data
stringlengths 62
36k
| criteria
stringlengths 174
19.2k
| NCT_ID
stringlengths 11
11
| metadata
dict |
|---|---|---|---|
#Study Description
Brief Summary
This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak') for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.
#Intervention
- PROCEDURE : periodontal dressing (coe-pak)
- Guided tissue regeneration and periodontal dressing
- PROCEDURE : Guided Tissue Regeneration
- Regeneration of lost periodontal tissues
- Other Names :
- GTR
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years.
* A minimum of 18 teeth, wisdom teeth excluded.
* Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%.
* Presence of at least one pocket with probing pocket depth (PPD) >=6 mm per quadrant, which was BOP.
* Presence of at least three teeth per quadrant.
Exclusion Criteria:
* Periodontal treatment in the last 3 years.
* Antibiotic intake 6 months before
* the screening visit.
* Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05756946
|
{
"brief_title": "Guided Tissue Regeneration With a Periodontal Dressing",
"conditions": [
"Periodontal Diseases"
],
"interventions": [
"Procedure: periodontal dressing (coe-pak)",
"Procedure: Guided Tissue Regeneration"
],
"location_countries": [
"Palestinian Territory, occupied"
],
"nct_id": "NCT05756946",
"official_title": "Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-10",
"study_completion_date(actual)": "2023-04-15",
"study_start_date(actual)": "2023-03-01"
},
"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)": "2023-07-20",
"last_updated_that_met_qc_criteria": "2023-02-23",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-07",
"first_submitted": "2023-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall goal of this study is to use MRI to:
* Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;
* Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,
* Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.
Detailed Description
Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes
#Intervention
- PROCEDURE : MR Imaging of the Coronary Arteries
|
#Eligibility Criteria:
Inclusion Criteria:
* Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center
* Male or Female adult equal to or older than 45 years
* Willing/able to provide informed consent
Exclusion Criteria:
* Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)
* Metal in the eyes
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
|
NCT00353795
|
{
"brief_title": "Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)",
"conditions": [
"Coronary Arteriosclerosis",
"Arteriosclerosis, Coronary",
"Atherosclerosis, Coronary",
"Coronary Artery Disease",
"Coronary Atherosclerosis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00353795",
"official_title": "Coronary Atherosclerosis Evaluation by Arterial Wall MRI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2005-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-06-22",
"last_updated_that_met_qc_criteria": "2006-07-18",
"last_verified": "2009-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-07-19",
"first_submitted": "2006-07-18",
"first_submitted_that_met_qc_criteria": "2010-05-25"
}
}
}
|
#Study Description
Brief Summary
RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data are available about the levels of soluble forms and ligands of RAGE in the setting of ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with ALI/ARDS.
Detailed Description
BACKGROUND:
The receptor for advanced glycation end products (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Frequently, the biology of RAGE coincides with settings in which ligands of the receptor accumulate, especially in a proinflammatory environment. More work is needed for us to understand the mechanisms by which RAGE is regulated during ALI/ARDS, especially with regard to the expression of its soluble forms and the involvement of its potential ligands.
DESIGN NARRATIVE:
This observational prospective clinical study will describe and compare soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS, and from patients under mechanical ventilation (control group).
Edema fluid and plasma samples will be collected simultaneously on day 1, day 3 and day 6, in order to describe kinetics of evolution of soluble forms and ligands of RAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be simultaneously gathered from indwelling arterial and central venous catheters. The concentrations of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) will be measured in duplicate by ELISA.
|
#Eligibility Criteria:
Inclusion Criteria:
* ICU patients under mechanical ventilation
* Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)
Exclusion Criteria:
* Pregnancy
* Acute exacerbation of diabetes
* Dialysis for end-stage kidney disease
* Alzheimer's disease
* Amyloidosis
* Evolutive neoplastic lesion
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01270295
|
{
"brief_title": "Soluble Forms and Ligands of RAGE in ALI/ARDS (SoLiRAGE).",
"conditions": [
"Acute Lung Injury",
"Acute Respiratory Distress Syndrome",
"Mechanical Ventilation"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT01270295",
"official_title": "Soluble Forms and Ligands of the Receptor for Advanced Glycation End Products (RAGE) in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS : an Observational Prospective Study.",
"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)": "2013-03-13",
"last_updated_that_met_qc_criteria": "2011-01-04",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-05",
"first_submitted": "2011-01-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.
#Intervention
- DRUG : Zonisamide
- Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
- Other Names :
- Zonegran
- DRUG : Carbamazepine
- Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
Subjects will be eligible for the study if they meet all of the following inclusion criteria:
* Male or female subjects, 18 <= age <= 75 of age inclusive.
* Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) or generalized tonic-clonic seizures (without clear focal origin) within 12 months of the Screening Visit, of which at least one seizure occurred within three months of the Screening Visit (> one seizure within a 24 hour period will be counted as one seizure).
* Subjects will either have had no previous use of an AED, or treatment with one AED for a maximum duration of two weeks before the Randomization Visit (T1).
* Subjects have a documented electroencephalogram (EEG) within 12 months of the Screening Visit, compatible with localization-related epilepsy (to exclude primary generalized epilepsy).
* Subjects have a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the absence of a progressive neurological lesion within 12 months of the Screening Visit.
* Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and randomization, must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. Medically acceptable contraception is defined here as oral contraception pill with at least 50 micrograms ethinylestradiol per intake, contraceptive injections and implants, or intrauterine device in place for at least three months.
* Subjects who are able and willing to follow investigational study procedures, maintain a seizure diary, and report AEs.
* Subjects who are able and willing to give written informed consent.
EXCLUSION CRITERIA:
Subjects who meet any of the following exclusion criteria will not be eligible for the study:
* Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
* Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
* Subjects have a history of status epilepticus, and/or non-epileptic seizures (e.g., metabolic, pseudo-seizures).
* Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
* Subjects have progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination, or tumour).
* Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
* Subjects have been previously treated with carbamazepine or zonisamide.
* Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
* Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
* Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
* Subjects have a history of acute intermittent porphyria.
* Subjects have a history of renal disorder (serum creatinine level of > 135 ìmol / l (1.5 mg/dL at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper normal limit.
* Subjects have a body weight of less than 40 kg.
* Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
* Subjects have a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
* Subjects are currently taking carbonic anhydrase inhibitors.
* Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
* Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other excluded medications.
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
|
NCT00477295
|
{
"brief_title": "A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy",
"conditions": [
"Epilepsy"
],
"interventions": [
"Drug: Carbamazepine",
"Drug: Zonisamide"
],
"location_countries": [
"France",
"India",
"Slovakia",
"Sweden",
"Poland",
"Germany",
"Denmark",
"Taiwan",
"United Kingdom",
"South Africa",
"Serbia",
"Russian Federation",
"Korea, Republic of",
"Spain",
"Australia",
"Hungary",
"Italy",
"Greece"
],
"nct_id": "NCT00477295",
"official_title": "A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2007-05"
},
"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)": "2015-12-24",
"last_updated_that_met_qc_criteria": "2007-05-21",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-23",
"first_submitted": "2007-05-21",
"first_submitted_that_met_qc_criteria": "2013-02-06"
}
}
}
|
#Study Description
Brief Summary
This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.
Detailed Description
Information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. The group will provide swim instruction using the Halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. Groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. There will be a certified lifeguard present at all times. Qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. Swim skills will be tracked at each session via goal attainment scaling and daily documentation. Descriptive and correlational statistics will be completed as well as coding of interview and survey data. Participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the WOTA or plateau in progress of swim skills.
#Intervention
- BEHAVIORAL : Aquatic Occupational Therapy
- Group of 4-8 children, paired with a swim buddy. Intervention techniques including discrete teaching, motor shaping, behavioral management, therapeutic relationship and individualized goals.
|
#Eligibility Criteria:
Inclusion Criteria:
* pre-existing diagnosis of autism spectrum disorder from a medical professional
* family interest in swimming
Exclusion Criteria:
* ventilation system for breathing such as trachea not capped
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05092321
|
{
"brief_title": "Aquatic Therapy for ASD",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": [
"Behavioral: Aquatic Occupational Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05092321",
"official_title": "Exploration of Aquatic Therapy in Children With Autism and Their Families",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-31",
"study_completion_date(actual)": "2024-08-31",
"study_start_date(actual)": "2021-09-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-13",
"last_updated_that_met_qc_criteria": "2021-10-12",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-25",
"first_submitted": "2021-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to test the central hypothesis that adding to the diet daily yogurt provides beneficial effects on digestive health and subjective mood in healthy adults.
Detailed Description
This clinical trial will include a 4-week lead-in period and a 2-week treatment period. The lead-in period will be devoid of all supplemental and dietary probiotics, fermented dairy products, and fermented foods. Participants will be asked to refrain from consuming all supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout the entire study. During the treatment period, participants will be given yogurt with sugar. This trial will serve as a continuation of the NECTAR Study (NCT04187950).
#Intervention
- DIETARY_SUPPLEMENT : Yogurt with B. lactis and added cane sugar
- The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with cane sugar twice daily for 14 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Between the ages of 22 <= age <= 64 years at the time of consent
* Body mass index of 18.5 to 29.9 kg/m^2.
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
* Ability to drop off fecal sample within 30 minutes of defecation
* Have between 3 <= age <= 6 bowel movements per week
* Have completed the NECTAR Study (NCT04187950)
Exclusion Criteria:
* Current pregnancy, lactation, or post-menopausal
* Tobacco use
* Honey allergy or intolerance
* Dairy allergy, lactose intolerance
* Food dye allergy/intolerance
* Prior physician diagnosed gastrointestinal disease (chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, or gastroesophageal reflux disease (GERD))
* Current use or use of antibiotics in the past 3 months
* Current use of any of the following types of medications: laxatives, anti-diarrhea medications, narcotics, enemas, antispasmodics, anticonvulsants, prescription proton pump inhibitors, prokinetic agents, histamine-2 Rc antagonists (prescription GERD medication)
* Body mass index > 29.9 kg/m^2
* Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy)
* Restrictive bariatric surgery (i.e. adjustable gastric band) within the past 5 years
* Concurrent enrollment in another dietary, exercise, or medication study (except for the NECTAR Study (NCT04187950))
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04901390
|
{
"brief_title": "Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts",
"conditions": [
"Gastrointestinal Dysfunction",
"Physiological Stress",
"Cognition - Other"
],
"interventions": [
"Dietary Supplement: Yogurt with B. lactis and added cane sugar"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04901390",
"official_title": "Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-23",
"study_completion_date(actual)": "2022-11-23",
"study_start_date(actual)": "2021-09-20"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-21",
"last_updated_that_met_qc_criteria": "2021-05-20",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-25",
"first_submitted": "2021-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase I trial studies the side effects and best dose of pomalidomide in treating younger patients with tumors of the brain or spine (central nervous system) that have come back or are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow and spread and may also stimulate the immune system to kill tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of pomalidomide, in children from \>= 3 years to \< 21 years of age with recurrent, progressive or refractory central nervous system (CNS) tumors when given once daily for 21 consecutive days of a 28-day course.
II. To describe the toxicity profile and dose-limiting toxicities of pomalidomide in children from \>= 3 years to \< 21 years of age with recurrent, progressive or refractory CNS tumors.
III. To characterize the pharmacokinetics of pomalidomide when administered orally in children from \>= 3 years old to \< 21 years of age with recurrent, progressive or refractory CNS tumors and study the association of pharmacokinetic (PK) parameters with age and steroid use.
SECONDARY OBJECTIVES:
I. To explore the preliminary efficacy of pomalidomide in this patient population as defined by radiographic response rate, duration of response, and event-free survival (EFS) within the confines of a Phase 1 study. \*For the purposes of this study, long-term stable disease will be considered a response (defined as stable disease for \>= 6 courses).
II. To investigate a relationship between pomalidomide dose and exposure with radiographic response and changes in immune function (for example, T-cell subsets, natural killer \[NK\] cell activity, granzyme B and circulating levels of IL-12, IL-2, IL-15, GM-CSF).
OUTLINE: This is a dose-escalation study.
Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
#Intervention
- OTHER : Laboratory Biomarker Analysis
- Optional correlative studies
- OTHER : Pharmacological Study
- Correlative studies
- DRUG : Pomalidomide
- Given PO
- Other Names :
- 4-Aminothalidomide, Actimid, CC-4047, Imnovid, Pomalyst
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have received standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy
* Patients with a histologically confirmed diagnosis of a primary CNS tumor that is recurrent, progressive or refractory to standard therapy; refractory disease will be defined as the presence of persistent abnormality on conventional magnetic resonance imaging (MRI) imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment; all tumors must have histological verification at either the time of diagnosis or recurrence except for patients with diffuse intrinsic brain stem tumors or optic pathway gliomas; patients with neurofibromatosis type-I (NF-1) associated CNS tumors are eligible if they meet all other eligibility criteria
* Patients must have evaluable disease on MRI imaging
* Patients must have body surface area (BSA) > 0.55 m^2 at the time of enrollment
* In the event of de-escalation from dose level 1 to dose level 0, patients with BSAs < 0.67 m^2 are not eligible
* Patients must have recovered from clinically significant, acute, treatment-related toxicities of prior therapies; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0, unless otherwise specified in the inclusion and exclusion criteria
* Agents that potentially fit into more than one category or do not clearly fit into any category listed above should be discussed with the study principal investigator (PI) prior to enrollment
* Patients must have received their last dose of known myelosuppressive anticancer therapy greater than 28 days prior to study enrollment or > 42 days if nitrosourea
* Patients must have received their last dose of any other investigational agent greater than 28 days prior to enrollment (with exception of fluorothymidine F-18 [FLT])
* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment
* Patients must have received their last dose of any other biologic agent greater than 7 days prior to enrollment
* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur and discussed with the PI
* Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
* Immunomodulatory therapy: greater than 28 days must have elapsed since last dose of an immune modulating agent, including vaccine therapy
* Administration of the radioisotope, 18-FLT, which is being concurrently investigated on an imaging study within the Pediatric Brain Tumor Consortium (PBTC), is allowed > 72 hours prior to initiation of pomalidomide on this study; any adverse events related to the FLT must have resolved completely
* Patients must have had their last fraction of:
* Craniospinal irradiation, total body irradiation (TBI), or >= 50% radiation of pelvis > 3 months prior to enrollment
* Focal irradiation > 6 weeks prior to enrollment
* Local palliative radiation therapy (XRT) (small port) >= 4 weeks
* Patient must be:
* >= 6 months since allogeneic bone marrow transplant prior to enrollment
* >= 3 months since autologous bone marrow/stem cell prior to enrollment
* >= 3 months since stem cell transplant or rescue without TBI with no graft vs. host disease prior to enrollment
* No graft versus host disease
* Patients on anticonvulsant therapy may continue these at the discretion of their treating physician; however, it is recommended that anticonvulsant levels be checked periodically as clinically indicated if possible
* Patients on alternative supplements should strongly be encouraged to discontinue them prior to enrollment; if they opt to continue, they may enroll on study as long as they have been receiving the supplement for at least 30 days, there is NO evidence of hepatic, renal or other organ dysfunction, administration is approved by the PI, and administration is documented in the study diary
* Patients must be on a stable or decreasing dose of corticosteroids for 5 days prior to enrollment; patient may be taking therapeutic doses of steroids during the initial dose escalations and prior to defining an RP2D; this should be recorded in the database; once the RP2D has been established, enrollment may be limited based on steroid use;*physiologic replacement doses will be defined on this protocol as no more than 0.75 mg/m^2/day of dexamethasone or equivalent of steroids; doses higher than this will be considered therapeutic
* All races and ethnic groups are eligible for this study
* Patients should have no significant worsening in clinical status for a minimum of 2 days prior to enrollment
* Patients must be able to swallow whole capsules
* Patients should undergo a repeat MRI prior to enrollment if there is a significant worsening or new neurologic symptoms in the interval between the eligibility scan and start of protocol therapy
* The repeat scan will act as a new baseline and the eligibility scan for these patients
* Karnofsky performance scale (KPS for > 16 years) or Lansky performance score (LPS for =< 16 years) assessed within 14 days of enrollment must be >= 50
* Absolute neutrophil count >= 1,000/mm^3
* Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days and recovery from nadir)
* Hemoglobin >= 8 g/dL (may receive transfusions)
* Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal
* Albumin >= 3 g/dL
* Serum creatinine based on age/gender as noted; patients that do not meet the criteria below but who have a 24-hour creatinine clearance or glomerular filtration rate (GFR) (radioisotope or iothalamate) >= 70 ml/min/1.73 m^2 are eligible
* Serum creatinine for age/gender
* 3 to < 6 years: 0.8 mg/dL
* 6 to < 10 years: 1 mg/dL
* 10 to < 13 years: 1.2 mg/dL
* 13 to < 16 years: 1.5 mg/dL (male) and 1.4 mg/dL (female)
* >= 16 years: 1.7 mg/dL (male) and 1.4 mg/dL (female)
* Oxygen saturation as measured by pulse oximetry must be >= 93% on room air
* Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (i.e. filgrastim, sargramostim); two weeks must have elapsed if patients received polyethylene glycol (PEG) formulations
* Pregnant or breast-feeding patients are excluded; female patients of childbearing potential must have a negative serum or urine pregnancy test at the time of enrollment; in addition, female patients of childbearing potential must have negative pregnancy tests within 10 - 14 days prior to starting pomalidomide (can use enrollment pregnancy test if within the 10 <= age <= 14 day limit) AND again within 24 hours prior to initiation of pomalidomide; this protocol defines the following childbearing potential risk categories as:
* Female child/young adult of childbearing potential as a female who has:
* Achieved menarche and/or breast development, in Tanner stage 2 or greater
* Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Note: amenorrhea following cancer therapy does not rule out childbearing potential
* Patients of childbearing or child fathering potential must use medically acceptable form(s) of birth control as stated within the pomalidomide Pregnancy Risk Minimization Plan, which includes abstinence, while being treated on this study; true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female patients of childbearing potential agree to and will have had effective contraception without interruption for 28 days before starting pomalidomide
* The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines
Exclusion Criteria:
* Patients with any clinically significant unrelated systemic illness (e.g., serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
* Patients with a history of any other malignancy will not be eligible
* Patients with radiation-associated gliomas will not be eligible
* Patients with a history of non-central line related thrombosis, more than one prior central-line related thrombosis, or known coagulopathy will not be eligible; patients with a first degree family member with a known coagulopathy will be excluded, and therefore, obtaining a family history is essential when possible; patients actively on anticoagulation therapy are not eligible
* Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide
* Patients who are receiving any other anti-cancer or investigational drug therapy are excluded
* Patients taking a known moderate to potent inhibitor of CYP1A2 are excluded; pomalidomide is primarily metabolized by CYP1A2 and CYP3A; pomalidomide is also a substrate for permeability (P)-glycoprotein (P-gp)
* Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions
* Patients who have received pomalidomide in the past are not eligible; patients who have prior treatment with other immunomodulatory drugs (IMiDs) (thalidomide, lenalidomide) ARE eligible if they meet all other eligibility criteria and did not have 'significant toxicity' associated with lenalidomide or thalidomide use; a 'significant' toxicity will be defined as one that required a dose reduction or discontinuation due to toxicity; please discuss any questions with the PI
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02415153
|
{
"brief_title": "Pomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors",
"conditions": [
"Neurofibromatosis Type 1",
"Recurrent Childhood Brain Stem Glioma",
"Recurrent Childhood Visual Pathway Glioma",
"Recurrent Primary Central Nervous System Neoplasm",
"Refractory Primary Central Nervous System Neoplasm"
],
"interventions": [
"Other: Laboratory Biomarker Analysis",
"Other: Pharmacological Study",
"Drug: Pomalidomide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02415153",
"official_title": "A Phase I Trial of Pomalidomide for Children With Recurrent, Progressive, or Refractory CNS Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-01",
"study_completion_date(actual)": "2020-05-27",
"study_start_date(actual)": "2015-07-14"
},
"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)": "2022-04-25",
"last_updated_that_met_qc_criteria": "2015-04-13",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-14",
"first_submitted": "2015-04-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric anastomosis by measure anastomotic stricture rate.
Detailed Description
The purpose of the proposed study is to demonstrate that a hand sewn anastomosis using STRATAFIX is safe and effective after minimally invasive esophagectomy and capture anastomotic leak and stricture rate after esophagectomy. If proven, one may reasonably conclude that STRATAFIX may be safely used in other less complex anastomoses and closures throughout the gastrointestinal tract. Furthermore, the work may promote the utilization of STRATAFIX for other applications, e.g. closure of the vaginal cuff after hysterectomy. The study is proposed to demonstrate the safety and efficacy of utilizing an absorbable running suture for completion of a hand swen intra thoracic esophago-gastric anastomosis during minimally invasive esophagectomy. There are many advantages to hand sewn anastomosis compared with stapled, e.g. EEA anastomosis. Two potential advantages are a lower leak rate and a lower stricture rate. Currently hand swen anastomosis is performed with interrupted suture of absorbable material. While effective, this technique requires multiple sutures, thus increasing operative time and material cost. Utilizing a running suture technique has the potential to reduce operative time and overall operative cost. Furthermore, it may lead to a reduction in postoperative morbidity by reducing anastomotic leak rate and structure formation. The hypothesis of the protocol is to evaluate the use of STRATAFIX in performing a hand swen intrathoracic anastomosis after minimally invasive esophagectomy is non inferior (and may be superior) to historical cases in which the anastomosis was completed using other types of suture material. Inclusion criteria: (1) All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrectomy. (2) Patients who provide written informed consent for the study. Exclusion criteria: Standard minimally invasive esophagectomy technique will be employed. (1) Creation of gastric conduit laparoscopically. (2) Robotic assisted esophageal mobilization through the right chest. (3) Robotic assisted intrathoracic anastomosis at or above the level of the azygous vein. (4) Barium swallow performed on post operative day 5-7 to assess anastomotic integrity. (5) Periodic clinical follow up on an outpatient basis to assess need for any interventions for anastomotic stricture.
#Intervention
- DEVICE : Stratafix PGA Suture
- Subject leak Stricture rates post procedure
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrostomy.
* Patients who provide written informed consent for the study.
Exclusion Criteria:
* Any patient with esophageal cancer who is not deemed a surgical candidate or who is not deemed a candidate for the Ivor Lewis technique of esophagectomy (with intrathoracic anastomosis).
* Any patient less than 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02609425
|
{
"brief_title": "Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX",
"conditions": [
"Esophageal Cancer"
],
"interventions": [
"Device: Stratafix PGA Suture"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02609425",
"official_title": "Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-25",
"study_completion_date(actual)": "2020-08-25",
"study_start_date(actual)": "2015-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-24",
"last_updated_that_met_qc_criteria": "2015-11-17",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-20",
"first_submitted": "2015-11-17",
"first_submitted_that_met_qc_criteria": "2023-02-18"
}
}
}
|
#Study Description
Brief Summary
Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms. There are little data describing the influence of nocturnal feeds on sleep, metabolism, and overall health in hospitalized children. To evaluate this association, the investigators will conduct a single-center, randomized, non-blinded controlled trial that will test the impact of nocturnal enteral/parenteral nutrition on patient outcomes.
Detailed Description
HSCT provides a potential cure for children and adults with high risk and relapsed malignancy, immune deficiency, and other fatal illnesses. Circadian cycles, metabolism, and nutrition are intimately linked, and the timing of meals play an important role in synchronizing peripheral circadian rhythms; however, the standard of care for HSCT recipients is to deliver continuous feeds (either enterally or parenterally).
The objective of this study is to evaluate the influence of the timing of feeding on sleep and metabolism in HSCT subjects. The investigators hypothesize patients receiving feeds during daytime hours (0800-2000) in comparison to continuous (24 hours), will have improved sleep efficiency, decreased blood glucose, insulin, and triglycerides over patients who receive feeding overnight. The aim of this study is to evaluate the influence of the timing of feeds on sleep, metabolism, and outcomes in HSCT subjects.
#Intervention
- OTHER : 12-16 hour nutrition
- Cases will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. Feeding will begin in morning hours unless otherwise directed by an investigator or registered dietician.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 12 months of age undergoing HSCT and receiving a myeloablative preparative regimen
Exclusion Criteria:
* Prior history of hypoglycemia, diabetes mellitus, metabolic disease, or other requirement for continuous nutrition
Sex :
ALL
Ages :
- Minimum Age : 12 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04549038
|
{
"brief_title": "Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients",
"conditions": [
"Hematopoietic Stem Cell Transplant"
],
"interventions": [
"Other: 12-16 hour nutrition"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04549038",
"official_title": "Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients: Impact on Circadian Rhythm, Insulin Regulation, and Outcomes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-25",
"study_completion_date(actual)": "2022-11-18",
"study_start_date(actual)": "2020-05-19"
},
"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)": "2023-02-08",
"last_updated_that_met_qc_criteria": "2020-09-08",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-16",
"first_submitted": "2020-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study 37 patients who had undergone percutaneous nephrolithotomy were included. Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative month. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In this way functional changes were investigated in the renal units. Twenty six of 37 cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple access sites. When each of the poles of a kidney was admitted as a surgical unit separately, there were 51 units.
Detailed Description
Total 37 patients who had undergone PCNL were included between June 2007-June 2009. All patients were evaluated routinely with physical examination, complete blood count (CBC), blood urine nitrogen (BUN), creatinine levels, and urinalysis. None of the patients had experienced pyelonephritis, and none had a solitary kidney, renal ectopy or history of any other urinary abnormality. At least one of the following techniques; namely computed tomography (CT), intravenous urography or ultrasonography, was preferred routinely before surgery in order to visualize the urinary system. Unilateral PCNL was performed in all patients. Postoperative CBC and BUN creatine levels were repeated.
Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized to indicate early and late term. The aim of randomization was to determine an optimal time for assessing patients. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In addition the uptake of all opposite poles was measured together and calculated as a percentage value separately (Figure-1), e.g., the two upper poles' uptake was measured together as if they were renal units and each poles' own portion in this total uptake was declared separately as a percentage. How the differential functions were changed between the sides undergoing PCNL and the opposite sides, as well the changes before and 6 months after surgery are manifested by using these parameters.
Twenty six of 37 cases underwent PCNL with a single access site (70.3%) and 11 separately with multiple accesses (29.7%). When each of the poles of a kidney was considered as a surgical unit, there were 51 units. In this manner the functional change of a unit would show the surgical trauma inflicted on the poles by PCNL access.
#Intervention
- PROCEDURE : Percutaneous nephrolithotomy
- The procedure is done under general anesthesia in the supine position. A Retrograde pyelogram is done to locate the stone in the kidney. With a small incision in the flank, the percutaneous nephrolithotomy (PCN) needle is passed into the pelvis of the kidney. The position of the needle is confirmed by fluoroscopy. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn with the guide wire still inside the pelvis. Over the guide wire the dilators are passed and a working sheath is introduced. A nephroscope is then passed inside and stones are taken out.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with renal stones which was bigger than 2cm.
Exclusion Criteria:
* Patients with acute urinary tract infection,
* Patients with bleeding disorder,
* Patients with chronic renal failure,
* Patients with solitary kidney, renal ectopy or history of any other urinary abnormality.
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:
No
|
NCT01819753
|
{
"brief_title": "Assessment of the Effects of Access Count in Percutaneous Nephrolithotomy on Renal Functions by Technetium-99M-Dimercaptosuccinic Acid Scintigraphy",
"conditions": [
"Renal Parenchymal Loss After the Percutaneous Nephrolithotomy"
],
"interventions": [
"Procedure: Percutaneous nephrolithotomy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT01819753",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2007-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-28",
"last_updated_that_met_qc_criteria": "2013-03-27",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-28",
"first_submitted": "2013-03-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research will test a technology adoption framework to increase use of the A-CHESS smartphone app. The project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI.
Terms - A-CHESS: Addiction Comprehensive Health Enhancement Support System NIATx-TI: Network for the Improvement of Addiction Treatment-Technology Implementation
Detailed Description
Patient-centered e-health has failed to achieve its promise despite considerable consumer interest in technology and research supporting its potential. E-health adoption rates in healthcare are poor, with specialty substance use disorder (SUD) treatment having the lowest technology adoption rate of any sector. Implementation science can address this emerging gap in the e-health field by augmenting existing models, that explain organizational and individual e-health behaviors retrospectively, with prospective models that can guide implementation. The organizational planning discipline, with its decades of research, could provide a cross-disciplinary 'jump start' to developing an e-health implementation model for health organizations. Henry Mintzberg, a respected pioneer in this field, describes 2 beneficial approaches to planning: the deliberate approach, which is grounded in pre-implementation planning, and the emergent approach that is grounded in adapting to the environment as the plan is implemented. The proposed e-health implementation model, called the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework, incorporates both approaches.
NIATx-TI was piloted in the Iowa Rural Health Information Technology Initiative (IRHIT) with 14 of Iowa's 105 SUD treatment sites and resulted in a 2-fold increase in patients receiving distance treatment. The framework's deliberate component includes using an organizational technology assessment and patient simulation. These tools identify and address assets and barriers to incorporate into the technology's implementation protocol. The framework's emergent component includes using a project team to uncover and prioritize implementation barriers as they arise, develop changes to address identified barriers, and monitor selected adoption measures, while receiving monthly coaching.
