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#Study Description
Brief Summary
This is a study of two treatment pathways \[Standard steroid treatment versus combined steroid and Mycophenolate (MMF)\] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). Patients are first given high dose steroids but most suffer side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and diabetes). In addition, the majority of patients become ill again when the steroids are stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature and the rare impact on survival of ITP have prevented it from being a priority for research funding, with first line treatment being unsatisfactory and unchallenged for decades. This underestimates the profound adverse impact an ITP diagnosis and its treatment has on individual patients, many of whom are young.
MMF is often used as the next stage treatment for ITP and it works well. However, it can take up to 2 months to work during which patients continue to be at risk of bleeding, bruising, fatigue and usually need more steroids which they find intolerable. They are required to come to hospital for weekly blood tests and for many this impacts on work. We want to find out whether it would benefit more patients if everyone takes MMF at diagnosis instead of current practice (waiting for the illness to come back). We plan to test this by comparing the current way we treat patients to a new way with patients given MMF right at the start of their treatment. 120 patients from 20 different hospitals will be asked to take part and half will be randomly chosen for the new pathway.
Detailed Description
This is a multicentre, randomised clinical trial of MMF with steroid as a first line treatment for participants with ITP against the standard care pathway involving steroids alone as first line treatment. This is not a blinded study, therefore patients and research team will know which treatment arm the participant will be randomised to.
There are no additional appointments or separate trial visits for this trial. Participants will be seen at their usual hospital appointments, which may take slightly longer than they do usually to gather all the information needed to carefully record information for the trial and to see how the participants are.
Participants will be screened and given up to one week of steroid prior to randomisation to enable sufficient time to read information, discuss and ask questions with informed consent in an appropriate setting.
Participants will then be randomised to one of either two treatment pathways below and be asked to complete quality of life questionnaires:
1. Steroid +MMF pathway: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop, (Dexamethasone 20mg or 40mg daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances).
For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection.
From randomisation (alongside steroid), MMF 500mg twice daily starting dose then increased to 750mg twice daily after 2 weeks if tolerated and 1g twice daily after another 2 weeks if tolerated (4 weeks after starting).
After 6 months of MMF therapy, all patients who have remained in complete remission (platelet count\> 100 x10 9/L) will reduce the dose by 250mg (one capsule) each month. The aim is to continue on the lowest dose that achieves a haemostatic (safe) platelet count (platelet 50-100 x10 9/L) and to ensure that patients who have gone into a spontaneous remission do not continue to take the drug indefinitely.
2. Steroid only group: 1mg/kg once daily prednisolone 4 days (maximum of 100mg), 40mg once daily 2 weeks, 20mg once daily 2 weeks, 10mg once daily 2 weeks, 5mg once daily 2 weeks then 5mg alternate days 2 weeks then stop (Dexamethasone 20mg or 40mg orally daily for 4 days is an alternative option to prednisolone if deemed clinically more appropriate for individual circumstances).
For the duration of steroid, patients will get a PPI (proton pump inhibitors) or H2 antagonist to protect against gastric bleeding and appropriate bone protection.
Patients will be seen at the following time points after randomisation:
2 months, 4 months, 6 months and 12 months when the following procedures will take place:
* Laboratory tests (safety bloods)
* Date of treatment failure (refractory or relapse AND need for second line therapy). \[If treatment failure occurs, choice of second line treatment will be individualised according to patient's clinical circumstances. Further steroid will be given according to clinical need. Hospital monitoring of platelet levels is part of routine care for ITP patients and we will collect these details from the medical notes without requiring patients to come in for additional samples to be taken. These locally collected samples may be collected monthly (or less often) for patients believed to be in stable remission and weekly at lower or declining platelet levels. We expect this to allow us to calculate the time in remission and time in relapse with reasonable accuracy over the 12 month follow up period\].
* Vital signs
* Blood sugar results
* Medication side effects (including infections)
* Dose and duration of steroids
* Need for rescue or other treatments (including second or third line). \[Emergency and rescue treatments will be permitted throughout the study. These include platelet transfusions, tranexamic acid and intravenous immunoglobulin. These are known not to impact on the natural history of ITP and it is recognised that they may be important for patient safety. The use of 'rescue treatments' will be recorded on the CRF\]
* Hospital attendances or admissions
* Days off work
* Patient questionnaires: Quality of life assessment
* Immunoglobulins rechecked at 6 months and 12 months
In addition at Screening and 2 months, participants will have the option to give an extra blood sample for the Bristol Biobank (ancillary translational basic science studies). There is an additional patient information sheet and consent form for this. Participants can consent to enter the trial, but decline to have bloods taken for bio banking.
In addition at 6 and 12 months, immunoglobulins will be checked.
#Intervention
- DRUG : Mycophenolate Mofetil
- 500 mg and 250mg tablets for oral administration
- DRUG : Prednisolone
- 5mg tablets for oral administration
- Other Names :
- Steroid
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients (males and females) >16 years with a diagnosis of ITP, a pl count <30x109/L AND a clinical need for first line treatment.
* Patients have provided written informed consent
Exclusion Criteria:
* The exclusion criteria include pregnancy and breastfeeding
* Patients with HIV, Hepatitis B or C, or Common Variable immunodeficiency.
* Women of child bearing potential require a pregnancy test result within 7 days prior to randomisation (as per 7.1 below) to rule out unintended pregnancy
* Contraindications to MMF or steroid (see SPC, Appendix 2) including patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients or active significant infection
* Patients not capable of giving informed consent (e.g. due to incapacity)
* Patients unwilling to follow contraceptive advice if allocated to MMF treatment arm.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03156452
|
{
"brief_title": "Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate",
"conditions": [
"Immune Thrombocytopenia"
],
"interventions": [
"Drug: Mycophenolate Mofetil",
"Drug: Prednisolone"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03156452",
"official_title": "A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-05",
"study_completion_date(actual)": "2020-03-05",
"study_start_date(actual)": "2017-10-25"
},
"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)": "2022-10-26",
"last_updated_that_met_qc_criteria": "2017-05-15",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-17",
"first_submitted": "2017-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
to investigate the effect of modifying GIC with different formulations on the antibacterial activity and clinical performance in reference to unmodified glass ionomer restorative materials.
Detailed Description
The study will be a randomized clinical trial, with a 1:1:1 allocation ratio and parallel arms that will enroll children from the outpatient clinic of pediatric dentistry department, Ain shams University Blinding: Enrolled children, assessors and statistician will be blinded. Randomization: block randomization with blocks of 6. A maximum of 2 primary molars per patient will receive the same treatment.
Allocation concealment: Allocation will be done just before placement of a restoration to avoid performance bias during the cavity preparation. The envelope will be only checked after cavity preparation when the filling material will be chosen
Groups Teeth will be randomly allocated to 3 groups all groups will receive the same cavity preparation and then a different restoration.
* Group A: glass ionomer powder will be mixed with chlorhexidine
* Group B: glass ionomer will be mixed with titanium dioxide powder.
* Group C: will be the positive control, glass ionomer with no additives
Sample Size The sample size: A total number is 39 (13 in each group) is calculated using Epicalc program version 1.02 assuming a power of 80 % and alpha=0.05. The sample size is based on percentage of success of ART restorations at 9 months follow up (GIC with chlorhexidine and GIC with miswak) was 60% and 90%, respectively.13
Intervention:
Teeth will be randomly allocated to the three groups. Care givers and patients involved will be informed about the study procedures, an informed consent form and assent will be obtained. Group A: Conventional glass ionomer cement (Fuji IX, GC, Tokyo, Japan) will be used and modified by incorporating CHX diacetate (0.5% wt) into the powder of the glass ionomer (Fuji IX, GC, Tokyo, Japan) Group B: Conventional glass ionomer cement (Fuji IX, GC, Tokyo, Japan) will be used and modified by incorporating titanium dioxide (3% wt) in glass-based powder component of the GIC.
Group C: Conventional glass ionomer
Cavity preparation and baseline sampling Rubber dam will be placed for isolation of the designated teeth. A step wise caries removal technique will be employed28. Access to the cavity was created using a high-speed dental handpiece fitted with a Meisinger (Hager \& Meisinger - Germany) round diamond bur (801G-16) , and all the caries on the lateral walls, caries in the dentine-enamel junction and undermined enamel was removed.
Using a discoid Lascod (Lascod S.p.A Italy) excavator (#1) elective removal of superficial soft necrotic dentine was attempted, leaving behind demineralized wet, leathery dentine centrally on the pulpal wall (Leathery dentine is characterized by being removed in flakes by the excavator) 8,27 A different sterile excavator of the size will be used with very light pressure to take a sample of dentine from the center of the cavity floor center, the sample will be inserted in a brain heart infusion tube and sent to the microbiology lab within 1 hour then added to the culture to measure the bacterial load for the baseline sample by measuring the colony forming units (CFU) 29,30. Blood agar will be used to quantify the total bacterial count, while mitis-salivaris -bacitracin agar will be used to selectively quantify S.mutans.
After cavity preparation, an endodontic file will be used to record the depth of the cavity to aid with the re-entry, and then the operator will reveal the patient's group by opening an envelope. GC cavity conditioner' (GC Japan) will be applied to the cavity walls for 20 seconds leaving the floor unconditioned then the material will be packed into the cavity using a ball burnisher and pressed into it with a petroleum jelly covered gloves for 30 s (press finger technique). Then the excess material will be removed using a carver, and occlusion will be checked and adjusted, then Equia coat varnish (GC Japan) will be applied.
Follow-up The patients will be recalled at 6 and 9 months for clinical performance evaluation by the USPHS evaluation criteria (table 1). Visual and clinical inspection with 3.5x magnification will be done with the help of a sharp explorer by a blinded secondary investigator.
#Intervention
- OTHER : glass ionomer-chlorhexidine
- chlorhexidine will be added to glass ionomer
- OTHER : glass ionomer-titanium dioxide powder
- titanium dioxide will be added to glass ionomer
- OTHER : glass ionomer
- glass ionomer will be used without any additives
|
#Eligibility Criteria:
Inclusion Criteria:
* The teeth will be primary molars selected from patients presented to the outpatient clinic that are
* Healthy patients.
* Children having at least one primary molar with only occlusal caries having dentine lesions (ADA caries classification system mostly 1 or 2 please check)
* Dentine caries must be apparent visually or radiographically
Exclusion Criteria:
.Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
* Patients with history of active para-functional oral habits, xerostomia.
* Patients who will have difficulties in cooperating
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05645029
|
{
"brief_title": "Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)",
"conditions": [
"Dental Caries in Children"
],
"interventions": [
"Other: glass ionomer",
"Other: glass ionomer-chlorhexidine",
"Other: glass ionomer-titanium dioxide powder"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05645029",
"official_title": "Antimicrobial Activity and Clinical Performance of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-01",
"study_completion_date(actual)": "2023-11-15",
"study_start_date(actual)": "2022-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-05",
"last_updated_that_met_qc_criteria": "2022-12-01",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-09",
"first_submitted": "2022-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
#Intervention
- DRUG : Docetaxel
- DRUG : Xeloda
|
#Eligibility Criteria:
Inclusion Criteria:
Metastatic Breast Cancer:
* women >=18 years
* Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
* Previous therapy should have included an anthracycline.
* Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
* Female patients with histopathologically proven metastatic breast cancer
* Adequate bone marrow, liver, renal and cardiac functions
Colon Cancer:
* Patients >18 years
* Patients with histologicaly confirmed colon cancer
* Patients with potential curative tumor resection within 8 weeks before enrolment in the study
* Patients previously not treated with chemiotherapy
Exclusion Criteria:
Metastatic Breast Cancer:
* Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
* Patients with contraindications for any of study drugs as listed in approved SmPC
Colon Cancer:
* Patients previously treated with chemiotherapy
* Patients with contraindications for study drug as listed in approved SmPC
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
|
NCT02479217
|
{
"brief_title": "Safety of Xeloda in Solid Tumours",
"conditions": [
"Metastatic Breast Cancer, Colon Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Xeloda"
],
"location_countries": [
"Serbia"
],
"nct_id": "NCT02479217",
"official_title": "Safety of Xeloda in Solid Tumours",
"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)": "2006-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-17",
"last_updated_that_met_qc_criteria": "2015-06-23",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-24",
"first_submitted": "2015-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill).
Following a screening visit, patients with histologically confirmed NASH will be randomized to either placebo or one of two active treatment groups of silymarin (Legalon®). One active treatment group will receive 420 mg, each dose given three times daily, the other active treatment group will receive 700 mg, each dose given three times daily. Patients will be treated for 48-50 weeks. Participation in this research study requires the patient to travel to the clinic for at least 11 visits so recruitment will be limited to a geographically restricted area around participating clinical centers. Liver biopsy must be performed up to 12 months prior to, and immediately after, the treatment phase.
Detailed Description
This is a multicenter, randomized, double masked, placebo controlled Phase II trial to evaluate the safety and explore the efficacy of silymarin (Legalon®) compared with placebo on hepatic histology in patients with NASH (nonalcoholic steatohepatitis) after 48-50 weeks of therapy. This study was originally sponsored through a cooperative agreement (U01) award from the NCCAM and the NIDDK (RFA-AT-05-006: 'Phase I/II Trials of Silymarin for Chronic Liver Diseases'), and now will continue with Madaus Inc. (Rottapharm Group) providing financial and regulatory support to the investigators. The broad aim of this study is to evaluate the safety and explore the efficacy of silymarin (Legalon®) in NASH patients and to form the basis for future studies which will establish its efficacy for treating patients with NASH. The specific objectives of this study are to determine the effect of silymarin (Legalon®) on the histologic NASH Activity Score (NAS), the liver enzymes, and HOMAr. The primary endpoint of the study is an improvement in the NAS by at least 2 points. Various secondary endpoints will be assessed, including the change in liver enzymes and HOMAr.
#Intervention
- OTHER : Placebo
- Placebo (5 pills, three times daily) for 48-50 week treatment period
- Other Names :
- lactose pill
- DRUG : Silymarin 700 mg
- 700 mg dose (5 pills, three times daily) for 48-50 week treatment period
- Other Names :
- Legalon, milk thistle
- DRUG : Silymarin 420 mg
- 420 mg dose (5 pills, three times daily) for 48-50 week treatment period
- Other Names :
- Legalon, milk thistle
|
#Eligibility Criteria:
Inclusion Criteria:
* Age at least 18 years at screening.
* Informed consent signature.
* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than 40 IU/L within one year of screening and at least once during the screening period.
* The participant must agree to adhere to the alcohol consumption guidelines.
* Have a liver biopsy performed within 12 months of randomization demonstrating features consistent with NASH without cirrhosis; NAS score of at least 4. Historical biopsy must include one Trichrome and one H&E slide, otherwise the biopsy must be redone.
* No change in diabetic medications or insulin sensitizers (if applicable) between biopsy and screening or during the screening period.
* Weight loss/gain of no more than 10% between biopsy and screening, or within 30 days of screening if the biopsy is performed during the screening period.
* Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study medication. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on study drug and during follow-up).
Exclusion Criteria:
* Use of silymarin or other milk thistle preparations for a period of 90 consecutive days or longer between biopsy and initial screening, or within 30 days prior to screening if the biopsy is performed during the screening period.
* Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. A multivitamin at standard doses will be allowed.
* Use of silymarin or other antioxidants or non-prescribed complementary alternative medications (as above) during the screening period or patient unwilling to refrain from taking these medications through completion of the study.
* BMI > 45 kg/m2 between screening and randomization.
* Type 2 diabetes treated with oral agents other than the secretagogues or metformin; these include, thiazolidinediones, alpha-glucosidase inhibitors, exenatide, pramlintide between screening and randomization. Januvia (sitagliptin) is allowed.
* Evidence of poorly-controlled diabetes (defined as HbA1c > 8% in patients with diabetes) between screening and randomization.
* Known allergy/sensitivity to milk thistle or its preparations.
* Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the 1 year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens at doses greater than those used for hormone replacement, valproate/valproic acid.
* For patients using antihyperlipidemic agents or accepted anti-diabetic agents, any change of agent or dose from screening through randomization.
* Use of warfarin, metronidazole, or acetaminophen (greater than 2 grams per day) from screening through randomization.
* Lactose intolerance defined as patient reported inability to tolerate milk products.
* History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s).
* Previous liver biopsy that demonstrated presence of cirrhosis.
* Radiologic imaging consistent with cirrhosis or portal hypertension.
* Clinical or histological evidence of cirrhosis or, in the opinion of the investigator, the inability to safely obtain a liver biopsy due to technical reasons, such as body habitus.
* Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dl, total bilirubin > 1.5 mg/dl, or PT/INR (Prothrombin Time/International Normalized Ratio) > 1.3 times normal at screening, or history or presence of ascites or encephalopathy, or bleeding from esophageal varices.
* Platelet count < 130,000/mm3 at screening.
* Serum creatinine of 2.0 mg/dL or greater or CrCl <= 60cc/min, or on dialysis, at screening. The creatinine clearance (CrCl) will be calculated according to Cockcroft-Gault.
* Average alcohol consumption of more than one drink or equivalent (>12 grams) per day or more than two (2) drinks on any one day over the 30 days prior to screening. Patients who met either criterion more than 30 days prior to screening must have consumed a monthly average of 12 grams or less per day of alcohol for at least six months prior to screening.
* Evidence of drug abuse in the year prior to screening or prior to randomization.
* History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers of inflammation.
* History of solid organ or bone marrow transplantation.
* History of thyroid disease poorly controlled on prescribed medications.
* Use of oral steroids for more than 14 days within 30 days of screening or prior to randomization.
* Primary hepatic malignancy.
* Secondary hepatic malignancy (metastatic disease) or extrahepatic malignancy.
* Women with ongoing pregnancy or breast feeding, or contemplating pregnancy.
* History of bariatric surgery, or undergoing evaluation for bariatric surgery.
* Participation in a research drug trial, exclusive of the SyNCH Phase I trial, within 30 days of screening.
* History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
* Inability or unwillingness to give informed consent or abide by the study 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
|
NCT00680407
|
{
"brief_title": "Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis",
"conditions": [
"Non-alcoholic Steatohepatitis"
],
"interventions": [
"Other: Placebo",
"Drug: Silymarin 700 mg",
"Drug: Silymarin 420 mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00680407",
"official_title": "A Multicenter, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Orally Administered Silymarin Preparation (Legalon®) for the Treatment of Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2008-04"
},
"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)": "2019-07-17",
"last_updated_that_met_qc_criteria": "2008-05-15",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-20",
"first_submitted": "2008-05-15",
"first_submitted_that_met_qc_criteria": "2015-12-23"
}
}
}
|
#Study Description
Brief Summary
Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.
Detailed Description
Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.
#Intervention
- DRUG : single-dose midazolam for sedation under spinal anesthesia.
- Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group O received 0.025mg/kg midazolam at skin incision.
- DRUG : Double-dose midazolam for sedation under spinal anesthesia.
- Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group M received 0.025mg/kg midazolam at skin incision and repeated 5 minutes before maximum stimulation.
- PROCEDURE : spinal anesthesia with no sedation.
- Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing total knee or total hip replacement.
* ASA I, II, or III.
* patients undergoing spinal anesthesia.
Exclusion Criteria:
* patient refusal.
* <24 hours sedative administration.
* patient with hearing impairment.
* neurological or memory disorder.
* abnormal kidney function tests.
* any contraindication for spinal anesthesia.
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
|
NCT04232150
|
{
"brief_title": "Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?",
"conditions": [
"Anesthesia",
"Orthopedic Surgery"
],
"interventions": [
"Procedure: spinal anesthesia with no sedation.",
"Drug: Double-dose midazolam for sedation under spinal anesthesia.",
"Drug: single-dose midazolam for sedation under spinal anesthesia."
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT04232150",
"official_title": "Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-31",
"study_completion_date(actual)": "2019-11-01",
"study_start_date(actual)": "2019-06-01"
},
"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)": "2021-06-03",
"last_updated_that_met_qc_criteria": "2020-01-15",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-18",
"first_submitted": "2020-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Cross Cancer Institute has recently acquired a tomotherapy radiotherapy treatment machine; the first of its kind in Canada. It has the potential to improve cancer treatment outcomes where radiotherapy is used. Cervix cancer is a disease where radiotherapy is a particularly important treatment modality. The researchers believe that by combining tomotherapy (which has the ability to give higher doses of radiation to areas of cancer while sparing normal tissues) with radiotherapy given from inside the uterus and vagina (brachytherapy) disease outcomes will be improved. For this to be possible the researchers will need to accurately map the doses of radiation given to the cervix, uterus and other pelvic organs from these two types of radiation treatment. As well as being used for treatment, the tomotherapy machine can also be used for taking medical images by using very much lower doses of radiation. This study will allow the researchers to develop the mapping process by using very low doses of radiation on the tomotherapy unit to take medical x-ray images of patients being treated by brachytherapy for cervix cancer. In this special circumstance the researchers expect the images to be of a higher quality than for conventional computed tomography (CT) scanning or magnetic resonance imaging (MRI) scanning.
Detailed Description
Megavoltage CT Imaging for Intracavitary Radiation Treatment in Cervix Cancer
Proposal
To assess the feasibility of performing CT imaging using a megavoltage CT scanner on five patients where remote afterloading intracavitary applicators have been inserted for the purpose of delivering intracavitary radiotherapy in the treatment of cervix cancer.
Rationale
While there has been recent improvements in the treatment of more advanced stages of cervix cancer by combining radical radiation treatment with concurrent cisplatin based chemotherapy, there is room for further improvements in local regional control. One approach to achieving this is to increase the dose of therapeutic radiation to the clinical target volume without exceeding the tolerance of the adjacent normal tissues. Modern radiotherapy techniques allow for better conformation of the high dose radiation volume to the clinical target volume by using external beam techniques (conformal radiation treatment and intensity modulated radiation treatment) and the use of tomotherapy is likely to be particularly advantageous in this regard. The mainstay of cervix cancer radiotherapy has always been and will likely remain the use of brachytherapy. Future improvements in the outcome of cervix cancer treated by radiotherapy are therefore likely to necessitate accurately combining intracavitary radiation treatment with intensity modulated external beam radiation treatment and particularly with the use of tomotherapy techniques.
The ability to accurately reconstruct the three-dimensional dosimetry achieved by the combined use of intracavitary radiation treatment and helical tomotherapy will be pivotal in the success of this strategy. Conventional CT imaging of patients receiving intracavitary radiation treatment is hampered by distortion artifacts from the metallic applicators. The opportunity to gain improved images using megavoltage CT scanning using the same equipment and same patient set-up that will ultimately by used for the delivery of tomotherapy offers some unique potential advantages and solutions to the problem.
By imaging patients with the remote afterloading applications in situ, the researchers should be able to generate accurate isodose distributions in three dimensions for the intracavitary component of the cervix cancer treatment. By contouring the clinical target volume, which includes the primary cancer, local routes of spread and regional pelvic lymph nodes, the researchers can explore the feasibility of generating combined helical tomotherapy and intracavitary radiation treatment plans.
Patients and Methods
Patients who are to receive intracavitary brachytherapy on the low dose rate selectron at the Cross Cancer Institute will be approached to participate in this pilot study. An informed consent will be obtained from five patients for this study. Following the insertion of the remote afterloading applicators in the operating room, patients are normally transferred from the operating room to Simulator C for orthogonal simulator films and then to Station 30 where treatment is started approximately two hours later after dosimetry calculations have been performed and treatment has been prescribed.
For the patients consenting to this study, they will proceed from Simulator C to Station 30 via the tomotherapy unit in CBIAR where megavoltage CT scans will be taken. Patients will be accompanied by a brachytherapy radiation therapist. The megavoltage CT scans will take approximately one hour to perform, but this will not result in any treatment delay for the patient.
Isodose volumes from the prescribed intracavitary brachytherapy will be reconstructed on the megavoltage images. The feasibility of defining the clinical target volume on the megavoltage scans will be explored. This may require fusion with conventional CT images that will already have been taken for diagnostic and external beam treatment planning purposes. Megavoltage and/or fused images will be used to pilot the integration of tomotherapy intensity modulated radiation therapy treatment plans with intracavitary brachytherapy dosimetry.
