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#Study Description
Brief Summary
The primary objective of the trial is to compare the acute safety and long term outcomes between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or non-Q wave MI) presenting to non-SOS hospitals.
Detailed Description
The MASS COMM trial is a prospective, multi-center, randomized, controlled two-arm trial of PCI performed at non-SOS hospitals (non-SOS-PCI arm) versus PCI performed at SOS hospitals (SOS-PCI arm). The trial is designed to reject the null-hypothesis of inferiority, and thereby show the non-inferiority of the non-SOS-PCI arm to the SOS-PCI arm.
Specifically, 3690 subjects will be enrolled in a multi-center, randomized, controlled trial (RCT), in which eligible subjects will be consented and randomized in a 3:1 ratio at the non-SOS hospitals for PCI to be performed at either the enrolling non-SOS hospital (3 chances out of 4) or a corresponding SOS hospital (1 chance out of 4).
#Intervention
- PROCEDURE : PCI
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years.
* Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).
* Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
* Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG).
* Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
* Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.
* Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm.
* Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
* Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
* The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater than 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.
* Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more than 72 hours following the ST segment elevation myocardial infarction (STEMI).
Lesions treated with PCI more than 72 hours following STEMI would be subject to the same protocol inclusion/exclusion criteria listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).
Exclusion Criteria:
* The patient is pregnant or breastfeeding.
* Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
* Cardiogenic shock on presentation or during current hospitalization.
* Left ventricular ejection fraction less than 20%.
* Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
* A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3.
* Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).
* Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
* Prior participation in this study.
* Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.
* Stroke or transient ischemic attack within the prior 3 months.
* Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.
* Subject has active sepsis.
* Unprotected left main coronary artery disease (stenosis greater than 50%).
* In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
* Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).
* Any target vessel has evidence of:
* excessive thrombus (e.g. requires target vessel thrombectomy)
* tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
* heavy calcification.
* Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
* Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
* The target vessel is in a 'last remaining' epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).
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
|
NCT01116882
|
{
"brief_title": "Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings",
"conditions": [
"Coronary Artery Diseases"
],
"interventions": [
"Procedure: PCI"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01116882",
"official_title": "A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2006-06"
},
"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)": "2015-04-07",
"last_updated_that_met_qc_criteria": "2010-05-04",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-05",
"first_submitted": "2010-04-29",
"first_submitted_that_met_qc_criteria": "2014-06-06"
}
}
}
|
#Study Description
Brief Summary
Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 18 years
* Legally competent male and female patients
* Advanced or metastatic transitional cell carcinoma of the urothelium
* Failure of a prior Cisplatinum-containing treatment
* Performance Status 0 or 1
* Signed patient informed consent
Exclusion Criteria:
* Missing signed patient informed consent
* Performance Status 2 or higher
* Life expectancy < 2 months
* Brain metastases
* Creatinine-clearance < 20 ml/min
* Child-Pugh-stadium C
* Prothrombin time < 50%
* Bilirubin > 5 x ULN
* Transaminases > 6 x ULN
* Gamma-Glutamyl-transferase > 15 x ULN
* Pregnant or breast-feeding women
* Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids
* Recent (within the last 2 weeks) or current severe infections
* Baseline ANC < 1,500/mm3 or platelets < 100,000/mm3
* Patients being institutionalised due to court/regulatory order
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
|
NCT01103544
|
{
"brief_title": "JAVLOR® Online Non-Interventional Trial",
"conditions": [
"Transitional Cell Carcinoma"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT01103544",
"official_title": "Usage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2010-04"
},
"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)": "2015-05-13",
"last_updated_that_met_qc_criteria": "2010-04-13",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-14",
"first_submitted": "2010-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeutic relationship between patients and physicians, resulting in short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way.
The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.
Detailed Description
Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.
The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home Monitoring capability. The latter allows wireless, everyday transfer of the essential status and therapy data from the ICD memory to a website accessible by the attending physicians. The website is managed by BIOTRONIK Home Monitoring Service Center.
Patients will be randomised into:
* Group 1: Home Monitoring is established from the outset.
* Group 2: Home Monitoring is introduced 9 months after ICD implantation.
Follow-up for both groups is 18 months.
Study Hypothesis: Home Monitoring improves the Hospital Anxiety Score in ICD patients.
Preoperatively, HADS (Hospital Anxiety and Depression Scale), Questionnaire on Type D personality (DS 14), and SF-12 Questionnaire will be applied. At follow-up visits every 3 months, HADS, SF-12 Questionnaire, Shock Sensation Questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. Home Monitoring ICD Impact Questionnaire will be collected at the final 18-month follow-up.
#Intervention
- DEVICE : HM on
- Home Monitoring activated after implantation
- DEVICE : HM Off
- Home Monitoring activated 9 months after implantation
|
#Eligibility Criteria:
Inclusion Criteria:
* Indication for ICD implantation either as primary or secondary prevention
* Patient informed consent
Exclusion Criteria:
* ICD replacement indication
* Indication for cardiac resynchronisation therapy
* Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits
* Co-morbidities with a resulting life expectancy of less than one year
* Psychosomatic disease (requiring psychiatric therapy)
* Age <18 years
* Patients who are already enrolled in another study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00325221
|
{
"brief_title": "Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)",
"conditions": [
"Arrhythmia",
"Quality of Life"
],
"interventions": [
"Device: HM Off",
"Device: HM on"
],
"location_countries": [
"Austria",
"Germany",
"Switzerland"
],
"nct_id": "NCT00325221",
"official_title": "QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2006-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-31",
"last_updated_that_met_qc_criteria": "2006-05-11",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-12",
"first_submitted": "2006-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.
Detailed Description
To determine and compare clinical and histological effectiveness of different (70 J/cm2 ir 100 J/cm2) light doses when treating actinic keratoses with photodynamic therapy.
To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.
#Intervention
- DEVICE : Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source
- Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp.
Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval.
- PROCEDURE : Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source
- Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subject older than 50 years.
* Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
* AK with the largest diameter <=3 cm (measuring the longest axis).
* 2 or more AK with symmetrical distribution on the face or scalp.
* Clinically and histologically confirmed AK of grade I or II.
* Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
* Patient is not the subject of the administrative or legal judicial proceeding.
* Subject has social health security required by laws of health care institutions.
Exclusion Criteria:
* Patients with more than 5 AK in the planned treatment area.
* A recurrent AK: AK that has been previously treated in the study area.
* Very hyperkeratotic, grade 3 (on a 0 <= age <= 3 scale) AK lesions among the target lesions.
* AK located on the nose.
* Other skin lesions (diseases) in the tumor study area.
* Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
* Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
* Subject who had received photosensitizing drugs 30 days before study start.
* Subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation.
* Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
* Subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of AKs within 2 months before study entry.
* Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
* Subject with known status after organ transplantation.
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
|
NCT01541228
|
{
"brief_title": "Photodynamic Treatment of Actinic Keratoses With Different Light Doses",
"conditions": [
"Actinic Keratosis"
],
"interventions": [
"Procedure: Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source",
"Device: Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source"
],
"location_countries": [
"Lithuania"
],
"nct_id": "NCT01541228",
"official_title": "Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2010-04"
},
"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)": "2013-09-04",
"last_updated_that_met_qc_criteria": "2012-02-23",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-29",
"first_submitted": "2012-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine the efficacy and safety of enzastaurin in participants with Cutaneous T-Cell Lymphoma (CTCL) who failed prior therapies.
#Intervention
- DRUG : Enzastaurin
- 1125 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression
- Other Names :
- LY317615
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed mycosis fungoides or Sezary Syndrome.
* Stage IB to IVB disease at screening.
* Recurrent or refractory disease after at least 1 prior systemic therapy.
* Have adequate organ function defined as:
* Hepatic: total bilirubin <=1.5 times the upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) <=2.5 times the ULN.
* Renal: serum creatinine <=1.5 times the ULN.
* Adequate bone marrow reserve: platelets >=75 * 10^9/Liters (L); absolute neutrophil count (ANC) >=1.0 * 10^9/L.
* At least 30 days must have passed since other treatment for CTCL.
Exclusion Criteria:
* Receiving concurrent treatment for CTCL.
* Unable to swallow tablets.
* Receiving high potency oral or topical steroids. Low potency oral steroid may be permitted in participants who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.
* Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin.
* Have a serious concomitant systemic disorder or Human Immunodeficiency Virus (HIV).
* Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV.
* Have electrocardiogram (ECG) abnormalities.
* Are pregnant or breastfeeding.
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
|
NCT00744991
|
{
"brief_title": "A Study for Participants With Relapsed Cutaneous T-Cell Lymphoma",
"conditions": [
"Cutaneous T-Cell Lymphoma"
],
"interventions": [
"Drug: Enzastaurin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00744991",
"official_title": "A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01",
"study_completion_date(actual)": "2010-02",
"study_start_date(actual)": "2008-09"
},
"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)": "2020-10-19",
"last_updated_that_met_qc_criteria": "2008-08-29",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-01",
"first_submitted": "2008-08-29",
"first_submitted_that_met_qc_criteria": "2020-09-23"
}
}
}
|
#Study Description
Brief Summary
Study to gather information about the optimal placement of Ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of Canadian patients with prostate gland cancer which spread to other parts of the body. In order to collect this information real world data from prostate gland cancer patients from four Canadian administrative databases will be analyzed.
Data collected from patients treated with their 2nd line of life-prolonging therapy for Non-Metastatic Castration Resistant Prostate Cancer (mCRPC) initiated from 01 Jan 2012 to 31 Dec 2017. For patients included in the study, all available data from the beginning for their record until death, lost to follow-up or database cut-off will be included. The index date is the date of initiation of the 2nd line life-prolonging therapy for mCRPC.
#Intervention
- DRUG : Radium-223 dichloride (Xofigo, BAY88-8223)
- Follow clinical administration
|
#Eligibility Criteria:
Inclusion Criteria:
* Use of at least 2 lines of life-prolonging mCRPC therapy
* The 2nd line of life-prolonging therapy was initiated between 01-Jan-2012 to 31-Dec-2017
Exclusion Criteria:
* No formal exclusion criteria will be applied in order to capture real world use of Ra-223
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04281147
|
{
"brief_title": "Study to Gather Information About the Use of Healthcare Services and the Way the Disease is Cared for in Canadian Patients With Prostate Gland Cancer Which Spread Throughout the Body",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: Radium-223 dichloride (Xofigo, BAY88-8223)"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04281147",
"official_title": "Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-22",
"study_completion_date(actual)": "2021-06-22",
"study_start_date(actual)": "2020-02-24"
},
"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)": "2022-06-23",
"last_updated_that_met_qc_criteria": "2020-02-20",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-24",
"first_submitted": "2020-02-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
Detailed Description
The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
#Intervention
- DRUG : Dexamethasone
- Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
- OTHER : Placebo
- Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
- DRUG : Morphine
- Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
- DRUG : Zofran
- Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
- DRUG : Paracetamol
- Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
- DRUG : Ibuprofen
- Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing lumbar disc surgery in general anaesthesia.
* Patients who have given their written consent to participate and understand the contents of the protocol.
* ASA 1 <= age <= 3.
* BMI > 18 og < 40.
* Fertile women need a negative HCG urine test.
Exclusion Criteria:
* Patients who cannot cooperate to the study.
* Patients who do not speak and/or understand Danish.
* Fertile women with a positive HCG urine test.
* Allergy to the drugs used in the trial.
* Alcohol or medicine abuse, assessed by investigator.
* Patients who have had spine surgery before.
* Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
* Daily oral steroid treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01953978
|
{
"brief_title": "The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery",
"conditions": [
"Pain"
],
"interventions": [
"Other: Placebo",
"Drug: Dexamethasone",
"Drug: Zofran",
"Drug: Morphine",
"Drug: Paracetamol",
"Drug: Ibuprofen"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT01953978",
"official_title": "The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2012-12"
},
"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)": "2015-10-27",
"last_updated_that_met_qc_criteria": "2013-09-26",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-01",
"first_submitted": "2013-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify 'triggering events' that lead to aliskiren initiation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Patients ages 18 yeras and older
* Hypertension Diagnosis
* Currently on at least 1 hypertensive medication
* At least 2 lab measure before and after aliskiren initiation
Exclusion Criteria:
* Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3 <= age <= 12 months prior to initiation of Aliskiren
* Pregnancy
* Development of secondary renal disease unrelated to diabetes (such as nephritis)
* Terminal illness
* AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply
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
|
NCT01393860
|
{
"brief_title": "Real-world Aliskiren Use in Diabetic Patients",
"conditions": [
"Diabetes",
"Hypertension"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01393860",
"official_title": "Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": null,
"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)": "2011-07-14",
"last_updated_that_met_qc_criteria": "2011-07-12",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-13",
"first_submitted": "2011-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.
SECONDARY OBJECTIVES:
I. Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.
ARM B: Patients and their support persons undergo the usual care over 8 weeks.
#Intervention
- BEHAVIORAL : exercise intervention
- Receive aerobic and exercise intervention
- PROCEDURE : standard follow-up care
- Receive usual care
- PROCEDURE : quality-of-life assessment
- Ancillary studies
- Other Names :
- quality of life assessment
- OTHER : laboratory biomarker analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer [NSCLC] or small cell lung cancer [SCLC])
* LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
* LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
* LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
* SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
Exclusion Criteria:
* LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
* LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
* LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
* LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
* LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
* LUNG CANCER PATIENTS: Current participation in an exercise program
* SUPPORT PERSONS: Symptomatic heart disease including congestive heart failure or arrhythmia
* SUPPORT PERSONS: Documented myocardial infarction in the last three months
* SUPPORT PERSONS: Cognitive or reading impairments that would preclude them from completing questionnaires
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
|
NCT01999881
|
{
"brief_title": "Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients",
"conditions": [
"Extensive Stage Small Cell Lung Cancer",
"Healthy, no Evidence of Disease",
"Limited Stage Small Cell Lung Cancer",
"Recurrent Non-small Cell Lung Cancer",
"Recurrent Small Cell Lung Cancer",
"Stage IA Non-small Cell Lung Cancer",
"Stage IB Non-small Cell Lung Cancer",
"Stage IIA Non-small Cell Lung Cancer",
"Stage IIB Non-small Cell Lung Cancer",
"Stage IIIA Non-small Cell Lung Cancer",
"Stage IIIB Non-small Cell Lung Cancer",
"Stage IV Non-small Cell Lung Cancer"
],
"interventions": [
"Behavioral: exercise intervention",
"Procedure: quality-of-life assessment",
"Other: laboratory biomarker analysis",
"Procedure: standard follow-up care"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01999881",
"official_title": "Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2013-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-18",
"last_updated_that_met_qc_criteria": "2013-11-25",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-03",
"first_submitted": "2013-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.
Detailed Description
This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged >= 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
* Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:
* unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
* unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis
Exclusion Criteria:
* Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
* Patients participating in another study program or clinical trial
* Patients who have been treated with Humira before
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
|
NCT01273519
|
{
"brief_title": "Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab",
"conditions": [
"Rheumatoid Arthritis",
"Ankylosing Spondylitis",
"Psoriatic Arthritis"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT01273519",
"official_title": "Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2011-01"
},
"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)": "2014-03-26",
"last_updated_that_met_qc_criteria": "2011-01-07",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-10",
"first_submitted": "2011-01-07",
"first_submitted_that_met_qc_criteria": "2014-01-09"
}
}
}
|
#Study Description
Brief Summary
The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.
Detailed Description
Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children.
Method:
* Retrospective inclusion of all patients \<18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment.
* Data collected (by collection in the medical file):
Patient data: Age, sex, personal and family history of hemorrhagic disease
Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease
* Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score
* Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.
|
#Eligibility Criteria:
Inclusion criteria:
* referred by their general practitioner or another caring physician for evaluation of bleeding symptoms
* abnormal laboratory test results or family study
* the patient being the first-degree relative of a patient with a known bleeding disorder.
Exclusion criteria:
* older than 18 years.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05214300
|
{
"brief_title": "Screening for Bleeding Disorders in Children",
"conditions": [
"Bleeding Disorder"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05214300",
"official_title": "Screening for Bleeding Disorders in Children: Evaluation of the Elements of the Interrogation, the Screening Workup and the Clinical Scores",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-01",
"study_completion_date(actual)": "2021-12-20",
"study_start_date(actual)": "2019-12-01"
},
"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)": "2022-01-28",
"last_updated_that_met_qc_criteria": "2022-01-17",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-28",
"first_submitted": "2021-12-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment
#Intervention
- DRUG : BIBW 2992
- patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
- DRUG : trastuzumab
- patients receive trastuzumab 2mg/kg intravenously every week
- DRUG : vinorelbine
- patients receive vinorelbine 25mg/m² intravenously every week
- DRUG : vinorelbine
- patients receive vinorelbine 25mg/m² intravenously every week
|
#Eligibility Criteria:
Inclusion criteria:
* Histologically confirmed diagnosis of HER2-overexpression breast cancer
* Stage IV metastatic disease
* Must have progressed on one prior trastuzumab treatment
* no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
* Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
* Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
* At least one measurable lesion according to RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .
Exclusion criteria:
* Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
* Prior treatment with vinorelbine
* Known pre-existing interstitial lung disease
* Active brain metastases
* History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
* Cardiac left ventricular function with resting ejection fraction of less than 50%.
* Patients unable to comply with the protocol.
* Any contraindications for therapy with vinorelbine or trastuzumab.
* Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
* Use of any investigational drug within 4 weeks of randomisation.
* Inadequate hepatic, renal and haematologic organ function
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
|
NCT01125566
|
{
"brief_title": "LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment",
"conditions": [
"Breast Neoplasms"
],
"interventions": [
"Drug: BIBW 2992",
"Drug: vinorelbine",
"Drug: trastuzumab"
],
"location_countries": [
"Netherlands",
"United States",
"China",
"Germany",
"Poland",
"Singapore",
"Austria",
"Belarus",
"Czechia",
"United Kingdom",
"France",
"Japan",
"Israel",
"Taiwan",
"South Africa",
"Russian Federation",
"Australia",
"Argentina",
"Italy",
"Slovenia",
"Lebanon",
"Turkey",
"Slovakia",
"Mexico",
"Egypt",
"Ireland",
"Peru",
"Brazil",
"Korea, Republic of",
"Latvia",
"India",
"Lithuania",
"Chile",
"Portugal",
"Canada",
"Spain",
"Belgium",
"Sri Lanka"
],
"nct_id": "NCT01125566",
"official_title": "LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06-08",
"study_completion_date(actual)": "2018-07-06",
"study_start_date(actual)": "2010-06-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-18",
"last_updated_that_met_qc_criteria": "2010-05-17",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-18",
"first_submitted": "2010-05-10",
"first_submitted_that_met_qc_criteria": "2014-08-05"
}
}
}
|
#Study Description
Brief Summary
Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.
Detailed Description
Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.
#Intervention
- DIAGNOSTIC_TEST : Oxygen Enhanced MRI scan
- Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.
|
#Eligibility Criteria:
Inclusion Criteria:
Non-patient Volunteer Inclusion Criteria:
* Age 18 years and above
* Signed written informed consent
Patient Inclusion Criteria:
* Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck
* Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT
* Age 18 years and above
* Adequate physical fitness (WHO performance status 0 to 2)
* Signed written informed consent
Exclusion Criteria:
Non-patient Volunteer Exclusion Criteria:
* Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol
Patient Exclusion Criteria:
* Poor physical fitness (WHO performance status greater than 2)
* Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04724096
|
{
"brief_title": "Evaluation of OE-MRI in Patients With H&N Cancer",
"conditions": [
"Head and Neck Squamous Cell Carcinoma"
],
"interventions": [
"Diagnostic Test: Oxygen Enhanced MRI scan"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04724096",
"official_title": "Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-28",
"study_completion_date(actual)": "2023-02-01",
"study_start_date(actual)": "2021-03-04"
},
"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)": "2023-05-06",
"last_updated_that_met_qc_criteria": "2021-01-21",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-26",
"first_submitted": "2021-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aluminum is a very abundant element in nature. Humans are exposed to this metal through the environment, diet, and drinking water, as well as through the consumption of certain medications.
Aluminum is not an essential element for human, being able to become neurotoxic when it reaches the brain once ingested at very high doses and, above all, if there is also kidney dysfunction.
Silicon is one of the most abundant elements on the planet and although it is not considered an essential element for humans, some beneficial activities have been documented.
Silicon has been found to be readily available in food and that 41% of ingested silicon is excreted in the urine, with a significant correlation between silicon ingested with food and urinary silicon excretion.
The most bioavailable silicon is that found in the form of silicic acid or orthosilicic acid.
Numerous studies suggest that silicon can reduce the oral absorption of aluminum and / or improve its excretion and, therefore, protect against the adverse effects induced by the ingestion of aluminum.
In a clinical study with healthy individuals as a control group for Alzheimer's disease, the levels of aluminum excretion were analyzed after the continuous ingestion of water enriched in silicon. The results in the first urine of the morning during the first week of ingestion of the enriched water showed that the excretion of aluminum was 136.9 ± 81.4 µmol / nmol creatinine while in the baseline week it was lower, 98.8 ± 64.3 nmol / nmol creatinine. These results indicated that the Al excreted came from Al stored in the body.
The main objective of the study is to evaluate the effect of the consumption of three food supplements formulated with different silicon compounds (monomethylsilanetriol and / or silicic acid) on the urinary excretion of aluminum.
The secondary objectives of the study are to evaluate:
* the bioavailability of the silicon contained in three food supplements formulated with different silicon compounds.
* the effect of the consumption of three food supplements formulated with different silicon compounds on urinary excretion of mercury, nickel, arsenic, cadmium, iron and copper.
* the safety of the consumption of three food supplements formulated with different silicon compounds.
Detailed Description
It will be conducted a single-center, randomized, controlled, double-blind clinical trial with four groups in parallel (placebo, Supplement A, Supplement B and Supplement C).
The study will be carried out with a total of 40 individuals (10 individuals per group), men and women aged 40 to 65 years. Individuals will have normal serum creatinine levels: up to 1.1mg/dl in women and up to 1.4mg/dl in men.
The investigational products involved in this study are four food supplements made from silicon compounds and the corresponding placebos.
Each participant will receive a kit containing a bottle with 10 capsules and a bottle of 100 ml of liquid according to the treatments corresponding to the randomly assigned group.
During the study, the volunteers will consume one capsule and 100ml of product each day for 7 days. The first morning urine will be collected during the 7 days of treatment and also during the previous 7 days to analyze the baseline values. In addition, on days 6 and 7 of the study, the urine will be collected in three fractions up to 24h to evaluate the bioavailability of silicon.
Participants will make a total of 5 visits, including the pre-selection visit. In these visits, the following will be carried out: Revision of Inclusion and exclusion criteria; Informed consent signature;Safety biochemistry; Demographic variables (age, sex), anthropometric variables; Evaluation of dietary intake; Randomization; Delivery of the sampling material; Verification of compliance with dietary requirements; Collection of urine samples; Investigation product delivery; Determination of metals in urine; Registration of Medication and food supplements; concomitants adverse event registry.
#Intervention
- DIETARY_SUPPLEMENT : ORGONO Living Silica Acacia Gum-MMST Powder
- Participants will consume one capsule per day and one bottle per day. Capsule composition: Acacia Gum 336.1 mg/capsule; Monomethylsilanetriol 34.9 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg.
- DIETARY_SUPPLEMENT : ORGONO Living Silica Malto-OSA Powder
- Participants will consume one capsule per day and one bottle per day. Capsule composition: Maltodextrin 311.4 mg/capsule; Silicic acid 35.6 mg/capsule; Hydroxypropyl methylcellulose 95 mg/capsule. Bottle composition: water 100 ml. Silicon content per dose: 10.4 mg.
- DIETARY_SUPPLEMENT : ORGONO Living Silica Collagen Booster
- Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 99.9646 g/100 ml; Silicic acid 23.65 mg/100 ml; Monomethylsilanetriol 11.75 mg/100 ml. Silicon content per dose: 10.4 mg.
- DIETARY_SUPPLEMENT : Placebo
- Participants will consume one capsule per day and one bottle per day. Capsule composition: Hydroxypropyl methylcellulose 320 mg/capsule. Bottle composition: water 100 ml.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 40 to 65.
* Individuals with normal serum creatinine levels: up to 1.1 mg/dl in women and up to 1.4 mg/dl in men.
Exclusion Criteria:
* Individuals taking any type of medication and/or supplement containing aluminum, including antacids.
* Individuals who take food supplements and/or medication that contains mercury, nickel, arsenic, cadmium, iron, copper, and silicon.
* Individuals who eat mineral-enriched foods.
* Individuals allergic to any component of the dietary supplements of the study.
* Individuals with urge, stress or mixed urinary incontinence. Involuntary loss of urine accompanied by symptoms of both urge or stress urinary incontinence diagnosed by your primary care physician. In case of absence of diagnosis, the IU-4 questionnaire will be carried out.
* Pregnancy or breastfeeding.
* Individuals with any chronic gastrointestinal disease.
* Individuals with chronic kidney disease (or serum creatinine levels >= 1.7 mg/dl in men and >= 1.5 mg/dl in women).
* Be participating or have participated in a clinical trial or study of nutritional intervention in the last 30 days before study inclusion.
* Being a smoker.
* Consume 2 or more Standard Beverage Units daily or 17 weekly in women, or consume 4 or more Standard Beverage Units daily or 28 weekly in mens.
* Individuals whose condition does not allow them to carry out the study procedures strictly.
* Individuals with diseases with manifest symptoms that may influence the objectives of the study.
* Individuals with BMI>= 30 kg/m^2.
* Individuals whose consumption of foods rich in silicon, aluminum, mercury, nickel, arsenic, cadmium, iron and copper are high.
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:
Yes
|
NCT05116982
|
{
"brief_title": "Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL)",
"conditions": [
"Aluminium Overload",
"Biological Availability"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: ORGONO Living Silica Collagen Booster",
"Dietary Supplement: ORGONO Living Silica Malto-OSA Powder",
"Dietary Supplement: ORGONO Living Silica Acacia Gum-MMST Powder"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT05116982",
"official_title": "Interventional Study to Evaluate the Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals. Randomized, Parallel, Controlled and Double Blind Study (SILIAL)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-12",
"study_completion_date(actual)": "2022-06-12",
"study_start_date(actual)": "2022-05-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-16",
"last_updated_that_met_qc_criteria": "2021-11-02",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-11",
"first_submitted": "2021-10-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Forty-six endurance runners, 23 males (age = 16.4±1.1) and 23 females (age=16.8±1.1) participated in our study. The contribution of abdominal, thoracic, and subclavian musculature to respiration and ventilation parameters during three different intensities on a cycle ergometer was assessed pre- and post-intervention.
Detailed Description
Subjects Forty six distance runners (14-18 years) participated in our study, 23 males (age = 16.4±1.1, height = 177.1±5.8 cm, weight = 62.4±5.8 kg) and 23 females (age = 16.8±1.1, height = 168.5±4.4 cm, weight = 55.9±4.0 kg). All participants reported a history of endur-ance running of at least six times a week for the past year. Participants were randomly al-located to an experimental group (n=23), which took part in an eight-week breathing in-tervention, or a control group (n=23), which continued training but did not carry out any breathing exercises. One participant did not complete the intervention for medical rea-sons, so was excluded from the study. The two groups, both experimental and control, followed the same training program, the only difference being that the experimental group performed breathing exercises. A randomization sequence has been generated using Randomization.org. An independent person not involved in this study made the comput-er-generated randomization sequence. The study protocol was reviewed and approved by the local Ethics Committee on October 19, 2018 (002/2018) and followed the guidelines of the World Medical Assembly Declaration of Helsinki. Written informed consent to partic-ipate was provided by guardians and verbal assessment was provided by the partici-pants.