This project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI. While e-health spans many modalities and health disciplines, this project will focus on the implementing Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app developed by our Center for a disease that affects 21.5 million and kills 136,000 Americans annually: substance use disorder. A mobile app was selected, as opposed to another e-health technology, because of the near ubiquitous daily use of mobile technology and because mobile e-health adoption requires supportive participation of both health centers and patients.
In response to the COVID-19 pandemic, the study team added a study component focused on describing how patients are responding to receiving remote treatment (e.g., telehealth). The study team will also seek to understand how using A-CHESS mitigates COVID-19 associated anxiety and loneliness among those with substance use disorders.
#Intervention
- BEHAVIORAL : NIATx-TI with Product Training/On-line Support
- NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework.
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be 18+ years old
* Understand English
* Have a SUD diagnosis
* Have access to a smartphone
Exclusion Criteria:
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03954184
|
{
"brief_title": "E-health Implementation (Iowa)",
"conditions": [
"Substance Use Disorders"
],
"interventions": [
"Behavioral: NIATx-TI with Product Training/On-line Support"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03954184",
"official_title": "Testing of a Patient-centered E-health Implementation Model in Addiction Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-30",
"study_completion_date(actual)": "2023-06-30",
"study_start_date(actual)": "2019-09-03"
},
"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)": "2024-05-03",
"last_updated_that_met_qc_criteria": "2019-05-16",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-17",
"first_submitted": "2019-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Rationale:
The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps, myomas and placental tissue. It withholds some technical advantages over resectoscopy. Previous data suggest that it's a faster technique than the latter, and shows that it has a low complication rate.
Objective:
To compare the HM to bipolar resectoscopy for removal of:
1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue, in terms of efficiency and complications.
Study design: Single blind, randomized controlled multicenter trial.
Study population: Women aged over 18 years old with:
1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual placental tissue, who are planned for hysteroscopic removal.
Intervention:
Patients are randomized between removal with the HM or the bipolar resectoscope.
Main study parameters/endpoints:
Installation and operating time.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Women who are referred to our polyclinic will be seen on a first visit, and, according to the standard work-up, an ultrasound will be performed when intrauterine pathology is suspected. To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is planned, women will be asked whether they want to take part in this study. At this moment, both techniques are used in our hospitals and the choice of treatment depends on the preference of the gynaecologist. All women will be treated with operative hysteroscopy in a daycare setting according to the standard of care, only now randomized between the two techniques. A standard postoperative visit with ultrasound examination and/or ambulant diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and complaints are recorded.
It is expected that the HM beholds some advantages over the bipolar resectoscope such as shorter operating time and less complications (e.g. risk of perforation, current and fluid related complications). Previous data do not demonstrate any additional risks related to the use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine adhesion formation, as this might influence patient's fertility.
After completion of the RCT, an observational study is planned considering pregnancies subsequent to the hysteroscopic procedure.
#Intervention
- PROCEDURE : Hysteroscopic morcellator
- Morcellation will be performed with the HM (TRUCLEAR, Smith \& Nephew, Andover, USA). The rotary blade is used for polypectomy and removal of residual placental tissue; the reciprocating blade is used for myomectomy. The blade has a window-opening at the end with cutting edges through which tissue is aspirated by means of a vacuum source. The removed tissue is discharged through the device, collected in a pouch and made available for pathology analysis.
- PROCEDURE : Resectoscope
- Resectoscopy will be performed with a rigid 8.5 mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany), equipped with a 0 or 30 degree optic. Normal saline is used for distension and irrigation of the uterine cavity. Fluid balance is closely monitored using a Hystero pump (Richard Wolf GmbH, Knittlingen, Germany) or Hysteromat pump (Karl Storz GmbH, Tuttlingen, Germany).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with one or more intrauterine polyp(s) with a diameter >= 1 cm as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
* Patients with one or more intrauterine myoma(s) with a diameter <= 3 cm as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
* Patients with residual placental tissue as seen by ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion Criteria:
* Only polyps < 1cm (Note: intrauterine polyps < 1 cm are treated in an ambulatory setting).
* Myomas with a diameter > 3 cm (Note: Myomas > 3 cm are treated with resectoscopy)
* Type 2 myomas
* Visual or pathological (e.g. on biopsy) evidence of malignancy preoperatively or at the time of operation.
* Untreated cervical stenosis making safe access for operative hysteroscopy impossible as diagnosed preoperatively or at the time of operation.
* With a contra-indication for operative hysteroscopy.
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
|
NCT01537822
|
{
"brief_title": "The Hysteroscopic Morcellator (HM).",
"conditions": [
"Large Intrauterine Polyps",
"Smaller Type 0 and 1 Myomas",
"Residual Placental Tissue"
],
"interventions": [
"Procedure: Resectoscope",
"Procedure: Hysteroscopic morcellator"
],
"location_countries": [
"Belgium",
"Netherlands"
],
"nct_id": "NCT01537822",
"official_title": "The Hysteroscopic Morcellator Versus the Bipolar Resectoscope for Removal of Lager Intrauterine Polyps, Removal of Submucous Myomas and Removal of Residual Placental Tissue: a Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-01",
"study_completion_date(actual)": "2018-07-01",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-04",
"last_updated_that_met_qc_criteria": "2012-02-17",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-23",
"first_submitted": "2012-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are not known. The investigators plan to perform an observational study including survivors of gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be mailed to survivors to generate prevalence rates and risk factors for PFD in women with a history of a gynecologic cancer diagnosis.
Detailed Description
Pelvic floor disorders negatively impact the quality of life of those afflicted by pelvic organ prolapse, lower urinary tract symptoms, defecatory or sexual dysfunction, or pain. Women who present for routine gynecologic care often have undiagnosed pelvic floor disorders, and physicians may not specifically question women to elicit pelvic floor symptoms. In the United States 24% of women report at least one pelvic floor disorder, which increases with age, parity , obesity. Gynecologic cancer survivors are a unique population who undergo a variety treatment regimens including surgery, chemotherapy, and radiation. Radical hysterectomy, a common surgical treatment for gynecologic cancers, is a well-established cause for lower urinary tract dysfunction. In contrast, data are lacking regarding risk factors for pelvic organ prolapse or fecal incontinence. Survivors of gynecologic malignancies may be at increased risk for symptomatic pelvic floor disorders, but may not be diagnosed due to lack of inquiry of these symptoms by practitioners. In addition, a recent qualitative study found that survivors of gynecologic malignancies believed that pelvic floor symptoms were an inevitable, untreatable corollary to treatment for their cancer and thus did not seek treatment. Furthermore, the study participants reported that they felt healthy despite these symptoms because of their oncologists assessment of their remission status. The lack of diagnosis and treatment of pelvic floor disorders has clinical and quality of life implications for the growing numbers of gynecologic malignancy survivors. The objective of this study is to identify the prevalence of an risk factors for pelvic floor disorders in women after treatment for gynecologic cancer. Our rationale for this project is that the investigators believe that pelvic floor disorders affect the quality of life of gynecologic cancer survivors and should be quantified. Successful completion of this study will provide evidence for practitioners to screen and treat pelvic floor disorders in gynecologic malignancy survivors.
#Intervention
- OTHER : Survey
|
#Eligibility Criteria:
Inclusion Criteria:
* Women with documented surgery for gynecologic malignancies at any of the three UPHS associated hospitals in center city Philadelphia (e.g., HUP, Pennsylvania hospital) and an accessible electronic medical record from the time of cancer diagnosis and beyond.
* Gynecologic cancer survivors at least 20 years diagnosed and treated for uterine, ovarian, peritoneal, fallopian tube, cervical, or vulvar tumors between 2008 to July 2010 will be included
Exclusion Criteria:
* Women who are pregnant, with benign tumors, those lost to follow-up, or deceased will be excluded from this study.
* Patients unable to complete a written survey due to physical or mental disabilities will also be excluded.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01370122
|
{
"brief_title": "Pelvic Floor Disorders in Survivors of Gynecologic Malignancies",
"conditions": [
"Uterine Cancer",
"Ovarian Cancer",
"Fallopian Tube Cancer",
"Peritoneal Cancer",
"Cervical Cancer",
"Vulvar Cancer"
],
"interventions": [
"Other: Survey"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01370122",
"official_title": "The Prevalence and Predictive Factors of Pelvic Floor Disorders in Gynecologic Malignancy Survivors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2011-05"
},
"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)": "2020-04-29",
"last_updated_that_met_qc_criteria": "2011-06-08",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-09",
"first_submitted": "2011-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: 'Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck' . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles
Detailed Description
Neck pain can over time negatively affect the central processing of any afferent input received because it can create a disturbance in the proprioceptive input to the Central Nervous System. Vuillerme stated that cervical muscle proprioceptors are stimulated by painful electrical stimuli. Therefore, joint proprioception can be affected in patients with mechanical neck pain .
The conservative management of mechanical neck pain includes many treatment options like electrotherapy which includes moist heat, Transcutaneous Electrical Nerve Stimulation therapy and different manual therapy options like cervical and thoracic mobilization and manipulation, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, Cyriax technique, manual pressure release, ischemic compression and proprioceptive neuromuscular facilitation. Postural reeducation and strength training of weak muscle group has beneficial effects. Joint mobilization and manipulation are widely used as a treatment for mechanical neck pain, as cervical mobilizations which are low velocity passive oscillatory movements are used by 90% of physiotherapist and chiropractors to treat people with neck pain.
#Intervention
- OTHER : cervical manipulation
- provide a high velocity, low-amplitude manipulation to each subject's cervical spine.
- OTHER : conventional therapy
- 15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with non-radiating neck pain of moderate intensity scoring 4 <= age <= 8 on the numeric pain rating scale (NPRS)
* Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
* Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees
Exclusion Criteria:
* Patients with a positive history of trauma, fracture or surgery of the cervical spine .
* anatomical cervical spine abnormality
* presented with any neurological signs
* history of benign paroxysmal positional vertigo
* Neck pain with radiation to the arm and upper extremity .
* Diagnosed cases of torticollis, and scoliosis
* History of osteoporosis, Any cardiac disorder
* had participated in a neck exercise program in the past 6 months .
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05649397
|
{
"brief_title": "Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain",
"conditions": [
"Neck Pain"
],
"interventions": [
"Other: conventional therapy",
"Other: cervical manipulation"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05649397",
"official_title": "Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-10",
"study_completion_date(actual)": "2023-07-10",
"study_start_date(actual)": "2022-12-01"
},
"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)": "2023-07-27",
"last_updated_that_met_qc_criteria": "2022-12-06",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-14",
"first_submitted": "2022-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
CYP2D6 metabolizes \~25% of all marketed drugs. There is an important variability in the activity of this enzyme among individuals. The cause of this variability might be environmental, genetic, ethnical or even related to a disease. The administration of a CYP2D6 probe drug (e.g. dextromethorphan) is a good way to characterize CYP2D6 phenotype. Nonetheless, it is relatively invasive and the vulnerable population (e.g. pregnant women) cannot be phenotyped in this manner. Therefore, finding an endogenous substance which is metabolized by CYP2D6 could replace usual phenotyping procedure using a probe drug. This study evaluates the impact of a CYP2D6 inhibitor and of genetic polymorphism on the metabolome of healthy volunteers in order to identify new CYP2D6 biomarkers. To this end, untargeted metabolomics analysis using LC-HRMS will be performed on plasma and urine samples This single-centre open-label clinical trial will include 40 healthy subjects (men and women) between 18 and 65 years. Eligible participants will be assigned to a study group according to their CYP2D6 genotypes: poor metabolizers (PMs) and extensive/ultrarapid metabolizers (EMs-UMs). Two sessions will take place for each subjects.
Session 1: CYP2D6 phenotyping (dextromethorphan 5 mg, single dose) Session 2: idem session 1 with prior uptake of a CYP2D6 inhibitor (paroxetine 10 or 20 mg, one dose a day for 7 days).
In both sessions, urine will be collected up to 24 hours and capillary/venous blood will be sampled before phenotyping for metabolomics analyses. Urine will also be collected for 4 hours after dextromethorphan intake in order to phenotype the CYP2D6 enzyme.
#Intervention
- DRUG : Dextromethorphan 5 MG
- dextromethorphan 5 mg po
- DRUG : Paroxetine 10Mg Tablet
- Paroxetine 10 mg po
- DRUG : Paroxetine 20Mg Tablet
- Paroxetine 20 mg po
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women
* Age 18 <= age <= 65 years
* Body Mass Index (BMI) 18 <= age <= 27
* Understanding of French language and able to give a written inform consent
* CYP2D6 genotype : activity score = 0 (PMs) or activity score >= 1 (EMs-UMs)
* Reliable contraception during the whole study, including a barrier method
Exclusion Criteria:
* Participation in any other interventional clinical study within 3 months prior to inclusion
* Pregnant or breastfeeding woman
* Any pathologies, use of drugs or food that may affect CYP activity (based on the 'drug interactions and cytochromes P450' table published by the Service of Clinical Pharmacology and Toxicology, HUG54 and on the investigator's knowledge)
* Regular smokers of >= 10 cigarettes/day
* Alcohol intake 2 days prior to session 1 and during paroxetine intake
* Medical history of chronic alcoholism or abuse of psychoactive drugs
* Regular use of psychotropic substances
* Sensitivity to any of the drugs used
* Alteration of hepatic tests (ASAT, ALAT, BILI, GGT) more than 3x normal
* Psychiatric disorders
* Beck Score >=10 (question related to suicide >0)
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
|
NCT04188028
|
{
"brief_title": "Endobiotics for Phenotyping of Human Cytochrome P450 Enzymes",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Paroxetine 20Mg Tablet",
"Drug: Dextromethorphan 5 MG",
"Drug: Paroxetine 10Mg Tablet"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04188028",
"official_title": "Endobiotics for Phenotyping of Human Cytochrome P450 Enzymes: Use of Metabolomics for the Identification of New CYP2D6 Endogenous Biomarkers in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-31",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2019-01-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-04",
"last_updated_that_met_qc_criteria": "2019-12-04",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-05",
"first_submitted": "2019-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2 inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic medications including DPP4 inhibitors.
Detailed Description
This study is a phase 3, randomized, double-blind, active-competitor, parallel-group study that is anticipated to enroll 120 patients. Patients taking metformin and/or DPP4 inhibitors as per local label for ≥12 weeks without a dose adjustment before enrollment will be eligible for screening. All patients will have a screening period comprised of an up to 2-week screening phase prior to randomization. In order to qualify for randomization, patients must demonstrate compliance based upon pill count (80%) and discretion of the investigators during the Run-in phase.
Glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) will be masked to patients after randomization. To prevent partial unblinding, urinary glucose excretion (UGE) results will be masked to patients. Urine glucose, albumin, calcium, and creatinine will be measured separately on-site visits.
#Intervention
- DRUG : Ertugliflozin
- Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
- Other Names :
- Steglatro
- DRUG : Placebo
- Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with T2D taking oral antidiabetic medications (metformin and/or DPP4 inhibitors) except SGLT2 inhibitors for at least 12 weeks without a dose adjustment before enrollment.
* eGFR >= 45 mL/min/1.73 m2.
* Stage B HF identified on the basis of either structural or functional markers.
Exclusion Criteria:
* Type 1 diabetes mellitus
* At the time of screening age <20 years
* HbA1c <7% or HbA1c >9.5% at Screening
* FPG >15 mmol/L (270 mg/dL) measured by the laboratory at Screening (Visit 1), and confirmed (>15 mmol/L [>270 mg/dL]) by a repeat test before randomization
* Treated with insulin and/or GLP-1R agonist within 12 weeks preceding the Screening Visit.
* Women of childbearing potential with no effective contraceptive method
* History of gastric surgery including history of gastric banding within 3 years before the Screening Visit
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma prior to the Screening Visit
* Mean blood pressure after 3 separate measurements >180 mmHg in systolic blood pressure (SBP) or >95 mmHg in diastolic blood pressure (DBP)
* Patients with current or prior symptoms of HF.
* Patients with severe anemia, severe respiratory, hepatic, neurological, psychiatric disorders or active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult
* Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN)
* Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome)
* Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
* Patient who has taken other investigational drugs or prohibited therapy for this study within 3 months
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03717194
|
{
"brief_title": "Effect of Ertugliflozin on Cardiac Function in Diabetes",
"conditions": [
"Type2 Diabetes",
"Heart Failure"
],
"interventions": [
"Drug: Placebo",
"Drug: Ertugliflozin"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03717194",
"official_title": "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, to Evaluate the Effect of Ertugliflozin on Cardiac Function in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control and Stage B Heart Failure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-04-30",
"study_start_date(actual)": "2019-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-20",
"last_updated_that_met_qc_criteria": "2018-10-23",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-24",
"first_submitted": "2018-10-22",
"first_submitted_that_met_qc_criteria": "2024-10-30"
}
}
}
|
#Study Description
Brief Summary
This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.
Detailed Description
The prevalence of chronic HBV infection in Senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors).
The prevalence of HBV chronic infection remains undocumented in the general population of Senegal, and its health-related and socio-economic consequences need to be estimated.
This research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of Niakhar (located at 135 kms at the East of Dakar).
The research includes three phases as follows:
(i) Preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey
(ii) Collection of data in the general population
(iii) Communication of results on HBV status to participants and collection of additional data among HBV chronic individuals
#Intervention
- DIAGNOSTIC_TEST : HBV testing with dried blood spots (DBS) technique
- Survey participants will be tested at home for chronic HBV infection using the DBS technique (collection of drops of whole blood dried onto filter paper).
|
#Eligibility Criteria:
Inclusion Criteria:
(i) Living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the Niakhar zone)
(ii) Being aged of at least 6 months
(iii) Giving informed consent to participate in the research
Exclusion Criteria:
(i) Being an adult unable to sign informed consent
(ii) Being a child whose parents or legal guardian is not present in the household at the time of the survey
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03215732
|
{
"brief_title": "Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal",
"conditions": [
"Chronic Hepatitis b"
],
"interventions": null,
"location_countries": [
"Senegal"
],
"nct_id": "NCT03215732",
"official_title": "Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-31",
"study_completion_date(actual)": "2019-07-31",
"study_start_date(actual)": "2017-10-19"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-09",
"last_updated_that_met_qc_criteria": "2017-07-11",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-12",
"first_submitted": "2017-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.
Detailed Description
Cardiovascular disease continues to be the major cause of morbidity and mortality in subjects with renal (kidney) disease. Left ventricular hypertrophy (LVH) has been correlated with a high risk of cardiac and all cause mortality. In the renal population , many factors have been shown to be important in the development of LVH, including anemia. This is a multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progress of left ventricular mass growth. Additionally, this study will evaluated the safety of maintaining hemoglobin within the normal range in pre-dialysis subjects. The trial duration is 24 months. Subjects randomized to the treatment arm will receive Eprex therapy to maintain hemoglobin between 120-140 g/L. Subjects randomized to the control arm will not receive any treatment unless their hemoglobin falls to less than or equal to 90 g/L. Those subjects will then be treated to maintain their hemoglobin between 90-105 g/L. The subjects were to receive injections of Eprex once weekly to maintain hemoglobin levels within the target range for the arm to which they were randomized. The subjects were to receive treatment for up to 24 months.
#Intervention
- DRUG : epoetin alfa
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients have had a decrease in hemoglobin >= 10 g/L within the past 12 months and a current hemoglobin level between 110 <= age <= 135 g/L (men) and 100 <= age <= 135 g/L (women) OR a hemoglobin level between 115 <= age <= 125 g/L (men) and 110 <= age <= 120 g/L (women)
* Have a calculated creatinine clearance <80 mL/min and >15 mL/min
Exclusion Criteria:
* No uncontrolled hypertension (diastolic blood pressure>= 105 mm Hg on average for the previous month)
No unstable angina or cardiac procedure within the past 12 months or a planned procedure
* No myocardial infarction with the past 12 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00364260
|
{
"brief_title": "A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.",
"conditions": [
"Anemia",
"Kidney Failure",
"Left Ventricular Hypertrophy"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00364260",
"official_title": "A Study to Determine the Impact of Hemoglobin Maintenance and Other Interventional Strategies to Prevent or Delay the Progression of Left Ventricular Mass Growth in Subjects With Early Renal Insufficiency.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2003-08",
"study_start_date(actual)": "1997-12"
},
"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)": "2011-02-01",
"last_updated_that_met_qc_criteria": "2006-08-14",
"last_verified": "2011-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-15",
"first_submitted": "2006-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.
Detailed Description
All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.
#Intervention
- DEVICE : LG1
- Application of LASER AsGa 904nm 10 J/cm².
- DEVICE : LG2
- Application of LASER AsGa 904nm 8 J/cm².
- DEVICE : LG3
- Application of LASER AsGa 904nm 4 J/cm².
- DEVICE : CC
- Application of placebo LASER.
- PROCEDURE : Dressing
- Application of Helianthus annuus oil dressing.
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus patients with diabetic foot ulcers;
* Patients aged 18 and over.
Exclusion Criteria:
* Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
* Patients with infected diabetic foot ulcers.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04246814
|
{
"brief_title": "Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers",
"conditions": [
"Diabetic Foot Ulcer",
"Diabetic Foot"
],
"interventions": [
"Device: CC",
"Procedure: Dressing",
"Device: LG1",
"Device: LG2",
"Device: LG3"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT04246814",
"official_title": "Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-18",
"study_completion_date(actual)": "2023-08-18",
"study_start_date(actual)": "2019-08-27"
},
"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)": "2024-02-22",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. It will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.
#Intervention
- OTHER : Pain neuroscience education and exercise
- PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will included genera exercise delivered at moderate intensity.
- OTHER : Usual Care
- Usual care delivered at primary care for older adults with pain.
|
#Eligibility Criteria:
Inclusion Criteria:
* be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body.
Exclusion Criteria:
* presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04528160
|
{
"brief_title": "Pain Neuroscience Education for Older Adults",
"conditions": [
"Chronic Pain"
],
"interventions": [
"Other: Pain neuroscience education and exercise",
"Other: Usual Care"
],
"location_countries": [
"Portugal"
],
"nct_id": "NCT04528160",
"official_title": "Pain Neuroscience Education for Older Adults With Pain From Primary Care: a Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-01",
"study_completion_date(actual)": "2020-10-01",
"study_start_date(actual)": "2018-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-18",
"last_updated_that_met_qc_criteria": "2020-08-24",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-27",
"first_submitted": "2020-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
#Intervention
- DRUG : MT-8554 low dose
- Capsule
- DRUG : MT-8554 middle dose
- Capsule
- DRUG : MT-8554 high dose
- Capsule
- DRUG : Placebo
- Capsule
|
#Eligibility Criteria:
Inclusion Criteria:
* Male subjects and female subjects aged >=18 years
* Subjects who have a history of pain at least 6 months and <=7 years attributed to diabetic peripheral neuropathy
* A body mass index ranging from 18 to 45 kg/m2
Exclusion Criteria:
* Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
* Unstable or uncontrolled diabetes
* Clinically significant 12-lead ECG abnormalities
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
|
NCT03172598
|
{
"brief_title": "Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy",
"conditions": [
"Painful Diabetic Peripheral Neuropathy"
],
"interventions": [
"Drug: MT-8554 middle dose",
"Drug: Placebo",
"Drug: MT-8554 low dose",
"Drug: MT-8554 high dose"
],
"location_countries": [
"Germany",
"Hungary",
"Poland"
],
"nct_id": "NCT03172598",
"official_title": "A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-08",
"study_completion_date(actual)": "2018-08-08",
"study_start_date(actual)": "2017-07-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-27",
"last_updated_that_met_qc_criteria": "2017-05-31",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-01",
"first_submitted": "2017-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.
Detailed Description
Arthroscopic rotator cuff repair (ARCR) provides excellent clinical outcomes but is often associated with significant postoperative pain. As rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. The purpose of this study was to determine whether using a field block of liposomal bupivacaine (LB) in addition to an interscalene block (ISB) would provide greater pain relief and reduction in opiate consumption when compared to ISB alone.
The study enrolled 50 patients undergoing primary ARCR surgery. Patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative 'Pain Journals' to document their daily pain on a visual analog scale (VAS) and to track their daily opioid consumption during the first five post-operative days.
#Intervention
- DRUG : Liposomal bupivacaine (LB)
- Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure
- Other Names :
- EXPAREL
|
#Eligibility Criteria:
Inclusion Criteria:
* at least 18 years
* undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear
* willing to fill out the 'Pain Journal'; able to understand the informed consent process
* willing to document informed consent prior to completion of any study-related procedure
* able to read, comprehend, and complete subject-reported outcome measures in English
Exclusion Criteria:
* pregnant
* documented history of drug or alcohol abuse
* use of narcotic painkillers greater than 3 months prior to surgery
* neurologic deficit or disability involving the surgical extremity
* known allergy or intolerance to hydrocodone or oxycodone
* known allergy to amide anesthetics
* currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
* history of cognitive or mental health status that interferes with study participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03692546
|
{
"brief_title": "Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair",
"conditions": [
"Rotator Cuff Tear",
"Postoperative Pain"
],
"interventions": [
"Drug: Liposomal bupivacaine (LB)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03692546",
"official_title": "Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-01",
"study_completion_date(actual)": "2018-09-01",
"study_start_date(actual)": "2017-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-02",
"last_updated_that_met_qc_criteria": "2018-09-30",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-02",
"first_submitted": "2018-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.
#Intervention
- DIAGNOSTIC_TEST : Chest Xray
- Daily chest xray
- DIAGNOSTIC_TEST : No daily chest xray
- Chest xray will be done post chest tube removal only
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
* Willingness to adhere to randomized treatment.
* Ability to answer self- and interviewer- administered questions in English
* Understand and sign a written informed consent form in English
Exclusion Criteria:
* Previous thoracic surgery history in the same side.
* Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03704870
|
{
"brief_title": "Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection",
"conditions": [
"Lung Cancer",
"Lung Diseases",
"Lung Cancer, Nonsmall Cell",
"Surgery",
"Lung Adenocarcinoma"
],
"interventions": [
"Diagnostic Test: No daily chest xray",
"Diagnostic Test: Chest Xray"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03704870",
"official_title": "A Randomized Controlled Feasibility Study Looking at Differences in Hospital Stay Variables Following Omission of Daily Routine Chest Radiographs After Pulmonary Resection.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-03-31",
"study_start_date(actual)": "2018-01-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-01",
"last_updated_that_met_qc_criteria": "2018-10-11",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-15",
"first_submitted": "2018-02-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC.
Detailed Description
Adenoid cystic carcinoma (ACC) is an uncommon malignancy that arises in secretory glands. The most common sites for the disease are the major and minor salivary glands but these tumors may also arise in the nasal cavity, lacrimal gland, tracheobronchial tree, breast or vulva. The mainstay of treatment for localized ACC is surgical resection often followed by post-operative radiotherapy. Although this leads to an initially high rate of local control, the 5-year disease-free survival rate is 50-75%. In addition, a significant proportion of the patients develop distant metastases, most frequently in the lung. Compared to other malignancies, ACC tends to grow more slowly. Thus, patients often do well in the short-term but long-term prognosis remains guarded and most succumb to the disease within 10-15 years. To date, systemic therapies have proven to be largely ineffective against recurrent and metastatic ACC. Dovitinib is a broad-targeted-profiled RTK inhibitor active against these three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. Based on its potency as an inhibitor of these RTKs both in vitro and in vivo, and the compound's oral availability, several clinical trials of dovitinib are underway. This phase II trial will test the hypothesis that dovitinib will be active against this disease. The rationale is based on pre-clinical studies that suggest that dovitinib suppresses tumor growth by blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1) and animal studies in which the drug proved to be active against primary ACC xenografts.
#Intervention
- DRUG : Dovitinib (TKI258)
- 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
* Patients must have histology or cytology studies that confirm the diagnosis of adenoid cystic carcinoma. (Note: Subsequent central review of the pathology slides will be provided by Drs. Christopher Moskaluk or Henry Frierson, Department of Pathology at the University of Virginia Health Sciences Center).
* Patients must have recurrent and/or metastatic disease that is not amenable to potentially curative surgical resection or radiotherapy.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral CT scan (or >20 mm with conventional techniques). Pathologic lymph nodes are measured by shortest diameter as per RECIST.
* Patients must have serial imaging that allows measurement of tumor growth rates by change point analysis:
* The remote baseline study scan must be within six calendar months of the immediate pre-study scan.
* The remote baseline scan must have measurable disease >= 10 mm for non-pulmonary lesions or >= 4 mm for pulmonary metastases that show subsequent progression.
* Comparison of the remote baseline and subsequent studies must show progressive disease in 1 <= age <= 5 selected target lesions based on the following:
* Modified RECIST criteria (i.e. proportional increase of 1.2 or the appearance of new lesions) AND/OR
* Progression by change point analysis with an increase in the slope of the average tumor measurements of at least 0.22 b
a = 'remote baseline scan' refers to scan done prior to pre-study scan which is used to determine pre-treatment tumor growth rate.
b = the estimated mean minus one standard deviation based on analysis of progressive tumors from untreated patients with ACC.
* Life expectancy > 16 weeks.