The current study will have no influence on individual patient treatments but is a prelude to a potential dose escalation study using tomotherapy for patients with cervix cancer.
#Intervention
- PROCEDURE : Megavoltage CT scan
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing brachytherapy for cervix cancer
Exclusion Criteria:
* Patient refusal
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00124423
|
{
"brief_title": "Megavoltage CT (MVCT) Imaging for Intracavitary Radiation Treatment in Cervix Cancer",
"conditions": [
"Cervix Cancer"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00124423",
"official_title": "Megavoltage CT (MVCT) Imaging for Intracavitary Radiation Treatment in Cervix Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": "2004-06"
},
"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)": "2016-02-26",
"last_updated_that_met_qc_criteria": "2005-07-26",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-07-28",
"first_submitted": "2005-07-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will be conducted to:
1. evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children
2. compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children.
Detailed Description
A. Patients preparation All the children demographic and outcome measures data will be collected in specially well-designed sheets1. Evaluation of fine motor skills using PDMS-2 Evaluation of hand function using Besta scale
. The traditional exercise program (given to both groups):
1. Treatment protocol in Group A, Reciprocal electrical stimulation protocol
* The device has two channels that can stimulate two opposing groups of muscles alternatively (reciprocate).
* During ES, the child sits in a chair with his treated forearm resting on a pillow placed on the bed in front of him.
* The electrodes will be placed as follows:
* Channel 1 (stimulates wrist and hand extensors) electrodes placed over the dorsum of the forearm as follows: the active electrode is placed over the common extensor origin, while in different over the motor point of extensor pollicis longus, abductor pollicis longus, and extensor indices.
* Channel 2 (stimulates wrist and hand flexors) electrodes placed on the palmar side of the forearm are as follows: the negative electrode is placed between the finger flexors and wrist flexors. The positive electrode is placed over the tendonportion of the forearm,
* The treatment duration will be 20 minutes.
* The treatment protocol will be repeated 3 times per week for 12 weeks.
2. Treatment protocol in Group B, Kinesio taping protocol:
* Kinesio taping will be applied on both sides of the upper limb.
* The applied area will be from the proximal one-third of the forearm to the wrist and then will be split into 5 straps into the distal interphalangeal joint of fingers.
* On the dorsal side, KT will be applied on the forearm, wrist, and fingers extensors for improvement of wrist and fingers extension.
* On the plantar side, KT will be applied on the forearm, wrist, and fingers flexors for inhibition of wrist and fingers flexion.
* Taping will be applied for 6 days, 24 h a day, on the affected upper limb, and it will be removed for only one day per week.
#Intervention
- DEVICE : electrical stimulation device
- the device has 2 channels ,4 electrodes with multiple ems programs
- OTHER : kinesio taping
- kinesio tape a therapeutic tape that's applied strategically to the body to provide support, lessen pain, reduce swelling, and improve performance
|
#Eligibility Criteria:
Inclusion Criteria:
* A medical diagnosis of spastic hemiplegic CP made by paediatricians or pediatric neurologists.
* Children with spasticity grades ranged from 1 to 1+ according to MAS.
* Their age range from 4 <= age <= 6.
* Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques
Exclusion Criteria:
* They had a permanent deformity (bony or soft tissue contractures).
* Children having visual or auditory defects.
* Children with intelligence quotient less than 70.
* Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.
* A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
* Children who are absent in two taping change sessions
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05799703
|
{
"brief_title": "Reciprocal Electrical Stimulation Versus Kinesio Taping",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Device: electrical stimulation device",
"Other: kinesio taping"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05799703",
"official_title": "Effect Of Reciprocal Electrical Stimulation Versus Kinesio Taping On Hand Functions In Hemiparetic Cerebral Palsy Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-15",
"study_completion_date(actual)": "2023-10-30",
"study_start_date(actual)": "2023-02-15"
},
"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)": "2024-03-12",
"last_updated_that_met_qc_criteria": "2023-04-03",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-05",
"first_submitted": "2023-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
30 patients with chronic cervical myofascial pain (4 males, 26 females) aged between 25 to 57 years (with average age 41,20±10,23 years) were included the study.
Participants were divided into two groups as intervention group (n=15) and control group (n=15). Patients in intervention group received radial shock-wave application one times a week for six weeks and home based stretching exercises. Patients in control group (CG) received home based stretching exercises. Rest and activity pain (Visual Analog Scale), pressure pain threshold (PPT), cervical range of motion (CROM) and disability (Neck Disability Index) were assessed at baseline and after the treatment.
Detailed Description
Thirty-four cervical MPS patients aged between 25-57 years (average age: 41,20±10,23 years) who diagnosed cervical MPS (myofascial pain syndrome), had cervical MPS for 6 months and who had at least one trigger point on their cervical, back and shoulder muscles were included to this study.
Thirty-four participant were included to the study. Taking into consideration including and excluding factors 34 participants divided into two groups: intervention shock-wave therapy group, control group. Because of several private reason (not attending treatment regularly and not participating in the final evaluations), 4 participant were excluded from study.
All assessments done by the same physiotherapist (FU) before the first session and one week after the last treatment session. Demographic data of participants recorded by using a form at the baseline of the study.
Patients in the intervention group (n=15) received 6 sessions radial shock wave treatment once a week during 6 weeks. During the treatment, the patients sat on chairs and supported their upper bodies with a pillow on the bed. Ultrasound gel was applied to the application area. Radial shock-wave therapy was applied to each trigger point in the preliminary evaluation. The muscles related trigger points were stretched position during the application. Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapulae muscles were treated.
Neck and upper back muscle static stretching exercises were teached to patients in the both groups as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
#Intervention
- PROCEDURE : Radial Shock-Wave Therapy
- Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapula muscles were treated. Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
- PROCEDURE : Control
- Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed cervical MPS
* Have cervical MPS for at least 6 months.
* Patients who has at least one trigger points on their cervical, back and shoulder muscles.
Exclusion Criteria:
* Fibromyalgia diagnosed patients in reference to 1990 ACR criteria.
* Patients who has characteristic cervical disc degeneration, radiculopathy, myelopathy.
* Patients who has cervical fracture, tumor, infection, malign, psychiatric and systemic illness.
* Patients who had an operation because of cervical problem.
* Patients who is treated with another treatment technique at the same time.
* Being pregnant
Sex :
ALL
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
|
NCT04814017
|
{
"brief_title": "Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome",
"conditions": [
"Myofascial Pain Syndrome",
"Chronic Pain"
],
"interventions": [
"Procedure: Radial Shock-Wave Therapy",
"Procedure: Control"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04814017",
"official_title": "Effectiveness of Radial Shock-wave Therapy Combined With Self-stretching Exercises in Patients With Myofascial Pain Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04-10",
"study_completion_date(actual)": "2013-06-30",
"study_start_date(actual)": "2013-01-28"
},
"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)": "2021-03-24",
"last_updated_that_met_qc_criteria": "2021-03-23",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-24",
"first_submitted": "2021-03-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.
Detailed Description
Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.
The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.
#Intervention
- OTHER : External cooling
- External cooling
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented or suspected infection
* Body temperature > 38.3°C
* Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure > 65 mmHg.
* Invasive mechanical ventilation
* Intravenous sedation
Exclusion Criteria:
* Temperature > 41°C
* Age < 18 years
* Pregnancy
* Continuous renal replacement therapy
* Paracetamol or NSAI administration within 6 hours before inclusion
* Need for paracetamol and/or NSAI therapy during the study period
* Burns or Lyell syndrome
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
|
NCT00527007
|
{
"brief_title": "External Cooling in Septic Shock Patients",
"conditions": [
"Septic Shock"
],
"interventions": [
"Other: External cooling"
],
"location_countries": [
"France"
],
"nct_id": "NCT00527007",
"official_title": "Impact of External Cooling in Septic Shock Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2007-10"
},
"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)": "2010-07-22",
"last_updated_that_met_qc_criteria": "2007-09-07",
"last_verified": "2008-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-10",
"first_submitted": "2007-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). There is a high prevalence in elderly and in patients with cancer. Several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities.
Diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip test with a 'Jamar®' hydraulic hand dynamometer. CT scan is more invasive and less easy to reach than handgrip test. This test is used to be performing in elderly but not in cancer patients having chemotherapy. Present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.
#Intervention
- PROCEDURE : handgrip strength test
- DRUG : chemotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with digestive cancer having a chemotherapy and/or biotherapy in the department of Reims
* > 18 years
* after patient agreement
* linked to social security system
Exclusion Criteria:
* legal guardianship
* < 18 years
* neuro-muscular issue
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
|
NCT02797197
|
{
"brief_title": "Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy",
"conditions": [
"Handgrip Strength Test",
"Sarcopenia",
"Digestive Cancer",
"Muscle Strength",
"Chemotherapy"
],
"interventions": [
"Drug: chemotherapy",
"Procedure: handgrip strength test"
],
"location_countries": null,
"nct_id": "NCT02797197",
"official_title": "Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-15",
"study_completion_date(actual)": "2017-02-15",
"study_start_date(actual)": "2016-05-18"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-08",
"last_updated_that_met_qc_criteria": "2016-06-10",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-13",
"first_submitted": "2016-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way that interferes with their wellbeing and every day functioning. In this project the investigators will study the effect of the group program The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific developed for children with ASD. The investigators expect a decrease in the overall anxiety level together with an increase in the ability of handling anxiety.
Detailed Description
The primary objective is to investigate the effect of a manualised Cognitive Behavioural Therapy (CBT) programme The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD) for anxiety disorder adapted to children with Autism Spectrum Disorder (ASD) in a waitlist controlled design.
The investigators will investigate treatment effects on anxiety diagnosis and anxiety symptoms. Further, the investigators will investigate outcomes related to general functioning, co-morbid psychiatric disorders (Obsessive-Compulsive Disorder (OCD), hyperkinetic disorder and depression) and level of ASD symptoms (social and communicative skills).
#Intervention
- BEHAVIORAL : CBT
- The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).
- Other Names :
- Cool Kids ASD
|
#Eligibility Criteria:
Inclusion Criteria:
* ASD
* Anxiety (not necessary diagnosed)
Exclusion Criteria:
* IQ under 70
* Not meeting diagnostic criteria for primary anxiety diagnosis on ADIS
* Active psychosis
* Untreated ADHD
* Families not able to follow program
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02908321
|
{
"brief_title": "CBT for Anxiety Disorder in Children With Co-morbid ASD",
"conditions": [
"Randomized Treatment Study"
],
"interventions": [
"Behavioral: CBT"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02908321",
"official_title": "Cognitive Behavioural Therapy for Anxiety Disorder in Children With Co-morbid Autism Spectrum Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09",
"study_completion_date(actual)": "2019-12",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-10",
"last_updated_that_met_qc_criteria": "2016-09-16",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-20",
"first_submitted": "2016-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism (VTE) due to the disease itself and the use of targeted therapies, including immunomodulatory drugs (IMiDs). Prevention of VTE has become a major management challenge during MM treatment. There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in the cancer population. However, the NOACs offer comparable efficacy but improved safety compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and prevention of recurrent VTE (1,2). The safety and efficacy of apixaban for primary prevention of VTE in MM patients has not been established.
Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.
Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher medical acuity than that of the previous large randomized controlled trials of apixaban, we will be selecting a stable population of MM patients who are appropriate for immunomodulatory therapy.
Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.
Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be \<7% (3). Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating agents may further increase the risk of VTE, the rate of incident VTE should be reduced to \<7% with apixaban.
Detailed Description
MM is associated with an increased risk of venous thromboembolism (VTE). The use of targeted therapies, including immunomodulatory drugs (IMiDs), has improved outcomes for patients with MM but also increases the risk of VTE. Prevention of VTE has become a major management dilemma during MM treatment. There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in the cancer population, including patients with MM. However, the NOACs have been shown to offer comparable efficacy but improved safety compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and prevention of recurrent VTE (1,2). Compared with injectable thromboprophylactic regimens such as enoxaparin, apixaban offers the advantages of being orally administered and less reliant on renal clearance. The safety and efficacy of apixaban for primary prevention of VTE in MM patients has not been established. The current study will evaluate apixaban (2.5 mg twice daily) in a patient population without a history of prior VTE. Although the current study population is high risk for VTE, it is likely to be lower risk for VTE than those of the prior randomized controlled trials of apixaban for secondary prevention. Furthermore, current practice is to provide MM patients receiving IMiDs with prophylactic doses (not treatment doses) of low-molecular weight heparin (such as enoxaparin 40 mg injected daily). Accordingly, the rationale to test apixaban (2.5 mg twice daily) is consistent with the standard practice of prophylactic anticoagulation.
The current study will provide event rates that will inform the design of a larger randomized controlled trial. If safe and effective, apixaban will satisfy a critical unmet need and will represent a substantial advance and 'game changer' in the prevention of VTE in this high risk patient population.
#Intervention
- DRUG : Apixaban
- apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
- Other Names :
- Thromboprophylaxis
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Age > 18 years
* Current or prior diagnosis of symptomatic MM based on International Myeloma Working Group (IMWG) guidelines (http://imwg.myeloma.org/category/guidelines-2/) and will be starting or already receiving IMiD therapy with thalidomide [Thalomid], lenalinomide [Revlimid], or pomalidomide [Pomalyst]
* IMiD therapy given in the setting of newly diagnosed MM, relapsed MM, progressive MM, maintenance therapy or consolidation therapy as per IMWG criteria
* Willing to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) functional status <= 2
* Providers must plan to treat the patient with IMiD therapy for a minimum of 6 cycles
Exclusion Criteria:
* Pregnancy
* Breastfeeding
* Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (such as oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, condoms, spermicides]) to avoid pregnancy for the entire study
* Any prior venous thromboembolism
* Contraindication to anticoagulant therapy
* Conditions for which serious bleeding may occur including:
1. Current or within last 6 months: intracranial bleeding, intraocular bleeding, gastrointestinal bleeding, endoscopically documented ulcer disease
2. Current or within last month: head trauma or other major trauma, major surgery
3. Current or within last 2 weeks: stroke, neurosurgical procedure
4. Current: gross hematuria, major unhealed wound, major surgery planned during the trial period, intracranial mass, vascular malformation, or aneurysm, overt bleeding, blood dyscrasia
5. CNS involvement of MM or other history of CNS malignancy
* Active and clinically significant liver disease
* Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
* Current endocarditis
* Requirement for ongoing anticoagulant therapy, including mechanical heart valve replacement and atrial fibrillation
* Severe valvular heart disease, including rheumatic heart disease and mitral stenosis
* Bioprosthetic heart valve replacement
* Requirement for dual antiplatelet therapy or single agent antiplatelet therapy with clopidogrel, prasugrel, or ticagrelor
* Requirement for aspirin at a dose higher than 165 mg daily.
* Hemoglobin < 9 mg/dL at time of screening
* Platelet count < 100,000/mm3 at time of screening
* Serum calculated creatinine clearance (CrCl) < 25 ml/m at time of screening
* Alanine aminotransferase or aspartate aminotransferase level > 2 times the upper limit of the normal at time of screening
* Total bilirubin level > 1.5 times the upper limit of the normal at time of screening
* Life expectancy < 12 months or hospice care
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
* Receiving concurrent non-FDA-approved or investigational agents or has received an investigational agent within the past 30 days prior to the first dose of study treatment (with the exception of approved medications being used for an approved indication, e.g., investigating a new dosing regimen for an approved indication).
* Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study
* Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study 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
|
NCT02958969
|
{
"brief_title": "Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma",
"conditions": [
"Venous Thromboembolism",
"Multiple Myeloma"
],
"interventions": [
"Drug: Apixaban"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02958969",
"official_title": "Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-30",
"study_completion_date(actual)": "2019-11-19",
"study_start_date(actual)": "2018-02-28"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-17",
"last_updated_that_met_qc_criteria": "2016-11-05",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-08",
"first_submitted": "2016-11-05",
"first_submitted_that_met_qc_criteria": "2019-11-19"
}
}
}
|
#Study Description
Brief Summary
The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.
Detailed Description
This is a randomised, double blind, multi-centre, double dummy, and two-way cross-over study.
There will be a total of three cohorts. Each cohort will be treated for two 72-hour periods in a cross-over design, with a 3-week washout period between treatment periods. The total length of participant engagement (from screening to follow-up) is 79 days.
#Intervention
- DRUG : AZD9567
- Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2.
- DRUG : Prednisolone
- Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3.
- OTHER : Placebo
- Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants with diagnosis of T2DM for 6 months prior to screening: HbA1c in the diabetes range or fasting plasma glucose 126 -220 mg/dL.
* On stable metformin therapy for at least 4 weeks, where no significant dose change (increase or decrease >= 500 mg/day) has occurred prior to screening and HbA1c 6% - 9.5%, or on dual therapy with metformin in combination with SGLT2i or DPP4i and HbA1c 6% - 8%. Participants on dual therapy will require 2 weeks wash-out of SGLT2i or DPP4i.
* Venous access suitable for multiple cannulations
* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Female participants must be not lactating and not of childbearing potential.
* If sexually active, nonsterilized males who have a female partner of childbearing potential must practice effective contraceptive measures.
* Capable of giving signed informed consent.
* Provision of informed consent prior to any study specific procedures.
Exclusion Criteria:
* History or presence of type 1 diabetes.
* History of severe hypoglycaemia or hypoglycaemia unawareness within the last 6 months.
* History or presence of diabetic foot ulcers
* Participants with advanced diabetic complications.
* History of clinically significant lactic acidosis or ketoacidosis following diagnosis with T2DM.
* History of, or known significant infection or positivity at Visit 1, including hepatitis A, B, or C, HIV, tuberculosis that may put the participant at risk during participation in the study.
* History and / or presence of COVID-19.
* Donation of blood (>= 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.
* History of or current alcohol or drug abuse (including marijuana), as judged by the investigator.
* Previous psychiatric disorders.
* Any latent, acute, or chronic infections or at risk of infection, or history of skin abscesses within 90 days prior to the first administration of investigational medicinal product (IMP) at the discretion of the investigator.
* History of adrenal insufficiency.
* History or current inflammatory disorder.
* Any other condition that, in the opinion of the investigator, would interfere with evaluations of the IMP or interpretation of participant safety or study results.
* History of severe allergy/hypersensitivity to AZD9567 or any of the excipients of the product, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
* Oral or parenteral steroids 8 weeks prior to randomisation and during the study. Topical and inhaled steroids 4 weeks prior to randomisation are acceptable.
* Use of any prohibited medication during the study or if the required washout time of such medication was not adhered to.
* Receipt of live or live attenuated vaccine within 4 weeks prior to the first administration of IMP.
* Planned in-patient surgery, major dental procedure, or hospitalisation during the study.
* Previous participation or participation in any other research study within 1 month prior to Visit 1.
* Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1.
* Uncontrolled hypertension (BP > 160 mmHg systolic or > 95 mmHg diastolic).
* Diagnosis of heart failure and current symptoms regardless of definition, ie, HfpEF, HfrEF.
* Acute coronary syndrome / unstable angina, coronary intervention procedures (percutaneous coronary intervention or coronary artery bypass graft) within the past 6 months.
* Stroke within the past 3 months.
* QTcF > 470 ms or family history of long QT-syndrome.
* AV-block II-III or sinus node dysfunction with significant pause, not treated with pacemaker.
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
|
NCT04556760
|
{
"brief_title": "Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: AZD9567",
"Other: Placebo",
"Drug: Prednisolone"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04556760",
"official_title": "A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-09",
"study_completion_date(actual)": "2021-06-09",
"study_start_date(actual)": "2020-11-26"
},
"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)": "2024-07-18",
"last_updated_that_met_qc_criteria": "2020-09-15",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-21",
"first_submitted": "2020-09-15",
"first_submitted_that_met_qc_criteria": "2024-02-02"
}
}
}
|
#Study Description
Brief Summary
The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.
Detailed Description
Many questions remain regarding optimal treatments for juvenile drug court. To address this gap, the investigators will compare two treatments delivered in a drug court setting: Multidimensional Family Therapy (MDFT) and adolescent group therapy (AGT). This 5-year study will employ a fully randomized (2 conditions) by 5 assessment points (baseline, 6, 12, 18, and 24 months following baseline), repeated measures intent-to-treat design with multiple dependent variables. Adolescents who have been accepted into the Miami Juvenile Drug Court (MJDC) will be randomized to receive one of two treatments: MDFT (n = 57) or AGT (n = 55). The substance abuse treatments will be equivalent in terms of therapeutic dosage, and all youth with receive the same drug court program with wtreatment received being the only difference (family vs non-family treatment). In order to maximize the ecological validity of the study, both treatments will be delivered by community-based drug abuse counselors. MDFT will be delivered by providers at Jackson Memorial Hospital's Adolescent Substance Abuse Program and AGT by providers at a separate facility, Here's Help.
Aim 1. Acceptability and Effectiveness. The study will address the comparative acceptability and effectiveness of the two drug court programs in ways that are consistent with recommendations from the juvenile drug court literature to consider multi-domain and multiple perspectives of program goals and outcomes. First, effectiveness will be assessed in terms of the differential rates at which youth in MDFT and AGT graduate from drug court, a primary goal of the drug court program. Juvenile offending substance abusers and their families are notoriously difficult to engage and retain in any type of treatment program, yet family-based interventions have demonstrated impressive retention rates with these populations. Thus an important aspect of the proposed effectiveness evaluation will be the extent to which the MDFT intervention improves drug court program completion rates. Our second perspective on effectiveness involves an examination of the rates of change in a number of critical domains, including reductions in substance use, arrests, and delinquent behaviors, as well as improvements in school/vocational performance over a 2-year period. With these multidimensional outcome assessments the investigators will be able to explore different dimensions and trajectories of recovery following drug court participation. This is consistent with the aims of juvenile drug courts not only to reduce drug use and delinquency but also to increase adolescents' prosocial skills and behaviors. The investigators are also interested in examining multiple perspectives on the relative acceptability of MDFT to drug court staff, teens, and families, as recommended by drug court researchers.
Aim 2. Drug Court Program Mechanisms. While the few existing studies of key drug court factors have focused mainly on the structural and judicial aspects of drug court programs, almost nothing is known about the treatment processes affecting drug court outcomes, or the mechanisms of clinical and judicial component impact. Clearly, an important next step in this specialty is to delineate the treatment processes and ingredients that maximize outcomes in drug court, particularly in relation to the application of evidence-based therapy models within drug court programs. Examination of change mechanisms is now recognized as an essential feature of state-of-the-art drug abuse intervention research. Among those process variables considered important in mediating drug treatment outcomes are the therapeutic alliance that is formed between provider and client , and the extent to which a positive collaborative relationship develops among all drug court team members, including the judge. Research on family-based interventions supports the contention that family-based treatments exert their effects through the reduction of family risk and the facilitation of protective processes, and family functioning has been found to play a primary role in helping teens achieve and maintain recovery after substance abuse treatment. In sum, given that the quest to improve drug court program development, implementation, and outcomes rests in large part on the clarification of the programs' mechanisms of action, drug court researchers have turned their attention to analyses linking within-program processes to outcomes. The proposed study will do likewise.
#Intervention
- BEHAVIORAL : Miami Juvenile Drug Court-MDFT
- MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
- BEHAVIORAL : Miami Juvenile Drug Court -TAU
- Each client is provided with a primary outpatient counselor who develops a treatment plan to address long-range goals. Family members are included in an assessment and treatment planning session at the beginning of treatment, but no formal family therapy is provided. Group therapy topics include self-esteem enhancement, decision-making skills, stress/anger management, communication skills, health education, teen pregnancy prevention, and occupational/career planning.
|
#Eligibility Criteria:
Inclusion Criteria:
(a) Substance abuse or dependence disorder requiring outpatient treatment, and (b)after consulting with his or her attorney, the youth and family voluntarily agrees to enter juvenile drug court.
