 12/min, PEEP 5 cm/H2O, FIO2 adjusted to maintain arterial oxygen saturation above 90%. And sedated with both fentanyl and midazolam intravenous infusion to adjust sedation level to achieve Richmond Agitation-Sedation Scale (RASS) -2 to -3 as illustrated in table. All patients received broad spectrum antibiotics in form of meropenem 1 gm slowly intravenous every 8 hours in this period (four days) and a qualitative sputum culture collected from all patients after 3 days from ventilation. Feeding started on the second day of ventilation to all patients through feeding pump at rate of 70 ml insure plus (Abbot company) with 1.47 kilo-calorie/ml to supply patients with approximately 2500 kilo-calorie in 24 hours calculated by approximately 35 kilo-calorie/kg. The 5 points of bundle for pneumonia prevention were strictly applied to all patients: Elevation of the head of the bed 30º to 45º, Daily evaluation for possible ex-tubation, The use of endotracheal tube with subglottic secretion drainage, oral care with oral antiseptics, initiation of safe enteral nutrition, within 24-48 hours from ICU admission and ventilation.
200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled \> 2 parameters on SOFA score and \> 6 on pneumonia score and randomly allocated in two groups 100 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time.
All patients selected underwent a percutaneous tracheostomy on the same day. Sepsis documented in our study by \> 2 on Sequential Organ Failure Assessment (SOFA) score. While VAP documented in our study by \>6 on CPIS score. Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl infusion to get same sedation score mentioned before (RASS-2/-3), increase FIO2 to 100% during the procedure, use xylocaine spray 10% by Astra Zeneca company 2 puffs in each nostril before application of the rubber tube of the bronchoscope, keep patient's head elevated 20 degree during procedure, use CMV mode with previous mentioned parameters with 100% FIO2 during the procedure, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture and the other isotonic saline injected in the remaining three syringe used only for wash the small airways and not for bacteriological sampling, monitoring of patients during the procedure done by SPO2, non-invasive blood pressure measurement every 5 minutes, electro cardiac gram for heart rate, clinical assessment of depth of sedation every 5 minutes.
Duration of the study selected to be 2 weeks and evaluation of all patients in both groups done on three periods, at the end of the first 5 days, at the end of the second 5 days and at the end of last 4 days.
#Intervention
- DRUG : Meropenem
- all patients in both groups receive meropenam and put on the ventilators for 2 weeks
- PROCEDURE : bronchoscopy
- Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period
- DEVICE : ventilator
- ventilator
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with age group between 18 <= age <= 65 years,patients Respiratory failure, patients with pneumonia
Exclusion Criteria:
* pediatric patients, patients with anoxic brain insult
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
|
NCT06072248
|
{
"brief_title": "Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation",
"conditions": [
"ARDS",
"Septic Shock"
],
"interventions": [
"Drug: Meropenem",
"Device: ventilator",
"Procedure: bronchoscopy"
],
"location_countries": [
"Saudi Arabia"
],
"nct_id": "NCT06072248",
"official_title": "Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation",
"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)": "2020-07-02"
},
"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)": "2023-10-10",
"last_updated_that_met_qc_criteria": "2023-10-02",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-10",
"first_submitted": "2023-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.
Detailed Description
OUTLINE:
CONDITIONING REGIMEN: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7, receive thiotepa intravenously (IV) over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or orally (PO) every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up for up to 5 years.
#Intervention
- PROCEDURE : Allogeneic Hematopoietic Stem Cell Transplantation
- Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
- Other Names :
- allogeneic stem cell transplantation, HSC, HSCT
- DRUG : Fludarabine Phosphate
- Given IV
- Other Names :
- 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Methotrexate
- Given IV
- Other Names :
- Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
- PROCEDURE : Peripheral Blood Stem Cell Transplantation
- Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
- Other Names :
- PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
- BIOLOGICAL : T Cell-Depleted Hematopoietic Stem Cell Transplantation
- Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
- DRUG : Tacrolimus
- Given IV or PO
- Other Names :
- FK 506, Fujimycin, Hecoria, Prograf, Protopic
- DRUG : Thiotepa
- Given IV
- Other Names :
- 1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa, STEPA, Tepadina, TESPA, Tespamin, Tespamine, Thio-Tepa, Thiofosfamide, Thiofozil, Thiophosphamide, Thiophosphoramide, Thiotef, Tifosyl, TIO TEF, Tio-tef, Triethylene Thiophosphoramide, Triethylenethiophosphoramide, Tris(1-aziridinyl)phosphine sulfide, TSPA, WR 45312
- RADIATION : Total-Body Irradiation
- Undergo TBI
- Other Names :
- TOTAL BODY IRRADIATION, Whole-Body Irradiation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
* Acute lymphocytic leukemia in first or subsequent remission
* Acute myeloid leukemia in first or subsequent remission
* Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3
* Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3
* Refractory anemia with excess blasts (RAEB-1 and RAEB-2)
* Chronic myelogenous leukemia with a history of accelerated phase or blast crisis
* Other acute leukemia (including but not limited to 'biphenotypic', 'undifferentiated' or 'ambiguous lineage' acute leukemia)
* Patient with a human leukocyte antigen (HLA)-identical (HLA-A, B, C, and ribonucleic acid [RNA] binding motif protein 45 [DRB1] molecularly matched) unrelated donor or related donor capable of donating PBSC
* DONOR: HLA-matched unrelated donors (HLA-A, B, C, and DRB1 matched based on high-resolution typing) capable and willing to donate PBSC
* DONOR: HLA-matched related donors >= 18 years and capable and willing to donate PBSC
Exclusion Criteria:
* Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation
* Patients on other experimental protocols for prevention of acute GVHD
* Patients who weigh >= 70 kg must be discussed with the principal investigator prior to enrolling on the protocol
* Patients who are human immunodeficiency virus positive (HIV+)
* Patients with uncontrolled infections for whom myeloablative hematopoietic stem cell transplant (HCT) is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
* Creatinine > 1.5 mg/dl
* Cardiac ejection fraction < 45%
* Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of < 60% predicted; patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is < 92% on room air
* Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal should be evaluated by a gastrointestinal (GI) physician unless there is a clear precipitating factor (such as an azole, methotrexate, Bactrim or another drug); if the GI physician considers that HCT on protocol 2660 is contraindicated for that patient the patient will be excluded from the protocol; patients with Gilbert's syndrome and no other known liver function abnormality and patients with reversible drug-related transaminitis do not necessarily require GI consultation and may be included on the protocol
* Patients with a life expectancy < 3 months from co-existing disease other than the leukemia or RAEB
* Patients who are pregnant or breast-feeding
* Fertile patients of child bearing age unwilling to use contraception during and for 12 months post-transplant
* Patients with a significant other medical conditions that would make them unsuitable for transplant
* Patients with a known hypersensitivity to tacrolimus
* DONOR: Donors who are HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
* DONOR: Donors who fail eligibility requirements for donation of cells or tissue per section 21 Code of Federal Regulations (CFR) 1271 for donation of a HCT/product (P) will be excluded unless use of the cells complies with 21 CFR 1271.65(b)(iii) (urgent medical need) or with 21 CFR 1271.65(b)(i) (allogeneic use in a first-degree or second-degree relative)
* DONOR: Unrelated donors donating outside of the United States of America (USA) or Germany
Sex :
ALL
Ages :
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01858740
|
{
"brief_title": "Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children",
"conditions": [
"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive",
"Acute Biphenotypic Leukemia",
"Acute Leukemia of Ambiguous Lineage",
"Acute Undifferentiated Leukemia",
"Adult Acute Lymphoblastic Leukemia in Remission",
"Adult Acute Myeloid Leukemia in Remission",
"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive",
"Childhood Acute Lymphoblastic Leukemia in Remission",
"Childhood Acute Myeloid Leukemia in Remission",
"Chronic Myelogenous Leukemia, BCR-ABL1 Positive",
"Myelodysplastic Syndrome With Excess Blasts-1",
"Myelodysplastic Syndrome With Excess Blasts-2",
"Recurrent Adult Acute Lymphoblastic Leukemia",
"Recurrent Adult Acute Myeloid Leukemia",
"Recurrent Childhood Acute Lymphoblastic Leukemia",
"Recurrent Childhood Acute Myeloid Leukemia",
"Refractory Adult Acute Lymphoblastic Leukemia",
"Refractory Childhood Acute Lymphoblastic Leukemia"
],
"interventions": [
"Drug: Fludarabine Phosphate",
"Drug: Methotrexate",
"Drug: Tacrolimus",
"Radiation: Total-Body Irradiation",
"Procedure: Peripheral Blood Stem Cell Transplantation",
"Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation",
"Drug: Thiotepa",
"Other: Laboratory Biomarker Analysis",
"Procedure: Allogeneic Hematopoietic Stem Cell Transplantation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01858740",
"official_title": "A Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-30",
"study_completion_date(actual)": "2023-07-30",
"study_start_date(actual)": "2014-04-10"
},
"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)": "2024-03-12",
"last_updated_that_met_qc_criteria": "2013-05-16",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-21",
"first_submitted": "2013-05-15",
"first_submitted_that_met_qc_criteria": "2024-03-08"
}
}
}
|
#Study Description
Brief Summary
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.
#Intervention
- DRUG : GSK598809
- Drug
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male smokers aged 18 <= age <= 65 with a desire to quit smoking.
* Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
* Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.
Exclusion Criteria:
* Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
* History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
* History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
* History of cardiac or pulmonary disease/abnormalities.
Sex :
MALE
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
|
NCT00605241
|
{
"brief_title": "A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward",
"conditions": [
"Substance Dependence"
],
"interventions": [
"Drug: GSK598809"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00605241",
"official_title": "A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03-20",
"study_completion_date(actual)": "2009-03-20",
"study_start_date(actual)": "2008-02-25"
},
"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)": "2017-07-21",
"last_updated_that_met_qc_criteria": "2008-01-18",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-31",
"first_submitted": "2008-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigated the safe and efficacious use of suramin as a novel treatment for ASD by testing two suramin doses vs placebo
Detailed Description
PUR-ONQ-ASD-001 was a multicenter, 3-arm, prospective, randomized, double blind, placebo-controlled multiple dose trial involving 2 dose levels of suramin vs. placebo. The study randomized 52 male participants who received treatment interventions for ASD; each treatment arm was assigned approximately 17 participants. The number of participants was increased to 52 participants (48 originally planned) due to early withdrawals related to the COVID-19 global pandemic lockdowns and other matters. Participants were stratified by age, ADOS-2, and Non-verbal Intelligence Quotient (NVIQ). Participants who met all the inclusion criteria and none of the exclusion criteria were randomized through an electronic system to either arm A (10 mg/kg suramin) or Arm B (20 mg/kg suramin) or Arm C (Placebo) in a targeted 1:1:1 ratio, as per the randomization schedule and stratified by age, ADOS-2, and NVIQ. All participants received a 50 mg test dose at their first administration (0.5 mL of freshly reconstituted 10% solution in 5 mL saline) to check for allergic reactions. The test dose was given by slow intravenous (IV) infusion for 30 minutes then flushed with 10 mL saline. Vitals were checked for 30 min and if there were no changes or evidence of allergic reaction, the rest of the study drug dose was administered (10 mg/kg or 20 mg/kg minus test dose \[minus 50 mg\] in a 50 mL saline up to a maximum of 1 g given over 30 minutes). Arm A - 50 mg test dose of suramin (upon first administration), then suramin 10 mg/kg (minus 50 mg suramin test dose) in 50 mL of saline administered by IV infusion over 30 minutes was given at Visits 2, 4 and 5. The maximum dose administered was 1 g.
Arm B - 50 mg test dose of suramin (upon first administration), then suramin 20 mg/kg (minus 50 mg suramin test dose) in 50 mL of saline administered by IV infusion over 30 minutes was given at Visits 2, 4 and 5. The maximum dose administered was 1 g.
Arm C - Test dose of saline placebo, then saline placebo IV infusion of 50 mL administered over 30 minutes was given at Visits 2, 4 and 5
#Intervention
- DRUG : Suramin Sodium
- Suramin sodium is a sodium salt form of suramin, an antitrypanosomal compound.
- Other Names :
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Male children aged 4 - 17 years
* Participants with or without treatment interventions for ASD
* Participants must have been diagnosed with ASD by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
* Autism diagnostic observation schedule, version 2 (ADOS-2) Comparison scores in the
* moderate and high level as evaluated on the ADOS-2
* Stable treatment intervention for >= 2 months
* Participants agreed to not change their treatment interventions throughout the study
* duration
* Participants on Ritalin and Risperdal or similar medication agreed to not change their
* dose during the study
Exclusion Criteria:
* Hospitalization within the previous 2 months
* An acute medical problem, Rett syndrome, microcephaly, tuberous sclerosis, neurofibromatosis, epilepsy, or clinically significant liver, kidney, or adrenal disease or persons suffering from any serious acute condition where, in the investigator's opinion, the participant's well-being may have been compromised
* Planning to start a new drug, diet, or behavioral intervention during the study
* Weight under the 5th percentile for age
* Unable to tolerate venipuncture, urine collection, or an indwelling IV catheter for 3 <= age <= 4 hours
* Plasma creatinine above normal for age and weight according to the laboratory reference ranges.
* Liver function alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 1.5-fold above the upper limit of normal
* Known intolerance to suramin or other antipurinergic drugs
* Unable to perform or cooperate with study requirements
* Children with known syndromic forms of ASD caused by DNA mutation or chromosomal copy number variation
Sex :
MALE
Ages :
- Minimum Age : 4 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06058962
|
{
"brief_title": "Double Blind Trial in Children With Autism Spectrum Disorder",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": [
"Drug: Suramin Sodium"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06058962",
"official_title": "A Three-Arm, Prospective, Randomized, Double Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of 2 Doses of Suramin vs. Placebo in Male Children With ASD Receiving Standard Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-15",
"study_completion_date(actual)": "2021-03-15",
"study_start_date(actual)": "2019-06-01"
},
"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)": "2023-11-13",
"last_updated_that_met_qc_criteria": "2023-09-22",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-28",
"first_submitted": "2023-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.
Detailed Description
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.
#Intervention
- DRUG : Cebranopadol
- Film-coated tablet; strengths: 200, 400, or 600 µg
- Other Names :
- GRT6005
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.
* Participants must be at least 18 years at the Enrollment Visit.
* Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.
* Participants must be willing to use medically acceptable and highly effective methods of birth control.
* Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.
Exclusion Criteria:
* The participant has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
* Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
* Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
* History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
* Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
* Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
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
|
NCT02031432
|
{
"brief_title": "CORAL XT - Open-label Extension Trial of the CORAL Trial",
"conditions": [
"Pain",
"Neoplasms",
"Chronic Pain"
],
"interventions": [
"Drug: Cebranopadol"
],
"location_countries": [
"Slovakia",
"Poland",
"Germany",
"Romania",
"Serbia",
"Austria",
"Bulgaria",
"Hungary",
"Belgium",
"Denmark"
],
"nct_id": "NCT02031432",
"official_title": "An Open-label, Multi-site Trial to Describe the Safety and Tolerability of Oral Cebranopadol Administered for 26 Weeks in Subjects With Cancer-related Pain Who Have Completed Treatment in the KF6005/07 Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-05-03",
"study_start_date(actual)": "2013-12-18"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-15",
"last_updated_that_met_qc_criteria": "2014-01-08",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-09",
"first_submitted": "2013-12-12",
"first_submitted_that_met_qc_criteria": "2020-01-14"
}
}
}
|
#Study Description
Brief Summary
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.
Detailed Description
This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.
The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. Inclusion criteria were: age ≥ 18 and ≤60 years; the presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA) and with indication for outpatient treatment; the absence of previous treatment for the current burn and an absence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others). Exclusion criteria included hypersensitivity to materials used in the study or to related compounds; history of severe adverse reactions; drug addiction, including alcohol; use of medications that could have an impact on wound healing (e.g., steroids) and pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed in sterile 0.9% saline for 5 minutes, with this process being repeated three times in a row. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. Randomization was performed using a predefined computer-generated list, with 57 patients being allocated in the test group and 58 patients being allocated in the control group.
#Intervention
- DEVICE : Nile Tilapia Fish Skin
- In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.
- Other Names :
- Tilapia Skin
- DRUG : Silver Sulfadiazine Cream 1%
- Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.
- Other Names :
- Silver Sulfadiazine
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 and <=60 years.
* Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
* Patient with indication for outpatient treatment.
Exclusion Criteria:
* Previous treatment for the current burn.
* Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
* Hypersensitivity to materials used in the study or to related compounds.
* History of severe adverse reactions; drug addiction, including alcohol.
* Use of medications that could have an impact on wound healing (e.g., steroids).
* Pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
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
|
NCT04202289
|
{
"brief_title": "Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study",
"conditions": [
"Burns"
],
"interventions": [
"Drug: Silver Sulfadiazine Cream 1%",
"Device: Nile Tilapia Fish Skin"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT04202289",
"official_title": "Evaluation of Nile Tilapia (Oreochromis Niloticus) Skin as an Occlusive Biological Dressing in the Treatment of Burn Wounds: Phase III Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-24",
"study_completion_date(actual)": "2018-10-24",
"study_start_date(actual)": "2017-04-03"
},
"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)": "2020-01-29",
"last_updated_that_met_qc_criteria": "2019-12-14",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-17",
"first_submitted": "2019-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effectiveness of five sessions of cathodal tDCS over the left DLPFC on inhibitory control/response inhibition in children and adolescents with ADHD. Investigators hypothesize that multiple sessions of cathodal tDCS will induce a greater and long-term effect on inhibitory response in children and adolescents with ADHD.
Detailed Description
Attention-deficit hyperactivity disorder (ADHD) is one of neural development disorder that characterized by a persistent pattern of inattention, impulsivity and hyperactivity. This disorder begins in childhood and often lasts into adulthood. Rates of ADHD diagnosis have been rising in recent years, a prevalence estimates from 3-7% of childhood worldwide. A recent national prevalence shows that 8.1% of Thai primary school-age children are affected by ADHD . Pharmacological treatment used in ADHD is well-established, however, each patient responds to medication differently and treatment in some of them are limited by side effect and abuse of medication.
In the last decade, transcranial direct current stimulation (tDCS) has received a surge of interest in clinical research since it could modulate cortical excitability and induce plasticity in human brain. The device sends a constant low direct current (e.g. 1-2 mA) delivered to the area of interest through the electrodes. This induces shifts in neuronal resting membrane potential changing cortical excitability. Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. To change the cortical excitability, tDCS differs from other brain stimulation techniques such as transcranial magnetic stimulation (TMS) in that it does not cause action potentials in cortical neurons, but rather induces shifts in neuronal resting membrane potential. This is considered to induce a lesser or no risk of a seizure. Given its advantages such as painlessness, safety, easiness to use, and low-cost, a number of tDCS studies has been increasing in the last decade particularly in motor rehabilitation and neuropsychiatric disorders such as depression, autism and schizophrenia with a positive and safety reports in adult and pediatric populations. Possible after-effect of tDCS has been also reported in motor and psychological disorders that opens a way to use tDCS as a therapeutic tool.
The most accepted theory of neural basis of ADHD is deficient of inhibitory control resulting in executive dysfunction. Inhibitory control or response inhibition is key feature of self-control and can be defined as ability to inhibit prepotent actions. Several evidences reveal a physiological association between the prefrontal cortex and its subcortical connection with the pathophysiology of ADHD. Neuroimaging studies demonstrate that regions of the right dorso-lateral prefrontal cortex (DLPFC) play a role in the inhibition of motor response. During preforming an inhibitory task that is usually used to evaluate the efficiency of response inhibition such as stop-signal and go/no-go tasks, this area become active in healthy individual, while in ADHD showed hypo-activation compared to control.
Evidences showed that the task performance in stop-signal and go/no-go tasks can be influenced by tDCS application to the DLPFC in healthy subjects. It was recently reported that a single session of cathodal tDCS, using a single session of 1.5 mA for 15 minutes over the left DLPFC improved their ability to inhibit themselves by do not response to no-go stimulus during go/no-go tasks compared to anodal and sham conditions in adolescents with ADHD. It was postulated that the inter-hemispheric inhibition (IHI) between two regions (left and right DLPFC) might play a role in this finding. Based on the possibility that cathodal stimulation decreases excitability and thus IHI drive from the left DLPFC is decreased, facilitating activity of the right DLPFC where is involved in inhibition of motor response as demonstrated by neuroimaging studies. Using a single session of oscillatory tDCS during early sleep, memory consolidation and reaction times in a go/no-go task were improved on the next day in children with ADHD. This is an argument to explore its possible therapeutic effect in long-term use. Five tDCS sessions for five consecutive days was reported to be safe and improves aspect of attention in children and adolescents with ADHD, however, its after-effect in this population is unknown. In patients with depressive disorder, multiple sessions of tDCS over the left DLPFC for five or ten days has been demonstrated to decrease depressive symptoms and lasted for a month. It was reported in patient with depressive disorder that after five days of tDCS sessions on alternative day did not show an improvement, positive results was observed after 10 days. This suggests that a longer observation period is probably required to detect a true tDCS effect.
The use of electrophysiological techniques, especially of event-related potentials (ERP) measured by means of electroencephalography (EEG) allows for analysis of neural change accompanying inhibitory process in the brain. Two ERP components, the no-go N2 and P3 that are the most commonly studied in go/no-go tasks have been linked to response conflict and response inhibition. Studies have reported lower N2 and P3 amplitudes during go/no-go tasks in children and adolescents with ADHD.
To expand current information on tDCS as an emerging treatment for ADHD patients, in this study, investigators will investigate the effectiveness of multiple sessions of cathodal tDCS over the left DLPFC on inhibitory control in children and adolescents with ADHD. tDCS (cathodal/sham) will be applied every day for five consecutive days. Behavioral and neurophysiological parameters using an inhibitory task (go/no-go tasks) and the no-go N2 and P3 ERP components will be measured before tDCS, immediately after 5 sessions of tDCS, one week later, and one month after treatment onset.
#Intervention
- DEVICE : tDCS
- Five sessions (active/sham) will be held on five consecutive days. The parameter of electrode size, current strength and current duration were previously tested for safety in children
|
#Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents aged 7 <= age <= 16 with suspected ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5TM). Diagnostic confirmation will be performed by pediatric neurologist or psychologist.
* Right-handed
* Free of any neurological antecedent, unstable medical conditions such as epilepsy; although tDCS is believed to induce very less or no risk of seizure and epileptic seizure have never been reported in tDCS study even in a study with active epilepsy.
Exclusion Criteria:
* Be unable to understand the instruction
* No clear neurological antecedent history
* Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
* Motor or perceptual handicap that would prevent using the computer program
* For patients who under medication, poor-adjusted to their medication, type and dosage of medication is changed less than 4 weeks prior to the start
* Subjects are participating in the other protocol or receiving alternative treatment such transcranial magnetic stimulation.
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03955692
|
{
"brief_title": "The Efficacy of Cathodal tDCS in ADHD",
"conditions": [
"ADHD"
],
"interventions": [
"Device: tDCS"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT03955692",
"official_title": "The Efficacy of Cathodal Transcranial Direct Current Stimulation in Children and Adolescents With Attention-deficit Hyperactivity Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-01",
"study_completion_date(actual)": "2019-12-01",
"study_start_date(actual)": "2017-12-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-06",
"last_updated_that_met_qc_criteria": "2019-05-17",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-20",
"first_submitted": "2017-11-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The ultimate goal of this study is to interpret Modified Oswestry Low Back Pain Scale into Urdu and analyse its reliability and validity in the population of Pakistan lumber radiculopathy patients. Examine its correlation with Quebec back pain disability scale and the visual analogue scale, as well as the Roland-Morris disability questionnaire.
Detailed Description
As per preceding commendation, Modified Oswestry Low Back Pain Scale will be translated into Urdu language from its English version and adapted culturally in Pakistan. 100 individuals will be selected on the basis of convenience sampling with clinical characteristics. The patient will answer the questionnaire package that included the Urdu version Modified Oswestry Low Back Pain Scale, Quebec back pain disability scale, Roland-Morris disability questionnaire and Visual analogue scale on the same day, with a 30-minute delay between the first and second application. Observer-1 will be conducting a third assessment after 7 days for intra-observer evaluation. Statistical Package of Social Sciences Version 24 will be used to enter and evaluate the data. Internal consistency will be measured using the Cronbach alpha value. To evaluated test-retest reliability, an intraclass correlation coefficient will be employed. The Modified Oswestry Low Back Pain Scale will be evaluated for content validity, construct validity, criterion validity, and responsiveness.
|
#Eligibility Criteria:
Inclusion Criteria:
* Both genders, between the ages of 18 to 65,
* Individuals who could read and speak Urdu as a first language
* People who have been diagnosed with lumbar radiculopathy by a physician or neurosurgeon,
* Low Back Pain in the lower extremities with or without radicular pain.
Exclusion Criteria:
* Female patients who were pregnant
* Patients with a mental health history, cancer, or neurological problems
* Acute low back pain is a frequent disease (included recent thoraco-lumbar trauma),
* Psychiatric and behavior issues, systemic disease (tumors and rheumatological diseases), and central or peripheral neurological problems
* Patients who had recently had a cerebrovascular accident or a myocardial infarction were also ruled out.
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
|
NCT05449288
|
{
"brief_title": "Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study",
"conditions": [
"Lumbar Radiculopathy"
],
"interventions": null,
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05449288",
"official_title": "Psychometric Properties and Cultural Adaptation of Urdu Version of Modified Oswestry Low Back Pain Scale Among Pakistani Low Back Pain Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-10",
"study_completion_date(actual)": "2022-03-12",
"study_start_date(actual)": "2021-05-30"
},
"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)": "2022-07-08",
"last_updated_that_met_qc_criteria": "2022-07-04",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-08",
"first_submitted": "2022-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot randomized controlled trial (RCT) is designed to test a new intervention designed to reduce college women's risk for sexual revictimization (SRV). The intervention targets women with a history of sexual assault (SA) and recent hazardous drinking (HD), as these women are at highest risk for SRV. The primary goals of the intervention are to decrease women's HD, improve their ability to perceive cues that signal risk for SRV, and strengthen their behavioral skills in situations associated with an increased risk for SRV. The intervention, Revictimization Prevention for College Women (RPCW) is a multi-modal intervention that includes two on-line interactive education modules and two in-person group skills-based training sessions that focus on problem solving training and behavioral rehearsal. The pilot RCT of the RPCW intervention will include 96 college women with follow-up assessments at 3- and 6-months post intervention. Women will be randomly assigned to either the RPCW intervention or to a Health Education Control (HEC) condition. The pilot RCT will be used to establish the feasibility of recruitment, the acceptability and safety of the RPCW intervention, and provide initial efficacy data that will assist in power calculations for a Stage II efficacy trial. The investigators hypothesize that women in RPCW intervention will report fewer days of hazardous drinking and improved perception of sexual assault risk cues compared with participants in the HEC condition. In addition, women in the RPCW intervention will report increased knowledge of safe dating practices and protective behavioral (drinking) strategies compared with participants in the HEC condition. Finally, women in the RPCW intervention will report lower rates of SRV as compared with participants in the HEC condition at the 6-month post-intervention follow-up.
Detailed Description
The investigators will be conducting a Stage 1b randomized controlled trial of a newly developed preventive intervention to reduce sexual revictimization of college women. The preventive intervention, Revictimization Prevention for College Women (RPCW), is designed to reduce sexual revictimization by reducing women's hazardous drinking, and increasing their awareness of protective dating and drinking behavioral strategies, as well as their awareness of risk cues for sexual assault during social situations. The intervention involves two in-person group skills-based training sessions held one week apart and two online interactive educational sessions designed for completion between the in-person sessions. During the pilot RCT, the active intervention (RPCW) will be compared to a time and attention Health Education Control.
The first group session of the RPCW involves viewing 4 cue recognition training videos and participating in an Interventionist lead discussion intended to highlight sexual assault risk cues in each of the videos. After the session, each participant will then complete two interactive, online learning module focused on safe drinking and safe dating. The second group session will occur one week after the first and is designed to elicit feedback on the drinking and dating learning modules (e.g., length, ease of use, engagement, interest). The training videos will be viewed again individually and participants will engage in behavioral skills rehearsal of appropriate responses in paired role plays with feedback from the Interventionist and a group discussion about the emotional barriers to engaging in appropriate dating and drinking safety behaviors (e.g., 'I feel bad for the guy', 'He might get really mad, 'I might miss out on being with a great guy') and strategies for overcoming these barriers. Adaptive emotion regulation strategies will be used such as cognitive reappraisal, distress tolerance, mindfulness of current emotions, acceptance, and problem solving. Immediately following this session, participants will be asked to complete a post-intervention survey, including feedback on the intervention content and process. Following the in-person RPCW sessions, a debriefing will occur to ensure that women have an opportunity to discuss any emotional discomfort or distress with the interventionist. Follow-up surveys will be administered again at 3- and 6-months post intervention. The Health education control (HEC) is a time and attention control and was developed in parallel with the RPCW. The two in-person sessions and two online units of the HEC condition will impart health information that is relevant and engaging for college women but does not directly address heavy drinking or sexual assault risk. It is intended to control for nonspecific intervention factors related to health behavior change. This 4-session active control condition will begin with an in-person session focused on stress management. The second in-person session focuses on sleep hygiene. The two online, interactive modules address nutrition on college campuses and physical exercise. These two modules are similar in format to the drinking and dating safety modules provided in the RPCW. To ensure that HEC participants receive SA risk reduction and HD reduction information, the participants will have the opportunity to receive the RPCW intervention following the 6-month follow-up assessment, if the participants choose to do so.