* ECOG (WHO) performance status 0 <= age <= 2
* Age >= 18 years
* Patients must have the following laboratory values:
* Absolute neutrophil count (ANC) >= 1.5 x 109/L
* Platelets >= 100 x 109/L
* Hemoglobin (Hgb) > 9 g/dL
* Serum total bilirubin: <= 1.5 x ULN
* ALT and AST <= 3.0 x ULN
* Serum creatinine <= 1.5 x ULN or serum creatinine >1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is >= 30 mL/min using the Cockroft-Gault equation, see formula below:
CrCl = [140-age (years)] x weight (kg) / [72 x serum Cr (mg/dL)] (if patient is female multiply the above by 0.85)
* Patients who give a written informed consent obtained according to local guidelines
Exclusion Criteria:
Patients are ineligible for this study if he or she has any of the following:
* Patients with brain metastases
* Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
* Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) <= 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
* Patients who have received the last administration of nitrosurea or mitomycin-C <= 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
* Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) <= 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
* Patients who have had radiotherapy <= 4 weeks prior to starting study drug or <= 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), if the measurable lesions are outside the radiation field. Also excluded would be those who have not recovered from toxicity radiotherapy.
* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury <= 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device <= 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
* Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of serious uncontrolled ventricular arrhythmias
* Clinically significant resting bradycardia
* LVEF assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) < 45%
* Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
* Uncontrolled hypertension defined by a SBP >= 160 mm Hg and/or DBP >= 100 mm Hg, with or without anti-hypertensive medication(s)
1. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
2. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
3. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
4. Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
5. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
* Pregnant or breast-feeding women
* Women of child-bearing potential not employing an effective method of birth control. Two birth control methods must be used throughout the trial and one month after the last dose of study drug (e.g. condom with spermicidal jelly, foam suppository or film; diaphragm with spermicide; male condom and diaphragm with spermicide). Contraceptives that are affected by cytochrome P450 interactions (e.g. oral, implantable, injectable, or intrauterine hormonal contraceptives) are not considered effective for this study. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test <= 7 days prior to starting study drug.
* Fertile males not willing to use contraception, as stated above
* Patients unwilling or unable to comply with the 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
|
NCT01524692
|
{
"brief_title": "Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma",
"conditions": [
"Adenoid Cystic Carcinoma"
],
"interventions": [
"Drug: Dovitinib (TKI258)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01524692",
"official_title": "A Phase II Pilot Study of Dovitinib (TKI258) in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2012-03"
},
"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)": "2018-11-09",
"last_updated_that_met_qc_criteria": "2012-01-30",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-02",
"first_submitted": "2012-01-17",
"first_submitted_that_met_qc_criteria": "2018-04-04"
}
}
}
|
#Study Description
Brief Summary
Inflammatory bowel diseases (IBD) is a chronic inflammatory condition of the gastrointestinal tract that significantly affects quality of life of patients.
Several studies have reported that the loss of work productivity is significantly higher than that of the general population due to disease-related symptoms and various factors in patients with inflammatory bowel disease in Western countries, but there is few data in Korea.
Therefore, this study is to assess the effect of disease on sick leave, work disability and health related quality of life in Korean patients with inflammatory bowel disease by using validated questionnaires.
Detailed Description
First, the investigators will estimate the prevalence of work disability in patients with inflammatory bowel disease using the Work Productivity and Activity Index (WPAI), that have been validated in patients with inflammatory bowel disease.
Secondary, the predictor of work productivity impairment in patients with inflammatory bowel disease and distribution of type and severity of work disability will be identified.
Third, the investigators will explore the correlation between the quality of life and psychosocial aspects (anxiety disorder, depression) of patients with inflammatory bowel disease.
One year later, the same questionnaire will be surveyed repeatedly in the same participants under usual care to investigate the changes in patient-reported outcome measures.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed with inflammatory bowel disease (Crohn's disease and ulcerative colitis) at Kyung Hee University Hospital
Exclusion Criteria:
* Patients who do not agree to fill out the questionnaire.
* Patients who can not fill out the questionnaire themselves.
* Patients who can not understand the questionnaire.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03565432
|
{
"brief_title": "Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases",
"conditions": [
"Inflammatory Bowel Diseases",
"Crohn Disease",
"Ulcerative Colitis"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03565432",
"official_title": "Sick Leave, Work Disability and Quality of Life in Korean Patients With Inflammatory Bowel Diseases : A Prospective Survey Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-30",
"study_completion_date(actual)": "2020-02-19",
"study_start_date(actual)": "2018-03-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-02",
"last_updated_that_met_qc_criteria": "2018-06-11",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-21",
"first_submitted": "2018-04-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to evaluate both bioavailability and its bioactivity in cheek cells.
Detailed Description
Avmacol is an over-the counter dietary supplement containing broccoli seed and sprout extracts in tablet form. Natural plant substances within Avmacol, called phytochemicals, are hypothesized to stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke. The purpose of this study is twofold: 1) to assess the protective effects of Avmacol on the mucosa (cheek cells) of healthy volunteers, and 2) to assess the collection of cheek cells by scraping, as a less invasive method of studying drug effects in the body compared to drawing blood or a tissue biopsy. Ultimately, these results will be used to design a larger study of Avmacol in patients with tobacco-related head and neck cancer. Avmacol will be studied as a way to possibly prevent a second cancer from developing in these patients.
#Intervention
- DIETARY_SUPPLEMENT : Avmacol
- Avmacol is an over-the-counter mixture of broccoli seed and sprout extracts in tablet form to promote detoxification. These tablets contain natural substances that stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke.
- Other Names :
- Sulforaphane Production System, broccoli seed and sprout extract
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years.
* Members of all racial and ethnic groups are eligible.
* Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration.
* No chronic use of steroids
* Karnofsky Performance Scale >=90%
* Able to provide written, informed consent
* For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
* Willing to avoid cruciferous vegetables during the study interventions
* Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
* Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
* Willing and able to perform self-collection of buccal cells as stated in the instruction manual
Exclusion Criteria:
* No current or former diagnosis of cancer, with the exception of: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1 <= age <= 2, N0, M0 differentiated thyroid carcinoma; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection
* No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
* Chronic use anticoagulation
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
|
NCT02800265
|
{
"brief_title": "Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Avmacol"
],
"location_countries": null,
"nct_id": "NCT02800265",
"official_title": "A Pilot Study Evaluating the Bioavailability and Mucosal Bioactivity of the Dietary Supplement, Avmacol®, in Healthy Volunteers With Optimization of Buccal Cell Biomarkers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-20",
"study_completion_date(actual)": "2016-06-20",
"study_start_date(actual)": "2016-06-16"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-13",
"last_updated_that_met_qc_criteria": "2016-06-09",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-15",
"first_submitted": "2016-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.
Detailed Description
The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.
The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.
#Intervention
- PROCEDURE : Endoscopic endonasal pituitary surgery
- Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter
|
#Eligibility Criteria:
Inclusion Criteria:
* age older than 45 years
* diagnosis of pituitary adenoma
* treatment-naive with endoscopic endonasal pituitary surgery
* absence of other neurological disease
* absence of vitreoretinal and vascular retinal diseases
Exclusion Criteria:
* age younger than 45 years
* No diagnosis of pituitary adenoma
* previous treatment with endoscopic endonasal pituitary surgery
* presence of neurological disease
* presence of vitreretinal and vascular retinal diseases
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04546386
|
{
"brief_title": "Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.",
"conditions": [
"Pituitary Adenoma"
],
"interventions": null,
"location_countries": [
"Italy"
],
"nct_id": "NCT04546386",
"official_title": "Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-10",
"study_completion_date(actual)": "2020-03-25",
"study_start_date(actual)": "2019-01-10"
},
"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)": "2021-02-03",
"last_updated_that_met_qc_criteria": "2020-09-08",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-14",
"first_submitted": "2020-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to assess the effect of co-ingestion of microbial proteases and whey protein concentrate (WPC) on postprandial plasma amino acid concentrations in healthy adult participants compared to WPC with placebo. The secondary purpose is to assess the effect of co-ingestion of microbial proteases and WPC on postprandial glycemic response, subjective appetite sensations, gut-derived appetite regulating hormones, ad libitum meal intake, and gastrointestinal tolerability in healthy adult participants compared to WPC with placebo.
Detailed Description
A within-subject crossover design will be used for this randomized, double-blind, placebo-controlled study in health adults to assess the efficacy of a microbial protease mixture (from Aspergillus species) on enhancing postprandial aminoacidemia after consumption of a whey protein shake. There are two treatment groups in this crossover trial, including one microbial protease group and one placebo group. A total of 24 participants will be enrolled and undergo both treatment phases with a minimum 7-day washout.
The study will last no less than 8 days and up to 72 days for each participant, including screening, washout, and end of study (EOS) visit. The study will include a screening visit (Visit 1) followed by a screening period lasting up to 30 days, the phase 1 aminoacidemia trial on Day 1 (Visit 2), minimum 7-day washout with a window of +35 days, followed by the phase 2 aminoacidemia trial (EOS Visit 3, Day 8 +35 days).
During the aminoacidemia trials, participants will arrive to the clinic in a fasted state, and 31.9 grams whey protein concentrate (WPC) in 300 mL water with microbial proteases or placebo will be administered. Blood will be collected at baseline and 11 postprandial timepoints across 4 hours for plasma amino acid, glucose, and insulin quantitation. Blood will also be utilized for quantitation of the anorexigenic, satiety-related peptide hormones glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), and the orexigenic peptide hormone ghrelin.
Additionally, changes in appetite sensations will be assessed by visual analog score (VAS) responses to 5 questions at baseline, directly after consumption of study products, and postprandially every half hour. Palatability of the study products will be assessed by 5-item Palatability Questionnaire. Gastrointestinal tolerability will be assessed by 8-item modified Gastrointestinal Tolerance Questionnaire (mGITQ) at the end of the 4-hour aminoacidemia trial.
To further investigate appetite and satiety, an test meal will be provided at 4 hours for the determination of energy intake, followed by a final appetite VAS questionnaire immediately after the test meal. The maximum time to finish the test meal is 30 minutes.
To account for the potential influence of menstrual cycle timing on the outcomes of interest, female subjects will be instructed to contact the clinic on day 1 of their menses so that Visit 2 (Day 1) can be scheduled at the end of menses, but still during the follicular phase of their menstrual cycle. The follicular phase is defined as days 1-14, where day 1 is the first day of menses. Therefore, Visit 2 (Day 1) and Visit 3 for female participants will occur approximately 3-5 days after start of menses, but on or before day 14 of the follicular phase (+4 day window), unless Visit 3 can be scheduled within the same follicular phase as Visit 2, with an at least 7-day washout.
The study will include a total of three in-person visit days: screening (Visit 1), phase 1 (Visit 2), and phase 2/EOS (Visit 3). Study endpoints include postprandial plasma amino acid concentrations, postprandial plasma glucose and insulin concentrations, and postprandial plasma GLP-1, PYY, and ghrelin concentrations. Endpoints also include appetite VAS scores, ad libitum meal consumption, mGITQ scores, vital signs, anthropometric measures, and reports of adverse events, which will be assessed at all clinic visits.
#Intervention
- DIETARY_SUPPLEMENT : OPTIZIOME® P³ HYDROLYZER® - WHEY
- One dose of P3 - WHEY will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.
- Other Names :
- P3 - WHEY, P3 HYDROLYZER® - WHEY
- OTHER : Placebo
- One dose of placebo maltodextrain will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult female or male participants who are 20 <= age <= 40 of age at screening (inclusive)
* Has a BMI between 18.5 to 29.9 kg·m^(-2) (inclusive) at Visit 1
* In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and able to consume the study product
* Individuals with childbearing potential must agree to practice an acceptable form of birth control (i.e., use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), or hormone implant (e.g., Norplant System); or condoms)
* Has maintained stable use of medication and supplements defined in the study protocol (Section 7.6), stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study
* Agree to avoid strenuous exercise 48 hours prior to each visit
* Willing to limit daily alcohol consumption to no more than 3 standard drinks per day throughout the study, and agree to entirely avoid alcohol consumption 48 hours prior to each visit (a standard serving is defined here as 4 oz wine, 12 oz beer, 1 oz spirits)
* Willing to maintain current use of cannabinoids (if applicable) throughout the study
* Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Exclusion Criteria:
* Individuals who are lactating, pregnant or planning to become pregnant during the study
* Individual with irregular menstrual cycles (defined as outside 24 <= age <= 38 days cycle range, based on self-reports)
* Individuals who adhere to a diet (e.g., vegan diet) that restricts consumption of dairy products
* Has a known sensitivity, intolerability, or allergy to any of the study products or their excipients
* Weight loss or gain > 3 kg in the 3 months prior to Visit 2 (Day 1)
* Currently or planning to be on a weight loss regimen during the study
* Received a vaccine for COVID-19 in the two weeks prior to screening or plans to receive a vaccine for COVID-19 during the study period, currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit, or currently has any post COVID-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis)
* Recent [within 2 weeks of Visit 2 (Day 1)] history of an episode of acute GI illness such as nausea/vomiting or diarrhea
* Have a history of irritable bowel disease (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery
* Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and/or digestion (e.g., history of bowel obstruction)
* Participated in upper gastrointestinal endoscopy and/or colonoscopy or preparation within 3 months prior to Visit 2 (Day 1)
* Diagnosed with hypercholesterolemia or hypertriglyceridemia (i.e., elevated fasting low-density lipoprotein (LDL) (>= 135 mg/dL; >= 3.5 mmol/L) or elevated triglycerides (>= 150 mg/dL; >=1.7 mmol/L)
* Has a history of heart disease/cardiovascular disease, uncontrolled hypertension (>= 140 systolic or >= 90 diastolic mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease
* Is Type I or Type II diabetic or pre-diabetic [i.e., elevated fasting blood glucose levels (>= 100 mg/dL; >= 5.6 mmol/L) and/or elevated hemoglobin A1c (>= 6.0%)]
* Has a history of liver or gallbladder disease or stomach ulcers
* Has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorders and/or immunocompromised (e.g., HIV/AIDS)
* Diagnosed with cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study
* Major surgery in 3 months prior to screening or planned major surgery during the study
* History of alcohol or substance abuse (including cannabinoids) in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program)
* Use of any treatment listed in the study protocol (Section 7.6) outside of the permitted timeframes and/or conditions.
* Receipt or use of test products in another research study within 30 days prior to Visit 2 or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study
* Current or previous tobacco use within the last 6 months
* Self-report of blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to screening or a blood donation of more than 450 mL within 56 days prior to baseline
* Self-report of donating plasma (e.g., plasmapheresis) within 14 days prior to screening.
* Any other active or unstable medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05957185
|
{
"brief_title": "Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite",
"conditions": [
"Digestive Health",
"Gastrointestinal Health",
"Appetitive Behavior"
],
"interventions": [
"Other: Placebo",
"Dietary Supplement: OPTIZIOME® P³ HYDROLYZER® - WHEY"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05957185",
"official_title": "Effects of Oral Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-18",
"study_completion_date(actual)": "2024-01-18",
"study_start_date(actual)": "2023-08-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-19",
"last_updated_that_met_qc_criteria": "2023-07-14",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-24",
"first_submitted": "2023-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared to multicomponent exercise training.
This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm, parallel group, randomized controlled trial in which 140 community-dwelling older adults at high risk of falls are randomly assigned to receive either a music-based multitask training intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed at three time points: baseline (before intervention initiation), 6-month (intervention mid-point), and 12-month (intervention termination). Outcomes of interest include physical and cognitive performances, and falls. In addition, the investigators specifically address brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.
#Intervention
- BEHAVIORAL : Jaques-Dalcroze eurhythmics training
- 12 months of weekly, supervised, structured, progressive, 60-min music-based multitask exercise classes (i.e., Jaques-Dalcroze eurhythmics). The music-based multitask program includes all exercises used in a previous work.
- BEHAVIORAL : Multicomponent exercise training
- 12 months of weekly, i) supervised, structured, progressive, 60-min multicomponent exercise classes, supplemented by ii) 30-min home-based exercise sessions. Briefly, the multimodal exercise program is based on core components for successful fall prevention in older adults. It contains balance, gait, coordination and strength training, with balance as a core component.
|
#Eligibility Criteria:
Inclusion Criteria:
* aged >= 65 years (no upper age limit)
* living in the community, even in protected housing
* identified as being at high risk of falls (i.e., one or more self-reported falls after the age of 65 years or balance impairment as assessed by a simplified Tinetti test or presence of one or two indicators of physical frailty based on Fried's criteria)
* willing to comply with all study requirements
Exclusion Criteria:
* neurological or orthopaedic disease (e.g., stroke with residual motor deficit, Parkinson's disease) with a significant impact on gait and balance performances
* fully dependent on a technical aid for walking such as canes or walker
* diagnosis of dementia based on a comprehensive neuropsychological assessment
* participation in a Jaques-Dalcroze Eurhythmics program or a supervised multicomponent exercise program in the past 12 months
* serious medical conditions or other factors that may limit adherence to interventions or affect conduct of the trial (e.g., terminal illness)
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01811745
|
{
"brief_title": "Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors",
"conditions": [
"Physical Function",
"Cognitive Function",
"Falls"
],
"interventions": [
"Behavioral: Multicomponent exercise training",
"Behavioral: Jaques-Dalcroze eurhythmics training"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01811745",
"official_title": "Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2013-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-01",
"last_updated_that_met_qc_criteria": "2013-03-14",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-15",
"first_submitted": "2013-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
#Intervention
- DRUG : BMS-754807
- Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response
|
#Eligibility Criteria:
Inclusion Criteria:
* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0 <= age <= 1
Exclusion Criteria:
* Any disorder with dysregulation of glucose homeostasis
* Dumping syndrome
* History of glucose intolerance
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
|
NCT00898716
|
{
"brief_title": "Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan",
"conditions": [
"Neoplasms"
],
"interventions": [
"Drug: BMS-754807"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00898716",
"official_title": "Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2009-09"
},
"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)": "2011-11-30",
"last_updated_that_met_qc_criteria": "2009-05-11",
"last_verified": "2010-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-12",
"first_submitted": "2009-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.
#Intervention
- DRUG : Peginterferon alfa-2b injection
- Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
- DRUG : Peginterferon alfa-2b injection
- Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
- DRUG : TDF
- Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.
- DRUG : Peginterferon alfa-2b injection
- Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Understand and sign the informed consent form voluntarily.
* Age between 18 and 65 years (including 18 and 65), no gender limit.
* HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
* HBsAg positive at screening.
* For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg<1500IU/mL, HBV DNA<100IU/ml, HBeAg<10s/co at screening.
* For treatment naive patients: HBV DNA>=1×10^4IU/ml, and 2×ULN (upper limit of normal) <=ALT<=10×ULN at screening.
* Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
Exclusion Criteria:
* Women who are pregnant, breastfeeding or planning to pregnant during the study period.
* Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
* Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
* Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
* Moderate to severe steatohepatitis.
* Evidence of acute severe hepatitis, e.g. ALT>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
* Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
* Evidence of hepatocellular carcinoma, or AFP>1×ULN.
* Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
* Neutrophil count less than 1.5×10^9/L, or platelet count less than 90×10^9/L at screening.
* Serum phosphorus lower than 0.8mmol/L.
* Antinuclear antibody (ANA) exceeds 1:100.
* Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
* Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
* Poorly controlled hypertension (blood pressure >=140/90 mmHg).
* Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
* Severe retinopathy or any other severe diseases in the eyes.
* Subject who had ever received organ transplants or are planning to receive organ transplant.
* For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
* For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
* Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
* Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.
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
|
NCT04846491
|
{
"brief_title": "A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B",
"conditions": [
"Chronic Hepatitis B"
],
"interventions": [
"Drug: TDF",
"Drug: Peginterferon alfa-2b injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT04846491",
"official_title": "A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30",
"study_completion_date(actual)": "2023-12-07",
"study_start_date(actual)": "2019-12-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-05",
"last_updated_that_met_qc_criteria": "2021-04-12",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-15",
"first_submitted": "2021-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.
Detailed Description
The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens. The investigators are using proven components of HIV prevention interventions, social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming principles to develop and evaluate this interactive HIV prevention video game. In Phase 1 of this project, the investigators have been working with Schell Games of Pittsburgh, PA, Digitalmill of Portland, ME, and the Farnam Neighborhood House in New Haven, CT to develop our interactive video game with the input from our experts and focus groups and interviews with adolescents. Phase 1 has been a developmental iterative process in which the investigators have been building the software for the game for the purposes of targeting HIV prevention in our population of interest: young minority adolescents. Following development of the video game, the investigators will move to Phase 2 in which the investigators will enroll 330 minority adolescents who are attendees at one of several after-school programs in the greater New Haven area and assign them to play either the experimental game or a control game. In the experimental game, the player will be presented with a series of 'risk challenges' thereby helping them to develop sex, drug and alcohol negotiation and refusal skills.
#Intervention
- BEHAVIORAL : Experimental Video Game
- Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
- BEHAVIORAL : Off the Shelf Video Game
- Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages 11 <= age <= 14 years
* Able to provide assent/parental/guardian consent
* Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
* English-speaking
Exclusion Criteria:
* Not between the ages of 11 <= age <= 14 years
* Not able to provide assent/parental/guardian consent
* Not willing to sit at a computer for 75 minutes twice weekly to play the game
* Non-English speaking
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01666496
|
{
"brief_title": "An Interactive Game for HIV Prevention in Early Adolescents",
"conditions": [
"HIV",
"Risk Reduction"
],
"interventions": [
"Behavioral: Experimental Video Game",
"Behavioral: Off the Shelf Video Game"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01666496",
"official_title": "An Interactive Video Game for HIV Prevention in Early Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-18",
"study_completion_date(actual)": "2016-06-18",
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-27",
"last_updated_that_met_qc_criteria": "2012-08-13",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-16",
"first_submitted": "2012-08-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.
Detailed Description
Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).
#Intervention
- DRUG : ramipril, candesartan
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with mild to moderate hypertension
Exclusion Criteria:
* We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00356395
|
{
"brief_title": "Safety and Effects of Ramipril Combined With Candesartan",
"conditions": [
"Hypertension"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00356395",
"official_title": "Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "2003-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2006-07-26",
"last_updated_that_met_qc_criteria": "2006-07-25",
"last_verified": "2006-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-07-26",
"first_submitted": "2006-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this prospective observational study is to compare pain control strategies in children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca compartment nerve block to IV pain control alone. The main questions it aims to answer are:
* Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain?
* Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't?
Participants will be asked to provide pain scores during their Emergency Department stay. Participants parents will be asked to complete a brief survey at the time their child is leaving the Emergency Department.
#Intervention
- PROCEDURE : Ultrasound-Guided Fascia Iliaca Compartment Nerve Block
- Patient's who receive this intervention will have an ultrasound-guided fascia iliaca compartment nerve block performed in the Emergency Department.
|
#Eligibility Criteria:
Inclusion Criteria:
* Acute femur fracture (less than 24 hours from initial injury)
* Glasgow Coma Scale of 14 or greater at time of enrollment
Exclusion Criteria:
* Allergy or hypersensitivity to local anesthetic agents
* Pregnant
* Prisoner
* Neurovascular injury to the affected limb
* Bilateral femur fractures
* Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis
* Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury
* Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury
* A fracture not limited to the extremities (i.e. vertebral compression fracture)
* A significantly displaced extremity fractures (aside from the primary femur fracture)
* An open fracture (aside from the primary femur fracture)
* An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05947292
|
{
"brief_title": "Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture",
"conditions": [
"Femur Fracture"
],
"interventions": [
"Procedure: Ultrasound-Guided Fascia Iliaca Compartment Nerve Block"
],
"location_countries": [
"Australia",
"United States"
],
"nct_id": "NCT05947292",
"official_title": "PLEXUS (Pediatric Lower Extremity Ultrasound-Guided Nerve Block) Study: A Prospective, Multi-center, Observational Study Comparing Ultrasound Guided Fascia Iliaca Compartment Nerve Block to Systemic Analgesia for Femur Fractures in the Pediatric Emergency Department",
"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)": "2022-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-29",
"last_updated_that_met_qc_criteria": "2023-07-12",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-17",
"first_submitted": "2023-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes
Detailed Description
Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.
Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.
#Intervention
- DRUG : Avastin
- 2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
- Other Names :
- Bevacizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
* distance acuity < 0.5
* > 20 yearsyears
Exclusion Criteria:
* noncooperative patients
* ocular infections / inflammations
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
|
NCT00564148
|
{
"brief_title": "Intravitreal Avastin in Proliferative Retinopathies",
"conditions": [
"Retinal Neovascularization"
],
"interventions": [
"Drug: Avastin"
],
"location_countries": [
"Romania"
],
"nct_id": "NCT00564148",
"official_title": "Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2007-07"
},
"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)": "2011-07-22",
"last_updated_that_met_qc_criteria": "2007-11-26",
"last_verified": "2008-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-11-27",
"first_submitted": "2007-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although blood volume is such an important parameter in everyday clinical medicine it cannot be measured easily. As a matter of fact, it is almost never measured but estimated or calculated based upon numbers derived from mostly healthy patients.
The investigators do not even know whether someone's normal - i.e. before a surgery - blood volume is actually anywhere close to the generally accepted estimate or calculation.
Tests exist in which a substance of known concentration is diluted in a person's blood volume and the resulting concentration is then measured, which allows the blood volume to be calculated. However, none of these tests can be completed at the bedside since they are not fast and require considerable set-up.
This study turns the above approach upside-down: we will dilute the blood slightly with a known small volume of an intravenous fluid commonly used in many clinical settings and measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells - before and after adding the fluid. That allows for similar calculations without using neither specialized substances nor equipment.
Hemoglobin is routinely measured in laboratories and is often a routine test before and during surg-eries and in intensive care units.
Devices that can measure hemoglobin through the skin without actually drawing any blood are avail-able. If found comparable to laboratory determination of hemoglobin they could provide for a bedside and almost real-time assessment of blood volume, something that could be extremely valuable for de-cision making in critical areas of medicine and promoting goal directed therapies.
#Intervention
- DRUG : Blood Volume Dilution
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy adults of normal constitution (weight/height)
Exclusion Criteria:
* any ongoing or recent infusions (< 24h ago) of any fluid/substance
* morbid obesity
* heart disease
* hypertension
* coagulopathy (bleeding disorder)
* therapy with anti- or procoagulants
* transfusion of any blood product
* therapy with diuretics
* therapy with vasopressors
* vasodilators or inotropes
* acute or chronic infections
* immunocompromised status
* hemodynamically unstable
* hemorrhage (bleeding)
* recent surgery
* pregnancy
* younger than 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01900769
|
{
"brief_title": "Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study",
"conditions": [
"Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume."
],
"interventions": [
"Drug: Blood Volume Dilution"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01900769",
"official_title": "Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2013-05"
},
"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)": "2014-02-19",
"last_updated_that_met_qc_criteria": "2013-07-15",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-16",
"first_submitted": "2013-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous NSCLC
Detailed Description
The anti-tumor activity of anti-PD-1 therapy in previously untreated Chinese squamous NSCLC patients will be investigated in this clinical trial.
#Intervention
- DRUG : Sintilimab
- 200mg, Q3W, day1, I.V.; consecutive cycles
- Other Names :
- IBI308
- DRUG : Gemcitabine
- 1000mg/m\^2, Q3W, day 1and 8, I.V.; first 4 or 6 consecutive cycles.
- DRUG : Cisplatin
- 75 mg/m\^2, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
- DRUG : Placebo
- NA, Q3W, day1, I.V.; consecutive cycles
- DRUG : Carboplatin
- AUC 5mg/ml/min, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must sign written ICF prior tothe implementation of any procedures related to the study;
* Aged >= 18 years and <= 75 years;
* With a life expectancy of more than 3 months;
* With at least one measurable lesion confirmed by the investigator according to RECIST v1.1.
Measurable lesions locatedin the field of previous radiotherapy or locoregional therapy canbe selected as target lesions if PD is confirmed;
* Participants with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) who are ineligible for radical surgery or concurrent chemoradiotherapy, metastatic (stage IV)or recurrent squamous NSCLC based on the '8th Edition of the TNM Classification for LungCancer' issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification;
* With an ECOG PS score of 0 or 1;
* Have not received any prior systemic anti-tumor therapy for advanced/metastatic disease; for participants who have received prior platinum-based adjuvant chemotherapy/radiotherapy,neoadjuvant chemotherapy/radiotherapy, or radical chemoradiotherapy, they are eligible for the study if PD occurs at > 6 months after the last treatment;
* With adequate hematologic function, defined as ANC >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 90 g/L (noblood transfusion history within 7 days);
* Adequate hepatic function, defined as TBIL <= 1.5 × ULN and AST as well as ALT <= 2.5 × ULN for all participants, or AST and ALT <= 5 × ULN for participants with liver metastasis;
* Adequate renal function, defined as CCr >= 50 mL/min (Cockcroft-Gault formula);
* Adequate coagulation function, defined as INR or PT <= 1.5 × ULN; for the participant who is receiving anticoagulant therapy, INR or PT within the proposed scope of the anticoagulantmedication is acceptable;
* Female participants of childbearing age should be tested negative for urine or serum pregnancy within 3 days before the first dose of the study treatments. A blood pregnancy testis required if the urine pregnancy test is inconclusive;
* For male and female participants with conception potential, highly effective contraception measures (failure rate < 1% per year) should be taken until at least 180 days afterdiscontinuation of the study treatment;
Note: Abstinence is acceptable as a method of contraception if it is the usual lifestyle and preferred method of contraception for the participant.