Exclusion Criteria:
(a) Their current offense is the sale of drugs, a gun offense, a violent offense, or sexual battery,(b) their current offense is likely to merit commitment to a secure or locked juvenile justice facility or (c) they have severe mental illness or retardation according to their intake MJDC evaluation.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01668303
|
{
"brief_title": "Family-Based Juvenile Drug Court Services",
"conditions": [
"Substance Use",
"Delinquency"
],
"interventions": [
"Behavioral: Miami Juvenile Drug Court-MDFT",
"Behavioral: Miami Juvenile Drug Court -TAU"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01668303",
"official_title": "Family-Based Juvenile Drug Court Services",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2004-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-20",
"last_updated_that_met_qc_criteria": "2012-08-14",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-20",
"first_submitted": "2012-08-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients who receive intensive care are known to be at high risk for physical, psychological, and cognitive impairments, a constellation known as PICS. COVID-19 patients are expected to have high chances of suffering from PICS (PICS-COV) as they frequently require several weeks of intensive care and traditional PICS preventive measures are virtually impossible due to infection control precautions, prone positioning, and deprivation of social contact. To prevent PICS after ICU discharge in COVID-19 patients, physical therapy is recommended. From recent but limited experience it appears that even patients with COVID-19 who have not been admitted to the ICU can suffer from impairments in the same domains and sometimes to a similar degree of severity. Also for these patient group rehabilitation seems warranted.
Yet, the resources needed to provide rehabilitation treatment to COVID-19 patients are inadequate because healthcare systems faced a shortage of high-quality treatment for these impairments already before the COVID-19 crisis emerged. Virtual Reality (VR) provides potential to healthcare practitioners to administer fast, temporary, and tailor-made rehabilitation services at a distance, and offers a solution to address the impending surge of demand for rehabilitation after COVID-19 infection. VR consists of a head mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Current VR technology is accessible, easy in use for a large audience, and safe in use. There already exist multiple VR applications for providing physical, psychological, and cognitive rehabilitation. These applications have been brought together in a VR suite for rehabilitation after COVID-19. Patients visiting a physiotherapist for rehabilitation from COVID-19 will be asked to participate in this study. They receive a VR HMD for training purposes. This study aims to understand the usability, feasibility, and tolerability of VR for rehabilitation after COVID-19, and to pilot the effectiveness of VR improving the physical ability, mental and cognitive status of patients.
#Intervention
- DEVICE : Virtual Reality
- Participants will use a Virtual Reality headset with a range of applications applicable for rehabilitation after COVID-19. Applications target physical, psychological, and cognitive rehabilitation. VR headset will be used for six weeks first at the physiotherapist's practice, and when possible, at home.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient has had COVID-19.
* Patient has an indication for physical therapy in the context of rehabilitation after COVID-19.
* At the day of recruitment, the estimated length of the physical therapy is at least 3 weeks after inclusion.
* Patient is willing and able to comply with the study protocol.
* Patient is at least 16 years on the day the informed consent form will be signed.
* Patient can read and understand the Dutch language.
Exclusion Criteria:
* The patient is participating in another study interfering with this study.
* Patient has difficulties to handle virtual reality:
1. Patient suffers from delirium or acute confusional state.
2. Patient has (a history of) dementia, seizure, or epilepsy.
3. Patient has severe hearing/visual impairment not corrected.
4. The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
* Patient has a high risk of contamination with a therapy resistant micro-organism e.g. MRSA.
* Patients suffers from severe anxiety or depression (HADS>=16).
* Red flags (see Appendix 1).
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04505761
|
{
"brief_title": "The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19",
"conditions": [
"Coronavirus",
"Post Intensive Care Unit Syndrome"
],
"interventions": [
"Device: Virtual Reality"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT04505761",
"official_title": "The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19: An Explorative Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-01",
"study_completion_date(actual)": "2021-03-31",
"study_start_date(actual)": "2020-08-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-06",
"last_updated_that_met_qc_criteria": "2020-08-07",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-10",
"first_submitted": "2020-07-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lesions of herpes labialis are caused by the herpes simplex virus type 1 (HSV-1) and cause pain and aesthetic compromise. It is characterized by the formation of small vesicles that coalesce and rupture forming extremely painful ulcers, that evolve to crusts, dry desquamations until their complete remission. Currently, the treatment of these lesions is done with acyclovir. Although it diminishes the symptomatology, it causes viral resistance and does not prevent the recurrence of the lesions. It is known that photodynamic therapy (PDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause resistance.
A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into two groups: G1 control and G2 experimental. After signing informed consent, patients in group G1 will undergo the standard gold treatment for cold sores with acyclovir and simulated PDT treatment. Patients in the experimental G2 group will be treated simulating the gold standard treatment of herpes labialis (placebo) and PDT.
Detailed Description
Lesions of herpes labialis are caused by the herpes simplex virus type 1 (HSV-1) and cause pain and aesthetic compromise. It is characterized by the formation of small vesicles that coalesce and rupture forming extremely painful ulcers, that evolve to crusts, dry desquamations until their complete remission. Currently, the treatment of these lesions is done with acyclovir. Although it diminishes the symptomatology, it causes viral resistance and does not prevent the recurrence of the lesions. It is known that photodynamic therapy (PDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause resistance.
Materials and methods: A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into two groups: G1 control and G2 experimental. After signing TCLE and TA, patients in group G1 will undergo the standard gold treatment for cold sores with acyclovir and simulated PDT treatment. Patients in the experimental G2 group will be treated simulating the gold standard treatment of herpes labialis (placebo) and PDT. In all patients will be collected saliva samples for analysis of cytokines, and will be performed exfoliative cytology in the lesions. The pain will be assessed through a pain scale and a questionnaire of quality of life-related to oral health (Ohip- 14) will be given to them. Patients will continue to be followed up after 7 days, 1 month, 3 months, 6 months and 1 year and, if there is a recurrence of the lesion, they will contact the researchers.
#Intervention
- DEVICE : photodynamic therapy herpes labialis
- Patients will receive Photodynamic Therapy (PDT), irradiations will be performed with the Laser Duo® red laser diode (MMOptics, São Carlos, SP, Brazil) with a wavelength of 660 nm, with a power of 100 mW, the energy density of 300 J / cm², with energy of 3 J in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each isolated lesion that presents with fixed energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. All treatment proposed in group 1 (simulation of PDT + delivery of aciclovir cream) in each patient will be concluded in a single session. Treatment for group 2 (PDT + placebo cream) will also be completed in a single session. All possible adverse effects will be noted and qualified during the treatment protocol and maintenance period (3/3 months) using the questionnaire developed for this protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both sex,
* with no predilection for race or socioeconomic status,
* negative medical history
Exclusion Criteria:
* Patients with a herpes infection in the dry desquamation stage will be excluded.
* Participants in continuous use of non-steroidal anti-inflammatory drugs and continued corticosteroid therapy for less than 1 week.
* Diabetic participants, smokers
* who need immunosuppressants,
* pregnant women and/or nursing mothers.
* HIV positive,
* hepatitis B or C.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04037475
|
{
"brief_title": "Treatment of Herpes Labialis by Photodynamic Therapy",
"conditions": [
"Photodynamic Therapy",
"Herpes Simplex, Labial"
],
"interventions": [
"Device: photodynamic therapy herpes labialis"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT04037475",
"official_title": "Treatment of Herpes Labialis by Photodynamic Therapy: Controlled, Prospective, Randomized, Double-blind Protocol Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-30",
"study_completion_date(actual)": "2023-10-15",
"study_start_date(actual)": "2020-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-21",
"last_updated_that_met_qc_criteria": "2019-07-26",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-30",
"first_submitted": "2019-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of a drug called Poly-ICLC, also known as HiltonolTM, in boosting the body's immune system's response to an experimental vaccine therapy (called the MUC-1 vaccine).
Detailed Description
This is a one-arm clinical trial, to evaluate 2 doses of poly-ICLC for reversing systemic immuno-suppression: 25 μg/kg and 50 μg/kg. These doses will be administered I.M. three times a week for 2 weeks. Following 2 weeks of treatment with poly-ICLC alone, patients will be immunized subcutaneously with the 100-mer MUC-1 peptide + GM-CSF. Subjects will be boosted twice at two week intervals, and subsequently 3 months later, if they experience clinical benefit or if they have clinically stable disease. Poly-ICLC will be administered continually 3 times a week I.M. for the first 2 weeks and 2 times a week I.M. thereafter. Subjects will continue on study until they have evidence of progressive disease. The primary objective of this study is to evaluate the efficacy of Poly-ICLC in boosting the immunologic response of a MUC1 vaccine. Secondary objectives are to evaluate a) changes in markers of systemic immunosuppression; b) changes in dendritic cell number and function; and c) clinical response. Up to 30 subjects will be enrolled in this single-site study.
#Intervention
- DRUG : MUC_1
- Pretreatment with Poly-ICLC alone week 1 \&2 (50 ug/kg 3 days/week) Weeks 3-7 Poly-ICLC, 2 days/week; MUC-1 vaccine (100ug) admixed with GM-CSF (100ug), administered subcutaneously at weeks 3, 5 and 7 Tetanus toxoid, administered via intramuscular injection, 1x at week 3 GM-CSF 100ug, administered subcutaneously on days 2-4
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older and must have histologically confirmed adenocarcinoma of the prostate with systemic disease are potentially eligible. Patients with an early relapse must have undergone and failed definitive surgery and/or radiation. Patients can either be hormone naive, may be on concurrent hormone therapy with LHRH analogues, or may be hormone refractory (see section 3.1.4 of the full protocol)
* Must have evidence of systemic immunosuppression as evidenced by the presence of one or more of the following: 1) Low or absent T cell zeta chain expression in peripheral blood (PB), 2) Low level cytokine production ( i.e., IFN-gamma , IL-4 ) by T cells in PB, 3) Upregulation of granulocyte activation markers (CD 15) in PB
* Availability of at least 2 PSA measurements over 2 to 6 weeks, clearly documenting a rising PSA. The minimum rise in PSA must be at least 50% from baseline PSA. The last of these PSA values must be > 2 .
* Patients may be hormone-refractory (rising PSA, despite castrate testosterone levels, i.e., < 50 ng/ml); may have metastatic disease; and maybe on bisphosphonates. If patients are on anti-androgens (Flutamide/Casodex), they must have been off of these agents for at least 28 days prior to enrollment for flutamide, and at least 42 days prior to enrollment for bicalutamide (Casodex)), without a drop in PSA. If hormone refractory, patients will continue LHRH analogues.
* Signed written informed consent given by the patient before or at enrollment in the study and following receipt of verbal and written information about the study.
* No concomitant therapy with steroids
* No other investigational therapy within 4 weeks of enrolling on this protocol
* No chemotherapy or radiation therapy within 6 weeks of enrolling on this protocol.
* ECOG performance status 0 or 1
* Patients must have adequate organ and marrow function
* Men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Exclusion Criteria:
* Patients who have had chemotherapy or radiation therapy within 6 weeks of study entry.
* No concurrent use of other investigational agents.
* 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.
* Presence of an active acute or chronic infection, including urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). HIV patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
* Patients with either previously irradiated or new CNS (central nervous system) metastases at entry are excluded. Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.
* Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
* Subjects with active prior malignancy within the past 5 years (with exception of non-melanoma skin cancers and carcinoma in situ of the bladder).
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
|
NCT00374049
|
{
"brief_title": "MUC1 Vaccine in Conjunction With Poly-ICLC in Patients With Recurrent and/or Advanced Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: MUC_1"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00374049",
"official_title": "A Pilot Dose Finding Study of MUC1 Vaccine in Conjunction With Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) or HiltonolTM in Patients With Recurrent and/or Advanced Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2006-06"
},
"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)": "2016-07-12",
"last_updated_that_met_qc_criteria": "2006-09-07",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-08",
"first_submitted": "2006-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.
#Intervention
- DRUG : Unfractionated heparin (UFH)
- UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours
- DRUG : Bendavia
- Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours
- DRUG : Saline (0.9%, sterile, for infusion)
- Saline (placebo) Constant IV infusion for 4 hours
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males or females aged between 18 and 65 years with signed informed consent.
* Women who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study [Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device (IUD) 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used]
Exclusion Criteria:
* Serum sodium level below the lower limit of the site's clinical laboratory normal range at both study period qualification visits,
* Platelet value below the lower limit of normal range at screening or admission,
* aPTT value outside the normal range at screening or admission,
* Creatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females,
* Any addition laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening,
* Clinically significant abnormalities on physical examination,
* Body Mass Index (BMI) of less than 18 kg/m2 or greater than 32 kg/m2,
* Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
* History of seizures or history of epilepsy,
* History of serious (Principal Investigator judgment) mental illness,
* Receipt of investigational medicinal product within 30 days before planned date of unfractionated heparin and/or study drug administration,
* Positive serology for human immunodeficiency virus 1 or 2 (HIV1 or 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV),
* Fever greater than 37.5°C at the time of planned dosing,
* Suspicion of or recent history of alcohol or substance abuse,
* Donated blood or blood products within the past 30 days,
* Women who are pregnant or breastfeeding,
* Employee or family member of the investigational site,
* Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco products in the 30 days prior to screening,
* Subjects who are either unwilling to agree to refrain from using or found to be using:
1. Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
2. Prescription medications from 14 days prior to and 7 days post treatment (excluding hormonal contraceptives)
3. Hormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment
* Subjects taking aspirin or any other non-steroidal anti-inflammatory agent, either prescription or over-the-counter, within 10 days of treatment,
* Subjects known to have allergic or untoward effects when using unfractionated heparin,
* Subjects having previous exposure to Bendavia,
* Subjects who are expected to undergo any surgical procedure within 14 days of the completion of 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
|
NCT01513200
|
{
"brief_title": "Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Unfractionated heparin (UFH)",
"Drug: Saline (0.9%, sterile, for infusion)",
"Drug: Bendavia"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01513200",
"official_title": "A Two Part Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers and the Effects of Bendavia™ and Unfractionated Heparin When Administered Concurrently",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-19",
"last_updated_that_met_qc_criteria": "2012-01-16",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-20",
"first_submitted": "2012-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve patients' understanding of instructions for use.
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. Patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive their prescribed medicines from this location. Recruited subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes. Other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study.
#Intervention
- OTHER : Enhanced Label
- A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Type II diabetes or hypertension in their medical chart.
* >= 30 years.
* Fluent in English.
Exclusion Criteria:
* Uncorrectable hearing or visual impairment.
* Too ill to participate.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00973180
|
{
"brief_title": "Enhanced Prescription Drug Label to Improve Patient Understanding and Use",
"conditions": [
"Prescription Medication Understanding"
],
"interventions": [
"Other: Enhanced Label"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00973180",
"official_title": "Enhanced Prescription Drug Label to Improve Patient Understanding and Use",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2009-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-09-29",
"last_updated_that_met_qc_criteria": "2009-09-08",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-09",
"first_submitted": "2009-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and Locking Compression Plates(LCP).
Detailed Description
Despite fractures of the wrist being widely regarded as 'fragility fractures', there is good evidence that they are caused by diminished Bone Mineral Density (BMD) and that a low BMD value predicts a higher fracture risk at the distal radius. Both measurements of areal BMD with DXA and volumetric BMD with peripheral Quantitative Computer Tomography (pQCT)showed a lower BMD in women with Colles' fractures. Thus, Colles' fractures can be recognized as a good indication of underlying osteoporosis. High resolution peripheral Quantitative Computer Tomography at the distal radius will be evaluated in a subset of patients.
Clinical experts are concerned that osteoporosis increases the risk for poor outcomes and complication rates in surgical patients with osteoporosis. However, this has not yet been confirmed in clinical studies. It is important to investigate this question in order to correctly advise clinicians and patients and possibly develop tailored approaches for treatment of osteoporotic patients with distal radius fractures.
|
#Eligibility Criteria:
Inclusion Criteria:
* Radiologically confirmed closed fracture (within 7 days) of the distal radius
* Primary fracture treatment with a volar LCP 2.4 mm
* Age equal greater 50 and equal younger 90 years
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-ups according to the CIP
* Willing and able to comply with the post-operative management program
* Able to understand and read country national language at an elementary level
Exclusion Criteria:
* Fracture of ulna (except an associated fracture of the ulnar styloid process)
* Open distal radius fracture
* Concomitant contralateral radius fracture
* Previous distal radius fracture on either side after the age of 25 years
* Time to operation > 7 days
* Polytrauma
* Regular systemic therapy with corticosteroids due to chronic disease
* Legal incompetence
* Patient received radio- or chemotherapy prior to, during, or within the last year
* Currently active cancer
* Recent history of substance abuse (i.e recreational drugs, alcohol)
* Prisoner
* Currently involved in a pharmaceutical study
* Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01144208
|
{
"brief_title": "The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures",
"conditions": [
"Distal Radius Fractures",
"Poor Bone Quality",
"Treatment Complications"
],
"interventions": null,
"location_countries": [
"United States",
"Germany",
"Singapore",
"Austria",
"Switzerland",
"Italy"
],
"nct_id": "NCT01144208",
"official_title": "The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2007-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-06-16",
"last_updated_that_met_qc_criteria": "2010-06-14",
"last_verified": "2010-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-15",
"first_submitted": "2010-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.
Detailed Description
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
#Intervention
- DRUG : Pistachio
- Unsalted pistachios
- OTHER : Usual care
- Advice and resources will be provided
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI >=25 and <=45 kg/m2
* Fasting plasma glucose 100 - 125 mg/dL
* non-Smoking
Exclusion Criteria:
* Diagnosed diabetes or fasting glucose >126 mg/dl
* Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
* Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
* Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
* Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
* Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
* Smoking or use of any tobacco products
* Allergy/intolerance/sensitive to pistachios
* Consumption of >14 alcoholic drinks/week
* Shift-workers and those who cannot consume a snack in the evening
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04056208
|
{
"brief_title": "Pistachios Blood Sugar Control, Heart and Gut Health",
"conditions": [
"Type 2 Diabetes",
"Cardiovascular Diseases"
],
"interventions": [
"Other: Usual care",
"Drug: Pistachio"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04056208",
"official_title": "The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-17",
"study_completion_date(actual)": "2022-11-17",
"study_start_date(actual)": "2019-09-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-18",
"last_updated_that_met_qc_criteria": "2019-08-13",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-14",
"first_submitted": "2019-08-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Subclinical inflammation is now indisputably recognized as a key etiological factor in the development of atherosclerosis and subsequent cardiovascular disease. Obesity and related dysmetabolic states including metabolic syndrome (MetS) are highly prevalent causes of subclinical inflammation. Obesity and MetS are both diet and lifestyle-related and there is a growing body of literature suggesting that specific nutrients, such as long chain omega-3 polyunsaturated fatty acids (LCn-3PUFA), may attenuate the pro-inflammatory state associated with these conditions. However, careful review of existing literature on this topic reveals important gaps in knowledge, the purported anti-inflammatory effects of LCn-3PUFA even being questioned by many. Significant confounding attributable to study design, sample size and biomarker selection may be responsible in part for inconsistencies in the literature on LCn-3PUFA and inflammation. We also found that evidence available to date (for and against) is based primarily on secondary analyses, as most of the studies published were not primarily designed to investigate inflammation as a primary outcome. It remains unclear whether the different LCn-3PUFA, primarily docosahexaenoic acid (DHA, 22:6n-3) and eicosapentaenoic acid (EPA, 20:5n-3), have similar effects on pro-inflammatory processes as almost all studies were undertaken using a mix of LCn-3PUFA. Whether efficacy of EPA and DHA is influenced by sex/gender is also unknown. Finally, a better understanding of the systemic and tissue-specific mechanisms underlying the anticipated anti-inflammatory effects of different LCn-3PUFA in MetS would also be of great value. Addressing these gaps has important public health implications, considering that LCn-3PUFA supplements are broadly and indiscriminately recommended for the prevention of cardiovascular disease.
The overarching objective of the proposed research is to compare the anti-inflammatory effects of EPA and DHA in men and women with MetS.
Detailed Description
The proposed study will be undertaken according to a double-blind randomized placebo controlled cross-over design with 3 treatment phases: 1- high DHA, 2- High EPA, 3- Control. Each treatment phase will last 10 weeks and will be separated by 8-week washouts. Participants will be randomized to one of 6 treatment sequences while stratifying for sex. Treatments will provide 3 identical 1g capsules per day. During the 3 treatment periods, subjects will receive in random order 0g/d EPA+DHA (3g corn oil placebo), 3g/d EPA (\>90% EPA), and 3g/d DHA (\>90% DHA). Long chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) will be provided in their re-esterified triacylglycerol form as studies have shown that bioavailability was greater when EPA and DHA were consumed as TG rather than as ethyl esters. The therapeutic dose that maximizes the anti-inflammatory effects of LCn-3PUFA in patients with inflammation has not been established, although data suggest that they may be dose-dependent. However, studies in healthy human volunteers suggest that an intake \> 2 g EPA + DHA/day is required to affect inflammatory processes. Many of the available studies have used a dose of EPA+DHA that was lower than 2g/d, with no apparent anti-inflammatory effects. A study has shown that a dose of 1.8g/d of EPA+DHA induced significant changes in peripheral blood cell (PBC) inflammation gene expression, with no change in plasma CRP concentrations. In the present study, we propose to use a dose of 3 g/d for each individual LCn-3PUFA tested, which is at the higher end of the recommended intake for patients with high plasma TG, but which will maximize our chance to observe changes in inflammatory markers and to differentiate the effects of EPA and DHA, if they exist. Participants will be instructed to maintain a constant body weight during the course of the study. They will also be counselled on how to exclude fatty fish meals (including salmon, tuna, mackerel, and herring), fish-oil supplements, flax products, walnuts, and omega-3-enriched eggs during the study. Vitamin supplements and natural health products will be strictly forbidden during the entire experimental period, with the exception of calcium and vitamin D, which will be allowed at a stable dose. Although alcohol consumption will be permitted during the study with intakes not exceeding one serving (12-15 g alcohol) per day, it will be forbidden for the 4 days that precede the various tests at the end of each treatment phase. Subjects will also be instructed to maintain their usual physical activity except for the 4 days that precede blood sampling at the various stages of the study, during which they will be asked to remain sedentary.
#Intervention
- DIETARY_SUPPLEMENT : High DHA
- 10 week supplementation period
- DIETARY_SUPPLEMENT : High EPA
- 10 week supplementation period
- DIETARY_SUPPLEMENT : Placebo
- 10 week supplementation period
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 18 and 70 years with abdominal obesity as defined by the International Diabetes Federation criteria and a measure of plasma CRP >1 mg/L
* Stable body weight for at least 3 months prior to randomization.
* Pre-menopausal women with regular menstrual cycle (25 <= age <= 35 days)
Exclusion Criteria:
* Plasma CRP > 10 mg/L at screening
* Extreme dyslipidemias such as familial hypercholesterolemia
* Previous history of cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease)
* Subjects taking medications known to affect inflammation (e.g. steroids, binging alcohol)
* Subjects taking LCn-3PUFA supplements within 2 months of study onset.
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:
Yes
|
NCT01810003
|
{
"brief_title": "Impact of EPA and DHA Supplementation on Plasma Biomarkers of Inflammation (n3)",
"conditions": [
"Cardiovascular Disease, Inflammation"
],
"interventions": [
"Dietary Supplement: High EPA",
"Dietary Supplement: Placebo",
"Dietary Supplement: High DHA"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01810003",
"official_title": "Impact of EPA and DHA Supplementation on Plasma Biomarkers of Inflammation in Men and Women With Metabolic Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2013-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-22",
"last_updated_that_met_qc_criteria": "2013-03-11",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-13",
"first_submitted": "2013-03-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There is a critical need to develop an affordable, valid, and reliable techniques to assess free-living energy expenditure (EE), energy storage (ES), and energy intake (EI). The purpose of this project is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Garmin) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI.