All participants will participate in the intervention over one week. The participants will attend two in-person group intervention sessions one week apart, and complete their two on-line units during the intervening week. The participants will be asked to complete a baseline survey prior to their first in-person session, a post-intervention session following their second in-person session and two follow-up on-line assessment surveys at 3 months and 6 months post intervention.
The investigators have three specific hypotheses for the RCT:
Hypothesis a: Participants in the RPCW intervention will report fewer days of hazardous drinking and improved perception of SRV risk cues on the video risk perception measure (primary outcomes) as compared with participants in the HEC condition.
Hypothesis b: Participants in the RPCW intervention will report increased knowledge of safe dating practices and protective behavioral (drinking) strategies (secondary outcomes) compared with participants in the HEC condition.
Hypothesis c: Participants in the RPCW intervention will report lower rates of SRV as compared with participants in the HEC condition at 6-month post-intervention follow-up.
#Intervention
- BEHAVIORAL : RPCW
- Psychosocial intervention that includes two in-person group sessions two weeks apart and two on-line units during the intervening two weeks. Behavioral training, educational materials, discussions and videos, as well as interactive online materials are included to increase awareness of sexual assault cues, dating and drinking protective behavioral strategies, barriers to defending oneself, and saying no to hazardous drinking and sexual advances.
- BEHAVIORAL : HEC
- Health Education time and attention control that includes two in-person sessions two weeks apart and two on-line units during the intervening two weeks. The in-person sessions cover stress management and sleep, while the online units cover nutrition and physical activity. The in-person and online sessions are designed to foster discussion and be interactive.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 22 years
* Current first- or second-year female student at the college
* Able to comprehend the study protocol, consent form and provide written consent
* Had a prior SA experienced since the age of 14 years (i.e., adolescent or young adult)
* Engaged in hazardous drinking in the past month (i.e., >= 4 drinks 1 or more times in past 30 days).
Exclusion Criteria:
* Major mental illness as indicated by: (a) severe level of depressive symptoms as assessed by the Beck Depression Inventory-II or a self-reported diagnosis of: (b) Schizophrenia, (c) Bipolar Disorder
* Report experiencing homicidal or suicidal ideation
* Unable to commit to attending 2 weekly in-person group sessions
* No access to a computer to complete the on-line intervention modules.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 22 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05257603
|
{
"brief_title": "Prevention of Alcohol-related Sexual Revictimization in College",
"conditions": [
"Sexual Assault"
],
"interventions": [
"Behavioral: HEC",
"Behavioral: RPCW"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05257603",
"official_title": "Assessing the Feasibility of a New Prevention to Reduce Alcohol-related Sexual Revictimization of College Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30",
"study_completion_date(actual)": "2023-11-30",
"study_start_date(actual)": "2022-03-05"
},
"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)": "2024-12-31",
"last_updated_that_met_qc_criteria": "2022-02-17",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-25",
"first_submitted": "2022-02-08",
"first_submitted_that_met_qc_criteria": "2024-12-19"
}
}
}
|
#Study Description
Brief Summary
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
#Intervention
- DIETARY_SUPPLEMENT : Lactobacillus reuteri DSM 17938
- 10\^8 CFU
- Other Names :
- BioGaia Protectis Baby
- DIETARY_SUPPLEMENT : Bifidobacterium longum infantis
- 10\^9 CFU
- Other Names :
- Align
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy infants.
* Infants 1 -3 months of age at the beginning of the study.
* Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
* Parents and child are planning to remain in Dhaka for the next four months.
Exclusion Criteria:
* Infants with known birth defects.
* Infants who have been hospitalized.
* Infants who have an acute infection or illness at the time of enrolment.
* Infants who are currently taking antibiotics
* Infants <1 month of age or >3 months of age.
* Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
* Infants who are already receiving a probiotic product or treatment.
* A diagnosis or suspicion of immunodeficiency disorder.
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 3 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01899378
|
{
"brief_title": "Safety and Efficacy of Probiotics in Bangladeshi Infants",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Lactobacillus reuteri DSM 17938",
"Dietary Supplement: Bifidobacterium longum infantis"
],
"location_countries": [
"Bangladesh"
],
"nct_id": "NCT01899378",
"official_title": "Safety and Efficacy of Probiotics in Bangladeshi Infants",
"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)": "2013-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-17",
"last_updated_that_met_qc_criteria": "2013-07-12",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-15",
"first_submitted": "2013-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.
Detailed Description
The term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. Frailty stratification predicts a patient's risk of death and need for institutional care. The construct is well validated, but there is not one single accepted operational definition. The CSHA Clinical Frailty Scale (CFS) is a 7-point scale relying on clinical judgement. It is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.Though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with NSTEMI. The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients, 75 years or older, with diagnosed NSTEMI, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit.
Exclusion Criteria:
* Not willing to participate.
* Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01049997
|
{
"brief_title": "Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)",
"conditions": [
"Non ST Elevation Myocardial Infarction (NSTEMI)",
"Frailty"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT01049997",
"official_title": "Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2009-10"
},
"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)": "2015-03-31",
"last_updated_that_met_qc_criteria": "2010-01-14",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-15",
"first_submitted": "2010-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of the protocol is to study the long-term outcome of a large group of traumatic brain injury patients.
This outcome is to be described in terms of activity, participation, quality of life, SOCIO-professional outcome and impact on caregivers, and in relation to health care provision.
The secondary outcome is to measure the impact on functional outcome of several predictive factors, and their relative importance on outcome. Our principal hypothesis is that SOCIO-professional and health provision factors play a major role on long-term outcome, further even than initial severity of brain injury.
Detailed Description
This work represents a part of a larger collaborative prospective study called PariS-TBI (Severe Traumatic Brain Injury in the Parisian area) financed by the French National Authority for Health. The PariS-TBI study was undertaken in 2005, to provide epidemiological data. Patients aged 15 or more were included if they had sustained a severe TBI in the Parisian area, defined by an initial Coma Glasgow Score (GCS) of 8 or less. During a 20-months period, all consecutive patients who met inclusion criteria were recruited by mobile emergency services. Data from patients' demographics, injury characteristics, acute and post acute phase were collected prospectively. Patients were evaluated through a phone interview at one year post traumatism.
A total of 504 patients were included, of which 257 were alive at the end of acute care.
Investigations of the present work will be undertaken between four and six years after brain injury for survivors. Patients of the initial cohort will be contacted twice through phone call or post. Information about this follow up study will be given orally and through written form. Informed consent of patient or legal advisor will be obtained before setting an appointment for the evaluation.
Evaluation will take place either in the patient's place of living, or in a clinical setting in the hospitals Broussais, Paris, France or Raymond POINCARE, GARCHES, France, according to the patient's choice.
Two trained neuropsychologists will lead the evaluations, during an interview with the patient and the informal care giver, defined as the person (family member or friend), most responsible for day-to-day decision making and care for the patient. If a patient refuses the interview, a short questionnaire will be proposed to him by the neuropsychologist by phone.
Demographic and pre-traumatism clinical data will be available from the initial study, as well as data on type and severity of traumatism, and on evolution during acute care. Early outcome data include cognitive disability (Dysexecutive Questionnaire), global participation (Glasgow Outcome Scale-Extended), and return to work.
Data assessed through the present study will include an evaluation of deficiencies: presence and importance of motor sequelae, cerebellar dysfunction, visual or auditive deficiencies, epilepsy, chronic pain. Cognitive deficiencies will be assessed through the Neurobehavioural Rating Scale-Revised, the Dysexecutive Questionnaire, and a questionnaire of complaints from the patient and from his informal care giver.
Activities will be evaluated by the Barthel index. Capacity of motor vehicle driving will be assessed. Participations will be measured globally with the Glasgow Outcome Scale-Extended, and specifically by a SOCIO-professional integration questionnaire and the BICRO-39 scale.
Quality of life will be assessed through the EuroQoL questionnaire, and a global evaluation of the patient's quality of life on a 0-10 numeric scale from the patient and from his care giver. The Hospital Anxiety and Depression Score will be measured.
Data on patients' pathway and intensity of clinical care will be collected: the clinical pathway from acute care to home or health care facility discharge, a quantification of clinical follow up and rehabilitation. The patient's environment (place of living, presence of informal carers) will be assessed, as well as modality of return to work.
The questionnaire will include data on financial compensations and intensity of formal home care.
Data on the quality of life of the informal care giver and an evaluation of the burden of care will be collected, using the ZARIT questionnaire.
The exploitation of this large data base will enable an up-to-date description of the long term outcomes of severe TBI patients in the Parisian area. It will be used to clarify the role of several factors on long term activities, participations and quality of life for severe TBI patients, the hypothesis being that factors directly related to the severity of the traumatism play a smaller role in long term outcome than SOCIO-environmental characteristics such as professional category, intensity of rehabilitation care, presence of informal care.
Statistical analysis will be conducted with the R® statistical software. Association between various predictive factors and outcome (GOSE, BICRO-39, EuroQoL) will be assessed through UNIVARIOUS tests, followed by multivarious regression models, using a backward selection strategy to select relevant variables.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults and children > 15 years.
* Severe TBI with a Glasgow Coma Scale (GCS) score of 8 or less before admission to the hospital.
* Accident within the Regional Parisian area (Paris and 7 surrounding districts).
* Alive at emergency arrival
Exclusion Criteria:
* Dead before care by emergency
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01437683
|
{
"brief_title": "PariS-TBI Study : Paris Severe Traumatic Brain Injury Study",
"conditions": [
"Brain Injury",
"Craniocerebral Trauma",
"Trauma Nervous System"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT01437683",
"official_title": "Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2010-02"
},
"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)": "2012-10-15",
"last_updated_that_met_qc_criteria": "2011-09-20",
"last_verified": "2010-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-21",
"first_submitted": "2011-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital.
The aim of this study is to assess the status of pneumococcal vaccination in patients at the NOVO hospital - Pontoise site, who have received anti-TNF alpha therapy.
Detailed Description
Immunosuppressed patients are at risk of infections, sometimes severe with life-threatening consequences. Some of these are vaccine-preventable, notably pneumococcal infections. Specific vaccination recommendations have been published since 2012 by the French High Council for Public Health. However, vaccine coverage is below the desired immunisation objectives for immunosuppressed patients.
As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital, in order to propose, if necessary, measures, in particular a specialised consultation, with the aim of improving the vaccination coverage of this population at risk The aim of this study is to assess the status of pneumococcal vaccination in patients who have received anti-TNF alpha therapy.
#Intervention
- OTHER : Pneumococcal vaccine
- Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy
|
#Eligibility Criteria:
Inclusion Criteria :
* Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site
Exclusion Criteria :
* Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha
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
|
NCT05788510
|
{
"brief_title": "Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy",
"conditions": [
"Pneumococcal Vaccine"
],
"interventions": [
"Other: Pneumococcal vaccine"
],
"location_countries": [
"France"
],
"nct_id": "NCT05788510",
"official_title": "Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-06",
"study_completion_date(actual)": "2023-05-06",
"study_start_date(actual)": "2023-04-03"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2023-03-28",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-29",
"first_submitted": "2023-03-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1 between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary endpoint is duration of remission defined as platelets ≥50/nl.
Detailed Description
Patients above the age of 18 years with a first episode of immune thrombocytopenia (ITP) are eligible for inclusion, except pregnant women and patients unable to tolerate glucocorticoids. Diagnosis is made and treatment requirement defined according to the 1996 practice guidelines of the American Society of Hematology. The primary endpoint is duration of remission defined as platelets ≥50/nl. Secondary endpoints are response rate, complete remission (platelets ≥150/nl), cumulative cortisol equivalent dose (potency of prednisone / dexamethasone relative to cortisol: x 4 / x 30) and adverse events. During the first week of treatment all patients receive prednisone at 1 mg/kg/d. This period is used to confirm the diagnosis and identify patients with ITP secondary to lymphoproliferative, autoimmune (systemic lupus erythematosus, antiphospholipid syndrome) or infectious diseases (human immunodeficiency, hepatitis C, cytomegalovirus infection). Patients are stratified by age (cut-off: 50 years), gender and primary versus secondary ITP and then randomized 1:1 between daily prednisone (arm A) and pulsed dexamethasone (arm B). In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to \<25 mg/d by week 14 and \<7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above. In arm B patients receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4). Patients failing to achieve or maintain a remission are switched to the alternative treatment arm (A: no response after 4 weeks of prednisone at 1-2 mg/kg/d, loss of response, maintenance doses exceeding the above limits; B: no response after 2 cycles, loss of response).
#Intervention
- DRUG : Prednisone
- Continuous daily therapy
- DRUG : Dexamethasone
- 4-day pulses every 3 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* First episode of ITP
Exclusion Criteria:
* Pregnancy
* Glucocorticoid intolerance
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
|
NCT02334813
|
{
"brief_title": "Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia",
"conditions": [
"Purpura, Thrombocytopenic, Idiopathic"
],
"interventions": [
"Drug: Dexamethasone",
"Drug: Prednisone"
],
"location_countries": null,
"nct_id": "NCT02334813",
"official_title": "A Randomized Trial of Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2002-07"
},
"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)": "2017-06-09",
"last_updated_that_met_qc_criteria": "2015-01-07",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-08",
"first_submitted": "2015-01-06",
"first_submitted_that_met_qc_criteria": "2017-05-04"
}
}
}
|
#Study Description
Brief Summary
To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances
#Intervention
- DRUG : Propranolol
- DRUG : Talsaclidine
|
#Eligibility Criteria:
Inclusion Criteria:
All participants in the study should be healthy males, range from 50 <= age <= 65 of age and be within +- 20% of their normal weight (Broca-Index).
Exclusion Criteria:
* Volunteers will be excluded from the study if the result of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values
* Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60 beats/min
* Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80 mg propranolol
* Volunteers with Raw-values higher than their predicted normal upper limit
* Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half life (>=24 hours) within at least one month or less than ten half lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the trial during the week prior the start of the study
* Volunteers who have participated in another study with an investigational drug within the last 2 month preceding this study
* Volunteers who are unable to refrain from smoking on the study days
* Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who have donated blood (>=100ml) within the last 4 weeks
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02264093
|
{
"brief_title": "Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Talsaclidine",
"Drug: Propranolol"
],
"location_countries": null,
"nct_id": "NCT02264093",
"official_title": "Effects on the Airway Lumen of Single Oral Doses of Talsaclidine (12, 24, 48 and 60 mg) in Combination With a Single Oral Doses of 160 mg Propranolol in Comparison to the Effects of the Monosubstances (60 mg Talsaclidine and 160 mg Propranolol) in Healthy Elderly Male Volunteers (Partially Randomised, Open Label, Intraindividual Comparison)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2000-02",
"study_completion_date(actual)": null,
"study_start_date(actual)": "1999-11"
},
"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)": "2014-10-15",
"last_updated_that_met_qc_criteria": "2014-10-13",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-15",
"first_submitted": "2014-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.
#Intervention
- DRUG : Fecal Microbiota Transplantation
- Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
- Other Names :
- FMT
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults age 18 or greater
* Confirmed recurrent CDI by positive PCR or EIA toxin test defined at >= 2 episodes and vancomycin failure within one year with the most recent being within the past 3 months.
* Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's colitis or ileocolitis or indeterminate colitis) for >= 3 months
* Undergoing FMT via colonoscopy for CDI as part of standard medical care
Exclusion Criteria:
* Unable or unwilling to undergo a colonoscopy
* Inpatient status
* Anticipated immediate or upcoming surgery within 30 days
* Need for continued non-anti-CDI antibiotic therapy
* History of total or subtotal proctocolectomy
* Isolated ileal or small bowel disease
* Pregnancy or lactation
* Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
* Patients who are unable to give informed consent
* Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
* Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
* Life expectancy < 6 months
* Unable to adhere to protocol requirements
* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
* Known concurrent HIV, Hepatitis B or C infection
* Concurrent PSC
* Patients with WBC< 3.0 x109th/L at baseline
* Patients with platelet count < 100 x109th/L
* Patients with initial elevation of AST or ALT > 1.5 times above normal limit at baseline
* Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
* Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment
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
|
NCT03106844
|
{
"brief_title": "The ICON Study: Outcomes After FMT for Patients With IBD and CDI",
"conditions": [
"Inflammatory Bowel Diseases",
"Clostridium Difficile Infection"
],
"interventions": [
"Drug: Fecal Microbiota Transplantation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03106844",
"official_title": "The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-07",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2017-08-01"
},
"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)": "2021-02-10",
"last_updated_that_met_qc_criteria": "2017-04-04",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-10",
"first_submitted": "2017-04-04",
"first_submitted_that_met_qc_criteria": "2020-08-31"
}
}
}
|
#Study Description
Brief Summary
Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment for people with Major Depressive Disorder. This study plans to explore the potential that Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to the Emergency Department with severe depression. Since this is a controlled trial we will use an IV of Ketamine or and equivalent volume of Diphenhydramine. Subjects will be randomly assigned to receive Ketamine or Benadryl. Investigators will then compare measures of mood pre- and post-infusion in the Emergency Department. To supplement self-reported measures of depressive symptoms(e.g. mood), investigators will obtain objective measures of the biological aspects of Major Depressive Disorder.
Detailed Description
To explore the use of ketamine as a potential rapidly-acting antidepressant (RAA) for Emergency Department (ED) patients with major depressive disorder (MDD).
Investigators will conduct a randomized controlled study to evaluate the rapidity and persistence of antidepressant effects of a single sub-anesthetic dose of intravenous (IV) ketamine (0.25mg/kg) or an equivalent volume of diphenhydramine (25mg) delivered IV over 1-2 minutes, by comparing measures of mood pre- and post-infusion in Emergency Department (ED) patients with MDD. Subjects will be randomly assigned (1:1) to receive a bolus of ketamine or diphenhydramine. To supplement self-reported measures of depressive symptoms (e.g., mood, suicidal ideation, etc.), investigators will obtain objective measures of heart rate and heart rate variability, measure serum levels of the pro- and anti-inflammatory cytokines (interleukin IL-1, IL-2, IL-6, IL-8, IL-10, IL-12, and tissue necrosis factor, TNF-α), which have been shown to play an important role in stress, depression and suicidal behavior. In addition, investigators will obtain serum levels of brain derived neurotrophic factor (BDNF) because reduced serum BDNF has been described during acute depressive episodes in patients with MDD, with reports of rescue effects following treatment with various antidepressants and with ketamine (Aydemir 2005, Gervasoni 2005, Karege 2002, Karege 2005, Duncan 2013, Shimizu 2003). Investigators will also measure serum magnesium levels, as these have been shown to correlate in a predictive manner with response to conventional antidepressants (Camardese 2012), and there are data to suggest that ketamine's efficacy in treatment-resistant depression could be related to a relative magnesium deficiency in such patients (Murck 2013).
This study will allow investigators to determine to what extent low-dose ketamine, an N-Methyl-D-Aspartate (NMDA) antagonist, achieves a rapid reduction in symptoms for severely depressed ED patients with or without suicidal ideation. For decades, much higher doses of IV ketamine (1-2mg/kg) have been used routinely in the ED as a dissociative anesthetic (Green 2011). In 2011, an open-label study was the first published of the use of low dose ketamine (0.2mg/kg), administered by rapid intravenous infusion, in the ED setting for acutely depressed patients which demonstrated its feasibility, safety, preliminary efficacy and acceptability to both ED patients and staff (Larkin 2011). One long-term goal of this research is to expand treatment options available to depressed ED patients that mitigate the need for inpatient admission and serve as a safety bridge to future out-patient treatment for major depression. As an adjunct to standard treatment, low-dose NMDA receptor antagonists have the potential to positively impact: ED waiting times; repeat visits to the ED; short-term risk of suicide attempts; length of stay on inpatient units and the need for hospital admissions for many acutely depressed patients.
#Intervention
- DRUG : Ketamine
- IV of Ketamine (.25mg/kg)
- Other Names :
- Other names for ketamine: ketalar
- DRUG : Diphenhydramine
- Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
- Other Names :
- Other names for diphenhydramine: benadryl
|
#Eligibility Criteria:
Inclusion Criteria:
* Medically stable as determined by the medical physician
* Meets criteria for Major Depressive Disorder (MDD) based on a structured clinical Interview (MINI International Neuropsychiatric Interview).
* Reports symptoms of severe depression at the time of presentation, defined as a score of 24 or greater on the MADRS.
* Patients for whom a psychiatric evaluation and disposition decision has been made by emergency psychiatry staff to admit to an inpatient psychiatric unit at Bellevue Hospital Center or NYU Tisch Hospital.
* Each subject must have a level of understanding sufficient to sign an informed consent stating that the treatment being offered is not FDA approved for the treatment of depression and is being provided as an off-label option.
Exclusion Criteria:
* Pregnancy
* Inability to read or understand English
* Current clinical signs of intoxication or delirium at time of study intervention
* Overdose, within previous 24 hours, of any agent which would impair ketamine metabolism
* Lifetime misuse/abuse of ketamine, phencyclidine (PCP),or related substances
* Lifetime history of psychotic spectrum illness
* First-degree relative with history of psychotic illness
* Lifetime diagnosis of borderline personality disorder, or as confirmed by assessment using items #90 <= age <= 104 of the SCID-II (for DSM-IV).
* Subjects with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), O2 saturation measure, 12-lead ECG, clinical laboratory tests (CBC, chemistry panel, thyroid function tests), urine drug screen, and urine pregnancy test (for females of childbearing potential only).
* Clinically unstable medical, surgical or neurological conditions at ED presentation
* History of stroke or intracranial hypertension
* History of glaucoma
* Subjects with one or more seizures without a clear and resolved etiology
* Current NMDA antagonist medications (eg. Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)
* Known hypersensitivity to ketamine or amantadine
* Anti-psychotic medications (Typicals or Atypicals), with the exception of low-dose quetiapine (total daily dose of 100mg or less).
* Actively trying to commit suicide, even in a hospital setting
* Current homicide risk
* Unable or unwilling to give informed consent according to HIC guidelines
* Unable or unwilling to provide 2 contact phone numbers or be followed up per study protocol.
* Previous enrollment in this study.
* Concurrent enrollment in a research protocol investigating experimental pharmacologic treatments for depression at this or any other institution.
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
|
NCT02106325
|
{
"brief_title": "Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients",
"conditions": [
"Depression"
],
"interventions": [
"Drug: Diphenhydramine",
"Drug: Ketamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02106325",
"official_title": "A Randomized, Double-Blinded Controlled Trial of an N-Methyl D-Aspartate Antagonist as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2017-03",
"study_start_date(actual)": "2013-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-14",
"last_updated_that_met_qc_criteria": "2014-04-03",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-08",
"first_submitted": "2013-12-12",
"first_submitted_that_met_qc_criteria": "2018-08-16"
}
}
}
|
#Study Description
Brief Summary
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
#Intervention
- DRUG : Cyclophosphamide
- 100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning
* Written informed consent
* No uncontrolled infections
Exclusion Criteria:
* Severe organ dysfunction defined as:
* Cardiac left ventricular ejection fraction (LVEF) of less than 35%
* diffusing lung capacity (DLCO) of less than 40%
* total lung capacity (TLC) of less than 40%
* forced expiratory volume (FEV1) of less than 40%
* total bilirubin >3mg/dl
* creatinine-clearance of less than 40 ml/min
* pregnancy or breast feeding
* participation in other experimental drug trials
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
|
NCT01283776
|
{
"brief_title": "Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation",
"conditions": [
"Multiple Myeloma",
"Non-Hodgkin-Lymphoma",
"Hodgkin's Disease"
],
"interventions": [
"Drug: Cyclophosphamide"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01283776",
"official_title": "A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2011-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-10",
"last_updated_that_met_qc_criteria": "2011-01-25",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-26",
"first_submitted": "2011-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.
Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.
Detailed Description
Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024
#Intervention
- OTHER : Focusing on Maryam's Flower
- Effect of Focusing on Maryam's Flower During the First Phase of the labor
- Other Names :
- Foccusing on Maryam's Flower
|
#Eligibility Criteria:
Inclusion Criteria:
* Being >= 18 years,
* being in 37 <= age <= 42 weeks of pregnancy,
* being primiparous,
* having a single healthy fetus,
* cervical dilatation not more than 3 cm.the one which,
* in the first stage of labor,
* Does not have any complications preventing vaginal birth,
* volunteer women who do not have disabilities in communication and perception
Exclusion Criteria:
* maternal and fetal complications
* pregnant with assisted reproductive techniques,
* having a presentation anomaly,
* having a twin pregnancy,
* electing cesarean section,
* Women whose cervical dilatation exceeds 3 cm and who are not willing to participate in the study
Sex :
FEMALE
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
|
NCT06128759
|
{
"brief_title": "Focusing on the Maryam's Flower During the Birth",
"conditions": [
"Labor Pain"
],
"interventions": [
"Other: Focusing on Maryam's Flower"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06128759",
"official_title": "The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-03",
"study_completion_date(actual)": "2024-04-03",
"study_start_date(actual)": "2023-11-21"
},
"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)": "2024-10-23",
"last_updated_that_met_qc_criteria": "2023-11-08",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-13",
"first_submitted": "2023-11-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to examine if exposure to vegan soul food restaurants can increase African American adults' perceived benefits of consuming plant-based foods more so than standard guidelines. Although the health benefits of vegan diets are well documented, many people are reluctant to commit to a vegan diet long term. Various issues like food preparation, a lack of social support, or other barriers are often mentioned as reasons why people can't be vegan. This study will (1) find out if short term exposure (i.e. 3 weeks) to culturally tailored curriculum focusing on the health benefits of consuming plant-based foods increases African American adults' perceptions of adopting a vegan diet. And (2) if eating out a few times a week at vegan soul food restaurants can further increase African American adults' perceived benefits of a vegan than having to prepare all meals at home.
Detailed Description
The goal of this study is to examine if exposure to vegan soul food restaurants can increase African American adults' perceived benefits of consuming plant-based foods more so than standard guidelines. Although the health benefits of vegan diets are well documented, many people are reluctant to commit to a vegan diet long term. Various issues like food preparation, a lack of social support, or other barriers are often mentioned as reasons why people can't be vegan. This study will (1) find out if short term exposure (i.e. 3 weeks) to culturally tailored curriculum focusing on the health benefits of consuming plant-based foods increases African American adults' perceptions of adopting a vegan diet. And (2) if eating out a few times a week at vegan soul food restaurants can further increase African American adults' perceived benefits of a vegan than having to prepare all meals at home.
Study participants will receive counseling and informational materials from a trained research assistant to follow a vegan diet for 3 weeks. Participants will be randomly assigned to either a standard group or a restaurant group. The standard group will receive gift cards to shop at local super markets. The restaurant group will receive gift cards to eat out a few times a week at local vegan soul food restaurants. Changes in individuals' perceived benefits and barriers to consuming plant-based foods will be assessed with a validated survey at baseline and at the end of the 3 week period.
#Intervention
- BEHAVIORAL : Dietary Intervention: Restaurant
- Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to local vegan soul food restaurants.
- BEHAVIORAL : Dietary Intervention: Standard/Grocery
- Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to grocery stores.
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-identify as African American
* Be between the ages of 18 <= age <= 65 years
* Live in the Columbia, SC/Midlands area
* Be able to attend all meetings with the study coordinator
* Be willing to be randomized to either condition
Exclusion Criteria:
* Currently following a vegan diet
* Under the age of 18 years
* Over the age of 65 years
* Not willing to attend meetings with the study coordinator
* Not willing to be randomized to either condition
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
|
NCT03565718
|
{
"brief_title": "The Plant-Based and Soul-Full Study (PASS)",
"conditions": [
"Dietary Modification"
],
"interventions": [
"Behavioral: Dietary Intervention: Standard/Grocery",
"Behavioral: Dietary Intervention: Restaurant"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03565718",
"official_title": "The Plant-Based and Soul-Full Study: Increasing African American Adults' Perceived Benefits of Consuming Plant-Based Foods",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-30",
"study_completion_date(actual)": "2019-01-21",
"study_start_date(actual)": "2018-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-24",
"last_updated_that_met_qc_criteria": "2018-06-20",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-21",
"first_submitted": "2018-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The trial is a randomized control trial about the effective of an eating disorders prevention programmer for young Saudi women.
The prevention program is title The Body Project. Participants will be Saudi undergraduates from Princess Nourah Bint Abdulrahman University. Sample size is 64 participants. They will be divided randomly to two groups, each group has 32 participants. The first group is the intervention group where the prevention program will be provided. The second group will be the control group where healthy eating education material will be provided. The outcomes will be measured with adapted tools to local culture at three points (pre, post and 3 month follow-up).
#Intervention
- OTHER : The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
- The Body Project is a a selective dissonance-based prevention program that targets women with body image concerns. It has been developed with University and similar populations in mind, making it appropriate to the current research.The Body Project is based on a protocol, and aims to create cognitive dissonance that encourages participants to reduce pursuit of the thin-ideal. It involves the use of a scripted manual, covering four interactive weekly sessions. These involve role play, behavioural, verbal and written exercises.
|
#Eligibility Criteria:
Inclusion Criteria:
undergraduate Saudi female
Exclusion Criteria:
undergraduate Saudi female with eating disorders
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05071521
|
{
"brief_title": "The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia",
"conditions": [
"Eating Disorder Symptom and Body Image Dissatisfaction"
],
"interventions": [
"Other: The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention"
],
"location_countries": [
"Saudi Arabia"
],
"nct_id": "NCT05071521",
"official_title": "The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-07",
"study_completion_date(actual)": "2021-03-07",
"study_start_date(actual)": "2020-10-01"
},
"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)": "2021-10-08",
"last_updated_that_met_qc_criteria": "2021-09-27",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-08",
"first_submitted": "2021-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.
Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids, candidate for elective abdominal myomectomy.
Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given.