Study design We evaluated ventilatory musculature involvement in three basic areas using a muscle dynamometer MD03 as previously described. The device is a four-channel digital muscle dynamometer that, by design, al-lows instantaneous values of muscle force to be measured in relation to time (i.e., both the force size and its dynamics can be evaluated). In general, different muscles and muscle groups on the human body can be measured. MD03 is made up of four muscle probes (we used three probes) that attach themselves to the human body with belts. The probes contain a strain transducer to a digital signal that is transmitted to a microprocessor evalua-tion unit that adjusts digital signals from the probes into a compatible form with a USB input to a notebook. Two software levels (SW1 and SW2) are part of MD03. Probe attachment sites were selected based on the kinematics of the aforementioned thoracic sectors. The first probe was placed in the lower respiratory sector on the ventral side of the level L4-5. In the middle wind sector at the level of 8.-9. ribs, on the ventral side below the sternum, a second probe was placed. A third level probe was placed in the upper respiratory sector 3.-4. ribs on the ventral side in the sternal area. Chest compression and expansion during respiration change the force applied to the individual sensors in the attached belt.
Inspiratory and expiratory forces exerted on individual probes located in the given breathing sectors were recorded for 60-sec and minute averages were determined for each probe. After 60-sec of resting data acquisition using spontaneous breathing and deep breathing, participants underwent an incremental test on a cycle ergometer (Lode, Gro-ningen, The Netherlands) and oxygen consumption, tidal volume, respiratory rate and minute ventilatory volume were continuously monitored (Metalyzer B3, Cortex, Leipzig, Germany). The testing protocol was made relative to participant body weight (i.e., W·kg-1) and began with a 4-min stage at 1 W·kg-1 followed by three, two-minute stages at progres-sive intensities (2, 3, 4 W·kg-1) and cadence was standardized to 95-100 rev·min-1. Ventilatory muscular involvement of the abdominal, thoracic, and subclavian body sectors was monitored during the last minute of each of the three submaximal intensities.
The training program lasted eight weeks. The experimental group performed breath-ing exercises daily. In the first week of the breathing intervention, training of breathing ex-ercises took place in the form of three supervised as group breathing sessions. In the following weeks, there were always two group training sessions, each last \~30 minutes. They practiced right on the schedule. On unsupervised days, participants were asked to perform exercises individually at home for at least 10 minutes. Information about the length of each individuals training session was recorded in a diary by the participant.
The set of breathing exercises was based on yoga, the aim was to activate the dia-phragm and become aware of individual breathing sectors. As such, breath training in-cluded a variety of exercises such as breathing wave training, full breathing (breathing in-to all sectors) and paced breathing (breathing in a specified rhythm). The exercises were performed in various positions, including lying down, sitting in the kneeling position, sit-ting, kneeling, and standing. All breathing was performed through the nose. At the begin-ning of the intervention, the participants breathed spontaneously, later switching to pro-longing the inspiratory and expiratory phases. They started with a 1: 1 ratio of inhale to exhale length. Gradually, the pre-exhalation and pre-exhalation phases of breath holding were included: inspiration - 6 periods, holding breath - 3 periods, exhaling - 6 periods, holding breath - 3 periods. Each of the participants adapted the exercise to their individual respiratory rate. Each of the exercises was repeated 6 times. The exercises were slow, with a deep focus on breathing, in line with the movement. Very important was the perception of the direction of movement and expansion of the chest, the behavior of the axis of the body (head, spine, pelvis), which they learned during the introductory meetings. The control group did not participate in any form of breathing training and were told to go about their lives as usual.
The follow-up testing, which was the same as the aforementioned described graded maximal test on the cycle ergometer, was performed after 8 weeks of intervention. The control group was always tested at the same time as the members of the intervention group.
#Intervention
- OTHER : Breathing exercises
- Based in yoga, common load
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy runners
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04950387
|
{
"brief_title": "Impact of Breathing Exercise Intervention on Breathing Sectors Engagement in Adolescent Runners During Load",
"conditions": [
"Healthy Lifestyle"
],
"interventions": [
"Other: Breathing exercises"
],
"location_countries": [
"Czechia"
],
"nct_id": "NCT04950387",
"official_title": "Impact of Breathing Exercise Intervention on Breathing Sectors Engagement in Adolescent Runners During Load",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-10",
"study_completion_date(actual)": "2021-03-15",
"study_start_date(actual)": "2020-07-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-06",
"last_updated_that_met_qc_criteria": "2021-07-02",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-06",
"first_submitted": "2021-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.
Detailed Description
* After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures.
* Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned.
* During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week.
* Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing.
* Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.
#Intervention
- DRUG : Dasatinib
- Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
* Must have failed at least 1 prior fludarabine containing regimen or have failed at least 2 non-fludarabine containing regimens or have a contraindication to fludarabine use
* ECOG performance status of 2 or better
* Adequate organ function to tolerate chemotherapy
* Adequate method of contraception
Exclusion Criteria:
* Pregnant or breast-feeding women
* Uncontrolled angina within 3 months
* Diagnosed or suspected congenital long QT syndrome
* History of clinically significant ventricular arrhythmias
* Prolonged QTc interval on pre-entry electrocardiogram
* Uncontrolled hypertension
* Drugs that are generally accepted to have a risk of causing Torsades de Pointes
* Patient known to be HIV positive
* Known significant bleeding disorder unrelated to CLL
* Drugs that interfere with platelet function or coagulation must be stopped at least 7 days prior to entry
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
|
NCT00438854
|
{
"brief_title": "Dasatinib in Relapsed Chronic Lymphocytic Leukemia",
"conditions": [
"Chronic Lymphocytic Leukemia"
],
"interventions": [
"Drug: Dasatinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00438854",
"official_title": "Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2006-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-13",
"last_updated_that_met_qc_criteria": "2007-02-20",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-02-22",
"first_submitted": "2007-02-20",
"first_submitted_that_met_qc_criteria": "2012-09-12"
}
}
}
|
#Study Description
Brief Summary
Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally, with more than 10 million new cases and over 2 million deaths annually. Developing countries bear the greatest brunt of the disease. The long duration of current treatment is associated with poor compliance, thereby contributing to frequent relapses and to the emergence of drug-resistant TB. In addition, individuals who have been clinically cured may have lung damage, which could be permanent. Therefore, new and more effective therapeutic agents against TB are needed. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatments. This proof-of-concept clinical trial will add the repurposed drug atorvastatin, commonly used to reduce cholesterol levels, to the standard therapies of TB patients in Nigeria. Atorvastatin is a well-tolerated and safe drug, and its addition is expected to accelerate clearance of the TB-causing bacteria without additional side effects. If this research is successful, it could provide evidence for using a common, easily available generic drug to improve treatment of one of the most debilitating infectious diseases.
Detailed Description
INTRODUCTION Tuberculosis is a chronic disease responsible for most deaths from infectious disease with an estimated I0 million cases and close to 2million deaths globally. 1 Despite the availability of therapy for TB, the scourge of the disease has not abated especially in the developing countries. The disease is caused by a bacterium called Mycobacterium tuberculosis, a non-spore forming intracellular organism. TB exists in two forms; primary and secondary infection. While primary infection most times goes unnoticed and are usually associated with non-specific symptoms, secondary infections are usually associated with profound symptoms and signs in various organs especially in the lungs. Majority of persons overcome primary infection but the tubercule bacilli may lie dormant in the macrophages.2 Secondary infection occurs as a result of either endogenous reactivation or exogenous re-infection. Pulmonary TB is responsible for more than 85% of the cases.
MTB infect and survive humans by evading the various immune defense systems.3 The organism accumulates and utilizes an abundant amount of lipids and cholesterol for its cell wall, and as a source of carbon for synthesis of virulence factors. 4 Mycobacterium tuberculosis also utilizes cholesterol as a vehicle to enter macrophage, inhibit phagocytosis and inhibit growth and development of phagocytes.5 These greatly impairs the hydrolytic and antimicrobial properties and activities of phagocytes.5,6 Current therapy is as old as the disease itself; is of long duration, hence it is associated with poor compliance. This contributes to frequent relapses and emergence of resistant form of the disease. Average interval between one episode of TB and another range from 6-18 months after completion of therapy. Despite clinical cure, approximately half of patients have permanent lung damage. In Nigeria, TB is a major risk factor for Chronic Obstructive Pulmonary Disease, lung fibrosis/scarring and other diseases. It is clear that new and innovative therapeutic agents are needed to tackle this hydra- headed disease. In order to address these challenges, a lipid lowering agent, atorvastatin is being repurposed.
The use of statins have been demonstrated in infectious diseases and especially in tuberculosis than other organisms.7 In vitro studies have demonstrated that statins could strengthen the host response against M. tuberculosis and inhibit the activation of T cells induced by M. tuberculosis antigens.8,9 In another study, murine bone marrow-derived macrophages that were exposed to simvastatin and were infected with M. tuberculosis, showed a significant reduction in mycobacterial growth, without adverse effects on cell viability.10 Treatment of TB in animal model with statins and anti TB drugs showed that treatment with anti-TB drugs plus simvastatin reduced the percentage of relapses by 50% compared with treatment with only anti-TB drugs.11 Taken together, all these studies in animal model indicate that statins has anti-TB effect, reduces bacillary load, shortens the duration of therapy and decreases relapse rate when used with first-line anti-TB drugs.
Most of the clinical evidence on the role of statins in TB were from retrospective and nested case control studies from Asian continent.12,13 In one study in Taiwan, diabetic subjects older than 65 treated with statins had a lower risk of developing active tuberculosis, with a risk of 0.76 (95% CI, 0.60-0.97). 12 Chronic use of statins (more than 90 days) was associated with the lowest risk (RR 0.62; 95% CI 0.53-0.72) as shown in another study.13 Within the limits of the designs of these studies, the positive and protective role of statins in TB in humans were demonstrated and has provided basis for further studies. This proposal seeks to provide robust evidence in a well designed study, for repurposing statins to treat TB.
If this is successful, the investigators anticipate a significant improvement in health and well being for patients. Patients will have the option of being treated with an effective and safe regimen with minimal side effects including patients with HIV/TB co-infection, as statins can be co-administered safely with antiretroviral drugs. Additionally, the investigators anticipate a reduction in relapse rate, persistence and resistance to Mycobacterium tuberculosis. Currently, patients still experience post treatment non-infectious complications that limit their functionality. The investigators anticipate this treatment will mitigate against this and lead to improvement in the quality of life of patients and survivors. Both direct and indirect costs of the disease can be rechanneled to revamp the health system and other economic potentials of the developing world. If this prove successful, there would be an accelerated and significant progress to achieving the World Health Organization and End TB Sustainable Development Goals. Overall the investigators anticipate a great turn around in the socio-economic life of people and countries of the developing world where TB has caused untoward and unimaginable stagnation.
1.3 Study Design
Experimental design/Research Plan The investigators propose a Phase IIA/IIB randomized open label trial to evaluate the safety, tolerability, pharmacokinetics(PK), and efficacy of atorvastatin in subjects with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis. See Figure I.
Consented and eligible patients with active tuberculosis will be recruited and be randomized to receive either 30/40mg of atorvastatin with standards anti-TB drugs for 2months or the standards anti-TB drugs alone for 2months. Randomization will be based on Zelen rule 14 and follow a predefined allocation ratio of 1:1
Phase IIA will seek to determine the safety and early bactericidal efficacy of atorvastatin in combination with standard anti-TB in 40 patients. Phase IIB, will seek to determine safety, and sputum culture conversion of atorvastatin in combination with standard anti-TB compared with standard anti-TB drugs alone after 2months in a total of 150 patients. Figure I.
Patients will be hospitalized for supervised drug administration and assessed daily for vital signs and adverse effects AEs especially at phase IIA. Semi intensive profiling of plasma atorvastatin concentrations with a validated high-performance liquid chromatography will be conducted after the first dose on day 1 through to the last dose on day 14. Sputum will be collected for 16hours overnight for two nights before drug intake, daily from days 1 to 4, and every alternate day until day 14 in both cohorts. Samples will be transported and refrigerated till colony forming unit is done. Full blood count, coagulation studies, serum chemistry, lipid profile, Creatinine phosphokinase, urinalysis, and 12-lead electrocardiograms (ECGs) will be performed prior to drug intake and at regular intervals during and at 2 weeks. Patients recruited for this phase will continue in the assigned study arm and join the phase IIB.
Interim analysis will be done in the two groups at the end of the 2weeks with particular emphasis on safety profile, incidence and number of adverse effects, bactericidal activity and a preliminary report of serum levels of atorvastatin in two groups.
For the phase IIB, patients will be randomized as previously stated into any of the two groups and will be monitored closely. Sputum will be collected at 4, 6 and 8 weeks for smear/GenXpert. At the end of 8 weeks, sputum will be collected overnight for MTB culture in addition. During this period, number and types of AEs in the participants will also be noted. At the end, patients will be discharged from the study to continue and complete course of standard anti-tuberculosis chemotherapy. To determine the performance of the Sweat TB test, patients will be prospectively enrolled and the results from the test compared with sputum/GenXpert result.
All investigations will be done at laboratories at OAU/OUATHC, Ile Ife. Microbiological assessment including CFU/ culture conversion will be done at the Mycobacterial Laboratory, OAU/OAUTHC, Ile Ife. Drug assays will be done at the collaborating center; Birmingham Heartlands Hospital/University of Birmingham, UK
Patients will not be coerced to enroll in the study but they will be allowed to enroll after full written and informed consent. However they will be encouraged to attend all clinic and research appointment. However in order to ensure adherence to research protocol especially the period they need to be assessed, they will be provided with transport fare for the period of evaluation. For the initial 2 weeks of hospilisation, all fee including feeding will be borne by the research.
.
2.0 STUDY OBJECTIVES B. SPECIFIC AIMS, EXPECTED MEASURABLE OUTCOMES AND DELIVERABLES.
1.1.Specific aims:
1. To determine the safety profile of atorvastatin in combination with anti-TB drugs
2. Determine the efficacy of atorvastatin in treating patients with tuberculosis, i.e if atorvastatin has early bactericidal activity and effect on sputum culture conversion
3. To determine the pharmacodynamics and pharmacokinetics of atorvastatin in combination with anti-TB drugs in patients with active TB
1.2. Primary outcome measures:
1. Efficacy of atorvastatin treatment in combination with standard anti-TB chemotherapy as measured by:
1. Sputum conversion at 2 month as measured by the number of patients with a negative culture at 2 months
2. Time to sputum conversion as measured by the time interval to the first sputum negative result with sputum smear microscopy/GenXpert \[ Time Frame: up to 2 months
3. Early Bactericidal Activity /Overall response rate associated with atorvastatin treatment in combination with standard anti-TB chemotherapy. \[ Time Frame: up to 2weeks ) Measured as the Daily Rate of Change in log10 Colony Forming Units of M. Tuberculosis in Sputum on Solid Media \[ Time Frame: up to 2weeks )
2. Incidence of treatment-emergent adverse events associated with atorvastatin treatment in combination with standard anti TB chemotherapy. \[ Time Frame: up to 2 months \] The incidence of AEs will measured by the incidence of abnormalities in clinical laboratory tests (serum chemistry, hematology, urinalysis, and coagulation), physical examinations, vital signs, and electrocardiograms.
1.3. Secondary Outcome Measure :
1. Plasma level of atorvastatin in combination with standard anti TB chemotherapy \[ Time Frame: up to 2 months \] Measured by Pharmacokinetics: Maximum Plasma Concentration (Cmax) of atorvastatin
2. Early bactericidal activity as measured by change in CFU for days 0-2 and 7-14
1.4. Exploratory Outcome measure:
1. Diagnostic utility of Sweat TB test in detecting tuberculosis. This is as measured by sensitivity, specificity, PPV and degree of agreement.
#Intervention
- DRUG : Atorvastatin with standard anti tuberculosis drugs
- Participants will receive oral 30/40mg of atorvastatin daily for 2 months together with oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
- Other Names :
- Atorvastatin, Statins
- DRUG : Standard anti tuberculosis drugs only
- Participants will receive oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
- Other Names :
- Rifampicin, INH, Ethambuthol and Pyrazinamide
|
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
1. Newly diagnosed, uncomplicated, drug-susceptible pulmonary TB
2. Sputum Smear, culture or GenXpert result positive for pulmonary TB
3. Ability to provide written, informed consent prior to trial initiation
4. Male or and non pregnant female participants between 18 and 65 years
5. Body mass index 16.0 and 32.0 kg/m2
6. Ability to produce an adequate volume of sputum (approximately 10 -15mL or more estimated overnight production).
Exclusion Criteria:
Exclusion Criteria:
<!-- -->
1. Participants known or suspected of having any form of drug resistance TB.
2. Patients co infected with HIV
3. Those with poor general condition where no delay in treatment can be tolerated
4. Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.
5. Known or family history of bleeding disorders.
6. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.
7. Myositis and or Creatinine phosphokinase three times upper limit of normal
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
|
NCT04721795
|
{
"brief_title": "Treating Tuberculosis With the Lipid Lowering Drug Atorvastatin in Nigeria(ATORvastatin in Pulmonary TUBerculosis)",
"conditions": [
"Tuberculosis, Pulmonary",
"Tuberculosis"
],
"interventions": [
"Drug: Atorvastatin with standard anti tuberculosis drugs",
"Drug: Standard anti tuberculosis drugs only"
],
"location_countries": [
"Nigeria",
"United Kingdom"
],
"nct_id": "NCT04721795",
"official_title": "Repurposing a Lipid Lowering Drug to Treat Tuberculosis: Effectiveness of Statins as Adjuvant to Treatment of Pulmonary Tuberculosis in Nigeria",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-31",
"study_completion_date(actual)": "2022-06-30",
"study_start_date(actual)": "2021-01-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-08",
"last_updated_that_met_qc_criteria": "2021-01-19",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-25",
"first_submitted": "2021-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Various tools for measuring nursing workload have been described in the national and international literature. For this purpose, Cullen et al. The Therapeutic Intervention Scoring System (TISS)-28, created by Miranda et al. Nursing Activities Score (NAS) was created by revising by. NAS covers 80.8% of all nursing activities, surpassing the 43.3% coverage of TISS-28.
Critical Nursing Situation Index (CNSI) has been validated and adapted in our country and has been found to be a valid and reliable scale for the Turkish society. The aim of this study is to adapt the Nursing Activities Score (NAS) to Turkish and determine its correlation with CNSI scores.
Detailed Description
Various tools for measuring nursing workload have been described in the national and international literature. The Therapeutic Intervention Scoring System (TISS)-28, which is designed to classify the nursing workload of patients in intensive care units according to the severity of their illness to be evaluated by a panel of experts, evaluates 43.3% of nursing activities. Miranda et al. In order to reduce possible erroneous evaluations, some changes were made to TISS-28 and the Nursing Activities Score (NAS) was created. NAS covers 80.8% of all nursing activities, surpassing the 43.3% coverage of TISS-28.
The Critical Nursing Situation Index (CNSI), which was finalized with 84 items developed by Binnekade et al., was validated and adapted in our country and was found to be a valid and reliable scale for the Turkish society.
In this study, which was carried out to adapt and validate the Nursing Activities Score (NAS) into Turkish, the internal consistency Cronbach's alpha coefficient was found to be p = 0.718 after a pilot study with a sample of 30 adult intensive care patients and 30 nurses. After the significant internal consistency obtained in the pilot study, it was aimed to examine the correlation of NAS internal consistency and CNSI scores in 150 work shift.
#Intervention
- OTHER : NAS
- NAS Turkish language validation will be carried out. NAS and CNSI scores will be recorded during the shifts of nurses serving patients in Level 3 intensive care units by the nurse in charge and another independent evaluator, and the correlation between the two scores will be investigated.
- Other Names :
- CNSI
|
#Eligibility Criteria:
Inclusion Criteria:
* Nurses who serve patients over the age of 18 who stay in Level 3 intensive care for at least 24 hours
Exclusion Criteria:
* Those nurses; Serving patients under the age of 18, Caring for patients who are scheduled to be discharged from intensive care within 24 hours, Those who change their workplace for any reason during the work shift Who did not agree to participate in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06206889
|
{
"brief_title": "Nursing Activity Score (Nursing Activities Score-NAS) Verification of Turkish Version",
"conditions": [
"Nurse's Role"
],
"interventions": [
"Other: NAS"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06206889",
"official_title": "Nursing Activity Score (Nursing Activities Score-NAS) Verification of Turkish Version",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-11",
"study_completion_date(actual)": "2023-11-12",
"study_start_date(actual)": "2023-05-05"
},
"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)": "2024-01-16",
"last_updated_that_met_qc_criteria": "2024-01-04",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-16",
"first_submitted": "2023-12-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this prospective, clinical observational trial is to assess the incidence of pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in patients undergoing craniotomy surgery at three major children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the United States.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients 0 <= age <= 18 years, who are scheduled to undergo craniotomy surgery for any reason (e.g., brain tumor, epilepsy surgery, craniofacial reconstruction) at either the Boston Children's Hospital, the Children's Hospital of Philadelphia, or the Children's Center of the Johns Hopkins Hospital will be eligible for enrollment.
Exclusion Criteria:
* Patients who remain intubated after surgery. Additionally, we will exclude patients who are allergic to opioids or who have a history of substance abuse
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01576601
|
{
"brief_title": "The Management of Postoperative Craniotomy Pain in Pediatric Patients",
"conditions": [
"Post Craniotomy Surgery",
"Cancer",
"Epilepsy",
"Vascular Malformations",
"Craniofacial Reconstructive Surgery"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01576601",
"official_title": "The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study",
"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)": "2011-08"
},
"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)": "2017-12-11",
"last_updated_that_met_qc_criteria": "2012-04-11",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-12",
"first_submitted": "2012-04-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
#Intervention
- DRUG : EE30/DRSP (Yasmin, BAY86-5131)
- Patients under regular daily life treatment receiving Yasmin according to local drug information
- DRUG : Any other OC
- Patients under regular daily life treatment receiving any other OC according to local drug information
|
#Eligibility Criteria:
Inclusion Criteria:
* Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
* Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Exclusion Criteria:
* The contraindications and warnings of the Summary of Product Characteristics must be followed.
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
|
NCT00905684
|
{
"brief_title": "Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)",
"conditions": [
"Contraception"
],
"interventions": [
"Drug: Any other OC",
"Drug: EE30/DRSP (Yasmin, BAY86-5131)"
],
"location_countries": [
"Jordan",
"Kenya",
"Saudi Arabia",
"Albania",
"Kuwait",
"United Arab Emirates",
"Oman",
"Egypt",
"Macedonia, The Former Yugoslav Republic of",
"Qatar",
"Bahrain",
"Hungary",
"Lebanon"
],
"nct_id": "NCT00905684",
"official_title": "Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-03-07",
"last_updated_that_met_qc_criteria": "2009-05-19",
"last_verified": "2012-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-20",
"first_submitted": "2009-05-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.
Detailed Description
Patients with advanced or treatment-refractory Multiple Myeloma (MM), Hodgkin's Disease (HD) and Non-Hodgkin's Lymphoma (NHL) may be successfully treated with high dose chemotherapy followed by autologous transplantation of peripheral blood stem cells (PBSCs). Successful engraftment of peripheral blood stem cells (PBSCs) is well correlated with the number of CD34+ cells infused.
Stem cell collection with plerixafor could have a major benefit by increasing the circulating number of PBSCs and decreasing the number of apheresis sessions required to collect a sufficient number of PBSCs for transplant.
This is a multi-centre, open label, single-arm study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.
Screening for eligibility will take place up to 30 days before the first dose of G-CSF. Patients will receive a stem cell mobilisation regimen consisting of plerixafor and G-CSF. Patients will be given G-CSF for 4 consecutive days in the morning. Starting on the evening of Day 4, plerixafor will be administered subcutaneously (SC). The plerixafor dose will be timed to allow for a 10- to 11-hour interval between the plerixafor dosing and the initiation of apheresis. Patients may continue to receive the evening dose of plerixafor then G-CSF the next morning followed by apheresis for up to a total of 5 apheresis procedures until a minimum of at least 5 x 106 CD34+ cells/kg for NHL/HD or 6 x 106 CD34+ cells/kg for MM are collected. More cells may be collected if done within the 5 apheresis procedures. Stem cell collection will take place using standard procedures.
Following the last apheresis, patients will undergo pre-transplant myeloablative chemotherapy followed by transplantation of the collected autologous stem cells, using the established protocols and procedures at each site.
Peripheral blood samples will be collected for determining the number of CD34+ cells in the peripheral blood. In addition, a sample will be obtained from each apheresis product to determine the quantity of CD34+ cells collected after each procedure.
Safety data will be reported according to guidelines provided in the protocol. Adverse event (AE) guidance is summarised in the protocol. Investigators will grade AEs using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent engraftment and graft status. Patients who undergo haematopoietic stem cell transplantation will be monitored for graft status at 100 days, 6 months, and 12 months.
#Intervention
- DRUG : Generic = Plerixafor
- 240µg/kg administered as an SC injection 10 to 11 hours prior to initiation of apheresis. Daily administration for 1 up to 5 consecutive days
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)
* Eligible and planned for an autologous haematopoietic stem cell transplantation
* Written informed consent
* At least 18 years (inclusive)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* White blood cell (WBC) count >=2.5 x 10^9/L
* Absolute neutrophil count (ANC) >=1.5 x 10^9 /L
* Platelet count >=100 x 10^9/L
* Serum creatinine <=2.2 mg/dL
* Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin <2.5 x upper limit of normal (ULN)
* Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
* All patients must agree to use a highly effective method of contraception whilst on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential). Effective birth control includes: a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method, or b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known.
Exclusion Criteria:
* History of any acute or chronic leukaemia (including myelodysplastic syndrome)
* Prior allogeneic transplantation or more than one prior autologous transplantation
* Failed previous CD34+ cell collection attempts (either due to insufficient yield in apheresis product, or ineligible for apheresis because of inadequate mobilisation of CD34+ cells into peripheral blood)
* Less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy with nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free interval of at least 2 half-lives should be considered) with the exception of ; Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) which is allowed up to 7 days prior to the first dose of G-CSF.
* Bone marrow involvement >20% assessed based on the most recent bone marrow aspirate or biopsy
* Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilisation
* Known to be human immunodeficiency virus (HIV) positive
* Active hepatitis B or hepatitis C
* Acute infection (febrile, i.e., temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF
* Hypercalcaemia as evidenced by >1 mg/dL above ULN
* Previously received investigational therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase
* Central nervous system involvement including brain metastases or leptomeningeal disease
* Pregnant or nursing women
* Electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischaemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial.
* Co-morbid condition(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol
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
|
NCT00838357
|
{
"brief_title": "A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).",
"conditions": [
"Lymphoma (Non-Hodgkin's Lymphoma)",
"Hodgkin's Disease or Multiple Myeloma",
"Front Line Mobilization",
"Transplantation"
],
"interventions": [
"Drug: Generic = Plerixafor"
],
"location_countries": [
"France",
"Netherlands",
"Sweden",
"Germany",
"Spain",
"Italy",
"United Kingdom"
],
"nct_id": "NCT00838357",
"official_title": "Plerixafor and G-CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) - Safety Study in a General Autologous Transplant Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2010-11",
"study_start_date(actual)": "2008-09"
},
"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)": "2015-03-24",
"last_updated_that_met_qc_criteria": "2009-02-05",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-06",
"first_submitted": "2009-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
Detailed Description
1. LDL-C after 12 weeks of treatment
2. Safety and tolerability
3. Plasma levels of SLx-4090
#Intervention
- DRUG : SLx-4090
- tablet
- DRUG : SLx-4090
- tablet
- OTHER : Placebo
- matching tablet
- DRUG : Statin
- Subjects were dosed with the statin prescribed specifically by their prescribing physician.
|
#Eligibility Criteria:
Inclusion Criteria:
* LDL-C > or = 100 mg/dL
* On stable statin therapy for at least 6 weeks
Exclusion Criteria:
* Coronary heart disease or risk factors for CHD
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
|
NCT00810979
|
{
"brief_title": "Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia",
"conditions": [
"Hyperlipidemia"
],
"interventions": [
"Other: Placebo",
"Drug: Statin",
"Drug: SLx-4090"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00810979",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2008-12-17",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-18",
"first_submitted": "2008-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.