Detailed Description
Dietary intake and physical activity are important lifestyle behaviors that have a profound role in the development of my many chronic diseases, including heart disease, diabetes, kidney disease, certain cancers, and overweight/obesity. It is clear that there are a multitude of physiological, environmental, and behavioral factors that influence obesity risk, but at the most basic level body weight is determined by the energy balance of energy intake (EI) and energy expenditure (EE). Standard assessment techniques of EI in population-based studies rely on individuals to self-report the foods they eat, but these estimates are typically 12-31% below expected values. This has led expert dieticians and nutritional epidemiologists to declare 'EI is inaccurately measured by self-report' and 'wholly unacceptable for scientific research.' Thus, there is a critical need to develop an affordable, valid, and reliable techniques to assess free-living EE, energy storage (ES), and EI. The investigator's long-term goal is to assess the components of energy balance to better inform obesity prevention and treatment. The short-term goal, and the purpose of this application, is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Fitbit) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI. The status quo as it relates to the use of non-gold standard devices is that there exists large variability compared to criterion measures that may produce erroneous estimates, particularly in mean EE, making their use at a population-level ill-advised. In contrast, the investigator's working hypothesis is that the error inherent in consumer devices can be quantified and adjusted for, allowing for the accurate assessment of EE and ES. The purpose of this project is to apply measurement error techniques to a pilot sample (N=24) of free-living adolescents to improve energy balance estimates. The investigators will use a consumer physical activity monitor (Garmin Vivofit 4), and a consumer body composition analyzer (Garmin Smartscale) to estimate daily EE and change in ES over two consecutive 14-day periods, separated by a 14-day washout period. The investigators will develop calibration models using simultaneously collected gold-standard techniques including doubly labeled water for EE and duel-energy x-ray absorptiometry for ES as references. The investigators will use the calibrated EE and ES to calculate EI using the intake-balance technique. Lastly, the investigators will evaluate the feasibility and acceptability of the protocols and methodology. At the completion of the proposed study, it is the investigators expectation that they will have generated important pilot data and assessed project feasibility in adolescents for a large-scale NIH R01 application. A fully powered study will improve the assessment of EE and ES in free-living conditions using research grade and consumer devices, allowing for the estimation of EI with greater accuracy than currently available techniques. This project will make significant advancements on the assessment of energy balance in free-living settings.
|
#Eligibility Criteria:
Inclusion Criteria:
* All participants will need to have an in-home Wi-Fi network and access to a smartphone that can operate mobile applications to automatically sync with the Garmin devices
* BMI percentile between 5th and 99th
Exclusion Criteria:
*BMI percentile <5th or >99th
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05296330
|
{
"brief_title": "Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents",
"conditions": [
"Childhood Obesity"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05296330",
"official_title": "Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-11",
"study_completion_date(actual)": "2023-12-01",
"study_start_date(actual)": "2022-03-26"
},
"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)": "2023-12-05",
"last_updated_that_met_qc_criteria": "2022-03-24",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-25",
"first_submitted": "2022-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.
#Intervention
- DRUG : Surotomycin
- A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules
- Other Names :
- CB-183,315
- DRUG : Placebo
- A single oral dose of placebo for surotomycin in hard gelatin capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
* Electrocardiogram (ECG) shows no clinically significant abnormalities
* Is able to swallow capsules
* is in good health
Exclusion Criteria:
* Pregnant or lactating females
* Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
* Participants 18 <= age <= 49 of age had taken any regular, prescribed, or over-the-counter medication
* Has any significant concurrent therapies
* Has a positive drug screen
* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
* Has given more than 450 mL of blood (one unit) in the 60 days preceding screening
* Is an active intravenous drug user or abuses alcohol
* Has had a malignancy within the last 5 years
* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
* Has received any antibiotics within 30 days prior to first dose of study drug
* Has been hospitalized within the past 30 days prior to Study Day 1
* Has known hypersensitivity to daptomycin
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
|
NCT02835105
|
{
"brief_title": "A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)",
"conditions": [
"Clostridium Difficile Associated Diarrhea (CDAD)"
],
"interventions": [
"Drug: Placebo",
"Drug: Surotomycin"
],
"location_countries": null,
"nct_id": "NCT02835105",
"official_title": "A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2009-01"
},
"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)": "2016-07-22",
"last_updated_that_met_qc_criteria": "2016-07-13",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-15",
"first_submitted": "2016-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present study aims to initially test a community dog walking intervention that addresses individual, interpersonal and community factors associated with dog walking. The study will be conducted in two cities, Worcester and Lowell, as a collaboration between investigators from UMass Medical School and UMass-Lowell.
Detailed Description
This is a group randomized trial where 8 communities in Worcester and Lowell (4 per city) will be randomly assigned to the 6-month dog walking intervention or a standard, self-help, print-based physical activity control condition. Dog owners (N=120; 15 per community) will be recruited. The intervention includes a social networking website, monthly newsletters, twice monthly neighborhood dog walks and community events. The intervention will: 1) educate owners about the benefits of dog walking to themselves and their dog, 2) teach strategies for regular dog walking, 3) teach dog walking tips and provide dog training seminars, 4) promote self-monitoring and goal setting for dog walking, 5) provide social networking opportunities for dog owners and 6) promote a sense of community via participation in neighborhood dog walks and community events. Intervention feasibility will be assessed by measures of implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events. Initial efficacy will be assessed via change in weekly steps measured via a pedometer from baseline to 6-months after baseline.
#Intervention
- BEHAVIORAL : Community-based social networking intervention
- Participation in this study lasts for 7 months and includes a baseline visit, an orientation visit, the 6 month intervention, and a 6 month assessment visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible participants will own a dog that is in good health and considered a household pet, be a Worcester or Lowell resident, be aged > 21 years and have home internet access. Participants with cardiovascular disease, diabetes or other chronic health condition are eligible with permission from their PCP to participate.
Exclusion Criteria:
Participants will be excluded for any of the following:
* Inability or unwillingness to give informed consent
* Plans to move out of the area within the study period
* Participated in a focus group during the developmental phase
* Another household member is participating in the study
* Pregnant or planning a pregnancy in the next six months
* Condition that inhibits exercise (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
* Incapable of engaging in physical activity as assessed by the Physical Activity Readiness Questionnaire
* Self-report engaging in > 150 minutes of moderate and vigorous intensity physical activity per week.
* The participant's dog has a history of biting a human or has not received a rabies vaccination.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01593449
|
{
"brief_title": "A Community-based Social Networking Intervention to Increase Walking in Dog Owners",
"conditions": [
"Sedentary"
],
"interventions": [
"Behavioral: Community-based social networking intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01593449",
"official_title": "A Community-based Social Networking Intervention to Increase Walking in Dog Owners",
"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)": "2011-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-15",
"last_updated_that_met_qc_criteria": "2012-05-07",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-08",
"first_submitted": "2012-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;
Secondary Objectives:
* To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
* To evaluate the durability of splenic response
* To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
* To evaluate the splenic response to SAR302503 at the end of Cycle 3
* To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
* To evaluate the safety and tolerability of SAR302503 in this population
* To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
Detailed Description
The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subjects who will not continue the treatment after completing the 6 cycles of SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit which should occur 30 days after the last administration of SAR302503. Patients who continue to benefit clinically will be allowed to remain on study medication beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.
#Intervention
- DRUG : SAR302503
- Pharmaceutical form:capsule
Route of administration: oral
|
#Eligibility Criteria:
Inclusion criteria:
* Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
* Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days (exposure of <14 days is allowed for subjects who discontinued Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503
* MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System (Passamonti et al., Blood 2010)
* Spleen >=5 cm below costal margin as measured by palpation
* Male and female subjects >=18 years
* Signed written informed consent
Exclusion criteria:
* Splenectomy
* Eastern Cooperative Oncology Group (ECOG) performance status of >2 before the first dose of SAR302503 at Cycle 1 Day1
* The following laboratory values within 14 days prior to the initiation of SAR302503:
* Absolute Neutrophil Count (ANC) <1.0 x 10exp9/L
* Platelet count <50 x 10exp9/L
* Serum creatinine >1.5 x Upper limit of normal (ULN)
* Serum amylase and lipase >1.5 x ULN
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=2.5 x ULN
* Total bilirubin >=3.0 x ULN
* Subjects with total bilirubin between 1.5 <= age <= 3.0 x ULN must be excluded if the direct bilirubin fraction is >=25% of the total
* Subjects with known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers
* Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])
* Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years
* Any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503.The only chemotherapy allowed will be hydroxyurea within 1 day prior to initiation of SAR302503
* Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503
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
|
NCT01523171
|
{
"brief_title": "Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib",
"conditions": [
"Hematopoietic Neoplasm"
],
"interventions": [
"Drug: SAR302503"
],
"location_countries": [
"France",
"Netherlands",
"United States",
"Germany",
"Canada",
"Austria",
"Spain",
"Italy",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT01523171",
"official_title": "A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2012-04"
},
"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)": "2016-03-17",
"last_updated_that_met_qc_criteria": "2012-01-31",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-01",
"first_submitted": "2012-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Persons post stroke executed stepping activities under four conditions: standard of care, interacting with: an off-the-shelf Microsoft-Kinect game, with a self-paced repeated custom video game and a game-paced random custom video game. Exercise intensity (neuromuscular and cardiovascular), enjoyment and perceived effort were measured during and after each condition.
Detailed Description
Persons post stroke were first familiarized with the four exercise conditions and then instrumented with a metabolic system and heart rate sensor. They played the games in two counter balanced blocks: repeated (standard of care and self-paced repeated custom) and random (Microsoft-Kinect game and game-paced random custom). Games were played for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. During exercise they reported exertion and at the end of teach exercise trial they completed an enjoyment questionnaire. At the end of the first block, participants removed the metabolic system's mask and were assessed for motor recovery. Performances were video taped. At the end of data collection preferences for the activities were ranked and participants answered open ended questions. Data for neuromuscular and cardiovascular intensity, enjoyment and perceived effort were reduced and analyzed using a Repeated Measures Analysis of Variance (RMANOVA) with the appropriate post-hoc corrections. Where possible clinically meaningful changes were calculated.
#Intervention
- BEHAVIORAL : Exercise
- Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.
- Other Names :
- Video Game Play, Standard of Care Stepping Activities
|
#Eligibility Criteria:
Inclusion Criteria:
* men and women post-stroke at least six months T
* able to ambulate 100 feet without physical assistance but allowed to use assistive devices and orthotics,
* able to stand for 3 minutes.
* cleared for exercise with the PARQ.
Exclusion Criteria:
* history of severe heart disease, heart attack, valve replacement or coronary artery bypass surgery, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than stroke
* Are unable to follow directions.
* Do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids
* Are unable to sign a consent form.
* Unstable medical condition or musculoskeletal disorder such as severe arthritis, knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to perform the required stepping for the games presented.
* Any other medical condition contraindications to exercise.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04538326
|
{
"brief_title": "Exercise Intensity and Video Games: Persons Post-stroke",
"conditions": [
"Stroke"
],
"interventions": [
"Behavioral: Exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04538326",
"official_title": "Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-30",
"study_completion_date(actual)": "2018-08-30",
"study_start_date(actual)": "2017-05-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-04",
"last_updated_that_met_qc_criteria": "2020-08-28",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-04",
"first_submitted": "2020-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
By integrating sexuality and disability literatures, theories, and research methodologies, this study aims to: 1) contribute to the limited knowledge professionals have of parents as the primary sexuality educators; 2) create a resource for parents in order to be sexuality educators for their young adults with I/DD; and 3) evaluate the effectiveness of the Home B.A.S.E. for Developmental Disabilities Curriculum.
In order to meet the objectives the study seeks to answer the following questions:
1. What is the effectiveness of a sexuality education workshop for parents of young adults with DS on improving the self-efficacy and attitudes around sexuality and healthy relationships for young adults with DS as well as increase the parent-child communication on sexuality topics?
2. What are parents' concerns that impact their ability to be the primary sexuality educators for their young adults with DS? It is proposed that parent confidence and comfort talking about sexuality topics with their young adult with Down syndrome will increase thereby increasing the parent-child communication as a result of this study.
Detailed Description
Enrollment will begin and will end once 30 eligible subjects have been identified. Anticipated duration is one year. Participants will enroll in one of the 4 different training series. Each series will have 3 dates they must attend. Once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. Participants will be expected to attend 3 training sessions over a 4 week period, each are up to 3 hours in length. There will be a follow-up post-survey one month after the last training and an optional phone interview that will occur 2 months after the final training. Participants will be compensated for their time with a $50 gift card once the final post-survey has been received. The gift card will be mailed to the family. Data analysis will begin once all trainings have been completed. Investigators anticipate completing the study, including primary analyses, within two years from the date recruitment begins.
#Intervention
- BEHAVIORAL : Parent training
- Participants will attend 3 trainings. There will be a pre-test before training 1 and an initial post-test after training 3. There will be a final post-test 1 month after the final training.
|
#Eligibility Criteria:
Inclusion Criteria:
* Parents of young adults with Down syndrome ages 20 <= age <= 30.
* Be able to communicate in English
Exclusion Criteria:
* Parents of young adults between the ages of 20 and 30 without Down syndrome
* Parents of individuals with Down syndrome younger than >= 20 years than 30.
* Parents unable to attend 3 training sessions.
* Not fluent English communicators.
* Any vulnerable populations including pregnant women, neonates, prisoners, children, cognitively impaired adults, or adults unable to consent
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03135236
|
{
"brief_title": "Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome",
"conditions": [
"Down Syndrome",
"Intellectual Disability",
"Sexuality",
"Parent-Child Relations"
],
"interventions": [
"Behavioral: Parent training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03135236",
"official_title": "Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome: The Effectiveness of a Family-based Training",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-30",
"study_completion_date(actual)": "2018-06-01",
"study_start_date(actual)": "2017-03-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-04",
"last_updated_that_met_qc_criteria": "2017-04-27",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-01",
"first_submitted": "2017-04-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with resectable liver metastases of colorectal origin will be assigned to laparoscopic liver resection or conventional open liver surgery.
Blood samples will be drawn preoperatively and 24 hours after resection. Determination of Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and laparoscopic liver resection (Elisa test).
The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2 (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction (RT-PCR).
Detailed Description
According to the null hypothesis, no difference in the IL6 postoperative value, between the two groups would be expected. To calculate sample size, a IL6 postoperative value of 100±40 pg/mL in the laparoscopic group and 60±40 mL/m pg/mL in the open group was hypothesized. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 17 subjects in both groups in a 1:1 randomization. Laparoscopic group was increased by 20% of patients considering a conversion rate of 20% accordingly. Randomization will be performed using computer-generated random numbers the day before operation and stopped when 20 patients per group will be reached.
#Intervention
- PROCEDURE : Liver resection
- liver resections for colorectal liver metastases
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 80 years
* Patients with colorectal liver metastases
* Colorectal liver metastases <=10 cm in size -
Exclusion Criteria:
* Patients not fit for laparoscopic surgery due to comorbidities
* Patients with tumors close or infiltrating the major vessels -
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
|
NCT03131778
|
{
"brief_title": "The Inflammatory Response to Stress and Angiogenesis in Liver Resection",
"conditions": [
"Liver Cancer",
"Colorectal Cancer",
"Metastatic Cancer",
"Liver Metastases"
],
"interventions": [
"Procedure: Liver resection"
],
"location_countries": null,
"nct_id": "NCT03131778",
"official_title": "The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06-30",
"study_completion_date(actual)": "2011-06-30",
"study_start_date(actual)": "2010-04-01"
},
"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)": "2017-05-01",
"last_updated_that_met_qc_criteria": "2017-04-24",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-27",
"first_submitted": "2017-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine the impact of the offer to participate in Safer Sex Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and frequency of sex) six months after the end of treatment.
Detailed Description
The Policy \& Research Group (PRG) will be evaluating the Safer Sex Intervention (SSI). The Safer Sex Intervention is based in Social Cognitive Theory, the Transtheoretical Model of Behavior Change, and motivational interviewing. Coupled with skill-building exercises, the intervention is intended to increase knowledge related to risk and safe-sex behaviors, to increase awareness of risk and need for behavior change, to help build self-efficacy to engage in safe-sex behaviors, and, ultimately, to motivate participants to engage in and maintain safe sex practices. The intervention is meant to be delivered in four, one-on-one sessions over the course of six months. Each session is to be conducted in a private setting by a female health educator trained in motivational interviewing and Safer Sex Intervention. The initial or primary intervention session should take approximately 30 to 50 minutes. Subsequent 'booster sessions' delivered 1, 3, and 6 months following the initial session are to take 10 to 30 minutes. Booster sessions are intended to sustain any resulting behavior change. The control (counterfactual) condition, Female Sexual Health, was developed specifically for use in this study; it consists of a 30-minute PowerPoint presentation, intended to be delivered in one face-to-face session that provides information about reproductive anatomy and STIs. After the presentation, participants receive free condoms. This is the only session for the control condition; there are no booster sessions. Though there were some variations in consent requirements across sites, there were no differences in the recruitment process between the treatment and control groups. All eligible individuals who provided the proper consent to participate were randomized and enrolled into the study at the time they attended their first scheduled study session. Data were collected via self-administered questionnaires that were scheduled at baseline and six months post treatment (12 months after baseline). The study took place in New Orleans, Louisiana, at five clinics that served young women between the ages of 14 and 19.
#Intervention
- BEHAVIORAL : Safer Sex Intervention (SSI)
- Safer Sex Intervention (SSI) is an in-person, individual-level, clinic-based intervention implemented by a female health educator trained in the intervention. It is intended to be implemented in one initial session lasting 30-50 minutes and three booster sessions lasting 10-30 minutes at one, three, and six month intervals.
- BEHAVIORAL : Female Sexual Health
- Female Sexual Health is a knowledge-based intervention that intends to provide information on how STIs are contracted, the consequences of contracting STIs, and how to prevent them. Female Sexual Health includes the information-only component of the first session of SSI and baseline exposure to a health educator but does not include booster sessions.
|
#Eligibility Criteria:
Inclusion Criteria:
Between the ages of 14 <= age <= 19 Had engaged in sex with a male in the three months prior to enrollment Provide parental consent (if under age 18) and participant assent to participate in the study.
Exclusion Criteria:
Not have previously participated in any of the following pregnancy/HIV prevention programs:
* 4 Real Health
* Becoming a Responsible Teen (BART)
* Healthy Living
* Staying Mature and Responsible Towards Sex (SMARTS)
* Sisters Informing Healthy Living and Empowering (SIHLE)
* Project AIM
* Making Proud Choices
* Be Proud Be Responsible
* Focus on Your Future
Sex :
FEMALE
Ages :
- Minimum Age : 14 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02544841
|
{
"brief_title": "Evaluation of Safer Sex Intervention (SSI)",
"conditions": [
"Teen Pregnancy Prevention"
],
"interventions": [
"Behavioral: Female Sexual Health",
"Behavioral: Safer Sex Intervention (SSI)"
],
"location_countries": null,
"nct_id": "NCT02544841",
"official_title": "Evaluation of Safer Sex Intervention (SSI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2012-02"
},
"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)": "2016-11-08",
"last_updated_that_met_qc_criteria": "2015-09-04",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-09",
"first_submitted": "2015-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.
#Intervention
- DRUG : placebo cream
- placebo cream applied to 2 adjacent fingers of non-dominant hand one time
- DRUG : Glyceryl Trinitrate
- 0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
- DRUG : Glyceryl Trinitrate
- 1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
- DRUG : Glyceryl Trinitrate
- 1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
- DRUG : Glyceryl Trinitrate
- 2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female volunteers aged between 18 and 50 inclusive
* Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
* If a female, subject must be non-pregnant and non-lactating
* The subject has provided written informed consent prior to admission to this study
Exclusion Criteria:
* History of clinically relevant medical illnesses (not considering RP) that in the Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders
* History in the past five (5) years of drug or alcohol abuse
* History in the past five (5) years of vascular migraine or other chronic severe headache
* History in the past five (5) years of autonomic neuropathy or postural hypotension
* Unwilling or unable to comply with the restrictions outlined in the protocol
* Current use of smoking cessation treatment, including nicotine patches
* History of drug allergies, anaphylaxis or laryngeal oedema, including allergy to GTN, propylene/ethylene glycol or common moisturizing creams
* Use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug
* Currently treated for hypertension
* Currently receiving treatment for prevention and/or treatment of RP
* Use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study
* Open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied
* Use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug
* Withdrawal of consent at any time during the study
* Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study
* Previously enrolled in the study
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
|
NCT00700518
|
{
"brief_title": "Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon",
"conditions": [
"Raynaud's Phenomenon"
],
"interventions": [
"Drug: Glyceryl Trinitrate",
"Drug: placebo cream"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00700518",
"official_title": "A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-11",
"study_completion_date(actual)": "2008-11",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-12-30",
"last_updated_that_met_qc_criteria": "2008-06-17",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-18",
"first_submitted": "2008-06-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
MRI though not painful requires deep sedation for children due to the loud noise created. With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For standardization MRI brain was chosen and also for the fact that patients usually have history of convulsions where drugs like ketamine may not be a good option. Patients were recruited after ethics committee approval. After pre-medication with intranasal midazolam 0.2 mg/kg body weight, Intravenous access was established and then patients were divided in two groups. One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg body weight per minute. The other group received intravenous bolus of Dexmedetomidine 1mcg/kg over 10 minutes and then a infusion of Dexmedetomidine 1mcg/kg/hour.
Primary out come was to study the recovery time of patients sedated with Dexmedetomidine compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were analysed in terms of time for induction,procedural disruptions due to awakening and haemodynamic stability . Follow up was done on phone for any adverse events.
Detailed Description
Patients were evaluated on out patient department basis. On the day of MRI nil per oral status of 6 hours was confirmed and consent taken from the parent. In recovery room after recording of vitals, children were given intranasal midazolam 0.2mg/kg body weight. The intravenous line was secured after the child was sedated. Patients were then divided in two groups. In the MRI console, the dexmedetomidine group received intravenous dexmedetomidine 1mcg/kg body weight over 10 minutes. An intravenous infusion of dexmedetomidine was then started at 1mcg/kg/hour.
The propofol group received 2mg /kg of intravenous propofol and an infusion of 100mcg/kg/minute.
MRI monitoring included pulseoximetry, cardioscope, respiratory pattern and rate. Oxygen was delivered by nasal prongs. Primary outcome measured was the time for recovery.
Secondary outcomes were number of awakening during procedure, haemodynamic stability, induction time and any adverse events.
After MRI the children were observed in the recovery room and discharged after achieving 'modified aldred score' of 10. Vitals and any adverse events were recorded during this phase.
#Intervention
- DRUG : Dexmedetomidine
- intravenous dexmedetomidine 1 mcg per kg body weight over 10 minutes followed by infusion of dexmedetomidine at dose of 1 mcg per kg body weight per hour till end of procedure
- Other Names :
- Dexem
- DRUG : propofol
- intravenous propofol 2mg per kg body weight followed by infusion of propofol at a dose of 100 mcg per kg body weight per min till end of procedure
- Other Names :
- propoven, diprivan
- DRUG : Midazolam
- Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation
- Other Names :
- Versed, Fulsed
|
#Eligibility Criteria:
Inclusion Criteria:
* children posted for elective MRI brain
* American society of anaesthesiologist physical status I and II
Exclusion Criteria:
* age less than 1 year and more than 7 years
* American society of anaesthesiologist physical status III and IV
* emergency cases
* upper respiratory tract infection
* patients on digoxin and beta blockers
* allergy to study drugs
* Body mass index more than 35
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 7 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02776189
|
{
"brief_title": "Dexmedetomidine Verses Propofol for Paediatric MRI Brain",
"conditions": [
"Brain Diseases"
],
"interventions": [
"Drug: propofol",
"Drug: Dexmedetomidine",
"Drug: Midazolam"
],
"location_countries": [
"India"
],
"nct_id": "NCT02776189",
"official_title": "Comparative Study of Dexmedetomidine-midazolam Combination and Propofol-midazolam Combination for MRI Brain in Paediatric Patient",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2012-10"
},
"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)": "2016-07-19",
"last_updated_that_met_qc_criteria": "2016-05-16",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-18",
"first_submitted": "2016-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Liver cirrhosis (LC) is a leading cause of morbidity and mortality worldwide. Life- threatening complications of liver cirrhosis are ascites, gastrointestinal bleeding, variceal bleed, hepatic encephalopathy and hepatocellular carcinoma (HCC) which are associated with poor prognosis.The leading causes of liver cirrhosis include excess alcohol consumption, viral hepatitis and non-alcoholic fatty liver disease. Malnutrition is common in end-stage liver disease (cirrhosis) and is often associated with a poor prognosis. It occurs in all forms of cirrhosis with different etiology and prevalence ranges from 65 to 100% depending upon the methods used for nutritional assessment and the severity of liver disease. Nutritional state influences survival in patients with decompensated cirrhosis. Protein malnutrition manifested by reduced skeletal muscle mass and hypoalbuminemia, exist in patients with cirrhosis despite apparent adequate food consumption and these patients have a higher rate of complications and, overall, an increased mortality rate. Also, Malnutrition has significant implications for liver transplantation; patients with poor nutritional status before transplantation have increased complications and higher mortality rates postoperatively. Screening all patients with chronic liver disease for nutritional abnormalities can identify those at risk of developing preventable complications.