Exclusion Criteria:
* Histological type of nonsquamousNSCLC. The dominant cell morphology must be identified for mixed cell type (participants with squamous cell carcinoma components > 50% can beenrolled); participants with small cell carcinoma, neuroendocrine carcinoma, and sarcoma components cannot be included;
* Participants with known EGFR-sensitive mutations or ALK rearrangement;
* Currently participating in an interventional clinical study, or treated with another study drug therapy or investigational device therapy within 4 weeks before the first dose;
* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or agents targeting another stimulation or synergistically inhibiting TCR (e.g., CTLA-4, OX-40,and CD137);
* Received proprietary Chinese medicines with anti-tumor indications or immunomodulators (thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first dose, or received a major surgery within 3 weeks prior to the first dose;
* With active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastases requiring clinical intervention;
* Have undergone solid organ transplantation or hematologic transplantation;
* With clinically uncontrolled pleural effusion/ascites (participants who do not need effusion drainage or have no significant increase in effusion within 3 days after stopping drainage canbe enrolled);
* With a tumor compressing the surrounding important organs (such as esophagus) with relevant symptoms, compressing the superior vena cava, or invading the mediastinal great vessels,heart, etc.;
* With Class III-IV congestive cardiac failure (based on New York Heart Association Classification) or poorly controlled and clinically significant arrhythmia;
* With any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, and transient ischemicattack. With a history of deep venous thrombosis, pulmonary embolism, or any other seriousthromboembolic events within 3 months priorto enrollment (implantable port or catheter-related thrombosis, or superficial venous thrombosis is not considered as 'serious'thromboembolism);
* With known allergy to the active ingredients and/or any excipient of sintilimab , gemcitabine, cisplatin, orcarboplatin;
* With active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years before the first dose.Replacement therapy (e.g., thyroxine, insulin, or physiologic doses of corticosteroids foradrenal or pituitary insufficiency) is not considered systemic;
* Participants requiring long-term systemic use of corticosteroids. Participants requiring intermittent use of bronchodilators, inhaled corticosteroids, or localinjection ofcorticosteroids for COPD or asthma can be included in the study;
* Full recovery (i.e., <= Grade 1 or reaching the baseline, excluding asthenia or alopecia) from toxicity and/or complications caused by any intervention has not achieved before thestart oftreatment;
* Diagnosed with other malignant tumors within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/orradically resected carcinoma in situ. For other malignant tumors or lung cancer diagnosedmore than 5 years before the first dose, pathological or cytological diagnosis should beperformed for recurrent and metastatic lesions;
* Symptomatic CNS metastasis. Participants with asymptomatic brain metastases or with stable symptoms after treatment of brain metastases are allowed to participate in this study as longas meeting all of the following criteria: presence of measurable lesions outside the CNS;absence of metastases in midbrain, pons, cerebellum, meninges, medulla oblongata, or spinalcord; maintain clinical stable condition for at least 2 weeks; discontinue hormone therapy 14 days prior to the first dose of the study treatments;
* With a history of non-infectious pneumonia requiring corticosteroid therapy within 1year prior to the first dose or with non-infectious pneumonia at present;
* With an active infection requiring treatment or have used systemic anti-infective drugs within one week prior to the first dose;
* With known psychiatric disorder or substance abuse that could affect the compliance with study requirements;
* Known history of HIV infection (i.e. HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), or active tuberculosis;
* With untreated active hepatitis B;
Note: Participants with hepatitis B who meet the following criteria are also eligible forinclusion:
HBV viral load must be less than 1000 copies/mL (200 IU/mL) or below LLD prior to thefirst dose, and participants should receive anti-HBV treatment to avoid virus reactivation throughout the therapeutic phase of the study; For participants with HBcAb (+), HBsAg (-), HBsAb (-), and HBV load (-), close monitoring is required instead of prophylactic anti-HBV treatment to avoid virus reactivation;
* Participants with active HCV infection (HCV antibody positive and HCV-RNA level above the LLD);
* Have received live vaccines within 30 days prior to the first dose; Note: Seasonal inactivated influenza virus vaccines for injection are allowed, while liveattenuated influenza vaccines forintranasal use are not acceptable;
* With any medical history, disease, treatment, or laboratory abnormal finding that would interfere with the study results or prevent the participant from participating in the whole study,or the investigator believes that participation in this study is not in the best interest of theparticipant;
* With local or systemic diseases not attributing to malignancy, or with cancer-related secondary diseases, which would result in a high medical risk and/or uncertainty in survivalevaluation
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
|
NCT03629925
|
{
"brief_title": "Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC",
"conditions": [
"Squamous NSCLC"
],
"interventions": [
"Drug: Placebo",
"Drug: Sintilimab",
"Drug: Gemcitabine",
"Drug: Cisplatin",
"Drug: Carboplatin"
],
"location_countries": [
"China"
],
"nct_id": "NCT03629925",
"official_title": "A Randomized, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Sintilimab (IBI308) in Combination With Gemcitabine and Platinum-Based Chemotherapy vs. Placebo in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Treatment for Patients With Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) (ORIENT-12)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-25",
"study_completion_date(actual)": "2021-09-30",
"study_start_date(actual)": "2018-09-28"
},
"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)": "2023-02-28",
"last_updated_that_met_qc_criteria": "2018-08-13",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-14",
"first_submitted": "2018-08-09",
"first_submitted_that_met_qc_criteria": "2021-03-08"
}
}
}
|
#Study Description
Brief Summary
Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.
#Intervention
- DRUG : RC-1291 HCl
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Community-dwelling patients >= 18 years with incurable,histologically diagnosed cancer.
* Involuntary loss of body weight of >= 5 % within the past 6 months
Exclusion Criteria:
* Presently hospitalized or in a nursing care facility.
* Inability to increase food intake from secondary causes.
* Liver disease
* If female-pregnant, breast-feeding or of childbearing potential.
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
|
NCT00267358
|
{
"brief_title": "Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.",
"conditions": [
"Cancer Cachexia"
],
"interventions": [
"Drug: Placebo",
"Drug: RC-1291 HCl"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00267358",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-10",
"study_completion_date(actual)": "2006-10",
"study_start_date(actual)": "2005-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-02",
"last_updated_that_met_qc_criteria": "2005-12-19",
"last_verified": "2013-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-20",
"first_submitted": "2005-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
Detailed Description
This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.
#Intervention
- DEVICE : Safe'N'Sound
|
#Eligibility Criteria:
Inclusion Criteria:
The Evaluator must be:
* Minimum of age 18
* Able to understand and provide signed consent for the study
* Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires
* Have no concerns about the ability to perform the simulated injections
* With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)
Exclusion Criteria:
* If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
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
|
NCT02663635
|
{
"brief_title": "Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges",
"conditions": [
"Needle Stick"
],
"interventions": [
"Device: Safe'N'Sound"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02663635",
"official_title": "Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-28",
"last_updated_that_met_qc_criteria": "2016-01-21",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-26",
"first_submitted": "2016-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation.
Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays.
This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.
Detailed Description
If you enter the study, in the cardiac catheterization lab, after the anesthesiologist has done his part (placed the breathing tube while you are asleep and obtained the x-ray), we will use the ultrasound to check the position of the breathing tube. To help us see the breathing tube better, we will put some fluid in the cuff ( the balloon at the tip of the breathing tube). The tube may be repositioned as needed based on the chest x-ray. The entire procedure is estimated to take no more than 10 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* English and Spanish-speaking patients
* Age 0 <= age <= 21 years
* Elective cardiac catheterization procedure
* Endotracheal intubation with a cuffed ETT
Exclusion Criteria:
* Abnormal neck/tracheal anatomy
* Emergent cardiac catherization procedure
* Endotracheal intubation with an uncuffed ETT
* Inability to consent
Sex :
ALL
Ages :
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02131974
|
{
"brief_title": "Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff",
"conditions": [
"Pediatric Endotracheal Intubation (no Specific Condition)"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02131974",
"official_title": "Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10-10",
"study_completion_date(actual)": "2014-10-10",
"study_start_date(actual)": "2013-10-22"
},
"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)": "2018-10-12",
"last_updated_that_met_qc_criteria": "2014-05-02",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-06",
"first_submitted": "2014-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
PhXA41 is not inferior to timolol in reducing intra-ocular pressure
#Intervention
- DRUG : timolol
- One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
- DRUG : PhXA41
- One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
|
#Eligibility Criteria:
Inclusion Criteria:
* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
* IOP of 22mmHg or higher obtained during the pre-study period.
Exclusion Criteria:
* History of acute angle closure.
* Severe trauma at any time.
* Intraocular surgery or argon laser trabeculoplasty within 6 months.
* Current use of contact lenses.
* History of severe dry eye syndrome.
* Ocular inflammation/infection with three months of inclusion.
* Any condition preventing reliable applanation tonometry.
* Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
* In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
* Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
* Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
* Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Having participated in any other clinical study within the last month.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00751062
|
{
"brief_title": "A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia",
"conditions": [
"Open Angle Glaucoma",
"Ocular Hypertension"
],
"interventions": [
"Drug: PhXA41",
"Drug: timolol"
],
"location_countries": [
"Finland",
"Norway",
"Sweden",
"Denmark"
],
"nct_id": "NCT00751062",
"official_title": "A 6-month, Randomized, Double-masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in Scandinavia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1993-12",
"study_completion_date(actual)": "1993-12",
"study_start_date(actual)": "1992-11"
},
"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)": "2021-02-02",
"last_updated_that_met_qc_criteria": "2008-09-10",
"last_verified": "2008-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-11",
"first_submitted": "2008-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main focus of the study is:
* To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations.
* To estimate the incidence of AI in poultry-exposed and non-exposed human populations.
* To investigate risk factors associated with AI infections in occupationally-exposed poultry workers.
The secondary objectives of the study:
* To investigate patterns in transmission of AI to household contacts of AI clinical cases
* To isolate AI viruses from acute cases
* To monitor the pathogenicity and disease severity of AI viruses causing human infections
Detailed Description
This 4-year prospective cohort study to compare individuals with occupational exposure to poultry with non-poultry exposed adult controls for evidence of incident and previous infections with AI viruses. At the start of this study, study staff will obtain informed consent, and a blood sample will be obtained from study volunteers to establish baseline levels of antibodies against avian influenza types H4-H12. Subjects will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. After one year, study subjects will be interviewed again to note any changes in exposure variables. At this time, another blood sample will be obtained and tested for any changes in antibodies' levels. The same procedures will be repeated at the final visit after another year. Exposed individuals will be selected from rural areas where poultry is commonly raised. Non-exposed controls will be selected from urban neighborhoods in Cairo.
|
#Eligibility Criteria:
Inclusion Criteria:
* Be willing to participate by signing a consent/assent form, completing the study questionnaire, and permitting the withdrawal of blood.
* Does not buy poultry from live bird markets (for controls only).
Exclusion Criteria:
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy.
* Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.
* Children who are less than 2 years when baseline enrollment is performed.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01150552
|
{
"brief_title": "Studies of Avian Influenza Transmission to Humans in Egypt",
"conditions": [
"Avian Influenza"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT01150552",
"official_title": "Prospective Studies of Avian Influenza Transmission to Humans in Egypt",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05",
"study_completion_date(actual)": "2014-05",
"study_start_date(actual)": "2010-06"
},
"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)": "2014-07-14",
"last_updated_that_met_qc_criteria": "2010-06-24",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-25",
"first_submitted": "2010-06-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate changes in force and power production, soreness, inflammation, and oxidative stress after repeated sprinting activity and powdered tart cherry ingestion in trained males and females.
Detailed Description
The purpose of this study is to evaluate changes in force and power production, soreness, inflammation, and oxidative stress after repeated sprinting activity and powdered tart cherry ingestion in trained males and females. This study will utilize a randomized, double-blind, placebo group study design. Prior to any data collection, potential participants will be explained the protocol and then review and sign an IRB-approved consent form. Healthy male and female (n=40) participants who report regularly practicing or competing in high-intensity multi-modal resistance based exercise will complete the study protocol.
#Intervention
- DIETARY_SUPPLEMENT : Tart Cherry Extract Powder
- Tart Cherry Extract Powder (NordicCherry, SpecNova, LLC). Dispensed during visit 1. Participants will consume 1 dose per day for 10 days.
- DIETARY_SUPPLEMENT : Placebo
- Rice power placebo. Dispensed during visit 1. Participants will consume 1 dose per day for 10 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female (n=40) participants between the ages of 18 - 35 years will finish the study protocol. An even distribution of males (n=20) and females (n=20) is planned.
* Participating in some form of exercise at least four days per week with at least two days consisting of some form of high-intensity exercise for the past six months.
* Examples include regular gym attendance to complete resistance training, interval exercise, or participation in some form of organized physical activity involving high-speed running or other forms of high-intensity exercise.
* Have a body mass index (BMI) range of 18.0 - 30.0 kg/m2. Males with a body mass index greater than 30.0 kg/m2, but a body fat percentage less than 27.5% fat will be accepted into the study. Females with a body mass index greater than 30.0 kg/m2, but a body fat percentage less than 32.5% fat will be accepted into the study.
Exclusion Criteria:
* Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes.
* Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within five years prior to screening visit.
* Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
* Positive medical history for any neurological condition or neurological disease
* Currently smoke or have quit within the past six months
* Current daily use of aspirin, NSAIDS, naproxen sodium, COX-2 inhibitors, or any other over-the-counter or prescribed medication indicated for pain relief.
* Intake of any dietary supplement known or purported to impact muscle repair and recovery such as antioxidants, curcumin, turmeric, branched-chain amino acids, vitamin D, tart cherry, pomegranate, fish oils, or creatine monohydrate.
* Individuals who indicate they are actively involved in any form of a dietary program in the past 30 days to lose weight
* Participants who are lactating, pregnant or planning to become pregnant
* Have a known sensitivity or allergy to any of the study products
* Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
* History of alcohol or substance abuse in the 12 months prior to screening
* Receipt or use of an investigational product in another research study within 28 days prior to baseline testing
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
|
NCT06122038
|
{
"brief_title": "Impact of Powdered Tart Cherries on Recovery From Repeated Sprints",
"conditions": [
"Inflammation",
"Oxidative Stress",
"Soreness, Muscle",
"Muscle Damage"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Tart Cherry Extract Powder"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06122038",
"official_title": "Impact of Powdered Tart Cherries on Recovery From Repeated Sprints in Trained Males and Females",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-20",
"study_completion_date(actual)": "2023-12-20",
"study_start_date(actual)": "2023-04-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-08",
"last_updated_that_met_qc_criteria": "2023-11-02",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-08",
"first_submitted": "2023-05-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin.
The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.
The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.
Detailed Description
Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. A sensitive skin is characterized by the occurrence of tingling sensations, tightness, heat, burning, itching or pain triggered by non pathogenic factors such as wind, heat, cold, water , cosmetics, toiletries, stress...
The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.
The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.
#Intervention
- DEVICE : Quantitative Sensory Testing
- Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: between 20 and 60 years
* Cooperating patient
* Informed and written consent of the subject
* Affiliated to the social security
* For subjects with sensitive skin:
subjects with a score greater than 50 on the scale sensitive scale
* To control subjects: subjects with result of less than 20 sensitive to the scale scale
Exclusion Criteria:
* Adults subject with legal protection
* Subject in a social institution.
* Subject with major cognitive or psychiatric disorders
* Subject with pathological use of alcohol or consumption of another drug.
* Subject with skin involvement of the back of the dominant hand or malformation.
* Known sensitive neuropathy
* Pregnant woman
* Subject receiving medical treatment which may interfere with the results.
* Subject with treatment in the back of the dominant hand.
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
|
NCT03081403
|
{
"brief_title": "Quantitative Sensory Testing in Subjects With Sensitive Skin or Not",
"conditions": [
"Sensitive Skin"
],
"interventions": [
"Device: Quantitative Sensory Testing"
],
"location_countries": [
"France"
],
"nct_id": "NCT03081403",
"official_title": "Quantitative Sensory Testing in Subjects With Sensitive Skin or Not",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-22",
"study_completion_date(actual)": "2017-10-17",
"study_start_date(actual)": "2017-04-14"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-10-19",
"last_updated_that_met_qc_criteria": "2017-03-10",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-16",
"first_submitted": "2017-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Botox for a total of 12 weeks after the administration in treatment of glabellar frown lines.
#Intervention
- DRUG : Botulinum toxin type A
- Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged between 19 <= age <= 65
* Subjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the Investigator
* Subjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the study
Exclusion Criteria:
* Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy
* Subjects with the history of eyelid paralysis or ptosis
* Subjects with significant facial asymmetry
* Individuals whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
* Subjects who have received medication that inhibits neuromuscular function within the 4 weeks prior to screening such as muscle relaxants, anticholinergics, benzodiazepines and similar drugs, benzamides, tetracycline antibiotics, lincomycin antibiotics, and aminoglycoside antibiotics
* Subjects taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)
* Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP.
* Subjects with skin abnormalities such as infection at the injection site, dermatopathy, or scars.
* Subjects with the history of treatment of the glabellar region (including the forehead) such as face lifting, permanent implants, or fillers
* Subjects who have received other procedures that may affect the assessment of the glabellar or forehead lines during the following periods:
* Within 6 months of screening: facial plastic surgery such as tissue augmentation, brow lift, or dermal resurfacing.
* Within 6 months of screening: injection of dermal fillers with hyaluronic acid as the main ingredient.
* Within 12 months of screening: injection of dermal fillers with ingredients other than hyaluronic acid as the main ingredient.
* Individuals planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period.
* Individuals who have received a botulinum toxin preparation within 5 months prior to screening or those who are expected to receive a botulinum toxin preparation for any other purpose than the indication of this study (glabellar lines).
* Subjects with the history of excessive alcohol consumption or drug addiction
* Individuals with an anxiety disorder or other significant psychiatric disorders (e.g., depression), which, in the Investigator's opinion, may affect study participation or objective assessment of efficacy outcomes
* Individuals who answered 'yes' to any of the questions on the Columbia University Suicide Severity Rating Scale (C-SSRS) regarding a case within the past 12 months at the screening
* Female subjects of childbearing age who do not agree to practice contraception using medically allowed contraceptive methods during the study period (hormonal contraception, IUD (intrauterine device) or IUS (intrauterine system), tubal ligation, dual protection (using a combination of male condom, female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge)
* Pregnant or lactating women
* Subjects who are allergic or sensitive to the IP or its components
* Individuals with concomitant illnesses that make them unsuitable for participation in the study by the Investigator such as malignant tumors, immunodeficiency (immune deficiency), kidney disease, liver disease, or lung disease
* Individuals who have participated in other clinical trials within 3 months prior to participating in this study and have received an IP or medical device during the previous clinical studies
* Individuals who are not eligible for this study for any reason as per the Investigator's discretion
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
|
NCT04281095
|
{
"brief_title": "A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines",
"conditions": [
"Glabellar Frown Lines"
],
"interventions": [
"Drug: Botulinum toxin type A"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04281095",
"official_title": "A Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-30",
"study_completion_date(actual)": "2020-04-30",
"study_start_date(actual)": "2019-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-09",
"last_updated_that_met_qc_criteria": "2020-02-20",
"last_verified": "2020-07"
},
"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 Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this paper.
Detailed Description
The study sample group consists of 100 children who are studying in a primary school registered to Hatay Provincial Directorate of National Education. The children's ages range between 6 years and 8 years 11 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* not having any physical, psychological or mental disabilities,
* to be aged between 6 years and 8 years and 11 months,
* to have the consent of both the child and the parents.
Exclusion Criteria:
* identified as having any kind of physical, visual or hearing disabilities,
* having mental retardation, or possessing a learning disability.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 9 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03781180
|
{
"brief_title": "Validity and Reliability Study of the Motor Accuracy Test",
"conditions": [
"Test-Retest Reliability"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03781180",
"official_title": "Randomised, Validity and Reliability Study of the Motor Accuracy Test in Turkey, One of the Sensory Integration and Praxis Tests",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-08",
"study_completion_date(actual)": "2018-01-07",
"study_start_date(actual)": "2016-02-17"
},
"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)": "2018-12-26",
"last_updated_that_met_qc_criteria": "2018-12-17",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-19",
"first_submitted": "2018-01-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. The aim of this work is to determine whether the provision of lockable storage containers to poor households in rural Asia can reduce the incidence of intentional pesticide self-poisoning. Secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.
Detailed Description
We will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning.
The study will be based in Anuradhapura District where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed.
The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clustering and stratification, for the analysis.
The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia.
#Intervention
- DEVICE : Ultraviolet light-resistant plastic in-ground pesticide storage container
- In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages
|
#Eligibility Criteria:
Inclusion Criteria:
* Any village in the study area that gives consent to the study
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01146496
|
{
"brief_title": "A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia",
"conditions": [
"Pesticide Poisoning"
],
"interventions": [
"Device: Ultraviolet light-resistant plastic in-ground pesticide storage container"
],
"location_countries": [
"Sri Lanka"
],
"nct_id": "NCT01146496",
"official_title": "A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2010-12"
},
"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)": "2019-07-18",
"last_updated_that_met_qc_criteria": "2010-06-16",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-17",
"first_submitted": "2010-06-16",
"first_submitted_that_met_qc_criteria": "2019-04-16"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.
#Intervention
- DRUG : olmesartan medoxomil
- oral tablets, once daily for 8 weeks
- DRUG : losartan potassium
- capsules, once daily for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* mild to moderated essential hypertension (mean seated diastolic blood pressure >= 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
* able to give written informed consent
Exclusion Criteria:
* known or suspected secondary hypertension
* history of chronic hepatic diseases
* obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
* cardiac arrhythmia
* unstable angina pectoris
* congestive heart insufficiency (New York Heart Association classification III-IV)
* bilateral renal artery stenosis
* isolated renal artery stenosis
* post renal transplantation
* history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
* retina bleeding/effusion
* insulin dependent diabetes mellitus
* uncontrolled non-insulin dependent diabetes mellitus
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
|
NCT00856271
|
{
"brief_title": "Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension",
"conditions": [
"Essential Hypertension"
],
"interventions": [
"Drug: olmesartan medoxomil",
"Drug: losartan potassium"
],
"location_countries": [
"China"
],
"nct_id": "NCT00856271",
"official_title": "A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-02",
"study_completion_date(actual)": "2005-04",
"study_start_date(actual)": "2004-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-09-29",
"last_updated_that_met_qc_criteria": "2009-03-04",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-05",
"first_submitted": "2009-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the clinical efficacy (event-free survival) of an intensive short-term chemotherapy regimen (Hyper- cyclophosphamide, vincristine, doxorubicin, dexamethasone \[CVAD\] program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or B-cell receptor BCR-ABL-positive acute lymphoblastic leukemia (ALL).
II. To evaluate other clinical efficacy (overall response rate and survival) and safety of an intensive short-term chemotherapy regimen (Hyper-CVAD program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL).
OUTLINE:
HYPER-CVAD THERAPY: Participants receive cyclophosphamide intravenously (IV) twice daily (BID) over 3 hours on days 1-3, vincristine IV over 30 minutes on days 4 and 11, and doxorubicin IV over 24-48 hours on day 4. Participants also receive dexamethasone orally (PO) or IV over 30 minutes on days 1-4 and 11-14, and dasatinib PO once daily (QD) on days 1-14 of course 1 and on days 1-21 for subsequent courses. Courses repeat every 21 days for up to 4 odd courses (1, 3, 5, and 7) in the absence of disease progression or unacceptable toxicity.
METHOTREXATE PLUS CYTARABINE: Participants receive methotrexate IV over 24 hours on day 1, dasatinib PO on days 1-21, and cytarabine IV BID over 2 hours on days 2 and 3. Courses repeat every 21 days for up to 4 even courses (2, 4, 6, and 8) in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Participants receive vincristine IV over 30 minutes on day 1, prednisone PO on days 1-5, and dasatinib PO BID. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. During courses 6 and 13, participants may receive an additional course of hyper-CVAD therapy.
After completion of study treatment, participants are followed for up to 12 months.
#Intervention
- DRUG : Cyclophosphamide
- Given IV
- Other Names :
- (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
- DRUG : Cytarabine
- Given IV or IT
- Other Names :
- .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
- DRUG : Dasatinib
- Given PO
- Other Names :
- BMS-354825, Sprycel
- DRUG : Dexamethasone
- Given IV or PO
- Other Names :
- Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
- DRUG : Doxorubicin
- Given IV
- Other Names :
- Adriablastin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
- DRUG : Methotrexate
- Given IV or IT
- Other Names :
- Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
- DRUG : Prednisone
- Given PO
- Other Names :
- .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, SK-Prednisone
- DRUG : Vincristine
- Given IV
- Other Names :
- LEUROCRISTINE, VCR, Vincrystine
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of one of the following: Previously untreated Ph-positive acute lymphoblastic leukemia (ALL) (either t(9;22) and/or BCR-ABL positive) (includes patients initiated on first course of hyper-CVAD before cytogenetics known). These groups will be analyzed separately. After 1 <= age <= 2 courses of chemotherapy with or without imatinib mesylate (Gleevec). If they achieved complete response (CR), they are assessable only for event-free and overall survival, or if they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients with relapsed Ph-positive ALL or lymphoid blast phase of chronic myelogenous leukemia (CML)
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)
* Adequate cardiac function as assessed clinically
* Signed informed consent
Exclusion Criteria:
* Active serious infection not controlled by oral or intravenous antibiotics
* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
* Active grade III-V cardiac failure as defined by the New York Heart Association criteria. Uncontrolled angina, or myocardial infarction (MI) within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 470 msec). Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives)
* Prior history of treatment with dasatinib
* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
* History of significant bleeding disorder unrelated to cancer, including:
* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
* Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
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
|
NCT00390793
|
{
"brief_title": "Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.",
"conditions": [
"Acute Lymphoblastic Leukemia",
"BCR-ABL1 Fusion Protein Expression",
"Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive",
"Philadelphia Chromosome Positive",
"Recurrent Acute Lymphoblastic Leukemia",
"t(9;22)"
],
"interventions": [
"Drug: Methotrexate",
"Drug: Dexamethasone",
"Drug: Prednisone",
"Drug: Doxorubicin",
"Drug: Cytarabine",
"Drug: Dasatinib",
"Drug: Cyclophosphamide",
"Drug: Vincristine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00390793",
"official_title": "Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-02",
"study_completion_date(actual)": "2024-02-02",
"study_start_date(actual)": "2006-09-28"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-07",
"last_updated_that_met_qc_criteria": "2006-10-19",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-20",
"first_submitted": "2006-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study examines the effect of a video-based intensity level demonstration on self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video demonstration is to achieve a better concordance of physical activity reports with accelerometer-based measurements.
Detailed Description
This study examines whether the demonstration of different intensity levels of physical activity by video in the context of a tablet PC (personal computer)-based survey can achieve a higher degree of concordance between self-reported and accelerometer-measured physical activity compared to an assessment without video demonstration. The recruitment of the study participants in the age range between 40 and 75 years takes place in a shopping center in the city Greifswald in Germany.
Informed consent consists of: (i) activity recording over 7 days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a standardized measurement of weight and height as well as waist and hip circumference.
Participants are asked to wear an accelerometer during the day for a period of 7 days. Subsequently, a questionnaire about the frequency, duration and intensity of physical activity in the last 7 days will be answered in the DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung)- examination center. Prior to the physical activity assessment the study participants are randomly assigned to the study conditions 'Video' or 'No Video' (ratio 1:1). Optionally, participants may receive feedback on their physical activity measured by accelerometer upon completion of the study.
#Intervention
- OTHER : Video demonstration of physical activity intensity levels
- In the video demonstration, an approximately 50 year old male explains 1) light-intensity, 2) moderate-intensity, and 3) vigorous-intensity physical activity referring to differences in heart rate, breathing frequency and capability to talk normally. Simultaneously, on a treadmill he demonstrates the body signs of the three intensity levels. He gives examples and points out that there are individual differences in the intensity evaluation of comparable activities.
|
#Eligibility Criteria:
Inclusion Criteria:
*
Exclusion Criteria:
* cognitive impairment
* inadequate language skills
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03539237
|
{
"brief_title": "Closing the Gap Between Self-reported and Accelerometer-based Physical Activity",
"conditions": [
"Physical Activity"
],
"interventions": [
"Other: Video demonstration of physical activity intensity levels"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03539237",
"official_title": "Effect of an Intensity Level Video Demonstration on the Gap Between Self-reported and Accelerometer-measured Physical Activity in Individuals Aged 40 to 75 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-28",
"study_completion_date(actual)": "2018-11-28",
"study_start_date(actual)": "2018-05-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-04",
"last_updated_that_met_qc_criteria": "2018-05-15",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-29",
"first_submitted": "2018-05-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the response of a treatment with testosterone undecanoate and determine the levels of total and free testosterone in hypogonadal patients with erectile dysfunction.
Detailed Description
Hypogonadism is a pathophysiologic and clinical factor in a substantial number of patients with ED,and data indicate that a threshold level of testosterone is necessary for normal erectile function.Testosterone therapy is clearly indicated in hypogonadal patients and is beneficial in other patients with ED and hypogonadism.However,testosterone efficacy as monotherapy for ED could be limited,and combination therapy with testosterone and other ED treatments,such as PDE-5 inhibitors may be valuable in certain subpopulations of patients.
#Intervention
- DRUG : Testosterone Undecanoate,1000mg
- duration for 4 injections
- Other Names :
- Nebido 1000 mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with ED over 3 months (specify using IIEF score)
* Age >= 18 years.