#Intervention
- DEVICE : BF-P190 4 mm thin bronchoscope
- * EVIS EXERA III Bronchofiberviedoscopes
* Olympus
- DEVICE : BF-MP190F 3 mm ultrathin bronchoscope
- * EVIS EXERA III Bronchofiberviedoscopes
* Olympus
- DEVICE : Radial ultrasound probe (UM S20-17S)
- -Olympus
- DEVICE : PeriView FLEX 21G Single Use Aspiration Needle
- * NA-403D-2021
* Gyrus ACMI, Inc.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients age 18 and older
* Patients presenting with peripheral pulmonary lesions 1 <= age <= 7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes
Exclusion Criteria:
* Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
* Patients unwilling or unable to provide informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04331587
|
{
"brief_title": "Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions",
"conditions": [
"Peripheral Pulmonary Nodules"
],
"interventions": [
"Device: BF-P190 4 mm thin bronchoscope",
"Device: PeriView FLEX 21G Single Use Aspiration Needle",
"Device: Radial ultrasound probe (UM S20-17S)",
"Device: BF-MP190F 3 mm ultrathin bronchoscope"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04331587",
"official_title": "Evaluation of Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-22",
"study_completion_date(actual)": "2024-08-22",
"study_start_date(actual)": "2020-04-20"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2020-04-01",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-02",
"first_submitted": "2020-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators aimed to assess the impact of a mobile phone application facilitating real-time visual and verbal communication on reducing emergency room admissions following circumcision.
Detailed Description
Today, communication devices make our lives easier and provide convenience in the healthcare sector. Some studies have mentioned that a definitive diagnosis can be made with digital photographs and video images in children with normal findings at the time of examination, and further diagnostic tests become unnecessary . Readmission to the hospital after surgery, especially in children, is a situation that increases the level of anxiety. The use of smart device applications to evaluate both the operation site and functional results after many surgical procedures has reduced the number of re-applications and anxiety levels of patients . Through communication, the patient can articulate their needs to the physician, either verbally or visually, and with the assistance of the physician, navigate through this process much more smoothly. In our randomized prospective study, the investigators aimed to assess the role of a mobile phone application facilitating real-time visual and verbal communication, as well as instant information exchange, in reducing emergency room and urology policlinic admissions due to potential complications after circumcision.
#Intervention
- BEHAVIORAL : Comminication via Telemedicine
- Comminication via Telemedicine With Patients
- BEHAVIORAL : Information
- Informing the patient and their relatives
|
#Eligibility Criteria:
Inclusion Criteria:
* Circumcision
Exclusion Criteria:
* hypospadias
* cryptoorchidism
* bleeding diathesis
Sex :
MALE
Ages :
- Minimum Age : 1 Year
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06585956
|
{
"brief_title": "Prevent Post-discharge Hospital Admissions Using Mobile Phone App",
"conditions": [
"Surgery"
],
"interventions": [
"Behavioral: Comminication via Telemedicine",
"Behavioral: Information"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06585956",
"official_title": "The Role of Physician-Patient Communication Through Mobile Phone Application in Preventing Emergency Room Admissions After Circumcision: a Randomized Prospective Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-30",
"study_completion_date(actual)": "2024-06-30",
"study_start_date(actual)": "2024-04-01"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2024-09-03",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-09-19",
"first_submitted": "2024-08-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography.
Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection.
To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).
#Intervention
- DRUG : Cefazolin used in antimicrobial prophylaxis
- Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours.
Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis.
The samples were processed by HPLC.
|
#Eligibility Criteria:
Inclusion Criteria:
* body mass index greater than 35 and less than 50kg/m2
Exclusion Criteria:
* Hypotension during surgery with use of vasoactive drugs
* renal disfunction (creatinine >1.5 mg/dL)
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
|
NCT01845363
|
{
"brief_title": "Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue",
"conditions": [
"Obesity"
],
"interventions": [
"Drug: Cefazolin used in antimicrobial prophylaxis"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01845363",
"official_title": "Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2011-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-05-03",
"last_updated_that_met_qc_criteria": "2013-04-29",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-03",
"first_submitted": "2013-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
Detailed Description
OBJECTIVES:
* To evaluate the progression-free survival of patients with advanced K-ras wild-type colorectal cancer, following progression on bevacizumab-contained chemotherapy, treated with irinotecan hydrochloride and cetuximab with versus without ramucirumab as second-line therapy.
* To evaluate the response rate in patients treated with these regimens.
* To evaluate the grade 3-4 toxicity rates of these regimens in these patients.
* To evaluate the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), discontinuation of oxaliplatin before disease progression (yes vs no), and time to disease progression since last treatment (≤ 6 months vs \> 6 months). Patients are randomized to 1 of 2 treatment arms.
* Arm A: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride over 60-90 minutes on day 1.
* Arm B: Patients receive ramucirumab IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Arm B was closed early due to excessive toxicities and Arm C was then added to the study with reduced dose of protocol drugs.
* Arm C: Patients receive reduced dose of ramucirumab, cetuximab and irinotecan hydrochloride as in arm B.
In all arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically for 5 years.
#Intervention
- BIOLOGICAL : cetuximab
- Given IV
- Other Names :
- IMC-C225, Erbitux®, NSC-714692
- BIOLOGICAL : ramucirumab
- Given IV
- Other Names :
- IMC 1121B, 1121B
- DRUG : irinotecan hydrochloride
- Given IV
- Other Names :
- Irinotecan hydrochloride trihydrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Measurable disease
* Histologically confirmed adenocarcinoma of the colon or rectum
* K-ras wild type based on either primary or metastatic tumor
* Must have received prior first-line therapy comprising oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal cancer
* Registration within 42 days since confirmed disease progression
* Performance status 0 <= age <= 1
* ANC >= 1,500/μL
* Platelet count >= 75,000/μL
* Hemoglobin >= 9 g/dL
* Serum creatinine <= 1.5 times upper limit of normal (ULN) OR creatinine clearance >= 40 mL/min
* Urine protein <= 1+ on dipstick or routine urinalysis (if >= 2+, a 24-hour urine collection must demonstrate < 1,000 mg of protein)
* Total bilirubin <= 2.0 mg/dL
* AST and ALT <= 3.0 times ULN (5.0 times ULN for patients with liver metastases)
* INR <= 1.6 (<= 3.0 for patients on warfarin and no active bleeding [i.e., no bleeding within the past 14 days])
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* At least 28 days and no more than 90 days since prior bevacizumab
* Concurrent stable dose of oral anticoagulant or low-molecular weight heparin allowed
Exclusion Criteria:
* Brain or CNS metastases
* Pregnant or nursing
* Prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus bevacizumab for colorectal cancer
* Clinically significant (equivalent to NCI CTCAE grade 3 <= age <= 4) bleeding episodes within the past 3 months
* Active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Symptomatic or poorly controlled cardiac arrhythmia
* Uncontrolled thrombotic or hemorrhagic disorder
* Uncontrolled or poorly controlled hypertension despite standard medical management (e.g., consistently systolic BP > 160 mm Hg and diastolic BP > 90 mm Hg)
* Acute arterial thrombotic events within the past 6 months, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina
* Other cancer requiring therapy within the past 3 years except in situ carcinoma or nonmelanoma skin cancer
* Acute or subacute intestinal obstruction
* History of inflammatory bowel disease requiring pharmacological and/or surgical intervention within the past 12 months
* Known allergy to any of the treatment components
* Major surgery within the past 28 days
* Subcutaneous venous access device placement within the past 7 days
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
|
NCT01079780
|
{
"brief_title": "Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Biological: ramucirumab",
"Drug: irinotecan hydrochloride",
"Biological: cetuximab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01079780",
"official_title": "A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-22",
"study_completion_date(actual)": "2021-08-17",
"study_start_date(actual)": "2011-01-18"
},
"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)": "2023-06-28",
"last_updated_that_met_qc_criteria": "2010-03-02",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-03",
"first_submitted": "2010-03-02",
"first_submitted_that_met_qc_criteria": "2022-06-09"
}
}
}
|
#Study Description
Brief Summary
The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval.
Detailed Description
The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).
Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.
#Intervention
- DEVICE : Respiree
- The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval
|
#Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female, aged >=18 and <50.
* The subject is in good general health with no evidence of any medical problems.
* The subject is fluent in both written and spoken English.
* The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion Criteria:
* The subject is obese (BMI>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05139693
|
{
"brief_title": "Accuracy of Pulse Oximeters With Profound Hypoxia",
"conditions": [
"Healthy Volunteers"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05139693",
"official_title": "Accuracy of Pulse Oximeters With Profound Hypoxia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-16",
"study_completion_date(actual)": "2021-12-16",
"study_start_date(actual)": "2021-12-15"
},
"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)": "2022-04-29",
"last_updated_that_met_qc_criteria": "2021-11-17",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-01",
"first_submitted": "2021-11-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This feasibility study has therefore several aims:
1. construct a dedicated CT perfusion protocol for GIT wall perfusion;
2. used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model;
3. from the image acquired, evaluate current parameters of perfusion including the permeability ones
#Intervention
- RADIATION : Dynamic contrast enhanced computerised tomography
|
#Eligibility Criteria:
Inclusion Criteria:
* all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution
Exclusion Criteria:
* contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
* inability to provide informed consent
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
|
NCT03367065
|
{
"brief_title": "Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study",
"conditions": [
"Mesenteric Ischemia",
"Permeability CT Technics"
],
"interventions": [
"Radiation: Dynamic contrast enhanced computerised tomography"
],
"location_countries": [
"France"
],
"nct_id": "NCT03367065",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2016-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-13",
"last_updated_that_met_qc_criteria": "2017-12-04",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-08",
"first_submitted": "2016-08-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.
#Intervention
- DEVICE : HD-tDCS
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages 18 - 40 years
* Right-handed
Exclusion Criteria:
* concurrent medication likely to affect mental performance
* current history of drug or alcohol abuse or dependence
* any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.
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
|
NCT01733576
|
{
"brief_title": "High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning",
"conditions": [
"Verbal Learning and Memory"
],
"interventions": [
"Device: HD-tDCS"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT01733576",
"official_title": "Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": null,
"study_start_date(actual)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-23",
"last_updated_that_met_qc_criteria": "2012-11-26",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-27",
"first_submitted": "2012-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.
Detailed Description
This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.
#Intervention
- DRUG : AM-101
- AM-101 gel for intratympanic injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Completion of TACTT3 study;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to attend the study visits.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Adverse event leading to treatment discontinuation in TACTT3;
* Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
* Ongoing drug-based therapy for otitis media or otitis externa;
* Drug-based therapy known as potentially tinnitus-inducing;
* Other treatment of tinnitus;
* Drug abuse or alcoholism;
* Subjects with psychiatric diseases requiring drug treatment;
* Use of antidepressant or anti-anxiety medication;
* Any clinically relevant disorder or abnormality in physical examination;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception.
Other protocol-defined exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 76 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02040207
|
{
"brief_title": "AM-101 in the Treatment of Post-Acute Tinnitus 2",
"conditions": [
"Tinnitus"
],
"interventions": [
"Drug: AM-101"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02040207",
"official_title": "AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study",
"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)": "2014-06"
},
"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)": "2023-09-14",
"last_updated_that_met_qc_criteria": "2014-01-17",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-20",
"first_submitted": "2014-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This was a Phase 1, non-randomized, open-label, multicenter study of the ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine administered with the granulocyte macrophage-colony stimulating factor (GM-CSF) sargramostim in patients with NY-ESO-1- or LAGE-1-positive epithelial ovarian, fallopian tube, or primary peritoneal cavity cancers who had completed standard therapy for primary or recurrent disease and would have normally entered a period of observation. The primary study objective was to determine the safety and tolerability of study vaccination, with secondary objectives including the determination of clinical and immunological responses.
Detailed Description
Patients received subcutaneous (SC) injections with 0.5 mL of ALVAC(2)-NY-ESO-1(M)/TRICOM on Day 1 and 100 μg of the GM-CSF sargramostim on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles. No dose escalation of either vaccine component was permitted. Patients received study vaccinations until disease progression or unacceptable toxicity.
Safety was evaluated by continuous monitoring of adverse events (AEs), concomitant medications, and vital signs, as well as through hematology and chemistry laboratory testing and physical examinations. Efficacy was determined through tumor response evaluations, cancer antigen (CA)-125 levels, and cellular and humoral immune responses (i.e., NY-ESO-1-specific T cells, antibodies to NY-ESO-1 and ALVAC, and delayed-type hypersensitivity \[DTH\] testing).
#Intervention
- BIOLOGICAL : ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine
- The vaccine comprises the modified canary pox vector, ALVAC(2), inserted with the following genes: NYESO-1(M), TRICOM (LFA-3, ICAM-1, B7.1), vvE3L, vvK3L. The vaccine is administered at a dose of 0.5 mL SC.
- BIOLOGICAL : Sargramostim
- The GM-CSF sargramostim is administered at a dose of 100 μg SC.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, from stage II-IV at diagnosis, treated with initial surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
* Complete response to frontline therapy as evidenced by negative clinical examination, CA-125 tumor marker, and computed tomography (CT) scan. In addition, if second look surgery was performed (by laparoscopy or laparotomy), the result must have been either negative or microscopic positive. These patients would have normally entered a period of observation after standard management.
* Patients with recurrent disease were eligible if they had completed surgery and/or chemotherapy for recurrent disease and would have normally entered a period of observation after completion of standard management. Eligible patients could have had asymptomatic residual measurable disease on physical examination and/or CT scan, and/or could have had an elevated CA-125 or could have been in complete clinical remission (defined as a serum CA-125 <= 35 IU/mL, CT scan without objective evidence of disease, and normal physical examination).
* Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) (preferably) or immunohistochemistry (IHC); or 2) LAGE-1 by RT-PCR. Patients whose primary surgery was performed outside the study site were pre-screened and required to release tissue sections or blocks to the study site in order to determine tumor expression of NY-ESO-1 by IHC.
* Expected survival of at least 6 months.
* Full recovery from surgery.
* Karnofsky performance status of 70 or more.
* Laboratory parameters for vital functions were required to be in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were required to be within the ranges specified:
* neutrophil count: >= 1.5 × 10^9/L
* lymphocyte count: >= 0.5 × 10^9/L
* platelet count: >= 100 × 10^9/L
* serum creatinine: <= 2 mg/dL
* serum bilirubin (total): <= 2 mg/dL
* hemoglobin: >= 10 g/dL
* Have been informed of other treatment options.
* Age >= 18 years.
* Able and willing to give valid written informed consent.
Exclusion criteria:
* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
* History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo.
* Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
* Known immunodeficiency or human immunodeficiency virus positivity.
* Known allergy or history of life-threatening reaction to GM-CSF.
* Known allergies to eggs, neomycin, and bovine products, determined by history.
* History of severe allergic reactions to vaccines or unknown allergens.
* Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent.
* Mental impairment that could have compromised the ability to give informed consent and comply with the requirements of the study.
* Lack of availability for immunological and clinical follow-up assessment.
* Previous NY-ESO-1 vaccine therapy.
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
|
NCT00803569
|
{
"brief_title": "Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers",
"conditions": [
"Fallopian Tube Cancer",
"Ovarian Cancer",
"Peritoneal Cavity Cancer"
],
"interventions": [
"Biological: ALVAC(2)-NY-ESO-1(M)/TRICOM vaccine",
"Biological: Sargramostim"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00803569",
"official_title": "Phase I Study of ALVAC(2)-NY-ESO-1(M)/TRICOM (VCP2292) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01-24",
"study_completion_date(actual)": "2011-01-24",
"study_start_date(actual)": "2008-11-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-04",
"last_updated_that_met_qc_criteria": "2008-12-04",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-05",
"first_submitted": "2008-12-04",
"first_submitted_that_met_qc_criteria": "2018-09-21"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.
#Intervention
- DRUG : Dasatinib
- Tablets; oral; 70 mg BID, depending on response
|
#Eligibility Criteria:
Inclusion Criteria:
* Age of 18 years and older.
* Chronic myeloid leukemia (CML)
* Previous treatment with imatinib at a dose of >600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR
* CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR
* Intolerance to imatinib at any dose
* Adequate organ function
* Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.
Exclusion Criteria:
* Woman who are pregnant or breastfeeding
* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
* Previous diagnosis of accelerated phase or blast crisis CML.
* Participants who are eligible and willing to undergo transplantation during the screening period
* Uncontrolled or significant cardiovascular disease
* Use of imatinib within 7 days.
* Use of interferon or cytarabine within 14 days
* Use of a targeted small-molecule anticancer agent within 14 days
* Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants
* Prior therapy with dasatinib.
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
|
NCT00101660
|
{
"brief_title": "Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib",
"conditions": [
"Chronic Myeloid Leukemia",
"Philadelphia-Positive Myeloid Leukemia"
],
"interventions": [
"Drug: Dasatinib"
],
"location_countries": [
"Netherlands",
"United States",
"Germany",
"Singapore",
"Austria",
"Switzerland",
"Finland",
"United Kingdom",
"France",
"Israel",
"Sweden",
"South Africa",
"Australia",
"Italy",
"Denmark",
"Ireland",
"Norway",
"Peru",
"Korea, Republic of",
"Canada",
"Spain",
"Belgium"
],
"nct_id": "NCT00101660",
"official_title": "A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-09",
"study_completion_date(actual)": "2008-04",
"study_start_date(actual)": "2005-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-03-02",
"last_updated_that_met_qc_criteria": "2005-01-12",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-01-13",
"first_submitted": "2005-01-12",
"first_submitted_that_met_qc_criteria": "2010-02-09"
}
}
}
|
#Study Description
Brief Summary
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
Detailed Description
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.
#Intervention
- DEVICE : Ulthera® System
- Focused ultrasound energy delivered below the surface of the skin.
- Other Names :
- Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 19 - 55 years.
* Subject in good health.
* Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
* Mild to moderate laxity of the upper arm.
* Mild to moderate subcutaneous fat of the upper arm.
* Mild crepiness of the skin of the upper arm.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion Criteria:
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the upper arm.
* Excessive skin laxity in the upper arm.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01713933
|
{
"brief_title": "Evaluation of the Ulthera® System for Treatment of the Brachia",
"conditions": [
"Brachial Ptosis"
],
"interventions": [
"Device: Ulthera® System"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01713933",
"official_title": "Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2011-06"
},
"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)": "2017-12-11",
"last_updated_that_met_qc_criteria": "2012-10-22",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-25",
"first_submitted": "2012-10-15",
"first_submitted_that_met_qc_criteria": "2014-04-25"
}
}
}
|
#Study Description
Brief Summary
Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The researchers aim to investigate whether this supplement can affect metabolic control in diabetic patients.
#Intervention
- DIETARY_SUPPLEMENT : creatine
- OTHER : Exercise training
|
#Eligibility Criteria:
Inclusion Criteria:
* males and females type 2 diabetic patients
* glycated hemoglobin between > 9%
* non insulin users
* physically inactive
* only metformin and/or sulfonylurea users
* BMI > 30 kg/m2
* age of years > 50 y
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00992043
|
{
"brief_title": "Creatine Supplementation and Diabetes",
"conditions": [
"Diabetes",
"Renal Function"
],
"interventions": [
"Dietary Supplement: creatine",
"Other: Exercise training"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT00992043",
"official_title": "Efficacy and Safety of Creatine Supplementation Combined With Exercise Training in Type 2 Diabetic Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2009-10"
},
"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)": "2010-03-23",
"last_updated_that_met_qc_criteria": "2009-10-07",
"last_verified": "2009-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-08",
"first_submitted": "2009-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of Chinese populations of surgically unsalvageable or severe post-surgery morbidity associated giant cell tumor of bone (GCTB), collectively referred to as unresectable GCTB, during 2013-2021 in three medical centers, serving as the external control for a single arm phase Ib/II trial on JMT103 treatment of GCTB. 301 patients were enrolled and divided into 2 groups according to their actual previous exposures. Group 1 (n=135) was denosumab group. Group 2 (n=166) included two types of exposures other than denosumab: other anti-GCTB drug therapies, or no therapy on GCTB patients. The dosage, route, frequency and other administration methods was collected according to the actual previous treatment records. The primary outcome measure was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline\]. The key secondary endpoint was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDS or EORTC criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline\]. Other secondary Outcome Measures include: proportion of patients whose tumors was surgically resectable; median duration of tumor response (DOR), disease control rate (DCR), and time to disease progression (TTP); and types and proportion of key adverse reactions.
#Intervention
- DRUG : Denosumab
- Denosumab, subcutaneous injection, specific usage to see the medical records. Non-denosumab, specific usage to see the medical records.
- Other Names :
- Non-denosumab
|
#Eligibility Criteria:
Inclusion Criteria:
* 1. Both genders, aged 18 years or above;
* 2. Patients pathologically diagnosed of giant cell tumor of bone (GCTB), and are surgically unsalvageable, or salvageable but surgery was associated with severe morbidity based on physician's judgement;
* 3. For patients received denosumab or other anti-GCTB medications, one of the two is required: imaging data (including X-ray, CT, MRI or PET-CT) prior to and at least once followed to administration, or pathological data on surgically resected GCTB; for patients with no medication, imaging data or pathological data on surgically resected GCTB is required.
Exclusion Criteria:
* 1. No access to definite treatment information;
* 2. Bone metabolic diseases diagnosed before treatment: hypo-/ hyperparathyroidism, hypo-/hyperthyroidism, hypopituitarism, hyperprolactinemia, Cushing syndrome, acromegaly, Paget disease, etc;
* 3. Complication of malignant tumor receiving anti-tumor therapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05402865
|
{
"brief_title": "A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone",
"conditions": [
"Giant Cell Tumor of Bone"
],
"interventions": [
"Drug: Denosumab"
],
"location_countries": [
"China"
],
"nct_id": "NCT05402865",
"official_title": "A Real-world Study on Patients of Surgically Unsalvageable or Severe Post-surgery Morbidity Associated Giant Cell Tumor of Bone",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-01",
"study_completion_date(actual)": "2022-02-18",
"study_start_date(actual)": "2021-11-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-02",
"last_updated_that_met_qc_criteria": "2022-05-30",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-02",
"first_submitted": "2022-05-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A clinical study to evaluate the tolerability, PK and PD characteristics of BDB-001 Injection in healthy subjects.
#Intervention
- DRUG : BDB-001 injection
- Intravenous injection
- DRUG : Placebo
- Intravenous injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between 18~55 years (including 18 and 55 years);
* A healthy subject evaluated by medical history etc;
* Physical examination and vital signs normal, or abnormal without clinical significance;
* Weight: 80 kg >= male >=50 kg, and 80 kg >= female >=45 kg. Body Mass Index (BMI) between 18~28kg/m2 (including 18 and 28). Body mass index (BMI) = body weight (kg) / height 2 (m2);
* Be able to complete the study in compliance with protocol;
* The subjects (including sex partners) willing to take effective contraception measures within 6 months after the last dose. Refer to the appendix for the detailed contraceptive methods;
* Informed consent form signed prior to the study and the content, process and possible adverse reactions of the study fully understood.
Exclusion Criteria:
* More than 5 cigarettes were smoked daily within 3 months prior to screening period of the study;
* Allergic history (drugs and food);
* A history of drug abuse and / or drinking (drinking 14 units per week of alcohol: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100ml);
* Subjects who had donated blood or massive blood loss (> 450 mL) within 3 months prior to screening period, or those who had plasma exchange within 4 weeks prior to screening period;
* Any prescription drugs, OTC drugs, any vitamin products or herbs were used within the 14 days prior to screening period, and immunomodulators were used within 28 days prior to screening period;
* Subjects who had taken other investigational product(s) or vaccine within 3 months prior to screening period, or those who were expected to be vaccinated within 2 months after completion of the study;
* Vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion within 2 weeks prior to screening;
* Significant change in eating or exercise habits recently;
* Subjects who have taken BDB-001 injection or participated in clinical trials of investigational drugs within three months prior to taking study drugs;
* Subjects with a history of previous tuberculosis and exposure to active tuberculosis, TB-spot test results is greater than 2 UL(upper limit) of normal range, and those with infectious diseases recently;
* Subjects with autoimmune or immunodeficiency diseases, or with a family history of autoimmune diseases or immunodeficiency diseases;
* Abnormal ECG with clinical significance;
* Female subjects are in the lactation period or have positive serum pregnancy results during the period of trial (from screening to completion);
* Clinical laboratory examination result with clinical significance, or other clinical findings within 12 months prior to screening period with clinical significance ( including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
* Subjects whose white blood cell count, high-sensitivity C-reactive protein test results were abnormal with clinical significance during screening and baseline period (-1 day), hemoglobin: male <120g/L or female <110g/L;
* Subjects with positive result of viral hepatitis (including hepatitis B and C), AIDS antibody, or treponema pallidum antibody;
* Subjects with acute disease or with concomitant medication from the screening stage to the start time of drug administration;
* Subjects with more than 5 cups (150mL cups) of coffee, tea or cola each day;
* Subjects with any alcohol-containing products within 48 hours before taking study medication;
* Subjects with a positive urine drug screening or with a history of drug abuse or drug use within the past five years;
* The investigators suggested the subject was not suitable to participate in this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05361005
|
{
"brief_title": "Tolerability and Safety of BDB-001 Injection in Healthy Subjects",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Placebo",
"Drug: BDB-001 injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT05361005",
"official_title": "A Phase Ic Single Center, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation and Multiple Dose Study to Evaluate the Tolerability and Pharmacokinetics of BDB-001 Injection in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-08",
"study_completion_date(actual)": "2020-05-08",
"study_start_date(actual)": "2020-03-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-04",
"last_updated_that_met_qc_criteria": "2022-04-29",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-04",
"first_submitted": "2022-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to test the feasibility, acceptability, safety of a 3-month hatha and restorative yoga intervention to decrease sedentary behavior, stress and blood pressure in sedentary African-American women.
Detailed Description
This study aims to assess feasibility of a hatha and restorative yoga intervention compared to a control group. Investigators will examine feasibility of participant recruitment, retention and adherence; fidelity of intervention delivery; and intervention materials. Investigators also aim to evaluate the acceptability and safety of a hatha and restorative yoga intervention compared to a control group. Investigators will examine the acceptability of intervention location and strategies, class format, enjoyment of sessions, and safety of the intervention. Finally, investigators aim to test feasibility and appropriateness of the targeted outcomes for subsequent trials. Expected outcomes will be properly measured, but no comparisons between intervention and control groups will be made.
#Intervention
- BEHAVIORAL : Yoga Intervention
- This group will have in-person, 60 minute yoga sessions three times per week for 12 weeks. These sessions will also include a sharing circle to provide group feedback as to how the practice felt and integration into ones' daily life. There will be biweekly themes established for these sessions (i.e. common yoga poses, importance of breath) and biweekly in-person workshops will be offered. These will be specialty classes for participants to experience additional exposure to meditation and breathing. They will be a longer format so participants can delve deeper into yogic philosophy and practice. There will also be a private Facebook group for participants to connect with each other and for the research staff to maintain contact and share information with the participants (eg. weekly reminder for yoga sessions and workshops).
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-identified as an African-American woman at least 18 years
* Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity
* If employed, working in a sedentary occupation that requires primarily seated work;
* If unemployed, typical day involves sedentary, primarily seated activities
* Able to exercise for 20 minutes continuously
* No pre-existing condition that limits physical activity
* Access to a computer (or mobile device) and internet service
Exclusion Criteria:
* Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease
* Take more than two daily medications for lipids or blood pressure
* Current smoker
Sex :
FEMALE
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
|
NCT04710979
|
{
"brief_title": "Feasibility of a Yoga Intervention in Sedentary African-American Women",
"conditions": [
"Sedentary Behavior"
],
"interventions": [
"Behavioral: Yoga Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04710979",
"official_title": "Feasibility of a Yoga Intervention in Sedentary African-American Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-06",
"study_completion_date(actual)": "2023-01-19",
"study_start_date(actual)": "2022-05-02"
},
"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)": "2023-10-26",
"last_updated_that_met_qc_criteria": "2021-01-12",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-15",
"first_submitted": "2020-12-11",
"first_submitted_that_met_qc_criteria": "2023-10-01"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.