Malnutrition is commonly associated with protein catabolism and the protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3.
GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis.
However there is scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on nitrogen economy, malnutrition and liver regeneration in patients with cirrhosis.
#Intervention
- DRUG : Standard Medical Therapy
- Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required
- DRUG : Growth Hormone
- GH therapy is initiated at a low dose of 1U/day and titrated slowly upward to a maximum dose of 3U/day (depending on IGF-1 levels) subcutaneously for 1 year.
|
#Eligibility Criteria:
Inclusion Criteria:
* Decompensated Cirrhosis of liver irrespective of etiology
Exclusion Criteria:
* Acute on chronic liver failure (fulfilling either APASL or CANONIC criteria of ACLF)
* Splenic diameter of more than 18 cm
* Concomitant HCC or other active malignancy
* Upper gastrointestinal bleeding in the previous 7 days
* Portal vein thrombosis
* Severe renal dysfunction as defined by creatnine > 1.5mg/dl
* Severe cardiac dysfunction
* Uncontrolled diabetes (Hb A 1c >= 9) or diabetic retinopathy
* Acute infection or disseminate intravascular coagulation
* Active alcohol abuse in last 3 months
* Known hypersensitivity to GH
* HIV co-infection
* Pregnancy
* Refusal to give informed consent
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
|
NCT03420144
|
{
"brief_title": "Growth Hormone Therapy in Liver Cirrhosis",
"conditions": [
"Cirrhosis, Liver"
],
"interventions": [
"Drug: Standard Medical Therapy",
"Drug: Growth Hormone"
],
"location_countries": [
"India"
],
"nct_id": "NCT03420144",
"official_title": "Growth Hormone Therapy and Its Effect on Nitrogen Metabolism and Malnutrition in Liver Cirrhosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-30",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2018-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-03",
"last_updated_that_met_qc_criteria": "2018-02-01",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-05",
"first_submitted": "2018-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.
Detailed Description
Contrary to supportive care, well-being care is imperfectly assessed. Well being care (WBC) consist on complementary programs, with no real consensus. Very few studies have rigorously evaluated its benefits
The objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, Sophrology and singing) provided in a healthcare facility
|
#Eligibility Criteria:
Inclusion Criteria:
* all type of cancer treated at the general Hospital of Valence
* patient agree to participate on Well being session: foot reflexology, socio-aesthetics, Sophrology and singing
* Age >= 18 years
* Affiliation to a Social security system
* Patient who has given written consent signed before any specific procedure of the protocol
Exclusion Criteria:
* Patient under guardianship, deprived of liberty, safeguard of justice
* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator)
* Refusal to participate in research
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05493150
|
{
"brief_title": "Antalgic Effects of Well-being Treatments in Cancer Care",
"conditions": [
"Cancer",
"Cancer Pain"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05493150",
"official_title": "Antalgic Effects of Well-being Treatments in Cancer Care; Foot Reflexology, Socio-aesthetics, Sophrology, Singing",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-30",
"study_completion_date(actual)": "2021-12-30",
"study_start_date(actual)": "2020-01-22"
},
"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)": "2022-08-09",
"last_updated_that_met_qc_criteria": "2022-08-05",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-09",
"first_submitted": "2022-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.
Detailed Description
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
#Intervention
- DRUG : Part 1: CNTO 7160
- Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
- DRUG : Part 2 (Asthma): CNTO 7160
- Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
- DRUG : Part 2 (Atopic Dermatitis): CNTO 7160
- Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
- DRUG : Part 1 and Part 2: Placebo
- Participants will receive single IV infusion of placebo matched to CNTO 7160.
|
#Eligibility Criteria:
Inclusion Criteria:
* Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
* Part 1 (Healthy Participants): Participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
* Part 2 (Asthma Participants): Participant must have a body weight in the range of 50 to 125 kg inclusive and have a BMI of 19 to 32 kg/m^2 inclusive
* Part 2 (Asthma Participants): Participant must have a physician documented diagnosis of asthma for at least 12 months before screening
* Part 2 (Atopic Dermatitis Participants): Participant must have a body weight in the range of 50 to 100 kg inclusive and have a BMI of 19 to 30 kg/m^2 inclusive
* Part 2 (Atopic Dermatitis Participants): Participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on UK refinements of the Rajka and Hanifin criteria
Exclusion Criteria:
* Part 1 (Healthy Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
* Part 1 (Healthy Participants): Participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
* Part 2 (Asthma Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
* Part 2 (Asthma Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
* Part 2 (Atopic Dermatitis Participants): Participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit.
* Part 2 (Atopic Dermatitis Participants): Participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for a serious infection during the 4 months prior to the Screening Visit
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02345928
|
{
"brief_title": "A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis",
"conditions": [
"Asthma",
"Atopic Dermatitis",
"Healthy"
],
"interventions": [
"Drug: Part 2 (Asthma): CNTO 7160",
"Drug: Part 1 and Part 2: Placebo",
"Drug: Part 1: CNTO 7160",
"Drug: Part 2 (Atopic Dermatitis): CNTO 7160"
],
"location_countries": [
"Germany",
"Belgium"
],
"nct_id": "NCT02345928",
"official_title": "A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-16",
"study_completion_date(actual)": "2017-03-16",
"study_start_date(actual)": "2014-08-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-16",
"last_updated_that_met_qc_criteria": "2015-01-19",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-26",
"first_submitted": "2014-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.
HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.
Detailed Description
Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality.
Cardiac surgery is a challenge in the management of coagulation because of the requirement for both a fully anticoagulated state for CPB and a return-to-normal hemostasis at its conclusion. Conditions during CPB, such as hemodilution, hypothermia, platelet activation and coagulopathy are know to cause falsify elevated ACT readings. For these reasons, relying on the ACT alone may lead to inadequate anticoagulation.
Moreover, no consensus about the monitoring or level of anticoagulation required has been reached. Similarly, the neutralization of heparin is performed with protamine (dose/dose). This empirical approach does not include inter- and intra-individual variations, which can involve bleeding complications. By using the HMS Plus, heparin and protamine dosing are individualized based on each patient's responsiveness to heparin, eliminating the need for empiric weight-based dosing.
HMS Plus provided a rapid assessment of heparin concentration that correlated well with anti-Xa assays. This could attenuates this hemostatic activation by decreasing excessive generation of thrombin and plasmin. Also, this ensures preservation of coagulation factors and decreases thrombin-mediated consumption and activation of platelets during CPB.
HMS Plus is ability to calculate the amount of circulating heparin at the end of CPB and give the exact dose of protamine necessary to neutralize the heparin. Targeted dosing can prevent excessive protamine administration and reduce protamine-induced platelet dysfunction.
In a meta-analysis of 4 randomized controlled trials involving a total of 507 patients, postoperatively blood loss was lower in the HMS group compared with the control group. But the supporting studies were limited by small sample sizes, outdated practice techniques, not involve surgery at risk and have liberal transfusion practices. Moreover, studies observed errors in calculating the heparin bolus dose with HMS Plus if patient had an inadequate antithrombin level. The administration of more heparin is a cause of heparin rebound in the postoperative period and potentially was increasing the risk for bleeding.
So, it would be necessary to compare ACT Plus and HMS Plus devices on postoperatively bleeding in a study involve patients at risk to bleeding and with a transfusion protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)
Exclusion Criteria:
* Minors
* Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
* Contra indication to heparin and/or protamine
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03885193
|
{
"brief_title": "Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery",
"conditions": [
"Cardiac Surgical Procedure"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03885193",
"official_title": "Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-14",
"study_completion_date(actual)": "2019-11-14",
"study_start_date(actual)": "2019-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-04",
"last_updated_that_met_qc_criteria": "2019-03-19",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-21",
"first_submitted": "2019-03-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pregnant women are more likely to form clots than non-pregnant women as pregnancy increases the clotting factors present in the blood. This helps to prevent excess bleeding (hemorrhage) at the time of delivery. Hemorrhage occurs in 5-15% of pregnancies throughout the world, even when delivery is by cesarean section. When hemorrhage occurs the anesthesiologist will normally administer fluids into the woman's vein (intravenously) rapidly to replace the blood that the woman has lost. Two types of fluids are commonly used. One is a salt water solution (saline) and the other is a starch water solution (pentastarch). Use of either or both of these solutions is common during hemorrhage.
These same solutions (salt water solution and starch solution) are used at BC Women's Hospital during spinal anesthesia to prevent and treat low blood pressure (a common side effect of spinal anesthesia). This is standard practice whether you are in this study or not. You may also be given, depending on the anesthesiologist's preference, a drug (vasopressor) that causes the blood vessels to become narrow (constrict) to prevent or treat the low blood pressure. Whether you agree to be part of the study or not, your anesthesiologist will be watching your blood pressure closely throughout your operation and if your blood pressure becomes low he/she will treat it as is normally done.
Low blood pressure will also occur during hemorrhage. It is therefore important that we determine whether the starch solution, which is more effective than the salt solution in preventing low blood pressure during spinal anesthesia, does or does not affect clotting.
Research in non-pregnant adults (male and female) has found that laboratory tests of blood clotting change with these solutions. For saline the evidence in some studies suggests that the blood may clot better than normal while other studies suggest the opposite (does not clot as well). In pregnant and non-pregnant adults the blood does not clot as well with certain starch solutions. The starch solution used at BC Women's Hospital is called pentastarch and no research has looked at its effect on clotting in pregnant women. In non-pregnant adults pentastarch has less effect on clotting than other starch solutions.
The purpose of the study is to see how pentastarch (starch solution) and normal saline (water with salt in it) given at the time of spinal anesthesia for elective cesarean section affect the ability of pregnant woman's blood to clot.
Detailed Description
Study patients will be randomized to one of two groups. One group will receive saline solution (salt water) and the other group will receive the pentastarch solution. Neither the patient, the anesthesiologist, the obstetrician nor nurses will know which group the patient is in.
All women who participate in the study will have an intravenous. Once the tube is in the vein, a blood sample will be taken from it before an intravenous solution is started. The amount of blood taken will be approximately 1 tablespoon (15mL). This is not part of routine care but is part of the study. This blood will be checked to see how well it forms a clot. The study solution (15 ml/kg of either saline or starch solution, approximately 1 litre) will then be attached to the intravenous. Once the patient is in the operating room and the spinal anesthetic has been given the remainder of the study solution will be given very rapidly over 10 minutes into the vein. Once the study solution has been given, the patient will receive a saline solution through their intravenous at a rate determined by the anesthesiologist according to their normal practice.
Five minutes after the study solution is given, a further blood sample (15 mL) will be taken from the intravenous and it will be tested the same as for the first blood sample. A third blood sample will be taken approximately 85 minutes later. As these blood samples will be taken from the intravenous, the patient will not have to have a needle inserted to take them. Approximately 10% of the time it may not be possible to take the blood sample from the intravenous. If this should happen the investigator or the anesthesiologist will want to take the blood sample from the opposite arm to the intravenous. The patient will be told that this is going to happen and can withdraw from the study at that time. This will not affect any further care that the patient receives. To minimize discomfort if blood is taken from the opposite arm the skin will be made numb with local anesthetic.
You will be treated the same as any woman having a cesarean section under spinal anesthesia with the exception that
1. the patient and the anesthesiologist will not know which study solution is being given and 2 three blood samples will be taken - to total 3 tablespoons (total: 3x1 tablespoon).
For the purposes of the study we will be using the information collected about the patient in the normal course of the anesthetic, including the total amount of fluid that received during cesarean section, the need for, type and amount of any medication during the cesarean section, and an estimate of the total amount of blood lost during the operation. These are in addition to the results of the laboratory tests of clotting.
There is no extra time or cost involved for the patient.
#Intervention
- DRUG : Pentaspan®
- 15 ml/kg of starch solution, approximately 1 litre
- DRUG : Normal Saline
- 15 ml/kg of either saline solution, approximately 1 litre
|
#Eligibility Criteria:
Inclusion Criteria:
* aged 19 years or over
* having an elective cesarean section under spinal anesthesia
* at least 36 weeks gestation
* in general good health
Exclusion Criteria:
* blood does not clot normally
* taking heparin or Aspirin® (acetylsalicylic acid) within 7 days of surgery
* high blood pressure
* expecting twins
* any heart abnormality (including heart failure)
* kidney or liver disease
* known allergy to hydroxyethylstarch, corn, starch or any drugs
* insulin dependent diabetes
* aged less than 19 years
* do not understand English
* having emergency surgery
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00474162
|
{
"brief_title": "The Clotting Effects of Pentastarch and Normal Saline in Obstetric Patients",
"conditions": [
"Elective Cesarean Section"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00474162",
"official_title": "Observational Pilot Study of the Effect of Intravenous Saline or Pentastarch on Coagulation in Women Having an Elective Cesarean Section",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-02",
"study_completion_date(actual)": "2008-02",
"study_start_date(actual)": "2007-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-02-21",
"last_updated_that_met_qc_criteria": "2007-05-15",
"last_verified": "2008-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-16",
"first_submitted": "2007-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the present study was to evaluate the effect of a xylitol containing propolis tablet on the salivary pH, total microorganisms count and soluble and insoluble extracellular polysaccharide concentration of the dental biofilm of adolescents in a randomized controlled clinical trial. In addition, evaluate the acceptability of the individuals regarding the characteristics of the tablets (appearance, taste, aroma and texture) through a questionnaire. To that end, healthy adolescents between 10 and 19 years old, without active carious lesions, who seek care at the Pediatric Dentistry Clinic of the Universidade Federal do Rio de Janeiro (UFRJ) will be randomly assigned to the two groups of the study: control group (propolis- consumers of tablets with propolis), respecting an interval of 30 days of rest between the consumption of the tablets. The study will be cross-checked and the principal investigator will be blind. The tablets will be given to the participants on an exact number of days of use and they will be instructed to consume two tablets per day for 7 uninterrupted days. After 30 days of interval, they will consume the other type of tablet with the same recommendations of the first one. The total non-stimulated saliva collection will be performed at the beginning of the study (before the consumption of the tablets) and 7 days after the intervention of each type of tablet, as well as the collection of the dental biofilm. Saliva and biofilm samples from all individuals will be identified and later analyzed in the laboratory, on the same day of collection, to measure the salivary pH, with the aid of a phmeter, and evaluation of the growth of total microorganisms (CFU / mg biofilm ), respectively. From the biofilm collected and stored in saline, concentrations of soluble and insoluble extracellular polysaccharides will also be measured by means of a spectrophotometer. Statistical tests will be used to compare the groups, with a significance level of 5%. As results, the propolis-containing tablet is expected to increase the salivary pH and decrease the number of total microorganisms in the dental biofilm.
Detailed Description
Test tablets (with xylitol and propolis) and control (xylitol only) will be offered in an exact number of days of use to be consumed orally. Collection of total non-stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days, for both types of pellets and both tests. All individuals (n=300) will use the tablet with and without propolis, respecting interval of 30 days without consumption of any other tablet or substance containing propolis and/or xylitol.
#Intervention
- DRUG : Propolis tablet to limit dental biofilm
- The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days
- Other Names :
- Propolis+Xylitol tablet
- DRUG : Xilytol tablet to limit dental biofilm
- The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days.
- Other Names :
- Xylitol tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 10 <= age <= 19 years;
* Both genders;
* Individuals without cavitary caries lesions;
* Healthy individuals without any systemic diseases.
Exclusion Criteria:
* Individuals intolerant to some component of the propolis-containing tablet;
* Subjects undergoing antimicrobial treatment during the course of the study or for a period of 30 days prior to the study;
* Individuals who used products containing xylitol up to 30 days before the start of study or during the course of the study;
* Individuals who used products containing propolis up to 30 days before the start of the study or during the course of the study;
* Individuals with orthodontic appliances;
* Individuals who are using oral mouthwashes during the period of study;
* Individuals with a history of intraoral surgery within the last 6 months;
* Individuals who are making use of products rich in polyphenols: coffee, mate, acai, in the previous period (30 days) and during the research;
* Individuals who consume alcohol.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03394729
|
{
"brief_title": "Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes",
"conditions": [
"Dental Plaque"
],
"interventions": [
"Drug: Propolis tablet to limit dental biofilm",
"Drug: Xilytol tablet to limit dental biofilm"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03394729",
"official_title": "Effect of a Propolis-containing Tablet on the Acidity of Saliva and the Amount of Adolescent Dental Plaque Microbes: a Randomized Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-21",
"study_completion_date(actual)": "2020-10-21",
"study_start_date(actual)": "2017-09-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-04",
"last_updated_that_met_qc_criteria": "2018-01-03",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-09",
"first_submitted": "2017-12-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Recently, VILI has been linked to mechanical power, or the amount of energy the mechanical ventilator sends to the respiratory system in a given time. The hunt for lung damage-reducing characteristics, notably after VILI and ARDS (Acute respiratory distress syndrome), has increased after Covid-19. Mechanical power must be used more to promote lung protection. We examined the effects of bilateral rectus sheath and OSTAP (Oblique Subcostal Transversus Abdominis Plane ) block on mechanically powered patients.
Detailed Description
MP is the energy transmitted over time to the respiratory system during mechanical ventilation. Although mechanical ventilation is a life-supporting treatment, it has the potential to cause damage to the lung structure in a process referred to as VILI. Recently, the degree of VILI has been associated with the amount of energy transmitted to the respiratory system by the mechanical ventilator within a specific time frame, which is referred to as mechanical power. After the occurrence of Covid-19, the search for parameters to reduce lung damage, especially following VILI and ARDS, has become more prominent. In this regard, promoting lung protection requires the more widespread use of mechanical power. We aimed to investigate the effect of bilateral rectus sheath and OSTAP block applied to patients on mechanical power.
#Intervention
- PROCEDURE : Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed.
- The OSTAP block will be conducted in-plane using a 100mm 22 G needle and a linear probe under ultrasound (USG) guidance. The 20cc block will contain 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral OSTAP will be administered with 20cc (10cc per side). To apply the block, position the linear probe parallel to the rib edge immediately below it on the anterior abdominal wall. Visible will be the external, internal, transversus abdominis, and rectus muscle junction. The needle tip will move toward the TAP space (between the internal oblique and transversus abdominis muscles). To ensure medication delivery, the needle tip will be visible in the TAP and the drug will be aspirated negatively. USG will also observe drug distribution at the rectus abdominis muscle-TAP space junction.
- PROCEDURE : Bilateral Rectus Sheath Block (RSB) will be performed.
- When the patient is in the supine position, the ultrasound (USG) linear probe is held in the transverse plane at the level just above the umbilicus, where the posterior rectus sheath is best visualized. Using the in-plane technique with a 100mm 22 G needle under USG guidance, the drug prepared will be administered between the rectus muscle and the posterior rectus sheath. For this block, a volume of 20cc will be prepared, consisting of 10cc of 0.5% bupivacaine and 10cc of normal saline. Bilateral Rectus Sheath Block (RSB) will be applied with a total volume of 20cc, 10cc to each side.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 65 years
* ASA 1 <= age <= 2 patients
* Patients undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
* Mental retardation,
* Severe presence of COPD,
* Uncontrolled Bronchial Asthma,
* Decompensated Heart Failure (NYHA 3 <= age <= 4),
* History of previous lung surgery,
* Patients unwilling to participate in the study,
* Local anesthetic allergy,
* History of chronic pain and treatment,
* Morbid obesity (body mass index (BMI) >35),
* Pregnancy,
* Patients converted to open cholecystectomy
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
|
NCT06202040
|
{
"brief_title": "The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power",
"conditions": [
"Mechanical Power"
],
"interventions": [
"Procedure: Bilateral Rectus Sheath Block (RSB) will be performed.",
"Procedure: Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed."
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06202040",
"official_title": "The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-15",
"study_completion_date(actual)": "2024-01-25",
"study_start_date(actual)": "2023-12-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-23",
"last_updated_that_met_qc_criteria": "2024-01-02",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-11",
"first_submitted": "2023-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals.
#Intervention
- OTHER : BE-FAST
- This intervention includes those randomized to the education with the BE-FAST mnemonic.
- OTHER : FAST
- This intervention includes those randomized to the education with the FAST mnemonic.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject 18 years or older
* Subject speaks English (Does not need interpreter)
* Subject able to read English
* Subject willing to provide a phone number for future follow up
* Subject willing and agreeable to up to 2 phone follow up calls
* Subject willing to provide verbal consent to participate
Exclusion Criteria:
* Subject non-English speaking (needs interpreter)
* Subject has visual or hearing impairment
* Subject has history of Dementia or a learning disability
* Subject had stroke education within the past year
* Subject had a previous stroke
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
|
NCT06152016
|
{
"brief_title": "BE FAST vs. FAST: A Study in the General Public.",
"conditions": [
"Stroke"
],
"interventions": [
"Other: BE-FAST",
"Other: FAST"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06152016",
"official_title": "BE FAST vs. FAST: A Randomized Trial Comparing Retention of Stroke Symptoms Between Two Mnemonics in the General Public.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-18",
"study_completion_date(actual)": "2023-06-23",
"study_start_date(actual)": "2021-11-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-03",
"last_updated_that_met_qc_criteria": "2023-11-21",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-30",
"first_submitted": "2023-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and interventions of these three geriatric syndromes are often related. Frailty is often defined as accumulations of multi-system deficiencies with increased vulnerability to multiple worse outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older adults may have positive impacts on measurements associated with not only frailty, but also depression, or osteoporosis. The objective of this proposed study is to conduct a randomized control trial (RCT) to exam the effectiveness of integrated interventions on multiple outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or osteoporosis, depression. We also plan to determine the differential effects of intervention between urban and rural area.
Detailed Description
This is a three-year study. In the first year, we conducted a pilot study to test the feasibility of implementing integrated model on frailty, osteoporosis, depression, and other outcomes. Another objective is to determine optimal sample size for next level intervention in year 2 and 3 (2009 study).
Subjects are community-dwelling Taiwanese elders (65-79 years of age) living in Toufen Town in Miaoli County, Taiwan. Subjects are first screened with telephone interviews with the Chinese Canadian Study of Health and Aging _Clinical Frailty Scale (CCSHA_CFS). Eligible subjects are invited to a community hospital to be screened with the Health Study Phenotypic Classification of Frailty (CHS_PCF). Subjects scored ≥ 1 on the CHS_PCF are enrolled. With a 2 by 2 factorial design, subjects are first randomized into exercise/nutrition integrated care (ENIC) group and usual care (UC) group with education. Within each group, subjects are further randomized into problem solving therapy (PST) and usual care (UC) group with education by study care managers with pre-specified protocol. UC group subject received a study educational booklet with telephone follow up on compliance of booklet reading and suggested diet and exercise programs. Besides the booklets, ENIC group subjects received structured exercise 3 times/week with nutrition consultation as needed at hospital for 3 months while PST group subjects received 6 sessions of PST at hospital in 3 months.
Subjects were followed at 3, 6 and 12 months. Primary outcome is improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline analysis. Secondary outcomes include the physical function and performance, cognition, depression, quality of life, healthcare resource utilizations and bone-mineral density (BMD). Intention-to-treat analysis was applied.
The pilot study enrolled 117 subjects, after analysis of the preliminary results, the study protocol for the second and third year (2009 study) is modified as follows:
1. The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly 150 participants at each site.
2. Convenient samples referred from participant physicians' clinics instead of the population based samples in year 1 are used to decrease administration cost.
3. Telephone based first stage screening instrument will be modified and validated for face to face interview.
4. Longer intervention period (6-months) than year 1.
5. Interventions provided in ENIC and PSTIC groups are combined into a single integrated care (IC) group. Interventions for IC group and UC group are minor changed, as described below.