Main outcome measure: Intra-operative blood loss
#Intervention
- OTHER : oxytocin in abdominal myomectomy
- Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given
|
#Eligibility Criteria:
Inclusion Criteria:
* women of ASA class I-II with intramural fibroids,
* women planned to undergo elective abdominal myomectomy
Exclusion Criteria:
* Women with hemoglobin (Hb) < 10g/dl
* Women with any respiratory or cardiovascular disease.
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03702946
|
{
"brief_title": "Oxytocin Infusion and Abdominal Myomectomy",
"conditions": [
"Oxytocin and Abdominal Myomectomy"
],
"interventions": [
"Other: oxytocin in abdominal myomectomy"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT03702946",
"official_title": "Effect of Oxytocin Infusion on Reducing the Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-15",
"study_completion_date(actual)": "2018-01-15",
"study_start_date(actual)": "2017-07-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-11",
"last_updated_that_met_qc_criteria": "2018-10-09",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-11",
"first_submitted": "2018-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.
Detailed Description
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.
1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure.
2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.
#Intervention
- DEVICE : Balloon Angioplasty
- Device: Balloon Angioplasty Selection is driven by preference of the operator
- DEVICE : Atherectomy System
- Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator
|
#Eligibility Criteria:
Inclusion Criteria:
Screening Criteria
* Male or non-pregnant female >=18 years
* Rutherford Clinical Category 2 <= age <= 4
* Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb.
* Patient is willing to provide informed consent and comply with the required follow up visits Procedural Criteria
* De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site
* >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk)
* Reference vessel diameter >=3mm and <= 8mm
* Successful wire crossing of lesion
* A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable)
Exclusion Criteria:
Screening Criteria
* Pregnant, nursing or planning on becoming pregnant in < 2years
* Life expectancy of <2 years
* Known active malignancy
* History of solid organ transplantation
* Patient actively participating in another investigational device or drug study
* History of hemorrhagic stroke within 3 months
* Previous or planned surgical or interventional procedure within 30 days of index procedure
* Chronic renal insufficiency with eGFR <29
* Prior bypass surgery, drug-coated balloon or stenting of the target lesion
* Contra-indication or known hypersensitivity to contrast media or physician prescribed antiplatelet regimen as applicable
* Systemic fungal infection
* Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment
* Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset
* Acute limb ischemia
* Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)
* Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial Procedural Criteria
* Lesions extending into the trifurcation or above the profunda
* Heavy eccentric or moderate circumferential calcification at index lesion
* Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
* Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot
* Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)
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
|
NCT02469532
|
{
"brief_title": "DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes",
"conditions": [
"Peripheral Arterial Disease"
],
"interventions": [
"Device: Atherectomy System",
"Device: Balloon Angioplasty"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02469532",
"official_title": "DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2015-05"
},
"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": "2015-06-08",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-11",
"first_submitted": "2015-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A health care initiative will be implemented December 4, 2017 in the Newborn Intensive Care (NICU) setting in an attempt to reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event (CSCPE). We would like to compare LOS in infants born \< 30 weeks gestation before and after standardization to see if LOS is reduced.
Detailed Description
The LOS of infants born \< 30 weeks prior to implementation of the standardized definition of a CSCPE (11/30/2015-11/30/2017) will be compared to the LOS for all infants who meet the inclusion criteria and born \< 30 weeks from 6/1/2018 - 12/31/20. Data collection will begin June 1,2018, seven months after implementing the CSCPE definition. This will allow time for the nursing staff, the physicians and nurse practitioners to become familiar with the new CSCPE definition and management.
Following implementation of the new definition, the researchers will also do a 6 month audit on nursing response to a CSCPE based on the current alarm settings. Initially we do not plan to change the alarm limits but we may find the lower alarm limits for heart rate and oxygen saturation are set too high and may need to be lowered to more accurately assist nurses in recognizing when an infant is having a CSCPE. If the 6 month audit shows nurses are 'missing' a CSCPE because the current lower alarm limits are set too high, or stimulating an infant inappropriately too early, the alarm limits will be changed at every bedside. If the alarm limits are reset, data collection will begin 6 months after the alarms are changed. This is expected to be starting 1/1/2019 and conclude 12/31/20. If it is decided the lower alarm limits will not need to be changed, data collection will begin 6/1/2018 and conclude 8/31/20 instead of 12/31/20.
|
#Eligibility Criteria:
Inclusion Criteria:
* All infants born < 30 weeks gestation admitted to the Swedish Hospital NICU from 11/30/2015 <= age <= 11/30/2017 (historical control, pre-standardized defined CSCPE) and 6/1/2018 - 12/31/20 (the group following implementation of the standardized defined CSCPE).
Exclusion Criteria:
* Those babies who:
* expired during the evaluation periods
* transferred in after 30 weeks PMA
* transferred out and then lost to follow-up
* had a significant congenital, neurological, facial or airway anomaly affecting the infant's breathing beyond 36 weeks PCA
* subjects who are not yet adults (infants, children, teenagers)
Sex :
ALL
Ages :
- Minimum Age : 23 Weeks
- Maximum Age : 29 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03414671
|
{
"brief_title": "The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay",
"conditions": [
"Apnea of Prematurity"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03414671",
"official_title": "The Effect of Standardizing the Definition and Approach to a Clinically Significant Cardiopulmonary Event in Infants Less Than 30 Weeks on Length of Stay",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-31",
"study_completion_date(actual)": "2021-09-21",
"study_start_date(actual)": "2018-06-01"
},
"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)": "2021-10-04",
"last_updated_that_met_qc_criteria": "2018-01-23",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-30",
"first_submitted": "2018-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling older adults is effective with regards to functional ability and municipal costs.
Detailed Description
Early detection of functional decline among home dwelling older adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and nursing home placement. Towards year 2050 there will be a significant increase in number of elderly persons in Norway, with an urgent need for new models for early intervention and rehabilitation in order to give service to a larger amount of elderly persons. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been conducted regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning and economic costs compared to standard home-based treatment and care.
The study will be conducted in the municipality of Voss in Western Norway, a municipality with only 14000 inhabitants. It is a double-blinded, block-randomized controlled intervention trial, recruiting home-dwelling older adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist or a physiotherapist. The control intervention is standard home-based treatment and care.
Thirty participants will be recruited in each arm of the study. The participants will be assessed at baseline, and at 3-, and 9 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a daily registration of the working hours different health care professions spend in the private homes of the participants.
Power calculations based on study with a similar target group using the instrument Canadian Occupational Performance Measure, estimate a need for only 21 participants in each group due to the longitudinal design. However, in order to account for possibilities of frailer target group or a large drop out rate (40 %), a total number of 30 participants in each group will be tried recruited. Data analyses will be performed according to intention to treat. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.
#Intervention
- BEHAVIORAL : Reablement
- The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
- Other Names :
- Hverdagsrehabilitering, Hemrehabilitering, Re-ablement, Restorative care
- BEHAVIORAL : Standard treatment
- The control intervention is standard home-based treatment/care in Norway.
- Other Names :
- Usual care, Treatment as usual
|
#Eligibility Criteria:
Inclusion Criteria:
* Home-dwelling person
* Applicant of home-based services
* Above 18 years
* Functional decline in at least one activity
* Able to understand written and oral Norwegian
Exclusion Criteria:
* Cognitive disability
* Terminal ill
* Being assessed as needing nursing home placement
* Being assessed as needing institution-based rehabilitation
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
|
NCT02043262
|
{
"brief_title": "The Effectiveness of Reablement in Home Dwelling Older Adults. A Randomized Controlled Trial",
"conditions": [
"Physical Disability"
],
"interventions": [
"Behavioral: Reablement",
"Behavioral: Standard treatment"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT02043262",
"official_title": "Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2012-05"
},
"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)": "2016-06-03",
"last_updated_that_met_qc_criteria": "2014-01-21",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-23",
"first_submitted": "2012-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.
Detailed Description
The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).
#Intervention
- OTHER : Early drain removal
- Removing drain(s) on postoperative day 3
- OTHER : Late drain removal
- Removing drain(s) on postoperative day 5 or later
|
#Eligibility Criteria:
Inclusion Criteria:
* PD with or without pylorus preserving;
* Age between 18 and 75 years;
* Drain amylase on POD 1 and 3 less than 5000 U/L;
* Drain output within POD 3 less than 300 ml per day.
Exclusion Criteria:
* Vascular reconstruction using an artificial graft;
* Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
* Refusale to participate in after signed informed consent.
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
|
NCT03055676
|
{
"brief_title": "Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy",
"conditions": [
"Pancreaticoduodenectomy",
"Drainage"
],
"interventions": [
"Other: Late drain removal",
"Other: Early drain removal"
],
"location_countries": [
"China"
],
"nct_id": "NCT03055676",
"official_title": "A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03",
"study_completion_date(actual)": "2020-04",
"study_start_date(actual)": "2017-01"
},
"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)": "2020-04-24",
"last_updated_that_met_qc_criteria": "2017-02-14",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-16",
"first_submitted": "2017-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment.
Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients.
Patients understanding the nature of the study by providing their informed consent prior to participation.
* Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based chemotherapy. No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks before Avelumab initiation date.
* Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).
Detailed Description
Multicentre, observational, ambispective (retrospective and prospective) study to evaluate the real-world evidence of Avelumab as maintenance therapy in patients diagnosed with Urothelial Carcinoma (WHO classification) and previously treated with platinum-based treatment in first line. Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients. Patients are selected based on the existing medical record of have been treated with Avelumab as maintenance therapy in first line before initiating the study (retrospective data); patients who continues receiving Avelumab after inclusion will also contribute to data collection until the end of treatment or end of study (prospective data).
According to mUC incidence and the selective inclusion criteria from this study of having initiated Avelumab as maintenance therapy in 1L between EMA approval date (Jan. 2021) and date of national reimbursement prize (Apr.2022), which is a narrow period of time to recruit the necessary number of candidates, therefore, prospective data from each participant patient will be a key to ensure the assessment of the study objective eventually.
Investigators will review the medical history of patients treated or under treatment of Avelumab and select chronologically those who matches the inclusion criteria. Patients will be informed during a regular follow up visit about the nature of the study and requested to sign the patient consent form once the decision of participating is made. At this point, the retrospective data from patients is collected (such as demographics, toxicity, anthropometrics, vital signs, comorbidities, hemogram, dosage modification etc.) previous adverse reactions (ARs) and serious adverse reaction (SARs) related to Avelumab. Included patients, that continues under Avelumab treatment will be monitored by investigators and prospective data from them will be collected during follow up visits and/or from electronic medical records (eMR).
Deceased patient who fulfils the inclusion criteria can be also included, being able to access to its clinical data at the beginning of the study according to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) and the Spanish Organic Law 3/2018 of 5th December, on the protection of personal data and digital rights. Additionally, the investigator team will consult in the eMR of deceased patients to ensure that they did not express in life opposition to the use of their data for investigational purposes.
#Intervention
- DRUG : Avelumab
- Single Group Assignment
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients understanding the nature of the study by providing their informed consent prior to participation.
* Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease (AJCC ed. 8th, 2017) before first line with carboplatin/cisplatin-based chemotherapy (ChT). No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor (RECIST 1.1) with a treatment free interval of 4 <= age <= 10 weeks before Avelumab initiation date.
* Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05700344
|
{
"brief_title": "SOGUG-AVELUMAB_RWD",
"conditions": [
"Metastatic Urothelial Carcinoma"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT05700344",
"official_title": "Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-31",
"study_completion_date(actual)": "2023-11-02",
"study_start_date(actual)": "2022-09-05"
},
"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)": "2024-02-29",
"last_updated_that_met_qc_criteria": "2023-01-17",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-26",
"first_submitted": "2023-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.
This study aims to validate the procedure of patient specific cutting guides.
Detailed Description
30 patients will be included in a mono centric, single-arm study with evaluation of the primary outcome by an independent expert comity. Each participant will have an MRI which will be sent to the society in charge of creating the patient specific cutting guides. The intervention will be performed using the patient specific cutting guides and in parallel, a station of navigation will be used to provide a safety control of the orientation of the cutting guide and to collect per operative data.
Evaluation visit is performed 6 months after surgery.
#Intervention
- PROCEDURE : Unicompartmental Knee Replacement
|
#Eligibility Criteria:
Inclusion Criteria:
* patients aged >= 18 years;
* indication of medial unicompartmental knee replacement (validated by the orthopedic surgeons staff) ;
* written informed consent.
Exclusion Criteria:
* MRI contraindication ;
* Absence of the main investigator or the associated scientist during the surgical procedure ;
* Adults under legal protective regimen or deprived of liberty.
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
|
NCT02018484
|
{
"brief_title": "Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.",
"conditions": [
"Knee Prosthesis"
],
"interventions": [
"Procedure: Unicompartmental Knee Replacement"
],
"location_countries": [
"France"
],
"nct_id": "NCT02018484",
"official_title": "Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.",
"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)": "2013-12"
},
"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)": "2016-08-19",
"last_updated_that_met_qc_criteria": "2013-12-17",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-23",
"first_submitted": "2013-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
#Intervention
- DEVICE : SedLine Vs Comparator Test Group
- Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years and older at the time of consent.
* ASA status I, II, or III.
* English-speaking subjects.
* Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Exclusion Criteria:
* Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
* Subjects who are developmentally delayed.
* Subjects deemed not suitable for study at the discretion of the investigator.
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
|
NCT03865316
|
{
"brief_title": "Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia",
"conditions": [
"Anesthesia"
],
"interventions": [
"Device: SedLine Vs Comparator Test Group"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03865316",
"official_title": "Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-11",
"study_completion_date(actual)": "2021-03-11",
"study_start_date(actual)": "2019-01-25"
},
"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)": "2022-04-11",
"last_updated_that_met_qc_criteria": "2019-03-05",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-06",
"first_submitted": "2019-02-04",
"first_submitted_that_met_qc_criteria": "2022-03-11"
}
}
}
|
#Study Description
Brief Summary
In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).
Detailed Description
Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values:
1. Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR
2. Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve
3. Diffusion parameters on DWI A. Mean ADC B. fDM
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically proven NSCLC
* Newly diagnosed Stage stage IV
* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
* At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST
* Performance status of 0 to 2 on the ECOG scale
* Age >= 18 years
* Able to tolerable PET/CT and MRI imaging required by protocol
* Able to give study-specific informed consent
Exclusion Criteria:
* Pure bronchioloalveolar cell carcinoma histology
* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
* Poorly controlled diabetes
* Prior malignancy
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
|
NCT01482182
|
{
"brief_title": "Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy",
"conditions": [
"Non-small Cell Lung Cancer"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01482182",
"official_title": "Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2011-11"
},
"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)": "2015-11-20",
"last_updated_that_met_qc_criteria": "2011-11-28",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-30",
"first_submitted": "2011-11-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.
#Intervention
- DIETARY_SUPPLEMENT : Oolong tea containing L-arabinose and indigestible dextrin
- DIETARY_SUPPLEMENT : Oolong tea (Placebo)
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy as based on medical history and physical examination
* BMI between 25 and 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed
Exclusion Criteria:
* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00880646
|
{
"brief_title": "Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity",
"conditions": [
"Obesity"
],
"interventions": [
"Dietary Supplement: Oolong tea (Placebo)",
"Dietary Supplement: Oolong tea containing L-arabinose and indigestible dextrin"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00880646",
"official_title": "Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity: a Double-Blind, Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2009-10",
"study_start_date(actual)": "2009-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-10-29",
"last_updated_that_met_qc_criteria": "2009-04-13",
"last_verified": "2009-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-14",
"first_submitted": "2009-04-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence.
and to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback.
Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.
Detailed Description
A self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the Meuhedet Institutes' physiotherapy clinics.
Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) 'contract your pelvic floor - all sphincters'; (2) 'contract your anus'; (3) 'contract your pelvic floor as if you're trying to stop urinating'. Those who will not be able to contract will be taught by the ultrasound as biofeedback.
The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on-screen caliper and measurement tool will be used to measure bladder displacement.
#Intervention
- OTHER : Verbal instruction
- Verbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
- Other Names :
- Trans abdominal Ultrasound examination for pelvic floor contraction
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of urinary incontinence
* Understand the language and simple instruction
* Willing to participate in the study
Exclusion Criteria:
* Has been treated before for pelvic floor rehabilitation by a physiotherapist
* Received medication or surgery for the problem
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03940794
|
{
"brief_title": "Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence",
"conditions": [
"Urinary Incontinence"
],
"interventions": [
"Other: Verbal instruction"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT03940794",
"official_title": "Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-23",
"study_completion_date(actual)": "2020-03-01",
"study_start_date(actual)": "2019-07-17"
},
"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)": "2020-06-24",
"last_updated_that_met_qc_criteria": "2019-05-05",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-07",
"first_submitted": "2019-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.
Detailed Description
(none provided)
#Intervention
- DRUG : TS022
- Lotion
- DRUG : Vehicle
- Lotion
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults, males or females, 18 - 65 years at the time of obtaining the written Informed Consent
* Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
* A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
* A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
* Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
* Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
* Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria:
* Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
* Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
* Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
* Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
* Inability or unwillingness to discontinue current AD treatment(s)
* Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
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
|
NCT00914186
|
{
"brief_title": "Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)",
"conditions": [
"Atopic Dermatitis"
],
"interventions": [
"Drug: TS022",
"Drug: Vehicle"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00914186",
"official_title": "A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-01",
"last_updated_that_met_qc_criteria": "2009-06-02",
"last_verified": "2011-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-04",
"first_submitted": "2009-05-28",
"first_submitted_that_met_qc_criteria": "2011-11-10"
}
}
}
|
#Study Description
Brief Summary
Gastrodia and Uncaria Recipe is a well-known effective prescription in Traditional Chinese Medicine (TCM) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. However, it lacks consolidated evidence by multi-center randomized controlled trials. The hypothesis of this study is that Gastrodia and Uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo.
This study is a randomized, controlled, multi-center, double-blind clinical trial. This study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmHg, an office diastolic blood pressure of \<100 mmHg, and a 24-hour ambulatory mean systolic blood pressure of \>=130 mmHg. The patients will be stratified according to center, sex, and the TCM type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of Gastrodia and Uncaria granules or placebo for 2 months. The blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.
#Intervention
- DRUG : Gastrodia and Uncaria granule
- Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.
- DRUG : Placebo of Gastrodia and Uncaria granule
- Patients allocated to the control group take 10g of placebo of Gastrodia and Uncaria granule each time, twice per day, and for two months. The placebo has similar appearance and smell to genuine drug but has no effective anti-hypertensive agents.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female sex, aged 18 <= age <= 80 years.
* Not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks.
* Office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmHg, and diastolic blood pressure <100 mmHg.
* 24h ambulatory mean systolic blood pressure >= 130mmHg.
* Agreed to participant, able to join follow-up and to come to hospital at each visit.
* Signed informed consent.
Exclusion Criteria:
* Secondary hypertension, confirmed or suspected.
* Failed at ambulatory blood pressure monitoring: effective reading < 70%, or the number of awakening BP reading <20, or sleep time BP reading <7.
* Taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy.
* Having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months.
* Having a history of atrial fibrillation or frequent arrhythmia.
* Having abnormal lab test results: liver function (ALT, AST, TBL) >= 2 times the upper normal limit, or serum creatinine >= 176umol/L, or serum potassium >= 5.5mmol/L.
* Pregnant or breastfeeding (for females).
* Complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors.
* Possible poor compliance with the research process.
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
|
NCT04035824
|
{
"brief_title": "Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: an Evidence-based Optimization Study",
"conditions": [
"Hypertension"
],
"interventions": [
"Drug: Gastrodia and Uncaria granule",
"Drug: Placebo of Gastrodia and Uncaria granule"
],
"location_countries": [
"China"
],
"nct_id": "NCT04035824",
"official_title": "Evidence-based Optimization of Gastrodia and Uncaria Recipe in Treating Stage-one Hypertension: a Multi-center, Randomized, Double-blind, Placebo Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-12",
"study_completion_date(actual)": "2024-04-24",
"study_start_date(actual)": "2019-10-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-07",
"last_updated_that_met_qc_criteria": "2019-07-26",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-29",
"first_submitted": "2019-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine the effectiveness of the helmet-less tackling training (the HuTT Technique) intervention to reduce head impacts in high school football players and to gain an understanding of the neurocognitive effects of repetitive head impacts in football. The investigators hypothesis is that the HuTT Technique will result in a reduced frequency and magnitude of helmet impacts than the control group measured by a head impact measurement system. Also, the investigators hypothesize the HuTT Technique group will demonstrate less changes in neurocognitive scores in the mid and post season evaluations compared to the control group. Head impacts will be measured using the SIM-G impact monitor made by Triax Technology. The SIM-G impact monitor measures the location, magnitude, and direction of every head impact in real time and is stored on a protected cloud-based system. The sensor is worn by each athlete in a headband or skullcap. Neurocognitive function will be measured using the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) test. The test is used as a tool to determine baseline neurocognitive function and is used in comparison if an athlete was to be injured to ensure he/she returns to baseline. ImPACT measures memory (verbal, visual, working), processing speed and reaction time using a variety of tests. Subjects will be recruited from local high school football teams and will include freshman, sophomores and juniors. Since the study is expected to run for 2 years, seniors will not be eligible for participation. The target is to recruit at least 150 total subjects. All subjects will be equipped with a new helmet that is fitted to their head and a headband that will be used to hold the head impact telemetry sensor. In addition, all subjects will take an ImPACT test preseason, midseason and postseason. At the conclusion of each season, all of the impacts from the SIM-G impact monitor system and ImPACT test scores will be analyzed. The relevant outcome measures to be analyzed include head impact frequency, location, magnitude, symptom scores, memory, visual motor speed and reaction time composite scores. Statistical analysis will be used to determine if the HuTT intervention minimized head impacts and neurocognitive decline compared to the control group.
#Intervention
- BEHAVIORAL : Helmetless Tackling Training (HuTT)
- see previous sections
|
#Eligibility Criteria:
Inclusion Criteria:
* high school football participant
* two years eligibility
Exclusion Criteria:
* one year eligibility (high school senior)
* use of a Riddell Speed 'Flex' helmet
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02519478
|
{
"brief_title": "Prevention of Head Impacts in Football: The HuTT Technique",
"conditions": [
"Head Trauma",
"Cognitive Manifestations"
],
"interventions": [
"Behavioral: Helmetless Tackling Training (HuTT)"
],
"location_countries": null,
"nct_id": "NCT02519478",
"official_title": "Prevention of Head Impacts in Football: The HuTT Technique",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2015-08"
},
"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)": "2018-01-16",
"last_updated_that_met_qc_criteria": "2015-08-06",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-11",
"first_submitted": "2015-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single-center, open-label clinical study. Up to 11 subjects will be enrolled to use the Neuro-trigger device for blinking stimulation for a duration of 14 days.
Detailed Description
Facial paralysis is a well-known and severe condition. The paralysis can be permanent or temporary, depending on the cause and on the severity. It usually affects only one side of the patient's face, and so it makes the affected side of the face look like it is drooping.
The two facial nerves control each the muscles on one side of the face. A damaged facial nerve distal to the impaired area is dead and is unable to carry messages from the brain to the facial respective muscles either completely or partially, depending on the level of damage. This leads to muscle weakness, twitching or paralysis. In addition, damage to the nerve can cause the eyelid to drop, and the angle of the patient's mouth can also be twisted, usually towards down. In some cases of bell's Palsy, the nerve is capable to regenerate into the tunnel where it run before, and some studies have shown that stimulation may facilitate the growth toward the desired direction.
Under normal circumstances, the human eye blinks every 2-10 seconds. With every blink the eyelid spreads moisture over the cornea. With facial paralysis the ability to blink may be impaired or absent all together.The dry eye syndrome gets exacerbated since damage to the facial nerve also impairs the signal to the tear gland to generate tears, which mean that the production and secretion of tears in the affected eye is impaired.
With no effective treatment so far, and as paralysis persists, the severity of secondary damage to the eye increases including irritation of the eye (conjunctivitis), ulceration of the cornea, and it might cause severe disability and even blindness.
All the treatment options currently offered in the cases described above are partial and insufficient, and are aimed at alleviating symptoms and providing relief only.
The current treatment options are:
1. Application of eye drops (artificial tears), gel and\\or ointment
2. Tarsorrhaphy is the surgical fusion of the upper and lower eyelid margins.
3. Eyelid gold weight insertion.
4. A punctual plug.
Most of the existing treatment options deal with the symptoms of the dry eye syndrome, such as blurred vision, while the solution proposed by us is designed to address the original cause of the problem - the loss of eye muscle blinking due to loss of nerve stimulus due to the injury of the facial nerve.
The Neurotrigger device offers a comprehensive treatment system mainly designed for cases of functional impairment of the eye due to facial paralysis.
People with facial nerve paralysis cannot blink and cannot close the affected eye, day or night. As a result, the patients suffer from short and long-term consequences, including pain, discomfort, dry eye syndrome, and possible graduate impairment of vision.
Therefore, we suggest a novel daytime stimulating device based on an electrical stimulation of the facial nerve designed to restore blinking. This device is estimated to advance/improve/create a breakthrough in the current available treatment for rehabilitation of the affected eye in cases of facial nerve paralysis.
We recommend using this novel daytime system in combination with a specific solution for nighttime, designed to mechanically maintain the eye closed at night.
The day and night component of the solution have each separately its specific merits yet combining both solutions, creates a comprehensive treatment that may bring clear improvement for the patient.
The Neurotrigger device aims to restore eye blinking during the day based on electrical stimulation that is carried by the underlying injured nerve to activate the respective muscle unit and renew eye blinking and tear release.
#Intervention
- DEVICE : Neurotrigger Basic. eye blinking stimulator
- NeuroTrigger Basic is intended to stimulate healthy muscles in order to improve or facilitate muscle performance for maintaining/increasing muscle range of motion and for the prevention or retardation of disuse atrophy.
- Other Names :
- NTB-KT-0003
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects above 18 years
* Subject whom able to provide a written informed consent.
* Subjects who are willing to provide medical and demographic records of their facial paralysis, the consequences of the paralysis and general medical history.
* Patients who answer the full definition of continuous existing unilateral facial paralysis.
* Patients who comply with the definition of unilateral facial paralysis up to 12 months from the first diagnosis.
* Enrolment will depend on the subject's willingness and capability to perform the daily treatment with the use of the Neuro-trigger simulator (including operating the device and electrode placement ) for a duration of 2 weeks.
Exclusion Criteria:
* Patients with chronic facial paralysis and secondary established damage to the eye occurring prior to enrollment, who did not undergo facial reanimation surgery.
* Patients with psychiatric, addictive, or any other disorder that compromises ability to give genuine informed consent for participation in this study.
* Patients suffering from any skin condition that will prevent effective attachment of the electrodes, including but not limited to allergy to any of the components of the skin electrode
* Woman who is pregnant (positive pregnancy test)
* Woman who is nursing
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Patients who underwent an operation for facial reanimation at least one year prior to enrollment
* Patients whom are currently participating in other clinical study
* High probability of orbicularis oculi atrophy or damage (i.e. long-standing facial paralysis or cases
* History of ablative surgery where the musculature has been sacrificed)
* History of prior facial reanimation procedures
* History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe
* cognitive or motor impairment, severe immunological deficiency, and malignant diseases that are not in remission
* Signs of corneal infection or severe ocular surface inflammation
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06069128
|
{
"brief_title": "Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.",
"conditions": [
"Paralysis",
"Paralysis; Eye",
"Paralysis; Bell"
],
"interventions": [
"Device: Neurotrigger Basic. eye blinking stimulator"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT06069128",
"official_title": "A Single Center, Open Label, Pilot Study to Evaluate the Usability of the Neuro-trigger Artificial Eye Blinking Stimulation Device in Patients With Paralysis of the Facial Nerve.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-01",
"study_completion_date(actual)": "2024-09-05",
"study_start_date(actual)": "2023-10-01"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2023-10-01",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-05",
"first_submitted": "2023-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Multiple sclerosis (MS) is a chronic inflammatory disease that leads to demyelination of the central nervous system. Fatigue is one of the most frequent and most disabling symptoms of MS. Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue may limit or prevent participation in dayly activities and reduce psychological well-being (1, 2). Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent. The psychological approaches of fatigue management are interesting. To date, three RCTs using cognitive-behavioral group-based approaches in MS fatigue management programs have demonstrated their effectiveness (3-6). The results demonstrated a reduction in fatigue scores and better self-management of the disease in general. However, if these programs are effective at the time of their application and in the medium term, the issue of maintaining long-term therapeutic benefits is problematic.
The aim of this research is to assess the effectiveness of the FACETS program (6), on a population of French patients with RRMS over a 18 month period. This program focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes, with homework activities between the sessions. It is designed for groups of 6 to 10 people. The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12, 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and enhance the benefits of FACETS in the longer term.
This trial is randomized controlled comparative comparing a group receiving a FACETS program with a group receiving only a current local practice. Socio-demographic and medical data are measured as well as fatigue impact, fatigue severity, anxiety and depression, sleep disorder and quality of life.
The expected results are a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.
Detailed Description
In spite of the fatigue impact is well known in MS, medical care of this symptom is not usual. Moreover, treatments of fatigue are available, but evidence for effectiveness is limited. This study will build upon the existing evidence base for the effectiveness of cognitive behavioral approaches, and particularly the recent FACETS trial published by co-applicants.
Scientific aim is to assess the effectiveness of the FACETS program plus 4 additional booster sessions on a population of French patients with RRMS over a 12 months period.
This study will provide evidence on whether the FACETS program plus booster sessions is effective in helping MS patients with their fatigue. The program is designed to facilitate use within health services. Thus, if the results from this trial are positive, there is potential for directly adding to the treatment options available to MS patients who have troublesome fatigue, and improving the central nervous system affecting approximately 2.5 million people (5). Fatigue is one of the most commonly reported and disabling symptoms of MS, often occurring daily (6) and with a variable course (7-8). Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue has been defined as a 'subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual or desired activities' (9).