#Intervention
- DRUG : Baloxavir Marboxil
- 2 to4 X 20-mg tablets taken orally
- Other Names :
- S-033188
- DRUG : Placebo to Baloxavir Marboxil
- 2 to4 X 20-mg tablets taken orally
- DRUG : Oseltamivir
- 75 mg capsules taken orally
- Other Names :
- Tamiflu®
- DRUG : Placebo to Oseltamivir
- Placebo capsules matching oseltamivir 75 mg capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately. As for adolescent patients, informed consent/assent of voluntary participation should be obtained in accordance with local requirements
* Male or female patients aged >= 12 to <= 64 years at the time of signing the informed consent/assent form.
* Patients with a diagnosis of influenza virus infection confirmed by all of the following:
1. Fever >= 38ºC (axillary) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken
2. At least one of the following general systemic symptoms associated with influenza are present with a severity of moderate or greater
* Headache
* Feverishness or chills
* Muscle or joint pain
* Fatigue
3. At least one of the following respiratory symptoms associated with influenza are present with a severity of moderate or greater
* Cough
* Sore throat
* Nasal congestion
* The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either:
1. Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature)
2. Time when the patient experiences at least one general or respiratory symptom
* Women of childbearing potential who agree to use a highly effective method of contraception for 3 months after the first dose of study drug
Exclusion Criteria:
* Patients with severe influenza virus infection requiring inpatient treatment.
* Patients aged >= 20 years with known allergy to oseltamivir (Tamiflu®).
* Patients with any of the following risk factors
1. Women who are pregnant or within 2 weeks post-partum
2. Residents of long-term care facilities (eg, welfare facilities for the elderly, nursing homes)
3. Chronic respiratory diseases including bronchial asthma
4. Neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (eg, cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
5. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms)
6. American Indians and Alaskan natives
7. Blood disorders (such as sickle cell disease)
8. Endocrine disorders (including diabetes mellitus)
9. Kidney disorders
10. Liver disorders
11. Metabolic disorders
12. Compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus [HIV] infection)
13. Morbid obesity (body mass index [BMI] >= 40)
* Patients unable to swallow tablets or capsules.
* Patients who have previously received Baloxavir Marboxil.
* Patients weighing < 40 kg
* Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations.
* Women who are breastfeeding or have a positive pregnancy test in the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test in the predose examinations:
1. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women
2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
* Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the predose examinations.
* Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, or amantadine within 30 days prior to the predose examinations.
* Patients who have received an investigational monoclonal antibody for a viral disease in the last year.
* Patients with severe underlying diseases.
* Patients with known creatinine clearance <= 60 mL/min.
* Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02954354
|
{
"brief_title": "A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza",
"conditions": [
"Influenza"
],
"interventions": [
"Drug: Oseltamivir",
"Drug: Placebo to Baloxavir Marboxil",
"Drug: Placebo to Oseltamivir",
"Drug: Baloxavir Marboxil"
],
"location_countries": null,
"nct_id": "NCT02954354",
"official_title": "A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-04",
"study_completion_date(actual)": "2017-04-24",
"study_start_date(actual)": "2016-12-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-08",
"last_updated_that_met_qc_criteria": "2016-11-01",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-03",
"first_submitted": "2016-10-27",
"first_submitted_that_met_qc_criteria": "2018-11-20"
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients with lymphedema caused by breast cancer or head, neck, and throat cancer.
PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion works in improving well-being and quality of life in patients with breast cancer or head, neck, and throat cancer who are undergoing standard treatment for lymphedema.
Detailed Description
OBJECTIVES:
* To test the acupuncture and moxibustion treatment strategies to obtain a first measure of response for the approach(es) used in patients with breast cancer or head, neck, and throat cancer undergoing standard treatment for secondary lymphedema.
* To assess whether this treatment is an acceptable intervention to cancer patients with secondary lymphedema and to their health care professionals.
* To disseminate the data to begin to build the evidence base for using this treatment in the management of lymphedema.
OUTLINE: Patients undergo acupuncture and moxibustion therapy once weekly for 7 treatment (Series 1). After completion of therapy, patients may choose to continue treatment for an additional 6 treatments (Series 2).
Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale (PANAS), and Measure Yourself Medical Outcome Profile (MYMOP)) at the first treatment and then periodically during study. Patients also complete a series of follow-up questionnaires designed to elicit feedback about their acupuncture experience.
After completion of study treatment, patients are followed at 1 and 3 months.
#Intervention
- OTHER : Acupuncture and moxibustion
- Acupuncture is a form of traditional east Asian medicine that uses needles inserted superficially under the skin to stimulate sites on the body known as acupuncture points. Traditional practice encompasses moxibustion, the application of heat (usually from the smouldering herb artemisia vulgaris or mugwort) to stimulate the points by warming them.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
* male or female patients with either breast or head and neck cancer
* diagnosis of mild to moderate uncomplicated lymphoedema
* age 18 or over
* under the care of the lymphoedema service for at leas:
* two months (head and neck cancer patients)
* three months (breast cancer patients)
* no active cancer disease
* at least 3 months since prior active cancer treatment (surgery, radiotherapy, chemotherapy, intravenous treatment)
* more than 6 months since prior acupuncture treatment
* concurrent adjuvant hormonal therapy allowed
* concurrent anti-depressant medication allowed provided there has been no change in prescription or dosing within the past 3 months and patient intends to remain on the medication for the duration of study treatment and follow-up
* Able to understand and communicate in English
* Able to travel to the Lynda Jackson Macmillan Centre for treatment
* Able to attend treatment once weekly for at least 7 consecutive weeks
* Able to complete outcome measures
EXCLUSION CRITERIA:
* bilateral breast cancer
* advanced cancer disease
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
|
NCT00828516
|
{
"brief_title": "Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema",
"conditions": [
"Breast Cancer",
"Head and Neck Cancer",
"Lymphedema"
],
"interventions": [
"Other: Acupuncture and moxibustion"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00828516",
"official_title": "Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment",
"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)": "2008-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-17",
"last_updated_that_met_qc_criteria": "2009-01-23",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-26",
"first_submitted": "2009-01-23",
"first_submitted_that_met_qc_criteria": "2012-12-07"
}
}
}
|
#Study Description
Brief Summary
This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.
#Intervention
- DRUG : eptacog alfa (activated)
- Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery
Exclusion Criteria:
* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01579968
|
{
"brief_title": "Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery",
"conditions": [
"Congenital Bleeding Disorder",
"Haemophilia A With Inhibitors",
"Haemophilia B With Inhibitors"
],
"interventions": [
"Drug: eptacog alfa (activated)"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01579968",
"official_title": "Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03-09",
"study_completion_date(actual)": "2010-03-09",
"study_start_date(actual)": "1999-03-10"
},
"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)": "2017-02-24",
"last_updated_that_met_qc_criteria": "2012-04-17",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-18",
"first_submitted": "2012-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching.
Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Group 1 bleached Maxillary arch, Group 2 bleached mandibular arch. Two weeks later subjects stopped bleaching the first arch and started second arch. Sensitivity was measured by VAS daily log scale for two weeks. Shade was taken with colorimeter and Classic Vita shade guide at baseline, immediate post-bleaching, and two weeks post-bleaching. Longitudinal sensitivity over the 14 days period of bleaching was summarized. The Wilcoxon Signed Rank test was used to compare summary measures.
Detailed Description
Study Design
This was a randomized, controlled, split-mouth cross-over design clinical trial. Subjects were randomized into two groups depending on the control and intervention arches:
* Group 1: The maxillary arch was the control arch (only bleaching) while the mandibular arch (MN) was intervention arch (bleaching and MI Paste).
* Group 2: The MN arch was the control arch (only bleaching) while the MX arch was the intervention arch (bleaching and MI Paste).
Ethical permission for the study was obtained from the University Intuitional Review Board (No. 200604706). The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines. Informed consents were obtained from the subjects prior to enrolment in the study.
Participants Forty-six participants were recruited at the Oral Health Center. Participants were included if they age between 18 and 55 years old with no prior history of bleaching, not using any desensitizing agents, and with anterior teeth of shade A2 or higher. Participants allergic to milk protein, pregnant, and/or on daily NSAIDs were excluded. They were also excluded if they have had an anterior crown or composite restoration, scaling or periodontal surgery performed in the past six months, and/or had a history of bleaching.
Intervention Both the bleaching gel (TiON whitening gel (GC America Inc) and MI paste (PROSPECTM MI paste) were delivered using custom trays with reservoir made for participants at the beginning of the study. To avoid contamination, the control arch was always bleached first. Group 1 subjects were instructed to use 15% carbamide peroxide on maxillary arch while group 2 were instructed to use it on the mandibular arch. Subjects stopped bleaching on their respective arches after 2 weeks. Subjects were then given bleach and MI paste to be used on the opposing arch (Group 1 used it on the mandibular arch and Group 2 used it on maxillary arch).
For bleaching only arch, participants were instructed to wear the trays each night for 6-8 hours for two weeks. Subjects were given a VAS daily log to document the sensitivity for two weeks. For bleach and MI Paste arch, participants were instructed to brush and floss their teeth, load the non-scalloped tray with MI Paste, wear it for 5 minutes, remove the tray, spit out the excess, and not to eat or drink for one hour. They were instructed to bleach after that for 6-8 hours for the next two weeks. Participants were instructed not to bleach the first arch anymore. Participants were given a VAS daily log to document the sensitivity score for each day for two weeks.
Measurements Measurements were made at baseline (Time 0), 2 weeks after initiation of bleaching (Time 1) and 2 weeks after the end of treatment (i.e., 4 weeks after initiation of bleaching; Time 2) for each arch. Longitudinal VAS scores were to be assessed at baseline (Day 0) and daily during the two weeks of bleaching (Days 1 through 14).
Sensitivity Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being 'no pain' and 10 being 'severe pain.' Subjects were asked to pick a number. Thermal sensitivity was measured by using a 1-second air blast at 70oF from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating 'no pain' and 3 indicating the 'severe pain' which lasted for more than 10 seconds12.
Shade Value-oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light. Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures. A hand held coloriometer 'Shade Vision' (X-rite, Inc) was used to measure shade digitally. Shade Vision identifies color difference using three dimensional CIE L\*a\*b\* values system.
Participants' Survey Participants were given a survey at the end of the study examining their perception on the ease of application of MI Paste as well as the impact of MI Paste on sensitivity and gingival inflammation.
#Intervention
- DRUG : CPP-ACP
- CPP-ACP WAS APPLIED AFTER TOOTH BLEACHING
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
* Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
* Subjects who were available for a potential recall period of one year.
* Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
Exclusion Criteria:
* Subjects who had any known allergies to any materials used in this protocol.
* Patients with milk protein allergies since one of the materials used is derived from milk protein.
* Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
* Subjects involved in other clinical trials utilizing a similar protocol.
* Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
* The subjects who have used any desensitizing agents including toothpaste in the past six months.
* Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
* Subjects who had any periodontal surgery or scaling performed in the past six months.
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
|
NCT04112706
|
{
"brief_title": "Efficacy of CPP-ACP on Bleaching Related Sensitivity",
"conditions": [
"Teeth Sensitivity",
"Tooth Discoloration"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04112706",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-02-16",
"study_completion_date(actual)": "2007-03-16",
"study_start_date(actual)": "2006-07-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-02",
"last_updated_that_met_qc_criteria": "2019-09-30",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-02",
"first_submitted": "2019-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine, in subjects with Type 1 Diabetes Mellitus:
1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.
#Intervention
- DRUG : Inhaled human insulin
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetes for more than 1 year
* Stable insulin regimen of at least 2 injections per day
Exclusion Criteria:
Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
* Subjects on insulin pump during 2 months prior to screening.
* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00424437
|
{
"brief_title": "Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.",
"conditions": [
"Diabetes Mellitus, Type 1"
],
"interventions": null,
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00424437",
"official_title": "Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2000-09",
"study_start_date(actual)": "1999-09"
},
"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)": "2007-02-13",
"last_updated_that_met_qc_criteria": "2007-01-17",
"last_verified": "2007-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-19",
"first_submitted": "2007-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.
#Intervention
- DRUG : Vandetanib
- Tablet, oral, daily
- Other Names :
- Zactima TM
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
* Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70 <= age <= 80mg/m^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
* WHO PS 0 <= age <= 1
* No prior radiotherapy to chest, immunotherapy or biologic therapy
Exclusion Criteria:
* Mixed small cell and non small-cell lung cancer history.
* Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is not permitted.)
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
* Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00777179
|
{
"brief_title": "Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy",
"conditions": [
"NSCLC"
],
"interventions": [
"Drug: Placebo",
"Drug: Vandetanib"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT00777179",
"official_title": "Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2008-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-10",
"last_updated_that_met_qc_criteria": "2008-10-21",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-22",
"first_submitted": "2008-10-21",
"first_submitted_that_met_qc_criteria": "2011-06-13"
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.
#Intervention
- DEVICE : Railroaded bougie
- Residents expose the glottis by a video laryngoscope and place the tip of bougie through the vocal cords. Then, an assistant loads an endotracheal tube on the free end of the bougie. Residents advance the endotracheal tube over the bougie and withdraw the bougie.
- DEVICE : Preloaded bougie
- Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation using a bougie with a preloaded endotracheal tube while an assistant secures the free end of the bougie. Residents withdraw the bougie when the endotracheal tube reaches an appropriate depth.
- DEVICE : Stylet
- Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation with the assistance of a stylet. An assistant withdraws the stylet when the tip of the endotracheal tube passes through the vocal cords. Then residents place the endotracheal tube to an appropriate depth.
|
#Eligibility Criteria:
Inclusion Criteria:
* Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023.
Exclusion Criteria:
* Residents who refuse to participate and residents who fail the pre-test.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05689125
|
{
"brief_title": "Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions",
"conditions": [
"Endotracheal Intubation",
"Cardiopulmonary Resuscitation",
"Simulation"
],
"interventions": [
"Device: Railroaded bougie",
"Device: Stylet",
"Device: Preloaded bougie"
],
"location_countries": [
"China"
],
"nct_id": "NCT05689125",
"official_title": "Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions by Anesthesia Residents: a Randomized Crossover Simulation Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-20",
"study_completion_date(actual)": "2023-02-20",
"study_start_date(actual)": "2023-02-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-13",
"last_updated_that_met_qc_criteria": "2023-01-09",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-18",
"first_submitted": "2023-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.
Detailed Description
We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.
#Intervention
- DRUG : ibuprofen
- DRUG : acetaminophen with codeine
|
#Eligibility Criteria:
Inclusion Criteria:
* 5 <= age <= 18 of age
* Spoke English as a primary language
* Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
* Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage
Exclusion Criteria:
* Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
* Administration of any analgesic within 6 hours of presentation;
* Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
* Inability to use the study pain instrument;
* Any laceration near the suspected injury;
* Chronic hepatic or renal disease;
* Pregnancy in the third trimester;
* Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
* Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00474721
|
{
"brief_title": "Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries",
"conditions": [
"Pain"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00474721",
"official_title": "A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-02",
"study_start_date(actual)": "2002-11"
},
"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)": "2007-05-17",
"last_updated_that_met_qc_criteria": "2007-05-16",
"last_verified": "2007-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-17",
"first_submitted": "2007-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators aim to investigate the effect of operating room noise on anesthetist hearing
|
#Eligibility Criteria:
Inclusion Criteria:
* anesthetist doctor and non-anesthetist doctor less than 40 years
Exclusion Criteria:
* doctors above 40 years
Sex :
ALL
Ages :
- Minimum Age : 28 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03118102
|
{
"brief_title": "Audiological Evaluation of Anesthetists",
"conditions": [
"Hearing Loss"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT03118102",
"official_title": "the Effects of Noise in Operating Rooms on Anesthetists Hearing",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-08",
"study_completion_date(actual)": "2018-01-08",
"study_start_date(actual)": "2017-04-10"
},
"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)": "2018-01-09",
"last_updated_that_met_qc_criteria": "2017-04-14",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-18",
"first_submitted": "2017-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in 'real-world' clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are 'improved', 'unchanged' or 'worsened' after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
Detailed Description
Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.
The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.
#Intervention
- DEVICE : Cardiac Resynchronization Therapy - MPP
- The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Exclusion Criteria:
* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03232944
|
{
"brief_title": "Personalized CRT - MPP Post Approval Study",
"conditions": [
"Heart Failure"
],
"interventions": [
"Device: Cardiac Resynchronization Therapy - MPP"
],
"location_countries": [
"France",
"Slovakia",
"Netherlands",
"United States",
"Germany",
"United Kingdom",
"Canada",
"Malaysia",
"Spain",
"Hungary",
"Italy",
"Belgium",
"Korea, Republic of"
],
"nct_id": "NCT03232944",
"official_title": "Personalized CRT - Multiple Point Pacing Post Approval Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-04",
"study_completion_date(actual)": "2021-01-07",
"study_start_date(actual)": "2017-07-05"
},
"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)": "2021-02-17",
"last_updated_that_met_qc_criteria": "2017-07-26",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-28",
"first_submitted": "2017-07-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.
#Intervention
- DRUG : Avelox (Moxifloxacin, BAY12-8039)
- Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
- DRUG : Placebo
- Matching placebo capsules orally once daily for 5 days every 8 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female out-patients >= 45 years
* Subjects suffering from chronic bronchitis
* FEV1<= 70% and FEV1/FVC <= 70% predicted from age, height and sex
* No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening
* Sputum production on most days, even when exacerbation free
* Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening
* Smoking history of at least 20 pack-years
* Subjects willing and able to give fully informed written consent
Exclusion Criteria:
* Subjects with contra-indications to moxifloxacin- Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis- Subjects who are actively participating in intensive pulmonary rehabilitation programs
* Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA
* No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage
* Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00473460
|
{
"brief_title": "Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis",
"conditions": [
"Lung Diseases",
"Bronchitis, Chronic"
],
"interventions": [
"Drug: Placebo",
"Drug: Avelox (Moxifloxacin, BAY12-8039)"
],
"location_countries": [
"France",
"Israel",
"Mexico",
"United States",
"Chile",
"Germany",
"United Kingdom",
"South Africa",
"Brazil",
"Spain",
"Ireland",
"Andorra",
"Argentina",
"Italy",
"Greece"
],
"nct_id": "NCT00473460",
"official_title": "A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-01",
"study_completion_date(actual)": "2007-01",
"study_start_date(actual)": "2004-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-10-28",
"last_updated_that_met_qc_criteria": "2007-05-14",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-15",
"first_submitted": "2007-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.
Detailed Description
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that are responsible for cell growth. Researchers believe that when certain genes and proteins are turned off, the ability of the cancer cell to survive is decreased.
Before treatment starts, participants will have a complete checkup, blood tests, a urine test, a heart test, a chest x-ray, and either a CT scan or MRI scan. Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment. Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends. Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study.
Participants in this study will receive Bortezomib and carboplatin through a catheter (tube) placed in a vein. This is Day 1 of therapy. Bortezomib is given first (over 5 to 10 seconds) followed by carboplatin (over one hour). Bortezomib is then given alone on Days 4, 8, and 11. There is no treatment given on Days 12-28. One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib. All treatment is given on an outpatient basis at M. D. Anderson.
There are 4 different dose levels of Bortezomib being studied. The dose of Bortezomib that participants receive will depend on when they are enrolled. It will also depend on whether or not other participants had side effects from their treatment. Up to 6 patients could be treated at each dose.
Before each course of therapy, participants will have a physical exam and blood tests. A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have a repeat CT or MRI 4 weeks later to confirm the response.
Participants may receive up to 8 courses of treatment. If the disease gets worse or if intolerable side effects occur, participants will be taken off study.
This is an investigational study. Bortezomib is approved for use by the FDA, in patients with multiple myeloma. Carboplatin is approved by the FDA, though its use with Bortezomib is experimental. A total of 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
#Intervention
- DRUG : PS-341 (Bortezomib)
- Starting dose 0.8 mg/m\^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.
- Other Names :
- Velcade, LDP-341, MLN341
- DRUG : Carboplatin
- AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.
- Other Names :
- Paraplatin
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically-confirmed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with advanced and/or metastatic disease. All patients must be considered platinum- and taxane- resistant.
* Platinum resistance is defined as:
1. Progression of disease during platinum or taxane chemotherapy, or
2. Progression of disease within 6 months of completing platinum or taxane chemotherapy
3. Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
* Patients may have had any number of prior chemotherapy regimens, except high dose chemotherapy an/or peripheral blood stem cell transplantation (high dose: higher than the standard doses of chemotherapy)
* Patients must have measurable disease.
* Zubrod performance status of < 2.
* Patients must give voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
* Adequate liver, renal and bone marrow function, defined as:
* Absolute neutrophil count (ANC) > 1.5 x 10^9/L.
* Platelets > 100 x 10^9/L
* Total bilirubin < 1.7 umol/L
* Alanine transaminase (ALT) and aspartate transaminase (AST) < 1.5 x Upper Limits of Normal (ULN)
* Alkaline phosphatase < 2.5 x ULN.
* Serum creatinine < 1.5 x ULN.
Exclusion Criteria:
* Chemotherapy within four weeks of first course of PS-341. (Patients may have been on hormonal therapy).
* Patients who previously received high-dose chemotherapy (higher than the standard doses of chemotherapy) and/or peripheral blood stem cell transplantation.
* Radiation therapy within four weeks of enrollment (excepting palliative XRT).
* Patients not recovered from toxic effects of previous chemotherapy, radiation therapy, or antibody therapy.
* Patients with > Grade 2 peripheral neuropathy.
* Surgery within four weeks of study enrollment.
* History of severe hypersensitivity reaction to carboplatin
* Electrocardiographic evidence of acute ischemia or new conduction system abnormalities.
* Myocardial infarction within six months of enrollment.
* Patients with brain metastases or central nervous system disease as evidenced by clinical symptoms.
* History of other malignancy, except nonmelanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for that disease for a minimum of 5 years. Chemotherapy given for prior cancers will not exclude patients from participating in this study.
* Patients with previously documented human immunodeficiency virus (HIV) infection. HIV-positive patients are excluded from the study based on theoretical concerns regarding the effect of PS-341 on certain aspects of immune function. NF-KB is a critical T cell activation protein (including through CD40L/CD 154 stimulation) and also is involved in cytokine production. Because PS 341 effectively blocks NF-KB and therefore could reduce or block the ability of T lymphocytes and other immune cells to fight HIV, PS-341 should not be administered to HIV-positive patients. Additional experiments in animal models are being conducted to better elucidate the effects of PS-341 on HIV.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
* Patients who are pregnant, suspected to be pregnant, or breast-feeding.
* Patients with a known hypersensitivity to PS-341, boron, or mannitol.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00059618
|
{
"brief_title": "PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer",
"conditions": [
"Ovarian Cancer",
"Primary Peritoneal Cancer",
"Fallopian Tube Cancer"
],
"interventions": [
"Drug: Carboplatin",
"Drug: PS-341 (Bortezomib)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00059618",
"official_title": "A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": "2007-04",
"study_start_date(actual)": "2003-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-02",
"last_updated_that_met_qc_criteria": "2003-04-29",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-04-30",
"first_submitted": "2003-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
Detailed Description
It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.
#Intervention
- PROCEDURE : Non-surgical periodontal treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* had no systemic disease,
* had not used any antibiotics
* had not used medications with an impact on the immune system,
* had not received any periodontal and/or medical treatment within the last 6 months.
Exclusion Criteria:
* smokers of cigarettes or other tobacco products,
* pregnant or breastfeeding,
* non-stable cardiovascular condition.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02977351
|
{
"brief_title": "Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms",
"conditions": [
"Atherosclerosis",
"Chronic Periodontitis"
],
"interventions": [
"Procedure: Non-surgical periodontal treatment"
],
"location_countries": null,
"nct_id": "NCT02977351",
"official_title": "Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2014-01"
},
"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)": "2016-11-30",
"last_updated_that_met_qc_criteria": "2016-11-29",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-30",
"first_submitted": "2016-11-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to assess if nitrate supplementation influence motor unit (MU) activity following a sustained ischemic contraction and whether this is affected by blood flow restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6 years) completed two experimental trials following 5-days of supplementation with either nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded, cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with BFR. These variables were also assessed during a 90 s recovery period with the first half completed with, and the second half completed without, BFR. Nitrate supplementation can expedite the recovery of MUP duration following a sustained ischemic contraction in healthy adults. These novel observations improve understanding of the effects of nitrate on the recovery of neuromuscular function post-exercise and might have implications for recovery of muscle contractile function.
#Intervention
- DIETARY_SUPPLEMENT : Nitrate supplementation
- Participants ingested 2 × 70 mL/day shots of concentrate nitrate-rich (\~12.8 mmol/day nitrate) or nitrate-depleted (\~0.08 mmol/day nitrite) beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK). Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
- DIETARY_SUPPLEMENT : Placebo supplementtaion
- 2 × 70 mL/day shots of concentrate nitrate-depleted (\~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male between 18 - 30 years
* free from known respiratory insufficiency, cardiovascular disease and neuro-musculo-skeletal problems at present or in the preceding 6 months.
* having at least 5 years competitively (team) sport experience.
Exclusion Criteria:
* having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.
Sex :
MALE
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
|
NCT05993715
|
{
"brief_title": "Nitrate Supplementation on Motor Unit Activity",
"conditions": [
"Dietary Supplements",
"Healthy"
],
"interventions": [
"Dietary Supplement: Nitrate supplementation",
"Dietary Supplement: Placebo supplementtaion"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05993715",
"official_title": "Influence of Nitrate Supplementation on Motor Unit Activity During Recovery Following a Sustained Ischemic Contraction.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-03",
"study_completion_date(actual)": "2020-03-01",
"study_start_date(actual)": "2019-12-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-15",
"last_updated_that_met_qc_criteria": "2023-08-08",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-15",
"first_submitted": "2023-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.
In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .
The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.
Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.
Detailed Description
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design.
In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old .
The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects.
Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.
BCG-PPD and EC skin test were performed during the screening period, and the skin test results were followed up at 48 hours; blood routine, urine routine, blood biochemistry, HIV antibody test, electrocardiogram, chest X-ray examination, physical examination, vital signs (heart rate, blood pressure) And body temperature), female subjects of childbearing age undergo a blood pregnancy test. Those eligible for entry will receive a dose of the trial vaccine or placebo on the same day (day 0); Observe vital signs (heart rate, blood pressure and body temperature), reactions at the inoculation site, and reactions at the non-inoculation site at 30 minutes, 7 days, and 14 days after vaccination; Blood routine, urine routine, blood biochemistry, electrocardiogram examination on the 14th day after vaccination; BCG-PPD and EC skin tests were performed on the 84th and 180th days after inoculation.
If the blood routine, urine routine, blood biochemistry, electrocardiogram examinations after vaccination are abnormal and have clinically meaningful results, a re-test is required. Under special circumstances, the number of re-tests can be appropriately increased until the follow-up outcome.
#Intervention
- BIOLOGICAL : BCG vaccine 1（0.025mg/0.1ml/person）
- Intradermal injection of 0.025mg/0.1ml/person dose BCG.
- BIOLOGICAL : BCG vaccine 2 （0.05mg/0.1ml/person）
- Intradermal injection of 0.05mg/0.1ml/person dose BCG.
- BIOLOGICAL : BCG vaccine 3（0.075mg/0.1ml/person）
- Intradermal injection of 0.075mg/0.1ml/person dose BCG.
- BIOLOGICAL : BCG vaccine 4 （0.075mg/0.1ml/person）
- Intradermal injection of 0.075mg/0.1ml/person dose BCG.