UC group: Inform the subjects about results of frailty, osteoporosis or depression assessment. The study educational booklet and CD-ROM on frailty, depression, osteoporosis, healthy diets, exercise protocols, and self-coping strategies will be given to participants. One 2-hour educational session is provided to participants to go through the booklet with demonstration of study exercise protocol. Subjects are encouraged to have balanced nutrition and regular exercises at home following the study protocol. Subjects were contacted bimonthly to check on how much they had read and watched the study material, and how well they had complied with the suggested diet and exercise protocols. However, it is at the subjects' discretion to discuss with their primary care physicians regarding the clinical interventions.
IC group: Subjects will receive all interventions provided to the UC group. Furthermore, subjects will take exercise/rehabilitation courses at the participating hospitals twice a week for 24 weeks and 6 sessions of problem solving treatment (PST). If subjects do not improve on any of the 5 indicators from the (CHSPCF), comprehensive geriatric assessments (CGAs) are applied to identify more potential modifiable factors for frailty for individualized managements.
Actual number of subjects enrolled in pilot study and 2009 study are 117 and 289 respectively and the total number of subjects enrolled in pilot study and 2009 study is 406.
#Intervention
- BEHAVIORAL : Exercise and nutritional integrated care
- Besides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions.
- BEHAVIORAL : Usual care with education
- The study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments.
- BEHAVIORAL : Problem solving therapy (PST) integrated care
- Besides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements.
|
#Eligibility Criteria:
Inclusion Criteria:
* Scored 3 <= age <= 6 with the 'Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese Telephone Interview Version' (Telephone Interview Version is replaced by In-Person Interview Version in 2009 study)
* Frailty index >= 1
Exclusion criteria:
* Nursing home residents
* Cannot speak any of the following three dialogues: Mandarin, Taiwanese and Haga
* Hearing impairment interfering with communication or daily activities
* Visual impairment interfering with communication or daily activities.
* Cannot complete the screening instrument with the CSHA-CFS Chinese Telephone/In-Person Interview Version
* Scored 1, 2, or 7 with the CSHA-CFS Chinese Telephone/In-Person Interview Version
* Cognitive impairment defined as 3-item recall <= 1
* Functional Impairment defined as not able to walk for 5 meters without assistance
* Suicidal Ideation defined as Suicide Subscale of The Mini-International Neuropsychiatric Interview (M.I.N.I.) >= 6
* Alcohol abuse disorders active within the last year. (score >= 2 on the CAGE)
* Organic mental disorders (Seizure, brain tumor, brain surgeries), History of schizophrenia or bipolar diagnosed from psychiatrist
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00718432
|
{
"brief_title": "An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression",
"conditions": [
"Frailty",
"Osteoporosis",
"Depression"
],
"interventions": [
"Behavioral: Exercise and nutritional integrated care",
"Behavioral: Problem solving therapy (PST) integrated care",
"Behavioral: Usual care with education"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT00718432",
"official_title": "Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-25",
"last_updated_that_met_qc_criteria": "2008-07-17",
"last_verified": "2009-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-18",
"first_submitted": "2008-07-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
#Intervention
- DRUG : mesenchymal stem cells
- Intramuscular injection
- DRUG : Plasmalyte A
- Intramuscular injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Males or females with non-child bearing potential in the age group of 18 <= age <= 60 yrs of Indian origin.
* Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
* Ankle Brachial Pressure Index (ABPI) <= 0.6 or ankle pressure <= 70 mm Hg or TcPO2 <= 60 mmHg in the foot
* Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c <= 8%) without complications
* Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
* Normal liver and renal function
* On regular medication for hypertension if any
Exclusion Criteria:
* Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
* CLI patient requiring amputation proximal to trans-metatarsal level
* Patients with gait disturbance for reasons other than CLI.
* Type I diabetes
* Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months
* Patients who are contraindicated for MRA
* Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
* Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
* Patients already enrolled in another investigational drug trial or completed within 3 months.
* History of severe alcohol or drug abuse within 3 months of screening.
* Hb% < 10 gm%, Serum Creatinine >= 2mg%, Serum Total Bilirubin >=2mg%, HbA1c > 8%
* Women with child bearing potential, pregnant and lactating women.
* Patients tested positive for HIV 1, HCV, HBV,
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
|
NCT00883870
|
{
"brief_title": "Mesenchymal Stem Cells in Critical Limb Ischemia",
"conditions": [
"Critical Limb Ischemia"
],
"interventions": [
"Drug: mesenchymal stem cells",
"Drug: Plasmalyte A"
],
"location_countries": [
"India"
],
"nct_id": "NCT00883870",
"official_title": "A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2009-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-05",
"last_updated_that_met_qc_criteria": "2009-04-17",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-20",
"first_submitted": "2009-04-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 monotherapy given as 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression).
#Intervention
- DRUG : SEP-4199 200 mg
- SEP-4199 200 mg/day (supplied in two 100mg tablets)
- DRUG : SEP-4199 400 mg
- SEP-4199 400 mg/day (supplied in two 200mg tablets
- DRUG : Placebo
- Placebo (supplied in two tablets/day)
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 <= age <= 65 of age, inclusive, at the time of informed consent with bipolar I disorder, current episode depressed with or without rapid cycling disease course (>= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features (diagnosed by DSM 5 criteria, and confirmed by the SCID 5 CT). The current episode of major depression associated with bipolar I disorder must be confirmed by the Investigator and noted in the source records.
* Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
* Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
* Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history.
* Subject's current major depressive episode is >= 4 weeks and less than 12 months in duration at Screening.
* Subject has a MADRS total score >= 22 at both Screening and Baseline.
* Subject has a YMRS total score <= 12 at Screening.
* Female subjects of childbearing potential must have a negative serum ß-hCG test at Screening.
* Females who participate in this study must be . one of the following:
* unable to become pregnant (e.g., postmenopausal, surgically sterile, etc.) -OR-
* Practicing abstinence or part of an abstinent lifestyle
* using and willing to continue using a highly effective form of birth control for at least 28 days prior to administration of the first dose of study drug, during the treatment period, and 2 months after completion or premature discontinuation from the study drug.
* Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control. See Section 10.4 for further information on acceptable methods of birth control.
* Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
* Subjects with type 2 diabetes are eligible for study inclusion only if all of the following conditions are met within 30 days prior to Screening:
* Subject's random screening glucose is < 200 mg/dL (11.1 mmol/L).
* Subject's Hemoglobin A1c (HbA1c) <= 7.0%.
* If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 30 days prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.
* Subject has not required hospitalization for diabetes or related complications in the past 12 months.
* Note: Subjects with type 2 diabetes that is newly diagnosed during screening are ineligible for the study.
* Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times: 1) oral hypoglycemics must be stabilized for at least 30 days prior to baseline; 2) thyroid hormone replacement must be stable for at least 90 days prior to baseline; 3) anti hypertensive agents must be stable for at least 30 days prior to baseline. The subject's medical condition should be deemed clinically stable following consultation with the Medical Monitor as needed.
Exclusion Criteria:
* Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM 5. Exclusionary disorders include but are not limited to moderate to severe alcohol use disorder (within past 12 months), substance use disorder (other than nicotine or caffeine) within past 12 months, bipolar II disorder, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder.
* Subject demonstrates a decrease (improvement) of >= 25% in MADRS total score from Screening to Baseline, or subject's MADRS total score is < 22 at Baseline.
* Subject has received treatment with antidepressants within 3 days of randomization, fluoxetine at any time within 28 days, an MAO inhibitor within 21 days or clozapine within 120 days. All other psychotropic medications with the exceptions of lorazepam, temazepam,eszopiclone, zopiclone, zolpidem and zolpidem CR require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization.
* Subject has suspected/confirmed Borderline Personality Disorder
* Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with a known history of HIV seropositivity will be excluded.
Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being randomized in the study.
* Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, active (or history of) seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of intellectual disability or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, is not exclusionary.
* Subject has a history of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Subjects with pituitary tumors of any duration are excluded.
* Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (use screening values for laboratory evaluation). Subject has a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications.
* Subject has knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders, or requires treatment with an antiarrhythmic medication.
* Subject has family history of QTc prolongation or of unexplainable sudden death at < 50 years.
* Abnormal 12 lead ECG at Screening, including:
* QTcF > 450 ms (male subjects) or > 470 ms (female subjects)
* QRS > 110 ms
* PR > 200 ms
* Second- or third-degree atrioventricular block
* Any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant
* Subject has a history of neuroleptic malignant syndrome (NMS).
* Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the investigator.
* Subject has been diagnosed with type 1 diabetes, or insulin-dependent diabetics.
* Subject who has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the investigator. Subjects with fasting blood glucose at screening >= 126 mg/dL (7.0 mmol/L) will be excluded from the study. Subjects with fasting blood glucose from 100 <= age <= 125 mg/dL (5.6 <= age <= 6.9 mmol/L) may enter the study based on the approval of the Medical Monitor. Subjects with HbA1c > 7.0% will be excluded. Subjects who are found to have been non-fasting at Screening may be allowed if their blood glucose is < 200 mg/dL. Subjects with random (nonfasting) blood glucose at screening >= 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Subjects with HbA1c > 7.0% will be excluded.
* Subject has a prolactin concentration > 100 ng/mL at screening or have a history of pituitary adenoma.
* Subject has a body mass index (BMI) >= 40 or < 18 kg/m2.
* Subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode.
* Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or answers 'yes' to 'Suicidal Ideation' item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the Screening visit (in the past month [30 days]) or Baseline.
* Subject tests positive for drugs of abuse at screening or baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from cannabis during the study. This information will be discussed with the Medical Monitor for study enrollment consideration.
* Subject has a history of hypersensitivity to more than two distinct chemical classes of drug (e.g., sulfas and penicillins).
* Subjects have received depot neuroleptics unless the last injection was at least one treatment cycle before randomization.
* Subject requires treatment with a drug that consistently prolongs the QTc interval
* Subject has received ECT within 90 days prior to randomization or is expected to require ECT during the study course.
* Subject is currently participating, or has participated in a study with an investigational or marketed compound or device within 6 months prior to signing the informed consent, or has participated in 3 or more studies within 18 months prior to signing the informed consent.
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
|
NCT03543410
|
{
"brief_title": "A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression",
"conditions": [
"Depressive Episode",
"Bipolar 1 Depression"
],
"interventions": [
"Drug: SEP-4199 200 mg",
"Drug: Placebo",
"Drug: SEP-4199 400 mg"
],
"location_countries": [
"Japan",
"Slovakia",
"Ukraine",
"Poland",
"United States",
"Serbia",
"Russian Federation",
"Bulgaria"
],
"nct_id": "NCT03543410",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-23",
"study_completion_date(actual)": "2020-04-23",
"study_start_date(actual)": "2018-06-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-18",
"last_updated_that_met_qc_criteria": "2018-05-21",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-01",
"first_submitted": "2018-05-21",
"first_submitted_that_met_qc_criteria": "2023-04-24"
}
}
}
|
#Study Description
Brief Summary
* To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.
* To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815
* To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815
* To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
#Intervention
- DRUG : (14C)-OPC-61815
- On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
|
#Eligibility Criteria:
Inclusion Criteria:
* Male subjects between 35 and 55 years, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.
Exclusion Criteria:
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.
Sex :
MALE
Ages :
- Minimum Age : 35 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04182958
|
{
"brief_title": "A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects",
"conditions": [
"Healthy Adult Male"
],
"interventions": [
"Drug: (14C)-OPC-61815"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04182958",
"official_title": "A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-19",
"study_completion_date(actual)": "2019-12-19",
"study_start_date(actual)": "2019-11-25"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-06",
"last_updated_that_met_qc_criteria": "2019-11-27",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-02",
"first_submitted": "2019-11-27",
"first_submitted_that_met_qc_criteria": "2021-09-08"
}
}
}
|
#Study Description
Brief Summary
This study is designed to assess the best method for caring for elders reported to Adult Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in improving the health and quality of live among elders with substantiated self-neglect.
#Intervention
- OTHER : Comprehensive Geriatric Assessment and APS Usual Care
- Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.
- Other Names :
- Randomized Controlled Trial
- OTHER : APS usual care
- APS usual care consists of social, medical, and legal assistance.
- Other Names :
- Randomized Controlled Trial
|
#Eligibility Criteria:
Inclusion Criteria:
* 65 years or older
* English Speaking
* Resident of Harris County, Houston Texas
* Community-dwelling
* Substantiated Self-Neglect
Exclusion Criteria:
* No other substantiated allegations
* Non-community dweller
* No available for projected follow-up period
* Impaired decision-making with no available proxy
* Already receiving care from TEAM or within the past year
* 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:
Yes
|
NCT00901706
|
{
"brief_title": "Multidimensional Assessment and Intervention for Elder Self-Neglect",
"conditions": [
"Self-Neglect",
"Cognitive Ability, General",
"Geriatric Disorder"
],
"interventions": [
"Other: APS usual care",
"Other: Comprehensive Geriatric Assessment and APS Usual Care"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00901706",
"official_title": "Multidimensional Assessment and Intervention for Elder Self-Neglect",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2009-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-18",
"last_updated_that_met_qc_criteria": "2009-05-13",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-14",
"first_submitted": "2009-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.
Detailed Description
Study is 6 weeks long, with 7 clinical visits.
#Intervention
- DRUG : Depakote-ER
|
#Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics
Exclusion Criteria:
* Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
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
|
NCT00226343
|
{
"brief_title": "Depakote-ER for Depressive and Bipolar Depression",
"conditions": [
"Bipolar Disorder"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00226343",
"official_title": "Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-01",
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2003-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-18",
"last_updated_that_met_qc_criteria": "2005-09-26",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-27",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Urinary Tract Infection (UTI) is the most common hospital acquired infection worldwide, and is most commonly associated with catheterisation of the bladder. Catheter associated urinary tract infection (CAUTI) causes increased hospital costs, increased length of stay and increased mortality. This burden of disease is, in part, mediated by a lack of diagnostic and monitoring modalities for CAUTI. Both traditional and novel UTI diagnostic tests are susceptible to false positives associated with bacterial colonisation, and correlate poorly with clinically meaningful symptomatic CAUTI. As such, the current standard of care is reliant on clinical monitoring, which is susceptible to diagnostic delays, over and under treatment.
Imperial College London have developed a wireless biosensor for continuous monitoring of catheter-urine biochemistry. This project aims to validate this biosensor and demonstrate it's potential for preemptive CAUTI diagnosis through continuous urinary biochemical monitoring.
Detailed Description
This research project aims to demonstrate that continuous urinary biochemical monitoring using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated urinary tract infection (CAUTI). The primary research question will then be: 'Does the Smart Catheter device reduce the time to diagnosis of CAUTI?'
This will be accomplished through four studies: The aim of the first study will be to show the reliability and robustness of the Smart Catheter device through the question: 'Is there any difference between the biochemical measurements from the Smart catheter device and a gold-standard laboratory measurement?'
The aim of the second and third studies aim to demonstrate the different biochemical profiles of infected and healthy urine by addressing the research question: 'What is the difference in biochemical concentrations in healthy urine as compared to infected urine?' Study 3 will accomplish this by comparing infected human catheter-acquired urine as compared to uninfected human catheter-urine. Study 3 will monitor the changes in biochemical changes in an artifical bladder with artificial urine over time while an infection is induced.
The final study will demonstrate the reduced time to diagnosis in a clinical setting by addressing the research question: ' What is the time difference in diagnosis of CAUTI from the CAUTI as compared to the current standard of clinical monitoring?'
#Intervention
- DIAGNOSTIC_TEST : Smart Catheter Biosensor
- A novel biosensor in-built into the catheter drainage system that monitors the chemical composition of the urine, with the intention of providing early diagnosis of developing infection
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years Subjects expected to undergo catheterisation as part of their clinical care. Signed informed consent is a prerequisite for inclusion in the study.
Exclusion Criteria:
* Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04315129
|
{
"brief_title": "Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection",
"conditions": [
"Catheter-Associated Urinary Tract Infection"
],
"interventions": [
"Diagnostic Test: Smart Catheter Biosensor"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04315129",
"official_title": "Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-31",
"study_completion_date(actual)": "2021-07-31",
"study_start_date(actual)": "2018-04-01"
},
"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)": "2021-09-02",
"last_updated_that_met_qc_criteria": "2020-03-18",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-19",
"first_submitted": "2020-03-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diabetes mellitus is among the most common chronic diseases, with significant and well documented impact on oral cavity health. Among the most common diseases of the oral cavity mucosa and complications in patients with impaired glucose metabolism and diabetes mellitus is oral lichen ruber (OLR), which according to World Health Organisation (WHO) is considered potentially malignant disorder. It was found that lichen ruber in diabetes mellitus has a much more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. Although OLR etiology is unknown, evidence suggests cell-mediated autoimmune pathogenesis. OLR epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (IGF-1 and IGF-2) metabolism. The hypothesis of our research is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.
Detailed Description
Oral lichen ruber (OLR) in the diabetes mellitus patients has more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. OLR epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like Growth Factors 1 and 2 (IGF-1 and IGF-2) metabolism. The role of insulin-like growth factors (IGFs) is of great importance in normal growth and cell development (cell proliferation, differentiation and apoptosis), and is involved in different aspects of cell transformation in malignant phenotype. A change in the expression of IGF1, IGF2 and IGF2R proteins is described in several types of malignant tumors including oral cancer. However, data on their role in the development of malignant lesions of the oral cavity are scarce, and the results are inconsistent. Our hypothesis is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.
#Intervention
- GENETIC : comparative semiquantitative immunohistochemistry
|
#Eligibility Criteria:
Inclusion Criteria:
* histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus
* healthy volunteers referred for alveolotomy
Exclusion Criteria:
* non-consent patients
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03257228
|
{
"brief_title": "The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)",
"conditions": [
"Oral Lichen Planus",
"Diabetes Mellitus"
],
"interventions": [
"Genetic: comparative semiquantitative immunohistochemistry"
],
"location_countries": null,
"nct_id": "NCT03257228",
"official_title": "The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11-01",
"study_completion_date(actual)": "2015-11-01",
"study_start_date(actual)": "2014-11-01"
},
"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)": "2017-08-31",
"last_updated_that_met_qc_criteria": "2017-08-18",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-22",
"first_submitted": "2017-08-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.
Detailed Description
This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.
#Intervention
- DRUG : Allopregnanolone injection
- Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
- Other Names :
- 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)
- DRUG : Placebo injection
- Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
- Other Names :
- Product P (placebo)
|
#Eligibility Criteria:
Inclusion Criteria:
* English or Spanish speaking person
* Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow Coma Score (GCS) 3 <= age <= 12 with abnormal head CT scan if GCS is 9 <= age <= 12]
* Less than 8 hours from injury to study initiation
* Able to participate for the full term of the study
Exclusion Criteria:
* Subjects with life expectancy of less than 24 hours
* Isolated epidural hematoma
* Hypoxia (pulse oximetry saturation <=90% for 15 or more minutes before enrollment)
* Hypotension (systolic blood pressure <=90 mm Hg on 2 or more reliable measurements before enrollment)
* Cardiopulmonary arrest prior to randomization
* Spinal cord injury with motor deficits
* Bilateral non-reactive pupils with Glasgow Coma Scale 3
* Body weight >120 kg
* Pregnancy
* Active breast or reproductive organ cancer
* Allergy to progesterone
* History of thromboembolic events
* Receipt of activated Factor VII before enrollment
* Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance <50 ml/min)
* Prisoner/ward of the state
* Known treatment with another investigational drug therapy or procedure within 30 days of injury
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01673828
|
{
"brief_title": "Allopregnanolone for the Treatment of Traumatic Brain Injury",
"conditions": [
"Traumatic Brain Injury",
"Posttraumatic Epilepsy"
],
"interventions": [
"Drug: Allopregnanolone injection",
"Drug: Placebo injection"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01673828",
"official_title": "A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2013-04"
},
"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)": "2017-06-28",
"last_updated_that_met_qc_criteria": "2012-08-27",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-28",
"first_submitted": "2012-08-20",
"first_submitted_that_met_qc_criteria": "2017-05-25"
}
}
}
|
#Study Description
Brief Summary
Perimetry is a well-established method that is used to measure the visual field functions of humans. Commercially available products, such as the OCTOPUS 900 (Haag-Streit AG, Koeniz, Switzerland), are commonly used for assessing the visual field. Such devices are of critical value for patients suffering of glaucoma and neuro-ophthalmic conditions. The operating principle is to sequentially present light stimuli of different intensity at different locations within the visual field in an automatic way. Algorithms that select what locations and intensities to present over time are called strategies. These have the goal to provide both a fast and accurate estimation of the visual field function.
Recently, new strategies were developed that are faster and equally accurate as the strategies used today. The technological advancement of these new methods lies primarily in the ability to estimate location sensitivities without observing them directly but by leveraging previously queried locations. For this the investigators plan to implement the next generation of perimetry strategies into an OCTOPUS 900 and to test it in healthy subjects and glaucoma patients.
#Intervention
- DIAGNOSTIC_TEST : Visual field testing
- Standard Automated Perimetry using a perimeter is one of the most commonly used techniques for measuring perceived visual ability of a subject. For a given eye, it provides quantitative measurements of visual function represented as a 2D spatial visual field map. It is of great clinical importance for diagnosing and monitoring glaucoma and detecting neurological conditions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Cataract yes or no
* Age range 40 - 80 years
* Normal visual field (MD: < +2 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of < -3 dpt.
* Visual acuity of >=0.3 logMar (decimal >=0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination
* Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
* Early to moderate visual field loss (MD: +2 to +12 dB)
* Written informed consent
Exclusion Criteria:
Exclusion criteria are children (<18 years), inability to follow the procedure, insufficient knowledge of project language, the history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03325751
|
{
"brief_title": "Visual Field Defect Estimation Using Sequentially Optimized Reconstruction Strategy on Healthy and Glaucoma Subjects",
"conditions": [
"Glaucoma, Open-Angle"
],
"interventions": [
"Diagnostic Test: Visual field testing"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03325751",
"official_title": "Non-inferiority Study for Visual Field Mean Defect Estimation Using Sequentially Optimized Reconstruction Strategy (SORS) With an OCTOPUS 900 Perimeter on Healthy and Glaucoma Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-02",
"study_completion_date(actual)": "2019-11-01",
"study_start_date(actual)": "2018-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-09",
"last_updated_that_met_qc_criteria": "2017-10-25",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-30",
"first_submitted": "2017-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate
#Intervention
- OTHER : Observational: Arrhythmogenic Substrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed HCM
* Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
* Maximal left ventricular wall thickness of > 30mm
* Extensive fibrosis on cardiac MRI (>15% of total myocardial volume)
* >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD
Exclusion Criteria:
* age < 18 years
* Pregnancy
* Atrial Fibrillation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02806479
|
{
"brief_title": "Hypertrophic Cardiomyopathy Pilot Study",
"conditions": [
"Hypertrophic Cardiomyopathy",
"Coronary Artery Disease"
],
"interventions": [
"Other: Observational: Arrhythmogenic Substrate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02806479",
"official_title": "Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09",
"study_completion_date(actual)": "2020-09",
"study_start_date(actual)": "2016-09"
},
"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)": "2020-09-16",
"last_updated_that_met_qc_criteria": "2016-06-16",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-20",
"first_submitted": "2016-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.
Detailed Description
This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.
#Intervention
- DRUG : Bevacizumab and Oxaliplatin
- Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histological or serologic proof of metastatic germ cell neoplasm (gonadal or extragonadal primary). Patients with seminoma and non-seminoma are eligible, as are women with ovarian germ cell tumors.
* Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of the investigator.
* Patients must have failed initial cisplatin combination chemotherapy administered with curative intent such as BEP, EP, VIP, or similar regimens.
* Patients should have failed and demonstrated progressive disease with high dose chemotherapy such as carboplatin and etoposide. (With the exception of late relapse or primary mediastinal non-seminomatous germ cell tumor.
* Patients with late relapse or primary mediastinal non-seminomatous germ cell tumors must have failed at least 1 salvage chemotherapy regimen.
* Patients must have had prior exposure to paclitaxel, gemcitabine, or the combination of paclitaxel + gemcitabine.
* Patients must have adequate hematologic function (WBC > 4,000/mm3 and platelets > 100,000/mm3) obtained < 4 weeks prior to registration.
* Patients must have adequate hepatocellular function (SGOT < 4 x normal and Bilirubin <2.0 mg/dl) obtained < 4 weeks from protocol registration.