Researchers have distinguished between primary and secondary fatigue (10). 'Primary' fatigue relates to aspects of fatigue deemed to be directly related to the disease process such as lassitude or asthenia (an overwhelming sense of tiredness not directly related to participation in activity or exercise), 'short-circuiting' fatigue (when muscular performance deteriorates during sustained activity but recovers after a short rest break) and heat sensitive fatigue (where fatigue is triggered or worsened by heat). 'Secondary' fatigue refers to fatigue that is not unique to MS and is related to factors common to a range of chronic and disabling conditions (e.g. sleep disturbance, medication side effects, infection, physical exertion, depression, anxiety, stressful life events, characteristics of the local environment - such as lighting and temperature within a work setting). The relationship between these dimensions is complex; various symptoms of MS may act as predisposing factors for secondary fatigue.
Fatigue may limit or prevent participation in everyday activities, work, leisure and social pursuits, restrict role fulfilment and reduce psychological well-being (1-2) and is one of the key precipitants of early retirement (11-12). Its 'invisible' nature may lead to difficulties in personal and work relationships (13-14).
Although fatigue is one of the major symptoms of MS patients, the pathophysiology of fatigue is unclear (15) but likely to be multi- factorial (16-17). Findings on the relationships between fatigue and other clinical variables (such as age, gender, disease duration, and clinical activity) have been equivocal (18). The neural correlates are poorly components such as peripheral vs. central fatigue or physical vs. cognitive or mental, which are difficult to define or operationalize.
Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent (19-20). Non-pharmacological studies exploring the effectiveness of energy conservation programs for MS-fatigue have tended to be small and uncontrolled (21-22). Although the important relationships between physical and psychological aspects of MS-fatigue are recognized, high quality randomized and controlled trials (RCTs) of psychological interventions are rare (23).
The integration of cognitive-behavioral approaches in fatigue management programs is interesting. Indeed, their effectiveness has been demonstrated in Chronic Fatigue Syndrome. To date, three RCTs using cognitive-behavioral group-based approaches in the context of MS have been conducted (3-4). Cognitive behavioral approaches are potentially more profitable than the dual interventions, more easily integrated into a framework of routine care, and they also offer the possibility of peer support. The results of these studies demonstrated a reduction in fatigue scores and better self-management of the disease in general, resulting in improvements in quality of life. In their meta-analysis (24) indicate that the results obtained with CBT or with physical exercises are similar, but when people are anxious or depressed, which is often the case with MS (25-26), CBT shows better improvement. Knoop \& al. (27) highlighted the importance of cognitive representations on fatigue and the potential relevance of CBT: they showed that the strongest mediators of fatigue severity were fatigue avoidance, symptom focusing and the belief that fatigue symptoms are a sign of damage.
Thomas et al., (4) found that modest effects on fatigue severity were largely maintained at one year (unpublished data). Given that MS typically is diagnosed during the most productive years of individuals' lives and lasts the life course it is important to give people flexible tools and strategies to manage fatigue that can be used in the long term. Booster session might therefore help to 'boost' or enhance the effectiveness of the program in the longer term Methodology A multicentre parallel arm randomized controlled trial comparing a group receiving 'enhanced' FACETS plus current usual practice versus a group receiving current local practice only.
Inclusion criteria: clinically confirmed diagnosis of relapsing remitting MS; Significant fatigue levels (score at the Modified Fatigue Impact Scale - MFIS \> 45); Expanded Disability Status Scale score \< 6; age ≥ 18 years; written informed consent; speak and understand French; be able to follow the program.
Exclusion criteria: Individuals with cognitive deficits such that they would not be able to engage and benefit from this group-based program. Indeed, if individuals have significant cognitive deficits, most of the content of the fatigue management program would not be appropriate; People who have had a relapse within the past three months: (a relapse might result in increased fatigue) People who have started treatment on a disease modifying drug or anti-depressant in the past 3 months (one of the possible initial side effects of these drugs is fatigue); People who have psychiatric disorders Sample size: if one uses the results of the study (30) (matched groups), these authors show that in 59 MS patients treated with Modafinil, the mean fatigue score on the MFIS is 52.3 (SD/SE = 18.5), whilst in 56 MS patients treated by placebo the mean fatigue score is 49.2 (SD/SE = 16.6). The investigators will seek to uncover an absolute difference of 10 points between mean scores. The FACETS trial found a standardized effect size of 0.35 on their fatigue severity primary outcome, which would translate to around 6 points on the MFIS. It is anticipated that by using booster sessions and by running the programme using psychologists, that the anticipated effect size will be larger (10 points). In order to detect a 10 points absolute difference between the mean scores (on the MFIS) of the efficaciousness of the cognitive-behavioral intervention, power to detect an effect size of 8.5 points Participants will be identified and recruited by the neurologists of the hospitals who take part in the program, when they come for a medical examination.
Randomization: After giving their informed consent, the patients will be entered onto the trial database and randomized in a 1:1 ratio to either the fatigue management program and or current local practice using a computer, generated randomization sequence stratified by site.
Intervention FACETS (4). Focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes (with a break), with homework activities between the sessions. It is designed for groups of 8 to 10 people and will be delivered by two psychologists. The program is standardized: PowerPoints presentations support each session and a detailed facilitator manual and companion patient workbook. accompany the program.
The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12 et 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and they hope to enhance the benefits of FACETS in the longer term.
Measures For the FACETs group these will be administered pre, post and 12 months after the end of the FACETS program and at the same times for those in the control group Socio-demographic and medical data: age, sex, level of education, marital status, number of children and professional status; date of diagnosis, disease type, level of disability.
Neuropsychological measures: Paced Auditory Serial Addition Task (PASAT,28) \& the Computerized Speed Cognitive Test (CSCT,29).
Statistical analysis: They will register the trial and endeavor to publish the full trial protocol prior to its commencement. The primary analysis of effectiveness will use an 'intention-to-treat' approach and focus on comparing MFIS at 12 months post treatment (ie after the program and all booster sessions are complete) between the two trial arms using analysis of covariance to take into account MFIS at baseline, and study center. In addition to these analyses they will conduct further comparative analyses using a mixed model approach that permits analysis of repeated measures (baseline, post treatment and 12 months follow-up), takes into account missing data (i.e. model allows participants to contribute to the model even if they don't have complete data), and takes into account the group-based nature of the program (cluster effects). A similar approach will be used for other interval scaled outcome measures, and adapted if the outcome measure is nominal (eg the EDSS) Hypotheses There will be a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.
There will be a significantly greater improvement in sleepiness and sleep quality, anxiety, depression, stress, attention and working memory in the FACETS group than the control group at the end of the program and at 12 months The FACETS group will show a significantly greater reduction in cortical atrophy, axonal loss and demyelination within white matter tracts of DMN than those in the control group Ethics The protocol was submitted to the French competent authorities and a declaration was made to the CNIL.
Patients allocated to the control group (current local practice) will be offered the FACETS program after the 12 months follow-up.
Finally, all information collected will be strictly confidential. Identification numbers of participants will be noted on the questionnaires which will not contain any names or details to identify the participants. Only members of the research team will be allowed to access the trial data.
#Intervention
- BEHAVIORAL : Behavorial Cognitive Therapy (BCT)
- Check-in : review of the homewok Talk : Presentation of the aim of the session Group Activity : Relaxation and Execises Refreshment break Homework : exercises to practice at home and explanation about the forms to fill in.
Passout : session handbook and supports for exercises.
|
#Eligibility Criteria:
Inclusion Criteria:
* RRMS
* EDSS <= 5,5
* MFIS score > 45
* Outpatient treatment
* Enable to follow the BCT sessions
* French understanding
* More than 18 years
* Inform consent signature
* Membership in a social protection
Exclusion criteria
* Cognitive disorders avoiding patient participation
* Relapse within last 3 months before baseline
* Onset of DMT within 3 months
* Onset of antidepressive treatment within 3 months
* Onset of treatment for fatigue within 3 months
* Psychiatric disorders
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
|
NCT03758820
|
{
"brief_title": "Behavior Cognitive Therapy on Fatigue Impact in MS Patients",
"conditions": [
"Relapsing Remitting Multiple Sclerosis",
"Fatigue",
"Cognitive Therapy"
],
"interventions": [
"Behavioral: Behavorial Cognitive Therapy (BCT)"
],
"location_countries": [
"France"
],
"nct_id": "NCT03758820",
"official_title": "Multicenter Study, Randomized, Parallel Group Controlled, Testing the Effectiveness of a Behavioral Cognitive Therapy (BCT) vs Usual Local Practice on the Fatigue of Patients With Relapsing Remittent Multiple Sclerosis (RRMS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-15",
"study_completion_date(actual)": "2020-10-15",
"study_start_date(actual)": "2017-05-31"
},
"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)": "2021-03-16",
"last_updated_that_met_qc_criteria": "2018-11-28",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-29",
"first_submitted": "2017-10-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical trial is to find out the optimal technique of anesthesia for eye examination in children. The main question it aims to answer is:
Is propofol infusion and simple oxygen facemask associated with earlier discharge from the operating room, and hence rapid turnover and greater efficiency compared to sevoflurane via LMA? Researchers will compare time to discharge from the operating room to see if eye examination for children less than 7 years using a propofol infusion pump based anesthesia and simple oxygen facemask results in a shorter discharge time from the operating room in comparison with sevoflurane via LMA.
Participants will will be assigned to receive general anesthesia by one of two treatment groups.
Detailed Description
Children younger than 5 years can be uncooperative during an examination and may render it impossible. The main objective of anesthesia for ophthalmic examination is to provide ideal conditions for optimal exam with a quick onset and offset of anesthesia as well as rapid recovery and early discharge. Two commonly used sedation techniques for young children are: sevoflurane via laryngeal mask airway (LMA) or propofol infused intravenously. Both have been shown to be safe and effective and allow rapid changes in anesthesia depth and minimal postoperative morbidity. However, their induction, emergence characteristics, and side effect profiles may differ. From previous studies, it is still not evident whether propofol infusion using oxygen facemask or sevoflurane administration via LMA is superior with respect to earlier discharge from operating room in children undergoing eye examination under anesthesia (EUA).
In the literature, there are no studies directly comparing those two different techniques for ophthalmic examination.
The aim of this study is to find out the optimal technique of anesthesia for eye examination in children resulting in earlier discharge from the operating room thus decreasing the turnover time between cases and providing optimal surgical conditions, without interfering with the well-being of the child or compromising the airway security.
In a prospective randomized study, a total sample of 60 children scheduled for eye examination under anesthesia (30 in each arm of the study) aged between 1-7 years with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive general anesthesia by one of two treatment groups. After induction with sevoflurane 8% in oxygen, patients randomized to group S will be given propofol 2 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with sevoflurane via LMA. Patients randomized to group P will be given propofol 1 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with a continuous infusion of propofol 200 µg/kg/min with oxygen 3 L/min via simple mask and oral airway if needed. In both groups sevoflurane concentration or propofol infusion will be titrated to keep optimal conditions. The primary outcome is time to discharge from the operating room. Secondary outcomes are surgical conditions, respiratory events, agitation and other side effects as well as recovery times. Normally distributed data will be summarized as mean ± SD and nonnormally distributed data will be summarized as median \[interquartile range\].
It is believed that propofol infusion and simple oxygen facemask will be associated with earlier discharge from the operating room, and hence rapid turnover and greater efficiency compared to sevoflurane via LMA. This study would have an impact on the current practice for pediatric ophthalmic EUA and may help find out the best technique that decreases the turnover time between cases resulting in higher operating time efficiency while providing optimal surgical conditions and patients' safety.
#Intervention
- DRUG : sevoflurane via LMA
- In Group S, co-induction is used whereby the patient continues to receive 8% sevoflurane through the facemask followed after IV insertion by propofol 2mg/kg and fentanyl 1mic/kg administration. Thirty seconds afterwards, an age-appropriate LMA will be inserted. Sevoflurane is maintained initially at a concentration of 2%. The ventilation at first is assisted manually until the child starts breathing. If movement requires interruption of the exam, a bolus of propofol 1mg/kg is given and sevoflurane is increased by 1% until a maximal sevoflurane concentration of 4%. If apnea related to the depth of anesthesia occurs more than 10 sec or the saturation drops below 94%, sevoflurane will be turned off until the proper airway intervention is taken to achieve saturation above 95% and sevoflurane will be resumed at a concentration decreased by 1%.
- DRUG : Propofol with oxygen via simple mask
- In group P, the sevoflurane will be discontinued, and propofol 1 mg/kg and fentanyl 1µg/kg will be administered IV. Propofol pump is maintained initially at a rate of 200mic/kg/min. with oxygen at 3 liters/min via facemask.
If movement requires interruption of the exam, a bolus of propofol 1mglkg is given and the infusion rate is increased by 20mic/kg/min up to a maximal rate of 350mic/kg/min. The total number of boluses needed will be recorded as the need for additional sedation. If apnea related to the depth of anesthesia occurs more than 10 sec or the saturation drops below 94%, the infusion pump will be stopped until the proper airway intervention is taken to achieve saturation above 95% with spontaneous breathing. Afterwards, the propofol pump will be resumed at a rate decreased by 20mic/kg/min.
|
#Eligibility Criteria:
Inclusion Criteria:
* Children presented to the Operating Room of the American University of Beirut Medical Center
* Aged less than 7 years
* With American Society of Anesthesiologists physical status 1 <= age <= 3
* Scheduled for ophthalmic EUA with or without laser/cryotherapy procedure
Exclusion Criteria:
* Children with full stomach or significant aspiration risk (including hiatal hernia)
* Children who are morbidly obese or have a current upper respiratory tract infection
* Children who have oropharyngeal pathology (e.g., radiotherapy for hypopharynx/larynx), tracheostomies, or a family history of malignant hyperthermia
* Children of parents who refuse to give consent
* Children having allergy to the anesthetics used
* Any surgical procedure expected to last for more than 60 minutes
Sex :
ALL
Ages :
- Maximum Age : 7 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06656455
|
{
"brief_title": "Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children",
"conditions": [
"Anesthesia",
"Children, Only"
],
"interventions": [
"Drug: Propofol with oxygen via simple mask",
"Drug: sevoflurane via LMA"
],
"location_countries": [
"Lebanon"
],
"nct_id": "NCT06656455",
"official_title": "Comparison of Two Anesthetic Protocols (Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask) for Eye Examination Under Anesthesia in Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-08",
"study_completion_date(actual)": "2024-07-08",
"study_start_date(actual)": "2017-05-23"
},
"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)": "2024-10-24",
"last_updated_that_met_qc_criteria": "2024-10-22",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-24",
"first_submitted": "2024-10-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objectives:
Dose escalation (Part 1)
Part 1A (SAR439459 monotherapy)
* To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors.
Part 1B (SAR439459 and cemiplimab combination therapy)
* To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors.
Dose expansion (Part 2)
Part 2A (SAR439459 monotherapy)
* To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1.
Part 2B (SAR439459 and cemiplimab combination therapy)
* To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
Secondary Objectives:
* Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459.
* Immunogenicity of SAR439459 monotherapy and combined with cemiplimab.
Dose escalation (Part 1)
* Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab.
* Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab.
Dose expansion (Part 2)
* Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab.
* To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.
Detailed Description
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 4 weeks (28 days), a treatment period of at least 1 or 2 cycles (21 or 14 days per cycle, respectively), an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier. For the urothelial cancer cohort in Part 2B, follow-up visits will occur every 3 months until death, study cut-off date, or upon cancellation of Survival follow-up at the discretion of the Sponsor at any prior timepoint. For the overall survival analysis (approximately 12 months after last patient first dose), whichever comes first.
Patients who have no disease progression, and continue to benefit from the study drug(s), will be allowed to continue treatment beyond the common study end-date at their assigned dose unless the study is terminated by the Sponsor. The expected enrollment period is approximately 42 months.
#Intervention
- BIOLOGICAL : SAR439459
- Pharmaceutical form: powder for solution for infusion
Route of administration: intravenous infusion
- DRUG : Cemiplimab REGN2810
- Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
|
#Eligibility Criteria:
Inclusion criteria:
Dose escalation (Part 1A and Part 1B)
* Patients with histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator does not have a suitable alternative therapy.
Dose expansion (Part 2A)
* Patients with histologically confirmed, advanced unresectable or metastatic melanoma whom in the opinion of the Investigator does not have a suitable alternative therapy.
* Patients must have failed after any prior therapy based on anti-PD-1 or anti-PD-L1 as defined by disease progression within 26 weeks of initiating anti-PD-1 or anti-PD-L1 based therapy without any evidence of a response (primary resistance to anti-PD-1 or anti-PD-L1).
* Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy. Patients must be able and willing to provide mandatory tumor biopsies prior to and during study treatment.
Dose expansion (Part 2B)
* Patients with disease location amenable to mandatory tumor biopsy at baseline with histologically confirmed advanced unresectable or metastatic melanoma, colorectal adenocarcinoma, urothelial cancer, hepatocellular carcinoma (HCC), or non-small cell lung cancer (NSCLC).
* Melanoma patients must have failed one prior therapy based on anti-PD-1 or anti-PD-L1.
* Patients with colorectal cancer must have progressed after last line of therapy.
* Patients with urothelial cancer must have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients must not have received >2 lines of therapy for advanced disease. Patients must not have received prior treatment with anti-PD-1 or anti-PD-L1.
* Patients with HCC must have failed after 1 prior therapy based on anti-PD-1 or anti-PD-L1.
* Patients with NSCLC must have failed during or after 1 prior therapy based on anti-PD-1 or anti-PD-L1.
* Patients with histologically confirmed, advanced unresectable or metastatic melanoma, or colorectal cancer or NSCLC whom in the opinion of the Investigator do not have a suitable alternative therapy.
Dose expansion parts 2A and 2B
* At least 1 measurable lesion by RECIST v1.1.
All cohorts
* Patient understands and has signed Informed Consent form and is willing and able to comply with the requirements of the trial.
Exclusion criteria:
* Age <18 years or < the country's legal age of majority if the legal age is more than 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status >1.
* Concurrent treatment with any other anticancer therapy (including radiotherapy or investigational agents) or participation in another clinical study.
* Washout period of less than 3 weeks to prior anticancer therapy.
* Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy by using highly effective contraceptive.
* Pregnant or breast-feeding women.
* Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
* Significant and uncontrolled concomitant illness, including any psychiatric condition.
* Active infections, including unexplained fever (temperature >38.1ºC), or antibiotic therapy within 1 week prior to enrollment.
* Any prior organ transplant including allogeneic bone marrow transplant.
* History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
* History of known human immunodeficiency virus (HIV), HIV serology at screening will be conducted only for patients in German study sites.
* Known uncontrolled hepatitis B virus (HBV) infection.
* Known untreated current hepatitis C virus (HCV) infection.
* Any major surgery within the last 28 days.
* Patients with primary central nervous system (CNS) tumors and/or CNS metastases of non-CNS primary tumors.
* History of congestive heart failure, myocardial infarction with reduced ejection fraction, symptomatic coronary artery disease, documented uncontrolled hypertension, major clinically significant Electrocardiography (ECG) and echocardiogram abnormalities, significant ventricular arrhythmias, significant valvular heart disease (including valve replacement), vascular malformation, aneurysm, significant pulmonary conditions such as idiopathic pulmonary hypertension, uncontrolled chronic lung disease.
* History of severe, acute or chronic renal diseases.
* Any of the following within 6 months prior to study enrollment: pulmonary embolism, deep vein thrombosis, active uncontrolled bleeding, infectious or inflammatory bowel disease, diverticulitis, intestinal obstruction or perforation and gastrointestinal hemorrhage.
* Inadequate hematological, renal or liver function.
* Non-resolution of any prior treatment related toxicity to Grade <2.
* Prior treatment with any anti-transforming growth factor β (anti-TGFβ) inhibitors.
* Known allergies to any component of SAR439459 and/or cemiplimab.
* Patients with uveal melanoma and patients with prior or ongoing uveitis.
* Patients who received prior immunotherapy who developed toxicity leading to a permanent discontinuation of immunotherapy.
* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
* Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of SAR439459 and/or cemiplimab (occasional use of inhaled, intraocular, nasal or topical steroids for symptomatic relief allowed).
* History of interstitial lung disease or active non-infectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
* Patients with underlying cancer predisposition syndromes.
* Receipt of a live vaccine within 30 days of planned start of study medication.
* Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior the first dose of SAR439459.
* Prothrombin time (PT) or international normalized ratio (INR) > 1.5 × upper limit of normal (ULN).
* Patients accommodated in an institution because of regulatory or legal order; prisoners or patients who are legally institutionalized.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
|
NCT03192345
|
{
"brief_title": "A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors",
"conditions": [
"Malignant Solid Tumor"
],
"interventions": [
"Drug: Cemiplimab REGN2810",
"Biological: SAR439459"
],
"location_countries": [
"France",
"Netherlands",
"United States",
"Germany",
"Taiwan",
"United Kingdom",
"Canada",
"Spain",
"Australia",
"Estonia",
"Italy",
"Belgium",
"Korea, Republic of"
],
"nct_id": "NCT03192345",
"official_title": "A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-21",
"study_completion_date(actual)": "2022-01-17",
"study_start_date(actual)": "2017-06-09"
},
"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)": "2024-08-07",
"last_updated_that_met_qc_criteria": "2017-06-16",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-20",
"first_submitted": "2017-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will compare two different needles for interfascial blocks. All participants will execute the block on simulator with both needles. The participants will be randomized in two groups to choose the starting needle.
Detailed Description
Interfascial blocks are an emerging field of anesthesia. They are executed injecting local anesthetics inside a fascia plane using a needle.
Actually no evidence supports the use of a needle upon one other. Investigators would like to compare 'Ultraplex 360®' (Braun) needle with ' STIMUPLEX D SH, 30°'(Braun) while performing a Trasversus Abdominis Plane Block on BluePhantom simulator.
Ultraplex 360® (Braun) has an innovative surface pattern and clear coating that could result in better ultrasound visualization and tip identification.
#Intervention
- DEVICE : Ultraplex 360(Braun)
- This group will use as first needle the 'ultraplex 360' (Braun)
- DEVICE : STIMUPLEX D SH, 30°(Braun)
- This group will use as first needle the ' STIMUPLEX D SH, 30°' (Braun)
|
#Eligibility Criteria:
Inclusion Criteria:
* Novice interfascial block operators (< 15 interfascial blocks executed)
* informed consent
Exclusion Criteria:
* Exper Interfascial blocks operators
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03875742
|
{
"brief_title": "Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles",
"conditions": [
"Anesthesia"
],
"interventions": [
"Device: Ultraplex 360(Braun)",
"Device: STIMUPLEX D SH, 30°(Braun)"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03875742",
"official_title": "Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-20",
"study_completion_date(actual)": "2019-05-20",
"study_start_date(actual)": "2019-05-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-04",
"last_updated_that_met_qc_criteria": "2019-03-14",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-15",
"first_submitted": "2019-02-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this clinical trial was to test the hypothesis that clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.
Detailed Description
The primary approach to improving psychosocial treatment for youths has been to implement evidence-supported treatments (ESTs) in community services. However, this approach has not produced clear cut results of effectiveness. A recently developed alternative is to improve outcomes through routine measurement and feedback to clinicians and supervisors. The investigators used a cluster randomized experiment with 28 sites affiliated with a national behavioral health organization to assess whether clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.
#Intervention
- BEHAVIORAL : Contextualized Feedback Systems (CFS)tm
- After clinical questionnaires are entered, an automated feedback report is available online weekly to clinicians (and supervisors) in the experimental group. The report shows current mental health status of youths, alerts, and trends over time. Reports also show some clinical data on youths' caregivers.
|
#Eligibility Criteria:
Inclusion Criteria:
* all youths 11 <= age <= 18 years, entering treatment as usual, home-based services through the service provider. Youths' primary caregiver and clinician also participate.
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:
No
|
NCT01308879
|
{
"brief_title": "Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design",
"conditions": [
"Mental Health Wellness 1",
"Psychosocial Problem"
],
"interventions": [
"Behavioral: Contextualized Feedback Systems (CFS)tm"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01308879",
"official_title": "Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2004-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-03-04",
"last_updated_that_met_qc_criteria": "2011-03-03",
"last_verified": "2011-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-04",
"first_submitted": "2011-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.
#Intervention
- BEHAVIORAL : Accelerated Skill Acquisition Program (ASAP)
- A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
- BEHAVIORAL : Active Monitoring
- This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
|
#Eligibility Criteria:
Inclusion criteria:
* Ischemic or hemorrhagic stroke that occured at least 6 months ago.
* At least 21 years
* Persistent arm and hand weakness, with some ability to release a grasp
* Able to provide consent to participate
* No history of a medical condition that limited arm or hand use prior to the stroke
* Medically stable
* Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
* Able to communicate in English or Spanish.
Exclusion criteria:
* Severe upper extremity sensory impairment
* Neglect
* Current major depressive disorder
* Severe arthritis or orthopedic problems that limit arm or hand movement
* Pain that interferes with daily activities
* Currently enrolled in other rehabilitation or drug intervention studies
* Living too far from the training site to participate reliably
* Receiving oral or injected anti-spasticity medications during study treatment.
* Pregnancy.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01749358
|
{
"brief_title": "Dose Optimization for Stroke Evaluation",
"conditions": [
"Stroke",
"Cerebrovascular Disorders",
"Brain Ischemia",
"Infarction"
],
"interventions": [
"Behavioral: Accelerated Skill Acquisition Program (ASAP)",
"Behavioral: Active Monitoring"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01749358",
"official_title": "Optimizing the Dose of Rehabilitation After Stroke.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2012-03"
},
"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)": "2017-04-06",
"last_updated_that_met_qc_criteria": "2012-12-11",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-13",
"first_submitted": "2012-06-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
#Intervention
- DRUG : Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
- Single dose of one 0.75 mg coated tablet
- DRUG : Levonorgestrel (Postday)
- Single dose of one 0.75 mg tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers age between 18 and 55 years with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis
Exclusion Criteria:
* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
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
|
NCT01096498
|
{
"brief_title": "Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel",
"conditions": [
"Contraception",
"Contraception, Postcoital"
],
"interventions": [
"Drug: Levonorgestrel (Postday)",
"Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT01096498",
"official_title": "Open-label, Randomized, Crossover Study to Prove Bioequivalence Between Opxion® (Levonorgestrel 0.75 mg From Bayer de Mexico) and Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2009-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-11",
"last_updated_that_met_qc_criteria": "2010-03-30",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-31",
"first_submitted": "2010-03-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.
Detailed Description
Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.
The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:
1. Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
2. Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION.
The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.
Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.
Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
* Subject age: Age >10
* NA-AION diagnosis requires:
* disc edema seen by site PI or by referring doctor
* visual field defect in the study eye consistent with NA-AION and mean deviation worse than 3.0 dB using the study visual field examination protocol
* relative afferent pupillary defect (unless the fellow eye had previous NA-AION or other optic nerve or retinal disease that is not exclusionary)
Exclusion Criteria:
* Previous episode of NA-AION in the study eye only
* Intraocular pressure of >21 mm Hg in the study eye
* Clinical or pathological evidence of giant cell arteritis
* Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05305079
|
{
"brief_title": "NA-AION Risk Factors: New Perspectives",
"conditions": [
"Non-arteritic Ischemic Optic Neuropathy",
"Optic Disk Drusen"
],
"interventions": null,
"location_countries": [
"France",
"Israel",
"United States",
"United Kingdom",
"New Zealand",
"Canada",
"Iran, Islamic Republic of",
"Australia",
"Denmark"
],
"nct_id": "NCT05305079",
"official_title": "Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-31",
"study_completion_date(actual)": "2024-08-31",
"study_start_date(actual)": "2021-08-01"
},
"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)": "2024-11-22",
"last_updated_that_met_qc_criteria": "2022-03-22",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-31",
"first_submitted": "2021-07-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objectives.
* To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (\< 30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (\> 60 mg/dL).
* To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. 2.1.1 Hypotheses.
* The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a) concentration, with higher absolute and relative reduction in Lp(a) in subjects with hyperlipoproteinemia(a).
* Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related to the lowering effect variability of niacin in human.
Detailed Description
Open-label 12-week study, 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day. Subjects with normal Lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study.
Subjects: volunteers from the Lipid Clinic of Hospital Universitario Miguel Servet of Zaragoza, Spain. Subjects were selected according to their previously determined Lp(a)concentration. All volunteers before any study procedure will have to give written inform consent to a protocol previously approved for the Ethical Committees of our institutions.
Biochemical determinations: lipids: total cholesterol and triglycerides; lipoproteins: HDL-cholesterol, Lp(a); apolipoproteins: Apo A1 and apo B and safety biochemical parameters (glucose, uric acid, creatinine, liver and muscle enzymes will be measured at baseline and at the end of the two treatment periods (weeks 4 and 8).
An adverse experience questionnaire will be done in each visit. Genetic analysis: apo(a) genetic polymorphism responsible of the Lp(a) size variability will be analyzed by a PCR-based methodology (Lanktree et al. J Lipid Res 2009; 50: 768-72 ).
#Intervention
- DRUG : Niacin/Laropiprant
- 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >18 and < 80 years
* LDL cholesterol between 70 and 190 mg/dL
* Triglycerides < 500 mg/dL
* At least 2 Lp(a) determinations previous to the beginning of the study without differences >20% or > 20 mg/dL.
* No lipid lowering therapy or on stable doses in the last 3 months
Exclusion Criteria:
* Liver disease or liver enzymes >2 times higher than reference values
* Creatinine > 2 mg/dL
* Active peptic ulcer
* Clinical gout in the last year
* Uncontrolled diabetes (HbA1c >8%)
* Enrolment in other drug clinical trial in the previous 3 months.