- BIOLOGICAL : Placebo of BCG vaccine （0.1ml/person）
- Intradermal injection of 0.1ml/person dose Placebo.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 6 <= age <= 65 years, able to provide legal identification;
* The guardian and/or I agree to participate in this trial, and have the ability to understand the research procedures and sign an informed consent form, and are willing and able to comply with the requirements of the research protocol;
* The female agrees to have no birth plan within 180 days after participating in the research and voluntarily take effective contraceptive measures;
* There is no contraindication to BCG vaccination (①Known allergy to any component of this vaccine; ②Patients suffering from acute disease, severe chronic disease, acute episode of chronic disease and fever; ③Immune deficiency, immunocompromised or receiving immunosuppression Treatment; ④patients with encephalopathy, uncontrolled epilepsy and other progressive neurological diseases; ⑤pregnant women; ⑥patients with eczema or other skin diseases), no history of tuberculosis;
* There are no contraindications to the use of BCG-PPD and EC (patients suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, patients with extensive skin diseases and allergic constitution);
* According to the medical history, physical examination and laboratory index test results, the investigator judges to be healthy (for example: no history of tumor, abnormal laboratory index but no clinical significance);
* The average diameter of BCG-PPD 48-hour skin test induration is less than 5mm without double circles, blisters, necrosis and lymphangitis. The average diameter of EC 48-hour skin test induration and redness is less than 5mm without blisters, necrosis, and lymphangitis. reaction.
Exclusion Criteria:
* Any previous history of severe side effects of vaccines or drugs, such as urticaria, dyspnea, angioedema;
* The interval between inoculation of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days;
* Those who have a history of convulsions, epilepsy, mental illness and/or family history of mental illness;
* Human immunodeficiency virus (HIV) antibody test results are positive;
* Have received blood or blood-related products within 3 months before screening;
* A history of drug abuse upon inquiry;
* Women who are breastfeeding;
* Those who have participated in other clinical trials in the past 3 months and used study drugs;
* 6 <= age <= 17 years systolic blood pressure >=120mmHg and/or diastolic blood pressure >=80 mmHg; 18 <= age <= 65 years diastolic blood pressure >=90mmHg and/or systolic blood pressure >=140mmHg;
* Those with axillary body temperature >=37.3℃;
* Disabled upper limbs;
* The researcher believes that the subject has any conditions that may affect the evaluation of the research purpose.
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:
Yes
|
NCT04563273
|
{
"brief_title": "Clinical Study of BCG Vaccine for Intradermal Injection",
"conditions": [
"Tuberculosis"
],
"interventions": [
"Biological: BCG vaccine 4 （0.075mg/0.1ml/person）",
"Biological: BCG vaccine 1（0.025mg/0.1ml/person）",
"Biological: Placebo of BCG vaccine （0.1ml/person）",
"Biological: BCG vaccine 3（0.075mg/0.1ml/person）",
"Biological: BCG vaccine 2 （0.05mg/0.1ml/person）"
],
"location_countries": [
"China"
],
"nct_id": "NCT04563273",
"official_title": "Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG Vaccine for Intradermal Injection in 6-65 Year Olds",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-30",
"study_completion_date(actual)": "2022-10-30",
"study_start_date(actual)": "2020-10-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-09",
"last_updated_that_met_qc_criteria": "2020-09-22",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-24",
"first_submitted": "2020-06-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.
#Intervention
- DRUG : bevacizumab [Avastin]
- 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
- DRUG : docetaxel
- 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
- DRUG : capecitabine [Xeloda]
- 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* female patients, 18 <= age <= 70years of age;
* histologically-proven invasive breast cancer;
* no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
* no distant disease/secondary cancer.
Exclusion Criteria:
* pregnant or lactating women;
* pre-operative local treatment for breast cancer;
* prior or concurrent systemic antitumor therapy;
* clinically significant cardiac disease.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02005549
|
{
"brief_title": "A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: bevacizumab [Avastin]",
"Drug: capecitabine [Xeloda]",
"Drug: docetaxel"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT02005549",
"official_title": "A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": "2008-04",
"study_start_date(actual)": "2006-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-14",
"last_updated_that_met_qc_criteria": "2013-12-04",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-09",
"first_submitted": "2013-12-04",
"first_submitted_that_met_qc_criteria": "2014-05-07"
}
}
}
|
#Study Description
Brief Summary
Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs, including Delta and Omicron, are locally trapped and blocked from entering the cells by the highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
Detailed Description
The transmission of SARS-CoV-2 through inhalation results in the nasal cavity and nasopharynx being the primary entry point of the virus and containing the highest viral load in the body during the virus incubation period. Recently, the administration of vaccines and agents via a nasal route has gained a lot of momentum because it takes advantage of the direct delivery of an agent to the site of primary infection. The local defence system, especially antibody-mediated immunity at the nasal epithelium, is crucial for COVID-19 prevention. However, people who responded to the vaccination against COVID-19 typically maintain sufficient local antibody levels in the nasal cavity for only a short period; hence a repeated boosting strategy is required to control the rate of SARS-CoV-2 breakthrough infection. In addition, the new VOCs such as Omicron are known to escape vaccine immunity; therefore, an innovative approach is needed in this unprecedented situation
Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs, including Delta and Omicron, are locally trapped and blocked from entering the cells by the highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
#Intervention
- DEVICE : Human IgG1 anti-SARS-CoV-2 antibody cocktail
- Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail
- DEVICE : Placebo
- Normal saline
|
#Eligibility Criteria:
Inclusion criteria
* Male or female, >= 18 and <= 50 years with BMI >= 18 and <= 30 kg/m2
* Healthy as defined by:
1. No previous clinically significant disease and surgery within 4 weeks prior to dosing.
2. No previous sinus and nasal septum surgery or radiotherapy
3. No evidence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease which the Investigator believes may be detrimental to the study or its aims.
4. No evidence of febrile or infectious disease within 1 week prior to dosing.
* Have received at least 2 doses of COVID-19 vaccine.
* Have no history of close contact with COVID-19 patients within 2 weeks before enrolment
* Have negative result of COVID-19 test using RT-PCR method using sample collected from nasopharyngeal or nasal or oropharyngeal swab within 72 hours before sinusoscopy
* Provide signed written informed consent prior to the initiation of any study-specific procedures.
* Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial.
Exclusion criteria
* Any clinically significant abnormality at physical examination at screening or enrolment
* Vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 bpm, respiratory rate less than 10 or over 22 bpm, oral temperature less than 35.5°C or over 37.5°C) at screening.
* Positive urine pregnancy test for women or women who are breast feeding
* History of COVID-19 infection within 3 months before enrollment
* History of allergic reactions or hypersensitivity to any excipients of the study products.
* Use any nasal product use within 14 days prior to the first dosing
* History of pulmonary infiltrate or pneumonia within 6 months before the screening visit.
* Signs or symptoms of respiratory tract abnormalities such as allergies or chronic obstructive pulmonary disease.
* History or signs of chronic allergic rhinitis that may interfere with study procedures and/or interpretation of local adverse events.
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:
Yes
|
NCT05358873
|
{
"brief_title": "Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail",
"conditions": [
"SARS CoV 2 Infection",
"SARS-CoV-2 Acute Respiratory Disease"
],
"interventions": [
"Device: Human IgG1 anti-SARS-CoV-2 antibody cocktail",
"Device: Placebo"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT05358873",
"official_title": "A Phase I Double-blind, Randomized, Placebo-controlled Study to Evaluate Safety of Hypromellose-based Nasal Spray Solution Containing Human IgG1 Anti-SARS-CoV-2 Antibody Cocktail in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-01",
"study_completion_date(actual)": "2022-07-01",
"study_start_date(actual)": "2022-04-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-07",
"last_updated_that_met_qc_criteria": "2022-04-30",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-03",
"first_submitted": "2022-04-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Repeated exposure to trauma is an unavoidable part of the job for firefighters. Because of this, many Canadian firefighters screen positive for posttraumatic stress disorder/injury (PTSD/I). Unfortunately, like the general population, firefighters face many barriers to accessing mental health care. As a result, additional efforts are needed to increase timely access to effective PTSD/I services that are delivered in a way that reduces confidentiality and stigma risk.
This research study will test the preliminary efficacy and feasibility of distance-delivered Narrative Exposure Therapy (NET) delivered by a paraprofessional for firefighters with PTSD/I. NET is an evidence-based intervention approach developed specifically for PTSD/I resulting from repeated and continuous trauma. The intervention will be conducted via videoconference with a trained paraprofessional supervised by a clinical psychologist. The NET intervention will consist of 12 weekly 90-minute videoconference sessions.
Approximately 25 firefighters will be recruited to participate in the study. To test the efficacy of the intervention, participants will complete self-report questionnaires about PTSD/I and other mental health symptoms pre- and post-intervention as well as two- and six-months following intervention completion. Participants will also complete an open-ended interview at the end of the intervention to assess feasibility and participant satisfaction.
#Intervention
- BEHAVIORAL : Distance-delivered NET
- One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
Participants must meet the following criteria to be eligible to move on to Consent
* Be at least 19 years
* Be able to understand spoken and written English at a Grade 8 level
* Be employed, or have been employed, by the fire service or be current or past fire service volunteers.
* Fulfill the criteria of full or subclinical PTSD/I according to the PCL-5.
* Have access to a computer with Internet.
* Live in Atlantic Canada or Ontario.
* Consent to be audio- (for consent and interview) and video-recorded (for intervention sessions).
Exclusion Criteria:
* Having a psychotropic medication change in the past three weeks.
* Are currently engaged in or have previously been engaged in exposure therapy for PTSD/I.
* Meet criteria for current mania or psychosis.
* Endorse suicidal ideation with plan or intent.
* Experience high levels of dissociation (as assessed by a score of >18.5 on the Shutdown Dissociation Scale).
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04386330
|
{
"brief_title": "Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms",
"conditions": [
"Post Traumatic Stress Disorder",
"Post Traumatic Stress Injury"
],
"interventions": [
"Behavioral: Distance-delivered NET"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04386330",
"official_title": "Firefighters Accessing Care for Trauma: A Clinical Case Series Testing the Efficacy of Distance-Delivered Narrative Exposure Therapy in Reducing PTSD/I Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2020-06-29"
},
"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)": "2022-03-31",
"last_updated_that_met_qc_criteria": "2020-05-12",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-13",
"first_submitted": "2020-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China.
Detailed Description
The aim of this study is to translate the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) into Chinese and evaluate its validity, and reliability among soft contact lens wearers in China. One hundred and thirty-four Chinese soft contact lens wearers will be included in the study. Subjects are required to complete the Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (C-CLDEQ-8) on paper before eye examinations. A subgroup of 50 participants will be asked to complete C-CLDEQ-8 twice to evaluate the repeatability.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 <= age <= 60
* Native Chinese citizens with Chinese as first language
* Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months;
* Willing to sign informed consent
Exclusion Criteria:
* Any extended wear of SCLs, including wearing toric or multi-focal SCLs
* Use SCL for monovision correction
* Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa)
* Having ocular or systemic disease that would preclude SCL wearing
* Best corrected visual acuity of less than 0.8 in either eye
* History of refractive or other types of corneal surgeries
* Having eyelid abnormalities or functional ocular disorders that would induce relevant discomfort.
8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire
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:
Yes
|
NCT05416528
|
{
"brief_title": "Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)",
"conditions": [
"Contact Lens",
"Questionnaire",
"Contact Lens Discomfort"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT05416528",
"official_title": "Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-18",
"study_completion_date(actual)": "2023-04-22",
"study_start_date(actual)": "2022-11-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-28",
"last_updated_that_met_qc_criteria": "2022-06-08",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-13",
"first_submitted": "2022-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.
#Intervention
- PROCEDURE : ultrasound-guided fine needle aspiration biopsy
- Fine needle aspiration (FNA)with cytologic analysis has become a mainstay of thyroid nodule evaluation was used. Nonpalpable nodules were aspirated under ultrasound guidance to facilitate precise targeting of the nodule and to sample the part most likely to improve diagnostic yield.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
Exclusion Criteria:
* Patients who refuse participation.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00551486
|
{
"brief_title": "Pyrosequencing of the BRAFV600E Mutation",
"conditions": [
"Thyroid Neoplasms"
],
"interventions": [
"Procedure: ultrasound-guided fine needle aspiration biopsy"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT00551486",
"official_title": "Diagnostic Value of Pyrosequencing for the BRAFV600E Mutation in Ultrasound-Guided Fine-Needle Aspiration Biopsy Samples of Thyroid Incidentalomas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-10-31",
"last_updated_that_met_qc_criteria": "2007-10-30",
"last_verified": "2007-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-31",
"first_submitted": "2007-10-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.
Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output
All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.
#Intervention
- DRUG : Morphine
- we observe the self-patient controlled morphine consumption during the first 48h after surgery
- OTHER : Cardiac output measure
- we observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory )
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteers
* Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
* Video or robot assisted procedure
Exclusion Criteria:
* Advanced stage of cancer (T3Nx and greater)
* Need of thoracotomy conversion during procedure
* Morphine intolerance or addiction.
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
|
NCT03111797
|
{
"brief_title": "Robot-assisted Lobectomy Versus Video-assisted Lobectomy",
"conditions": [
"Robotic Surgical Procedures",
"Pneumonectomy; Status",
"Anesthesia and Analgesia",
"Cardiac Output"
],
"interventions": [
"Drug: Morphine",
"Other: Cardiac output measure"
],
"location_countries": [
"France"
],
"nct_id": "NCT03111797",
"official_title": "Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-30",
"study_completion_date(actual)": "2017-05-30",
"study_start_date(actual)": "2016-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-22",
"last_updated_that_met_qc_criteria": "2017-04-08",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-13",
"first_submitted": "2017-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Parkinson's disease (PD) is a degenerative disease that can be difficult to diagnose. The clinicopathological studies had demonstrated a 76% accuracy in the clinical diagnosis of PD.
At the beginning of PD is difficult for the clinician to distinguish from Parkinsonism Plus Syndromes (PPS) due to the similarity of symptoms and the lack of specific diagnostic tests.
Specific biomarkers to help improve the accuracy of diagnosis and to separate these two entities are highly needed
The histological hallmark for definite diagnosis of PD is the presence of fibrillar aggregates of phosphorylated alpha-synuclein called Lewy bodies (LBs) and Lewy neurites. Previous autopsy-based studies have revealed that alpha-synuclein is deposited in the peripheral autonomic nervous system including the enteric nervous system of the alimentary tract, cardiac plexus, adrenal medulla and skin.
For this reason, in patients with parkinsonism, an alternative tool could be to demonstrate alpha-synuclein fibrillar aggregates in the skin, allowing early and appropriate diagnosis.
Detailed Description
Parkinsonism, the syndrome, is a common movement disorder, and Parkinson's disease, the most common cause of parkinsonism, is the second most prevalent neurodegenerative disease after Alzheimer's disease.
The clinical diagnosis of PD is based on the presence of the four common features: tremor when the limb is at rest, resistance to passive movement of the joints (rigidity), slowness and paucity of movement (bradykinesia and akinesia) and postural abnormalities.
Approximately 25 percent of patients who received an initial clinical diagnosis of PD are found to have parkinsonism as part of another disorder, such as one of the so-called Parkinsonism-Plus Syndromes (PPS) The number and complexity of PPS seem to be increasing. This, along with the lack of diagnostic tests, makes it difficult for the clinician to distinguish between disease types.
Some characteristic clinical features are used for the differential diagnosis, this manifestations include early and severe postural instability, falls in the first year of onset, abnormal eye movements, autonomic dysfunction, cerebellar signs and upper motor neuron signs. The PPS respond poorly to antiparkinsonian medications and have a worse prognosis than does PD. In spite of these suggestive features, not all PD patients have the same progression, in some cases it is impossible to separate typical PD from PPS, especially at the early stage. In this context, biological markers must be of great usefulness for the differential diagnosis of these entities.
Some reports have described early features of PD such as (SPECT) imaging of the dopamine transporter that demonstrated the reduction of dopamine transporter in the striatum body at the early stage of PD and degeneration of the cardiac sympathetic nerve at the beginning of the disease process of PD; this occurs before neuronal cell loss is present in the dorsal vagal nucleus; This fact accounts for reduced cardiac uptake of meta-iodobenzylguanidine (MIBG), a physiological analog of norepinephrine. However, these diagnostic methods are not often performed. Therefore, more sensitive methods are needed to help improve the accuracy of diagnosis of PD.
#Intervention
- PROCEDURE : Biopsy of skin
- Under local anesthesia with 1% xylocaine, 4-mm punch biopsies with 3-mm depth, including the dermis and subcutaneous fat tissue, will undergone from two regions, neck and lower back.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Parkinson's Disease or Parkinson Plus Syndrome
* Subject is a male or female between the age of 50 and 95
* Subject will write the informed consent
Exclusion Criteria:
* History of stroke or/and trauma
* Signs of cerebrovascular pathology
* Brain tumor
* Severe unrelated neurological or physical disease
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01380899
|
{
"brief_title": "Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.",
"conditions": [
"Parkinson Disease",
"Parkinsonian Disorders"
],
"interventions": [
"Procedure: Biopsy of skin"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT01380899",
"official_title": "Usefulness of α-synuclein as a Marker for Early Diagnosis of Parkinson's Disease in Skin Biopsy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2011-02"
},
"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)": "2021-05-25",
"last_updated_that_met_qc_criteria": "2011-06-23",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-27",
"first_submitted": "2011-06-17",
"first_submitted_that_met_qc_criteria": "2021-05-01"
}
}
}
|
#Study Description
Brief Summary
A 3-arm, patient-randomized trial among Latino and African-American older adults with poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs. home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.
Detailed Description
Older asthmatics experience worse outcomes than younger adults, especially if they identify as Latino or African-American. Several factors contribute to worse outcomes in these populations including frailty, cognitive impairment, managing multiple chronic diseases and multiple daily medications, low health literacy and English proficiency, high healthcare costs, and misunderstandings about asthma. To our knowledge, there are no programs designed to help older asthmatics manage their illness. In order to address these factors two emerging patient-centered strategies, clinic- and home-based care coordination and self-management support led by an Asthma Care Coach (ACC) and a community health worker (CHW), respectively, will be tested. These strategies will be combined a clinician-centered strategy, use of electronic medical record (EMR)-based asthma decision support that guides medication prescribing, basic counseling, and provision of asthma action plans.
Specific aims are:
1. To compare the effectiveness of (1) ACC/clinic- or (2) CHW/home-based asthma care coordination and self-management support with (3) no care coordination/self-management support (usual care) for improving asthma-related outcomes;
2. To identify subsets of individuals who have greater benefit from home-based care coordination and self-management support compared to clinic-based support.
A 3-arm, randomized trial will be conducted among 450 adult asthmatics ages 60 and older at primary care practices in East and Central Harlem and the South Bronx. All patients, regardless of assignment, will receive care from primary care providers (PCP) with access to the EMR-based asthma decision support. Patients in the ACC and CHW arms will be assessed for barriers to asthma control and will receive support specifically tailored to the identified barriers, including those arising from physical, mental, social/economic, or cognitive issues. Program participation will be 12 months, during which the ACCs and CHWs will also work with the patients' PCPs to optimize care. The study team will engage stakeholders (patients and caregivers, clinicians, community-based organizations, others) to develop and prepare study materials and protocols. In addition to studying patient outcomes, the process of implementing these models of care will be evaluated and documented.
Patients in the ACC and CHW arms will have similar asthma outcomes (asthma control, quality of life, use of urgent care, appointment keeping, medication adherence, use of asthma actions plans). Compared to usual care, patients in the ACC and CHW arms will perform better on these outcomes. Patients with more severe asthma and those at greater risk of missed clinic appointments because of physical or cognitive impairment and psychosocial issues (e.g., substance abuse, mental illness) will be more likely to benefit from the CHW/home-based intervention.
#Intervention
- BEHAVIORAL : Supporting Asthma Management Behaviors in Aging Adults (SAMBA)
- The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). All interventions, including usual care, will include EMR-based asthma self-management and decision support tools for clinicians in all practice sites. The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months. Outcomes will be measured through interviews, EMR chart abstractions, and from the Statewide Planning and Research Cooperative System (SPARCS) dataset to identify all ED visits and hospitalizations to any New York State facility.
- Other Names :
- SAMBA
|
#Eligibility Criteria:
Inclusion Criteria:
* ages <=60 years
* physician diagnosis of asthma
* English- or Spanish-speaking
Exclusion Criteria:
* physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung condition
* <=15 pack-years
* enrollment in another asthma self-management program
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02316223
|
{
"brief_title": "Supporting Asthma Management Behaviors in Aging Adults",
"conditions": [
"Asthma"
],
"interventions": [
"Behavioral: Supporting Asthma Management Behaviors in Aging Adults (SAMBA)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02316223",
"official_title": "Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-02",
"study_completion_date(actual)": "2018-02-02",
"study_start_date(actual)": "2015-01"
},
"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)": "2021-10-06",
"last_updated_that_met_qc_criteria": "2014-12-10",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-12",
"first_submitted": "2014-12-10",
"first_submitted_that_met_qc_criteria": "2021-09-09"
}
}
}
|
#Study Description
Brief Summary
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.
Detailed Description
Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.
#Intervention
- PROCEDURE : Tracheostomy with aerosol box in COVID-19 positive patients
- Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.
|
#Eligibility Criteria:
Inclusion Criteria:
* who underwent percutaneous tracheostomy with COVID-19(+)
Exclusion Criteria:
* Patients who do not give informed consent or do not want to participate in the study
* Coagulopathy, thrombocytopenia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04447638
|
{
"brief_title": "Percutaneous Tracheostomy With COVID-19",
"conditions": [
"Tracheostomy"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT04447638",
"official_title": "Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-01",
"study_completion_date(actual)": "2020-06-01",
"study_start_date(actual)": "2020-03-20"
},
"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)": "2020-09-24",
"last_updated_that_met_qc_criteria": "2020-06-24",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-25",
"first_submitted": "2020-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.
#Intervention
- BIOLOGICAL : Infanrix-Hexa
|
#Eligibility Criteria:
Inclusion Criteria:
* A male or female infant at the age of 11 - 17 weeks.
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by clinical examination before entering into the study.
* Hepatitis B vaccine at birth and one month of age.
Exclusion Criteria:
* Previous vaccination against measles, mumps, rubella and/or varicella.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* Major congenital defects.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Sex :
ALL
Ages :
- Minimum Age : 11 Weeks
- Maximum Age : 17 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00366366
|
{
"brief_title": "To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines",
"conditions": [
"Hepatitis B"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00366366",
"official_title": "Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-09",
"study_completion_date(actual)": "2002-09",
"study_start_date(actual)": "2001-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-16",
"last_updated_that_met_qc_criteria": "2006-08-18",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-21",
"first_submitted": "2006-08-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.
Detailed Description
CLBR001 + SWI019 is a two-component therapy comprising an autologous chimeric antigen receptor T (CAR-T) cell product (CLBR001, the switchable CAR-T cell (sCAR-T)) and an anti-CD19 (cluster of differentiation antigen 19) antibody (SWI019, the switch, a biologic). In combination, SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
#Intervention
- COMBINATION_PRODUCT : CLBR001 and SWI019
- Investigational immunotherapy for B cell malignancies
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
* Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
* Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
* Patients must be ineligible for allogeneic stem cell transplant (SCT)
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Estimated life expectancy of >= 12 weeks from the first day of SWI019 dose administered
* Willing to undergo pre- and post-treatment core needle biopsy
* Adequate hematological, renal, pulmonary, cardiac, and liver function
* Resolved adverse events of any prior therapy to either baseline or CTCAE Grade <=1
* Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
* Men sexually active with female partners of child bearing potential must agree to practice effective contraception
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
Exclusion Criteria:
* Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
* Pregnant or lactating women
* Active bacterial, viral, and fungal infections
* History of allogeneic stem cell transplantation
* Treatment with any prior lentiviral or retroviral based CAR-T
* Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
* Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
* History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
* Involvement of cardiac tissue by lymphoma
* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
* HIV-1 and HIV-2 antibody positive patients
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04450069
|
{
"brief_title": "CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies",
"conditions": [
"Relapsed/Refractory B-cell Lymphomas",
"Diffuse Large B Cell Lymphoma (DLBCL)",
"Follicular Lymphoma (FL)",
"Chronic Lymphocytic Leukemia (CLL)",
"Marginal Zone Lymphoma (MZL)",
"Mantle Cell Lymphoma",
"Small Lymphocytic Lymphoma (SLL)",
"Primary Mediastinal Large B Cell Lymphoma",
"Transformed Follicular Lymphoma",
"Waldenstrom Macroglobulinemia",
"Lymphoplasmacytic Lymphoma",
"Burkitt Lymphoma"
],
"interventions": [
"Combination Product: CLBR001 and SWI019"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04450069",
"official_title": "A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-06",
"study_completion_date(actual)": "2024-05-06",
"study_start_date(actual)": "2020-08-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-20",
"last_updated_that_met_qc_criteria": "2020-06-25",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-29",
"first_submitted": "2020-06-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A comparative study of different swab types used for collection of specimens for rapid inluenza testing
#Intervention
- DEVICE : Swab Specimen Collection (QuickVue)
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects must have:
* Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:
* Chills/sweats
* Cough
* Dyspnea (labored, difficult breathing)
* Fatigue
* Headache
* Myalgia (deep muscle aches)
* Nasal congestion
* Runny nose
* Sore throat
Exclusion Criteria:
* Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00491283
|
{
"brief_title": "QuickVue Influenza A+B Clinical Field Trial",
"conditions": [
"Influenza"
],
"interventions": null,
"location_countries": [
"Australia"
],
"nct_id": "NCT00491283",
"official_title": "Comparison of Swab Types for Specimen Collection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-08",
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-01-28",
"last_updated_that_met_qc_criteria": "2007-06-25",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-26",
"first_submitted": "2007-06-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary objective was to assess ultrasound visibility of each relevant structure and overall visibility between these two methods.
Detailed Description
Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.
Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this prospective cohort study. Ultrasound visualization results were compared between methods.
#Intervention
- PROCEDURE : shamrock
- This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.
- PROCEDURE : paramedian transverse scan
- The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy volunteer, age >= 18
Exclusion Criteria:
* spinal deformity and history of previous back or spine surgery
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
|
NCT02982031
|
{
"brief_title": "A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade",
"conditions": [
"Lumbar Plexus Blockade"
],
"interventions": [
"Procedure: shamrock",
"Procedure: paramedian transverse scan"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT02982031",
"official_title": "A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-05",
"last_updated_that_met_qc_criteria": "2016-12-01",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-05",
"first_submitted": "2016-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.
Detailed Description
A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.
#Intervention
- DEVICE : GRR laser
- A total of 15 sessions were applied to each patient for three weeks, five times per week.
- DEVICE : Nd:YAG laser
- A total of 10 sessions, five sessions per week, were applied
|
#Eligibility Criteria:
Inclusion Criteria:
*patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.
Exclusion Criteria:
* Patients with internal TMJ irregularities or degenerative joint changes,
* patients with restricted mouth opening, deviation or deflection,
* patients with systemic diseases,
* pregnant women,
* patients who had received MPS treatment within the previous year
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06442553
|
{
"brief_title": "New Generation Low Level Laser Effect in Myofacial Pain Syndrome",
"conditions": [
"Myofascial Pain Syndrome"
],
"interventions": [
"Device: Nd:YAG laser",
"Device: GRR laser"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06442553",
"official_title": "New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-25",
"study_completion_date(actual)": "2024-04-01",
"study_start_date(actual)": "2024-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-04",
"last_updated_that_met_qc_criteria": "2024-05-29",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-04",
"first_submitted": "2024-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.
PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (\<1% of 'candidate' patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.
The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.
Detailed Description
More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 - €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.
Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with \<1% of 'candidate' patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority.
It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally.
3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will:
1. Implement 4 community-based PR programmes (Task 1);
2. Create an online platform for clinical storage and analysis of the data collected (Task 2);
3. Perform a cost-benefit analysis of the implemented PR programmes (Task 3);
4. Create a Portuguese online PR toolkit (Task 4);
5. Promote knowledge transfer about PR (Task 5). The plan is to implement community-based PR programmes in 4 primary care centres of 2 ACES (Baixo Vouga - BV, and Baixo-Mondego - BM) of the centre region and assess the impact of such intervention in several domains. Surrogate and patient/family centered outcome measures will be used. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization and costs. Finally, dissemination and knowledge transfer of the project will be conducted through: an international conference, activities with the community, three PR courses; the development of the Portuguese online PR toolkit to support the widespread implementation of PR in Portugal and via publications.