* Serum Creatinine must be < 2.0 mg/dl obtained < 4 weeks from protocol registration.
* Patients must have an ECOG performance status of 0, 1, or 2.
* Patients must be at least 28 days post major surgery, open biopsy, or significant traumatic injury at time of study registration.
* Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration.
* Patients must be at least 18 years at time of consent.
Exclusion Criteria:
* Patients who have an active, unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible. Patients are eligible after antibiotics have been discontinued for at least 7 days.
* Patients may not have any significant bleeding.
* Patients with INR > 1.5 are not eligible unless the patient is on anti-coagulants with a therapeutic INR between 1.5 and 3. Patients on coumadin are not eligible unless they are on low dose coumadin to keep a vascular access device patent.
* Patients with a history of arterial thromboses, unstable angina, transient ischemic attach (TIA), cerebral vascular accident (CVA), or a myocardial infarction within the last 6 months are not eligible.
* Patients must not have known CNS metastases. A Head CT or MRI will be performed only if clinically indicated.
* Patients must not have received any radiotherapy or chemotherapy within 28 days prior to study registration, and have recovered from all toxicity from prior treatments.
* Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy.
* Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* Patients must not have history of significant vascular disease.
* Patients must not have evidence of bleeding diathesis or coagulopathy.
* Patients must not have inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
* Patients must not have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration.
* Patients must not have serious, non-healing would, ulcer or bone fracture.
* Patients must not have proteinuria at screening as demonstrated by a urine protein: Creatinine (UPC) ratio of >= 1.0.
* Patients must not have a known sensitivity to any component of bevacizumab.
* Patients must not be pregnant or lactating.
* Patients must not have grade 3 or 4 neuropathy.
* Females of child bearing potential must not be pregnant. A negative pregnancy test is required within 7 days prior to beginning treatment.
NOTE THE FOLLOWING GUIDELINES FOR USE IN THIS PROTOCOL:
* Progressive metastatic disease will be documented by the appearance of metastatic lesions on PA and lateral chest x-ray, C.T. scan, or other imaging studies, or the presence of a rising serum HCG or AFP.
* If a rising serum marker is the only evidence of progressive disease, at least 2 consecutive determinations must be done exhibiting serologic progression and alternative causes for increased serum levels of these substances must not be present [cross reaction with LH (tested if necessary by testosterone suppression of LH), ingestion of marijuana, hepatitis, etc.].
* Patients will be considered to have failed a prior regimen if they fail to obtain a complete response per RECIST as outlined in section 6.
* Patients with clinical situation of growing teratoma (normal or declining markers and radiographic or clinical progression) should be considered for surgery.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00393861
|
{
"brief_title": "Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients",
"conditions": [
"Neoplasms, Germ Cell and Embryonal"
],
"interventions": [
"Drug: Bevacizumab and Oxaliplatin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00393861",
"official_title": "Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2006-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-24",
"last_updated_that_met_qc_criteria": "2006-10-27",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-29",
"first_submitted": "2006-10-26",
"first_submitted_that_met_qc_criteria": "2015-01-21"
}
}
}
|
#Study Description
Brief Summary
Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.
Our principal goals are:
1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
2. To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.
#Intervention
- PROCEDURE : Urgent major general surgery
- All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre
|
#Eligibility Criteria:
Inclusion Criteria:
* Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies
Exclusion Criteria:
* Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04725968
|
{
"brief_title": "Morbimortality in Major Urgent General Surgery in the Geriatric Patient.",
"conditions": [
"Surgery--Complications",
"Emergencies"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT04725968",
"official_title": "Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-15",
"study_completion_date(actual)": "2021-03-15",
"study_start_date(actual)": "2021-01-28"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-24",
"last_updated_that_met_qc_criteria": "2021-01-21",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-27",
"first_submitted": "2021-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).
Detailed Description
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.
#Intervention
- DRUG : Sirolimus
- A single dose of sirolimus delivered locally
- Other Names :
- Rapamycin
- PROCEDURE : AV Fistula Surgery
- AV Fistula Surgery
- DEVICE : Sirolimus-eluting Collagen Implant (SeCI)
- SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
- Other Names :
- Rapamycin
|
#Eligibility Criteria:
Inclusion Criteria:
* Currently on hemodialysis for <=12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.
* Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound
* Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula
Exclusion Criteria:
* Prior AV access created on the limb where the fistula surgery is planned
* ST-elevation MI or cerebrovascular accident within 30 days of the index procedure
* Known hypersensitivity to the following: sirolimus, beef or bovine collagen
* Hypotension with systolic blood pressures <100 mm Hg at the time of screening
* Known or suspected active infection at the time of the AV fistula surgery
* Known to be HIV positive
* Prisoner, mentally incompetent, and/or alcohol or drug abuser
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
|
NCT02513303
|
{
"brief_title": "Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes",
"conditions": [
"Complication of Renal Dialysis",
"End Stage Renal Disease",
"End Stage Kidney Disease",
"ESRD",
"Chronic Kidney Failure",
"Complication of Hemodialysis",
"Vascular Access Complication",
"Arteriovenous Fistula"
],
"interventions": [
"Drug: Sirolimus",
"Device: Sirolimus-eluting Collagen Implant (SeCI)",
"Procedure: AV Fistula Surgery"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02513303",
"official_title": "A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06",
"study_completion_date(actual)": "2021-06",
"study_start_date(actual)": "2015-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-22",
"last_updated_that_met_qc_criteria": "2015-07-29",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-31",
"first_submitted": "2015-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study proposes a novel behavioral intervention to help smokers in Thailand to achieve their goals of quitting. Smoking treatment programs are rare throughout most of Asia and unlikely to meet the impending demand for quitting that tobacco control regulations is stimulating. New approaches are needed.
The present study is a randomized controlled trial to test the effectiveness of a novel, scalable approach to smoking cessation that is targeted toward rural Southeast Asian communities. Thailand is used as a test case to explore if pairs of smokers quit successfully after making financially-backed commitments and receiving cash incentives to quit. The control group receives education and counseling about quitting. In addition to education and counseling about quitting, the intervention includes two key components:
1. Each participant is encouraged to deposit his 'cigarette money' on a weekly basis, to be returned only if the smoker quits successfully within three months. Such commitment contracts, based on theory from behavioral economics, are designed to help a person to maintain self-control and motivation in the face of temptation.
2. Each participant is paired with another study participant. If both quit, each receives a cash bonus. The joint incentives are designed to lead partners to support each other throughout the quit attempt.
Thus, group commitment contracts marshal a robust blend of elements: financial commitment, social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will clarify the relative importance of each of these elements.
#Intervention
- BEHAVIORAL : Group commitment contract
- 1. Each participant is required to deposit at least 50 baht at enrollment. A deposit collector visits each participant on a weekly basis and collects additional deposits on a voluntary basis. All deposits are returned only if the smoker quits successfully within three months.
2. The project gives a matching contribution of 150 baht for the initial deposit of at least 50 baht. All participants in the treatment group are further randomized to a one-month group and a three-month group. The one-month group receives an additional 150 baht of project funds if they deposit 100 baht of their money within one month of enrollment. The three-month group receives 150 baht for depositing 100 baht within three months of enrollment.
3. Each participant is paired with another study participant. If both quit, each receives a cash bonus of 1,200 baht. At enrollment, pairs receive brief counseling on ways to support each other during the quit attempt.
- Other Names :
- Commitment contract, Deposit contract, Contingency contract, Buddy intervention, Partner intervention
- BEHAVIORAL : Smoking cessation education and counseling
- Participants receive educational pamphlets on reasons to quit smoking and strategies for quitting smoking. They also receive one-time, group counseling on quitting smoking from a nurse trained in smoking cessation counseling.
- Other Names :
- Smoking cessation counseling
|
#Eligibility Criteria:
Inclusion Criteria:
* Current smoker of at least 10 cigarettes per week and at least 100 cigarettes over the course of a lifetime
* Residents of the study area in Nakhon Nayok province, which includes the six subdistricts of Klong Yai, Chumpon, Bueng San, Pak Phli, Khao Phoem, or Ongkharak
Exclusion Criteria:
* Pregnant
* Plans to leave the study area within the next 12 months
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
|
NCT01311115
|
{
"brief_title": "Using Group Commitment for Smoking Cessation",
"conditions": [
"Smoking"
],
"interventions": [
"Behavioral: Group commitment contract",
"Behavioral: Smoking cessation education and counseling"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT01311115",
"official_title": "Using Group Commitment for Smoking Cessation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2010-11"
},
"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)": "2022-09-15",
"last_updated_that_met_qc_criteria": "2011-03-08",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-09",
"first_submitted": "2011-03-08",
"first_submitted_that_met_qc_criteria": "2022-08-23"
}
}
}
|
#Study Description
Brief Summary
This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.
#Intervention
- DRUG : mometasone furoate
- 50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning
- Other Names :
- Nasonex, SCH 32088
- DRUG : Placebo
- Two sprays in each nostril once daily in the morning
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be 12 years or older, of either sex and of any race.
* Must have at least a 2-year documented history of SAR which exacerbates during the study season.
* Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
* Must be clinically symptomatic at the Screening Visit.
* Must be clinically symptomatic at the Baseline Visit.
* Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
* Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
Exclusion Criteria:
* A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
* A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
* A subject with rhinitis medicamentosa.
* A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
* A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
* A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00453063
|
{
"brief_title": "Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)",
"conditions": [
"Seasonal Allergic Rhinitis"
],
"interventions": [
"Drug: Placebo",
"Drug: mometasone furoate"
],
"location_countries": null,
"nct_id": "NCT00453063",
"official_title": "Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": "2007-03"
},
"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)": "2022-02-09",
"last_updated_that_met_qc_criteria": "2007-03-26",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-03-28",
"first_submitted": "2007-03-26",
"first_submitted_that_met_qc_criteria": "2010-04-01"
}
}
}
|
#Study Description
Brief Summary
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The 'BEAUTIFY' (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.
The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the 'BEAUTIFY' care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.
#Intervention
- DEVICE : BEAUTIFY application
- Interview with the coordinating nurse in the postoperative period to install the BEAUTIFY application on the patient's smartphone and to train her to record any Patients will monitor their symptoms weekly. In case of toxicity grade \> 2, the nurse will contact the patient for further information.
|
#Eligibility Criteria:
Inclusion Criteria:
* Breast cancer patient scheduled for surgery
* Patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
Exclusion Criteria:
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject unable to express consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
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
|
NCT05449340
|
{
"brief_title": "Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Device: BEAUTIFY application"
],
"location_countries": [
"France"
],
"nct_id": "NCT05449340",
"official_title": "Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-16",
"study_completion_date(actual)": "2024-02-16",
"study_start_date(actual)": "2022-07-25"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-01",
"last_updated_that_met_qc_criteria": "2022-07-04",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-08",
"first_submitted": "2022-06-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.
Detailed Description
This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.
#Intervention
- BEHAVIORAL : Behavioral Activation
- Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years
* Presenting at initial (approximately 2-week) postoperative follow-up
* Prior management of isolated fracture or multi-trauma
Exclusion Criteria:
* Incarceration
* Problems, in the judgement of study personnel, with maintaining follow-up
* Cognitive disability (either acute or chronic)
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
|
NCT04426981
|
{
"brief_title": "Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study",
"conditions": [
"Fractures, Bone"
],
"interventions": [
"Behavioral: Behavioral Activation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04426981",
"official_title": "Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-03",
"study_completion_date(actual)": "2021-09-03",
"study_start_date(actual)": "2020-10-09"
},
"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)": "2022-01-27",
"last_updated_that_met_qc_criteria": "2020-06-09",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-11",
"first_submitted": "2020-06-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Appendectomy is the most effective treatment option for acute appendisitis, which is the most commen emergent surgical pathology. However with in time period, surgical treatment borders are narrowed. Especially in uncomplicated acute appendicitis cases, nonoperative management (NOM) with antibiotherapies becomes primary treatment option. The COVID-19 pandemic, which is caused by 2019 novel coronavirus (2019-nCoV) and we encountered in the current process, has led to the re-questioning of surgical elective and emergency cases. Serious complications and increased mortality rates of the 2019-nCoV creates a novel problems of patient selection for emergent surgery and health care workers faced with potential health problems. As the same as the other surgical procedures, in the uncomplicated acute appendisitis cases NOM become more mandantory. NOM of uncomplicated acute appendisitis doen't increase perforation risk and general practice for decreasing surgical complications in the COVID-19 pandemic period. Additionally complicated acute appendicitis accounts for 20 to 30% of the patients undergoing appendectomy and lead to increased risk of postoperative complications, delayed recovery and longer hospital stay. Therefore, early diagnosis of complicated acute appendicitis is important; however, the most appropriate and inexpensive diagnostic method to make this diagnosis has not been established yet. Although the use of imaging methods is widespread, these methods are not accessible in many rural hospitals due to the high costs and unavailability of specialists. Thus, the need for an inexpensive and effective diagnostic technique allowing to make a differential diagnosis has not been met yet. For this purpose, several inexpensive and easily accessible blood parameter tests have been proposed; including the white blood cell count, immature granulocyte (IG) percentage, C-reactive protein levels or the neutrophil-to-lymphocyte ratio.
An increase in the IG count shows that the bone marrow is active. This parameter has been used as a prognostic factor in many infectious and non infectious diseases including sepsis, acute pancreatitis, and acute myocardial infarction. The Immature granulocyte (IG) fraction includes promyelocytes, myelocytes, and metamyelocytes but not band neutrophils or myeloblasts. The IG count and percentage has become an easy-to-use method, especially with the introduction of technological advances, as it can be easily determined using the results of a routine complete blood count.
It is aimed to efficacy of IG count and percentage which are calculated automatically in CBC samples, to differatiate the complicated and uncomplicated acute appendicitis cases with a cheap, easily applicable and cost effective test, especially in rural areas without enough diagnostic tests in COVID-19 pandemy.
Detailed Description
The data of 146 patients elder than 18 years, who admitted to the Emergency Department and General Surgery outpatient clinic with the complaint of abdominal pain diagnosed with acute appendicitis and who were operated by the same surgical team between June 2018 and June 2019 were evaluated retrospectively after the approval of the local ethics committee. Patients' data were obtained by reviewing the patient follow charts, laboratory findings in the the electronic database of the hospital and epicrisis forms. Totally 76 patients excluded from the study; 22 patients were excluded because of the pathological diagnosis did not confirm acute appendicitis (negative appendectomies and appendiceal mucinous cystadenomas), 54 patients who were operated by the other surgical team were excluded.
The patients were assigned to the complicated acute appendicitis group (Group C) based on the preoperative imaging findings (periappendiceal abscess formation or significant periappendiceal fat tissue contamination in ultrasonography and computed tomography), intraoperative exploration findings (presence of gangrenous appendicitis, perforation or abscess formation), and pathological examination findings (acute phlegmonous appendicitis, acute gangrenous appendicitis or acute perforated appendicitis). The patients were assigned to the uncomplicated acute appendicitis group (Group UC) based on the increased diameter and wall thickness of the appendix and detection of minimal contamination in the surrounding fat tissue in the imaging tests; the presence of edema and the absence of gangrene, perforation or abscess in the the exploratory surgery of appendix, and confirmation of the diagnosis of acute appendicitis by the pathological examination findings \[17-20\].
The WBC, IG count and IG percentage automatically calculated in the complete blood count (CBC) parameters. WBC count, neutrophil count, lymphocyte count, and IG% were measured using an automated hematological analyzer (XN 3000; Sysmex Corp., Kobe, Japan) from blood samples obtained at the initial admission to the emergency department . Neutrophyl and Lymphocyte counts were obtained from automatically from the CBC parameters and NLR was calculated manually.
The demographic data (age, sex) of the patients, the white blood cell count (WBC), the neutrophil-to-lymphocyte ratio (NLR), and the IG count and percentage were evaluated retrospectively.
Statistical Analysis Statistical analyses were performed with the IBM Statistical Package for Social Sciences (SPSS) version 20.0 software. The student t-test or Mann-Whitney U test were used for analyzing the quantitive values based on normality of the distrubution calculated with Shapiro Wilk Test. The chi-square test or Fischer's exact test was used for analyzing the categorical data. ROC analysis was used to determeine spesivity and sensitivity of the parameters. Binary logistic regression analysis was performed to determine the preoperative diagnostic accuracy of the parameters. The quantitive data were given mean ± standard deviation (minimum - maximum values) or median (minimum - maximum values). The qualitative values were given number of cases (n) and percentage (%). A p-value of \<0.05 was considered statistically significant.
#Intervention
- PROCEDURE : Appendectomy
- Open or Laparascopic Surgery
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >18 years,
* Patients diagnosed as acute appenditicitis cases according to clinical (preoperative and peroperative) and preoperative laboratory findings and imaging modalities (ultrasound, computed tomography), and pathologic results
* Patients who were operated by the same surgical team of the Kahramanmaras Sutcu Imam University Hospital.
Exclusion Criteria:
* Patients younger than 18 years,
* Negative appendectomies according to peroperative findings and pathologic findins
* Patients whose data were not available
* Patients who were operated by the other surgical team of the Kahramanmaras Sutcu Imam University.
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
|
NCT04440150
|
{
"brief_title": "Preoperative Immature Granulocyte Count and Percentage for Acute Appendisitis",
"conditions": [
"Acute Appendicitis"
],
"interventions": [
"Procedure: Appendectomy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04440150",
"official_title": "Preoperative Immature Granulocyte Count and Percentage for Complicated and Uncomplicated Appendisitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-01",
"study_completion_date(actual)": "2019-06-01",
"study_start_date(actual)": "2018-06-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-17",
"last_updated_that_met_qc_criteria": "2020-06-17",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-19",
"first_submitted": "2020-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.
Detailed Description
OBJECTIVES:
I. Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.
II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.
III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.
IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
OUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.
GROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.
GROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.
After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.
#Intervention
- OTHER : educational intervention
- Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
- OTHER : questionnaire administration
- Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
- PROCEDURE : end-of-life treatment/management
- Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
- PROCEDURE : psychosocial assessment and care
- Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
- PROCEDURE : quality-of-life assessment
- Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
|
#Eligibility Criteria:
Inclusion Criteria:
* The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
* Patients having been accrued to project 1 or project 2
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
|
NCT00827333
|
{
"brief_title": "Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer",
"conditions": [
"Lung Cancer"
],
"interventions": [
"Procedure: psychosocial assessment and care",
"Other: educational intervention",
"Other: questionnaire administration",
"Procedure: end-of-life treatment/management",
"Procedure: quality-of-life assessment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00827333",
"official_title": "Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2009-09"
},
"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)": "2016-08-02",
"last_updated_that_met_qc_criteria": "2009-01-21",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-22",
"first_submitted": "2009-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the effect of adding Vildagliptin versus Glimepiride to Metformin on markers of inflammation, thrombosis, and atherosclerosis in diabetic patients with symptomatic Coronary artery diseases.
The pre-specified established biological markers of inflammation, thrombosis, and atherosclerosis will include: Interleukin 1 beta (IL-1 beta)), hs-CRP, Atherogenic index and coronary risk index, Lipid profile. and adiponectin levels..
Detailed Description
The study is designed as a single-center, randomized, double-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. The investigators plan to prospectively enroll 80 patients with proven coronary artery disease ,Diabetes type2 and randomize them in a 1:1 ratio to either vildagliptin-metformin therapy (n=40) or glimepiride /metformin therapy (n=40).
1. All participants agreed to take part in this clinical study and provide informed consent.
2. Patients with Coronary artery diseases.and uncontrolled Diabetes type2 who's taking metformin only will be enrolled (n=80) from endocrinology clinic at Alexandria Armed Forces hospital.
3. Complete physical, laboratory, radiological assessment will be done for all patients to exclude any signs of inflammation or thrombosis.
4. Serum samples will be collected for measuring the biomarkers.
5. All enrolled patients will be mentioned as two groups; Group I (n=40) are patients who the endocrinologist prescribed them vildagliptin plus their metformin to control their blood sugar level. Group II (n=40) are patients who the endocrinologist prescribed them glimepiride plus their metformin.
6. All patients will be followed up during 3 months' period.
7. At the end of 3 months on the new regimen, steps 4 and 5 will be repeated.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Measuring outcome: The primary outcome is the change of serum levels of the measured inflammatory markers after 3 months.
10. Results, conclusion, discussion and recommendations will be given.
#Intervention
- DRUG : Vildagliptin 50 mg Oral Tablet
- Patients who the endocrinologist prescribed them Vildagliptin 50 mg Oral Tablet plus their Metformin 1000 mg Oral Tablet to control their blood sugar level.
- Other Names :
- Galvus 50 mg
- DRUG : Metformin 1000 mg Oral Tablet
- Patients with Coronary artery diseases.and uncontrolled Diabetes Mellitus type 2 who's taking Metformin 1000 mg Oral Tablet only will be enrolled from endocrinology clinic.
- Other Names :
- Glucophage 1000 mg
- DRUG : Glimepiride upto 4 mg Oral Tablet
- Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet
- Other Names :
- Amaryl 4 mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients with Type II-diabetes mellitus on metformin who are planned to be managed with vildagliptin or glimepiride plus metformin at the time of inclusion.
* Symptomatic Coronary Artery Diseases. (>30 days).
Exclusion Criteria:
* Hepatic impairment.
* Active malignancy.
* Planned surgical intervention.
* Any signs of hypersensitivity or contraindication to study drugs developed.
* Any patient with any signs of active infection or thrombosis at the time of assessment.
* Addition of any antidiabetic medications or insulin during follows up.
* Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
* Clinically advanced congestive heart failure - New York Heart Association III-IV
* Severe left ventricular dysfunction (LVEF<30%) with New York Heart Association II or any New York Heart Association class with documented recent heart failure decompensation (<3 months)
* Severe stable cardiac angina Community Competence Scale III - IV or Unstable angina
* Pregnancy, lactation or child-bearing potential.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03693560
|
{
"brief_title": "Effect of Adding Vildagliptin vs Glimepiride to Metformin on Inflammation's Markers in Type-2 Diabetic Patients With CAD",
"conditions": [
"Coronary Artery Disease",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Vildagliptin 50 mg Oral Tablet",
"Drug: Metformin 1000 mg Oral Tablet",
"Drug: Glimepiride upto 4 mg Oral Tablet"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03693560",
"official_title": "The Effect of Adding Vildagliptin Versus Glimepiride to Metformin on Markers of Inflammation, Thrombosis, and Atherosclerosis in Diabetic Patients With Symptomatic Coronary Artery Diseases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-10",
"study_completion_date(actual)": "2019-10-10",
"study_start_date(actual)": "2018-10-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-13",
"last_updated_that_met_qc_criteria": "2018-10-02",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-03",
"first_submitted": "2018-09-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.
#Intervention
- BIOLOGICAL : rLP2086
- 0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
* Male or female subject aged >=18 to <=65 years at the time of enrollment.
* Negative urine pregnancy test.
Exclusion Criteria:
* Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Current chronic use of systemic antibiotics.
* Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
* Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
* History of microbiologically proven disease caused by Neisseria meningitidis.
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
|
NCT01768117
|
{
"brief_title": "Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age",
"conditions": [
"Meningitis, Meningococcal, Serogroup B"
],
"interventions": [
"Biological: rLP2086"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01768117",
"official_title": "A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2013-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-20",
"last_updated_that_met_qc_criteria": "2013-01-11",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-15",
"first_submitted": "2013-01-08",
"first_submitted_that_met_qc_criteria": "2015-02-23"
}
}
}
|
#Study Description
Brief Summary
Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.
Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.
Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.
#Intervention
- BEHAVIORAL : Cognitive-behavioral therapy and hypnosis group
- BEHAVIORAL : Support group
|
#Eligibility Criteria:
Inclusion Criteria:
* Non-metastatic breast cancer (in situ or invesive)
* End of active treatments (surgery, chemotherapy and radiotherapy)
* No recurrence nor palliative care
* Min. 18 years
* Able to speak French
* Willing to be randomized to study intervention group
* Accept to give their written informed consent
Exclusion Criteria:
* No cognitive dysfunction
* No severe or uncontrolled psychiatric illness
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
|
NCT01797354
|
{
"brief_title": "Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Behavioral: Support group",
"Behavioral: Cognitive-behavioral therapy and hypnosis group"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01797354",
"official_title": "Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-09",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2011-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-09-04",
"last_updated_that_met_qc_criteria": "2013-02-20",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-22",
"first_submitted": "2011-12-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.