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
|
NCT01321034
|
{
"brief_title": "Effect of Niacin in the Lipoprotein (a) Concentration",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: Niacin/Laropiprant"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01321034",
"official_title": "Effect of Niacin in the Lipoprotein (a) Concentration With Regard to Apolipoprotein (a) Size and Baseline Lipoprotein (a) Concentration.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-10",
"last_updated_that_met_qc_criteria": "2011-03-22",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-23",
"first_submitted": "2011-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to determine if restoring primary molars with SSCs would improve children's OBF.
Detailed Description
Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system. The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF has been widely used in dentistry to provide useful data for the evaluation of jaw muscle function and activity as well as effectiveness of prosthetic therapy.
Many indicators have been believed to assess the functional status of the masticatory system, such as body size, bite force, number of functional tooth units, and the occlusal contact area. Dental status formed with dental fillings, dentures, position and the number of teeth is an important factor in the value of the OBF.
Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that the overall tooth decay was not related to the strength of OBF. They suggested that the severity of tooth decay may be more important than the number of teeth exhibiting decay.
Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but restorable primary molars. A recent systematic review by Seale and Randall confirmed their previous work and reviews and appeared to continue to be supportive and in favor of SSCs.
SSCs has been blamed for premature contact related discomfort in the first few weeks after placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth will equilibrate over time and return to pretreatment levels in 15 to 30 days.
Several opinions have been reported by parents, children and dentists regarding the improved mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on primary molars on OBF have not yet been investigated
#Intervention
- DEVICE : Stainless Steel Crowns
- SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.
- Other Names :
- SSCs
|
#Eligibility Criteria:
Inclusion Criteria:- Caucasian
* Healthy child
* In the primary dentition stage
* Class I occlusion
* No facial asymmetry
* No cross bite
* Have caries in the eight primary molars indicating placement of SSCs, with no reported pain on biting and no previous restorations
* No gingival inflammation
* No para functional habits
Exclusion Criteria: did not meet the inclusion criteria stated above
*
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03254069
|
{
"brief_title": "Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children",
"conditions": [
"Dental Caries"
],
"interventions": [
"Device: Stainless Steel Crowns"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT03254069",
"official_title": "Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2011-11"
},
"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)": "2017-08-18",
"last_updated_that_met_qc_criteria": "2017-08-15",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-18",
"first_submitted": "2016-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.
Detailed Description
Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.
For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.
#Intervention
- OTHER : EOIP
- Ultrasound guided External oblique intercostal block will be performed bilaterally.
- OTHER : OSTAP
- Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI < 35 kg/m² Patients with ASA scores I and II
Exclusion Criteria:
* Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site
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
|
NCT06172465
|
{
"brief_title": "Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies",
"conditions": [
"Analgesia",
"Pain, Post Operative"
],
"interventions": [
"Other: OSTAP",
"Other: EOIP"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06172465",
"official_title": "Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-11-24",
"study_completion_date(actual)": "2024-11-25",
"study_start_date(actual)": "2024-01-05"
},
"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)": "2024-11-27",
"last_updated_that_met_qc_criteria": "2023-12-07",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-15",
"first_submitted": "2023-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety and efficacy of lenalidomide in combination with standard induction therapy (CHOEP- cyclophosphamide, doxorubicin \[doxorubicin hydrochloride\], etoposide, vincristine \[vincristine sulfate\] and prednisone) in patients with newly diagnosed stage II, III and IV peripheral T-cell lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (anaplastic lymphoma receptor tyrosine kinase \[ALK\] negative) (ALK positive if International Prognostic Index \[IPI\] 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma or hepatosplenic gamma delta T-cell lymphoma.
II. To establish the maximum tolerated dose of lenalidomide in combination with CHOEP chemotherapy. (Phase I) III. To assess the efficacy (complete response rate) of this combination. (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate overall response rate (complete response \[CR\] + partial response \[PR\]) of the combination of lenalidomide and CHOEP chemotherapy.
II. To evaluate the safety and tolerability of the regimen. III. To assess the 2 year progression free survival (PFS) and overall survival (OS) using this regimen.
OUTLINE: This is a phase I, dose-escalation study of lenalidomide, followed by a phase II study.
Patients receive cyclophosphamide intravenously (IV), doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone orally (PO) on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:
TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.
MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
#Intervention
- PROCEDURE : Autologous Hematopoietic Stem Cell Transplantation
- Undergo autologous stem cell transplant
- Other Names :
- Autologous Stem Cell Transplantation
- DRUG : Cyclophosphamide
- Given IV
- Other Names :
- (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
- DRUG : Doxorubicin Hydrochloride
- Given IV
- Other Names :
- 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
- DRUG : Etoposide
- Given IV
- Other Names :
- Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Lenalidomide
- Given PO
- Other Names :
- CC-5013, CC5013, CDC 501, Revlimid
- PROCEDURE : Peripheral Blood Stem Cell Transplantation
- Undergo peripheral blood stem cell transplant
- Other Names :
- PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
- DRUG : Prednisone
- Given PO
- Other Names :
- .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, SK-Prednisone
- DRUG : Vincristine Sulfate
- Given IV
- Other Names :
- Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed new diagnosis of stage II, III and IV peripheral T-cell non-Hodgkin's lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (ALK negative) (ALK positive if IPI 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma
* Pathology material: hematoxylin and eosin (H&E) stain and immunohistochemistry (IHC) slides or a representative formalin-fixed paraffin-embedded (FFPE) tissue block along with the pathology report from initial diagnosis, should be sent to be reviewed, and the diagnosis confirmed by Mayo Clinic department (retrospective diagnostic review: treatment may commence prior to the Mayo Clinic review)
* No prior therapy with the exception of prior radiation therapy and/or prednisone alone, at the discretion of the investigator based on current diagnosis and clinical condition; this prednisone treatment will not count toward the 6 cycles of treatment given in the study
* Expected survival duration of > 3 months
* Karnofsky performance status > 70
* Absolute neutrophil count (ANC) > 1000 cells/mm^3, unless cytopenias due to non-Hodgkin lymphoma (NHL) (i.e., bone marrow involvement or splenomegaly)
* Platelet count > 100,000/uL or > 75,000/uL if bone marrow (BM) involvement or splenomegaly
* Total bilirubin =< 1.5 x upper normal limit, or =< 3 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert's disease
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper normal limit (=< 5 x upper normal limit if documented hepatic involvement with lymphoma)
* Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min (Cockcroft-Gault)
* Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic range
* If currently not on anticoagulation medication, willing and able to take aspirin (81 or 325 mg) daily; if aspirin is contraindicated, the patient may be considered for the study if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
* Patients with measurable disease; patients with non-measurable but evaluable disease may be eligible after discussion with the principal investigator (PI); baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal positron emission tomography (PET)/computed tomography (CT) scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
* Patients with measurable disease must have at least one objective measurable disease parameter; a clearly defined, bi-dimensionally measurable defect or mass measuring at least 1.5 cm in diameter on the CT portion of a PET/CT or CT scan or magnetic resonance imaging (MRI) (if appropriate) will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy; skin lesions can be used as measurable disease provided bi-dimensional measurements are possible
* All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
* Women must not be pregnant or breast-feeding
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
* All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy
* Pregnancy testing is not required for post-menopausal or surgically sterilized women
* Male and female patients of reproductive potential must agree follow accepted birth control measures
* Patient must be able to adhere to the study visit schedule and other protocol requirements
* Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care as noted above; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
* No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
Exclusion Criteria:
* Pregnant or breast feeding females
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive ( i.e. hepatitis B core antibody positive; quantitative deoxyribonucleic acid [DNA] negative) are eligible with appropriate prophylaxis
* Major surgery within 2 weeks of study drug administration
* Prior malignancies within the past 3 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levels
* Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other than those specified in the inclusion criteria
* Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, or antiviral drugs
* Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
* Known hypersensitivity to thalidomide or lenalidomide
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
* Ejection fraction of < 45% by either multi gated acquisition scan (MUGA) or echocardiogram (ECHO)
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
|
NCT02561273
|
{
"brief_title": "Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma",
"conditions": [
"Anaplastic Large Cell Lymphoma, ALK-Negative",
"Anaplastic Large Cell Lymphoma, ALK-Positive",
"Hepatosplenic T-Cell Lymphoma",
"Peripheral T-Cell Lymphoma, Not Otherwise Specified",
"Stage II Angioimmunoblastic T-cell Lymphoma",
"Stage II Enteropathy-Associated T-Cell Lymphoma",
"Stage III Angioimmunoblastic T-cell Lymphoma",
"Stage III Enteropathy-Associated T-Cell Lymphoma",
"Stage IV Angioimmunoblastic T-cell Lymphoma",
"Stage IV Enteropathy-Associated T-Cell Lymphoma"
],
"interventions": [
"Procedure: Autologous Hematopoietic Stem Cell Transplantation",
"Drug: Doxorubicin Hydrochloride",
"Drug: Prednisone",
"Drug: Lenalidomide",
"Procedure: Peripheral Blood Stem Cell Transplantation",
"Drug: Vincristine Sulfate",
"Drug: Etoposide",
"Drug: Cyclophosphamide",
"Other: Laboratory Biomarker Analysis"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02561273",
"official_title": "A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-01",
"study_completion_date(actual)": "2020-11-01",
"study_start_date(actual)": "2015-09-28"
},
"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)": "2023-12-13",
"last_updated_that_met_qc_criteria": "2015-09-25",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-28",
"first_submitted": "2015-09-24",
"first_submitted_that_met_qc_criteria": "2021-05-24"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the incidence and status of urgent medical conditions. After defining the urgent situations, the investigators will evaluate the adequacy of the standard medical kits and trainings.
Detailed Description
In this study, the incidence and status of urgent medical conditions, the attitudes of health professionals who encounter such conditions, adequacy of Aerospace Medical Association (ASMA) suggested medical kits and training of cabin crew in data-received-company aircrafts and the demographic data of patients have been evaluated.
|
#Eligibility Criteria:
Inclusion Criteria:
* All passengers (no age limitations) needed urgent medical support during flights
Exclusion Criteria:
* Patients whom medical urgency records are insufficient
Sex :
ALL
Ages :
- Minimum Age : 2 Weeks
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02457455
|
{
"brief_title": "Urgent Medical and Surgical Conditions During Flights",
"conditions": [
"Syncope",
"Arrest",
"Vertigo",
"Pain",
"Chronic Obstructive Pulmonary Disease",
"Hypertension",
"CAD"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT02457455",
"official_title": "Inflight Emergencies During Eurasian Flights",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2014-10"
},
"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)": "2015-05-29",
"last_updated_that_met_qc_criteria": "2015-05-27",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-29",
"first_submitted": "2015-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
"The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."
Detailed Description
"Background: Studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias.
This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. Rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and should have a life expectancy of more than 18 months.
Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."
#Intervention
- DEVICE : ICD
|
#Eligibility Criteria:
Inclusion Criteria:
* indication for an ICD according to ACC/AHA guidelines
* ICD with rate response function implanted
* at least 5% rate response ventricular pacing during the one month screening phase
* signed informed patient consent'
Exclusion Criteria:
* rate responsive pacing contraindicated
* patient not able to perform 6 min walktest
* heart failure NYHA IV
* life expectancy below 18 months'
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
|
NCT00180427
|
{
"brief_title": "VERRARI - 'Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?'",
"conditions": [
"Ventricular Fibrillation"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT00180427",
"official_title": "VERRARI - 'Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?'",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-11",
"study_start_date(actual)": "2001-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-04-24",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-16",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to measure forces applied using standard surgical instruments at the skull base during resection of skull base lesions. This data will be useful for optimizing an active canula robot for assisting in skull base surgery. We hypothesize that through measurement of forces generated during routine endoscopic skull base surgery we will be able to optimize the canulas of an active canula robot for skull base surgery.
Detailed Description
At some time in their lives, 1 in 5 people will have a pituitary tumor, and 1 in 600 of these will have the tumor grow large enough (\>1 cm in diameter) that surgical resection is required. Traditionally, surgery to remove pituitary tumors or other tumors at the skull base requires transcranial or transfacial access. In these approaches, large traumatic, often disfiguring, openings must be created in the patient's forehead or cheek. Endonasal skull base surgery reduces invasiveness resulting in less trauma, fewer complications, and shorter surgical time. However, despite the compelling advantages for the patient, only a small percentage of skull base surgeries are done endonasally. While exact statistics are not available, the current best estimate in the literature is that less than 50% and most likely less than 20% of these tumors are addressed by endonasal surgery.
The endonasal approach is underemployed despite its demonstrated benefits to the patient because existing surgical instruments have limited dexterity and approach angles, and simultaneously manipulating several of them through a nostril while performing complex surgical procedures is so technically challenging that only a small number of expert surgeons can accomplish it. Even for these experts, mortality rates are non-negligible (0.9%), and there remain contraindications to the endonasal approach, including occlusion of the surgical site by delicate and critical neurovascular structures (e.g. carotid arteries, optic nerves), inability to fully reconstruct the dura due to lack of surgical tool dexterity, and long surgical duration. All of these contraindications are directly related to limitations in instrument dexterity and visualization, which motivates the development of a robotic system for endonasal skull base surgery. Such a robot can potentially increase surgical dexterity and reduce the technical complexity of the procedure for surgeons, thereby increasing the percentage of patient who benefit from the endonasal technique.
While many robotic systems have been developed for intravascular interventions as well as natural orifice surgery though other orifices, comparatively few systems have been targeted at endonasal surgery. This is likely due to the smaller size of the nasal cavity and nostril compared to other natural orifices.
For endonasal robots, the limited space available in the nostril opening, combined with the need to work dexterously within the cavities in the head, implies that instrument shafts must be small in diameter while enabling dexterous motions of instrument tips. A recently invented robot design that matches these characteristics is the concentric tube robot concept, which is also known as by the name active cannula.
A robot suitable for endonasal surgery is being developed (see reference #3), however in order to optimize this robotic system, intraoperative data must be obtained to determine how the robot interacts with the patient's tissues. The aim of this study is to modify a traditional tool used in the operating room to allow determination of forces at the skull base on both hard and soft tissues. This surgical curette will be used in the standard fashion during endonasal skull base surgery, however will provide valuable information.
The modified curette will consist of two segments joined by a Nano17 6-axis force sensor. (Image 1) The force sensor is integrated into the shaft of the instrument (a standard neurosurgical ring curette) and insulated from the shaft with two polyetherimide (also known as ULTEM) disks so that no current can be transmitted from the force sensor to the curette. The sensor is held to the shaft by medical grade adhesive and set screws.
The patients will be recruited from the PIs clinical practice. Informed consent will be obtained. At the appropriate time during surgery this curette will be used to collect force date. This force transducer operates at 5V (4.8-9V range). These transducers are commonly used in medical and dental research (see reference #5).
No additional operating room or anesthesia time will be required.
#Intervention
- DEVICE : Use of force sensing surgical curette
- Use of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery.
- PROCEDURE : Removal of pituitary tumor using modified curette
|
#Eligibility Criteria:
Inclusion criteria:
* Any male or female patient 18 <= age <= 75 years undergoing endonasal skull base surgery for a skull base lesion.
* Competent in decision making process and able to sign a written informed consent form.
Exclusion Criteria:
*Any patient not able to give written informed consent.
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
|
NCT01705821
|
{
"brief_title": "Forces During Skull Base Surgery",
"conditions": [
"Skull Base",
"Pituitary",
"Robotics",
"Endonasal Surgery",
"Sinus Surgery"
],
"interventions": [
"Device: Use of force sensing surgical curette",
"Procedure: Removal of pituitary tumor using modified curette"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01705821",
"official_title": "Measuring Forces Applied During Skull Base Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2012-10"
},
"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)": "2014-12-09",
"last_updated_that_met_qc_criteria": "2012-10-11",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-12",
"first_submitted": "2012-10-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This multicenter randomized (block randomization) controlled parallel arm pilot study comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid naïve or opioid experienced will be enrolled into the study.
Detailed Description
The Nurse Pain Educator arm shall have two phases: a Pre-Teaching Phase and a Teaching/Knowledge Maintenance Phase. During the Pre-Teaching Phase, all subjects who are enrolled will complete different baseline assessments and will be prescribed an opioid. Subjects will then enter the Teaching/Knowledge Maintenance Phase. Subject enrolled into the Nurse Pain Educator arm will be educated on different opioid pain management topics with a focus on safe and appropriate use and consumption of opioid analgesics. Subjects will meet monthly with the Nurse Educator for up to 5 months for reinforcement of their training and to assess their use of their medication, their quality of life and their physical and mental well-being.
Subjects who are enrolled into the study arm with no Nurse Pain Educator will be monitored every month to assess their use of their medication, their quality of life and their physical and mental well-being. No intervention will be conducted with these subjects beyond that of standard of care at the facility. Subjects will be evaluated monthly but primary differences in outcomes will compare baseline to 6 months.
#Intervention
- OTHER : Opioid Education
|
#Eligibility Criteria:
Inclusion Criteria:
* Ability to read, understand, and provide written informed consent
* Male or Female patients >= 18 years
* Diagnosed with non-cancer pain for >3 months
* Ability to meet study requirements (i.e., can attend monthly visits, able to complete questionnaires, etc.)
* Prescribed an oral opioid that will last duration of the study period
* Provide a completed Opioid Patient Prescriber Agreement
Exclusion Criteria:
* Diagnosed with chronic cancer pain
* Personal or family history of alcohol or drug abuse in the past 5 years
* Personal or family history of major mental illness
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
|
NCT03044522
|
{
"brief_title": "Use of a Nurse Pain Educator for Patients With Chronic Pain",
"conditions": [
"Chronic Pain",
"Opioid Use",
"Nurse's Role"
],
"interventions": [
"Other: Opioid Education"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03044522",
"official_title": "A Multicenter Study Comparing the Patient Outcomes Associated With Use of a Nurse Pain Educator for Patients With Chronic Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-21",
"study_completion_date(actual)": "2017-11-21",
"study_start_date(actual)": "2016-11-14"
},
"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)": "2017-12-11",
"last_updated_that_met_qc_criteria": "2017-02-02",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-07",
"first_submitted": "2017-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.
#Intervention
- DRUG : Bosutinib
- Once daily oral dose of 200 mg of bosutinib
- DRUG : Bosutinib
- Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
- DRUG : Placebo
- Once daily oral dose of placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females, 18 <= age <= 50 old at the time of consent.
* Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
* Total kidney volume >= 750 cc, as measured by centrally evaluated MRI.
Exclusion Criteria:
* eGFR < 60 mL/min/1.73m2.
* Uncontrolled hypertension (defined as systolic blood pressure >=140 or diastolic blood pressure >=90 mm Hg).
* Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.
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
|
NCT01233869
|
{
"brief_title": "Bosutinib For Autosomal Dominant Polycystic Kidney Disease",
"conditions": [
"Polycystic Kidney, Autosomal Dominant"
],
"interventions": [
"Drug: Placebo",
"Drug: Bosutinib"
],
"location_countries": [
"Lithuania",
"Slovakia",
"Sweden",
"United States",
"Poland",
"United Kingdom",
"Romania",
"Canada",
"Spain",
"Australia",
"Moldova, Republic of",
"Switzerland",
"Hungary",
"Italy",
"Turkey",
"Czech Republic",
"Korea, Republic of"
],
"nct_id": "NCT01233869",
"official_title": "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-07",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2010-12"
},
"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)": "2016-03-11",
"last_updated_that_met_qc_criteria": "2010-11-02",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-03",
"first_submitted": "2010-10-28",
"first_submitted_that_met_qc_criteria": "2015-09-29"
}
}
}
|
#Study Description
Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
#Intervention
- DRUG : Thalidomide
- Per os thalidomide
- DRUG : Biphosphonates
- Biphosphonates
|
#Eligibility Criteria:
Inclusion Criteria:
* de novo myeloma
* according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
* patients from 18 <= age <= 65 old
* beta2microglobulin < 3 mg/l or del13 absent
* signed informed consent
* eligible for transplantation
Exclusion Criteria:
* peripheral neurological toxicities
* uncontrolled or severe cardiovascular disease
* other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
* patient who received biphosphonate during the last 60 days
* renal failure definited as creatinine > 150 µmol/l
* patient with obvious vascular cerebral medical history
* liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
* respiratory dysfunction
* HIV +
* Patient who refused to use an acceptable barrier method for contraception
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
|
NCT00222053
|
{
"brief_title": "IFM 99-02 Thalidomide in Myeloma",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: Biphosphonates",
"Drug: Thalidomide"
],
"location_countries": [
"France"
],
"nct_id": "NCT00222053",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2000-04"
},
"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)": "2010-04-02",
"last_updated_that_met_qc_criteria": "2005-09-15",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.
Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.
#Intervention
- DRUG : Diclofenac sodium gel 1%
- Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
- DRUG : Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
- Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
- DRUG : Placebo gel
- Vehicle Gel 4 gm, 4 times a day for 4 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
* Evidence of OA with Kellgren-Lawrence grade 1 <= age <= 3 disease.
* After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
* After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of >= 9 immediately prior to randomization.
* Able to tolerate rescue medication with acetaminophen
* Subjects who can read and understand WOMAC pain sub scale
Exclusion Criteria:
* Pregnancy, lactation
* OA of Kellgren-Lawrence grade 4
* OA pain in the contralateral knee requiring medication (OTC or prescription)
* History of OA of either Hip or Hands
* History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
* History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
* History of Drugs or Alcohol abuse within the previous year
* Symptomatic peripheral vascular disease of the study leg
* Any musculoskeletal condition
* Skin disease at the application site
* Active asthma requiring periodic treatment with systemic steroids
* Known history of positive HIV, hepatitis C virus, or HBsAg
* Uncontrolled hypertension
* History of myocardial infarction, thrombotic events, stroke etc.
* Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03172780
|
{
"brief_title": "A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee'",
"conditions": [
"Osteoarthritis, Knee"
],
"interventions": [
"Drug: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%",
"Drug: Placebo gel",
"Drug: Diclofenac sodium gel 1%"
],
"location_countries": [
"India"
],
"nct_id": "NCT03172780",
"official_title": "A Randomized, Double Blind, Three-arm, Parallel, Placebocontrolled, Clinical Study to Evaluate the Bioequivalence Using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc.) in Patients With Osteoarthritis (OA) of the Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-05",
"study_completion_date(actual)": "2017-12-05",
"study_start_date(actual)": "2017-05-24"
},
"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)": "2022-03-03",
"last_updated_that_met_qc_criteria": "2017-05-30",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-01",
"first_submitted": "2017-05-30",
"first_submitted_that_met_qc_criteria": "2021-03-25"
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
* Various parameters of the metabolism and turnover in plasma of different lipoproteins
* Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
* Lipoprotein particle size profile
* PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
Detailed Description
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.
#Intervention
- DRUG : alirocumab
- Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous
- Other Names :
- SAR236553, REGN727, Praluent
- DRUG : Placebo
- Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous
|
#Eligibility Criteria:
Inclusion criteria:
Generally healthy; LDL-C level in serum or plasma >= 100 mg/dL and < 190 mg/dL at Screening.
Exclusion criteria:
* LDL-C >= 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
* Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
|
NCT01959971
|
{
"brief_title": "Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: alirocumab",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01959971",
"official_title": "A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2013-12"
},
"study_design": {
"allocation": null,
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-02",
"last_updated_that_met_qc_criteria": "2013-10-09",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-10",
"first_submitted": "2013-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression.
Detailed Description
Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors.
Participants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam.
#Intervention
- DRUG : Bupropion
- Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
- Other Names :
- Brand name of bupropion used in the trial: Wellbutrin SR
- DRUG : Placebo
- Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
|
#Eligibility Criteria:
Inclusion Criteria:
* Available for at least 9 months, or the duration of the study
* Willing to complete HIV testing and counseling
* History of HIV testing and counseling
* At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry
* Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Exclusion Criteria:
* HIV infected
* Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship
* Currently enrolled in another study involving repeated HIV testing and counseling
* Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry
* Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason
* Severe depression or at suicidal risk
* No evidence or prior history of depression
* Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants
* Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI.
* History of seizures
* History or current symptoms of bipolar disorder
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00285584
|
{
"brief_title": "Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)",
"conditions": [
"HIV Infections",
"Depression"
],
"interventions": [
"Drug: Placebo",
"Drug: Bupropion"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00285584",
"official_title": "Drug Abuse, Depression and Responses to HIV Counseling",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-03",
"study_completion_date(actual)": "2004-09",
"study_start_date(actual)": "2002-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-12",
"last_updated_that_met_qc_criteria": "2006-01-31",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-02",
"first_submitted": "2006-01-31",
"first_submitted_that_met_qc_criteria": "2012-05-17"
}
}
}
|
#Study Description
Brief Summary
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE).
EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are:
* To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE
* To describe the adverse events encountered
* To describe the proportion of clinical and technical success
* To assess its impact on the patients' quality of life.
* To assess the evolution of the oral intake during the first month after the procedure
Detailed Description
DESIGN
Prospective multicenter case series
AIMS
Primary aim To describe the proportions of technical and clinical success. To describe different variants in the nasobiliary drain assissted EUS-GE technique, offering a detailed step by step description of the procedure performance by different endoscopists
Secondary aims:
To describe the adverse encountered, their severity according to ASGE standards and their management.
To describe the time elapsed between the procedure and the initial oral intake.
To describe the evolution of the oral intake during the first month after the procedure To assess the impact of the operators experience on procedure times, adverse events and technical issues.
To assess the impact of the procedure on the quality of life of the participating patients.
STUDY POPULATION
All consecutive patients over 18 years of age receiving a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction requiring endoscopic treatment, a distal bowel obstruction, ascites grade 2 or superior, uncorrectable coagulation disorders (INR\>1,5) or severe thrombocytopenia (\<50000 platelets/mm3). or unable to understand the questionnaires will be excluded.
INTERVENTION
At inclusion
Informed consent will be obtained. A clinical interview and a physical examination will be performed. TheEuropean Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales will be assessed in a telephone interview.
Endoscopic procedure
All procedures will be performed under sedation. An assistant endoscopist or research nurse will retrieve all data regarding the procedure. Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
Post procedure: Oral liquid intake can be restarted 4h after the procedure in patients presenting no signs or symptoms suggesting any adverse event. Pacients with an adequate tolerance might be discharged.
Follow-up
Clinical telephone interviews by an experienced research nurse will be held via telephone calls 1 day, 7 days and 30 days after the procedure. Oral intake and adverse events will be assessed every visit. Thirty days after the procedure a second evaluation of the EORTC-QLQ-C30 will be performed.
STATISTICAL ANALYSIS
Categorical variables were reported as percentages. Normally distributed continuous variables were reported as the mean with the standard deviation values. Non-normally distributed continuous variables were reported as the median and interquartile range. The EORTC QLQ-C30 descriptive analysis was performed with a specifically programmed Stata command (10). Variables regarding the procedure step by step analysis will only undergo a descriptive analysis. Differences between the different outcomes of the EORTC-QLQ-C30 will be assessed using linear mixed models with fixed effects for baseline values, and interaction with oncological treatment. The statistical analysis will be performed using the Stata package (StataCorp. 2013, College Station, Texas).
#Intervention
- DEVICE : EUS-guided gastroenterostomy
- Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
- Other Names :
- AXIOS™ Stent and Electrocautery Enhanced Delivery System (Boston Scientific, Mass)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients > 18 years
* unresectable malignant gastric outlet obstruction
* Undergoing placement of nasobiliary drain assisted EUS-GE
Exclusion Criteria:
* Previous gastroduodenal surgery
* Previous endoscopic or surgical treatment for gastric outlet obstruction
* Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment
* Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure
* Unable to understand the questionnaires
* Distal bowel obstruction
* Ascites grade 2 or superior
* Uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3).
* Active, symptomatic SARS-CoV-2 infection
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
|
NCT04660695
|
{
"brief_title": "Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction",
"conditions": [
"Gastric Outlet Obstruction",
"Gastric Cancer",
"Pancreatic Cancer"
],
"interventions": [
"Device: EUS-guided gastroenterostomy"
],
"location_countries": [
"India",
"Spain"
],
"nct_id": "NCT04660695",
"official_title": "Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar",
"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)": "2019-08-15"
},
"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)": "2021-05-14",
"last_updated_that_met_qc_criteria": "2020-12-08",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-09",
"first_submitted": "2020-11-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subjects will be randomly assigned to one of three doses of study medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or placebo) followed by an optional open-label treatment period where subjects will be inpatient or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.
Detailed Description
This is a Phase 3, two-part, multicenter study to evaluate the dose-response, efficacy, and safety of lofexidine in alleviation of symptoms in subjects undergoing total and abrupt withdrawal from short-acting opioids. Any subject dependent on short-acting opioids (the primary projected indication for lofexidine) about to undergo opioid withdrawal will be eligible. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during a screening period, lasting up to 7 days.
The first part of the study will use an inpatient, randomized, double-blind, and placebo-controlled design (Days 1-7) followed by a second part, an open-label continuation treatment (Days 8-14). A total of 600 subjects will be randomized to receive lofexidine 2.4 mg total daily dose (0.6 mg QID), lofexidine 3.2 mg total daily dose (0.8 mg QID), or matching placebo in a 3:3:2 ratio (225:225:150) for 7 days (i.e., during the most intense stage of withdrawal). During the second part of the study (Days 8-14), all subjects, regardless of their treatment assignment (which will remain double-blinded), who successfully meet the definition for 'completer' based on Days 1-7 (i.e., receives at least one dose of study medication on Day 7 and completes the 3.5-hour post-dose SOWS-Gossop assessment on Day 7), will be eligible to receive open-label, variable dose lofexidine treatment (as determined by the Site Investigator, but not to exceed 3.2 mg/day) for up to an additional 7 days in either an inpatient or outpatient setting depending on the wishes of the investigator and the subject. No subject will receive lofexidine for more than 14 days total from the onset of abstinence. There will be no initial dose run-up and no mandated terminal dose taper.