* Stable sexual relationship
* With low or low normal serum testosterone level (either total or bioavailable testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml
* Aging Male Symptom scale with total score starting at 37 points (must not replace TT < 4 ng/ml)
* Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have discontinued their use for 1 month
Exclusion Criteria:
* Contraindication to treatment with Testosterone according to the SPC
* Hypersensitivity to the active substances or any of the excipients of Nebido
* Diagnosed or suspected carcinoma of the prostate or the male breast cancer
* Past or present liver tumors
* Acute or chronic hepatic diseases
* Severe cardiac, hepatic or renal insufficiency
* History of penile implant or significant penile deformity
* Diagnosed sleep apnea
* Polycythemia (Hematocrit >50%)
* Prolactin >25 ng/ml
* Organic hypothalamic-pituitary pathology
* Any unstable medical, psychiatric or drug/alcohol abuse disorder
* Prostate specific antigen (PSA)>= 4 ng/ml
* Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20)
* Diabetes mellitus which is uncontrolled (HbAlc level >10%)
* Epilepsy not adequately controlled by treatment
* Patients requiring fertility treatment
* Hypertension which is not adequately controlled on therapy
* Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
* Hypersensitivity to PDE-5 inhibitors
* Concomitant Medication:
* Nitrites or Nitric oxide donors
* Anti-androgens
* anti-coagulants, with the exception of anti-platelet agents
* Any of potent inhibitors of cytochrome P-450 3A4:such as HIV protease inhibitors (Ritonavir or Indinavir); Anti-mycotic agent (Itraconazole and Ketoconazole)-topical application allowed; or Erythromycin.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00421460
|
{
"brief_title": "The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction",
"conditions": [
"Hypogonadism",
"Erectile Dysfunction"
],
"interventions": null,
"location_countries": [
"Thailand"
],
"nct_id": "NCT00421460",
"official_title": "Phase IV Study of The Therapy of Long-acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-05-15",
"last_updated_that_met_qc_criteria": "2007-01-11",
"last_verified": "2012-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-12",
"first_submitted": "2007-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
"Children exposed to alcohol or drugs during pregnancy: Growth, health and development' Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway.
Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy.
Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare.
A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction.
Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI).
Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study.
Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.
|
#Eligibility Criteria:
Inclusion Criteria:
* Foetal exposure of drugs during pregnancy.
Exclusion Criteria:
* Non exposed children
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02842645
|
{
"brief_title": "Growth-Health and Development in Children Exposed to Drugs During Pregnancy",
"conditions": [
"Growth Failure",
"Mental Health Disorder",
"Foetal Exposure During Pregnancy"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT02842645",
"official_title": "Growth-Health and Development in Children Exposed to Drugs During Pregnancy.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-05",
"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)": "2016-08-17",
"last_updated_that_met_qc_criteria": "2016-07-20",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-25",
"first_submitted": "2011-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death
Secondary Objective:
To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.
#Intervention
- DRUG : Leucovorin
- Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV
Dose regimen:
- DRUG : OXALIPLATIN
- Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV
Dose regimen:
- DRUG : 5-Fluorouracil
- Pharmaceutical form: vials of 5 g/100mL Route of administration: IV
Dose regimen:
|
#Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically proven pancreatic carcinoma
* Measurable locally advanced or metastatic disease
* Patient previously treated with 5-FU as a 'radiation sensitizer' and all toxicities must have been resolved
* Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
* Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
* Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic Resonance Imaging (MRI) within 4 weeks prior to randomization
* Adequate liver and kidney function:
* Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)
* Creatinine clearance (ClCr) superior than 50 mL / min
* Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST inferior than 5 ULN if liver metastasis
* Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT inferior than 5 ULN if liver metastasis
* Adequate hematological function:
* Neutrophils superior or egal to 1.5 x 109/L
* Platelets superior or egal to 100 x 109/L
Exclusion criteria:
* Peripheral sensory or motor neuropathy > grade 1
* Eastern Cooperative Oncology Group (ECOG) Performance status > 2
* Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
* Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
* Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
* Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
* History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or to any ingredients in the formulations or the containers
* Severe renal impairment (ClCr < 50 mL/min)
* Pregnant women or breast-feeding
* Patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of 'effective method of contraception' will be based on the investigators' judgment)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01121848
|
{
"brief_title": "Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer",
"conditions": [
"Pancreatic Neoplasms"
],
"interventions": [
"Drug: Leucovorin",
"Drug: 5-Fluorouracil",
"Drug: OXALIPLATIN"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01121848",
"official_title": "A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10",
"study_completion_date(actual)": "2013-10",
"study_start_date(actual)": "2010-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-10-27",
"last_updated_that_met_qc_criteria": "2010-05-10",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-12",
"first_submitted": "2010-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as an autosomal dominant multisystemic disorder. It is the most common adult form of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people are DM1 patients in Europe.
The aim of OPTIMISTIC is to improve clinical practice in the management of patients with this rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a multi-centre, randomised controlled trial designed to compare a two component tailored behavioural change intervention to increase physical activity against standard patient management regimes, with particular attention given to the definition of appropriate outcome measures and new clinical guidelines for DM1 management. The two components of the intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and we will evaluate the intervention's effectiveness and safety against standard patient management.
Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18 years and older with genetically proven classical or adult DM1 suffering from severe fatigue (only DM1 patients with a CIS subscale fatigue score \> 35 are likely to benefit from the intervention), able to walk independently and able to complete the trial interventions will be included.
A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the patients and have a rate of change that is appropriate for a clinical trial timeframe. In addition, OPTIMISTIC will identify genetic factors that predict outcome and potential biomarkers as surrogate outcome measures that best explain the observed clinical variation.
Detailed Description
Background DM1 is a rare, inherited, progressive disease as well as an autosomal dominant multisystemic disorder. It is the most common adult form of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people are DM1 patients in Europe. Typical symptoms of the disease include progressive muscle weakness and wasting from distal to proximal, ptosis, weakness of facial, jaw and anterior neck muscles, myotonia, daytime sleepiness, fatigue and cataract. Other symptoms of adult DM1 include cardiac conduction defects, as well as endocrine, gastrointestinal and cognitive dysfunction. DM1 is one of the most variable human diseases, has complex, multisystemic and progressively worsening clinical manifestations and leads to severe physical impairment, restricted social participation and premature death.
There is no pharmaceutical treatment for causal or symptomatic relief of DM1 core symptoms (with the exception of Modafinil for excessive daytime sleepiness). Thus the aim of treatment is to relieve impairments, reduce limitations and optimise participation. Physical activity has been acknowledged as an important factor for health in general. For patients with a slowly progressive neuromuscular disease, such as DM1, there is accumulating evidence for prescribing low-to-moderate-intensity strength and aerobic exercise training, and an active lifestyle. Nevertheless, recent reviews conclude that existing studies are limited in number and quality, and that there is a need for disease-specific, randomised, controlled trials investigating the effect on quality of life.
RATIONALE FOR THE STUDY It was demonstrated recently by an OPTIMISTIC research partner that severe fatigue, defined as a score equal to or higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS-fatigue), was reported by around 70% of patients with DM1. These severely fatigued patients had more problems with physical and social functioning as well as with their mental and general health than similar patients without severe fatigue. They also had more problems with concentration and planning. As such, experienced fatigue should be clearly distinguished from muscle weakness, which is probably the most common and characteristic symptom of DM1 and also of a lack of initiative (apathy) that is known to occur often in DM1.
In a longitudinal study, we built a model of perpetuating factors for fatigue in patients with DM1. It appeared that lack of physical activity, sleep disturbances and pain all contributed to experienced fatigue. In addition, loss of muscle strength and pain contributed to fatigue through a lower level of physical activity. Ultimately, experienced fatigue and physical activity both contributed to the level of societal participation. A lack of initiative further increased fatigue but also had a direct negative effect on societal participation. Thus, theoretically, in order to improve societal participation one should compensate for a reduced initiative, optimise physical activity and alleviate experienced fatigue. To alleviate fatigue one should address the fatigue maintaining factors identified by the model, e.g. experience of pain or sleep disorders.
The main rationale for the combination of CBT and physical activity is based on our DM1-specific model. The DM1-specific model shows that physical activity, experienced fatigue and lack of initiative are the main determinants of DM1 health status. OPTIMISTIC is the first model-based clinical trial in DM1. It evaluates the effect, and the maintenance of effects, of CBT combined with exercise training on the reduction of chronic fatigue in patients with DM1.
Importantly, the intervention will also involve caregivers where they are willing to take part. The disabilities associated with DM1 put considerable strain on caregivers and can also lead to a negative interaction with the patient. The intervention will aim to support caregivers by installing realistic expectations about what can be expected from the patient, teach caregivers how to help patients to stay as self-reliant as possible and also reduce caregivers strain by taking time for themselves. If a DM1 patient has no caregiver or significant other, or no caregiver or significant other willing to take part in the study, the patient will not be excluded from the study. All patients will be asked if the study team could approach them to inform them for further research. This contact does not constitute consent.
\*\* CMRI-substudy in People with DM1 People with DM1 are at high risk of developing a cardiac complication. However, it is not known whether the high prevalence of cardiac complications can be affected by a sedentary lifestyle. Given the high risk of cardiac complications and the possibility that becoming more physically active may help these complications, the University of Newcastle, will conduct a sub-study to perform Cardiac Magnetic Resonance Imaging (CMRI) in 40 eligible participants at baseline and at end of the intervention period to acquire the evidence upon which clinical judgement about the use of exercise as a clinical therapy that is safe, can be based.
Cardiac Magnetic resonance imaging (CMRI) uses a combination of harmless radiofrequency (RF) waves and powerful magnets to cause hydrogen nuclei within the cardiac cell molecules to vibrate and emit RF energy. The MRI scanner detects the energy emissions and converts them to viewable images. When diseases begin, there are changes in the heart's tissue. Because even minor changes in tissue affect the rates at which energy is emitted, many medical conditions can be detected at their very early stages. MRI is done to evaluate the structure and function of the heart and blood vessels. MRI may provide information that cannot be obtained by other tests such as chest X-ray, ECG, echocardiogram, or nuclear tests.
The CMRI examinations will be performed with the contract enhancement gadolinium, in 40 eligible participants, 20 in each group. Participants will undergo:
1. cardiac cine imaging, to evaluate cardiac morphology
2. systolic and diastolic function and
3. cardiac tagging to evaluate wall motion and torsion.
MRI safety will be established prior to baseline and end of intervention scan. This includes; assessing for in vivo ferrous material, claustrophobia, abnormal renal function and pregnancy. The PI will assess renal function from the participant's medical notes at screening, if required a blood tests for U\&Es will be requested. In addition, child-bearing potential female participants will consent to have urine pregnancy test performed.
For participants that have had a baseline CMRI and withdraw from the study prior to the end of the intervention period, will be invited to have an end of study CMRI if the period from their initial CMRI is greater than 3 months.
No further statistical review is required for the CMRI sub-study as only frequencies and associations will be assessed.
#Intervention
- BEHAVIORAL : Behavioural change intervention
- The intervention is cognitive behaviour therapy (CBT). The CBT consists of six different modules. All patients will start with individual goal setting and psycho-education about the role of cognitive-behavioural variables in the disabilities patients' experience. The patient formulates his or her treatment goals in concrete terms and later on in the therapy the goals are realised step by step by the patient. The treatment is tailored to the patient's problems: which of the six modules a patient will receive is dependent on the scores on measures that have been collected at baseline assessment. Based on our previous experience with modular interventions we expect that most patients will receive less than four modules.
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* Genetically proven DM1
* Suffering from severe fatigue (CIS fatigue >35
* Able to walk independently
Exclusion Criteria:
* Neurological or orthopaedic co-morbidity interfering with the interventions or possibly influencing outcomes.
* Use of psychotropic drugs (except Modafinil, Ritalin and antidepressants where the dosing regimen has been stable for at least 12 months prior to screening). If the doses of Modafinil or Ritalin increase during the 10 months of the intervention then the participant will be excluded.
* Severe depression as screening (judged as meeting DSM-IV criteria for a depressive episode).
* Participation in another clinical trial of an investigational medicinal product (CTIMP) or other interventional study considered to influence outcomes being evaluated in OPTIMISTIC.
* Unable to complete study questionnaires.
* Subject participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this 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
|
NCT02118779
|
{
"brief_title": "Observational Prolonged Trial in Myotonic Dystrophy Type 1",
"conditions": [
"Myotonic Dystrophy Type 1"
],
"interventions": [
"Behavioral: Behavioural change intervention"
],
"location_countries": [
"France",
"Germany",
"Netherlands",
"United Kingdom"
],
"nct_id": "NCT02118779",
"official_title": "Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life Standards, a Target Identification Collaboration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03-29",
"study_completion_date(actual)": "2016-10-17",
"study_start_date(actual)": "2014-04-02"
},
"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)": "2017-07-18",
"last_updated_that_met_qc_criteria": "2014-04-18",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-21",
"first_submitted": "2014-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being done to evaluate the effect of targeted UV-B (a component of sunlight) on the treatment of acne keloidalis nuchae (AKN, or razor bumps on the back of the neck). The investigators believe targeted UV-B is a safe and effective way to reduce the appearance of AKN.
#Intervention
- RADIATION : Targeted UV-B
- Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
|
#Eligibility Criteria:
Inclusion Criteria:
* age 18 or over
* male gender
* African-American or other black ethnicity
* current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)
Exclusion Criteria:
* allergy to lidocaine or numbing medicine
* history of increased sensitivity to sunlight, lupus, or porphyria
* current use of a drug that increases sensitivity to sunlight
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01328080
|
{
"brief_title": "Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy",
"conditions": [
"Acne Keloidalis Nuchae"
],
"interventions": [
"Radiation: Targeted UV-B"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01328080",
"official_title": "Improving Acne Keloidalis Nuchae by Inducing Matrix Metalloproteinases in Vivo Using Targeted Ultraviolet-B Irradiation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2011-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-29",
"last_updated_that_met_qc_criteria": "2011-04-01",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-04",
"first_submitted": "2011-03-31",
"first_submitted_that_met_qc_criteria": "2014-05-19"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
#Intervention
- DEVICE : Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
- Surgical placement of the Surgisis AFP is performed under general anesthesia.
- Other Names :
- Surgisis Biodesign
- DEVICE : Flap
- Advancement flap surgery is performed; no anal fistula plug is placed
|
#Eligibility Criteria:
Inclusion Criteria:
* Over eighteen years old
* Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
* Pre-placement of seton required for at least 6 weeks prior to surgical treatment
* Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer
Exclusion Criteria:
* Recurrent fistula tracts
* J-pouch fistulas
* Superficial fistulas
* Fistulas with active abscess, infection, or acute inflammation
* History of Chron's Disease
* History of Ulcerative Colitis
* History of HIV or other immune system disease
* History of collagen disease
* History of radiation to the anorectal region
* Allergies to pig tissue or pig products
* Religious or cultural objection to the use of pig tissue
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
|
NCT00545441
|
{
"brief_title": "A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas",
"conditions": [
"Anal Fistula"
],
"interventions": [
"Device: Flap",
"Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00545441",
"official_title": "A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2008-06"
},
"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)": "2014-12-17",
"last_updated_that_met_qc_criteria": "2007-10-16",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-17",
"first_submitted": "2007-10-16",
"first_submitted_that_met_qc_criteria": "2014-10-24"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.
Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.
Detailed Description
Primary Objective - Determine overall response rate (ORR) in patients treated with CNP
Secondary Objective(s)
* Determine progression-free survival (PFS), and disease control rate (DCR) in patients treated with CNP.
* Determine duration of response in patients treated with CNP.
* Determine safety/tolerability of CNP.
Correlative Endpoints
- Identify pathologic and genomic correlates of response to CNP.
Study design including dose escalation / cohorts This is prospective pilot clinical trial of CNP in up to 30 patients with mTNBC
#Intervention
- DRUG : Carboplatin
- AUC 4.5 IV day 1 of 21-day cycle
- DRUG : Nab-paclitaxel
- 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
- Other Names :
- Abraxane
- DRUG : Pembrolizumab
- 200 mg IV every 21 days
- Other Names :
- MK-3475
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
* Subjects must have received no more than 2 prior therapies for this disease
* ECOG Performance Status 0 <= age <= 1
* Subjects must have normal organ and marrow function as defined below:
* Hemoglobin >= 10.0 g/dl
* Absolute neutrophil count >= 1,000/μL
* Platelet count >= 100,000/μL
* Total bilirubin within normal institutional limits
* AST (SGOT) <= 2.5 X institutional upper limit of normal
* ALT (SGPT) <= 2.5 X institutional upper limit of normal
* Serum creatinine <= 1.5 normal institutional limits
* Life expectancy of 12 weeks or more
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
* Subjects must have measurable disease per RECIST v1.1
* Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes. A second post-treatment biopsy will be offered but will not be mandated
Exclusion Criteria:
* Prior treatment toxicities have not resolved to <= Grade 1 according to NCI CTCAE Version 4.0 (except for alopecia and neuropathy)
* Subjects receiving any other investigational agents
* Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breastfeeding women are excluded from this study
* Patients with conditions requiring immunosuppressive medications or chronic infections (including HIV infection, hepatitis B and C)
* Patients with chronic autoimmune disease
* Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
* Patients with evidence of active, non-infectious pneumonia
* Patients active infection requiring intravenous systemic therapy
* Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
* Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
* Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
* Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
* Patients who have received chemotherapy, small molecule targeted therapy or radiation within the 2 weeks of first dose of study drugs
* Patients who have participated in MK-3475 Merck studies
* Patients with carcinomatous meningitis
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
|
NCT03121352
|
{
"brief_title": "Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer",
"conditions": [
"Metastatic Triple Negative Breast Cancer"
],
"interventions": [
"Drug: Carboplatin",
"Drug: Nab-paclitaxel",
"Drug: Pembrolizumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03121352",
"official_title": "Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-20",
"study_completion_date(actual)": "2022-05-23",
"study_start_date(actual)": "2017-05-19"
},
"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)": "2023-10-06",
"last_updated_that_met_qc_criteria": "2017-04-17",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-20",
"first_submitted": "2017-03-30",
"first_submitted_that_met_qc_criteria": "2023-10-05"
}
}
}
|
#Study Description
Brief Summary
The synergistic value of the fusion of physiologic and anatomical data has been described using several co-registration techniques for various nuclear medicine procedures and morphologic imaging modalities (single photon emission computed tomography-computed tomography \[SPECT-CT\], SPECT-magnetic resonance imaging \[MRI\], camera-based positron emission tomography \[PET\]-CT and PET-CT). The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.
The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.
Detailed Description
The researchers hypothesize that fusion of nuclear medicine (NM) and CT data acquired sequentially in a single imaging session on one device is clinically superior to side-by-side evaluation of separately performed imaging tests. They hypothesize that more accurate localization of increased radiotracer activity on NM procedures will improve the diagnostic accuracy for detection of infection and will subsequently have a significant impact on patient management.
The purpose of the present study is to assess the clinical value of this new technology of fused imaging in patients undergoing diagnostic nuclear medicine evaluation for suspicion of an infection process.
#Intervention
- DEVICE : Imaging
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients referred for NM imaging procedures to assess the presence of infectious processes.
* Patients signed informed consent
Exclusion Criteria:
* The study will not be performed in pregnant or lactating women.
* Patients unable or unwilling to tolerate the scan until its completion
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
|
NCT00230152
|
{
"brief_title": "Hybrid Imaging Modalities for the Evaluation of Infection",
"conditions": [
"Infectious Diseases"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT00230152",
"official_title": "Nuclear Medicine for the Evaluation of Infection-the Added Value of Hybrid Imaging Modalities",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2006-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-10-22",
"last_updated_that_met_qc_criteria": "2005-09-29",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-30",
"first_submitted": "2005-09-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.
The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.
Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.
This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.
#Intervention
- DRUG : Acarbose
- Acarbose 50 mg by mouth given during Meal Test
- Other Names :
- Prandase, Precose
- DRUG : Placebo
- Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
|
#Eligibility Criteria:
Inclusion Criteria:
* age 65 year and older
* Type 2 diabetes
Exclusion Criteria:
* less than 65 years
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02043886
|
{
"brief_title": "Acarbose, Postprandial Hypotension and Type 2 Diabetes",
"conditions": [
"Type 2 Diabetes",
"Postprandial Hypotension"
],
"interventions": [
"Drug: Acarbose",
"Drug: Placebo"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02043886",
"official_title": "The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2014-05",
"study_start_date(actual)": "2007-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-28",
"last_updated_that_met_qc_criteria": "2014-01-22",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-23",
"first_submitted": "2014-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed study will examine the role of reward and emotion in women with and without a history of binge eating. It is important to understand how the brain responds to reward and emotion in binge eating in order to identify different pathways toward binge eating and provide individualized targets for treatment. This is particularly important in light of the fact that for many patients, the current treatments for binge eating are not effective.
|
#Eligibility Criteria:
Inclusion Criteria:
* Female
* Ages 18 <= age <= 35
* with or without current binge eating behaviors
Exclusion Criteria:
* Any contraindication for MRI (orthodontia, vascular stents, metallic ear tubes, metal implants, piercings, etc).
* substance abuse
* traumatic brain injury
* BMI < 18.5
* pregnant women
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02743000
|
{
"brief_title": "Food and the Brain",
"conditions": [
"Binge Eating"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02743000",
"official_title": "Emotion and Reward Processing in Binge Eating",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04",
"study_completion_date(actual)": "2020-04",
"study_start_date(actual)": "2016-01"
},
"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)": "2020-10-20",
"last_updated_that_met_qc_criteria": "2016-04-13",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-19",
"first_submitted": "2016-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia.
Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.
Detailed Description
LYN-005-C-004 is a blinded, multiple-dose, randomized, parallel group, safety, tolerability and PK study of LYN-005 in subjects with a primary diagnosis of schizophrenia or schizoaffective disorder in general good health. Eligible subjects must be clinically stable and receiving a therapeutic dose of an approved oral antipsychotic drug for a minimum of 6 weeks at the time of Screening. Enrolled subjects will be evaluated under steady-state conditions on commercially-available IR risperidone tablets and then assigned in blinded fashion either to LYN-005 weekly or continued encapsulated IR risperidone daily for 3 weeks to attain (or continue) steady-state exposure.
#Intervention
- DRUG : LYN-005
- LYN-005 (14 or 28 mg weekly) plus IR risperidone matched placebo.
- Other Names :
- Risperidone
|
#Eligibility Criteria:
Inclusion Criteria: Eligibility for this study was met if each one of the following inclusion criteria was satisfied at Screening (or at baseline when specified):
* Male or female aged >=18 and <=50 years.
* Current diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 criteria as confirmed by the MINI 7.0.2.
* The following psychiatric criteria were used to determine subject eligibility:
1. Duration of diagnosis of schizophrenia or schizoaffective disorder of >=2 years.
2. Outpatient; not hospitalized for worsening of schizophrenia within the last 6 months (partial hospitalization for social management within this time period is acceptable).
3. Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months.
* Stabilized on an oral antipsychotic medication (single agent) for a minimum of 6 weeks at the time of Screening.
* On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month prior to the Screening visit and for the duration of the study.
* CGI-S score of <=4 (moderately ill).
* PANSS score of <=80 points.
* Body mass index (BMI) of >=18 kg/m2 and <=35 kg/m2.
* Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
* Willing to comply with all protocol-specified procedures and availability for the duration of the study.
* Subject has identified a caregiver or personal contact with whom the subject communicates with at least once a week.
Exclusion Criteria: Subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at Screening (or at baseline when specified):
* Subjects with known clinically significant esophageal or GI disease, including but not limited to:
1. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or subjects with high risk of stricture, e.g., Crohn's disease.
2. Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
3. Prior varices or small or large bowel obstructions.
4. Prior abdominal or upper gastrointestinal surgery (prior uncomplicated laparoscopic procedures including appendectomy or colectomy).
5. History of dysphagia or aspiration in the last 5 years.
6. History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder.
7. Significant history of diarrhea or constipation within 3 months of Screening
8. Multiple episodes of abdominal pain within 3 months of Screening.
9. Subjects who experience moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) within 3 months of Screening.
10. History of moderate to severe Acid Reflux Disease or a score of >=2 on the Acid Reflux Severity Scale (ARSS) [2], indicating moderate to severe symptoms. The ARSS scale is as follows:
None = 0 no symptoms Mild = 1 awareness of symptom, but easily tolerated Moderate = 2 discomfort sufficient to cause interference with normal activities Severe = 3 incapacitating, with inability to perform normal activities.
* Subjects with PILL-5 questionnaire score of 5 or greater.
* Medical history or current diagnoses indicating the presence of any of the below conditions:
1. Presence of an uncontrolled, unstable, clinically significant medical condition could that could put the subject at risk because of participation in the study, interfere with the subject's ability to participate in the study or influence the interpretation of safety or PK evaluations.
2. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure with 6 months of Screening.
3. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
4. Known immunocompromised status, including individuals who have undergone organ transplantation, on immunosuppression for an immunemediated disease, or are positive for human immunodeficiency virus (HIV).
5. Subjects with a positive test for active hepatitis B or C at Screening. Subjects with successfully treated hepatitis B infection which has been resolved for greater than 1 year or successfully treated hepatitis C infection will not be excluded.
6. Subjects who have donated more than 250 mL of blood within 30 days of Screening.
7. Subjects who have difficulties with venipuncture/cannulation, including difficulty accessing veins for blood sampling and/or history of coagulopathy or endocarditis.
8. Subjects with a current DSM-5 diagnosis of major depressive episode, panic disorder, agoraphobia, social anxiety disorder, obsessive- compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the MINI 7.0.2 or in the judgment of the Investigator. (Note that individuals with depression secondary to schizoaffective disorder are eligible).
9. Suicidal ideation associated with actual intent and a method or plan in the past 6 months, as measured by the C-SSRS (i.e., 'Yes' answers on items 4 or 5) at Screening or having made a suicide attempt within the last 2 years.
10. Known or suspected (non-febrile) seizure disorder.
11. History of neuroleptic malignant syndrome.
12. Current or history of clinically significant tardive dyskinesia.
13. Known or suspected diagnosis of intellectual disability or organic brain disorder or other diagnosis that is primarily responsible for current symptoms and functional impairment.
14. Medically non-adherent in the management of their schizophrenia/schizoaffective disorder.
* Use of the below medications/treatments in the 2 weeks before enrollment, including:
1. Proton pump inhibitors or H2 blockers.
2. Prokinetic agents.
3. Medications that may interfere with the absorption, metabolism, or excretion of risperidone, e.g.:
Drugs metabolized via CYP3A4 pathway, such as macrolide antibiotics and azole antifungals). Moderate or strong CYP3A4 p-glycoprotein (P-gp) enzyme inducers and inhibitors (carbamazepine, phenytoin, rifampicin, phenobarbital, itraconazole, verapamil). Moderate or strong CYP2D6 inhibitors (e.g., fluoxetine, fluoxetine combinations, paroxetine), or quinidine.
4. Concomitant medications, natural remedies, supplements or vitamins which are associated with changes to gastric motility or pH. Use of antacids is permissible, except within 2 hours of dosing with LYN-005.
5. Benzodiazepines; except lorazepam, diazepam and oxazepam, which are acceptable if for the treatment of depression, anxiety or insomnia.
6. Use of more than one antidepressant; or if on just one, a change in dose within 6 weeks of Screening.
7. Depot antipsychotic use within 9 months of Screening.
8. Electroconvulsive therapy within 3 months of Screening.
* Subjects with clinically significant abnormal safety (e.g. physical examination, vital sign) or safety laboratory assessments, specifically:
1. Presence of a clinically significant abnormal laboratory result on blood or urine safety tests at Screening.
2. Anemia (hemoglobin below lower limit of normal reference range) at Screening.
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) >=3.0 × upper limit of normal (ULN), or total bilirubin >=1.5 × ULN.
4. Moderate or severe renal insufficiency at Screening (glomerular filtration rate <60 mL/min, as determined using the Cockcroft-Gault formula).
5. Heart rate of <50 beats per minute (bpm) at Screening.
6. Systolic blood pressure <=100 or >=150 and/or diastolic blood pressure <=60 mmgHg or >=100 mmHg at Screening.
7. HbA1c >=6.5% at Screening.
8. Positive fecal occult blood test at Screening
9. Clinically significant prolactin elevation (>=200 ng/mL for females; >=100 ng/mL for males).
* Subjects with the below specified patterns of substance use at Screening:
1. Fulfillment of the DSM-5 criteria for moderate or severe substance use disorder (excluding nicotine and caffeine) within 6 months of Screening.
2. History of alcohol consumption exceeding moderate use; in males exceeding 21 units per week and in females exceeding 14 units per week (1 unit = 360 ml beer, 25 mL of 40% spirit or a 125 mL glass of wine) over the past month. Subjects are not permitted to consume alcohol during the inpatient stay nor 12 hours before any clinic visit while outpatient.
3. Positive ethanol breathalyzer.
4. Positive urine drug screen for substances of abuse other than cannabis.
5. Heavy nicotine use (consumption of >40 cigarettes or >36 mg of nicotine from other sources [e.g., vaping products] daily) or daily use of smokeless tobacco.
* Subjects of reproductive potential who are (hetero) sexually active but unwilling to use acceptable means of contraception through the EOS. For clarity, subjects who are at least 1 year post-menopausal are not of reproductive potential. Acceptable means of contraception include:
1. Subjects who have been surgically sterilized.
2. Females of reproductive potential: diaphragm, injectable, oral/patch contraceptives for a minimum of 6 weeks, contraceptive sponge, implant, or intrauterine device in use prior to enrollment.