To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration - Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão - SPP, RESPIRA and Fundação Portuguesa do Pulmão - FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project.
It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV \& BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team.
Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR.
Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated.
#Intervention
- OTHER : Pulmonary Rehabilitation
- Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component
- OTHER : Daily medication
- Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team.
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of a chronic respiratory disease
* clinically stable in the previous month
* >= 18 years
* able to provide their own informed consent
Exclusion Criteria:
* cognitive impairments
* inability to understand and co-operate
* history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.
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
|
NCT03799666
|
{
"brief_title": "(Re)Vitalizing Pulmonary Rehabilitation for Patients With Chronic Respiratory Diseases",
"conditions": [
"Chronic Respiratory Disease"
],
"interventions": [
"Other: Daily medication",
"Other: Pulmonary Rehabilitation"
],
"location_countries": [
"Portugal"
],
"nct_id": "NCT03799666",
"official_title": "(Re)Vitalizing Pulmonary Rehabilitation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-30",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2019-01-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-08",
"last_updated_that_met_qc_criteria": "2019-01-09",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-10",
"first_submitted": "2018-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
#Intervention
- DRUG : capecitabine [Xeloda]
- 825mg/m2 po bid on days 1-14 of each 3 week cycle
- DRUG : Taxotere
- 75mg/m2 iv on day 1 of each 3 week cycle
- DRUG : Taxotere
- 100mg/m2 iv on day 1 of each 3 week cycle
|
#Eligibility Criteria:
Inclusion Criteria:
* female patients 18 <= age <= 70 years;
* adenocarcinoma of the breast;
* previous invasive breast cancer if diagnosed >5 years before entering study;
* no evidence of metastatic disease.
Exclusion Criteria:
* history of severe hypersensitivity reaction to Taxotere;
* previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
* treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00089479
|
{
"brief_title": "A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: Taxotere",
"Drug: capecitabine [Xeloda]"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00089479",
"official_title": "A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2002-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-12-21",
"last_updated_that_met_qc_criteria": "2004-08-05",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2004-08-06",
"first_submitted": "2004-08-05",
"first_submitted_that_met_qc_criteria": "2011-05-24"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.
Detailed Description
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006). Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998). A promising tool in this area is the probiotic Lactobacillus reuteri
#Intervention
- DIETARY_SUPPLEMENT : L reuteri in children on antibiotics
- Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* 3 - 18 years
* Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
* The signed informed consent by one/both parents / legal guardian and by the subject if she/he is >= 12 years
* Available throughout the study period
* No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
* Subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol
Exclusion Criteria:
* Three or more soft and unformed or watery stools per day at admission
* Receiving chemotherapy or radiation therapy
* Diagnosis of inflammatory bowel disease
* Enteral or parenteral nutrition only
* Requiring care in an intensive care unit
* Status post-bowel resection during hospitalization
* Receiving antibiotics four weeks prior to hospitalization
* Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases)
* Pregnancy
* Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01295918
|
{
"brief_title": "Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children",
"conditions": [
"Antibiotic Associated Diarrhea",
"Clostridium Difficile Infection",
"Gastroenteritis"
],
"interventions": [
"Dietary Supplement: L reuteri in children on antibiotics"
],
"location_countries": [
"Bulgaria"
],
"nct_id": "NCT01295918",
"official_title": "Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2011-02"
},
"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)": "2013-09-10",
"last_updated_that_met_qc_criteria": "2011-02-14",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-15",
"first_submitted": "2011-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
Detailed Description
In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.
#Intervention
- PROCEDURE : Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy
- laparoscopic proximal gastrectomy with single-tract jejunal interposition (LPG-STJI) versus double-tract reconstruction (LPG-DTR) versus tube-like stomach reconstruction (LPG-TLR).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 <= age <= 75 years, male or female;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
* American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
* Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC;
* Patients without contraindications to surgery;
* Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;
Exclusion Criteria:
* Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
* Combined resection required due to other diseases (except cholecystectomy).
* History of cancer or concurrent cancer in other organs.
* Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
* Patients with coagulation dysfunction which could not be corrected;
* Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
* Receipt of chemotherapy or radiotherapy before either surgical procedure.
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
|
NCT06347757
|
{
"brief_title": "A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy",
"conditions": [
"Anti-Reflux Alimentary Reconstruction",
"Laparoscopic Proximal Gastrectomy",
"Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction"
],
"interventions": [
"Procedure: Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy"
],
"location_countries": [
"China"
],
"nct_id": "NCT06347757",
"official_title": "A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2024-03-15",
"study_start_date(actual)": "2020-01-01"
},
"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)": "2024-04-30",
"last_updated_that_met_qc_criteria": "2024-03-29",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-04",
"first_submitted": "2024-03-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.
Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.
#Intervention
- DRUG : Selegiline
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with moderate to severe negative symptoms
* Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month.
* No other psychotropic drugs during past month
Exclusion Criteria:
* Severe major depressive disorder
* Substance abuse
* Severe positive symptoms of schizophrenia
* Treatment of MDD with antidepressant drugs during past month.
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
|
NCT00456976
|
{
"brief_title": "Efficacy of Selegiline in Negative Symptoms of Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": null,
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT00456976",
"official_title": "Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-09",
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-07-23",
"last_updated_that_met_qc_criteria": "2007-04-04",
"last_verified": "2008-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-04-05",
"first_submitted": "2007-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not only the patient, but the personnel of ERCP team may have the effect from the scattered ray. According to the automatic beam adjustment function, the thicker object (eg. lying left lateral) might produce higher scatter ray than thinner object (eg. lying prone). The investigators evaluate the radiation exposure among ERCP personnel compare between patient's 2 different positions.
Detailed Description
Personal solid-state dosimeters were used to measure the radiation dose on personnel during ERCP procedure. The real-time effective doses were displayed at a monitoring screen. A dosimeter was attached outside thyroid collar of each ERCP team member included of 1st endoscopist, 2nd endoscopist, and nurse anesthetist.
Patients' age, gender, BMI, body thickness, and indications for ERCP were recorded. The patients were randomized into 2 groups by block-of-four. The patients' position was assigned to prone or left lateral decubitus. Each ERCP personnel wore a lead apron and the dosimeter was attached outside the thyroid collar. The ERCP procedure was performed according to the indication in a standard technique. After ERCP procedure, the total fluoroscopic time (minute), fluoroscopy tube voltage (kV), fluoroscopy tube current (mA), patient entrance skin dose (mGy) and personnel effective dose (Sv) from each dosimeter were recorded.
Continuous variables were compared by Student's t-test or Man Whitney U-test, where appropriate. Categorical variables were compared by Chi-square or the Fisher exact test. Statistical analysis was calculated by using SPSS statistical software (version17 for Window, Chicago, USA) and two sided p-value \< 0.05 was considered to be statistical significant.
#Intervention
- RADIATION : Automatic beam adjustment function
- The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
|
#Eligibility Criteria:
Inclusion Criteria:
* Indicated for ERCP
Exclusion Criteria:
* pregnancy
* American Society of Anesthesiologists (ASA) physical status class III - IV
* unstable vital signs
* patients' position needed to be changed during the procedure
* patients who need fixed position for ERCP (such as biliary hilar lesion)
* enteroscope-assisted ERCP
* the consent form can not be obtained
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
|
NCT02791659
|
{
"brief_title": "Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.",
"conditions": [
"Occupational Radiation Exposure"
],
"interventions": [
"Radiation: Automatic beam adjustment function"
],
"location_countries": null,
"nct_id": "NCT02791659",
"official_title": "Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-11",
"study_start_date(actual)": "2016-07"
},
"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)": "2017-05-30",
"last_updated_that_met_qc_criteria": "2016-06-01",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-07",
"first_submitted": "2016-06-01",
"first_submitted_that_met_qc_criteria": "2017-02-01"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.
#Intervention
- DRUG : HCV-796
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00385190
|
{
"brief_title": "Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"Japan"
],
"nct_id": "NCT00385190",
"official_title": "An Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Study Drug Administred Orally to Healthy Japanese Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-11",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-08-18",
"last_updated_that_met_qc_criteria": "2006-10-05",
"last_verified": "2009-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-06",
"first_submitted": "2006-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.
Detailed Description
Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.
#Intervention
- DEVICE : SOMVC001 Vascular Conduit Solution
- SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
- OTHER : Standard of care Heparin-dosed saline
- SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
- Other Names :
- active comparator
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein grafts (SVGs)
Exclusion Criteria:
* Patient has in-situ Internal Mammary Artery graft(s) (IMA) only, (no SVG or free arterial grafts)
* Patients has had prior CABG or planned concomitant valve surgery or aortic aneurysm repair.
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
|
NCT02272582
|
{
"brief_title": "A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)",
"conditions": [
"Coronary Artery Disease"
],
"interventions": [
"Other: Standard of care Heparin-dosed saline",
"Device: SOMVC001 Vascular Conduit Solution"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02272582",
"official_title": "A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-22",
"study_completion_date(actual)": "2016-12-22",
"study_start_date(actual)": "2014-09-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-12",
"last_updated_that_met_qc_criteria": "2014-10-21",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-23",
"first_submitted": "2014-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.
#Intervention
- DEVICE : Hydrocolloid dressing
- A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
- OTHER : Petrolatum jelly dressing
- The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult > 18 years
* Linear scars
* Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention
Exclusion Criteria:
* Scar localization on acral or hair bearing sites
* Patients unable to converse in English
* Patients requiring flap or graft for closure of wound
* History of allergy to adhesives
* Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
* Use of hydrocolloid dressings for post-operative wound care in the past
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
|
NCT05618912
|
{
"brief_title": "Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment",
"conditions": [
"Scar",
"Skin Scarring",
"Skin Cancer",
"Wound Heal",
"Wound of Skin",
"Surgical Wound",
"Patient Satisfaction",
"Patient Preference",
"Surgical Incision"
],
"interventions": [
"Device: Hydrocolloid dressing",
"Other: Petrolatum jelly dressing"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05618912",
"official_title": "Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-16",
"study_completion_date(actual)": "2023-10-16",
"study_start_date(actual)": "2022-10-17"
},
"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)": "2024-12-11",
"last_updated_that_met_qc_criteria": "2022-11-09",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-16",
"first_submitted": "2022-10-23",
"first_submitted_that_met_qc_criteria": "2024-12-07"
}
}
}
|
#Study Description
Brief Summary
Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).
Detailed Description
This is a prospective, parallel, randomized, comparative, interventional feasibility study. Eyes of Caucasian patients with medically uncontrolled glaucoma or intolerance to glaucoma medications, who are evaluated at the glaucoma service of the Athens Vision Eye Institute and are scheduled for filtration surgery within one calendar year, are enrolled. If both eyes of one patient are eligible one eye is randomly selected. Inclusion criteria include adult patients with primary or secondary open angle or angle closure glaucoma with preoperative intraocular pressure (IOP) \> 21 mmHg on maximally tolerated medical therapy at least on 2 occasions prior to randomization with the ability to attend regular follow-up. Exclusion criteria include age (\< 18 years), pregnancy, severe ocular surface disease, need for combined phacotrabeculectomy, uveitic or neovascular glaucoma, any prior intraocular surgery except for uncomplicated phacoemulsification and a history of a systemic thromboembolic event within 6 months before surgery. The research adheres to the tenets of the Declaration of Helsinki and is approved by the Human Research Ethics Committee of the Athens Vision Eye Institute. Informed consent will be granted from all patients preoperatively explaining indications and risks of the procedure.
All patients are recruited by the principal investigator and surgeon (GK). The study is unblinded to both patients and investigators. Eyes are randomly assigned to 2 treatment arms by an online random number generator (www.random.org): the 'mitomycin C group' that undergoes standard guarded trabeculectomy supplemented with mitomycin C (Kyowa, Galabank Business Park, UK); the 'bevacizumab group' that undergoes guarded trabeculectomy with a single 1.25 mg intracameral injection of bevacizumab (Roche, Welwyn Garden City, UK). The online random number generator is accessed for each individual patient by the nursing staff (circulating nurse), which is unaware of study design and patient's characteristics, immediately prior to the surgical procedure. Sample size analysis (www.powerandsamplesize.com) reveals that for a power of 80% assuming a 5% type I error, an average post-op intraocular pressure of 12mmHg and a similar sampling ratio, 13 eyes in each group are necessary to detect a 3mmHg difference in IOP at twelve months (superiority or non-inferiority design). Assuming a dropout rate of 30% at 5 years the investigators aim for 20 eyes in each study group. Furthermore, power analysis reveals that for a power of 80% assuming a 5% type I error, a surgical success rate of 90% at 1 year and a similar sampling ratio, 20 eyes in each group are necessary to detect a 24% difference in rate of surgical success at twelve months (superiority or non-inferiority design).
Before surgery, all patients undergo a comprehensive eye examination including slit lamp biomicroscopy, best corrected visual acuity (BCVA) determination, intraocular pressure measurement using Goldmann applanation tonometry (GAT) at least on 2 separate occasions performed one week apart, gonioscopy and dilated fundus examination. All patients should have at least one visual field test on file, performed not more than 6 months prior to randomization. The Humphrey Visual Field Analyzer (HFA II-i, Carl Zeiss Meditec Inc, Dublin, CA, USA) will be used and the 24/2 SITA-Standard protocol will be utilized in all instances. Preoperative data collected from the medical record of individual patients include age, race, sex, diagnosis, study eye, BCVA, number and type of glaucoma medications, intraocular pressure, global visual field indices, central corneal thickness (CCT), cup to disc ratio, number and type of previous intraocular surgeries and previous glaucoma laser procedures. All pseudophakic eyes should have a history of primary open angle or exfoliation glaucoma, and should have undergone uneventful cataract extraction with a posterior chamber intraocular lens implantation.
Patients are examined on post-operative day one, day three, week one and every week thereafter for the first month, and subsequently on post-operative months 1, 3, 6, 9, and 12. A window of + 1 week is allowed for the 1st and 3rd month post-operative visits, and a window of + 2 weeks is allowed for the 6th, 9th and 12th month post-operative visits. During each visit a comprehensive ophthalmic examination is carried out. This includes intraocular pressure measurement, glaucoma medication requirement update, BCVA, review of early and late complications related to surgery (i.e., blebitis, bleb leak) and additional surgical interventions. These data are recorded in the patients' medical record and are extracted and tabulated in Excel 2013 spreadsheets (Microsoft, Redmond, WA) by an individual who is not participating in patient's management decisions and is blinded with respect to treatment assignment. Subsequently, data are analyzed by a separate individual who reveals study group assignment and calculates means, surgical success rates and complication rates. All patients' data are dealt with confidentiality. Statistical comparisons are performed according to initial treatment group assignment (intention to treat analysis).
Additional post-operative visits and/or interventions at the slit lamp such as 5-fluorouracil (5-FU) injections, bleb needlings and laser suture lyses are at the discretion of the treating ophthalmologist and do not qualify as failures. BCVA is recorded by certified optometrists utilizing clear chart digital screens (Reichert, Depew, NY, USA) placed at 4 m. All patients will undergo 24/2 Swedish Interactive Threshold Algorithm (SITA) Standard Automated Perimetry (SAP) on an annual basis in the post-operative period. SAP will be repeated typically within one month if unreliable.
#Intervention
- PROCEDURE : Standard Guarded Trabeculectomy
- A fornix based conjunctival peritomy is performed. A partial thickness scleral flap is dissected. Then trabeculectomy is performed with a Kelly's punch. A surgical iridectomy is performed. The scleral flap is secured with two pre-placed 8-0 Vicryl sutures (Ethicon, Somerville, NJ). The anterior chamber (AC) is inflated with balanced salt solution and suture tension is adjusted. Finally, conjunctiva is closed with 10-0 running Nylon sutures (Ethicon, Somerville, NJ). Patients receive a subconjunctival injection of 0.4 ml dexamethasone (4 mg/ml) and of 0.4 ml gentamicin (40 mg/ml) at the end of the case. Adjuvant pharmacologic treatment to prevent episcleral fibrosis and failure of the procedure is applied according to treatment arm assignment.
- Other Names :
- trabeculectomy, glaucoma filtration surgery, trabeculectomy with antimetabolites, trabeculectomy with antifibrotic agents
- DRUG : Mitomycin C
- Sponges soaked in 0.02% mitomycin C (MMC) will be applied on bare sclera for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.
- Other Names :
- MMC
- DRUG : Bevacizumab
- After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.
- Other Names :
- Avastin
|
#Eligibility Criteria:
Inclusion Criteria:
* adult patients
* primary or secondary open angle or angle closure glaucoma
* preoperative intraocular pressure > 21 mmHg on maximally tolerated medical therapy at least on 2 occasions prior to randomization
* ability to attend regular follow-up
Exclusion Criteria:
* age (< 18 years)
* pregnancy
* severe ocular surface disease
* need for combined phacotrabeculectomy
* uveitic or neovascular glaucoma
* any prior intraocular surgery except for uncomplicated phacoemulsification
* a history of a systemic thromboembolic event within 6 months before surgery
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
|
NCT02901236
|
{
"brief_title": "Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma",
"conditions": [
"Glaucoma"
],
"interventions": [
"Drug: Mitomycin C",
"Procedure: Standard Guarded Trabeculectomy",
"Drug: Bevacizumab"
],
"location_countries": null,
"nct_id": "NCT02901236",
"official_title": "Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma: A Randomized Pilot Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-15",
"last_updated_that_met_qc_criteria": "2016-09-10",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-15",
"first_submitted": "2016-08-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Carpal tunnel syndrome is caused by the compression of median nerve at the wrist where it passes through a narrow space called carpal tunnel formed by the wrist bones, ligaments and tendons. The common symptoms include numbness and pain over the areas supplied by the median nerve namely the thumb, the index finger, the middle finger and the outer part of the ring finger. There can be loss of sensation, weakness or muscle atrophy in severe cases. The functions of the affected hands may be greatly impaired.
Carpal tunnel syndrome is very common. It can lead to significant economic impact both to the affected individual and the society either by the direct treatment cost and indirectly from the working ability loss. Despite the vast burden, there is no consensus regarding its treatment so far. Surgery is generally effective and often reserved for severe cases. There are many nonsurgical treatment options. Local steroid injection and wrist splinting are among the commonest and with more evidence. Local steroid injection into the carpal tunnel can reduce the inflammation and swelling. Wrist splinting can maintain the wrist at its neutral position where the pressure at the carpal tunnel is the least. However, there are only very few studies comparing these two treatments directly.
Patients complaining of finger numbness who have been confirmed to have carpal tunnel syndrome by nerve conduction test are invited to participate in the study. The patients who agreed to be recruited are asked about their basic informations and the details of the carpal tunnel syndrome symptoms. Their hands will be examined. They are asked to fill in a questionnaire specific for assessing the symptom severity and the functional status of patients with carpal tunnel syndrome. They will then be assigned to one of the two treatment groups randomly and receive the respective treatment. They need to come back for follow-up at one month and to fill in the questionnaire again.
The study hypothesis is local steroid injection is more effective than wrist splinting in treating carpal tunnel syndrome.
Detailed Description
Carpal tunnel syndrome (CTS) is caused by the pressure and consequent compression on the median nerve within a confined anatomical area at the wrist referred to as the carpal tunnel. It is very common and has an important socio-economic impact. The prevalence of CTS in the UK is 7-16%. Its incidence has been estimated at 88-125 per 100,000 in USA. Economic consequences include the direct financial implications of treatment and the indirect cost of absenteeism from the workplace. The median number of days away from work for CTS is among the highest at 27 days. In the US in 1995, between 400,000 and 500,000 patients underwent surgical decompression. This equates to an economic cost of in excess of $2 billion. CTS and hearing loss was found to account for more morbidity, measured by cases and working days lost, than any other illness in the US working population. CTS may also occur as a work- related disorder leading to compensation claims.
Despite the vast burden of the disease, there is no consensus regarding its best management. Surgical treatment is generally preferred in severe cases of CTS. A Cochrane review investigating surgical treatment of CTS showed surgical treatment relieves symptoms significantly better than splinting, but no conclusion could be drawn in people with mild symptoms and if surgical treatment is better than steroid injection. On the other hand, surgical treatment is relatively costly and carries risks of significant complications that may last several months and give rise to further work absence. In addition, the waiting time for surgery is usually long.
For non-surgical interventions many modalities have been trialed but only a few have shown discernable benefits. Local steroid injection and wrist splinting are among the most popular options. They are commonly employed in mild to moderate cases of CTS. For severe cases, they can also offer relief of complaints during the waiting period for surgery or when there are contra-indications for surgery. Systematic reviews of randomized controlled trials have concluded that local steroid injection provides greater clinical improvement at one month compared with placebo and that there is weak evidence that a splint worn at night is more effective than no treatment in the short term. However, the number of studies that compare the two methods is limited, and they are mostly either retrospective in design or prospective but non-randomized. Two randomized controlled trials comparing local steroid injection and splinting found respectively that local steroid injection does not significantly improve clinical outcome compared to anti-inflammatory drugs and splinting and that injections of steroids are ineffective. However, the conclusions of these two studies are limited either by a small sample size or the lack of a validated outcome measure.
We would like to conduct a prospective randomized clinical trial comparing the efficacy of local steroid injection and splinting in patients with CTS using the Boston Carpal Tunnel Questionnaire as outcome measure with a 4-week follow-up.
Patients attending the medical clinic of a local hospital (Kwong Wah Hospital) complaining of finger or hand numbness are referred to the electro-neuro-diagnostic unit for nerve conduction test. Consecutive patients with clinical and electrophysiological features of CTS are invited to participate in the study. Clinical features are pain, paresthesia or weakness in the median nerve distribution for at least 3 months. The neurodiagnostic criteria are based on the American Academy of Neurology summary statement, which further classifies the abnormalities as follows: (1) mild abnormality, i.e., abnormal comparative tests or prolonged median distal sensory latency (DSL \> 3.5 ms) but normal median distal motor latency (DML); (2) moderate abnormality, i.e., prolonged median DSL and DML (⩾4.2 ms); and (3) severe abnormality, i.e., absence of median sensory nerve action potential and prolonged median DML or absent compound muscle action potentials.
Patients are excluded if they have any recognized causes of CTS including inflammatory arthritis, diabetes mellitus, hypothyroidism, renal failure, polyneuropathy and history of significant local trauma. Other exclusion criteria include age younger than 18 years, previous treatment of CTS and pregnancy. Patients with motor impairment or thenar muscle atrophy are also excluded and they will be referred to the Orthopedic unit for assessment of surgery.
All potential participants are informed of the objectives and procedures of this study, as well as the possible complications. The patients who have given informed consent are interviewed by a single investigator within 4 weeks of the NCV. Their demographical data including age, gender and body mass index (BMI) are recorded. The duration of the symptoms, medical comorbidities and employment status are documented. Examination of the hand is performed by the same investigator focusing on the sensory loss at the tips of digits 1, 2, 3, or the medial side of digit 4, and weakness or atrophy of the abductor pollicis brevis or opponens pollicis. Sensation is assessed using pinpricks. Sensory and motor function is recorded to be either normal or impaired. In patients with bilateral CTS, the most symptomatic hand will be included. In case both hands are equally symptomatic, the dominant hand will be included. Recruited patients are asked to complete the Boston Carpal Tunnel Questionnaire (BCTQ). They will then be allocated to one of the two treatment arms according to the randomization procedure.
Patients are randomly assigned to one of the two treatment groups using sequentially numbered opaque sealed envelopes (SNOSE). Allocation concealment is maintained before the randomization procedure.
The local injection of steroid is performed by the same investigator after the randomization. Using a sterile technique, 20mg depomedrol premixed with lidnocaine is injected using a 25-gauge x 5/8' needle. The needle is inserted medially to the palmaris longus tendon at the distal palmar crease in the wrist at an angle of 45-degree to the forearm. The steroid is injected at approximately 1cm below the skin. The needle will be repositioned if there is any resistance to injection, or any pain or paraesthesia in the median nerve territory.
Minor complications of steroid injection include local pain, bleeding, skin depigmentation, skin atrophy and digital ischemia. Concerns that nerve or tendon injury may result from steroid injection appear to be unfounded. In 28 studies of local steroid injection treatment involving 1981 hands in total there have been no reported instances of such injury, suggesting that the risk is very low. There is a small risk of infection.
After randomization, the hands of the patients in the splinting group are splinted in neutral position with standard cotton-polyester splint. Patients are encouraged to use the splints during nighttime whenever possible for 1 months.
The potential side effects of splinting include discomfort due to the local pressure and allergic response to the splint material.
The primary outcome measure is clinical improvement at one month. The Boston Carpal Tunnel Questionnaire (BCTQ) is used as the measure assessing clinical response. It is a self-administered disease-specific questionnaire for assessing severity of symptoms and functional status based on two scales. The symptom severity scale (SSS) is comprised of 11 questions, and the functional status scale (FSS) is comprised of 8 questions. The assessment of each question is on a scale of 1-5 points, in which 1 indicates no symptom, and 5 indicates severe symptoms. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5. The evidence base of the psychometric properties indicates that the BCTQ is a valid, reliable, responsive and acceptable instrument and should be included as a primary outcome measures in CTS intervention trials. The questionnaire has Chinese validity.
Patients are interviewed at one month after randomization. They are asked to complete the BCTQ and rate the satisfaction of treatment each time. Duration of sick leave for employed patients, concomitant use of analgesics, and adverse effects are recorded.
As all participants have symptoms of CTS and will receive valid active treatments, they should be motivated and compliant to the protocol. They are encouraged to report to the PI should there be any problems occurred regarding the splints or any adverse effects developed in both treatment groups. Appropriate actions will be taken or advices given by the PI. The subjects in the splinting group are instructed to mark each night that they have worn the splints on a calendar. Subjects who missed the scheduled follow-up will be contacted and encouraged to attend the re-scheduled follow-up as soon as possible.
Based on previous studies, the minimum clinically important difference is 0.74 for the BCTQ. With 90% statistical power, 5% significance level, and two-sided statistical tests, and assuming a standard deviation of 0.8 for the BCTQ score the study can detect a true difference of at least 0.74 point on the BCTQ between the two intervention groups when 50 patients are randomized. Version 20.0 of the SPSS statistical package is used. Descriptive statistics are presented as frequencies, means with standard deviation or medians with ranges as appropriate. Baseline parameters of patient between two treatment groups are compared by chi-square test for categorical variables, Student's t test for continuous variables with normal distribution or Mann-Whitney U test for nonparametric continuous variables. BCTQ scores before treatment and at the one, four and twelve weeks after treatment are compared with paired samples t test. Differences of the BCTQ scores between the two treatment groups were investigated with independent samples t test. For multi-variate analysis, multiple linear regression is used to compute the differences of outcome measures between the two treatment groups, and within the groups before and after the respective treatments with adjustment for baseline variables. Results are considered statistically significant if the P value is less than 0.05.
This trial has been approved by the local ethics committee (Kowloon West Cluster Ethical Committee). The trial will be conducted in full compliance with the Helsinki Declaration and the Guideline for Good Clinical Practice of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
#Intervention
- PROCEDURE : Local methylprednisolone acetate and lidnocaine injection
- Other Names :
- depomedrol with lidnocaine
- DEVICE : wrist splinting
|
#Eligibility Criteria:
Inclusion Criteria:
* patients attending the medical clinic of Kwong Wah Hospital with clinical and electrophysiological features of CTS
Exclusion Criteria:
* any recognized causes of CTS including inflammatory arthritis, diabetes mellitus, hypothyroidism, renal failure, polyneuropathy and history of significant local trauma
* previous treatment of CTS
* pregnancy
* patients with motor impairment or thenar muscle atrophy
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
|
NCT02140632
|
{
"brief_title": "Efficacy Study of Local Steroid Injection and Wrist Splinting for Carpal Tunnel Syndrome",
"conditions": [
"Carpal Tunnel Syndrome",
"Local Steroid Injection",
"Wrist Splinting"
],
"interventions": [
"Device: wrist splinting",
"Procedure: Local methylprednisolone acetate and lidnocaine injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT02140632",
"official_title": "Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2013-12"
},
"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)": "2016-09-01",
"last_updated_that_met_qc_criteria": "2014-05-13",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-16",
"first_submitted": "2014-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.