Efficacy and safety assessments will be made daily throughout the study. Safety will be assessed by evaluation of adverse event, clinical labs, electrocardiograms (with special attention to QTc), vital signs, physical exam data, and the Columbia-Suicide Severity Rating Scale. Efficacy will be evaluated daily by subject- and observer-completed scales including the Short Opiate Withdrawal Scale of Gossop (SOWS-G)(the primary outcome measure is SOWS-G score area under the curve for Days 1-7), the Clinical Opiate Withdrawal Scales (COWS), Objective Opiate Withdrawal Scale (OOWS-Handelsman), the Visual Analog Scale for Efficacy (VAS-E), and the Modified Clinical Global Impressions scales for efficacy and side effects. Efficacy will also be evaluated by study retention, completion rates, concomitant medication use, incidence of withdrawal-related Adverse Events (AEs), and subject treatment status 30 days post last dose of study medication. Qualitative urine drug screening will be done every other day to monitor for contraband (inpatient setting) or illicit (outpatient setting) drug use. Upon a subject's exit from the study, Study Discontinuation/End of Study assessments will be done.
During the study, study drug compliance will be documented in the source daily. During the first part of the study (Days 1-7), subjects will be inpatient and each dose of study medication will be administered by study site personnel and recorded in the source. Study medication will be dosed QID at 8 AM, 1 PM, 6 PM and 11 PM. During the second part of the study (Days 8-14), subjects who remain inpatient will be administered each dose of study medication by study site personnel and dosing will be captured in the source. Subjects who complete the second part of the study on an outpatient basis will return to the clinic daily for study assessments. During the open-label period, subjects will be dispensed 1-2 days worth of study drug, as needed to allow for flexibility in scheduling daily visits, to get them through until they are supposed to return the following day for additional study assessments and dosing.
Study medication will be held if vital signs meet any of the following criteria: Resting (sitting or recumbent, if required, for treatment of an adverse event): Systolic blood pressure \<90 mmHg and \>20% below screen value; Diastolic blood pressure \<50 mmHg and \>20% below screen value; Heart rate \<50 bpm and \>20% below screen value; and Symptoms of hypotension and/or bradycardia (e.g., lightheadedness, dizziness, syncope).Orthostatic (after standing for 3 minutes): Systolic blood pressure diastolic blood pressure, or pulse \>25% below recumbent values.
A subject will be discontinued from the study if any of the following criteria are met: Systolic blood pressure \<70 mmHg and \>20% below screen value; Diastolic blood pressure \<40 mmHg and \>20% below screen value; Heart rate \<40 bpm and \>20% below screen value; QTc \>500 msec or \>25% above screen value for both males and females; Syncope; Subject misses more than 2 doses in 24 hours during Days 1-7 prior to meeting 'completer' criteria (i.e., receives at least one dose of study medication on Day 7 and completed the 3.5-hour post-dose SOWS-Gossop assessments on Day 7); Subject misses a total of 6 doses during Days 1-7 prior to meeting 'completer' criteria (i.e., receives at least one dose of study medication on Day 7 and completed the 3.5-hour post-dose SOWS-Gossop assessments on Day 7); Concomitant medication use (other than alumina, magnesia, and simethicone) for intolerable nausea and emesis.
Subjects should be discontinued from the study for any of the reasons listed below, and the event should be recorded as an Adverse Event (AE) and the subject followed until medically stabilized to the satisfaction of the attending physician: New onset of clinically significant abnormal ECG (e.g., second or third degree heart block or uncontrolled arrhythmia, prolonged QTcF interval); Persistent symptomatic hypotension (e.g., hypotension not responding to bed rest or fluids); Single occurrence of symptomatic bradycardia (as assessed by the Investigator, regardless of blood pressure) associated with chest pain, shortness of breath, or decreased level of consciousness; Persistent hypertension - blood pressure ≥185/110 mmHg recorded on 3 separate occasions taken at least 5 minutes apart AND within a 1-hour time period. If all 3 readings are ≥185/110 mmHg (either systolic ≥185 mmHg or diastolic ≥110 mmHg) the subject must be terminated; Medical Intervention for Cardiovascular Event: Any medical intervention (nonmedication or medication inclusive) used for the treatment of any cardiovascular event, with the exception of a positional intervention in subjects displaying hypotension; Any other clinically significant cardiovascular signs or symptoms that would place the subject at risk.
#Intervention
- DRUG : Lofexidine HCl
- Lofexidine HCl tablets will be available in 0.2 mg tablets. Lofexidine will be provided in total daily doses as indicated during the double blind portion of the study.
- DRUG : Placebo
- Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
- DRUG : Open Label Lofexidine HCL
- Lofexidine HCl tablets will are available in 0.2 mg tablets. During the optional open-label portion of the study, Lofexidine HCl can be prescribed at the discretion of the Investigator but total daily dose will not exceed 3.2 mg.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female at least 18 years.
* Currently dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.) [17, 18], on any opioid with a half-life similar to heroin or morphine, including Vicodin®, Lortab®, Lorcet®, Percocet®, Percodan®, Tylox®, or Hydrocodone (by any route of administration), or oxycodone (oxycodone and oxycodone time-released formulation when crushed and snorted, injected or swallowed after chewing).
* Seeking treatment for opioid dependence.
* Score of >=2 on the Objective Opiate Withdrawal Scale (OOWS-Handelsman) at Baseline.
* Reported use of heroin, morphine, or any opioid with a half-life similar to heroin or morphine for at least 21 of the past 30 days.
* Urine toxicology screen positive for opioids but negative for methadone and buprenorphine.
* Females of childbearing potential must agree to using birth control methods and must have had documented proof.
* Able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, and pass the study consent quiz with 100% accuracy (if necessary, quiz may be administered more than one time).
Exclusion Criteria:
* Female subject who is pregnant or lactating.
* Self-reported use of methadone or buprenorphine in the past 14 days.
* Serious medical illnesses including, but not limited to: seizures, pancreatic disease, liver disease, exposure to a hepatitis virus, and positive hepatitis results.
* Psychiatric disorder, based on the M.I.N.I., including but not limited to dementia or any disorder that, in the opinion of the study physician requires ongoing treatment that would make study participation unsafe or which would make treatment compliance difficult.
* Self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks.
* Abnormal cardiovascular exam at screening and before randomization, including any of the following: clinically significant abnormal electrocardiogram (ECG) (e.g., second or third degree heart block, uncontrolled arrhythmia, or QTcF interval greater than 450 msec for males and greater than 470 msec for females); heart rate less than 55 bpm or symptomatic bradycardia; systolic blood pressure (SBP) less than 95 mmHg or symptomatic hypotension; diastolic blood pressure (DBP) less than 65 mmHg; blood pressure (BP) greater than 155/95 mmHg; and prior history of myocardial infarction.
* Clinically significant abnormal laboratory values.
* Requiring any of the following medications currently or within the past 4 weeks: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics (excluding those listed in inclusion criterion #2 above), anticonvulsants, antihypertensives, antiarrhythmics, antiretroviral, and cholesterol lowering medications. Nicotine replacement therapy (patch, inhaler, gum, or nasal spray) will be allowed for nicotine-dependent subjects. Note: Use of a short-acting benzodiazepine (e.g., oxazepam) for insomnia during Days 8 14 will not disqualify a subject.
* Currently dependent (based on the M.I.N.I.) on any psychoactive substance (other than that listed in inclusion criterion #2, caffeine or nicotine) that requires detoxification.
* Donated blood within the last 8 weeks.
* Participated in an investigational drug study within the past 3 months.
* Has 'poor' veins that even a single venipuncture cannot be obtained during screening.
* Active tuberculosis (positive tuberculin test and/or confirmatory diagnostic chest x-ray).
* Active syphilis.
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
|
NCT01863186
|
{
"brief_title": "Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal",
"conditions": [
"Opioid Dependence",
"Acute Opioid Withdrawal Syndrome"
],
"interventions": [
"Drug: Placebo",
"Drug: Lofexidine HCl",
"Drug: Open Label Lofexidine HCL"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01863186",
"official_title": "Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Dose-Response Study of Lofexidine for Treatment of Opioid Withdrawal (Days 1-7) Followed by Open-Label, Variable Dose Lofexidine Treatment (Days 8-14)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-06"
},
"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)": "2022-03-22",
"last_updated_that_met_qc_criteria": "2013-05-24",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-27",
"first_submitted": "2013-05-22",
"first_submitted_that_met_qc_criteria": "2021-01-13"
}
}
}
|
#Study Description
Brief Summary
The primary aim of this study is to assess the relationship between obstructive sleep apnoea (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D.
The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship between OSA and diabetic-related complications if such a relationship is found.
Detailed Description
Obstructive sleep apnoea (OSA) has been reported to be very common in patient with type 2 diabetes (T2D), and this relation is expected as both conditions share obesity as a common risk factor. Despite that several articles have stated that OSA is an independent risk factor for abnormal glucose metabolism, hypertension, and cardiovascular diseases.
In contrast, patients with type 1 diabetes (T1D) are leaner and younger than patients with T2D, so it was expected that OSA might be less common in patients with T1D. However, few studies have reported the prevalence of OSA in T1D with a range between 8 and 46%. The relationship between OSA and diabetes-related vascular disease is poorly explored in patients with T1D. This suggests a mechanism other than obesity may be responsible for OSA in patients with T1D. Therefore, the investigators hypothesized that (1) OSA is related to CAN rather than obesity in patients with T1D. (2) OSA is common in patients with T1D. (3) OSA is associated with worse metabolic profile and microvascular complications in T1D. (4) Oxidative and nitrosative stress are possible mechanisms relating OSA to T1D complication.
|
#Eligibility Criteria:
Inclusion Criteria:
* T1DM patient aged 18 and above, who was diagnosed more than 4 years ago.
* Able to give informed consent.
* Has sufficient proficiency in English to verbally answer interview questions.
Exclusion Criteria:
* Past medical history of severe respiratory disorders including treated OSA.
* Patients using oxygen supplements.
* Patients with end-stage renal disease receiving dialysis.
* Pregnancy.
* Dementia.
* End stage diseases with life expectancy below 6 months.
* Patients with implantable devices
* Patients with known atrial fibrillation
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
|
NCT03481361
|
{
"brief_title": "Obstructive Sleep Apnoea in Patients With Type 1 Diabetes",
"conditions": [
"Type 1 Diabetes",
"Obstructive Sleep Apnoea"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03481361",
"official_title": "Obstructive Sleep Apnoea (OSA) in Patients With Type 1 Diabetes (T1D): A Cross-Sectional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-27",
"study_completion_date(actual)": "2019-06-27",
"study_start_date(actual)": "2018-02-14"
},
"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)": "2020-09-07",
"last_updated_that_met_qc_criteria": "2018-03-21",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-29",
"first_submitted": "2018-03-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this research project is to study how seizure-like activity affects the blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can change memory and thinking ability, as happens in Alzheimer's disease. The investigators are using a study drug called Levetiracetam, which helps control seizure-like activity to see if it can help change the abnormal blood flow in the brain that is seen in some people with Alzheimer's disease.
Detailed Description
Subjects will make four separate visits to BIDMC. Subject will come to the Clinical Research Center. All of the visits will take around 5 hours apiece.
If subjects agree to be in this study, subjects will be asked to read and sign the consent form. After subjects sign the consent form, the following things will happen:
1. Screening Procedures: Screening procedures are tests and procedures that will be done to determine if subjects are eligible to take part in the research study. For this research study, the screening procedures include:
* A thorough medical history. Investigators will ask if subjects have any medical problems. Investigators will ask about subjects Alzheimer's disease and if they have had any seizures.
* A physical examination. Investigators will take your blood pressure and your heart rate. They will examine your heart and lungs and take your height and weight
* Investigators will also assess the subject's nervous system. Investigators will examine subject's speech, memory, strength, coordination, and reflexes.
* Investigators will ask you to take some paper and pencil tests. This will help us to understand your memory and mood
* Subjects will have a blood test to check how your kidneys are functioning.
Subjects may have already had some of these tests done by their doctor when they were diagnosed with Alzheimer's disease.
The information we learned will help to decide whether subjects could join the study. Investigators will explain the reason if they decide subjects should not join the study. Our decision does NOT mean that subjects have a health problem or disorder .
2. Randomization Procedures: Investigators will meet with one of the study doctors if subjects continue in the study. The study doctor will explain to subjects when they are expected to come to the research center for study testing or to take the study drug. Subjects will come to the BIDMC Clinical Research Center for three visits. These visits will occur within one month.
All study participants will receive the same study drugs over the three (3) visits.
* Subjects will receive levetiracetam, the study drug, in a low dose, 2.5 milligrams for each kilogram of body weight, at one visit.
* Subjects will receive levetiracetam, the study drug, in a high dose, 7.5 milligrams for each kilogram of body weight, at one visit.
* Subjects will receive a placebo at one visit.
A placebo is an inactive injection that looks like the study drug, but a placebo contains no active medication. In this study, the placebo is a saline (sterile salt water) injection.
Sometimes study results are truly due to the study medication. Sometimes the study results are not due to the study medication. Investigators are using a placebo to help us understand the reason for the results in this study.
The order of the above visits will not be the same for all study participants. There are six different orders to receive the study drugs. For example, subjects could receive the placebo at the first visit, the high dose of levetiracetam at the second visit, and the low dose of levetiracetam at the third visit. Another example is that subjects could receive the low dose at the first visit, the placebo at the second visit, and the high dose at the third visit.
Deciding the order in which you get the study drugs will be done by to a method called 'randomization.' Randomization means that a computer will assign patients to study drugs in a random manner, like flipping a coin. Another way to say randomization is 'by chance.' When you flip a coin, you get heads or tails by chance. The chance of getting any dose of study drug or placebo is about equal. After the randomization, Subjects will be assigned to get one study drug or placebo at each visit. Subjects will not be able to choose which study drug you will get at each visit.
Subjects will not know which study drug dose or placebo will be given at a visit. The study doctor will not know which study drug dose or placebo will be given at a visit. The study doctor can find out this information quickly if there is an emergency.
3. Research Procedures: Subjects will come to the BIDMC Clinical Research Center three times if they continue in this study. A member of the study team will meet subjects when they arrive. Subjects will first have an intravenous catheter (also called an IV) put into a vein. A nurse will check blood pressure and heart rate. Subjects will have a brief physical exam and a nervous system exam by a doctor
Subjects will then have an electroencephalogram (EEG). An EEG gives investigators information about the nervous system - specifically the brain. Subjects will have their scalp cleaned with alcohol and small discs - called electrodes - placed on the scalp using gel. Then the head will be will be wrapped with gauze to. keep the discs from moving. The discs will be attached by wires to an EEG machine. The EEG machine will be at the bedside and will give investigators information about the electrical activity in the brain. Subjects will need to lie quietly with eyes closed during the one hour that the EEG machine is attached. Investigators will clean the gel from hair and skin when the EEG is over.
Investigators will give subjects either levetiracetam -- the study drug -- or placebo while subjects are having EEG. Investigators will give subjects the study drug or placebo through the intravenous catheter ('IV') in the arm. This will take around 20 to 30 minutes. The subjects nurse will take the subject's blood pressure and heart rate two times while the study drug is being given to the subject and again after it is finished. The subject will note any side effects they have during this time and after.
Subjects will then review what will happen during the MRI scan with the Investigator. The MRI study will be conducted at the Magnetic Resonance Imaging Center of the Department of Radiology at the Beth Israel Deaconess Medical Center.
The MRI is a method of taking pictures of the brain and of the blood flow in the brain, using a large magnet and radio signals. Subjects will be asked to lie down on a platform that can be slid into the magnet. An MRI imaging coil, which is made from special wires that are covered in plastic, will be placed around the head. Foam pads will be placed around the head to limit head movement during the scan. During the scan, subjects will be asked to lie still on their back for about 45 to 60 minutes. They will hear a loud knocking or hammering noise while the MRI is taking pictures, but the process itself will be painless. They will be given disposable earplugs to use to help lessen the noise. During the procedure, subjects will be in constant contact with the MRI technician through an intercom. If at any time during the scan you feel too uncomfortable to continue, no matter what the reason, the study will be immediately stopped and subjects will be removed from the magnet (MRI Scanner).
Subjects will return to the Clinical Research Center after the MRI. They will take a few pencil-and-paper tests for about one hour. These tests will tell the investigator about memory and mood. They will also learn about your attention skills. Investigators will also learn about the subjects= language skills and 'handedness' (a tendency to favor right or left hand).
As the medication (levetiracetam) may make the subject drowsy, they will not be able to drive. Someone will need to accompany them to and from the hospital for the three study visits.
The second and third study visits will have the same sequence of events.
SUMMARIES
Here is a summary of the Screening Visit
Screening visit / informed consent Review your medical history. Brief physical and neurological exam. Paper and pencil tests. Blood drawn to check the functioning of kidneys. Review and sign the informed consent form.
Here are summaries of the three Study Visits
Visit One
:
Vital signs. 2 minutes Brief physical and neurological exam. 10 minutes An intravenous catheter placed in your arm. 5 minutes EEG. 60 minutes Intravenous dose of the medication, levetiracetam, or placebo. 20 minutes MRI scan. 60 minutes Paper and pencil tests. 60 minutes
Study Visit Two: (This visit will occur one to two (1-2 )weeks after Study Visit One)
Vital signs. 2 minutes Brief physical and neurological exam. 10 minutes Intravenous catheter placed in your arm. 5 minutes EEG. 60 minutes Intravenous dose of the medication, levetiracetam, or placebo. 20 minutes MRI scan. 60 minutes Paper and pencil tests. 60 minutes
Study Visit Three: (This visit will occur one to two (1-2 )weeks after Study Visit Two)
Vital signs. 2 minutes Physical and neurological exam. 10 minutes Intravenous catheter placed in your arm. 5 minutes EEG. 60 minutes Intravenous dose of the medication, levetiracetam, or placebo. 20 minutes MRI scan. 60 minutes Paper and pencil tests. 60 minutes
Each visit will take a total of approximately 5 hours. This includes the time for the EEG, MRI imaging and neuropsychological tests. Subjects will be allowed time to rest between activities on a bed if they become tired. The CRC staff will serve lunch.
4. Monitoring/Follow-Up Procedures. Procedures performed to evaluate the effectiveness and safety of the research procedures are called 'monitoring' or 'follow-up' procedures. Subject follow-up procedure will be a phone call from the study doctor one week after the third visit. They will ask if any side effects from the study or study medication occurred
Timing: If subjects are enrolled into the study following the initial screening visit, each of the three study visits will be separated by 2-3 week intervals. Therefore, the entire study will last approximately 6-9 weeks.
#Intervention
- DRUG : Low/High/Placebo Dose Keppra (Levetiracetam)
- Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)
- Other Names :
- Levetiracetam
|
#Eligibility Criteria:
Inclusion Criteria:
* Meets the NINCDS-ADRDA criteria for probable Alzheimer's disease
* Mild AD (MMSE >= 20)
* Age >= 50 years
* English as first language
Exclusion Criteria:
* A history of seizures prior to the onset of AD
* Familial Alzheimer's Disease due to known genetic mutations
* Current use of an antiepileptic medication
* Current use of a medication known to lower seizure threshold (e.g. bupropion or a neuroleptic)
* Presence of parkinsonism
* Significant cerebrovascular disease
* Other Central Nervous System disease (e.g. stroke, severe traumatic brain injury)
* Major depression or other psychiatric or behavioral disorders (psychosis, agitation)
* Medical contraindication to MRI (e.g. pacemaker, intraocular or intracranial metallic objects)
* Severe claustrophobia or inability to lie flat for MRI
* Known allergy to levetiracetam, or history of previous adverse reaction to levetiracetam
* Serum creatinine >= 2
* A score of >9 on the Geriatric Depression Scale
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01554683
|
{
"brief_title": "Seizure Activity in Alzheimer's Disease",
"conditions": [
"Alzheimer's Disease",
"Seizures"
],
"interventions": [
"Drug: Low/High/Placebo Dose Keppra (Levetiracetam)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01554683",
"official_title": "Seizure-like Hippocampal Activity in Alzheimer's Disease Neurodegeneration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-01",
"study_completion_date(actual)": "2017-07-01",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-23",
"last_updated_that_met_qc_criteria": "2012-03-13",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-15",
"first_submitted": "2012-02-21",
"first_submitted_that_met_qc_criteria": "2020-07-08"
}
}
}
|
#Study Description
Brief Summary
This study evaluates the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgeries, specifically coronary artery bypass grafting (CABG) and heart valve replacement. It spans surgeries performed between 2012 and 2022 at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patients are categorized into two groups based on their preoperative EF: those with preserved EF (≥50%) and those with reduced EF (\<50%).
The primary aim is to assess how EF affects postoperative morbidity, mortality, hospital stay, and complications. Secondary aims include evaluating the development of postoperative arrhythmias, the need for vasopressors and inotropes, and transfusion requirements.
Data will be collected retrospectively from hospital records and electronic health systems. The study's findings are expected to provide insights into tailored perioperative and postoperative management strategies for patients with varying EF levels, ultimately improving clinical outcomes.
Detailed Description
Primary Objective The primary objective of this study is to evaluate the impact of ejection fraction (EF) on clinical outcomes in patients undergoing cardiovascular surgery. Specifically, the study aims to analyze the effects of EF on postoperative morbidity and mortality rates, length of hospital stay, and postoperative complications.
Secondary Objectives Secondary objectives include assessing the development of arrhythmias in the postoperative period, the need for vasopressors and inotropes, and the requirement for transfusions.
Scope of the Study Time Frame The study will encompass cardiovascular surgeries performed between 2012 and 2022. This time frame is selected to obtain a sufficient data set and evaluate long-term outcomes.
Research Center The study will be conducted at Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. Patient data from cardiovascular surgeries performed at this center will be analyzed.
Patient Population The study will include all patients who underwent cardiovascular surgery within the specified time frame and had preoperative ejection fraction (EF) measurements.
Study Design Group Formation
Patients will be divided into two main groups based on their preoperative EF values:
Preserved EF Group: Patients with an EF of 50 or above. Reduced EF Group: Patients with an EF below 50. Data to be Examined
The following postoperative data will be examined and compared between the two groups:
Development of Postoperative Arrhythmias: Whether patients develop arrhythmias in the postoperative period.
Vasopressor Requirement: The need for vasopressors in the postoperative period. Inotrope Requirement: Whether patients require inotropic support postoperatively.
Transfusion Requirement: The need for blood transfusions in the postoperative period.
Mortality: Survival rates of patients following surgery. Need for Revision Surgery: Whether patients require additional surgical interventions postoperatively.
Length of Stay in ICU: Duration of patients' stay in the intensive care unit. Total Hospital Stay: Overall length of hospital stay. Data Collection Method Data will be retrospectively collected from hospital records and electronic health record (EHR) systems.
This structured approach aims to comprehensively evaluate the clinical outcomes of patients with varying levels of ejection fraction undergoing major cardiovascular surgeries, thereby providing insights that can enhance patient management strategies.
#Intervention
- OTHER : mortality rates
- mortality rates
- Other Names :
- vasopressor/inotropic agent needs, transfusion needs, perioperative arrhythmias, intensive care stay
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: Patients aged 18 years and older.
* Cardiovascular Surgery: Patients who have undergone cardiovascular surgeries such as coronary artery bypass grafting (CABG), valve surgery, aortic surgery, etc.
* Ejection Fraction (EF): Patients with documented EF measurements.
Exclusion Criteria:
* Age: Patients under 18 years.
* Non-Surgical Interventions: Patients undergoing procedures other than cardiovascular surgery.
* Incomplete Data: Patients without documented EF measurements or with missing clinical data.
* Pregnancy: Patients who are pregnant.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06468657
|
{
"brief_title": "Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery",
"conditions": [
"Cardiac Output, Low"
],
"interventions": [
"Other: mortality rates"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06468657",
"official_title": "Evaluation of the Impact of Ejection Fraction on Clinical Outcomes in Patients Undergoing Cardiovascular Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-01",
"study_completion_date(actual)": "2024-10-02",
"study_start_date(actual)": "2024-07-01"
},
"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)": "2024-10-08",
"last_updated_that_met_qc_criteria": "2024-06-15",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-21",
"first_submitted": "2024-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims at investigating the metabolic cost of several fundamental exercises with sandbag. Sandbag training has become a popular training modality that is efficiently used to improve cardiovascular status and physical performance. Despite its widespread use and popularity the metabolic cost of exercises using sandbag remains to be elucidated. Therefore, the metabolic cost of various fundamental exercise with sandbag will be determined to aid the planning of exercise training programs.
Detailed Description
Ten healthy young adults will be assigned to this study. Participants will initially undergo a baseline assessment of their anthropometrics, body composition (by DXA), resting metabolic rate (RMR), cardiorespiratory fitness (VO2max), muscular strength \[maximal strength (1RM) and muscular endurance\] and functional capacity. After baseline screening, participants will execute in different days (one exercise per day) one set of each of the following 8 exercise: (1) lateral bag drag, (2) dead bag, (3) shoulder to shoulder thruster, (4) sumo DL with pull, (5) front lunge, (6) single leg RDL, (7) reverse lunge with rotation and (8) clean, in two different conditions: (i) 30 sec and (ii) 45 sec exercise duration, in a random order. Prior to each exercise resting heart rate, blood lactate concentration, oxygen consumption and rate of perceived exertion will be recorded. Heart rate and oxygen consumption (through portable gas analyzer) will be continuously monitored during the exercise and after the end of it, until the oxygen consumption reach the pre-exercise values (excess post-exercise oxygen consumption). Blood lactate and rate of perceived exertion will be reassessed post-exercise.
#Intervention
- OTHER : Sandbag exercise
- Both arms include an exercise intervention consisted of 8 different exercises with sandbag: (1) lateral bag drag, (2) dead bag, (3) shoulder to shoulder thruster, (4) sumo DL with pull, (5) front lunge, (6) single leg RDL, (7) reverse lunge with rotation and (8) clean
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers
Exclusion Criteria:
* Chronic disease
* Musculoskeletal injury
* Consumption of alcohol, caffeine and any type of ergogenic supplement during the study.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06080529
|
{
"brief_title": "Metabolic Cost of Sandbag Training",
"conditions": [
"Exercise Energy Expenditure"
],
"interventions": [
"Other: Sandbag exercise"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT06080529",
"official_title": "Metabolic Cost of Sandbag Training",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30",
"study_completion_date(actual)": "2023-12-15",
"study_start_date(actual)": "2023-10-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-19",
"last_updated_that_met_qc_criteria": "2023-10-06",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-12",
"first_submitted": "2023-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.
The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.
Detailed Description
The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. Through community education, family-based strategies and partnerships with schools, 3rd, 4th and 5th graders are encouraged to: Switch what you Do™ Switch what you View™ Switch what you Chew™.
#Intervention
- BEHAVIORAL : Switch active lifestyles brought to you by MediaWise
- The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity.
- Other Names :
- Iowa State University, Michigan State University, National Institute on Media and the Family
- BEHAVIORAL : Switch active lifestyles from MediaWise
- 1300 students (male and female) were recruited through two separate school districts in Lakeville, Minnesota and Cedar Rapids, Iowa. Informed consents went to all students who chose to participate. Demonstration and Control school were randomly selected. Baseline data was collected regarding physical activity, screen time, and nutrition, standard body measurements, and baseline data, and salivary cortisol levels were taken. Parent and teacher surveys were also conducted. After baseline selected demonstration sites and students were provided with information focused on improving healthy behaviors while the control sites served as matched comparison groups.
- Other Names :
- Switch, Switch program, The Switch program
|
#Eligibility Criteria:
Inclusion Criteria:
* All children in 3 <= age <= 5 grades who provide parental consent and child assent will be eligible to participate in the project.
Exclusion Criteria:
* Participants who meet the following exclusion criteria will not be considered for participation.
* Do not provide consent
* unable or unwilling to adhere to project procedures
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00685555
|
{
"brief_title": "Healthy Futures Project: A Community Based Obesity Prevention Program",
"conditions": [
"Overweight",
"Obesity"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00685555",
"official_title": "SWITCH: Rationale, Design, and Implementation of a Community, School, and Family-based Intervention to Modify Behaviors Related to Childhood Obesity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2005-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-23",
"last_updated_that_met_qc_criteria": "2008-05-27",
"last_verified": "2008-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-28",
"first_submitted": "2008-05-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
#Intervention
- DRUG : latanoprost 0.005% (Xalatan)
|
#Eligibility Criteria:
Inclusion Criteria:
* Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
* IOP of > 21 mm Hg on current treatment
Exclusion Criteria:
* Any previous or current treatment with latanoprost or other prostaglandin analogues
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
|
NCT00140062
|
{
"brief_title": "Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.",
"conditions": [
"Ocular Hypertension",
"Glaucoma, Open-Angle"
],
"interventions": null,
"location_countries": [
"Finland",
"Sweden"
],
"nct_id": "NCT00140062",
"official_title": "A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With 'Usual Care' Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-04",
"study_start_date(actual)": "2002-02"
},
"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)": "2008-04-07",
"last_updated_that_met_qc_criteria": "2005-08-30",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-08-31",
"first_submitted": "2005-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.