3. Males: condom in combination with any of the above means of contraception.
4. All subjects: abstinence may be an acceptable means of contraception as long as the individual consents to initiate immediate use of double barrier protection for the duration of the study should (hetero) sexual intercourse occur.
* Subjects who are nursing or who have positive or indeterminate pregnancy tests at either Screening (serum test) or enrollment (urine test).
* Use of any experimental agent within 1 month or 5 half-lives of Screening, whichever is longer.
* Subjects who are employees or immediate family members of employees of the site, Sponsor or study-related vendors.
* History of a serious allergic or hypersensitivity reaction to risperidone or LYN-005 excipients (refer to Investigator's Brochure).
* Subjects with history of X-ray, computed tomography (CT) scan or angiogram of the abdomen within one year of Screening.
* Subjects with CYP2D6 poor or underdetermined metabolizer status based on genetic testing.
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
|
NCT04567524
|
{
"brief_title": "A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules",
"conditions": [
"Schizophrenia Schizoaffective"
],
"interventions": [
"Drug: LYN-005"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04567524",
"official_title": "A Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Risperidone Extended Release Capsules in Subjects With Schizophrenia, Schizoaffective Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-22",
"study_completion_date(actual)": "2020-12-22",
"study_start_date(actual)": "2020-08-13"
},
"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)": "2023-02-08",
"last_updated_that_met_qc_criteria": "2020-09-23",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-28",
"first_submitted": "2020-09-16",
"first_submitted_that_met_qc_criteria": "2023-01-11"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.
#Intervention
- DIAGNOSTIC_TEST : Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
- Patient self-sampling swab kit to collect a vaginal sample for HPV testing
- DIAGNOSTIC_TEST : Clinician-collection of cervical sample for HPV testing
- Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)
|
#Eligibility Criteria:
Inclusion Criteria:
* Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
* Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).
Exclusion Criteria:
* Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
* Excluded if no cervix (history of total hysterectomy).
* Excluded if moderate to heavy vaginal bleeding on the day of the visit.
* Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.
* Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure).
* Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush.
(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05600283
|
{
"brief_title": "Patient Self-sampling of HPV to Screen for Cervical Cancer",
"conditions": [
"Human Papilloma Virus"
],
"interventions": [
"Diagnostic Test: Clinician-collection of cervical sample for HPV testing",
"Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05600283",
"official_title": "Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-04",
"study_completion_date(actual)": "2024-06-04",
"study_start_date(actual)": "2022-11-16"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-18",
"last_updated_that_met_qc_criteria": "2022-10-26",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-31",
"first_submitted": "2022-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that African Americans (AAs) smoke more for positive reinforcement from nicotine with a 'peak-seeking' pattern of smoking (smoking individual cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while whites smoke more for negative reinforcement with a 'trough-maintaining' pattern (avoiding withdrawal by maintaining more consistent nicotine levels throughout the day by means of a more regular smoking pattern). The investigators believe that these patterns are linked to identifiable racial differences in nicotine pharmacology and that there will be associated racial differences in responses to pharmacologic interventions.
Detailed Description
Smoking is the major preventable cause of cancer, premature cardiovascular disease and chronic obstructive lung disease, reproductive problems and infections. AA smokers have a substantially higher risk of cancer and reproductive disorders compared to whites. A recently published large cohort study (183,000 subjects) found a two-fold higher incidence of lung cancer in AAs compared to whites (at cigarette consumption levels of \<10 and 11-20 CPD, but not for \>30 CPD) (1).
Several lines of evidence indicate that AAs are more highly addicted to cigarette smoking than are whites. AAs are more likely to smoke their first cigarette within 10 minutes of awakening, an indicator of the severity of the dependence.(2) They are more likely to want to quit smoking and are more likely to try to quit (attempts lasting at least 24 hours),(3) but are significantly less likely than whites to be successful abstainers at one year. The quit ratio (former smokers/ever smokers) was recently reported to be 37.3% in AAs compared to 51% for whites.(2)
Research suggests that AAs, who smoke fewer CPD but take in more nicotine per cigarette, are behaving like peak-seekers (smoking primarily for the direct nicotine-mediated positive reinforcement). In contrast, whites, who smoke more CPD with less nicotine intake per cigarette, are behaving more like trough-maintainers (seeking to maintain consistent nicotine levels through the day, presumably to avoid withdrawal symptoms and/or to desensitize receptors).
Studies in our laboratory have shown that AAs metabolize nicotine, and to a greater extent, cotinine, more slowly than do whites (7,10) with slower metabolism by both the CYP2A6 and glucuronidation pathways. We have used the 3HC/COT ratio measured in blood or urine in several studies to show that CYP2A6 activity is lower in AAs compared to whites, including among children. More than 90 CYP2A6 gene variants have been identified. Although many are uncommon and their activity has not been determined (12), some are associated with large individual differences in the rate of nicotine metabolism (13). Studies of CYP2A6 genetics in AAs have only recently been reported. It is unclear whether reported gene variants in AAs can explain the substantial differences in nicotine and especially cotinine metabolism that we have observed in our prior studies. A comprehensive study of nicotine and cotinine kinetics and metabolism after IV dosing in relation to genotype, such as we have recently conducted in whites, is proposed to understand the metabolism of nicotine in AAs.
#Intervention
- DRUG : Deuterated nicotine and cotinine
- used as a marker for pharmacokinetic studies
|
#Eligibility Criteria:
Inclusion Criteria:
* African-American
* Age 18 <= age <= 65
* Smoke at least 5 cigarettes per day
Exclusion Criteria:
* Significant health conditions
* Drug use
* Pregnancy or breastfeeding
* Inability to read English
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
|
NCT00879918
|
{
"brief_title": "Pharmacogenetics of Nicotine Metabolism in African-Americans",
"conditions": [
"Cigarette Smoking"
],
"interventions": [
"Drug: Deuterated nicotine and cotinine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00879918",
"official_title": "Pharmacogenetics of Nicotine Metabolism in African-Americans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2008-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-05-24",
"last_updated_that_met_qc_criteria": "2009-04-10",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-13",
"first_submitted": "2009-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objectives of this Post Marketing Surveillance (PMS) are:
* Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
* Evaluation of the time to reaching maintenance dose of pramipexole
* Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire
#Intervention
- DRUG : Pramipexole
- Other Names :
- Sifrol®
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
* Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
* Male of female patients of any age
Exclusion Criteria:
* The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02248155
|
{
"brief_title": "Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)",
"conditions": [
"Restless Legs Syndrome"
],
"interventions": [
"Drug: Pramipexole"
],
"location_countries": null,
"nct_id": "NCT02248155",
"official_title": "Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-11",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-04"
},
"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)": "2014-09-25",
"last_updated_that_met_qc_criteria": "2014-09-22",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-25",
"first_submitted": "2014-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose: The purpose is to determine effect of game-based virtual reality phone application on nursing students' knowledge and skills on intestinal stoma and peristomal skin care.
Material and methods:This study will be conducted as a single-blind randomized controlled experimental study between March-April 2023. The students in the experimental group will play the developed mobile game on stoma and peristomal skin care as much as they want for 5 days, while the students in the control group will perform skills on stoma and peristomal skin care on the model in the skill laboratory for only one day. After performing the inteventions, the skills and knowledge measurements of the students in both groups will be measured by the researcher through the forms prepared in accordance with the literature. After four weeks, the permanence levels of the students in both groups regarding stoma and peristomal skin care will be measured and the data collection process of the study will be terminated.
#Intervention
- OTHER : Technological education method
- Students in the experimental group will play the mobile application developed for stoma and peristomal skin care and are expected to learn the skill in this way. The students in the control group, on the other hand, will learn stoma and peristomal skin care on a model in the traditional skill laboratory and are expected to learn the skill in this way. Afterwards, the knowledge and skill scores of the two groups will be compared and the results will be reported.
|
#Eligibility Criteria:
Inclusion Criteria:
* To register for the Nursing Fundamentals Course for the first time,
* Participating in theoretical lessons and group work,
* Participating in knowledge and skill assessments on stoma and peristomal skin care,
* Having an Android phone,
* Having internet access,
* Volunteer to participate in the research.
Exclusion Criteria:
* Have any previous training in stoma and peristomal skin care
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
|
NCT05720520
|
{
"brief_title": "Effect of Game-Based Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Care",
"conditions": [
"Healthy"
],
"interventions": [
"Other: Technological education method"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05720520",
"official_title": "Effect of Game-Based Virtual Reality Phone Application on Nursing Students' Knowledge and Skills on Intestinal Stoma and Peristomal Skin Care",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-25",
"study_completion_date(actual)": "2024-02-29",
"study_start_date(actual)": "2023-11-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-15",
"last_updated_that_met_qc_criteria": "2023-01-31",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-09",
"first_submitted": "2023-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery.
Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.
Detailed Description
Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively.
Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.
#Intervention
- PROCEDURE : Total Extraperitoneal repair (TEP)
- Operation for primary inguinal hernias i men
- Other Names :
- Total extraperitoneal patch, Laparoscopic hernia operation, Hernia mesh operation
- PROCEDURE : Lichtenstein
- Operation for primary inguinal hernias i men
- Other Names :
- Open on lay mesh repair, Anterior mesh repair
|
#Eligibility Criteria:
Inclusion Criteria:
* men between 30 <= age <= 75 years
* ASA class I-II
* primary unilateral inguinal hernia
Exclusion Criteria:
* lower midline incision below linea arcuate
* large scrotal hernia
* previously or current abuse,mental disease
* obesity BMI > 35
* another simultaneous operation
* nonreducible hernia
* severe pain in the groin without nonrelated to hernia
* contraindications to general anesthesia
* need of language translator
* liver cirrhosis or ascites
* spread cancer disease
* previously irradiation in the area
* lack of operations indication
Sex :
MALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00803985
|
{
"brief_title": "Study Comparing Total Extraperitoneal Patch 'TEP' Versus Lichtenstein According Chronic Pain",
"conditions": [
"Chronic Pain",
"Sexual Dysfunction"
],
"interventions": [
"Procedure: Total Extraperitoneal repair (TEP)",
"Procedure: Lichtenstein"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT00803985",
"official_title": "A Randomised Controlled Trial Comparing Total Extra-Peritoneal (TEP) to Lichtenstein Inguinal Hernia Repair Concerning Physical Sequelae and Quality of Life at One and Three Years - the TEPLICH Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03",
"study_completion_date(actual)": "2018-03",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-20",
"last_updated_that_met_qc_criteria": "2008-12-05",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-08",
"first_submitted": "2008-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to determine whether dietary inorganic nitrate (in beetroot juice) is able to reduce overall thickening of the heart (left ventricular hypertrophy or LVH) and stiffness of the arteries when given to patients with persistently raised blood pressure (hypertension). Half the patients will receive the beetroot juice containing inorganic nitrate and half will receive beetroot juice from which the inorganic nitrate has been removed. The volunteers will take the juice every day for 4 months.
Detailed Description
In hypertension persistent raised blood pressure (BP) is associated with endothelial dysfunction, arterial stiffness and left ventricular (LV) remodeling that are key phenomena associated with the pathogenesis and complications of hypertension.
One of the main substances that the healthy endothelium produces that is responsible for maintaining the patency of blood vessels is nitric oxide (NO). In hypertension, one of the key pathogenic effects is the dysfunction of the endothelium characterized by a decrease in ability to generate nitric oxide (NO). Previous studies have shown that dietary inorganic nitrate supplementation lowers blood pressure (Kapil et al. 2015), however, whether this approach might also improve endothelial function and LV remodeling is unknown. The effects of inorganic nitrate are due to its conversion in the body to inorganic nitrite and thereafter to NO.
This study will assess the effects of dietary inorganic nitrate on LVH using cardiac magnetic resonance imaging (NITRATE-LVH arm). In addition, the effects of dietary inorganic nitrate on central aortic blood pressure, arterial stiffness using pulse wave velocity and endothelial function using flow mediated dilatation will be evaluated (NITRATE-CBP arm).
#Intervention
- DIETARY_SUPPLEMENT : Beetroot juice
- Beetroot juice (70ml daily) with or without inorganic nitrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
* Aged 18 <= age <= 80 years.
* The study subjects will be hypertensives with evidence of difficulty treating to target BP (daytime ABPM 135 <= age <= 170/85 <= age <= 105 mmHg) on 1 or more antihypertensive agents, with insufficient efficacy or intolerance of medications.
* For NITRATE LVH, echocardiographic evidence of LV hypertrophy (LV mass indexed to body surface area (BSA); males >115g/m2; females >95 g/m2).
* Patients will have been established on an antihypertensive treatment regime for at least 1 month by the time of participation in the study and will not require changes in pharmacological intervention for the duration of the trial.
Exclusion Criteria:
Unless specified, a subject will not be eligible for inclusion in this study if any of the following criteria apply:
* History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
* History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, 3x above the upper limit of normal or bilirubin 1.5x above the upper limit of normal at screening.
* Renal impairment with creatinine clearance (eGFR) of <50 ml/min at screening.
* Patients with diabetes mellitus, defined by previous history of diabetes or HbA1c >6.5% (>48 mmol/mol) at screening.
* Subjects with LDLc, >7.5 mmol/l. TG level >10mmol/l.
* History of heart failure defined as NYHA class II - IV or those with known LV dysfunction (EF<40%) regardless of symptomatic status
* History of malignancy within the past 5 years, other than non-melanoma skin cancer.
* Current life-threatening condition other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study.
* Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
* Subjects who will commence or who are likely to commence regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (other than aspirin), from screening until study completion.
* Any non-stable dosing of ongoing medication regimens throughout the study trial.
* Drug abuse within the past 6 months.
* The subject has a three-month prior history of regular alcohol consumption exceeding an average weekly intake of > 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 21 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine.
* Any other subject whom the Investigator deems unsuitable for the study (e.g. due to other medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study-related study procedures).
* Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
* Subjects with any acute infection, or recent systemic (oral or IV) antibiotics within 1 month of screening, or significant trauma (burns, fractures).
* Subjects who have donated more than 500 mL of blood within 56 days prior to the study medication administration.
* Self reported use of anti-microbial mouthwash or tongue scrapes.
* Concomitant xanthine oxidase inhibitors (such as allopurinol).
* Known history of significant claustrophobia, previous intolerance of CMR imaging or known (or suspected) incompatible metallic implant.
* Pregnancy.
* Allergy to gadolinium-based contrast agents used for CMR.
* Patients with known LVH caused by another established pathology diagnosed prior to or at screening e.g. severe aortic stenosis, hypertrophic cardiomyopathy, amyloidosis and Fabry's disease.
Exceptions to the exclusion criteria:
* For criteria 18, patients can enter the trial if they discontinue the use of anti-microbial mouthwash for the duration of the clinical trial.
* nCriteria 20 and 22 do not apply to participants who will not have a CMR scan in the NITRATE-CBP arm
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
|
NCT03088514
|
{
"brief_title": "Investigation of Dietary Nitrate Effects in Hypertension-induced Target Organ Damage",
"conditions": [
"Hypertension"
],
"interventions": [
"Dietary Supplement: Beetroot juice"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03088514",
"official_title": "Investigation of Dietary Nitrate Effects in Hypertension-induced Target Organ Damage",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-15",
"study_completion_date(actual)": "2023-11-15",
"study_start_date(actual)": "2017-03-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-20",
"last_updated_that_met_qc_criteria": "2017-03-16",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-23",
"first_submitted": "2017-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.
Detailed Description
After a research subject's death during an inhalation study using medications/drugs not approved for this route, the FDA prohibited human use of non-approved chemicals including capsaicin administered via inhalation.
Capsaicin inhalation challenge tests (CICT) were performed on forty men of different ages utilizing pharmaceutical grade Capsaicin. Solutions were mixed by a registered pharmacist and Capsaicin doses, administered to subjects, were analyzed by high performance liquid chromatography (HPLC). Capsaicin solutions were stored in a refrigerator at 4 degrees C and shielded from ultraviolet light for 7 months. There was serial monitoring by spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements.
There were no adverse reactions at any dose, including the highest capsaicin concentration. Serial spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements did not change. The actual amount of pharmaceutical-grade capsaicin measured was 85.5% of the concentrations estimated by the registered pharmacist at time of mixing. The difference was more for the lowest 0.49 uMol dose (28.1) compared to a 2.2% lesser concentration for the 1000 uMol solution. Capsaicin concentrations fell after 3 months of storage.
Dilute capsaicin aerosol inhalation is relatively innocuous and CICT is safe. The actual amount of pharmaceutical-grade capsaicin inhaled by subjects is less than the estimate at mixing. Capsaicin loses potency after 3-months of protected storage. Inhalation studies involving non-approved drugs or chemicals/medications can be safely conducted when they follow the appropriate safety procedures such as described in this investigation.
#Intervention
- BIOLOGICAL : biological/vaccine
- Inhalation studies will immediately be terminated after a significant adverse response to a particular capsaicin dose and no further testing will occur.
- Other Names :
- >12% fall in FEV1, wheezing on chest auscultation or >4 on Symptom Questionnaire
|
#Eligibility Criteria:
Inclusion Criteria:
* Men of ages 18 and 30 (Dates of birth 1973 <= age <= 1985) or 55 <= age <= 92 years (Dates of birth 1911 <= age <= 1948).
* Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years.
* Agrees to volunteers for the study and willing to sign the informed consent form.
* There were negative/normal screening tests for the following
1. Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition.
2. 'Normal' spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69%
3. Impedance oscillometry were within normal limits
4. 'Negative' physical examination of the chest with absence of wheezing and crackles on auscultation of the chest.
5. Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups
Exclusion Criteria:
* men of: ages < 18, 31 <= age <= 54 and >92 years;
* current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years;
* refusal to volunteer for the study and not willing to sign the informed consent form;
* screening test not considered 'normal' by physician/PI and showing one or more of the following:
1. one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.);
2. Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%);
3. 'Positive' physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest;
4. Impulse oscillometry >4 times normal limits;
5. Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 92 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01621685
|
{
"brief_title": "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men",
"conditions": [
"COPD"
],
"interventions": [
"Biological: biological/vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01621685",
"official_title": "The Role of Age on the Human Cough Reflex",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-09",
"study_completion_date(actual)": "2007-09",
"study_start_date(actual)": "2004-09"
},
"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)": "2012-06-18",
"last_updated_that_met_qc_criteria": "2012-06-15",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-18",
"first_submitted": "2010-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
Detailed Description
There is very little data on drug metabolism during pregnancy, and how it may differ from the non-pregnant woman. There is even less data on placental transfer of drug to the neonate when medications are given prior to delivery. This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
The investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the profile of neonatal metabolism of the drug that crosses the placental barrier.
#Intervention
- PROCEDURE : Phlebotomy
- Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
|
#Eligibility Criteria:
Inclusion Criteria:
Adult participant:
* Age 18 <= age <= 45 years
* Term pregnancy (37 <= age <= 42 weeks)
* Delivers by planned cesarean section, or unplanned, non-urgent cesarean section.
* Generally healthy
* Able and willing to sign informed consent
Neonatal participant:
* Male of female
* 37 <= age <= 42 weeks gestation
Exclusion Criteria:
* Adult:Medical condition that would effect metabolism of the study drugs
* Known allergy to either study medication
* Use of medications in the last 48 hours that might induce or inhibit metabolism of ondansetron (e.g. barbiturates, fluconazole, erythromycin, etc.)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01357369
|
{
"brief_title": "Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates",
"conditions": [
"Pregnancy Complications"
],
"interventions": [
"Procedure: Phlebotomy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01357369",
"official_title": "Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2011-01"
},
"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)": "2016-04-21",
"last_updated_that_met_qc_criteria": "2011-05-18",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-20",
"first_submitted": "2011-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Mosaicism within an embryo is defined as the presence of two or more cell populations with different genotypes. Blastocysts classified as mosaic by Preimplamtation Genetic Testing for Aneuploidy (PGT-A) have been reported to implant less and miscarry more frequently than embryos classified as euploid. Because of the unknown impact of mosaicism on embryo development, these embryos are given low priority and are discarded for transfer. However, recent papers on the transfer of human embryos classified by PGT-A as mosaic suggest that embryos with a low fraction of abnormal cells resulting in viable, chromosomally normal ongoing pregnancies, and high-level mosaics resulting in fewer viable pregnancies, but so far none producing mosaic babies.
The apparent presence of mosaicism in an embryo is used as a selection criteria for embryo transfer (ET), introducing a strong bias in terms of patient prognosis and embryo quality. Additionally, it is also possible that some embryos are incorrectly classified as 'mosaic' due to technical variability derived from the processing of a uniform aneuploid embryo.
The aims of this study is to provide evidences about the clinical significance of chromosomal mosaicism in PGT-A cycles by a prospective non-selection based methodology.
Detailed Description
One of the most common reasons why in vitro fertilization (IVF) is unsuccessful, or why miscarriages occur, is because of chromosomal abnormalities in the embryo. Embryos with less than 20% aneuploidy are considered as euploid, while those between 20-80% are reported as mosaic, and those over 80% as aneuploid. Embryos with the correct number of chromosomes (euploid) have a higher chance of leading to a successful pregnancy than those with the incorrect number of chromosomes (aneuploid) or mosaics.
Mosaicism within an embryo is defined as the presence of two or more cell populations with different genotypes. Preliminary data suggested that embryos identified as mosaic by Preimplamtation Genetic Testing for Aneuploidy (PGT-A) may have a reduced chance of implantation compared with euploid and may play a significant role in pregnancy loss.
Because of the unknown impact of mosaicism on embryo development, these embryos are given low priority and are discarded for transfer. They are transferred mostly in poor prognosis patients, explaining the reported lower clinical performances. However, other recent data regarding the transfer of embryos diagnosed as mosaic has shown that embryos with a low fraction of abnormal cells may result in viable, chromosomally normal ongoing pregnancies.
The apparent presence of mosaicism in an embryo is used as a selection criteria for embryo transfer (ET), introducing a strong bias in terms of patient prognosis and embryo quality. Additionally, it is also possible that some embryos are incorrectly classified as mosaic due to technical variability derived from the processing of a uniform aneuploid embryo. Thus, there is an urgent need to understand how to appropriately select and counsel patients regarding such embryos.
This study aims to provide evidences about the clinical significance of chromosomal mosaicism in PGT-A cycles by a prospective non-selection based methodology.
The objectives are to investigate the clinical predictive value for intermediate copy number results consistent with the presence of low mosaicism in TE biopsies, and to validate the thresholds for the classification of embryos in relation with their reproductive potential, providing comprehensive data for clinicians and patients. To demonstrate these objectives, a total of 878 participants are expected to be recruited in 18 months. As the datapoints required for comparison concern embryo transfers rather than participants, this number could be lower depending on the number of embryo transfers received by each participant.
#Intervention
- DIAGNOSTIC_TEST : PGT-A
- PGT-A will be carried out following the usual clinical practice: Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.
|
#Eligibility Criteria:
Inclusion Criteria:
* PGT-A cases for any medical indication and sign the written informed consent form approved by the Ethics Committee (EC) after having been duly informed of the nature of the research and voluntarily accepted to participate in the study.
* Only PGT-A cycles with own oocytes.
* Female age up to 44 years (also included).
* ICSI treatment must be done in all oocytes.
* Have at least one euploid blastocyst or one low-grade mosaicism diagnosis for a single chromosome after PGT-A analysis (excluding aneuploidies compatible with life, e.g. chromosomes 13, 18, 21 and X/Y).
* Single or Double Embryo Transfer (SET or DET). The patient remains included in the study until the 4th ET (fresh or frozen) from the initial stimulation cycle or until patient's enrolment period ends (whichever comes first). The data collected until one of these points will be included in the study, whilst clinical outcomes from additional ET will be disregarded.
Exclusion Criteria:
* No embryo reaching blastocyst stage with a proper morphology for trophectoderm biopsy.
* Embryo transfer coming from the worst grade blastocyst morphology according to Gardner's criteria (Annex 1) will be excluded.
* DET resulting in singletons. (Note: DET resulting in dizygotic twins or implantation failure to the both embryos transferred will be allowed).
* Any illness or medical condition that is unstable or can put patient safety at risk and compliance in the study.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03673592
|
{
"brief_title": "Clinical Value of Mosaicism Diagnosis on the Trophectoderm Biopsies",
"conditions": [
"Aneuploidy",
"Chromosome Abnormality"
],
"interventions": [
"Diagnostic Test: PGT-A"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03673592",
"official_title": "Prospective Non-selection Study to Investigate the Clinical Predictive Value of Chromosome Copy Number Values Consistent With the Presence of Mosaicism Within the Trophectoderm Biopsy (NON-SELECTION MOSAICISM)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-05-20",
"study_start_date(actual)": "2018-09-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-19",
"last_updated_that_met_qc_criteria": "2018-09-14",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-17",
"first_submitted": "2018-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Motor functional neurological disorders (FND) correspond to motor symptoms that are unexplained by an organic lesion but are due to cerebral dysfunction. Patients with these disorders have high rates of disability and health care utilization, and their quality of life is as impaired as that of patients with an 'organic' disease. Accompanying these patients in their often-complex health journey represents a socio-economic and human challenge that demands interdisciplinary collaboration. Rehabilitation is seen as an important part of the therapy for motor FND. However, further research is needed to refine appropriate interventions and to create evidence-based recommendations. In this study, patients suffering from a functional neurological motor disorder of the upper limb will be included in a novel rehabilitation protocol that includes computerized mirror therapy. The study will used a multiple baseline, across subjects, single-case experimental design (SCED). In this type of design, each subject is his own control, with individual parameters being repeatedly measured in the presence and absence of the intervention of interest (computerized mirror therapy). Computerized mirror therapy could restore the coherence between the motor program and its execution. The investigators hypothesize that this process could re-normalize upper-limb motor activity and that this will have a beneficial impact on manual dexterity, quality of life, and mental representation capacities of the upper limb.
The objective of this project is to use the single case experimental design method to investigate the efficacy of rehabilitation with computerized mirror therapy for patients suffering from motor neurological disorders (FND) of the upper limb.
#Intervention
- OTHER : One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.
- atients will be admitted to the day hospital 2 days a week for 9 weeks. They will participate in a one-on-one rehabilitation program conducted by a multidisciplinary team including a physiotherapist, psychomotor therapist, occupational therapist and a physical activity monitor. Patients will also participate in 12 computerized mirror therapy sessions (twice a day, 2 days a week, from week 4 to 6 of the program).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years,
* Included in the PULSES program (University Program of Liaison and Care for Somatoform Etiologies),
* Announcement and explanation of the diagnosis already given to the patient,
* Motivated to participate in the project,
* Diagnosed with any type of motor functional neurological disorder : partial or complete deficits and abnormal movements,
* With a lateralized disorder (limited to one hemi-body) involving at least the upper limb,
* Disorder must primarily involve the distal part of the upper-limb (fingers, wrist),
* Admitted to the day hospital at Henry Gabrielle Hospital during the study,
* Given free, informed consent in writing after being informed orally and in writing of how the study will proceed.
Exclusion Criteria:
* Patients with visual disorders such as uncorrected diplopia, blindness or low visual acuity (corrected or uncorrected),
* Pregnant, parturient and breastfeeding women,
* Patients under a legal protection measure such as guardianship or curatorship
* Patients not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.
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
|
NCT04739176
|
{
"brief_title": "Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.",
"conditions": [
"Functional Neurological Symptom Disorder"
],
"interventions": [
"Other: One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation."
],
"location_countries": [
"France"
],
"nct_id": "NCT04739176",
"official_title": "Evaluation of the Therapeutic Benefit of Rehabilitation With Computerized Mirror Therapy for Patients Suffering From Motor Neurological Disorder (FND) of the Upper Limb.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-08",
"study_completion_date(actual)": "2023-12-08",
"study_start_date(actual)": "2021-03-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-09",
"last_updated_that_met_qc_criteria": "2021-02-01",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-04",
"first_submitted": "2021-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.
Detailed Description
Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition.
Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite.
Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population.
A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.
#Intervention
- DIETARY_SUPPLEMENT : Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey
- The intervention will assess the effects of three difference varieties of plant-based protein and fibre supplements on net peripheral amino acid appearance in blood compared to whey protein with matched fibre content as a control arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* Community-dwelling, Age 65+ years, not a heavy smoker (<=10/day), BMI 18 <= age <= 30 kg/m2
Exclusion Criteria:
* Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (>10/day)
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05420142
|
{
"brief_title": "Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products",
"conditions": [
"Aging",
"Undernutrition",
"Appetite Loss",
"Age-Related Sarcopenia"
],
"interventions": [
"Dietary Supplement: Net peripheral AA appearance following ingestion of 3 selected PPF products compared to whey"
],
"location_countries": [
"Italy",
"Ireland"
],
"nct_id": "NCT05420142",
"official_title": "Innovative plAnt Protein Fibre and Physical Activity Solutions to Address Poor appEtite and prevenT undernutrITion in oldEr Adults (APPETITE): Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-12",
"study_completion_date(actual)": "2022-07-31",
"study_start_date(actual)": "2022-03-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-26",
"last_updated_that_met_qc_criteria": "2022-06-14",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-15",
"first_submitted": "2022-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.
Detailed Description
Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.
Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 'preparatory' intervention and then monthly 8 'maintenance' individualized management sessions. The control arm received standard of care.
#Intervention
- BEHAVIORAL : Adherence support
- One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills)
+ One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions
- Other Names :
- Nurse-led multifactorial intervention, Individualised management
|
#Eligibility Criteria:
Inclusion Criteria:
* adult (>=18)
* chronic hemodialysis >=1 month
* treated with phosphate binders
* Dutch-speaking
Exclusion Criteria:
* receiving professional medication care
* cognitive impairment
* nursing home residents
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
|
NCT02063490
|
{
"brief_title": "Nurse-led Intervention to Improve Phosphate Binder Adherence",
"conditions": [
"End Stage Renal Failure on Dialysis"
],
"interventions": [
"Behavioral: Adherence support"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02063490",
"official_title": "A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2011-11"
},
"study_design": {
"allocation": "NON_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)": "2014-02-14",
"last_updated_that_met_qc_criteria": "2014-02-12",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-14",
"first_submitted": "2014-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This single centre study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.
Detailed Description
This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily use.
#Intervention
- OTHER : Stannous fluoride
- 0.454% weight by weight (w/w) stannous fluoride containing 1100 parts per million (ppm) fluoride
- OTHER : Sodium monofluorophosphate
- 0.76% w/w sodium monofluorophosphate containing 1000 ppm fluoride
|
#Eligibility Criteria:
Inclusion Criteria:
* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged 18 <= age <= 65 years.
* Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination and absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
* Understands and is willing, able and likely to comply with all study procedures and restrictions.
* At Visit 1 (Screening): Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years; Minimum of 20 natural teeth; Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR), tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of <=1, tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
* At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple <= 20g) and evaporative air assessment (Schiff sensitivity score >= 2)
Exclusion Criteria:
* A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
* A woman who is breast-feeding.
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, previous participation in this study and any participant who was randomised for inclusion in study 205710
* Recent history (within the last year) of alcohol or other substance abuse.
* An employee of the sponsor or the study site or members of their immediate family.
* Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes and any condition which, in the opinion of the investigator, causes xerostomia.
* Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments), Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of screening and vital teeth bleaching within 8 weeks of Screening.
* Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening, tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, dental implants, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine and sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator.
* Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients).
* Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering andanti-inflammatory drugs, currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
* Any participant who, in the judgment of the investigator, should not participate in the study.
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
|
NCT02923895
|
{
"brief_title": "To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)",
"conditions": [
"Dentin Sensitivity"
],
"interventions": [
"Other: Stannous fluoride",
"Other: Sodium monofluorophosphate"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02923895",
"official_title": "A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-16",
"study_completion_date(actual)": "2016-12-16",
"study_start_date(actual)": "2016-10-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-29",
"last_updated_that_met_qc_criteria": "2016-10-04",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-05",
"first_submitted": "2016-10-04",
"first_submitted_that_met_qc_criteria": "2018-06-15"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate development of hemolysis and the variation in isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)
1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to weekly treatment with subcutanoeus immunoglobulin (SCIG)
2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.
Hypotheses
* During treatment with IVIG blood hemoglobin will fluctuate with a decline due to infusion, whereas it will remain stable during SCIG treatment without fluctuation
* Isokinetic muscle strength in affected muscle groups is more stable during treatment with SCIG than with IVIG
* Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or Hizentra® and Gammanorm® treatment
Detailed Description
Due to planned switch of treatment with immunoglobulin at Department of neurology (Rigshospitalet) patients treated with IVIG will be shifted to treatment with SCIG with an unaltered dosage. The medication is administered at home two or three times weekly. IVIG is often administered every 3 to 6 weeks. All patients will be trained in managing the treatment with SCIG by a nurse from the neurological department. When the patient is able to manage the treatment regimen it can be done at home.
All patients will be evaluated eight times during the study period. Four times before and four times after shift of treatment.
Prior to participation the intervals will be standardized to 3 or 6 weeks giving an extra infusion for those with an interval of 3 weeks, i.e. patients on 4-week interval will be switched to 3-week interval while patients on 5-week interval will be switched to 6-week interval. The dose will be adjusted leading to an unchanged weekly dose of IVIG. All patients will be evaluated in connection to two IVIG infusions. For those receiving 3 infusions examinations will be executed before and 2 weeks after the first and last infusion. SCIG is initiated 2 weeks after the last IVIG infusion.
Patients on maintenance therapy with Subcuvia® or Hizentra® will be shifted to treatment with Gammanorm® according to guidelines from the Danish Healthcare Society, the weekly dose of immunoglobulin being unaltered. They will be evaluated 3 times (once before, at the time of shift of SCIG and once after).
All evaluations at each time point in both groups consist of measurement of isokinetic muscle strength of four affected muscle groups and blood sampling detecting blood hemoglobin and hemolytic parameters.
#Intervention
- DRUG : Immunoglobulins
- SCIG dosage is individualized for each patient according to previous IVIG dosage
- Other Names :
- Gammanorm(R), immunoglobulin for subcutaneous use
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with CIDP or MMN fulfilling the EFNS/PNS criteria
* Maintenance treatment with IVIG or SCIG for at least 3 months
* Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study
Exclusion Criteria:
* Pure sensory or severe ataxic CIDP
* Other cause of neuropathy (incl. pressure neuropathy)
* Known history of adverse reactions to IgA in other products
* Exposure to blood or any blood product or plasma derivatives, other than Privigen, within the past 3 months prior to first infusion of Gammanorm
* Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products.
* Requirement of any routine premedication for IgG administration
* History of malignancies of lymphoid cells and immunodeficiency with lymphoma
* Severe liver function impairment (ALAT 3 times above upper limit of normal)
* Known protein-losing enteropathies or proteinuria.
* Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of Gammanorm
* Treatment with any investigational medicinal product within 3 months prior to first infusion of Gammanorm
* Medication interfering with hematopoiesis
* Other immunomodulation therapy than low dose steroid (Prednisolone < 25 mg daily)
* Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of Gammanorm
* Known or suspected HIV, HCV, or HBV infection
* Pregnant or nursing women
* Planned pregnancy during course of the study
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
|
NCT02111590
|
{
"brief_title": "Immunoglobulin Dosage and Administration Form in CIDP and MMN",
"conditions": [
"Chronic Inflammatory Demyelinating Polyneuropathy",
"Multifocal Motor Neuropathy",
"Hemolytic Anemia"
],
"interventions": [
"Drug: Immunoglobulins"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02111590",
"official_title": "The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-07",
"study_start_date(actual)": "2014-01"
},
"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)": "2015-09-22",
"last_updated_that_met_qc_criteria": "2014-04-10",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-11",
"first_submitted": "2014-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
After surgical procedures, interventions to reduce postoperative pain and bleeding are of great importance. In this study, the effect will be investigated of smearing common drugs, which are designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. Although beneficial effects of such an easy and low-cost intervention would be expected, the investigators have found no previous reports on blinded and controlled studies.
Detailed Description
The drugs to be studied on whether they reduce bleeding are adrenaline (constricts blood vessels) and tranexamic acid (TXA) (prevents bloodclots from dissolving). The drug studied to what extent it reduces pain will be bupivacaine, a common local anaesthetic. Patients undergoing bilateral symmetric breast surgery or single sided mastectomies are candidates for enrollment in the study. The bilateral patients will have two identical procedures and hence two identical wounds in the same patient. This enables the investigators to use one side as control and hence design our study arms as prospective and placebo-controlled. The patients undergoing a one-sided procedure will need to be compared to similar patients, but as wounds will be of different sizes and in different people, larger groups are needed to find significant differences between treatment and controls.
#Intervention
- DRUG : Tranexamic Acid
- Topical administration - does it reduce surgical bleeding?
- DRUG : Bupivacaine
- Topical Bupivacaine- does it reduce surgical pain?
- Other Names :
- Marcaine
- DRUG : Adrenaline
- Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
- DRUG : tranexamic acid plus saline
- DRUG : saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing unilateral simple mastectomy
* patients undergoing bilateral symmetric breast surgery
Exclusion Criteria:
* pregnancy
* A history of former thromboembolic events (to receive TXA)
* cardiovascular disease (to receive adrenaline)
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
|
NCT01964781
|
{
"brief_title": "The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain",
"conditions": [
"Pain, Postoperative",
"Postoperative Hemorrhage"
],
"interventions": [
"Drug: Tranexamic Acid",
"Drug: saline",
"Drug: tranexamic acid plus saline",
"Drug: Adrenaline",
"Drug: Bupivacaine"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01964781",
"official_title": "The Effect of Topical Administration of Tranexamic Acid, Adrenaline and Bupivacain on Postoperative Bleeding and Pain in Patients Undergoing Breast Surgery. A Four-armed Placebo-controlled Double Blinded Randomized Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-17",
"last_updated_that_met_qc_criteria": "2013-10-14",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-17",
"first_submitted": "2013-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o
#Intervention
- DRUG : Iron sucrose
- 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
- Other Names :
- Venofer
- DRUG : Erythopoietin stimulating agent
- Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
- Other Names :
- Neorecormon
|
#Eligibility Criteria:
Inclusion Criteria:
* All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months
Exclusion Criteria:
* Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.
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
|
NCT02707757
|
{
"brief_title": "Treatment Response in Dialysis Anaemia",
"conditions": [
"Anaemia",
"Haemodialysis"
],
"interventions": [
"Drug: Erythopoietin stimulating agent",
"Drug: Iron sucrose"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02707757",
"official_title": "Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2017-04",
"study_start_date(actual)": "2015-07"
},
"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)": "2021-04-14",
"last_updated_that_met_qc_criteria": "2016-03-08",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-14",
"first_submitted": "2016-02-23",
"first_submitted_that_met_qc_criteria": "2021-02-16"
}
}
}
|
#Study Description
Brief Summary
This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dL.
#Intervention
- DRUG : MK-8666
- MK-8666, capsules, oral, QD, Days 1 to 14
- DRUG : Placebo
- Placebo, capsules, oral, QD, Days 1 to 14
|
#Eligibility Criteria:
Inclusion Criteria:
* If female, must be either postmenopausal or surgically sterile
* A Body Mass Index (BMI) >=18 kg/m^2 to <=40 kg/m^2, inclusive.
* A diagnosis of T2DM
* Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded)
* Judged to be in good health except for T2DM
* Willing to follow a standard weight maintaining diet throughout the study
* A nonsmoker or has not used nicotine or nicotine-containing products for at least 3 months
Exclusion Criteria:
* A history of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* A history of myositis or complaints including diffuse myalgias, muscle tenderness, or weakness.
* A history of cancer (malignancy) excepting adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
* Has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux, early satiety)
* A history of type 1 diabetes mellitus and/or history of ketoacidosis
* Taking a medication for a co-morbid condition that is not permitted during the study
* A history of significant multiple and/or severe allergies
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
* Had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study participation
* Participated in another investigational trial within 4 weeks prior to study participation
* Consumes excessive amounts of alcoholic or caffeine-containing beverages
* A regular user of illicit drugs or a history of drug or alcohol abuse within the past year
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
|
NCT01971554
|
{
"brief_title": "Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Placebo",
"Drug: MK-8666"
],
"location_countries": null,
"nct_id": "NCT01971554",
"official_title": "A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Type 2 Diabetes Mellitus Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04-26",
"study_completion_date(actual)": "2014-04-26",
"study_start_date(actual)": "2013-10-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-10",
"last_updated_that_met_qc_criteria": "2013-10-23",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-29",
"first_submitted": "2013-10-14",
"first_submitted_that_met_qc_criteria": "2016-10-14"
}
}
}
|
#Study Description
Brief Summary
This is an observational study, in which people recovering from COVID-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. The assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.
Detailed Description
The recent spread of COVID-19 has led to an international pandemic, with \>3 million confirmed cases to date worldwide, of which 1 million confirmed cases and \>50,000 deaths have been reported in the USA. Infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. Emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. Given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in People recovering from COVID-19 (PrC-19) and associated with poorer outcomes.
The investigators will offer comprehensive swallowing assessments to PrC-19 after initial recovery and a confirmed negative test for continuing COVID-19 infection. Study sites will be located in the Toronto area (PI Steele); the Hamilton-Niagara region to the west of Toronto (Co-I Namasivayam-MacDonald) and in Gainesville, Florida (Co-I Plowman). The assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. Detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the PI's NIH-funded research program exploring swallowing physiology on liquids of different consistencies.
#Intervention
- DIAGNOSTIC_TEST : Videofluoroscopic Swallowing Study (VFSS)
- A standardized dynamic radiographic examination of oropharyngeal swallowing
|
#Eligibility Criteria:
Inclusion Criteria:
* People who tested positive or received a presumed positive diagnosis of COVID-19 infection not earlier than March 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of COVID-19 infection
* Adequate comprehension of English to understand the consent form and follow study instructions
Exclusion Criteria:
* Age under 18 years
* Current pregnancy
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
|
NCT04537650
|
{
"brief_title": "Swallowing Impairment After COVID-19 Infection",
"conditions": [
"Covid19"
],
"interventions": [
"Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT04537650",
"official_title": "The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-31",
"study_completion_date(actual)": "2022-03-31",
"study_start_date(actual)": "2021-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-06",
"last_updated_that_met_qc_criteria": "2020-09-01",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-03",
"first_submitted": "2020-09-01",
"first_submitted_that_met_qc_criteria": "2023-12-05"
}
}
}
|
#Study Description
Brief Summary
This study examined the effects of 8 months of Yoga training on bone density and bone turnover markers in premenopausal women, ages 35-50 years. The style of Yoga used was power Yoga that involved postures with a jumping component. The investigators hypothesized that the Yoga intervention would result in beneficial improvements in bone turnover markers, by increasing the bone formation marker and decreasing the bone resorption marker.
#Intervention
- OTHER : Yoga Group
- 8 months of Yoga training
|
#Eligibility Criteria:
Inclusion Criteria:
* participants had not been engaged in resistance training or in Yoga exercise for at least 12 months prior to the study
* did not have chronic back or joint problems or cardiovascular disease
* not taking antihypertensive drugs or any medication that affects bone density
* not taking hormonal contraception
* they self-reported having regular menstrual cycles.
Exclusion Criteria:
* body weight more than 300 pounds
Sex :
FEMALE
Ages :
- Minimum Age : 35 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02163668
|
{
"brief_title": "Effects of Yoga on Bone Metabolism in Premenopausal Women",
"conditions": [
"Bone Health",
"Osteoporosis"
],
"interventions": [
"Other: Yoga Group"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02163668",
"official_title": "Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2012-04",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-16",
"last_updated_that_met_qc_criteria": "2014-06-13",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-16",
"first_submitted": "2014-06-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF.
Detailed Description
This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF. At randomization, the duration of the current episode of persistent AF must be shown to be greater than 7 days and not greater than 3 months, as confirmed by two ECGs (one ECG must be a 12-lead ECG) and further patient enquiry (including doctor visits, hospital admissions, symptom onset, etc.).
A sample size re-evaluation will be performed to avoid an underpowered study because of imprecise estimates for the study population or overoptimistic parameter estimates. Therefore, an interim analysis will re-evaluate sample size assumptions after approximately 15 patients per study arm (\~50 % of planned sample) have completed the treatment phase (Visit 8) of the study. Predefined rules will govern the decision for adjustment of sample size.
Patients will be monitored for cardiac events throughout the study using an Implantable Cardiac Monitor (ICM). Safety will be monitored throughout the study. Blood samples will be collected in pre-specified windows for popPK analysis and at pre-specified timepoints for PK/PD analysis. Patients will be provided with a diary to record timing of drug administration and clinical symptoms while not on site. Diaries will be reviewed and checked for compliance at each non-resident visit to the clinical site.
#Intervention
- DRUG : OMT-28
- 1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).
- DRUG : Placebo
- 1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).
|
#Eligibility Criteria:
Inclusion Criteria:
* Males or females between 18 and 85 years.
* Patients with persistent AF for > 7 days but <= 3 months suitable for electrical DCC.
* Male patients must be surgically sterile for at least 90 days or will be required to use a male condom with spermicide, and will refrain from donating sperm from the time of the first dose until 90 days after the last dose of study medication.
* Females of childbearing potential (postmenarchal, not surgically sterile, premenopausal) will agree to follow contraception requirements from the time of signing the Informed Consent Form (ICF) until 90 days after the last administration of study drug.
* Willing and able to give written informed consent before any study-related procedure.
* Willing and able to attend all the visits scheduled in the study.
Main Exclusion Criteria:
* Patients with known concurrent temporary secondary causes of AF
* Patients that have undergone surgical or catheter ablation for AF or atrial flutter.
* Patients with an existing cardiac treatment device, pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
* Patients with a history of ECG abnormalities that, in the opinion of the investigator (or designee), render the patient unsuitable for the study.
* Patients with congestive heart failure (NYHA class III and IV).
* Patients with left atrium size >= 55 mm.
* Patients with left ventricular ejection fraction <= 40 %.
* Known presence of a thrombus in the left atrial appendage, left atrium, left ventricle, aorta, or intracardial mass.
* Patients with moderate or severe mitral stenosis, mitral valve rheumatic disease, unresected atrial myxoma, or a mechanical heart valve and/or other conditions, such as pulmonary embolism, considered to be formal indication for conventional anticoagulation.
* Patients with any acute coronary event, stroke, or percutaneous coronary intervention within 6 months prior to randomization or who are receiving dual antiplatelet therapy.
* Uncontrolled/therapy-resistant bradycardia and/or uncontrolled/therapy-resistant hypertension within a 3-month period prior to randomization.
* Patients having more than two DCCs in the last 6 months. Any unsuccessful pharmacological and/or electrical cardioversion (within prior 3 months).
* Patients with signs of bleeding or conditions associated with a high risk of bleeding.
* Patients taking antiarrhythmic agents within 3 days of planned randomization will be excluded.
* Patients concurrently participating in another study or unable to communicate.
* Patients with active cancer, chronic kidney disease or intercurrent illness.
* Pregnant or breastfeeding women.
* Patients taking concomitant medication.
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
|
NCT03906799
|
{
"brief_title": "Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)",
"conditions": [
"Atrial Fibrillation"
],
"interventions": [
"Drug: OMT-28",
"Drug: Placebo"
],
"location_countries": [
"Hungary",
"Ukraine",
"Czechia",
"Bulgaria"
],
"nct_id": "NCT03906799",
"official_title": "A Placebo-controlled, Double-blind, Randomized, Dose-finding Phase II Study on OMT-28 in MaIntenance of Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (PROMISE-AF)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-20",
"study_completion_date(actual)": "2020-03-20",
"study_start_date(actual)": "2019-03-19"
},
"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)": "2021-09-09",
"last_updated_that_met_qc_criteria": "2019-04-05",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-08",
"first_submitted": "2019-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. Up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). Participants will have a one-hour session weekly for six weeks with daily home practice between sessions. Participants will complete the sessions online with a study iPad. Their home practice will also be installed on the study iPad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. The feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.
#Intervention
- BEHAVIORAL : Mindfulness Meditation
- A standardized and structured program based on Mindfulness Based Cognitive Therapy and Mindfulness Based Stress Reduction and has been piloted in our laboratory.Each session included 1) discussion on stress, relaxation, meditation, and mind-body interaction, 2) instruction and practice in formal and informal MM, and 3) enquiry about problem-solving techniques regarding success and difficulty in practicing mindfulness. Formal meditation instruction included a mindful Body Scan and Sitting Meditation (awareness of breath, body sensations, cognitive and emotional processes). Informal practice of mindful daily activities (e.g., washing dishes) was also taught to generalize mindfulness beyond the formal meditations. A 3-minute meditation was offered as a quick coping strategy, and it could be practiced with or without a guided recording.
- BEHAVIORAL : Education
- The Education control was matched for session time and home practice. The internet sessions included a general health video and questions about the material. For home practice, the participants listened to podcasts about the same topic. The session topics were 1) Healthy Eating, 2) Healthy Exercise, 3) Healthy Sleep, 4) Healthy Brain, 5) Healthy Mood, and 6) Community Involvement.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 65 - 90 years
* Baseline Perceived Stress Scale1 score >= 9
* Stable on medications six weeks prior to and during study
* Willing to learn and use study technology
* Can hear and understand instructions
* Willing to accept randomization scheme and agrees to follow the study protocol
Exclusion Criteria:
* Cognitive impairment limiting ability to give consent or follow the protocol (<=26 on the mTICS)2
* Significant acute medical illness that would decrease likelihood of study completion (self-report).
* Significant, untreated depression, as assessed by CESD-5 >16 during screening.
* Current daily meditation practice (>=5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01946893
|
{
"brief_title": "Mindfulness Meditation for Cognition and Mood",
"conditions": [
"Stress, Psychological"
],
"interventions": [
"Behavioral: Education",
"Behavioral: Mindfulness Meditation"
],
"location_countries": null,
"nct_id": "NCT01946893",
"official_title": "Mindfulness Meditation for Cognition and Mood: A Pilot Study Evaluating Feasibility and Collecting Preliminary Data",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2013-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-13",
"last_updated_that_met_qc_criteria": "2013-09-17",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-20",
"first_submitted": "2013-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a recumbent cycling ergometer. This feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.
#Intervention
- OTHER : Vertical climbing ergometer exercise
- Exercise using the CLMBR, a vertical climbing exercise ergometer.
- OTHER : Recumbent cycling
- Exercise using a recumbent cycle ergometer
|
#Eligibility Criteria:
Inclusion criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Confirmed chronic (>12 weeks) low back pain at screening assessment (based on patient history)
* Ability to comply with the current Mount Sinai Health system COVID-19 requirements for research participants (e.g., vaccination, masks)
Exclusion criteria:
* Criteria will be evaluated during the clinical evaluation at the screening visit. All determinations will be the decision of the study physician:
* Less than 2/10 low back pain on 0 <= age <= 10 numeric rating scale for average pain over past 7 days at baseline assessment
* Any cardiovascular or musculoskeletal contraindication to exercise
* Impaired balance contraindicating exercise
* Known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments
* Current pregnancy
* Current medications or new medications commenced that may impact the ability for change to be detected in study
* Any other contraindication in the opinion of the study physician
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05483608
|
{
"brief_title": "Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain",
"conditions": [
"Chronic Low Back Pain"
],
"interventions": [
"Other: Recumbent cycling",
"Other: Vertical climbing ergometer exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05483608",
"official_title": "Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-12",
"study_completion_date(actual)": "2023-11-12",
"study_start_date(actual)": "2022-11-08"
},
"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)": "2023-12-11",
"last_updated_that_met_qc_criteria": "2022-07-31",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-02",
"first_submitted": "2022-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and effectiveness of CG8020 and CG2505.
Detailed Description
To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas
#Intervention
- BIOLOGICAL : CG 8020 and CG 2505
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
* Chemotherapy naïve or chemotherapy experienced pancreatic cancer
Exclusion Criteria:
* Prior cancer vaccines or gene therapy
* History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
* History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
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
|
NCT00245362
|
{
"brief_title": "A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer",
"conditions": [
"Metastatic Pancreatic Cancer",
"Nonresectable Pancreatic Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00245362",
"official_title": "A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-06",
"study_start_date(actual)": "2002-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-10-28",
"last_updated_that_met_qc_criteria": "2005-10-27",
"last_verified": "2005-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-28",
"first_submitted": "2005-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.
Detailed Description
Before and during the treatment patients will have exams done. These may include blood tests, urine tests, bone marrow tests, tests of the central nervous system, x-rays, or MRI/CT test. These are needed to measure the patient's clinical condition and progress. A physical exam and blood tests (about 2 teaspoons) will be repeated at least one time weekly.
Since Liposomal Vincristine may prevent the body from making and/or keeping new blood cells, prior to treatment patients will also have a Human Immunodeficiency Virus (AIDS virus) test, a blood test to detect the presence of antibodies to the AIDS virus. A separate informed consent will be given to be signed, in order to obtain permission for this test. Female patients may also be required to have a urine pregnancy test before treatment may begin, as it is not known how the drug may affect the unborn child.
Patients will receive liposomal vincristine through a central venous catheter (a plastic tube usually inserted under the collar bone) over one hour, once every 14 days, + 2 days. Patient's will also be given the drug docusate by the day liposomal vincristine is started. This is done to try to prevent constipation as a side effect.
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months. Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor. Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment, and then every 8 weeks.
This is an investigational study. The FDA has authorized the use of the study drug in research. Up to 60 patients will take part in this study. Up to 30 patients will be enrolled at UTMDACC.
#Intervention
- DRUG : Liposomal Vincristine
- Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
- Other Names :
- Vincristine Sulfate Liposome
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed malignancies in the following strata: (As of 09/01/02, the soft tissue sarcoma strata will remain open for new patient accrual. Strata listed in b, c, d, e will be closed to entry).
1. soft tissue sarcoma
2. bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02)
3. Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02)
4. lymphoma(CLOSED TO ENTRY AS OF 09/01/02)
5. leukemia(CLOSED TO ENTRY AS OF 09/01/02)
* Performance status: Zubrod less than 3. Patients with long standing limited mobility requiring the use of a wheelchair will be considered ambulatory for the purpose of this protocol.
* Bidimensionally measurable disease radiologically.
* No anti-cancer treatment within the past 3 weeks.
* ANC greater than or equal to 500; platelets greater than or equal to 50,000; bilirubin less than or equal to 1.5 mg/dl; SGPT less than or equal to 4 x upper normal limit; creatinine less than or equal to 2 x normal. Patients with bone marrow infiltrative disease may be entered irrespective of ANC or platelets.
* Patients may be enrolled after BMT or PSCT if they meet all the above eligibility criteria.
Exclusion criteria:
* HIV positive.
* Serious intercurrent illness, active infections, or second cancer except basal cell carcinoma of the skin or cervical carcinoma in situ.
* Eligible for treatment of a higher priority.
* Pregnancy.
* Grade 3 or 4 sensory or motor dysfunction due to prior vinca alkaloids.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00038207
|
{
"brief_title": "Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies",
"conditions": [
"Soft Tissue Sarcoma",
"Lymphoma",
"Leukemia",
"Wilms' Tumor",
"Osteosarcoma"
],
"interventions": [
"Drug: Liposomal Vincristine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00038207",
"official_title": "Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-09",
"study_completion_date(actual)": "2005-09",
"study_start_date(actual)": "2000-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-31",
"last_updated_that_met_qc_criteria": "2002-05-29",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-05-30",
"first_submitted": "2002-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.
Detailed Description
Stereotactic Ablative Body Radiotherapy (SABR) is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited pulmonary 'oligometastases', SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. In the future, SABR may be an attractive alternative to invasive surgery. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. We aim to conduct the first clinical trial of SABR in patients with limited pulmonary metastases testing fractionated versus single fraction treatments.
The primary aim of this study is to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR in patients with oligometastases to the lung.
The secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction SABR and its prognostic implications for patient outcomes.
#Intervention
- RADIATION : Multi-fraction SABR
- Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
- RADIATION : Single Fraction SABR
- Single fraction SABR; 28Gy delivered in 1 fraction
|
#Eligibility Criteria:
Inclusion Criteria:
* A maximum of three metastases to the lung from any non-haematological malignancy
* Tumour diameter <=5cm
* Targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). Targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible.
* Patients must be medically inoperable, technically high risk or have declined surgery.
Exclusion Criteria:
* Previous high-dose thoracic radiotherapy.
* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators)
* Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
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
|
NCT01965223
|
{
"brief_title": "A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)",
"conditions": [
"Cancer",
"Metastases to the Lung"
],
"interventions": [
"Radiation: Multi-fraction SABR",
"Radiation: Single Fraction SABR"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT01965223",
"official_title": "Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-27",
"study_completion_date(actual)": "2020-07-27",
"study_start_date(actual)": "2015-02-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-04",
"last_updated_that_met_qc_criteria": "2013-10-15",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-18",
"first_submitted": "2013-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).
Detailed Description
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth)preparations. Both are tasteless. To take the product, patients will tear open the sachets, drop the contents directly on their tongue and wash it down with 8 ounces of water.
Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a 'blinded' treatment, which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo.
If, at the end of the first full course of randomized treatment, (8 weeks), patients are not showing an improvement in their condition, they may have the option to receive the alternate blinded treatment for one treatment course (8 weeks). The study doctor will discuss this option with each patient individually. During this second course of treatment, patients will be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be removed from the study at the discretion of the investigator.
If patients respond to either the initial treatment or the alternate blinded treatment, they will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition worsens or they relapse. Patients will not receive any study drug during this follow-up period.
Relapse is defined for this study as:
* an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response (response is defined as at least a 50% reduction in the number of draining fistulas at either Week 8, or for those patients receiving alternate blinded treatment, Week 16).
There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a review of concomitant medications, medical history/adverse events, physical exam, fistula exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body weight. Patients will also be asked to keep a daily diary to record frequency of bowel movements, general well-being, and use of antidiarrheal medication.
Treatment failure in this study is defined by one or more of the following occurring prior to Week 8:
* The need for additional therapies or dose increase for treatment of Crohn's disease, including an increase of corticosteroid dose to higher than baseline
* Clinical/symptomatic development of an abscess
* Clinical/symptomatic evidence of stricture
* The need for surgical intervention for Crohn's disease
* The patient withdraws from the study
Patients will be discontinued from the study at any time if one or more of the following complications occur:
* Development of an abscess or symptomatic stricture
* The need for surgical intervention for Crohn's disease
* Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study
In addition, patients whose CDAI score has risen by \> or = 70 points above baseline or risen above 400 will be discontinued from the study.