Detailed Description
Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.
Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery
#Intervention
- DRUG : Group DB/Dexamethasone-Bupivacaine
- The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
- DRUG : Group FB /Fentanyl-Bupivacaine
- The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
- DRUG : Group PB/Placebo-Bupivacaine
- Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists physical status (ASA) I or II
Exclusion Criteria:
* Contraindication to spinal anesthesia.
* Allergy to the study drugs.
* Refusal of the patients.
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:
Yes
|
NCT03847792
|
{
"brief_title": "Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery",
"conditions": [
"Knee Arthroscopic Surgery"
],
"interventions": [
"Drug: Group FB /Fentanyl-Bupivacaine",
"Drug: Group DB/Dexamethasone-Bupivacaine",
"Drug: Group PB/Placebo-Bupivacaine"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03847792",
"official_title": "Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-30",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2019-03-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-11",
"last_updated_that_met_qc_criteria": "2019-02-19",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-20",
"first_submitted": "2019-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the wear of denture teeth.
Detailed Description
Denture stomatitis is a prevalent disease among removable denture wearers. The cause of this disease stems from a myriad of factors including host immunity and poor oral hygiene. Denture acrylic material is very conducive for the growth and adhesion of bacteria because of its porous nature. The application of plasma enhanced chemical vapor deposited (PECVD) coatings on the surface of acrylic dentures can produce a less porous surface which may minimize the adhesion of bacteria and therefore colonization. The goal is the application of these coatings will help minimize the occurrence of denture stomatitis.
Another issue of removable dentures is the low wear resistance of denture teeth. The application of these coatings on denture teeth should minimize wear of these teeth and prolong the life of removable dentures.
#Intervention
- DEVICE : PECVD coating
- SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are missing some teeth and will need removable dentures
Exclusion Criteria:
* Medical contraindication for dental treatment
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02834832
|
{
"brief_title": "Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic",
"conditions": [
"Denture Stomatitis",
"Wear of Denture Teeth"
],
"interventions": [
"Device: PECVD coating"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02834832",
"official_title": "Novel Coating to Minimize Bacterial Adhesions and Tooth Wear in Denture Acrylic",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-18",
"study_completion_date(actual)": "2019-07-18",
"study_start_date(actual)": "2016-11"
},
"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)": "2020-07-23",
"last_updated_that_met_qc_criteria": "2016-07-12",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-15",
"first_submitted": "2016-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed research applies the highly innovative technology of real-time functional Magnetic Resonance Imaging (rtfMRI) to examine plasticity of brain-regulatory mechanisms related to cognitive and affective processing and to determine benefits for cognition and affect in young and older adults and in Parkinson Disease (PD) patients.
Detailed Description
There is increasing evidence that age-related alterations in brain function associated with affective processing and attention contribute to these motivational and emotional changes with age.
Based on these theoretical considerations as well as the previous study's data, the proposed research will apply well-tested emotion processing and attention paradigms to address the pivotal question of whether brain activity can be modulated in healthy aging and PD (in the substudy) via contingent rt-fMRI neurofeedback and whether this neuroregulatory modulation increases emotion processing and cognitive performance.
#Intervention
- BEHAVIORAL : Anterior cingulate cortex activation
- Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex.
The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing.
- BEHAVIORAL : Primary auditory cortex activation
- Functional Magnetic Resonance Imaging Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in primary auditory cortex. The primary auditory cortex is a brain region that is NOT specifically involved in emotion processing. Activation of this region is NOT expected to improve emotion processing; and thus activation of this brain region serves as 'control/placebo' condition in the current design (placebo comparator).
|
#Eligibility Criteria:
Inclusion Criteria: Young adults
* aged 18 <= age <= 35 years
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview (including not being pregnant)
* scores within normal limits on a cognitive screener (MoCA)
* no indication of serious psychiatric disturbance including major depression (based on Mental Health Screener)
* willing and able to give informed consent
Inclusion Criteria: Older adults
* age 55 <= age <= 100 years
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on score of 30 or above on the Telephone Interview for Cognitive Status and nonimpaired score on the Montreal Cognitive Assessment (MoCA -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression (based on Mental Health Screener)
* willing and able to give informed consent
Inclusion Criteria: Parkinson patients
* must meet criteria for diagnosis of idiopathic Parkinson disease according the UK Brain Bank by a movement trained neurologist.
* age 55 <= age <= 100 years
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy other than Parkinson disease
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on cognitive screening measures (TICS -- score of 30 or above, and MoCa -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression
* willing and able to give informed consent
Inclusion Criteria: Individuals with SCD and a family history of dementia or Alzheimer's disease
* age 55 <= age <= 100 years
* native English speaker
* at least 8th grade education
* generally physically and neurologically healthy as determined by the Health Demographics Screener
* eligible for MRI as determined by the MRI Eligibility Interview
* no indication of dementia based on score of 30 or above on the Telephone Interview for Cognitive Status and nonimpaired score on the Montreal Cognitive Assessment (MoCA -- score of 22 and above)
* no indication of serious psychiatric disturbance including current major depression (based on Mental Health Screener)
* willing and able to give informed consent
* community-dwelling with subjective report of cognitive complaints with scores >16 on the Cognitive Change Index (CCI-20)
* no evidence of dementia or mild cognitive impairment based on cognitive screening using the MoCA; scores must fall within normal limits for age, education, and sex
* no psychometric evidence of neuropsychological impairment on a modified Neuropsychological Battery from the NACC Unified Data Set, version 3
* score of 0 on the Global Clinic Dementia Rating (CDR) scale
* normal functional behavior in terms of daily activities, based on the Functional Activities Scale (FAQ)
* availability of an informant (over the phone) who can provide information about the participant's complaints using the informant version of the CCI-20, and corroborate normal activities of daily living on the FAQ and the CDR scale.
Exclusion Criteria:
* Pregnant or possibly pregnant
* Claustrophobia
* Large pieces of metal in the body, particularly in the face and neck.
* Piercings or metal implants that cannot be removed from the body
* Surgery on the brain or any prior serious brain damage or disease
* Dementia or severe cognitive disorders
* use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
* use of prescribed 'memory enhancing' medications such as Aricept or Namenda.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03872414
|
{
"brief_title": "Emotion Study/Substudy: Flexible Brain Study",
"conditions": [
"Aging",
"Emotions",
"Parkinson Disease"
],
"interventions": [
"Behavioral: Primary auditory cortex activation",
"Behavioral: Anterior cingulate cortex activation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03872414",
"official_title": "Emotion Study (Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach)/Substudy: Flexible Brain Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-08",
"study_completion_date(actual)": "2023-05-08",
"study_start_date(actual)": "2019-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-17",
"last_updated_that_met_qc_criteria": "2019-03-11",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-13",
"first_submitted": "2019-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The persistence of an aberrant state of immune activation and inflammation (pIA) may contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in HIV-infected patients. Although combined antiretroviral treatment (cART) reduces both cellular and soluble activation markers, it fails to completely control pIA despite consistent plasma viral load suppression. One of the mechanisms involved in pIA is may be an incomplete suppression of viral replication not reflected by plasma viral load, which only reflects a balance between viral replication and clearance of HIV-RNA. In addition, low-level viremia detected in most HIV-1-infected patients despite years on cART. Unintegrated 2-LTR HIV-DNA, and cellular associated HIV-RNAs, as products of active integrated DNA transcription, support this issue.
Furthermore, the key rationales behind simplifying cART are a reduction of toxicities, lower risk of resistance mutations in case of virological failure and saving costs. One of these simplification strategies is a dual therapy which, based on the data up to date and in our clinical experience, has similar virological efficacy than cART. However, it is unknown if this strategy could increase the persistent HIV-1 replication and, therefore, pIA. The CD4+/CD8+ T cell ratio as a marker of immune recovery, the changes in T cell immune activation, senescence, exhaustion and apoptosis, and the cellular associated HIV-DNA and -RNA would answer the question if simplification to dual therapy would provide less control of residual HIV replication and, therefore, a detriment on pIA compared to triple therapy and, therefore, would worsen the patients' long-term prognosis.
Detailed Description
Primary Outcome Measures: to evaluate the changes in the CD4/CD8 ratio, immune activation and other immunologic parameters at 48 weeks after switching to dual therapy based on dolutegravir plus emtricitabine o darunavir/cobicistat plus emtricitabine versus to continue on triple therapy based on integrase inhibitor plus 2 analogs Secondary Outcome Measures: to evaluate the changes in the CD4/CD8 ratio, immune activation and other immunologic parameters at 96 weeks after switching to dual therapy based on dolutegravir plus emtricitabine o darunavir/cobicistat plus emtricitabine versus to continue on triple therapy based on integrase inhibitor plus 2 analogs
Method: randomized clinical trial in which adult HIV-infected patients with an undetectable plasma HIV-RNA for at least one year on a triple therapy based on integrase inhibitors plus two nucleos(t)ide analogs will be randomized in 3 groups (1:1:1) with 4 strata according to the previous time with undetectable viral load to:
1. Continue the previous ART based on Elvitegravircobicistat 150150 mg + tenofovir alafenamide 10 mg + emtricitabine 200 mg (Genvoya™) o Dolutegravir 50 mg + abacavir 600 mg + lamivudine 300 mg (Triumeq™) once daily.
Or to switch to:
2. Darunavir/cobicistat (800150 mg) + 3TC (300 mg) once daily or
3. Dolutegravir (50 mg) + 3TC (300 mg) once daily.
#Intervention
- DRUG : Continue with triple therapy
- To continue with triple therapy
- DRUG : Switch to DTG + 3TC
- Switch to dolutegravir + lamivudine once daily
- DRUG : Switch to DRV/cobicistat + 3TC
- Switch to darunavir/cobicistat + lamivudine once daily
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-1-infected patients >= 18 years.
* Starting date of antiretroviral treatment later than 01/01/2010
* Plasma HIV-1 RNA <20 copies/ml for at least one year on triple therapy
* Antiretroviral treatment based on an integrase inhibitor plus two nucleos(t)ide analogs in the last 6 months.
* Signed written informed consent prior to inclusion.
Exclusion Criteria:
* Primary resistance to any of the drugs included in the study.
* Active opportunistic infection.
* Pregnancy at inclusion or during the follow-up
* Active hepatitis C and/or B virus co-infection.
* Cirrhosis, portal hypertension and/or hypersplenism of any etiology.
* Current or past malignancies subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
* Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS.
* Concomitant use of drugs with potential major interactions with the prescribed drugs according to the respective full prescribing information.
* Estimated creatinine clearance <50 ml/min
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
|
NCT03447873
|
{
"brief_title": "Tripe Versus Dual Antiretroviral Therapy in HIV-infected Patients With Virological Suppression (Tridual)",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: Switch to DRV/cobicistat + 3TC",
"Drug: Switch to DTG + 3TC",
"Drug: Continue with triple therapy"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03447873",
"official_title": "Is Dual Therapy as Effective as Triple Therapy Regarding CD4+/CD8+ Ratio Recovery and Improvement of Immune Activation and Inflammation in HIV-infected Patients With Consistent Plasma Viral Load Suppression (Tridual)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-15",
"study_completion_date(actual)": "2021-02-03",
"study_start_date(actual)": "2017-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-30",
"last_updated_that_met_qc_criteria": "2018-02-26",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-27",
"first_submitted": "2017-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).
#Intervention
- DRUG : Brexpiprazole
- 2 or 3 mg tablet
- DRUG : Brexpiprazole
- 0.5 to 3 mg tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must have participated in the 331 <= age <= 14-213 study.
* Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
Exclusion Criteria:
* Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331 <= age <= 14-213.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 91 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03594123
|
{
"brief_title": "A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type",
"conditions": [
"Alzheimer's Disease"
],
"interventions": [
"Drug: Brexpiprazole"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03594123",
"official_title": "A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-19",
"study_completion_date(actual)": "2022-09-19",
"study_start_date(actual)": "2018-10-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-14",
"last_updated_that_met_qc_criteria": "2018-07-11",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-20",
"first_submitted": "2018-07-11",
"first_submitted_that_met_qc_criteria": "2023-10-27"
}
}
}
|
#Study Description
Brief Summary
The ability to communicate and cooperate effectively is essential in geriatric nursing. However, nursing teachers lacked the exploration of the development of this ability and teaching evaluation in previous studies. The investigators used a systematic process to investigate methods for achieving the following goals: 1. Cultivate a positive attitude toward the elderly among nursing students. 2. Improve nursing students' communication competence and interaction skills when providing advanced health care services. 3. Improve the teaching skills of professional nursing instructors.
Detailed Description
The ability to communicate and cooperate effectively is essential in geriatric nursing. However, nursing teachers lacked the exploration of the development of this ability and teaching evaluation in previous studies. The investigators used a systematic process to investigate methods for achieving the following goals: 1. Cultivate a positive attitude toward the elderly among nursing students. 2. Improve nursing students' communication competence and interaction skills when providing advanced health care services. 3. Improve the teaching skills of professional nursing instructors.
Using an action research approach, the investigators designed a pair of geriatric nursing and practicum courses and recruited a class of in-service nursing students through convenience sampling in a college setting. The intervention was an 18-week course in geriatric nursing that meets once a week in the classroom and internship practice in settings used for training nursing students. The investigators collected using quantitative indicators (attitude measurements) and qualitative textual analysis. The quantitative data were analyzed by paired t-testing using SPSS 21.0 software.
#Intervention
- OTHER : Teaching intervention program
- Using an action research approach, The investigators designed a pair of geriatric nursing and practicum courses and recruited a class of in-service nursing students through convenience sampling in a college setting. The intervention was an 18-week course in geriatric nursing that meets once a week in the classroom and internship practice in settings used for training nursing students. The investigators collected data using quantitative indicators (attitude measurements) and qualitative textual analysis. The quantitative data were analyzed by paired t-testing using SPSS 21.0 software.
|
#Eligibility Criteria:
Inclusion Criteria:
* The research object of this project will be the students in the nursing class of a university (third year students), and the students who have taken 2 credits each of 'Geriatric Nursing' and 'Geriatric Nursing Internship' in a working class.
Exclusion Criteria:
* Not a junior in a working class in a university nursing department.Those who have not completed the courses of 'Geriatric Nursing' and 'Geriatric Nursing Internship'.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05290636
|
{
"brief_title": "Communication Competence and Transdisciplinary Cooperation in Geriatric Nursing",
"conditions": [
"Communication",
"Competence"
],
"interventions": [
"Other: Teaching intervention program"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT05290636",
"official_title": "Communication Competence and Transdisciplinary Cooperation in Geriatric Nursing: A Participatory Action Research",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-03",
"study_completion_date(actual)": "2020-10-21",
"study_start_date(actual)": "2019-06-10"
},
"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)": "2022-03-22",
"last_updated_that_met_qc_criteria": "2022-03-12",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-22",
"first_submitted": "2022-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to investigate the effect of a long-term exercise program using a wearable exoskeleton robot (EX1) on muscular strength in healthy adults aged 19 to under 65 years, compared to an exercise program without EX1.
#Intervention
- DEVICE : Wearable Hip Assist Robot(EX1)
- EX1 is a hip-type assist device developed by Samsung Electronics.
- BEHAVIORAL : Exercise Program 1
- Exercise program 1 for fast walking by applying resistance and assist mode of EX1
- BEHAVIORAL : Exercise Program 2
- Exercise program 2 for normal walking by applying resistance and assist mode of EX1
- DEVICE : Without Wearable Hip Assist Robot(EX1)
- Overground walking without EX1
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults aged 19 to less than 65 years without a history of central nervous system disease
Exclusion Criteria:
* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05862077
|
{
"brief_title": "Long-term Exercise Effect of EX1 Exercise Program",
"conditions": [
"Aging"
],
"interventions": [
"Device: Wearable Hip Assist Robot(EX1)",
"Behavioral: Exercise Program 1",
"Device: Without Wearable Hip Assist Robot(EX1)",
"Behavioral: Exercise Program 2"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05862077",
"official_title": "Long-term Exercise Effect of EX1 Exercise Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-30",
"study_completion_date(actual)": "2023-10-31",
"study_start_date(actual)": "2023-03-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-29",
"last_updated_that_met_qc_criteria": "2023-05-07",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-17",
"first_submitted": "2023-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.
#Intervention
- PROCEDURE : trabeculectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* intraocular pressure greater than 22 mmHg with two or more medications
* wide anterior chamber angle
* glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect
* visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry
Exclusion Criteria:
* the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, etc
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02638181
|
{
"brief_title": "The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork",
"conditions": [
"Open-angle Glaucoma"
],
"interventions": [
"Procedure: trabeculectomy"
],
"location_countries": [
"China"
],
"nct_id": "NCT02638181",
"official_title": "The Expression of Matrix Metalloproteinase 13（MMP13）, Tissue Inhibitor of Metalloproteinases 3（TIMP13）, and Calcium-sensing Receptor（CaSR） in Human Trabecular Meshwork",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-10",
"last_updated_that_met_qc_criteria": "2015-12-17",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-23",
"first_submitted": "2015-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.
Detailed Description
Cognitive impairment in patients with MS is a common problem that significantly affects quality of life. It shows an association between functional capacity and physical fitness levels and cognition in non-MS populations, and especially in the elderly.
Although cognitive dysfunctions are known, few studies have been found on its relationship with secondary problems caused by the disease and its correlation with other symptoms.
#Intervention
- OTHER : Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
- 6-minute walk test and 5-time sit-to-stand test (STS-5) were used for functional capacity assessment. For cognitive reserve assessment, the Cognitive Reserve Index questionnaire was used. Reaction time, cognitive function and visiospatial perception were evaluated with the mobile application. In addition, the Fatigue Severity Scale; Beck Depression Questionnaire and Nottingham Health Profile were used.
|
#Eligibility Criteria:
Inclusion Criteria:
* Relapsing-remitting MS diagnosis
* Expanded Disability Status Scale score <5.5
* Being able to use a smart phone
* No relapse during the last 30 days
* Being between the ages of 18 <= age <= 65
* Mini-Mental State Examination score>24
Exclusion Criteria:
* Severe Visual Impairment
* Severe Psychiatric Disorder,
* Severe Arthritis in Knee or Hip,
* Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination
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
|
NCT06084182
|
{
"brief_title": "Cognitive Function in Multiple Sclerosis",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Other: Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06084182",
"official_title": "The Relationship Between Cognitive Function and Functional Capacity, Cognitive Reserve, Reaction Time in Patients With Multiple Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-15",
"study_completion_date(actual)": "2022-11-15",
"study_start_date(actual)": "2021-11-15"
},
"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)": "2023-10-16",
"last_updated_that_met_qc_criteria": "2023-10-10",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-16",
"first_submitted": "2022-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
With the participation of an international consortium of investigators, the investigators will evaluate the validity of a new severity score system called DS3 for adult patients with Gaucher disease. The investigators hypothesize that initial DS3 scores will be predictive of both disease progression and patterns of response including imiglucerase dose sensitivity and completeness and maintenance of response and that sequential DS3 scores will accurately portray either clinical progression of disease or improvement in response to treatment. The investigators will also collect DNA specimens that in future research will be used in conjunction with the DS3 scores to evaluate determinants of the clinical course and the response to treatments for Gaucher disease.
Detailed Description
GD1 is a prototypical lysosomal storage disorder and the first disorder to have compelling evidence of successful treatment with enzyme replacement therapy. The common clinical manifestations are hematologic cytopenias, hepatomegaly, splenomegaly, and a spectrum of skeletal pathologies. Disease expression is diverse. The rate and extent of disease progression are variable and often independent of the age at which symptoms are first reported1. Despite a long history of treatment efficacy2, there is significant heterogeneity of response among patients with regard to the maximum improvement in hematologic, visceral, bone, and other manifestations and the dynamic speed of response during therapy1-3. There have been few well-designed studies that comprehensively annotate phenotypic variation over time or measure treatment efficacy and dose response. In part, this is attributable to lack of a validated disease severity scoring system for GD1 to standardize the monitoring of progression and treatment response and to define patient cohorts in clinical studies.
DS3 is a method of expressing an integrated assessment of the burden of disease in a given patient. It can be used to monitor patient status, determine endpoints in clinical studies, classify disease phenotypes and compare patients with the same disease. Although frequently referred to as 'disease severity indices,' DS3 instruments may also include measures of disease activity and damage. DS3s utilize a minimal data set to score the patient in a comprehensive manner. They usually are structured as a group of domains (often according to organ system) that are populated with non-redundant items that are valid, reliable, use feasible, standardized methods of assessment, and that are variably weighted based on associated morbidity and mortality. A DS3 for adult GD1 patients was recently developed and subjected to successful preliminary testing for validity, reliability and feasibility4. With respect to changes over time, a minimal clinically important difference was defined. Construct validity has been partially demonstrated. Using 20 patient profiles from the International Collaborative Gaucher Group (ICGG) Gaucher Registry, the instrument was shown to correlate very well with the 'gold standard' clinical global impression scale. However, larger scale testing in a population that is representative of the world wide distribution of GD1 phenotypes (including splenectomy patients) is needed and predictive validity has yet to be determined. Moreover, the DS3 has not yet been correlated with disease-specific measures of response such as achievement of therapeutic goals or broadly used biomarkers. Combining retrospective and prospective analysis, this study is designed to address these issues
#Intervention
- DRUG : Imiglucerase
- Imiglucerase intravenous infusions regardless of dose or schedule of administration.
- Other Names :
- Cerezyme
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients with Type 1 Gaucher disease regardless of treatment status who are enrolled in the International Collaborative Gaucher Group (ICCG) Gaucher Registry and who are cared for at one of the participating research sites.
Exclusion Criteria:
* Children under the age of 18 years
* Patients with Type 3 Gaucher disease
* Patients who have declined to be enrolled in the ICCG Gaucher Registry
* Patients not cared for at one of the participating research sites
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
|
NCT01136304
|
{
"brief_title": "Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1)",
"conditions": [
"Gaucher Disease"
],
"interventions": [
"Drug: Imiglucerase"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01136304",
"official_title": "Retrospective and Prospective Validation of a Disease Severity Score System (DS3) for Adults With Type 1 Gaucher Disease (GD1)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2010-04"
},
"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)": "2015-06-01",
"last_updated_that_met_qc_criteria": "2010-06-02",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-03",
"first_submitted": "2010-05-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
No study was found that investigated the effect of vibration therapy (VT) on recovery from exercise in WCB players. Therefore, the aim of the study was to investigate the effects of wearable local vibration device on muscle soreness and athletic performance during recovery from exercise in the elbow area in WCB players.
Detailed Description
Vibration therapy (VT) has been widely used to increase performance and rehabilitate injuries in athletes. Delayed onset muscle soreness (DOMS), caused by excessive overload after training and competitions, leads to loss of performance. The aim of this study was to investigate the effects of wearable local VT on muscle soreness and athletic performance in wheelchair basketball (WCB) players.
#Intervention
- DEVICE : Vibration
- Local vibration was applied
|
#Eligibility Criteria:
Inclusion Criteria:
* Being a wheelchair basketball players
Exclusion Criteria:
* Having had an upper extremity operation within the last 6 months
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06403384
|
{
"brief_title": "Vibration Therapy in Wheelchair Basketball Players",
"conditions": [
"Wheelchair Users",
"Athletic Performance",
"Disability",
"Disabled Persons"
],
"interventions": [
"Device: Vibration"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06403384",
"official_title": "Effects of Vibration Therapy on Muscle Soreness and Athletic Performance in Wheelchair Basketball Players",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-01",
"study_completion_date(actual)": "2022-08-01",
"study_start_date(actual)": "2021-08-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-07",
"last_updated_that_met_qc_criteria": "2024-05-03",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-05-07",
"first_submitted": "2024-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.
Detailed Description
The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.
#Intervention
- BEHAVIORAL : Graphic cigarette warning labels, plain packaging
- This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages 18 <= age <= 30
* Smoke at least 100 cigarettes in their lifetime
* Now smoke cigarettes on all or some days
* Reside in the Washington, DC metro area
* Willing to send and receive text messages on a personal mobile phone
Exclusion Criteria:
* No additional exclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03446170
|
{
"brief_title": "Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers",
"conditions": [
"Tobacco Use"
],
"interventions": [
"Behavioral: Graphic cigarette warning labels, plain packaging"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03446170",
"official_title": "Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers",
"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)": "2014-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-04",
"last_updated_that_met_qc_criteria": "2018-02-20",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-26",
"first_submitted": "2018-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Multiple myeloma (MM) is the second most common hematological disease in Denmark with an incidence of approximately 350 diagnosed cases per year. There is no curative treatment yet, but usually the disease is very sensitive to treatment, and patients have periods of varying length, where they do not require treatment. Thus the prognosis for MM has improved over recent years, and the rate of survival has been extended for both younger and elderly patients. With the increasing specialization and centralization that will occur in the coming years, some patients will have very long transport times to the hospital. When patients go to the hospital only to receive their anticancer therapy, their visits are relatively short and the amount of time spend on transportation might appear disproportionate. The frequent hospital appointments increase the patient's exposure for bacteria and viruses which should be calculated as a potential risk. Furthermore if the patient is an active part of the labor market, it can be challenging to request freedom to hospital visits.
It is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy it is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy. The aim of this project is to investigate the home administration of Daratumumab SC reported by both patients and healthcare professionals compared to the hospital administration setting. Furthermore, this project investigates the hypothesis that the home administration of Daratumumab potentially can reduce the time associated with the administration, thereby, resulting in a socio-economic gain.
The aim for this study: We want to examine patients 'and healthcare professionals' perspectives, the organizational and the socio economic aspects of administering subcutaneous Daratumumab in their own home to patients with multiple myeloma, and to illuminate the benefits and challenges of this.
Detailed Description
This study is a prospective, non-randomized, clinical parallel mixed-methods intervention project using qualitative and quantitative data in the form of semi-structured telephone interviews, focus group interviews, time registration, registration of patients' contact with the healthcare system and PRO data. The project will both include patients already being treated with SC Daratumumab and new patients planned to start Daratumumab treatment = 40 patients in all. The patients will be included in the department of hematology Odense University Hospital as they are found eligible.
The intervention of the study is home administration of Daratumumab SC by a home nurse, thereby, changing the administration setting from a hospital setting to at home setting. The intervention with home administration will be compared to the hospital setting. The patients will function as their own controls, as treatment will be given alternately at the hospital.
Patients scheduled for Daratumumab SC at home will be phoned by a nurse from the Hematology Outpatient Clinic the day before planned administration. This procedure is chosen as that it allows the nurse to determine whether it is justifiable, for the patient to receive treatment at home. If the nurse and doctor assess that the patient is fit for home administration of Daratumumab SC, the drug will be ordered at the pharmacy to be delivered to the patient the following day. Also an electronic message will also be sent to the home nurses with an instruction to administer Daratumumab SC between 12-02 PM.
Data collection will consist of:
* Semi-structured virtual (or alternative telephone) interviews with participating patients focusing on benefits / gains versus challenges / disadvantages in regard to the actual injection, collaboration with the home nurse, delivery of medication, empowerment, and suggestions for further improvements n = 2 x 10
* Semi-structured interviews with involved home nurses n = 1 x 5.
* Focus group interview with health professionals involved at OUH at the end of the project n = 1.
* Registration of unplanned contact to the health service during the study period to account for any extra health care usage during home treatment via the app 'My hospital' x 1 weekly n = 40
* Data on quality of life; EORTC custom built satisfaction questionnaire via the app 'My hospital' = 5 times per patient.
* Registration of the patients evaluation of whether the use of the app 'My hospital' can be useful in the future.
* Registration of patients' time used on treatment when at home or when at hospital including transport via the app 'My hospital'.
* Registration of the outpatient nurses' and home nurses time using the registration form via paper.
* Registration of patients general condition and possible side effects in order to clarify whether they are 'fit' for treatment via the app 'My hospital'. This ensures that a cure that is not used is not prepared.
All Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the Danish National Health Authorities according national law within 7 days after awareness. Since this is not at clinical trial, but merely a collection of data during a different logistics setup, the study will be submitted to the Danish Data Protection Agency, however not to the Danish National Ethical Committee nor the Danish National Health Authorities. Due to this Adverse Reactions (AEs) will not be systematically registered or reported to the Danish national health authorities. To make sure the logistics setup is safe for all patients we will register all unplanned hospitalizations as well as all other related Serious Adverse Reactions (SAR).
Processing of personal data in the project The project is notified to the Region's Register so that it complies with the Data Protection Regulation (GDPR). All electronic data will be stored on a secure SharePoint site that can only be accessed via the project group's work computer. All physical material is stored behind double-locked doors at the project group's workplace.
#Intervention
- DRUG : Darzalex
- Investigate the home administration of Darzalex SC reported by both patients and healthcare professionals compared to the hospital administration setting.
- Other Names :
- Daratumumab
|
#Eligibility Criteria:
Inclusion Criteria:
* have relapse of MM.
* be in or have planned to start treatment with Daratumumab SC.
* be cognitively capable to assess any side effects of Daratumumab SC based on the instructions provided.
* be able and willing to register in a timetable and to participate in two semi-structured telephone interviews.
* be able to understand and speak Danish.
* be in possession of a mobile phone (for SMS tracking).
Exclusion Criteria:
* receive other anti-myeloma treatment that require hospitalization with the exception of visit 1 in all cycles with Daratumumab SC administration.
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
|
NCT05306587
|
{
"brief_title": "Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project.",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: Darzalex"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT05306587",
"official_title": "Daratumumab Provided at Home Experience: An Open, Single-center, Mixed-method Project Initiated on Behalf of Odense University Hospital",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-15",
"study_completion_date(actual)": "2024-01-01",
"study_start_date(actual)": "2022-04-01"
},
"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)": "2024-04-03",
"last_updated_that_met_qc_criteria": "2022-03-21",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-01",
"first_submitted": "2021-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.
#Intervention
- DRUG : Oral Omega-3-acid ethyl esters
- 1 gram capsule by mouth four times daily for 45 days
- DRUG : Placebo corn oil capsule
- 1 gram by mouth 4 times daily for 45 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
* Schirmer Test < 8 mm/5 minutes
* Fluorescein tear break-up time < 8 seconds
* No current use of dry eye treatment (except artificial lubrication)
* Signature on consent form
Exclusion Criteria:
* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
* Eyelid or eyelash abnormalities
* Alteration of the nasolacrimal apparatus
* Treatment with drugs affecting tearing
* Concomitant ocular therapies
* Topical ophthalmic steroids taken during the 4 weeks before the study
* Pregnant/breast-feeding women
* History of liver disease
* History of fish and/or shellfish allergy or hypersensitivity
* History of corn allergy or hypersensitivity
* Treatment with systemic anticoagulation therapy
* Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)
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
|
NCT01107964
|
{
"brief_title": "Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome",
"conditions": [
"Dry Eye Syndrome"
],
"interventions": [
"Drug: Placebo corn oil capsule",
"Drug: Oral Omega-3-acid ethyl esters"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01107964",
"official_title": "Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2015-06-15",
"study_start_date(actual)": "2010-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-22",
"last_updated_that_met_qc_criteria": "2010-04-20",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-21",
"first_submitted": "2010-04-20",
"first_submitted_that_met_qc_criteria": "2017-11-29"
}
}
}
|
#Study Description
Brief Summary
To develop, and then evaluate a mobile phone app to deliver therapy homework activities between group sessions (social cognition intervention) in individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable.
The investigators will also assess whether there is an initial indication that offering homework via the app improves outcomes following the group therapy.
Detailed Description
This study is a pilot, feasibility trial of a clinical intervention.
The investigators will initially pilot the app with three clinical participants, who will be asked to use the app for a period of three days and provide feedback as to whether there are any difficulties with usability, glitches, display, etc.
Two therapy groups will then be run consecutively. The therapy delivered will be a modified version of Group Training for Social Cognition in Psychosis (GRASP). Both groups will receive their homework tasks delivered via an app. Participants will undergo an assessment before and after the therapy, and a follow up interview as detailed in the measures section below. Primary objective: To evaluate a mobile app to deliver therapy homework between sessions of a social cognition therapy group for individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable.
Secondary objective: To assess whether there is an initial indication that our intervention improves social cognition skills.
#Intervention
- BEHAVIORAL : Social Cognition Group
- Each session lasts 90 minutes and includes three 20-minute work packages tapping different social cognition skills; specifically affect recognition and theory of mind/mental state attribution in this study. Examples of the work packages include guessing the emotions of others based on their facial expressions, activities such as indicating how confident participants feel about guessing emotions when looking at more ambiguous pictures, and watching/discussing video clips with content relevant to the group.
- DEVICE : Novel Mobile App
- The novel homework app was designed to deliver tasks to the participants between group therapy sessions. Three types of task were delivered by the app; 'Stories', 'Emotions', and 'Facts and Guesses'. The 'Stories' task was designed to encourage participants to think about how thoughts, emotions and actions interact. Participants were presented with a short vignette and asked to identify the emotion or behaviour of a character. 'Emotions' aimed to target affect perception by presenting faces of different emotion presentations and asking clients to select the correct emotion from a list of three, whilst 'Facts and Guesses' aimed to address difficulties with jumping to conclusions in social situations by showing clients a photograph of a social situation and asking them to determine whether a given statement about the photo was a 'fact' or a 'guess'. Confidence in answers was also assessed in order to encourage flexible thinking.
|
#Eligibility Criteria:
Inclusion Criteria:
* A diagnosis on the psychosis spectrum (using either DSM 5, DSM-IV, or ICD-10 [F20-F29])
* Age 18 <= age <= 65 years
* Good command of the English language
* Premorbid IQ of over 70
* Owns a smartphone or willing to use a study smartphone for the required period
* Likely to benefit from social cognition intervention as assessed by clinical team [for intervention part].
Exclusion Criteria:
Lacks capacity to give informed consent to participate in research
* Poses significant risk to self or others
* Inability to understand verbal or written English (i.e. inability to understand information sheet or requires an interpreter).
* High levels of psychotic symptoms which precludes meaningful participation
* Unsuitable to attend groups (group-therapy part only)
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
|
NCT04260763
|
{
"brief_title": "Evaluating a Novel Mobile App for Social Cognition in Psychosis",
"conditions": [
"Schizophrenia; Psychosis"
],
"interventions": [
"Device: Novel Mobile App",
"Behavioral: Social Cognition Group"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04260763",
"official_title": "Evaluating the Feasibility and Acceptability of a Novel Mobile Intervention Targeting Social Cognition in Individuals With Psychosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-08",
"study_completion_date(actual)": "2019-04-08",
"study_start_date(actual)": "2018-08-30"
},
"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)": "2020-02-07",
"last_updated_that_met_qc_criteria": "2020-02-06",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-07",
"first_submitted": "2018-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This proposal aims to evaluate selective laser trabeculoplasty (SLT) as a safe and effective therapy to control open-angle glaucoma and reduce the risk of progression to visual dysfunction or blindness in the African-derived developing world. If funded, this work will complete the characterization of SLT's safety and efficacy profile as a means of long-term disease control in this population. This work will support the translation of SLT into a structured public health initiative to reduce glaucoma-related vision loss throughout the African-derived developing world.
Detailed Description
Glaucoma is a leading cause of blindness in the African-derived developing world and represents a significant public health challenge as the disease burden is substantial. In Ghana, the prevalence of open-angle glaucoma over age 40 is 8.5%. In Barbados, the prevalence is 7.0%. In neighboring St. Lucia, the prevalence has been estimated at 8.8% with a 16% ten-year incidence of glaucoma-related blindness in one or both eyes. (In contrast, the prevalence in US adults is 1.9%.) The burden of glaucoma-related visual dysfunction is also substantial in the developing world. Because the application of medical and surgical therapies is limited by issues such as cost, availability, and limited regional surgical expertise, undertreatment is pervasive. Also, there is little access to low vision or vision rehabilitation services and minimal social support for the visually impaired. Laser trabeculoplasty may be a part of the solution to the developing world's burgeoning glaucoma burden. The treatment is fast, safe, minimally invasive and requires minimal post-treatment care; the equipment is portable; and the incremental cost of trabeculoplasty treatment is small once the equipment and expertise are on-site. Our recent study in St. Lucia demonstrated that laser trabeculoplasty lowers IOP by an amount likely to favorably alter the clinical course of glaucoma (versus no treatment) and has the potential to bend the glaucoma-related blindness curve in the African-derived developing world. Our long-term goal is to translate this finding through a public health initiative by establishing a pan-Caribbean glaucoma laser program to provide safe, effective, and cost-effective therapy for glaucoma in this underserved and overburdened region. Before this can happen, several important research questions remain unanswered regarding SLT in this population and comprise the specific aims of this proposal. What is the long-term efficacy of SLT in this population? Is repeat SLT effective once the IOP reduction of initial SLT wanes? Are the results obtained in St. Lucia generalizable to other developing nations populated by people of African descent? In this application, we propose a prospective cohort study in St. Lucia in which qualifying subjects with open-angle glaucoma will receive bilateral selective laser trabeculoplasty, will be followed to failure of initial SLT, and will undergo repeat SLT and again be followed to failure. The long-term safety and efficacy of both initial and repeat SLT in glaucoma patients of African descent will thus be established. Further, we will replicate the cohort study in Dominica to confirm external validity of the St. Lucia outcomes. This proposal is designed to answer the questions posed above and thus to complete the research phase of this project and facilitate translation of the research findings into the public health space. Considering the population of the African-derived developing world, the prevalence of glaucoma in this population, and the observed preliminary benefits of laser therapy, this project's output could ultimately reduce the risk of glaucoma-related visual dysfunction in hundreds of thousands of individuals throughout the developing world.
#Intervention
- PROCEDURE : Selective laser trabeculoplasty
- laser therapy to trabecular outflow pathway of the eye to lower intraocular pressure, delivered to 360 degrees of both eyes in a single session
|
#Eligibility Criteria:
Inclusion Criteria:
* Afro-Caribbean ancestry
* Ages 30 and above
* Open-angle glaucoma (ISGEO criteria)
* CDR>=0.7 or CDR asymmetry >=0.2 or rim width <=0.1 CDR with typical VF loss; or
* CDR>=0.8 or CDR asymmetry >=0.3 (if unable to get VF); or
* VA <20/400 and IOP >= 32 mmHg (if unable to get VF or CDR)
* Receiving <=2 topical IOP-lowering medications
* IOP between 17 <= age <= 35 mmHg in both eyes after 30-day washout
Exclusion Criteria:
* Any glaucoma other than open-angle glaucoma
* Advanced glaucoma (CDR > 0.9 or field loss in central 10º)
* History of:
* Prior glaucoma laser or surgery
* Ocular inflammation within 3 months
* Ocular trauma or intraocular surgery within 6 months
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02375009
|
{
"brief_title": "Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty",
"conditions": [
"Glaucoma"
],
"interventions": [
"Procedure: Selective laser trabeculoplasty"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02375009",
"official_title": "Glaucoma Management in the African-Derived Developing World Using Trabeculoplasty",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09",
"study_completion_date(actual)": "2018-09",
"study_start_date(actual)": "2015-03"
},
"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)": "2021-06-18",
"last_updated_that_met_qc_criteria": "2015-02-23",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-02",
"first_submitted": "2015-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).
Detailed Description
We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.
#Intervention
- BIOLOGICAL : Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells
- Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.
- BIOLOGICAL : Plasma-Lyte A
- Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1 <= age <= 3 must all be present within a 24-hour time period and at the time of enrollment:
Acute onset (defined below) of:
* A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)
* Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
* No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
Exclusion Criteria:
* Age less than 18 years
* Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
* Pregnant or breast-feeding
* Prisoner
* Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
* Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Moderate to severe liver failure (Childs-Pugh Score > 12)
* Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
* Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Major trauma in the prior 5 days
* Lung transplant patient
* No consent/inability to obtain consent
* Moribund patient not expected to survive 24 hours
* World Health Organization (WHO) Class III or IV pulmonary hypertension
* Documented deep venous thrombosis or pulmonary embolism within past 3 months
* No arterial line/no intent to place an arterial line
* No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
* Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
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
|
NCT02097641
|
{
"brief_title": "Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)",
"conditions": [
"Respiratory Distress Syndrome, Adult"
],
"interventions": [
"Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells",
"Biological: Plasma-Lyte A"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02097641",
"official_title": "Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-09",
"study_completion_date(actual)": "2018-02-09",
"study_start_date(actual)": "2014-03-15"
},
"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)": "2019-04-10",
"last_updated_that_met_qc_criteria": "2014-03-24",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-27",
"first_submitted": "2014-03-19",
"first_submitted_that_met_qc_criteria": "2019-03-18"
}
}
}
|
#Study Description
Brief Summary
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus
#Intervention
- PROCEDURE : Bowman layer graft implantation
- For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.
|
#Eligibility Criteria:
Inclusion Criteria:
*Advanced keratoconus
Exclusion Criteria:
* Further ophthalmic diseases
* History of ocular surgery
* Pregnancy, brest feeding
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01686906
|
{
"brief_title": "Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus",
"conditions": [
"Advanced Keratoconus"
],
"interventions": [
"Procedure: Bowman layer graft implantation"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01686906",
"official_title": "Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12",
"study_completion_date(actual)": "2020-12",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-12",
"last_updated_that_met_qc_criteria": "2012-09-13",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-18",
"first_submitted": "2012-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a variety of baseline measures (such as serum biomarkers related to metabolic syndrome, anthropometrics, muscle strength, and fitness testing) along with genetic information from healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype associations that may predispose individuals to developing metabolic syndrome, type 2 diabetes, and/or related diseases such as obesity.
We hypothesized that certain genetic variations will be protective against metabolic syndrome, while others will show a strong correlation with specific components of metabolic syndrome disease. We expect that the study of 'pre-symptomatic,' young individuals will facilitate the identification of genetic risk loci for metabolic syndrome and type 2 diabetes. Younger populations typically have less confounding variables, and this facilitates normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young subjects can provide more robust longitudinal data, and be recruited into subsequent interventions to reverse the trend towards metabolic syndrome, rather than the more difficult task of reversing type 2 diabetes in older populations. The data collected will be stratified according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how these factors influence disease risk.
|
#Eligibility Criteria:
Inclusion Criteria:
* between the ages of 18 and 35 years
* post-puberty
* willing and able to provide informed consent
* stable medical and psychosocial status providing a high likelihood of follow-up and compliance with study protocol
* all ethnic backgrounds will be included in this study.
Exclusion Criteria:
* evidence of clinically relevant systemic disease associated with disorders of glucose metabolism
* chronic use of glucocorticoid or appetite suppressants
* concomitant use of drugs known to alter glucose metabolism (i.e., metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase) or other medications known to alter blood levels being tested in this study
* inability to provide the requested fasting blood sample
* pregnancy
* menopause
* alcohol dependency (as determined by CAGE screening questionnaire); (8) inability to provide informed consent
* previous diagnosis or treatment for any hematologic-oncologic disorder
* history or current treatment for an eating disorder
* current treatment for weight loss
* history of bariatric surgery
* history of neurosurgical procedure
* participation in another clinical trial involving an investigational drug
* history of psychiatric disorder, which in the opinion of the investigator would affect the conduct of the proposed trial
* age younger than >= 18 years than 35 at the time of recruitment
* weight that exceeds the capacity of equipment used for weight measurements.
Sex :
ALL
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
|
NCT00966407
|
{
"brief_title": "Assessing Inherited Markers of Metabolic Syndrome in the Young",
"conditions": [
"Metabolic Syndrome",
"Diabetes Mellitus, Type 2",
"Obesity"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00966407",
"official_title": "Assessing Inherited Markers of Metabolic Syndrome in the Young",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2007-02"
},
"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)": "2017-02-09",
"last_updated_that_met_qc_criteria": "2009-08-24",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-26",
"first_submitted": "2009-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim is to study the effects of weight loss and weight loss combined with different types of physical activity on changes in physical functioning of older adults who are at-risk for cardiovascular disease.
Detailed Description
Although aerobic exercise training (AT) has been the cornerstone of rehabilitation for patients with CVD or MetS, experts agree that with the escalating problem of obesity, prevention programs in this area need to target weight loss (WL) as well. This is reinforced by recent research of our own showing that obesity is a major risk factor for physical disability among older adults. From a translational perspective, clinical researchers have recommended that effective community partnerships are needed to deliver such programs. In response to this call, the investigators have recently completed a translational study funded by NHLBI, the Cooperative Lifestyle Intervention Program (CLIP). In this investigation, 288 obese, older adults with CVD or MetS were randomized to a successful aging control treatment (SA), AT, or AT+WL for 18-months. The primary outcome was mobility disability, assessed by performance on the 400 m Walk Test (400MWT), and our staff co-delivered the interventions with agents from 3 counties within the community infrastructure of North Carolina Cooperative Extension Centers. Whereas mobility improved significantly in the AT group compared to SA, AT+WL was superior to either SA or AT.
Building on CLIP, the investigators now propose to increase the translational significance of our interventions by having them delivered exclusively by community partners with our staff as 'trainers and advisers' for desired behavior change. In addition, this study will provide the first large scale randomized controlled clinical trial to evaluate the effects of diet-induced weight loss (WL) on mobility in obese, older adults with CVD or the MetS as compared to WL combined with physical activity. The dual primary outcomes will be the 400MWT and muscle strength. Because uncertainty exists about the best approach for promoting WL in older adults due to concerns with the loss of lean mass, the design also permits a contrast between AT+WL and resistance exercise training (RT)+WL on muscle strength. Consistent with CLIP, our WL intervention will target a protein intake of 0.8 g∙kg body mass-1∙d-1. Reasons to consider RT+WL for older adults include: 1) the central role of muscle loss and decline in strength in mobility disability; 2) the underappreciated role of RT in cardiovascular health; 3) the influence of muscle mass on both resting and total energy expenditure as well as fat mass and bone health; and 5) the potential value of RT for improving mobility on tasks that depend heavily on the vertical movement of the center of mass (e.g., stair climbing). Eves and Plotnikoff22 have emphasized the importance of RT in older diseased populations and stated that 'the investigators need to discover practical, sustainable, and economically viable ways to safely implement RT at the population level.' To accomplish our goals, the investigators have created a community partnership with the YMCA, using 4 sites in Forsyth County, NC. One of the sites serves a large African American population. The investigators are moving this project from Cooperative Extension Centers to the YMCA because the former have neither the equipment nor the personnel necessary to independently train and monitor RT or AT.
#Intervention
- BEHAVIORAL : Caloric restriction
- Caloric restriction
- BEHAVIORAL : Aerobic Training
- Walking
- BEHAVIORAL : Resistance Training
- Lifting weights
|
#Eligibility Criteria:
Inclusion Criteria:
* Residence: community-dwelling men and women from the counties of interest (SR)
* Age: between 60 <= age <= 79 yrs (SR)
* Activity Status: sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no less than 10 minute blocks; SR)
* Adiposity: obese as defined by a BMI >= 30 (OAC)
* Medical Criteria: documented evidence of an MI, PCTI, chronic stable angina, cardiovascular surgery (coronary artery or valvular heart disease) or an ATP III diagnosis of the metabolic syndrome (PCP)
* Mobility Disability: disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work (SR)
* Stability of Residence: does not plan to move out of the county of residence for the duration of the study (SR)
* Agreeableness: willing and able to participate in all aspects of the trial (SR)
* Consents: willing to give an informed consent and sign a HIPAA authorization form (SR)
Exclusion Criteria:
* Severe Symptomatic Heart Disease: evidence of unstable angina, symptomatic congestive heart failure, or exercise induced complex ventricular arrhythmias (PCP)
* MI or cardiovascular procedure within the last 3-months (PCP)
* Blood Pressure: a resting blood pressure > 160/100 mmHg (OAC)
* Severe Systemic Disease: diagnosis of Parkinson's disease, chronic liver disease (cirrhosis, chronic hepatitis, etc.), systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.), end stage renal disease or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study (PCP)
* Cancer: active treatment for cancer other than non-melanotic skin cancer (PCP)
* Hearing or Sight Impairments: significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation (SR, OAC)
* Psychiatric Illness: bipolar depression or schizophrenia (defined as self-reported treatment for these conditions), currently receiving lithium or neuroleptics (PCP)
* Cognitive Impairment: dementia, delirium or impaired cognitive function as defined by a score on the Folstein Mini-Mental Status Exam < 21 (OAC)
* Participation in Other Trials: currently participating in or planning to participate in another medical intervention study (SR)
* Alcohol Intake: consuming more than 21 alcoholic drinks per week or alcoholism (SR)
* Functional Limitations: unable to walk unassisted (SR, OAC)
* English Literacy: unable to speak or read English
* Clinical Center Staff Evaluation: judged to be unsuitable for the trial for any reason by the clinic staff. A participant can be excluded prior to randomization because of some unspecified health problem that has been identified that would put the patient at risk for adherence or retention. These cases are discussed with a recruitment team consisting of the person who has raised the concern, an MD, and the study PIs.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01547182
|
{
"brief_title": "Cooperative Lifestyle Programs (CLIP-II)",
"conditions": [
"Cardiovascular Disease",
"Obesity",
"Physical Disability"
],
"interventions": [
"Behavioral: Resistance Training",
"Behavioral: Aerobic Training",
"Behavioral: Caloric restriction"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01547182",
"official_title": "Cooperative Lifestyle Programs (CLIP-II)",
"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)": "2012-03"
},
"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)": "2018-08-15",
"last_updated_that_met_qc_criteria": "2012-03-06",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-07",
"first_submitted": "2012-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.
Detailed Description
This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.
#Intervention
- DRUG : PM060184
- PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.
|
#Eligibility Criteria:
Inclusion criteria
* Voluntary signed and dated written informed consent.
* Patients with advanced solid tumors refractory to Standard therapy.
* Age >= 18 years.
* Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
* Normal laboratory values within seven days prior to treatment administration.
* Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.
Exclusion criteria
* Pregnant or lactating women.
* Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
* Prior treatment with any investigational product less than 30 days prior to the first.
* Central Nervous System metastases
* Other relevant diseases or adverse clinical conditions:
* Increased cardiac risk:
* Presence of significant neurological or psychiatric disorders
* Neuropathy
* Active infection requiring treatment.
* Liver disease (e.g., cirrhosis, hepatitis).
* Immunocompromised patients.
* Any other major illness.
* Limitation of the patient's ability to comply with the treatment.
* Known hypersensitivity to any of the components of the drug product.
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
|
NCT01299636
|
{
"brief_title": "Study of PM060184 in Patients With Advanced Solid Tumors",
"conditions": [
"Solid Tumors"
],
"interventions": [
"Drug: PM060184"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01299636",
"official_title": "Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-01",
"last_updated_that_met_qc_criteria": "2011-02-17",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-18",
"first_submitted": "2011-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Detailed Description
OBJECTIVES:
I. Determine the safety and toxicity of MS-275 and azacitidine in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
II. Determine the maximum tolerated dose and optimal phase II dose of MS-275 when combined with azacitidine in these patients.
III. Determine, preliminarily, the potential therapeutic activity of this regimen in these patients.
IV. Correlate MS-275 pharmacokinetics with clinical response and laboratory correlative endpoints in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of MS-275. Patients receive azacitidine subcutaneously on days 1-10 and oral MS-275 on days 3 and 10.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose (MTD) is determined. Patients receive adjusted doses of azacitidine based on clinical response. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 9 additional patients are treated at the MTD.
\[Note: Patients who do not achieve hematologic improvement or partial or complete response but who have stable disease after 4 courses of therapy may receive an additional 4 courses of therapy at a higher dose than what was originally assigned\]
#Intervention
- DRUG : Azacitidine
- Given SC
- Other Names :
- 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza
- DRUG : Entinostat
- Given orally
- Other Names :
- HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1 of the following:
* Histologically confirmed myelodysplastic syndromes (MDS) by bone marrow aspiration and/or biopsy
* International Prognostic Scoring System (IPSS) score of intermediate-1, intermediate-2, or high
* International Prognostic Scoring System (IPSS) score of intermediate-1, intermediate-2, or high
* Low IPSS score allowed provided patient has a clinically significant cytopenia (i.e., absolute neutrophil count < 1,000/mm^3, untransfused hemoglobin < 8 g/dL, platelet count < 20,000/mm^3, or anemia requiring transfusion)
* Chronic myelomonocytic leukemia
* Acute myeloid leukemia (AML)
* Relapsed or refractory disease
* Untreated AML allowed provided patient meets >= 1 of the following criteria:
* Age 60 and over
* AML arising in the setting of an antecedent hematologic disorder
* High-risk cytogenetic abnormalities
* Medical conditions that may compromise the ability to give cytotoxic chemotherapy as the primary modality
* Refused cytotoxic chemotherapy
* WBC < 30,000/mm3 for >= 2 weeks before study entry
* Acute promyelocytic leukemia allowed provided patient is in at least second relapse and has already received treatment regimens containing arsenic trioxide and isotretinoin
* No clinical evidence of CNS or pulmonary leukostasis or CNS leukemia
* Peformance status:
* Zubrod 0 <= age <= 2
* Life expectancy:
* At least 6 months
* Hematopoietic:
* See Disease Characteristics
* Hemoglobin >= 8 g/dL (transfusion allowed)
* No disseminated intravascular coagulation
* Renal:
* Creatinine normal OR
* Creatinine clearance >= 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* No untreated, active infection
* No other serious or uncontrolled medical condition
* More than 3 weeks since prior hematopoietic growth factors for this malignancy
* At least 3 weeks since prior hydroxyurea (2 weeks for AML patients)
* No concurrent hydroxyurea
* Recovered from all prior therapy
* At least 2 weeks since prior cytotoxic therapy (AML patients)
* More than 3 weeks since other prior therapy for this malignancy
* No other concurrent investigational or commercial agents or therapies for this malignancy
* No concurrent valproic acid
* Hepatic:
* Bilirubin normal unless due to hemolysis or Gilbert's syndrome
* AST and ALT =< 2.5 times upper limit of normal
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
|
NCT00101179
|
{
"brief_title": "MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia",
"conditions": [
"Acute Myeloid Leukemia",
"Chronic Myelomonocytic Leukemia",
"de Novo Myelodysplastic Syndrome",
"Leukemia",
"Myelodysplastic Syndrome",
"Recurrent Adult Acute Myeloid Leukemia",
"Secondary Acute Myeloid Leukemia",
"Secondary Myelodysplastic Syndrome"
],
"interventions": [
"Drug: Azacitidine",
"Drug: Entinostat"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00101179",
"official_title": "A Dose-Finding Trial of the Histone Deacetylase Inhibitor MS-275 (NSC 706995) in Combination With 5-Azacitidine (5AC, NSC 102816) in Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMMoL) and Acute Myeloid Leukemia (AML)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04-20",
"study_completion_date(actual)": "2014-02-03",
"study_start_date(actual)": "2004-11-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-18",
"last_updated_that_met_qc_criteria": "2005-01-07",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-01-10",
"first_submitted": "2005-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compared with placebo for preventive treatment in Chronic Migraine patients
#Intervention
- DRUG : TEV-48125
- TEV-48125 will be subcutaneously administered once monthly for 3 months.
- DRUG : TEV-48125 or placebo
- TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
- DRUG : Placebo
- Placebo will be subcutaneously administered once monthly for 3 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis
* Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period
* Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.
Exclusion Criteria:
* Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
* Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.
* Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03303079
|
{
"brief_title": "Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine",
"conditions": [
"Migraine"
],
"interventions": [
"Drug: TEV-48125 or placebo",
"Drug: Placebo",
"Drug: TEV-48125"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT03303079",
"official_title": "A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-30",
"study_completion_date(actual)": "2019-11-30",
"study_start_date(actual)": "2017-12-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-15",
"last_updated_that_met_qc_criteria": "2017-10-02",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-05",
"first_submitted": "2017-10-02",
"first_submitted_that_met_qc_criteria": "2021-05-20"
}
}
}
|
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