#Intervention
- DIETARY_SUPPLEMENT : Lipid Nutrient Supplement
- DRUG : Sulfadoxine-pyrimethamine
- DRUG : Albendazole
- DRUG : Zinc
- OTHER : Insecticide-treated bednet
|
#Eligibility Criteria:
Inclusion Criteria:
* recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5 <= age <= 12.4 cm
Exclusion Criteria:
* not permanent resident in vicinity of site
* severe chronic illness
* receiving other supplementary food or participating in other research
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 59 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02351687
|
{
"brief_title": "Package of Interventions After Recovering From Moderate Acute Malnutrition",
"conditions": [
"Malnutrition"
],
"interventions": [
"Dietary Supplement: Lipid Nutrient Supplement",
"Drug: Sulfadoxine-pyrimethamine",
"Drug: Zinc",
"Other: Insecticide-treated bednet",
"Drug: Albendazole"
],
"location_countries": [
"Malawi"
],
"nct_id": "NCT02351687",
"official_title": "Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition",
"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)": "2014-04"
},
"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)": "2016-11-10",
"last_updated_that_met_qc_criteria": "2015-01-29",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-30",
"first_submitted": "2015-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine if respiratory muscle strength training will be beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe disease.
Detailed Description
Respiratory muscle weakness results in substantial morbidity and mortality in individuals with almost all forms of neuromuscular disease (NMD), including both the infantile and adult phenotypes of Pompe disease. Although individual patterns of involvement vary, respiratory weakness in Pompe disease typically affects both the inspiratory and expiratory muscle systems. Our pilot data in two individuals with late-onset Pompe disease suggest that RMST may be a treatment for the progressive respiratory weakness encountered in this condition.
Purpose of the Study
* Determine the effect of respiratory muscle strength training on maximum inspiratory pressure, maximum expiratory pressure, upright % predicted forced vital capacity, and aspects of cough function.
* Determine the effect of RMST on functional outcome measures of gross motor function appropriate for individual participants in terms of age and motor skills.
#Intervention
- OTHER : respiratory muscle strength training
|
#Eligibility Criteria:
Inclusion Criteria:
* include skin fibroblast acid α-glucosidase (GAA) activity <=1% of the normal mean, a minimum age of 3 years, the ability to participate in an intensive RMST research program, and the ability to maintain a consistent amount of nonresearch related physical activity over the course of the study.
Exclusion Criteria:
* include medical problems which preclude meaningful participation in the study, the inability to perform high effort respiratory tasks using maximum intensity, respiratory weakness so profound that RMST cannot be completed at the minimum pressure thresholds of available respiratory trainers, and the inability to safely perform the protocol. For example, high effort respiratory tasks are occasionally associated with mild, transient dizziness which quickly dissipates following a brief rest. If severe and/or prolonged dizziness were to occur in a particular case, then exclusion from the study would be necessary.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01701154
|
{
"brief_title": "The Effects of Respiratory Muscle Strength Training (RMST) on Inspiratory and Expiratory Muscle Strength in Adults and Children With Pompe Disease",
"conditions": [
"Pompe Disease"
],
"interventions": [
"Other: respiratory muscle strength training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01701154",
"official_title": "The Effects of Respiratory Muscle Strength Training (RMST) on Inspiratory and Expiratory Muscle Strength in Adults and Children With Pompe Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12-15",
"study_completion_date(actual)": "2012-12-15",
"study_start_date(actual)": "2010-12"
},
"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)": "2023-05-30",
"last_updated_that_met_qc_criteria": "2012-10-03",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-04",
"first_submitted": "2012-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility.
In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume.
Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised.
The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.
Detailed Description
Coronavirus 2019 disease - of recent appearance - has become a global public health problem due to its rapid spread, since 11 March declared by WHO as a pandemic. It represents a real challenge for health systems, which at first lack information to organize the response to this situation, effective treatments to combat this lethal infection and with health personnel lacking the necessary security in their daily work to minimize the risk of contagion. The COVID-19 pandemic has caused, up to July 21, more than 609,000 deaths worldwide, 28,422 in Spain. The number of professionals suffering from COVID-19 is high. In Spain it accounts for more than 20% of the total number of people infected.
In this way, health professionals have been taking on a notable role without hardly any intention of doing so. Situations of constant uncertainty and emotional distress have posed a risk to patients and to the quality of care, making health professionals the second most affected by SARS-CoV-2 (COVID-19), which also requires special biosecurity and protection measures.
In a global survey, 52% of the 2711 health workers included reported that at least 1 standard PPE piece was out of stock. For example, in the United States, the Food and Drug Administration and the Centers for Disease Control and Prevention have taken several steps to optimize the use of PPE due to its scarcity. Although professionals in Germany consider that they have been well prepared for the pandemic, there are substantial differences in the availability of PPE depending on the health professional and the setting (outpatient or acute care hospitals). In Spain, 54% of primary health care workers reported that they were not adequately trained to use PPE. No similar studies we found in the local context of South American countries.
Although the incidence of the pandemic has expanded differently in different geographical areas of each country, most hospitals and health centres around the world have had to reorganise themselves to prioritise the care of COVID-19 patients, breaking with their usual work dynamics. To this cause of work stress must be added the uncertainty in which decisions have had to be made and the lack of resources both to treat patients adequately and to protect against possible contagion. Reactions of compassionate fatigue, post-traumatic stress, and moral damage have been observed among health professionals, which has depended on the expansion of the pandemic, available means, and individual differences in stress response.
These types of responses and reactions to this crisis are natural and affect all staff and all professional levels, including care support staff (IT, supplies, cleaning, etc.). The opposite would be difficult to explain. However, the key question is not the number of professionals who have been emotionally affected as a result of their care work, a circumstance that is aggravated in this crisis but is inherent to the work they do, but rather how many are unable to recover, how their resilience is evolving or to what extent they are able to cope with a possible new outbreak.
Most studies have analysed the emotional responses in a short period of time (approximately one week) coinciding with a specific stage of the crisis. However, studies on community coping with catastrophic situations have described that the psychological response evolves over time resulting in: impact phase, heroic (intensification of efforts), honeymoon (optimism), disillusionment (fatigue) and restoration (recovery pre-crisis levels). Therefore, it is expected that the effects of the pandemic on the psychological and emotional well-being of health professionals will vary as the pandemic evolves.
#Intervention
- OTHER : Online survey
- Online survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale).
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthcare professionals, other professionals working in the front-line of COVID-19.
Exclusion Criteria:
*
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
|
NCT04486404
|
{
"brief_title": "Needs, Perceptions and Acute Stress of Healtcare Workers Caring for COVID-19 Patients in South America",
"conditions": [
"Acute Stress Disorder"
],
"interventions": [
"Other: Online survey"
],
"location_countries": [
"Ecuador",
"Colombia",
"Chile",
"Spain",
"Argentina"
],
"nct_id": "NCT04486404",
"official_title": "Personal Protective Equipmente Needs, Perceptions and Acute Stress Among Healthcare Workers Caring for COVID-19 Patients in South America",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-30",
"study_completion_date(actual)": "2021-12-30",
"study_start_date(actual)": "2020-04-01"
},
"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)": "2022-09-19",
"last_updated_that_met_qc_criteria": "2020-07-23",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-24",
"first_submitted": "2020-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.
Detailed Description
Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.
UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.
#Intervention
- DEVICE : Energy accumulator
- All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements.
- BEHAVIORAL : Home exercise program
- Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down.
|
#Eligibility Criteria:
Inclusion Criteria:
* male or female gender with age between 40 <= age <= 65
* affect one shoulder only
* onset is more than 3 months at the time of inclusion into the study
Exclusion Criteria:
* unstable medical conditions
* unstable mental state
* have skin lesion over the shoulder
* skin sensitivity to heat
* pregnant or under lactation
* could not comply with heat treatment of the shoulder.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04747938
|
{
"brief_title": "Frozen Shoulder Treated by Energy Accumulator",
"conditions": [
"Frozen Shoulder"
],
"interventions": [
"Behavioral: Home exercise program",
"Device: Energy accumulator"
],
"location_countries": null,
"nct_id": "NCT04747938",
"official_title": "Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08-03",
"study_completion_date(actual)": "2015-10-24",
"study_start_date(actual)": "2014-09-01"
},
"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)": "2021-08-06",
"last_updated_that_met_qc_criteria": "2021-02-05",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-10",
"first_submitted": "2021-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
Detailed Description
This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.
The study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. The effect of the intervention was evaluated with the Beck Depression Inventory, Beck Anxiety Inventory, Automatic Thoughts Questionnaire, and Ways of Coping Questionnaire. The measurements were taken 3 times: pre-test, post-test, and 2-months post-test.
#Intervention
- BEHAVIORAL : Cognitive Behavioral Therapy-Based Group Counseling
- * Relaxation techniques
* Providing personal development books
* Sharing the factors affecting the situation defined as depression (brainstorming)
* Explaining the link between depressive symptoms, thoughts, feelings, and behaviors
* Explaining automatic thoughts
* Application of relaxation techniques; deep-breathing exercises
* Identifying alternative thoughts
* Explaining the correlation between alternative thoughts and mood
* Introduction of the Automatic-Thought Registration Form and distribution to students
* Describing the effects of depression on social interaction
* Explaining activities that could be done individually and with the group
* Distribution of the activity list to students
* Description of ways of coping with stress
* Determination of individual stressors and their effects
* Planning for the future: preventing depression
* Discussion of assumptions/expectations about life
* Homeworks related to session contents
|
#Eligibility Criteria:
Inclusion Criteria:
* Having mild depressive symptoms according to the BDI
* Having moderate depressive symptoms according to the BDI
* Being native speakers of Turkish
* Agreeing to participate in the entire intervention process
Exclusion Criteria:
* Having substance abuse
* Having another psychiatric diagnosis
* Using psychotropic drugs
* Receiving other counseling or therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04192721
|
{
"brief_title": "Cognitive Behavioral Therapy-Based Group Counseling",
"conditions": [
"Depression Moderate",
"Depression Mild"
],
"interventions": [
"Behavioral: Cognitive Behavioral Therapy-Based Group Counseling"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04192721",
"official_title": "Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-29",
"study_completion_date(actual)": "2018-02-23",
"study_start_date(actual)": "2017-11-01"
},
"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)": "2019-12-10",
"last_updated_that_met_qc_criteria": "2019-12-09",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-10",
"first_submitted": "2019-11-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.
Detailed Description
Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
#Intervention
- DRUG : Nivolumab
- 40 mg of the nivolumab will be used intrapleurally (once).
- Other Names :
- Opdivo
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >=18 years
* Large volume of pleural effusion (1 liter and more), required evacuation
* Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)
* Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)
Exclusion Criteria:
* Autoimmune disorders
* Previous treatment for
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
|
NCT04749602
|
{
"brief_title": "Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.",
"conditions": [
"Renal Cell Cancer Metastatic",
"Non-small Cell Lung Cancer Metastatic",
"Pleural Effusion, Malignant"
],
"interventions": [
"Drug: Nivolumab"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT04749602",
"official_title": "A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-01",
"study_completion_date(actual)": "2023-03-01",
"study_start_date(actual)": "2020-08-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-08",
"last_updated_that_met_qc_criteria": "2021-02-07",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-11",
"first_submitted": "2021-02-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke.
This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3.
Cohort 1 Arm-1: JTR-161, 1 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not.
Cohort 2 Arm-1: JTR-161, 3 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3.
Cohort 3 Arm-1: JTR-161, 1 × 10\^8 cells/subject or 3 × 10\^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
#Intervention
- BIOLOGICAL : JTR-161
- JTR-161 (1 or 3 × 10\^8 cells/subject) will be suspended and administered in an intravenously infusion.
- BIOLOGICAL : Placebo
- Placebo will be suspended and administered in an intravenously infusion.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who have ischemic strokes in the anterior circulation
* Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke
* Patients whose NIHSS score of >=5 to <=20 at screening
* Patients who can be administered dosing solutions within 48 h of stroke onset
Exclusion Criteria:
* Patients who have new ischemic lesion in the cerebellum or brainstem
* Patients whose consciousness level drops severely
* Patients whose infarct area is widespread
* Patients who have a clinically significant hemorrhagic transformation
* Patients who had seizures after onset of ischemic stroke
* Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent
* Patients who have poor blood pressure control
* Patients who have poor glycaemic control
* Patients who have one of the following complications
1. Severe liver dysfunction
2. Severe kidney dysfunction
3. Severe heart failure
4. Severe pulmonary dysfunction
* Patients who have severe infections
* Patients who have any neurological disorder affecting informed consent or study assessments
* Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke
* Patients who have a contraindication for MRI
* Patients who have thrombocytopenia
* Patients who have medical history of allergy to products derived from human tissues, bovine or porcine
* Patients who have medical history of allergy to streptomycin
* Patients who have undergone splenectomy in the past
* Patients who have a possibility of transient ischemic attack
* Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
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
|
NCT04608838
|
{
"brief_title": "A Randomized Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cell, in Patients With Acute Ischemic stRoke (J-REPAIR)",
"conditions": [
"Acute Ischemic Stroke"
],
"interventions": [
"Biological: Placebo",
"Biological: JTR-161"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT04608838",
"official_title": "An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-15",
"study_completion_date(actual)": "2021-11-24",
"study_start_date(actual)": "2019-01-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"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": "2020-10-28",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-29",
"first_submitted": "2020-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Direct oral anticoagulants (DOAC) are a new drug group that has been approved for chronic anticoagulation of patients in atrial fibrillation or suffering acute thrombosis, between others. The need of surgery of a patient in atrial fibrillation is round 10% per year.
Due to DOAC short time of commercialization and the lack of experience, the proper management of DOAC when a patient in this treatment needs a scheduled or urgent procedure, has not yet been established. This fact may mean both the decrease of the anticoagulant treatment efficacy and the increase of the haemorrhage complications in the perioperative period.
With the aim of gaining additional information about this aspect, a multicentre, prospective and observational study (classified by the spanish drug society, AEMPS, as non-interventional trial, EPA-SP) about the DOAC management, before a scheduled or urgent surgery, in normal clinical practice, is proposed.
Detailed Description
When an anticoagulated patient is scheduled for surgery or an invasive procedure, the physician's worry is how to achieve needing an optimal haemostasis without increasing the risk of thrombosis. For decades, the main drug for chronic anticoagulation has been antivitamin-k (warfarin or acenocoumarol). In the majority of patients, the periprocedural management proposal has been stopping the drug and giving a short acting anticoagulant for some days before surgery, known as bridging therapy strategy, mostly done with a low-molecular weight heparin (LMWH).
The debate about the best perioperative management of the anticoagulated patients has increased with the arrival on the market of direct oral anticoagulants (DOAC), by the moment approved for long-term anticoagulation in patients with atrial fibrillation and for the treatment of pulmonary embolism. DOAC could be classified in two groups: direct inhibitors of thrombin (the only current available drug is dabigatran) and direct inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban, and others soon to come). DOAC have pharmacokinetic characteristics that seem to favour stopping the drug for some days without substitution in the vast majority of the patients. Nevertheless, current lack of experience in the management of high doses of DOAC during the perioperative period, the absence of effective antagonists to reverse the anticoagulation, the unsuitable standardized laboratory monitoring and, also, the different pharmacokinetics between patients receiving these drugs, have made challenging to standardize the optimal management in the perioperative period. Some proposals have been published in last years from expert consensus, based on pharmacokinetic data, but DOAC short time of commercialization and the difficulties to interpret the post-hoc analysis from the randomized trials, for the heterogeneity of the included population and the wide kind of surgeries, most of them with low bleeding risk, have moved the spanish working group on perioperative management of haemostasis to plan a multi-institutional registry to gain experience and information in the periprocedural (urgent or scheduled) management of DOAC.
The authors designed an observational, prospective, multicentre study including patients under long-term DOAC treatment for atrial fibrillation or treatment of venous thromboembolism who are scheduled or need an urgent procedure. Data collected were demographic, related with the DOAC management and with the possible haemorrhagic or thrombotic events with a follow-up of 30 day. A univariable analysis and a multivariate regression model were applied using all the available co-variables. Bilateral hypothesis contrast were considered significant if α \< 0.05.
#Intervention
- DRUG : Direct oral anticoagulant
- Time of direct oral anticoagulant withdrawal Use or not of bridging with low molecular weight heparin
- Other Names :
- low molecular weight heparin
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years and older
* Under direct oral anticoagulant
* Urgent or scheduled surgery or invasive procedure needed
* Signed and dated informed consent form
Exclusion Criteria:
* None
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
|
NCT03182218
|
{
"brief_title": "Periprocedural Direct Oral Anticoagulant Management",
"conditions": [
"Periprocedural Complication"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT03182218",
"official_title": "Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2015-02"
},
"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)": "2018-08-02",
"last_updated_that_met_qc_criteria": "2017-06-08",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-09",
"first_submitted": "2017-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
Detailed Description
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
#Intervention
- DRUG : Teneligliptin
- 20mg/qd
- DRUG : Placebo
- 1T/qd
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are >= 65 years on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% <= HbA1c <= 9.0% at the screening visit
* Patients with FPG < 270mg/dL on screening visit
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03508323
|
{
"brief_title": "Tenelia Elderly CGMS Study(TEDDY)",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Teneligliptin",
"Drug: Placebo"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03508323",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-12",
"study_completion_date(actual)": "2019-12-12",
"study_start_date(actual)": "2018-04-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"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": "2018-04-16",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-25",
"first_submitted": "2018-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.
Detailed Description
Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.
#Intervention
- DRUG : Intervention: inferior alveolar nerve block injection
- -22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of irreversible pulpitis
* good health
* had at least 1 adjacent tooth plus a healthy canine
Exclusion Criteria:
* took medication could be interacting with any of the anesthetics used
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:
Yes
|
NCT02054767
|
{
"brief_title": "Anesthetic Efficacy in Irreversible Pulpitis",
"conditions": [
"Anesthesia"
],
"interventions": [
"Drug: Intervention: inferior alveolar nerve block injection"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02054767",
"official_title": "Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2010-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-02-04",
"last_updated_that_met_qc_criteria": "2014-01-31",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-04",
"first_submitted": "2013-09-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or 'other' elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.
#Intervention
- DRUG : APD405
- IV
- DRUG : Placebo
- IV
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients >= 18 years
* Written informed consent
* Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:
1. Hysterectomy (any surgical technique)
2. Cholecystectomy (any surgical technique)
3. Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia
* Patients with at least 2 risk factors for PONV, defined as 2 of the following:
1. Past history of PONV and/or motion sickness
2. Non-smoking status
3. Female gender
4. Planned opiate use for post-operative analgesia
* American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)
* Adequate hepatic and renal function
* Alanine aminotransferase (ALT) <2.5 * upper limit normal (ULN)
* Aspartate aminotransferase (AST) <2.5 * ULN
* Bilirubin <1.5 * ULN
* Creatinine <1.5 * ULN
* Adequate haematological function
* Haemoglobin >=9.5 g/dL
* White blood count 4.0 <= age <= 11.0 * 10^9/L
* Platelet count >=150 - 400 * 10^9/L
* Ability and willingness to give written informed consent
Exclusion Criteria:
* Patients undergoing outpatient/day case surgery
* Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
* Patients undergoing intra-thoracic, transplant or central nervous system surgery
* Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks
* Patients with a pre-existing vestibular disorder or history of dizziness
* Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed
* Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
* Patients treated with regular anti-emetic therapy including corticosteroids
* Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin
* Patients with pre-existing nausea or vomiting 24 hours before surgery
* Patients who are breast feeding or pregnant
* Patients with a history of alcohol abuse
* Patients diagnosed with Parkinson's disease
* Patients who have received anti-cancer chemotherapy in the previous 4 weeks
* Patients with pre-existing clinically significant cardiac arrhythmia
* Patients with a history of epilepsy
* Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)
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
|
NCT00895830
|
{
"brief_title": "Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)",
"conditions": [
"Postoperative Nausea and Vomiting"
],
"interventions": [
"Drug: Placebo",
"Drug: APD405"
],
"location_countries": [
"France",
"Germany",
"Switzerland",
"United States"
],
"nct_id": "NCT00895830",
"official_title": "Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2009-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-03-29",
"last_updated_that_met_qc_criteria": "2009-05-07",
"last_verified": "2011-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-08",
"first_submitted": "2009-05-07",
"first_submitted_that_met_qc_criteria": "2011-02-24"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.
#Intervention
- DRUG : Placebo
- placebo matching tiotropium + olodaterol
- DRUG : Tiotropium + Olodaterol
- Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
- DRUG : tiotropium + Olodaterol
- tiotropium 5 mcg + olodaterol 5 mcg once daily
- DRUG : Tiotropium
- tiotropium
- DRUG : Olodaterol
- Olodaterol 5 mcg once daily
- DEVICE : Respimat
- Respimat inhaler
|
#Eligibility Criteria:
Inclusion criteria:
* All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
* All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.
* Male or female patients, between 40 and 75 years (inclusive) on day of signing informed consent.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Exclusion criteria:
* Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition
* Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
Patients with any of the following conditions:
* A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
* A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
* A history of myocardial infarction within 1 year of screening visit (Visit 1)
* Unstable or life-threatening cardiac arrhythmia
* Hospitalized for heart failure within the past year
* Known active tuberculosis
* A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
* A history of life-threatening pulmonary obstruction
* A history of cystic fibrosis
* Clinically evident bronchiectasis
* A history of significant alcohol or drug abuse
* Any contraindications for exercise testing.
* Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
* Patients being treated with any oral ß-adrenergics
* Patients being treated with oral corticosteroid medication at unstable doses
* Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
* Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program
* Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
* Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
* Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
* Pregnant or nursing women
* Women of childbearing potential not using highly effective methods of birth control.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01533935
|
{
"brief_title": "Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: Tiotropium + Olodaterol",
"Drug: Olodaterol",
"Drug: tiotropium + Olodaterol",
"Drug: Placebo",
"Drug: Tiotropium",
"Device: Respimat"
],
"location_countries": [
"Netherlands",
"United States",
"Sweden",
"Germany",
"Canada",
"Austria",
"Russian Federation",
"Argentina"
],
"nct_id": "NCT01533935",
"official_title": "A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 2]",
"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)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-09-15",
"last_updated_that_met_qc_criteria": "2012-02-15",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-16",
"first_submitted": "2012-02-13",
"first_submitted_that_met_qc_criteria": "2015-08-12"
}
}
}
|
#Study Description
Brief Summary
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called 'angiogenesis'). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.
In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.
The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.
This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.
The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy
#Intervention
- DRUG : Paclitaxel
- DRUG : Bevacizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* Female aged >= 18 years at inclusion
* Histologically confirmed diagnosis of ovarian Sex cord-stromal tumors including the following cell types: granulosa cell tumours (adults and juveniles types), granulosa cell-theca cell tumour, Sertoli-Leydig cell tumours, malignant steroid cell tumours, gynandroblastoma, unclassified SCST and mixed tumours
* Documented relapse of SCST defined by progression of disease (radiologic, clinic or biological progression)
* At least one measurable site of disease as defined by RECIST 1.1
* Tumours within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented or a biopsy is obtained to confirm persistence > 90 days following completion of radiotherapy.
* Patients must have been pre-treated with at least 1 prior line of platinum-based chemotherapy
* Adequate bone marrow, liver and renal functions including the following:
* Absolute neutrophil count >= 1.5 G/L, platelet count >= 100 G/L, and hemoglobin >= 9 g/dL. Prior transfusion is authorized to keep haemoglobin level to >=9g/dL
* AST/ALT <= 3 x upper limit of normal (ULN) (or <= 5.0 ULN if liver metastasis) and total bilirubin <= 1.5 ULN
* Serum creatinine <= 1.5 ULN or calculated creatinine clearance >= 50 mL/min according to Cockcroft formula (or to MDRD formula for patients older than 65 years-old).
* Adequate coagulation panel:
* PT <= 1.2 ULN
* aPTT <= 1.5 ULN
* INR <= 1.5 ULN
* Adequate neurologic function: only neuropathy (sensory and motor) grade <= 1 (CTCAE v4.3) are allowed
* ECOG Performance status of 0, 1, or 2 (Appendix 5)
* Life expectancy >= 4 months
* Satisfactory cardiac function
* Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry
* Women of childbearing potential* are required to have a negative serum pregnancy test within 7 days prior to study treatment initiation (i.e. Cycle 1 Day 1) and are willing to use adequate contraceptive method during the whole study period and for up to 6 months after the last treatment intake
*: Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
* >= 50 years and naturally amenorrheic for >= 1 year
* Permanent premature ovarian failure confirmed by a specialist gynaecologist
* Previous bilateral salpingo-oophorectomy or hysterectomy
* XY genotype, Turner's syndrome, or uterine agenesis
* Female patient who do not meet at least of the above criteria are defined as women of childbearing potential
* Covered by a medical insurance (in country where applicable)
Exclusion Criteria:
* Prior systemic therapy with bevacizumab
* Active peripheral neuropathy >= grade 3 (NCI-CTCAE v4.3)
* Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer
* No resolution of specific toxicities related to any prior anti-cancer therapy to grade <=1, excluding alopecia, according to the NCI-CTCAE v.4.3
* History or evidence of thrombotic or hemorrhagic disorders, including cerebro-vascular accident/stroke or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs
* Uncontrolled arterial hypertension (systolic >= 150 mmHg or diastolic >= 100 mmHg) despite optimal antihypertensive therapy or clinically significant cardiovascular disease including one of the following:
* Myocardial infarction or instable angina within 6 months prior to first dose of study drugs
* NYHA grade >= II congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Peripheral vascular disease >= grade 3
* History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion
* Prior treatments:
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study inclusion or anticipation of need for major surgical procedure during the course of the study
* Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment. In case of hormonotherapy , patients will be eligible if hormonotherapy is discontinued within at least 1 week before treatment initiation
* Current or recent (within 10 days prior to randomization) chronic use of aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation
* Chronic treatment (i.e. > 15 days) with non steroids anti-inflammatory agents unless a washout period of 15 days was observed before the inclusion.
* Intake of granulocyte growth factor within 3 weeks before study entry
* Presence of hematuria and proteinuria >= 2+ (urine dipstick). Patients with >= 2+ proteinuria on dipstick at screening should undergo a 24-hour urine collection and will be eligible only if 24-h proteinuria <= 1 g
* Untreated evolutive brain metastases
* Active bacteria or fungal infection (grade >=2, CTC AE V4.3)
* Known HIV1, HIV2 or chronic hepatitis B or C infection
* Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
* Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients (Ethanol Citric acid) (refer to Taxol® SPC for further details)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01770301
|
{
"brief_title": "Efficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR)",
"conditions": [
"Ovarian Sex-cord Stromal Tumor"
],
"interventions": [
"Drug: Paclitaxel",
"Drug: Bevacizumab"
],
"location_countries": [
"France"
],
"nct_id": "NCT01770301",
"official_title": "A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2021-04",
"study_start_date(actual)": "2013-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-02",
"last_updated_that_met_qc_criteria": "2013-01-15",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-17",
"first_submitted": "2013-01-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.
Detailed Description
Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular hemorrhage in very low birth weight infants. However, the effects of early indomethacin on long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were evaluated in follow-up at 18-22 months corrected age.
#Intervention
- DRUG : indomethacin
- Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa
- DRUG : Indomethacin
- 0.1 mg per kilogram of body weight
- DRUG : Placebo
- 0.1 mg per kilogram of body weight
|
#Eligibility Criteria:
Inclusion Criteria:
* Birth weight 500 to 999 grams;
* Postnatal age greater than 2 hours;
Exclusion Criteria:
* Unable to administer study drug within 6 hours of birth;
* Structural heart disease and/or renal disease;
* Dysmorphic features or congenital abnormalities;
* Tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery;
* Overt clinical bleeding from more than one site;
* Platelet count less than 50 x 109/L;
* Hydrops;
* Not considered viable
Sex :
ALL
Ages :
- Minimum Age : 2 Hours
- Maximum Age : 6 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00009646
|
{
"brief_title": "Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)",
"conditions": [
"Infant, Very Low Birth Weight",
"Infant, Premature",
"Ductus Arteriosus, Patent"
],
"interventions": [
"Drug: Placebo",
"Drug: indomethacin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00009646",
"official_title": "Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1999-03",
"study_completion_date(actual)": "2001-03",
"study_start_date(actual)": "1993-11"
},
"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)": "2015-06-08",
"last_updated_that_met_qc_criteria": "2001-02-02",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-02-05",
"first_submitted": "2001-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Detailed Description
The study consists of two parts: dose escalation and recommended phase 2 dose expansion. Each part of the study will include two separate groups of participants. Group A will include participants who will have cutaneous/subcutaneous tumors injected, and group B will include participants who will have visceral tumors injected. In dose escalation part only ASP9801 will be assessed. In dose expansion part along with ASP9801 (monotherapy) ASP9801 + Pembrolizumab (combination therapy) will be assessed. The study will consist of the following periods: screening, initial treatment period (two 28 day cycles), optional extended treatment period (continued 28 day cycles) and a follow up period (safety and survival follow up).
#Intervention
- BIOLOGICAL : ASP9801
- Administered by intratumoral injection
- COMBINATION_PRODUCT : Pembrolizumab
- Administered by Intravenous Infusion
- Other Names :
- KEYTRUDA®
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s).
* Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be >= 10 mm and <= 60 mm in longest diameter.
* Subject has had disease progression after, been intolerant to, or has refused all available therapies that are known to confer clinical benefit. Note: There is no limit to the number of prior treatment regimens.
* Subject has a predicted life expectancy >= 12 weeks.
* Subject has at least 2 sites of disease suitable for biopsy and is willing and able to undergo required tumor biopsies according to the treating institution's guidelines at screening and during study treatment.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* A female subject is eligible to participate if she is not pregnant as documented by negative pregnancy test within 72 hours prior to treatment and at least 1 of the following conditions applies:
* Not a woman of childbearing potential (WOCBP) OR
* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study investigational product (IP) administration.
* Female subject must agree not to breastfeed starting at screening, and throughout the study period and 180 days after the final study IP administration.
* Female subject must not donate ova starting at screening, and throughout the study period and for 180 days after the final study IP administration.
* Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.
* Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.
* Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.
* Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
* Subject agrees not to participate in another interventional study while receiving study IP.
* Subject has the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Subject has ongoing toxicity >= National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant.
* Subject who has had major surgery <= 4 weeks of screening. Subjects must have recovered from prior procedures and/or any complications from surgery prior to starting study treatment.
* Subject is concurrently participating in another interventional study or has received an investigational product <= 30 days or 5 half-lives whichever is shorter, prior to first IP administration.
* Subject with symptomatic or untreated central nervous system (CNS) metastases or leptomeningeal disease. Subjects with treated symptomatic brain metastases should be neurologically stable (without evidence of progression by imaging for at least 4 weeks prior to screening and any neurologic symptoms have returned to baseline) and off steroids for at least 2 weeks prior to first IP administration. Subjects with carcinomatous meningitis are excluded regardless of clinical stability.
* Subject with active or prior autoimmune or inflammatory disorders requiring systemic therapy within past 2 years (including inflammatory skin conditions or severe eczema, inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
The following are exceptions to this criterion:
* Subject with vitiligo or alopecia
* Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
* Subject with another malignancy that currently requires treatment.
* Subject with only tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for adverse events (AEs) or otherwise not considered appropriate for IT injection. Subjects with such tumors that have other injectable tumors would be eligible.
* Subject with inadequate organ and marrow functions meeting any of the below criteria:
* Leukocytes < 3000/μL
* Absolute neutrophil count < 1500/μL
* Platelets < 100,000/μL
* Hemoglobin (Hgb) < 9 g/dL (Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Subjects can be on stable dose of erythropoietin [>= approximately 3 months])
* International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits, except for subjects in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal
* Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits)
* Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 2.5 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits.
* Albumin < 3.0 g/dL
* Creatinine > 1.5 × institutional normal limits
* Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Subject has an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator.
* Subject is positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection.
* Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of ASP9801 is allowed.
* Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.
* Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia or congestive heart failure (New York Heart Association grade >= 2).
* Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia or hypotension during or following treatment with ASP9801.
* Subject has a known or suspected hypersensitivity to ASP9801 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).
* Subject has had previous exposure with ASP9801.
* Subject has an active infection requiring systemic therapy.
* Subject with known history of active Bacillus Tuberculosis.
* Subject has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4, OX 40, CD137) and was discontinued from that treatment due to an immune-related adverse event.
* Subject has received prior radiation therapy within 2 weeks of start of study treatment. Subject must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<= 2 weeks of radiotherapy) to non-CNS disease.
* Subject has received a live vaccine within 30 days prior to the first dose of study drug.
Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guérin and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
* Subject has severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients, or history of >= grade 2 infusion reactions that were not prevented by adequate premedication.
* Subject has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Subject has had an allogeneic tissue/solid organ transplant.
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
|
NCT03954067
|
{
"brief_title": "A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors",
"conditions": [
"Metastatic Cancer",
"Solid Tumors",
"Advanced Cancer"
],
"interventions": [
"Combination Product: Pembrolizumab",
"Biological: ASP9801"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03954067",
"official_title": "A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced/Metastatic Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-19",
"study_completion_date(actual)": "2024-04-19",
"study_start_date(actual)": "2019-08-08"
},
"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)": "2024-11-20",
"last_updated_that_met_qc_criteria": "2019-05-16",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-17",
"first_submitted": "2019-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten ingestion in celiac disease patients who are following gluten free diet for at least a period of one year. These noninvasive markers may be helpful to monitor the silent intestinal damage, possibly resulting from the accidental consumption of gluten due to cross contamination of gluten free diet.
Detailed Description
The gold-standard for monitoring of dietary adherence is consultation with an expert dietitian, but this may be time-consuming for patients and local expertise may not be available. Intestinal biopsy is the only direct method to document mucosal healing and can be considered in all adults with celiac disease. Non-invasive assessment of compliance with a gluten free diet(GFD) can be achieved with monitoring of IgA antibodies to tissue transglutaminase (IgA-tTG) or deamidated gliadin peptides, as these markers improve with gluten elimination. However, intestinal mucosal damage is present in a significant number of patients who report compliance with a gluten free diet and have normalized serology, potentially due to dietary lapses or unrecognized contamination with gluten. Furthermore, serologic testing may be normal in patients with partial adherence. Patient reported surveys show promise for assessing gluten free diet adherence, but further studies are needed.
Intestinal fatty acid-binding protein (I-FABP), a small (15 kD) cytosolic protein found exclusively in the small bowel enterocytes, has been studied as a marker of intestinal epithelial damage in septic shock and mesenteric ischemia. More recently, elevated levels of intestinal fatty acid-binding protein( I-FABP) have been described as a marker of intestinal injury in both adults and children with celiac disease. Intestinal fatty acid binding protein, (I-FABP) levels have been shown to significantly correlate with the degree of villous atrophy and IgA antibody to tissue transglutaminase (IgA-tTG), as well as decrease upon treatment with a gluten free diet(GFD). Incomplete normalization of intestinal fatty acid binding protein(I-FABP) on a gluten free diet points to ongoing intestinal injury, even in the absence of circulating antibodies, thus suggesting its potential as a non-invasive marker for gluten free diet adherence and intestinal damage in celiac disease.
The measurement of gluten immunogenic peptides (GIP) in stool is a novel method to monitor gluten free diet compliance. Recently, a technique to detect gliadin 33-mer equivalent peptide epitopes (33EPs) in the stool of pediatric patients has been described. These peptides show significant resistance to digestion and were detected in healthy individuals after normal gluten-containing diet ingestion. Importantly, these peptides are not detected in patients on a gluten free diet, and there appears to be a correlation between the amount of gluten intake and the peptide levels. A similar test has been developed for gluten intestinal peptide(GIP) detection in urine, although there are currently no peer-reviewed studies examining this technique. Further research on the utility of stool and urine gluten intestinal peptide (GIP)for monitoring of gluten free diet (GFD) adherence is warranted.
Given the lack of a non-invasive and accurate measure of gluten intake in celiac disease (CD), the investigators will investigate the effect of gluten intake in celiac disease (CD) patients using a variety of markers. Patients who are symptom-free on a gluten free diet (GFD) will be exposed to various amounts of gluten. Factors that will be studied include the effect on patient estimated gluten intake, Celiac disease symptoms, IgA-tTG level,intestinal fatty acid binding protein( I-FABP) level, and both stool and urine gluten peptide levels.
#Intervention
- OTHER : Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.
- After administering the capsules for 16 weeks during study periods, patients's blood will be tested for novel markers- Intestinal fatty acid binding protein(I-FABP), stool for gluten intestinal peptide (GIP), urine for gluten intestinal peptide(GIP), patient estimated gluten intake(PEGI), celiac severity index(CSI), Celiac dietary adherence test(CDAT) by standard questionnaire provided during the visits. These tests will be done over a period of 16 weeks and at a follow up 3 months later.
|
#Eligibility Criteria:
Inclusion Criteria:
* This study population will consist of patients with a prior diagnosis of celiac disease based on intestinal biopsy (Marsh score of 1 <= age <= 4) who report control of symptoms with adherence to gluten free diet(GFD) for at least one year and have a baseline IgA antibody to tissue transglutaminase(IgA-tTG) within the normal range.
Exclusion Criteria:
* Patients < 18 years
* Patients with refractory celiac disease (RFD), defined as persisting or recurring symptoms and mucosal villous atrophy, despite strict adherence to a gluten free diet (GFD) for >12 months and a negative IgA antibody to tissue transglutaminase (IgA-tTG)
* Patients with enteropathy-associated T-cell lymphoma
* Patients with IgA deficiency
* Patients with a diagnosis of inflammatory bowel disease, irritable bowel symptoms, or acute gastroenteritis
* Patients taking immunosuppressive medications
* Patients who are pregnant
* Patients who are breast feeding/lactating
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
|
NCT02389062
|
{
"brief_title": "Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients",
"conditions": [
"Adult Form of Celiac Disease"
],
"interventions": [
"Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals."
],
"location_countries": [
"United States"
],
"nct_id": "NCT02389062",
"official_title": "Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients: Prospective, Randomized,Placebo Controlled, Double Blind Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02-11",
"study_completion_date(actual)": "2017-02-11",
"study_start_date(actual)": "2015-02-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-19",
"last_updated_that_met_qc_criteria": "2015-03-09",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-17",
"first_submitted": "2015-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.
#Intervention
- OTHER : Allergic rhinitis
- Questionnaire
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged between 6 and 65 years.
* Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
* Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
* Patients presented for symptomatic management of allergic rhinitis.
* Patients having Symptoms score >= 6.
Exclusion Criteria:
* Patients involved in any other clinical/observational study.
* patients unable to fill in the study questionnaires.
* Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
* Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
* Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01953471
|
{
"brief_title": "Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)",
"conditions": [
"Allergic Rhinitis Due to Grass Pollen"
],
"interventions": [
"Other: Allergic rhinitis"
],
"location_countries": [
"France"
],
"nct_id": "NCT01953471",
"official_title": "Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2011-04"
},
"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)": "2016-11-03",
"last_updated_that_met_qc_criteria": "2013-09-26",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-01",
"first_submitted": "2013-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
Detailed Description
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.
#Intervention
- DEVICE : Repetitive magnetic stimulation to superior temporal gyrus
- Repetitive magnetic stimulation to superior temporal gyrus
- Other Names :
- MagPro X100 magnetic stimulator
- DEVICE : Repetitive magnetic stimulation to middle temporal gyrus
- Repetitive magnetic stimulation to middle temporal gyrus
- Other Names :
- MagPro X100 magnetic stimulator
- DEVICE : Repetitive magnetic stimulation (Sham)
- Repetitive magnetic stimulation (Sham)
- Other Names :
- MagPro X100 magnetic stimulator
|
#Eligibility Criteria:
Inclusion Criteria:
* fluent in Korean
* older than 18 years
Exclusion Criteria:
* younger than 18 years
* psychotic or psychiatric problems
* pregnant
* contraindications to MRI/fMRI
* uncooperative
* metalic implants, pacemaker or cochlear implants
* cannot perform outcome measure-related task
* known seizure history
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
|
NCT01877161
|
{
"brief_title": "Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types",
"conditions": [
"To Healthy Volunteer",
"Virtual Lesions for Aphasia"
],
"interventions": [
"Device: Repetitive magnetic stimulation (Sham)",
"Device: Repetitive magnetic stimulation to superior temporal gyrus",
"Device: Repetitive magnetic stimulation to middle temporal gyrus"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01877161",
"official_title": "Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types",
"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)": "2012-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-31",
"last_updated_that_met_qc_criteria": "2013-06-10",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-13",
"first_submitted": "2013-03-11",
"first_submitted_that_met_qc_criteria": "2014-05-20"
}
}
}
|
#Study Description
Brief Summary
Esophageal atresia is a rare but severe malformation, and it requires early surgery. Coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. In the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.
Detailed Description
Esophageal atresia (EA) is a defect of the embryogenesis of the laryngotracheal tube. There are isolated forms of EA and combinations with a tracheoesophageal fistula (TPF). Esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with EA. After this surgical intervention children require observation in the intensive care unit (ICU). During this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. However, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. Thus, fluid overload develops. It is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. As a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. Fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.
|
#Eligibility Criteria:
Inclusion Criteria:
* Аge from 1 month to 3 years
* EA with / without
* Tracheoesophageal fistula (TPF)
* Сoloesophagoplasty.
Exclusion Criteria:
* Аesophageal burn,
* Oesophageal peptic stenosis,
* Congenital heart disease
* Cardiotonic support in the postoperative period
* Renal malformations
* Bacterial pneumonia in the postoperative period,
* Bronchopulmonary malformations.
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05129930
|
{
"brief_title": "Fluid Overload and Pulmonary Function",
"conditions": [
"Water-Electrolyte Imbalance",
"Intensive Care Units",
"Pediatric",
"Critical Illness",
"Length of Stay",
"Respiratory Failure",
"Esophageal Atresia"
],
"interventions": null,
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT05129930",
"official_title": "Fluid Overload and Pulmonary Function After Coloesophagoplasty in Children. Single-central Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-20",
"study_completion_date(actual)": "2021-05-01",
"study_start_date(actual)": "2020-12-01"
},
"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)": "2021-11-22",
"last_updated_that_met_qc_criteria": "2021-11-11",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-22",
"first_submitted": "2021-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the effects of Low-Dye and Kinesio Taping on pain and function in individuals with plantar fasciitis.
Detailed Description
Subject: In this study, the effects of Low-Dye Taping and Kinesio Taping (KT) on pain and function will be investigated in individuals with plantar fasciitis. There are studies on both Low-Dye banding and KT in the literature and they are popular applications recently. However, to the best of our knowledge, when we look at the Turkish and English literature, no study has been found comparing these two therapeutic massages in terms of pain, functionality and performance.
Purpose: Plantar fasciitis (PF) is a clinical picture characterized by degeneration of the plantar fascia resulting from repetitive microtrauma to the plantar fascia causing an inflammatory reaction. It is one of the most common causes of heel pain in adults. The plantar fascia has a fundamental role in the biomechanics of the foot, supporting the medial longitudinal arch (MLA), distributing forces and stresses of the foot during gait or other loading conditions. Disorders in the musculoskeletal and somatosensory system in patients with plantar fasciitis may cause pain and decrease in functional capacity. Therefore, its purpose is; This study was planned to show the effectiveness of taping methods applied in addition to ESWT in individuals presenting with heel pain. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
#Intervention
- DEVICE : Extracorporeal Shockwave Therapy (ESWT)
- Extracoporeal shock wave, 2000 shots/time, once a week for 3 weeks, shock wave freqency: 10Hz, total energy: 166 mJ/mm2, Pressure 2.5 Bar
- OTHER : Low-Dye Taping
- After ESWT application, Low-Dye Taping will be applied 3 times, once a week.
- OTHER : Kinesio Taping
- After ESWT application, Kinesio Taping will be applied 3 times, once a week.
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals diagnosed with plantar fasciitis by a physician
* Age between 18 and 30 years
* Agree to participate in the study
Exclusion Criteria:
* Not having surgery
* Disagree to participate in the study
* Infection
* Pregnancy
* Tumor
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
|
NCT05592808
|
{
"brief_title": "Comparison of Taping Techniques in Plantar Fasciitis",
"conditions": [
"Plantar Fasciitis",
"Pain",
"Foot Diseases"
],
"interventions": [
"Other: Kinesio Taping",
"Device: Extracorporeal Shockwave Therapy (ESWT)",
"Other: Low-Dye Taping"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05592808",
"official_title": "Comparison of the Effects of Low-Dye and Kinesio Taping Methods in Plantar Fasciitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-20",
"study_completion_date(actual)": "2023-03-27",
"study_start_date(actual)": "2022-10-24"
},
"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)": "2023-03-30",
"last_updated_that_met_qc_criteria": "2022-10-20",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-25",
"first_submitted": "2022-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to examine the reproducibility of postprandial coronary heart disease (CHD) risk marker and sleep responses to acute exercise bouts and to quantify the magnitude of individual variability in responses using a replicated crossover design. Healthy, recreationally active men will complete two identical rest control and two identical exercise (60 min at 60% maximum oxygen uptake) conditions in randomised sequences. Fasting and postprandial venous blood samples, arterial blood pressure and arterial stiffness measurements will be taken at pre-determined intervals, and sleep duration and quality will be assessed. Reproducibility and individual variability will be examined using bivariate correlations and linear mixed modelling.
Detailed Description
Single bouts of exercise reduce circulating concentrations of postprandial triacylglycerol - an established independent risk marker for coronary heart disease (CHD). The exercise-induced reduction in postprandial triacylglycerol concentrations has been shown to coincide with transient changes in other CHD risk markers, including reductions in postprandial insulin, interleukin-6, arterial stiffness and resting arterial blood pressure, and exercise may also promote sleep duration and quality. Individual variability in these responses is suspected but has not been examined using robust designs and appropriate statistical models. A recent approach to quantify individual variability in the intervention response involves quantifying the participant-by-condition interaction from replicated intervention and comparator arms. Using this approach (the replicated crossover design), the present study will (i) examine whether the postprandial CHD risk marker and sleep responses to acute exercise are reproducible on repeated occasions; and (ii) determine whether there is true individual variability in postprandial CHD risk marker and sleep responses to acute exercise.
A total of 20 healthy, recreationally active men will be recruited. Participants will undertake a preliminary measures visit (visit 1) to confirm eligibility, to undergo anthropometric measurements and to determine maximum oxygen uptake. Participants will complete four, 2-day experimental conditions in randomised sequences separated by at least one week: two identical control and two identical exercise conditions. On day 1 (visits 2, 4, 6 and 8), participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and arterial stiffness measurement will be taken. Participants will consume a standardised high fat breakfast at 08:45 (0 h) and lunch at 12:45 (4 h). A second arterial stiffness measurement will be taken at 16:45 (8 h). The two control and two exercise conditions will be identical, except that participants will be asked to exercise on the treadmill for 60 minutes at 60% of their maximum oxygen uptake at 15:15 (6.5 h) in both exercise conditions. On day 2 (visits 3, 5, 7 and 9), participants will arrive fasted at 08:00 and will rest in the laboratory throughout the day in the two control and two exercise conditions. Participants will consume a standardised breakfast at 08:45 (0 h) and a standardised lunch at 12:45 (4 h). Venous blood samples will be collected at 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h. Resting arterial blood pressure will be measured at hourly intervals. Arterial stiffness will be measured at 0, 2.5 and 5 h. Sleep duration and quality will be assessed for three nights before and two nights after visits 3, 5, 7 and 9 using a triaxial actigraphy watch.
Reproducibility and individual variability will be explored by correlating the two sets of response differences between exercise and control conditions. Within-participant covariate-adjusted linear mixed models will be used to quantify participant-by-condition interactions. It is hypothesised that (i) control-adjusted postprandial CHD risk marker and sleep responses to acute exercise will be reproducible; and (ii) true interindividual variability will exist in postprandial CHD risk marker and sleep responses to acute exercise beyond any random within-subject variation.
#Intervention
- BEHAVIORAL : Exercise
- 60 min treadmill exercise performed at 60% of maximum oxygen uptake.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 45 men;
* Be able to run continuously for 1 hour;
* Body mass index between 18.5 and 29.9 kg/m2;
* No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Exclusion Criteria:
* Musculoskeletal injury that has affected normal ambulation within the last month;
* Uncontrolled exercise-induced asthma;
* Coagulation or bleeding disorders;
* Heart conditions;
* Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
* Taking any medication that might influence fat metabolism, blood glucose or appetite;
* Smoking (including vaping);
* Dieting or restrained eating behaviours;
* Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
* Presence of any diagnosed sleeping disorder;
* A food allergy.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05022498
|
{
"brief_title": "Individual Variability of Coronary Heart Disease Risk Markers and Sleep Responses to Exercise",
"conditions": [
"Coronary Heart Disease",
"Cardiovascular Risk Factor",
"Arterial Stiffness",
"Blood Pressure",
"Sleep"
],
"interventions": [
"Behavioral: Exercise"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05022498",
"official_title": "A Replicated Crossover Study Exploring Individual Variability of Postprandial Coronary Heart Disease Risk Markers and Sleep Quality in Response to Acute Exercise in Healthy Young Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-13",
"study_completion_date(actual)": "2021-07-13",
"study_start_date(actual)": "2019-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-17",
"last_updated_that_met_qc_criteria": "2021-08-20",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-26",
"first_submitted": "2021-08-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.
#Intervention
- DEVICE : W-GenZD
- W-GenZD is a program that delivers evidence based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief 'conversations' with a fully automated relational agent.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adolescents aged 16 <= age <= 17 years
* Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5 <= age <= 19, inclusive, assessed at screening/baseline
* Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
* Available and committed to engage with the program and complete assessments for an 8-week duration
* Able to read and write in English
* U.S. resident
* Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
* If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
* Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
Exclusion Criteria:
* Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
* Lifetime diagnosis of bipolar disorder
* Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
* Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
* History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
* Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
* Previous Woebot Application use
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04985331
|
{
"brief_title": "Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents",
"conditions": [
"Depression, Teen"
],
"interventions": [
"Device: W-GenZD"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04985331",
"official_title": "Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-16",
"study_completion_date(actual)": "2022-01-04",
"study_start_date(actual)": "2021-08-02"
},
"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)": "2022-01-05",
"last_updated_that_met_qc_criteria": "2021-07-30",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-02",
"first_submitted": "2021-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.
#Intervention
- DEVICE : Transcranial direct current stimulation (tDCS)
- The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.
Exclusion Criteria:
* Musculoskeletal or neurological disorder
* Under medication
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03870178
|
{
"brief_title": "Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.",
"conditions": [
"Healthy"
],
"interventions": [
"Device: Transcranial direct current stimulation (tDCS)"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03870178",
"official_title": "Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors in Healthy Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-30",
"study_completion_date(actual)": "2021-04-30",
"study_start_date(actual)": "2019-01-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"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": "2019-03-08",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-11",
"first_submitted": "2019-03-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to determine whether the injection of botulinum toxin A or placebo (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain relief and improved jaw function in those who suffer from myofascial pain disorder. The study hypothesis is that botulinum toxin A injection is superior to placebo. The specific research questions are:
1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain?
2. Is the injection of botulinum toxin A superior to placebo for the improvement in function or quality of life (QOL)?
3. Are there any adverse effects that result from injection of botulinum toxin A or placebo into the masseters and temporalis muscles? Limited data exists to support the use of botulinum toxin A in the management of myofascial pain disorder of the masticatory region. Botulinum toxin A is not FDA approved for intra-muscular injection within the masticatory region. Its use in the masticatory region is considered off-label but performed without significant known complications. This study will provide the opportunity to quantitate and qualitate any complications in a large prospective sample of patients.
Detailed Description
Myofascial pain is classically used to describe pain experienced in the masticatory muscles and its associated structures (Freund 1999). It afflicts nearly 10% of Americans (Freund 2000). There have been many described treatments such as the use of oral appliances, non-steroidal anti-inflammatory medications, physiotherapy, behavioral therapy and counseling, acupuncture, and botulinum toxin injections (Freund 2000). However, no single treatment has been found to be significantly superior to the others (Freund 2000).
This is a randomized, double-blind, placebo-controlled multicenter study. Subjects will be recruited from the divisions of Oral and Maxillofacial Surgery from all sites. Patients aged 18-65 years with myofascial pain involving the temporalis and masseters are eligible to enter the study. A complete history and physical examination will be performed for all patients in order to make an accurate diagnosis. The research diagnostic criteria (RDC/TMD) will be used to assign a diagnosis of myofascial pain of the masticatory region. All investigators and site-specific data collectors will be trained and calibrated in physical examination techniques and data collection to ensure uniformity between sites. Patients will complete a visual analog scale regarding pain during their screening appointment. To participate in the study, the subject must have greater than or equal to 3.5/10 on the visual analog scale of pain. Informed written consent will be obtained from all patients. Any patient lacking the capacity to make medical decisions will be excluded from the study, although they will be treated as deemed medically necessary. Consent will be written at the sixth grade level, and all potential subjects will be asked to verbally repeat the purpose, methods, and required follow-up to ensure adequate understanding.
The site specific PI will educate fellow faculty and referring departments that the study is enrolling new subjects, advertising is anticipated, and referring physicians will not receive any financial compensation. The intent is to enroll a total of 110 subjects from all sites. The study participants will be reimbursed $25 per treatment visit for their participation.
Previous studies have demonstrated a reduction of pain as indicated on the visual analogue scale of 45% and 32% with the use of intramuscular botulinum toxin A injections into masseter and temporalis (Freund 1999, Guarda-Nardini 2012). Von Lindern et. al. found a mean reduction of 3.2 points on a visual analog scale in the verum group. Based on the preliminary data and the sample size calculations estimating a difference in mean pre-post VAS change between groups of 1 point or greater (on a scale of 1-10), we plan to enroll a total of 110 subjects. With 50 patients in the botulinum toxin A injection group and 50 patients in the placebo group (N=100), the study will have more than 90% power to detect a difference in mean in pre-post change between groups of 1.0 point or greater on VAS, using a two-sided t-test and assuming a standard deviation of 1.5 for the mean difference. This calculation allows for 10% attrition rate. An intent-to-treat design will be followed and all subjects will have scheduled outcome evaluations until the end of the study, death of the subject, or subject refusal. Subjects will be withdrawn from their randomly assigned treatment for considerations of subject safety only.
Descriptive statistics including mean, standard deviation, median, range, frequency, and percent will be calculated for the entire cohort as well as by the study arm (botulinum toxin A and unpreserved 0.9% sodium chloride) to assess the results of randomization and identify potential confounders. The primary analyses of the data will be performed according to subjects' original treatment assignment (i.e., intention-to-treat analyses) and the inclusion of all data from all subjects randomized in the final analysis. To assess the primary endpoint of improvement of pain on a visual analog scale (VAS) between pre-op, 1, 2, and month post-op, and 3 months post-op, a repeated measure of analysis of variance will be performed with one between subject factor (botulinum toxin A versus placebo) and one within subject factor (time). This analysis will also be used for the secondary endpoints: function (MIO/jaw limitation scale) and quality of life (SF12). In the event of significant loss to follow-up, we will explore the use of a linear mixed model to assess the independent effect of the study group on VAS over the study visits. The paired t-test, or the signed-rank test as appropriate, will be used to assess change in pain, function, and QOL between pairs of relevant time points for both study arms. To assess the difference in proportion of adverse events between the botulinum toxin A and placebo groups, either the chi-square or Fisher's exact test will be used, as appropriate. All p-values will be two-sided with statistical significance evaluated at the 0.05 alpha level. Ninety-five percent confidence intervals (95% CI) will be calculated to assess the precision of the obtained estimates. All analyses will be performed in SAS Version 9.4 (SAS Institute Inc., Cary, NC). Note: This section was drafted in conjunction with Dr. Paul Christos and Gulce Askin, MPH in the Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research. They will be aiding in protocol design and development, data management, study implementation, study monitoring, and data analysis and reporting.
Adverse events will be reported to the Data and Safety Monitoring Board every six months. The participants will be provided with the phone number of the primary investigator and co-investigators for use in reporting any adverse events. The study participants will also be questioned at one, two, and and three months post-treatment for the occurrence of any adverse events. The report of any such events will provide details including severity, relationship to treatment, onset, duration, and outcome. The Data and Safety Monitoring Board will regularly review these reports, and should any trend develop that suggests significant adverse outcomes, the study will be discontinued. If any serious adverse events occur (death, life-threatening, those involving prolonged hospitalization or disability), the independent study monitor, other study sites, IRBs, and DSMB will be notified with 24 hours in the case of death or 72 hours in the event of other serious adverse events.
IRB approval for this study is currently in process (assigned protocol number 1607017383). Pending approval from the IRB for each involved site, research investigators will honor their responsibility to safeguard the rights and welfare of individuals who are or may become subjects of research. Investigators will also maintain compliance with Department of Health and Human Services regulations. All requirements and determinations made by the IRB will be followed to minimize unnecessary risks to subjects. The investigators will abide by procedures consistent with sound research design. Botulinum toxin A is currently not FDA approved for use in myofascial pain disorder of the masticatory region. If the IRB deems its use a 'subject risk,' an application for investigational new drug (IND) will be submitted to the FDA under the research or noncommercial category. This requirement is not anticipated given the routine use of botulinum toxin A, previous studies demonstrating benefit with minimal risk, and its existing FDA approval for use in the masseter and temporalis muscles for orofacial dystonia/dyskinesia.
#Intervention
- DRUG : Botulinum toxin type A
- 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
- Other Names :
- Botulinum, Botox, Allergan, Botulinum Toxin A
- DRUG : 0.9% Sodium Chloride Injection
- 1cc syringe
- Other Names :
- Saline, Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 65 years
* Ability to give informed consent
* Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
* Baseline pain measured by the subject >=3.5/10 on visual analog scale
Exclusion Criteria:
* Baseline pain measured by the subject <3.5/10 on visual analog scale
* Central/Neuropathic pain disorder affecting the masticatory muscles
* Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles
* Previous Temporomandibular Joint Surgery
* Systemic arthropathies
* Fibromyalgia
* Allergy to study medications
* Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
* Mandibular fracture within last 12 months
* Pregnancy or breast feeding
* Cervical radiculopathy or surgery
* Prior botox injection in the masticatory muscles
* Initiation of additional treatment of MPD within the past 3 months
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
|
NCT03223298
|
{
"brief_title": "Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles",
"conditions": [
"Pain, Head",
"Pain Syndrome",
"Temporomandibular Disorder",
"Myofascial Pain Syndrome",
"Myofascial Pain"
],
"interventions": [
"Drug: 0.9% Sodium Chloride Injection",
"Drug: Botulinum toxin type A"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03223298",
"official_title": "Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-13",
"study_completion_date(actual)": "2020-03-13",
"study_start_date(actual)": "2018-08-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-14",
"last_updated_that_met_qc_criteria": "2017-07-18",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-21",
"first_submitted": "2017-07-11",
"first_submitted_that_met_qc_criteria": "2023-01-19"
}
}
}
|
#Study Description
Brief Summary
Confirmation of safety profile
|
#Eligibility Criteria:
Inclusion Criteria:
* treatment of Ulcerative Colitis
Exclusion Criteria:
* hypersensitivity to mesalazine
* severe liver or renal impairment
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
|
NCT01517594
|
{
"brief_title": "Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis",
"conditions": [
"Ulcerative Colitis"
],
"interventions": null,
"location_countries": [
"Czech Republic"
],
"nct_id": "NCT01517594",
"official_title": "Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic",
"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)": "2011-10"
},
"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)": "2013-10-21",
"last_updated_that_met_qc_criteria": "2012-01-20",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-25",
"first_submitted": "2012-01-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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