Administration of any additional therapies or dose increases of concomitant medications (including corticosteroids) to control Crohn's disease to higher than baseline while receiving study drug (initial randomized treatment or alternate blinded treatment) will require discontinuation of the patient from the study.
Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given.
#Intervention
- DRUG : AST-120
- oral, sachet, 2 grams three times daily for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Body Weight > or = 40kg
* Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
* Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have > or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have > or = 1 draining perianal fistula.
* Crohn's Disease Activity Index (CDAI) score < 400
* Platelet count (thrombocytes) > or = 100,000/uL
* Able and willing to comply with all protocol procedures for the duration of the study
* Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
* Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
Exclusion Criteria:
* Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a > or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included
* Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
* Presence of symptomatic strictures or suggestion of significant clinical obstruction
* Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
* Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
* Platelet count (thrombocytes) < 100,000/uL
* CDAI score of > or = 400
* Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
* Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
* Severe diarrhea defined by > 10 liquid bowel movements per day
* Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
* Presence of an ileostomy
* Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
* Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen
* Women who are pregnant, breast feeding, or planning to become pregnant during the study
* Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
* Uncontrolled systemic disease
* Patients undergoing chemotherapy for the treatment of cancer
* Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used
* Participation in another study within eight (8) weeks prior to the study
* Unable to attend all visits required by the protocol
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
|
NCT00321412
|
{
"brief_title": "Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas",
"conditions": [
"Inflammatory Bowel Disease",
"Intestinal Fistula"
],
"interventions": [
"Drug: AST-120"
],
"location_countries": [
"France",
"Israel",
"Netherlands",
"United States",
"Poland",
"Germany",
"Canada",
"Austria",
"Hungary",
"Czech Republic",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT00321412",
"official_title": "A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-03",
"study_completion_date(actual)": "2008-09",
"study_start_date(actual)": "2006-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-30",
"last_updated_that_met_qc_criteria": "2006-05-01",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-03",
"first_submitted": "2006-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Needle biopsy is a way of determining whether a lung mass is cancerous or benign. Its accuracy was established by research in which patients underwent fine needle aspiration, a kind of needle biopsy that yields samples for cytology (similar to the way a pap smear or a fluid sample would be evaluated for malignant cells). This kind of needle biopsy may supplemented or replaced by core needle biopsy, which yields samples for histology (similar to surgical tissue samples but on a smaller scale) rather than for cytology. Core needle biopsy is believed to be helpful particularly in obtaining a diagnosis in patients who have a lung mass that their doctors think is cancerous but is, in fact, benign. In spite of the advances in needle biopsy, however, there are patients who do receive a pathology report indicating no evidence of cancer but whose lung mass actually is cancerous. The fraction of such patients, among all patients who have no evidence of cancer according to the biopsy, is called the 'false negative rate.' It is approximately 25% for needle biopsies that consist of fine needle aspiration alone. The false negative rate for needle biopsies that include core biopsy samples is not known.
We want to examine the accuracy of needle biopsy in patients who had core samples taken from a lung mass in addition to, or in place of, fine needle aspiration. In this study we will focus on such patients who had no evidence of cancer according to the biopsy, to determine how many actually had a cancer that was missed by the biopsy. To accomplish this goal, we will need to review the medical records of these patients for one of two things: either a definitive diagnosis of the lung mass by some other means (for example, surgical biopsy), or by seeing how the patient does over a period of time (usually in conjunction with medical imaging tests such as chest x-rays or chest CT scans). To establish that a lung mass is benign by observing a patient over time, it is necessary to show that the lung mass disappears, becomes smaller, or remains unchanged in size for 2 years.
Detailed Description
We will review medical records to identify patients who underwent percutaneous needle biopsy of a lung mass between 5/1/01 and 10/30/04. If the pathology report indicates that the biopsy showed no evidence of malignancy, we will examine the medical record for a 'gold standard' diagnosis of the lesion in question, including the pathology result from a surgical resection or a repeat biopsy, imaging follow-up demonstrating regression of the lesion or size stability for at least 2 years, or clinical follow-up for at least 2 years with no clinical evidence of malignant disease. If this information is not available in the University Hospital medical record, we will contact the patient to obtain consent for follow-up using external sources (physician records, imaging studies, pathology reports).
We will derive descriptive statistics (prevalence of malignancy, sensitivity, specificity, and false negative rates). The overall sample size will be \~500 patients who had PTNB of a lung mass within the study period. Approximately 80 are expected to have a biopsy result showing no evidence of malignancy, based on a retrospective review performed under an IRB exemption (87-04, letter dated 9/28/04). The expected proportion of cases with no evidence of malignancy is approximately 0.15. For a 95% confidence interval of 0.15+/-0.075 we will need follow-up information from 61 patients, considering that this is a descriptive study with a dichotomous variable. This gives us a margin for patients who will be lost to follow-up
|
#Eligibility Criteria:
Inclusion Criteria:
* subjects who underwent percutaneous needle biopsy of a lung mass during the study period of 5/1/01 to 10/30/04
Exclusion Criteria:
* subjects will be excluded if at least one core sample was not obtained in the course of the biopsy.
* subjects who had a pathology sample read as 'insufficient for diagnosis'
* subjects who underwent needle biopsy only for infection, to identify a causative organism
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
|
NCT00638352
|
{
"brief_title": "False/Negative Rate of Lung Percutaneous Needle Biopsy",
"conditions": [
"Lung Neoplasm"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00638352",
"official_title": "Determination of the False Negative Rate of Percutaneous Needle Biopsies That Include Core Tissue Samples",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-15",
"last_updated_that_met_qc_criteria": "2008-03-12",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-19",
"first_submitted": "2008-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.
Detailed Description
Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
#Intervention
- PROCEDURE : Renal Denervation
- Sympathetic nerve ablation via transcatheter renal denervation
- Other Names :
- Renal sympathetic nerve ablation
|
#Eligibility Criteria:
Inclusion Criteria:
* Individual is >=18 years
* Individual received renal denervation >=12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
* Systolic Office based blood pressure >=140mmHg
* Individual receives 3 or more antihypertensive drugs including one diuretic
* Individual is willing to provide written informed consent to participate in this study
Exclusion Criteria:
* Individual has hypertension secondary to an identifiable and treatable cause
* Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
* Individual is pregnant, nursing or planning to be pregnant
* Renal artery abnormalities which may affect the procedure
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
|
NCT01834118
|
{
"brief_title": "Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension",
"conditions": [
"Hypertension, Resistant to Conventional Therapy"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT01834118",
"official_title": "Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2013-06"
},
"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)": "2016-07-28",
"last_updated_that_met_qc_criteria": "2013-04-16",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-17",
"first_submitted": "2013-04-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.
#Intervention
- PROCEDURE : hydrotherapy
- hydrotherapy and ankle taping and land-based
- Other Names :
- ankle taping, land-based
|
#Eligibility Criteria:
Inclusion Criteria:
* recurrent ankle sprain in one year
* sustain at least one repeated injury or have the experience of ankle instability feelings or 'giving way'
* not undergoing formal or informal rehabilitation for the unstable ankle in the last three months
* have residual symptoms after recurrent sprain of the ankle
Exclusion Criteria:
* have the history of fracture or surgical procedures in the lower extremity
* have the history of neurological disorders affecting the lower extremities vestibular dysfunction or balance disorder
* allergic to the zinc oxide compound in the adhesive tape
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:
No
|
NCT01298856
|
{
"brief_title": "The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping in Athletes With Chronic Ankle Instability",
"conditions": [
"Sports Rehabilitation Program",
"Hydrotherapy",
"Ankle Instability"
],
"interventions": [
"Procedure: hydrotherapy"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT01298856",
"official_title": "The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping on Ankle Functional Ability and Re-injury Rate in Athletes With Chronic Ankle Instability",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-02-18",
"last_updated_that_met_qc_criteria": "2011-02-16",
"last_verified": "2011-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-18",
"first_submitted": "2011-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized trial of a gamification-enhanced home-based walking program compared with a standard home-based walking program in patients with intermittent claudication. Patients will be provided with a Fitbit device and set an exercise goal. Over the next 16 weeks, patients will receive text message reminders to exercise and daily steps will be tracked. Half of patients will be randomized to a gamified interface that leverages behavioral economic principles to encourage exercise.
Detailed Description
Peripheral artery disease, atherosclerotic vascular disease involving the lower extremities, leads to functional limitation by causing leg pain with ambulation (intermittent claudication). Supervised exercise programs improve walking endurance in patients with intermittent claudication, but many patients are unable to travel to centers for treatment. In a recent trial, a home-based exercise program using wearable fitness trackers and telephone coaching failed to increase walking distance in patients with intermittent claudication, but this intervention did not leverage gamification or health behavior theory. Therefore, a randomized controlled trial was proposed comparing a gamification-enhanced home-based walking program with an attention control in patients with intermittent claudication. Patients in both arms will be provided with a wearable fitness tracker, wear the tracker for 2 weeks to establish a baseline daily step count and set a goal for step increase by the end of the 16-week study period. Patients in the attention control arm will receive daily text messages with a report of their previous day's step count. Patients in the gamification intervention arm will receive automated coaching via daily text messages and the intervention will also involve a precommittment pledge, slow ramp-up of step goals, weekly progression (or regression) through levels with loss-framing of points, and support from a family member or friend. After 16 weeks, change in daily step counts from baseline will be compared between study arms. Secondary behavioral phenotyping analyses will be undertaken to identify psychometric features associated with response to the gamification intervention.
#Intervention
- BEHAVIORAL : Gamification and Social Incentives
- Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 18 years
* Peripheral artery disease, defined as ankle-brachial index < 0.90, lower extremity CT scan or ultrasound consistent with PAD, angiography with >= 70% stenosis in any lower extremity artery, or a history of medical or surgical revascularization
* Owns a smartphone or tablet operating the iOS or Android operating system
Exclusion Criteria:
* Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
* Critical limb ischemia, defined as rest pain, ulceration, or tissue loss involving the lower extremity
* Planned lower extremity revascularization
* Prior above or below the knee amputation
* Require a wheelchair or the use of a walking aid other than a cane
* Currently participating in a supervised exercise program for patients with PAD
* Anticipated life expectancy less than 6 months
* Any other reason why it is not feasible to complete the entire 6-month study
* Step count > 7500/day during the baseline data collection period
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
|
NCT04536012
|
{
"brief_title": "Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease",
"conditions": [
"Peripheral Artery Disease"
],
"interventions": [
"Behavioral: Gamification and Social Incentives"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04536012",
"official_title": "Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (GAMEPAD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-14",
"study_completion_date(actual)": "2024-01-08",
"study_start_date(actual)": "2020-10-05"
},
"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)": "2024-02-23",
"last_updated_that_met_qc_criteria": "2020-08-27",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-02",
"first_submitted": "2020-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Gliomas are the most common primary intracranial malignancy, and behavioral experiments in patients with supratentorial gliomas under sedation have shown potential neurological abnormalities; however, these behavioral experiments are susceptible to external influences. Therefore, more objective evidence is needed to support and extend the existing conclusions. The purpose of this study is to compare the EEG signatures (such as the EEG signal power) at various levels of anesthetics induced sedation in patients with supratentorial glioma in frontal lobe and in patients without intracranial-occupying lesion.
#Intervention
- OTHER : OAA/S=5
- Prior to anesthesia induciton, EEG signatures will be recorded at Observer's Assessment of Alertness/Sedation (OAA/S) score of 5 (awake, eye-close state) for few minutes.
- OTHER : OAA/S=3
- Given sedative anesthetics (propofol, midazolam or dexmetomidine), EEG signatures will be recorded after reaching steady state of OAA/S=3 (responds only after name called loudly and/or repeatedly) for few minutes.
- OTHER : OAA/S=1
- Increasing drug concentration, EEG signatures will be recorded after reaching steady state of OAA/S=1 (does not respond to noxious stimuli) for few minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with supratentorial glioma in right frontal lobe, and patients requiring general anesthesia without intracranial-occupying lesion;
* Aged 18 <= age <= 60 years;
* ASA I to II;
* All those who sign the informed consent form.
Exclusion Criteria:
* Obese patients, BMI>30kg/m2;
* Patients with Mallampati class III to IV airway anatomy;
* Combined with other neurological or psychiatric diseases;
* Combined with disturbance of consciousness;
* Previous intracranial surgery;
* Known or suspected cardiac dysfunction;
* Allergic to intravenous general anesthetics;
* Long-term history of analgesia, sedation and drug abuse.
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
|
NCT04365777
|
{
"brief_title": "EEG Characteristics of Different Sedation Depths in Neurosurgery Patients",
"conditions": [
"Electroencephalography"
],
"interventions": [
"Other: OAA/S=3",
"Other: OAA/S=5",
"Other: OAA/S=1"
],
"location_countries": [
"China"
],
"nct_id": "NCT04365777",
"official_title": "EEG Characteristics of Different Sedation Depths in Patients With Supratentorial Glioma in Frontal Lobe",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-05",
"study_completion_date(actual)": "2021-11-05",
"study_start_date(actual)": "2020-06-18"
},
"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)": "2023-02-06",
"last_updated_that_met_qc_criteria": "2020-04-25",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-28",
"first_submitted": "2020-04-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.
#Intervention
- DRUG : insulin detemir
- DRUG : insulin NPH
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes for at least one year
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
* HbA1C below 11.0%
* Willing to comply with Investigator's instructions
* Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
Exclusion Criteria:
* Impaired renal function
* Impaired hepatic function
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total daily insulin dose of more than 2.00 IU/kg
* Current treatment or expected at the screening to start treatment with systemic corticosteroids
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00605137
|
{
"brief_title": "Safety of Insulin Detemir in Children With Type 1 Diabetes",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 1"
],
"interventions": null,
"location_countries": [
"Japan"
],
"nct_id": "NCT00605137",
"official_title": "Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-04-23",
"study_completion_date(actual)": "2005-04-23",
"study_start_date(actual)": "2004-05-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-24",
"last_updated_that_met_qc_criteria": "2008-01-23",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-30",
"first_submitted": "2008-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
#Intervention
- DRUG : ozenoxacin placebo
- cream
- DRUG : retapamulin 1% ointment
- ointment
- DRUG : ozenoxacin 1% cream
- 1% cream
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1 <= age <= 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
* Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1
Exclusion Criteria:
* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
* Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01397461
|
{
"brief_title": "Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo",
"conditions": [
"Impetigo"
],
"interventions": [
"Drug: ozenoxacin 1% cream",
"Drug: retapamulin 1% ointment",
"Drug: ozenoxacin placebo"
],
"location_countries": [
"Germany",
"South Africa"
],
"nct_id": "NCT01397461",
"official_title": "A Phase III 3 Arms, Multicenter, Randomised, Investigator-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2012-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-07-01",
"last_updated_that_met_qc_criteria": "2011-07-18",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-19",
"first_submitted": "2011-07-12",
"first_submitted_that_met_qc_criteria": "2016-04-12"
}
}
}
|
#Study Description
Brief Summary
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).
#Intervention
- DRUG : Amikacin Inhalation Solution (BAY41-6551)
- 400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
- DRUG : Aerosolized Placebo
- Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant, non-lactating females, 18 years or older
* Intubated and mechanically-ventilated
* Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
* Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
* Impaired oxygenation
* Clinical Pulmonary Infection Score (CPIS) of at least 6
* Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Exclusion Criteria:
* History of hypersensitivity to amikacin or other aminoglycosides
* Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
* Known or suspected bacteremia secondary to Staphylococcus aureus
* A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
* Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment]
* Has been on mechanical ventilation for > 28 days
* Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
* The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
* Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
* Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
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
|
NCT01799993
|
{
"brief_title": "Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia",
"conditions": [
"Pneumonia, Bacterial"
],
"interventions": [
"Drug: Amikacin Inhalation Solution (BAY41-6551)",
"Drug: Aerosolized Placebo"
],
"location_countries": [
"Colombia",
"United States",
"Mexico",
"Taiwan",
"Thailand",
"Canada",
"Australia",
"Brazil",
"Philippines",
"Turkey",
"Czechia",
"Korea, Republic of"
],
"nct_id": "NCT01799993",
"official_title": "A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-07",
"study_completion_date(actual)": "2017-04-07",
"study_start_date(actual)": "2013-04-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-23",
"last_updated_that_met_qc_criteria": "2013-02-25",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-27",
"first_submitted": "2013-02-25",
"first_submitted_that_met_qc_criteria": "2018-05-14"
}
}
}
|
#Study Description
Brief Summary
Stereotactic radiosurgery (SRS) is increasingly administered as the sole treatment of brain metastases, in order to spare acute and long term side effects associated with whole brain radiotherapy. Local control of SRS treated lesions is good, but patients tend to develop additional brain metastases subsequently.
Nivolumab is a modulator of the immune system. Treatment with Nivolumab is associated with an increase in local control and survival in patients with non-small cell lung cancer and clear cell renal cell carcinoma. In the presence of Nivolumab, treatment of brain metastases with SRS may trigger an immune reaction against cancer. Therefore, the combination of SRS with Nivolumab may reduce the development of new brain metastases and improve patient survival.
The purpose of this study is to assess the effect of combining Nivolumab and SRS in controlling cancer progression. SRS will be administered to patients while they are receiving Nivolumab.
#Intervention
- DRUG : Nivolumab
- Nivolumab is administered to patients to a maximum of 2 year.
- RADIATION : Radiosurgery
- Up to 10 cubic centimeter of brain metastases will be treated with radiosurgery. The dose of radiosurgery depends on the size of individual metastases.
- Other Names :
- SRS
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women, >= 18 years
* Willing and able to give written informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 1 within 28 days prior to registration
* Radiation Therapy Oncology Group (RTOG) neurological function score of 0 <= age <= 1 within 28 days prior to registration
* Histologic diagnosis of NSCLC, SCLC, Melanoma OR ccRCC
* Stage IV cancer with brain metastases (Patients may have untreated primary disease)
* Presenting with previously un-irradiated brain metastasis (10 cc maximum volume of brain disease based on the diagnostic screening MRI done within 28 days of registration))
* Measurable/evaluable brain disease
* Having received less than 4 lines of prior systemic treatments
* Ability to be treated with either gamma knife or a linear accelerator based radiosurgery system
* Ability to complete neurocognitive exams without assistance
* Ability to complete QOL questionnaires with or without assistance
* Screening laboratory values must meet the following criteria and should be obtained within 28 days prior to registration:
* White Blood Cell (WBC) >= 2000/uL
* Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
* Platelets>= 100 x 109/L
* Hemoglobin >= 90 g/L (may be transfused)
* Serum creatinine <= 1.5 x Upper Limit of Normal (ULN) or Creatinine Clearance >= 50 ml/min (calculated -cockcroft-Gault)
* Aspartate aminotransferase/alanine aminotransferase (AST/ALT) <=3 x ULN without liver metastasis,<= 5 x ULN with liver metastases
* Total Bilirubin <= 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (28 days plus the time required for Nivolumab to undergo five half-lives) after the last dose of investigational drug
* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of Nivolumab
* Women must not be breastfeeding
* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of Nivolumab product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).
Exclusion Criteria:
* Brain metastasis in the brainstem
* Patients who experienced prior seizures are eligible, however patients should not have had a seizure within 7 days of registration without the use of corticosteroids.
* All other cancer histology other than NSCLC or ccRCC
* Patients who cannot undergo MRI
* Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
* Patients with a condition requiring systemic treatment with either corticosteroids including steroids used for treating peritumoral edema (> 50 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Drugs with a predisposition to hepatoxicity should be used with caution in patients treated with Nivolumab-containing regimen
* Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of Nivolumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
* History of prior treatment with a CTLA-4, PD-1 or PD-L1 inhibitor, CD137 agonist, or anti-PD-L2.
* Concomitant therapy with any of the following: IL-2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness.
* Known history of hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* History of allergy to study drug components.
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
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
|
NCT02978404
|
{
"brief_title": "Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases",
"conditions": [
"Clear-Cell Metastatic Renal Cell Carcinoma",
"Non Small Cell Lung Cancer Metastatic",
"Brain Metastases, Adult",
"Small Cell Lung Cancer",
"Melanoma"
],
"interventions": [
"Drug: Nivolumab",
"Radiation: Radiosurgery"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02978404",
"official_title": "A Phase II, Multi-centre Study, of Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases From Non-small Cell Lung Cancer and Renal Cell Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2017-06-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-28",
"last_updated_that_met_qc_criteria": "2016-11-28",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-01",
"first_submitted": "2016-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.
#Intervention
- OTHER : Vibrating ball
- Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have sustained cervical (neurological level C1-C8) SCI
* Any ISNCSCI severity classification (A, B, C or D)
* Have therapist-reported and self-reported spasticity in the arm or hand
* Ability to pick up, move, and release at least one block (on the Box & Blocks Test)
* May participate if utilizing prescription medications, including baclofen pump for control of spasticity
Exclusion Criteria:
* Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
* Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
* Severe pain or hypersensitivity of the arm/hand
* Current pregnancy
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
|
NCT04020770
|
{
"brief_title": "Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia",
"conditions": [
"Spinal Cord Injuries",
"Tetraplegia"
],
"interventions": [
"Other: Vibrating ball"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04020770",
"official_title": "Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-20",
"study_completion_date(actual)": "2019-02-20",
"study_start_date(actual)": "2018-10-28"
},
"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)": "2019-07-16",
"last_updated_that_met_qc_criteria": "2019-07-15",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-16",
"first_submitted": "2019-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.
The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.
About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.
All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.
Biopsies will be classified using the Updated Sydney system of classification of gastritis
Detailed Description
The patients will be randomized (closed envelopes) into one of two groups:
1. patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
2. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.
H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.
#Intervention
- DRUG : Comparing Load and Concomitant therapy
- Levofloxacin - Omeprazole - nitazoxanide - doxycycline
- Other Names :
- Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients who presented with epigastric pain and dyspeptic symptoms
Exclusion Criteria:
* Patients recently (within 6 months) treated with anti-H. pylori therapy.
* Allergy to any drugs used in our protocol
* Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
* Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
* Presence of GI malignancy.
* Pregnancy or lactating women.
* Unable or refuse to give consent. -
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06050824
|
{
"brief_title": "A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection",
"conditions": [
"H. Pylori Infection"
],
"interventions": [
"Drug: Comparing Load and Concomitant therapy"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06050824",
"official_title": "A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-19",
"study_completion_date(actual)": "2023-07-19",
"study_start_date(actual)": "2022-07-21"
},
"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)": "2023-09-26",
"last_updated_that_met_qc_criteria": "2023-09-16",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-22",
"first_submitted": "2023-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).
Detailed Description
This study will be divided into 3 timepoints:
* Epoch 1- Primary- From Day 1 to Day 301
* Epoch 2-Secondary-From Day 301 to Day 331
* Epoch 3-Safety follow up -From Day 331 to study end (Day 481 or Day 661). For subjects who have not yet reached the 6-month safety follow-up after the last dose at the time protocol amendment 7 takes effect, Visit 7 will take place on Day 481.
In addition to receiving the study vaccines, infants will also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix), to ease the disruption to the standard infant vaccine schedule caused by participating in this study.
#Intervention
- BIOLOGICAL : Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
- Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.
- BIOLOGICAL : Prevnar13
- Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : Pediarix
- Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : Hiberix
- Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : Rotarix
- Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : M-M-R II
- M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : Varivax
- Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
- BIOLOGICAL : Placebo (saline water)
- Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.
- BIOLOGICAL : Prevnar 20
- Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
|
#Eligibility Criteria:
Inclusion Criteria:
All subjects must satisfy all the following criteria at study entry:
* Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits).
* Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
* A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born full-term (i.e. after a gestation period of >= 38 weeks).
Exclusion Criteria:
If any exclusion criterion applies, the subject must not be included in the study:
* Child in care
Each subject must not have:
* Progressive, unstable or uncontrolled clinical conditions.
* Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study.
* Hypersensitivity to latex.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system resulting from:
* Clinical conditions.
* Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth.
* Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth.
* Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
* Received immunoglobulins or any blood products from birth.
* Received an investigational or non-registered medicinal product from birth.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
* Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
* Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
* Study personnel as an immediate family or household member.
* Current or previous, confirmed or suspected disease caused by N. meningitidis
* Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization.
* Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent.
* Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed.
* Serious chronic illness.
* Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
Sex :
ALL
Ages :
- Minimum Age : 6 Weeks
- Maximum Age : 12 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03621670
|
{
"brief_title": "Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants",
"conditions": [
"Infections, Meningococcal"
],
"interventions": [
"Biological: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)",
"Biological: Varivax",
"Biological: Rotarix",
"Biological: Prevnar 20",
"Biological: Hiberix",
"Biological: Pediarix",
"Biological: M-M-R II",
"Biological: Prevnar13",
"Biological: Placebo (saline water)"
],
"location_countries": [
"Puerto Rico",
"United Kingdom",
"United States"
],
"nct_id": "NCT03621670",
"official_title": "Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-27",
"study_completion_date(actual)": "2024-12-27",
"study_start_date(actual)": "2018-07-27"
},
"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)": "2025-01-14",
"last_updated_that_met_qc_criteria": "2018-08-03",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-08",
"first_submitted": "2018-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To test the feasibility of implementing digitally enhanced psychotherapy and research in a community child and adolescent mental health center including the acceptability of the digital technology to patients, parents and therapists.
To use passively collected physiological data and actively collected clinical and biochemical data from the patient and parents to detect and predict episodes of obsessive-compulsive disorder (OCD) -related episodes in children and accommodating behaviour in parents.
Detailed Description
Background: Psychiatric and specifically mechanistic research have stagnated mainly due to the time, labour and bias inherent in human-based technologies that dominate the field. To advance translational and precision psychiatry, researchers within psychiatry must forge long-term collaborations with researchers and developers within technology.
Objectives: To improve assessment and psychotherapy for youth obsessive-compulsive disorder (OCD) through developing an artificial intelligence tool to support patients, parents and therapists in cognitive behavioural therapy. To give an innovative push in the public sector hospitals and research through integration of wearable sensors and machine learning techniques.
Methods: 10 patients (8-17 years) and one of their parents from a child and adolescent mental health center will be recruited as in the larger TECTO project. To examine whether the algorithms can distinguish between patients and typically developing children, 10 typically developing sex and age matched children and one of their parents or guardians will also be recruited from the catchment area. Passively sensed physiological indicators of stress are used as input to privacy preserving signal processing and machine learning algorithms, which predict OCD-episodes, clinical severity and family accommodation. Oxytocin, as a biomarker for family accommodation, is measured through saliva samples. Signal processing will be used to extract acoustic and physiological features of importance for therapeutic response.
Expected results: Results from the proposed project will be used to develop artificial intelligence (AI) tools that support clinicians, patients and parents, which will be implemented and evaluated in a public-sector hospital. Technology-enhanced therapy can be used in a stepped care model, in which subclinical symptoms are first monitored using passive sensors and then AI interventions are offered, supported by a healthcare professional, and when outpatient care is needed, the AI tool can support patient engagement. The results of this project will also advance research in computational science and psychiatry by testing biomarkers of clinical relevance.
#Intervention
- DEVICE : wearable biosensor
- The E4 wristband will be worn by all groups for the duration of the study. It measures blood volume pulse, electrodermal activity, skin temperature, and movement. Patients will be asked to press the event tagging button when they feel stressed by OCD. Control will be asked to press the button when they feel anxious. Parents will be asked to press the button with they notice their child feels stressed by OCD or anxious.
- Other Names :
- E4 wristband
- BEHAVIORAL : Treatment as usual (TAU)
- Patients will receive treatment as usual at the child and adolescent mental health center. TAU can range from waitlist to one session of psychoeducation to group or individual psychotherapy to medication.
- BEHAVIORAL : Exposure and response prevention (ERP)
- One ERP session will be offered in Week 0 and Week 8.
|
#Eligibility Criteria:
Inclusion Criteria:
* OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using K-SADS-PL.
* CY-BOCS > 7: mild (8 <= age <= 15), moderate (16 <= age <= 23), severe (24 <= age <= 31), extreme (32 <= age <= 40)
* A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis.
* Patient is age 8 through 17 years (both inclusive).
* Signed informed consent.
Exclusion Criteria:
* Participation in other OCD trials.
* Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0 <= age <= 84.4 + F84.8 <= age <= 84.9)), schizophrenia/paranoid psychosis (ICD-10 F20 <= age <= 25 + F28 <= age <= 29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
* Intelligence Quotient <70.
* Any condition (e.g. allergies, eczema, hypersensitivity due to Asperger's syndrome) that would prevent the child or parent from wearing a wristband biosensor.
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05064527
|
{
"brief_title": "A Wearable AI Feedback Tool for Pediatric OCD",
"conditions": [
"Obsessive-Compulsive Disorder"
],
"interventions": [
"Behavioral: Exposure and response prevention (ERP)",
"Device: wearable biosensor",
"Behavioral: Treatment as usual (TAU)"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT05064527",
"official_title": "Wrist Angel: A Wearable AI Feedback Tool for OCD Treatment and Research",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-19",
"study_completion_date(actual)": "2023-01-19",
"study_start_date(actual)": "2021-09-15"
},
"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)": "2023-02-03",
"last_updated_that_met_qc_criteria": "2021-09-30",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-01",
"first_submitted": "2021-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.