Detailed Description
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase 3 multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell® in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.
CureXcell® is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock.
A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be randomized to receive either CureXcell® or control.
The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control.
The study has two phases: a core double-blind phase and a follow up phase.
#Intervention
- BIOLOGICAL : CureXcell®
- CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
- BIOLOGICAL : Sham injection
- The sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed
|
#Eligibility Criteria:
Inclusion Criteria:
* Males or females at least 18 years with diabetes type 1 or type 2;
* Patients with HbA1c <= 12%;
* Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;
* Ulcers with an area between >= 1 cm2 and <= 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);
* Ankle Brachial Index >= 0.65;
Exclusion Criteria:
* Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;
* Patients with ulcers primarily caused by venous insufficiency;
* Patients whose target ulcer has decreased > 25% in size from screening to baseline;
* Malignancy within the past 5 years excluding successfully treated basal cell carcinoma;
* Significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV;
* Current clinical osteomyelitis;
* Acute Charcot foot;
* Current sepsis;
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
|
NCT01421966
|
{
"brief_title": "Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes",
"conditions": [
"Lower Extremity Chronic Ulcers in Diabetics"
],
"interventions": [
"Biological: Sham injection",
"Biological: CureXcell®"
],
"location_countries": [
"Canada",
"Israel",
"United States"
],
"nct_id": "NCT01421966",
"official_title": "A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-02",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2011-08"
},
"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)": "2015-12-07",
"last_updated_that_met_qc_criteria": "2011-08-22",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-23",
"first_submitted": "2011-08-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary aim of this project is to test the effect of exercise on acute nicotine withdrawal. Acute nicotine withdrawal is characterized by a complex array of symptoms associated with increased risk of relapse among individuals attempting smoking cessation. The available remedies do not target all aspects of withdrawal. For example, pharmacologic treatments reduce withdrawal-based craving, but have no effect on cue-related craving, altered sleep, and mood disturbances during withdrawal. Therefore, non-pharmacologic behavioral techniques with the potential to attenuate persistent withdrawal symptoms are needed. We hypothesized that exercise can be a valid non-pharmacologic strategy to improve these domains.
Detailed Description
The goal of the proposed work is to test: 1) the effects of exercise on mood, objective measures of sleep, and cue reactivity; 2) the effects of exercise at a given intensity and duration, after a short (few hours) and more prolonged (24 to 72 hours) abstinence from smoking; and 3) the effects of exercising in the morning versus exercising in the evening on the proposed outcome domains. We plan to implement a within-subject design that will allow us to collect measures for each subject aged 18 to 45 in four different conditions: 1) ad libitum smoking; 2) evening exercise after 2 to 72 hours of abstinence; 3) morning exercise after 2 to 72 hours of abstinence; and 4) no exercise after 2 to 72 hours of abstinence. Exercise will be conducted at a fixed and monitored dose and duration. By collecting morning and evening measures of withdrawal symptoms and cue reactivity, we will also test whether the effects of exercise in reducing withdrawal symptoms and cue reactivity will show a prolonged effect beyond the minutes/hours immediately after the exercise bout. We also hypothesize that the timing of exercise may have differential effects on different aspect of withdrawal. The proposed work will allow us to examine the extent to which exercise, a promising nonpharmacologic behavioral treatment method, can attenuate key symptoms of withdrawal recognized to impede abstinence efforts. A better understanding of these effects will allow us to implement exercise at the time of day that may be more troublesome for the individual attempting to quit. The development of new behavioral methods for attenuating withdrawal symptoms will be directly transferable to smoking cessation treatments aimed at reducing withdrawal symptoms and aiding efforts to avoid relapse after quitting smoking.
#Intervention
- BEHAVIORAL : Exercise
- Each 3-day experimental period will include one of the following conditions:
1. Morning exercise - subject will exercise on each of the three mornings in the sleep laboratory, starting 30 minutes after their habitual rise-time;
2. Evening exercise - subject will start exercise 4 hours before their habitual bedtime on each of the three evenings;
3. No exercise - subject will watch television or read and they will be required to remain sedentary.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 45
* Not regularly exercising, defined as exercising fewer than three times per week and for no more than 20 minutes each time
* Free of medical illnesses (need to be cleared by a physician as able to exercise at 60% maximum heart rate (MHR))
* Currently meeting DSM-IV criteria for nicotine dependence (No Current or Past history of any other psychiatric disorder)
* Regularly smoking at least 08 cigarettes per day for at least 12 consecutive months, not attempted to quit smoking in the previous month, and not currently taking medication for smoking cessation
* Currently displaying carbon monoxide breath readings >10 and urine cotinine levels >3
* Habitual bedtime between 9:30 p.m. and 1:30 a.m.
* Body Mass Index (BMI) less than 40.
Exclusion Criteria:
* Unable to exercise
* Currently diagnosed or treated for any psychiatric disorder; treatment with psychotropic medication will be considered on a case by case basis
* History or active treatment or any treatment in past year for any mood or psychotic disorder
* Current or past diagnosis of a sleep disorder
* Currently taking sleep medications or other medications known to alter sleep architecture
* Currently doing shift work or working at night
* History of travel across time zones in the past month
* For women of child bearing potential: pregnant or actively trying to become pregnant
* Parent of a child under two years of age
* Diagnosis of Sleep Apnea
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01047930
|
{
"brief_title": "The Effect of Exercise on Acute Nicotine Withdrawal",
"conditions": [
"Nicotine Dependence",
"Smoking",
"Sleep Disorders, Intrinsic"
],
"interventions": [
"Behavioral: Exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01047930",
"official_title": "The Effect of Exercise on Acute Nicotine Withdrawal: Human Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2010-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"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)": "2014-12-02",
"last_updated_that_met_qc_criteria": "2010-01-12",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-13",
"first_submitted": "2010-01-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test whether a multi-component, community-level, HIV-prevention intervention is more effective than existing HIV prevention activities in reducing unprotected anal intercourse (UAI) among men ages 15-25 who have sex with men.
Detailed Description
In recent years, there have been increases in the rates of unprotected anal intercourse (UAI) reported by men who have sex with men (MSM) and in the numbers of newly diagnosed HIV infections among MSM. Surveys of young MSM (ages 15-29) in numerous U.S. cities from 1994-2000 found an HIV prevalence of 2.2% to 18%, however, HIV prevalence was higher among young MSM of color than among white men. In a survey of 23-29 year-old MSM,nearly 1/3 of African-American men and 15% of Hispanic/Latino men were infected with HIV.
The Community Intervention Trial for Youth (CITY) study is a 13-community randomized control trial designed to evaluate a multi-component, community-level intervention for MSM ages 15-25 (i.e., young MSM or YMSM). All 13 communities have some form of HIV-prevention activities naturally occurring in their jurisdiction, but 6 of the 13 communities were randomly assigned to also receive the multi-component intervention (1 additional city served as a case study and also received the intervention). This intervention includes 4 components: 1) community health advisor network (CHAN) consisting of YMSM who conduct outreach to their peers, including linking other YMSM to community services and conducting other parts of the intervention; 2) social marketing, to include the use media to disseminate HIV risk-reduction messages and promote positive norms for safer sex; 3) large group events with an HIV prevention theme; and 4) small group activities/workshops that focus on increasing HIV prevention skills and enhancing a positive self-identity.
The study population varies by site based on the specific racial or ethnic groups of YMSM that are targeted. African-American YMSM are the study population in Atlanta, Georgia (comparison site); Birmingham, Alabama (intervention site); and Chicago, Illinois (intervention site). Hispanic/Latino YMSM are the study population in Washington Heights/South Bronx, New York (intervention site); Jackson Heights/Queens, New York (comparison site); Orange County, California (intervention site); and San Gabriel Valley, California (comparison site). Asian and Pacific Islander YMSM are the study population in Seattle, Washington (intervention site) and San Diego, California (comparison site). YMSM regardless or race/ethnicity are the study population in Milwaukee, Wisconsin (intervention site); Detroit, Michigan (comparison site), Minneapolis, Minnesota (comparison site); and West Hollywood, California (intervention site).
The primary goals of the intervention are to 1) decrease UAI with any male partners; 2) decrease UAI with main male partners; and 3) decrease UAI with non-main (i.e., casual) male partners. Using a venue-based, time/space sampling strategy in each community, cross-sectional samples of YMSM were interviewed from May-August across 4 years (1999-2002). Data collected in 1999 and 2000 were prior to the implementation of the multi-component intervention, and data collected in 2001 and 2002 were during the implementation of the intervention.
#Intervention
- BEHAVIORAL : Community-Level Intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* 15 <= age <= 25 years
* reports having sexual contact with another man in the past year
* meets the race/ethnicity eligibility criteria for the particular community
Exclusion Criteria:
Sex :
MALE
Ages :
- Minimum Age : 15 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00164580
|
{
"brief_title": "Community Intervention Trial for Youth (CITY) Study",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00164580",
"official_title": "Prevention of HIV Infection in Youth at Risk: Developing Community-Level Intervention Strategies That Work (Community Intervention Trial for Youth (CITY) Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-08",
"study_completion_date(actual)": "2004-08",
"study_start_date(actual)": "1996-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-27",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2012-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background and Importance: When patients transition from hospital to home following surgery, perceived complications or poorly controlled pain can result in emergency department visits and readmissions. Continuity of care after discharge has been shown to reduce ED visits and readmissions rates. Hence any improved method of extending the continuity of care in a patient's home may improve postoperative outcomes. For patients who are at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behaviour, and creating better outcomes. Care teams can understand what's going on with each patient daily or weekly, as opposed to sporadically through an office visit.
Goals/Research Aims: Atrial fibrillation is one of the important complications after thoracic surgery, it is estimated to occur in 10.5% of patients. We will conduct a randomized controlled trial to test the use of a secured digital system to monitor vital signs and home-based ECG monitoring for 2 weeks after surgery in patients undergoing an elective thoracic surgical procedure at the London Health Sciences Centre \[LHSC\]. Specific objectives are to determine the feasibility of 30-day emergency department visits as the primary outcome, 30-day readmission rates, postoperative complications, in-hospital length of stay, pain scores, hospital case costing, societal costs, mortality, and patient satisfaction.
Methods/Approaches/Expertise: This trial will be a single centre, assessor-blinded, parallel arm, randomized controlled trial. Participants will be recruited from patients scheduled for thoracic surgical procedures at LHSC. Patients will be randomized to either the Continuity of care with Digital Home Monitoring (CDHM) group or the control group. The control group will be provided with the usual post-operative care, and the CDHM group will be provided with access to self-help resources, digital monitoring and access to a clinical navigator for two weeks. All outcomes will be compared between the CDHM group and control group at the end of 4 weeks post-discharge, including out-of-pocket costs, travel costs and lost productivity.
Expected Outcomes: The Ontario Hospital Association estimates the average cost of a one-day stay in an acute care hospital is $1,300. With digital monitoring and continuity of care, we expect to decrease visits and readmission rates by at least 50% and in-hospital length stay by at least one day. This is a feasibility study. We will follow the traffic light approach criteria for reporting feasibility outcomes: Feasible (green) 75-100%: all feasibility outcomes are met; no protocol modifications are needed; (2) Feasible with modification (amber) 50-75%: all feasibility outcomes are met or can be met with protocol modifications; (3) Not feasible (red) \<50%: even with protocol modifications, some feasibility outcome cannot be met.
Detailed Description
Introduction: Surgical recovery after discharge from the hospital often poses confusion and challenges for patients and caregivers. This is more so when early dismissal after surgery has become the norm. Furthermore, the Canadian health care system is fragmented, with poorly integrated services. Thus, when patients transition from hospital to home following surgery, complications and inadequately controlled pain results in return to hospital or ED visits. Family caregivers are frustrated that health care providers involved in different aspects of a patient's care do not always communicate with one another, resulting in caregivers having to retell a patient's story and spending unnecessary time clarifying information during the ED visits. Caregivers and healthcare providers are looking for one clear point of contact that ensures patients' needs are met at every segment of their healthcare journey. Patients believe that when they receive care, it is generally of high quality. Despite the positive feedback from the patients about the quality of care, the system continues to struggle with transitional care due to a lack of system-wide integration.
This randomized controlled trial on continuity of care with digital home monitoring for four weeks post-operatively in patients undergoing an elective thoracic surgical procedure.
Eligible patients will be recruited from the surgeon's office, and informed consent will be obtained. Patients will be randomized to the control group (no digital care) or the intervention groups (digital care provided). Intraoperative and immediate postoperative care in the post-anesthesia care unit (PACU) and surgical ward will remain the same for all patients. At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated once a day for two weeks. The control group will not be monitored with continuity of care. After this period, 30-day emergency department visits will be measured and compared between the two groups, along with 30-day readmission rates, in-hospital length of stay, mortality, quality of recovery 40 item scale (QoR-40), European Quality of Life 5 Dimensions (EQ5D), patient satisfaction score, and societal and hospital cost.
ED visits and readmission rate: In Ontario, between 2014 and 2016, within 30 days after lung cancer lobectomy surgery, the readmission rate was 5.9%, and the Emergency Department (ED) visit rate was 16.2%.(1) At the LHSC, the 30-day ED visit rates were 21.5% \[95% CI 15.91, 27.14\], and the 30-day readmission rates were 6.73% \[95% CI 3.21, 10.24\] for lung cancer lobectomy.(1) Between 2015/2016 and 2017/2018, unadjusted data of readmissions or ED visits within seven days after Video Assisted Thoracoscopic Surgery (VATS) and open thoracotomy were 9% and 7%, respectively, at LHSC. Post-surgical discharge hospital visits remain a significant problem in post-thoracic surgical care. Patients have to wait too long during ED visits, which negatively impacts provider, caregiver and patient well-being. The investigators believe that a virtual care option extending the continuity of care post-discharge is a viable solution to this problem.
Digital solution - virtual care: In the last few years, the focus on patient care has moved from clinical to home. Now, more than ever, it is necessary to engage patients before, throughout the perioperative period, and in rehabilitation, post-surgery to ensure the best possible patient health outcomes while reducing LOS and unplanned readmissions. Ensuring patients are prepared to adhere to the post-surgical plan of care once released from the hospital can increase the length of hospital stay by as much as 25%. Digital solutions can alleviate the problem by enabling remote monitoring of a patient's vital signs, symptoms and behaviour at home, sending medication reminders, monitoring medication use and the patient's understanding of the self-care content it is delivering, ensuring patients remain on the pathway toward better health, finally improving the patient's outcomes.
Continuity of care: Continuity of care after discharge has been shown to reduce readmissions and ED visits. Hence, extending the continuity of care in a patient's home may reduce revisit rates. (2) In one study on thoracic surgery, 30-day readmissions were reduced using a hospital-operated 'Integrated Comprehensive Care' program, comprised of a single nurse coordinator, eight registered and practical nurses, and six physiotherapists, along with respiratory therapists, dieticians, and occupational therapists on an 'as-needed' basis. (3) In another study, education, coordinated discharge, physician follow-up, \& home visits all contributed to reduced readmission rates. (4) Of note, Canadian data show that within the first seven days after surgical discharge, 28.3% of the diagnoses fall within the Canadian Emergency Department Triage and Acuity Scale (CTAS) IV or V; i.e. less or non-urgent. Those are likely manageable at the patient's home if appropriate transitional care is available and possibly preventable.
For patients at risk or rising at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behaviour, and creating better outcomes for patient populations. Care teams can understand what's going on with each patient daily or weekly, as opposed to once or twice a year through an office visit. With a continuous and more complete picture of patient health, they can adjust care plans as needed and proactively engage populations in managing their care.
ECG monitoring: The investigators incorporated home-based ECG monitoring in this population because atrial fibrillation is one of the critical indicators of adverse outcomes after thoracic surgery. After thoracic surgery, postoperative atrial fibrillation (POAF) occurs in 10.5% of patients(4), 7.3% after Video-Assisted Thoracoscopic Surgery (VATS) and 11.7% in open thoracotomy. (5) In major non-cardiac surgery as a group, the incidence of POAF is 3.0% (6), making POAF, after thoracic surgery, one of the highest in non-cardiac surgery. POAF is associated with infections (7); increased mortality (6); intra-operative transfusions (8); post-operative transfusions (9); post-operative pneumonia (10); respiratory failure (11); and therefore may be an important sign, or result, of postoperative complications, rather than the cause. In one study, POAF occurred at a mean of 3.55 days, with an increased in-hospital length of stay \[LOS\]. (7) Long-term follow-up of over 900 days showed that POAF recurs in 17.1% of non-cardiac surgical patients, with implications for long-term cerebrovascular accidents (CVA). (12) In a database study of 1,729,360 patients, POAF in non-cardiac surgery was associated with a CVA within one year, at an HR of 2.0 (1.7 - 2.3) compared to cardiac surgery or a cumulative rate of 1.47% (95% CI 1.24 - 1.75%). (13) Associated with higher mortality and complications, POAF adds another dimension to the high rate of unplanned hospital visits after thoracic surgical discharge.
Digital Monitoring: Even though continuous monitoring is the standard of care in the postanesthesia care unit, patients are managed by periodic vital checks by the nursing team in the surgical wards and no monitoring after the hospital discharge. Once patients are discharged from the hospital, patients and family caregivers feel vulnerable and abandoned. Digital home monitoring and digital self-care, such as blood pressure and SPO2 measurement at home, enable a small number of providers to coach many patients. Post-operative home monitoring with non-invasive blood pressure (NIBP), heart rate (HR), hemoglobin oxygen saturation (SpO2), \& pain scores collected at regular intervals has been instituted previously. (14) Such monitoring will help stratify CTAS IV/V patients from CTAS I, II, or III cases. Along with the vitals, home-based ECG monitoring will allow detection of early signs and symptoms of any concerns, which can be intervened and managed remotely.
The proposed trial:
Therefore, the investigators propose a pilot randomized controlled trial on continuity of care with digital home monitoring for two weeks post-operatively in patients undergoing an elective thoracic surgical procedure and four weeks of two-way communication.
#Intervention
- OTHER : Home Monitoring
- Patients in this group will receive home monitoring for NIBP (non-invasive blood pressure), SPO2 (pulse oximetry), and pain scores. These will be monitored 4 times a day for 2 weeks following surgery.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient willing to provide informed consent
* Availability of a caregiver at the patient's home
* Wi-fi or cellular connectivity at the patient's home
* Undergoing elective segmentectomy, lobectomy, or pneumonectomy; VATS or open procedure and any thoracic foregut procedure like esophagectomy etc
* ASA III or lower
* Ability to comprehend and consent in English
* Patient or caregiver familiar/comfortable with the use of the technology like online banking
Exclusion Criteria:
* Unstable disease process preoperatively
* Patient requiring postoperative ICU admission
* Expected unstable disease process in the postoperative 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
|
NCT04340960
|
{
"brief_title": "Home Monitoring for Thoracic Surgery Patients",
"conditions": [
"Atrial Fibrillation"
],
"interventions": [
"Other: Home Monitoring"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04340960",
"official_title": "Effect of Continuity of Care With Digital Home Monitoring on Postoperative Outcomes in Patients Undergoing Thoracic Surgery: A Pilot Randomized Controlled Trial (CDHM: RCT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-01-31",
"study_start_date(actual)": "2022-08-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-28",
"last_updated_that_met_qc_criteria": "2020-04-07",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-10",
"first_submitted": "2020-03-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.
#Intervention
- DRUG : Sodium bicarbonate
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 21 years
* Serum bicarbonate 22 <= age <= 25 mEq/L on 2 separate measurements (at least 1 day apart)
* CKD stage 3B or 4 at time of screening (eGFR 15 <= age <= 44 ml/min/1.73m2)
* Blood pressure <130/80 mm Hg prior to randomization
* BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).
Exclusion Criteria:
* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium < 3.3 or >= 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF <=30%, or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 12 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
* Use of immunosuppression in past 3 months
* Metal implant or implanted electrical device (patient will be unable to get MRI)
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02915601
|
{
"brief_title": "Bicarbonate Administration in CKD",
"conditions": [
"Chronic Kidney Disease",
"Metabolic Acidosis"
],
"interventions": [
"Drug: Placebo",
"Drug: Sodium bicarbonate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02915601",
"official_title": "Bicarbonate Administration in CKD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-19",
"study_completion_date(actual)": "2022-05-19",
"study_start_date(actual)": "2017-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-25",
"last_updated_that_met_qc_criteria": "2016-09-23",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-27",
"first_submitted": "2016-09-23",
"first_submitted_that_met_qc_criteria": "2023-06-30"
}
}
}
|
#Study Description
Brief Summary
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed Description
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients.
This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).
#Intervention
- DRUG : KRX-0502
- 1g tablets of KRX-0502
- Other Names :
- ferric citrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening
* Age >= 18 years
* Serum ferritin <= 300 ng/mL and TSAT <= 25% at Screening
* Hemoglobin >=9.0 g/dL and <=11.5 g/dL at Screening
* eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation
Exclusion Criteria:
* Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening
* Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \\ Screening
* Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening
* Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening
* History of hemochromatosis
* IV iron administered within 4 weeks prior to Screening
* Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening
* Blood transfusion within 4 weeks prior to Screening
* Receipt of any investigational drug within 4 weeks prior to Screening
* Cause of anemia other than iron deficiency or chronic kidney disease
* History of malignancy in the last five years
* Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening
* Any known allergies to iron products
* Previous intolerance to oral ferric citrate
* Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
* Planned surgery or hospitalization during the trial
* Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
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
|
NCT02128074
|
{
"brief_title": "A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia",
"conditions": [
"Anemia of Chronic Kidney Disease"
],
"interventions": [
"Drug: KRX-0502"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT02128074",
"official_title": "A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2014-04"
},
"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)": "2018-08-24",
"last_updated_that_met_qc_criteria": "2014-04-29",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-01",
"first_submitted": "2014-04-28",
"first_submitted_that_met_qc_criteria": "2017-11-30"
}
}
}
|
#Study Description
Brief Summary
AI-09 In Subjects with Glabellar Lines
Detailed Description
A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.
#Intervention
- BIOLOGICAL : AI-09
- Botulinum toxin, Type A, intramuscular injection, administered once at baseline
- BIOLOGICAL : Vehicle
- Vehicle Formulation
|
#Eligibility Criteria:
Inclusion Criteria:
* able to understand and give written informed consent
* willingness to have their pictures taken
* 20 - 70 years
* moderate to severe glabellar lines (IGA 2 <= age <= 3) on contraction
* moderate to severe glabellar lines (SSA 2 <= age <= 3) on contraction
* none to mild glabellar lines wrinkles (IGA 0 <= age <= 1) at rest
* willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
* female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
* female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy)
* subjects should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product
Exclusion Criteria:
* the inability to substantially lessen glabellar lines by physically spreading them apart
* excessive weakness or atrophy in the target muscle(s)
* eyelid ptosis
* presence or history of 'dry eye'
* history of periocular surgery, brow lift or related procedures, or deep dermal scarring
* concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
* history of immunization or hypersensitivity to any botulinum toxin serotype
* history of non-response to any prior botulinum toxin treatments
* anticipated need for treatment with botulinum toxin of any serotype for a reason during the trial (other than the investigational treatment)
* any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* pregnancy or lactation
* application of any topical prescription medication to the treatment area within 14 days prior to treatment
* subjects on clinically significant, concomitant drug therapy
* participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
* alcohol or drug abuse within the past 3 years
* psychiatric disease interfering with the subject's ability to give informed consent
* refusal or inability to comply with the requirements of the protocol for any reason
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05565950
|
{
"brief_title": "AI-09 In Subjects With Glabellar Lines, GL-101",
"conditions": [
"Glabellar Frown Lines"
],
"interventions": [
"Biological: Vehicle",
"Biological: AI-09"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05565950",
"official_title": "A Phase 1/2 Study to Establish An Initial Therapeutic Range and Safety Data for AI-09 in the Treatment of Glabellar Lines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-03",
"study_completion_date(actual)": "2024-06-03",
"study_start_date(actual)": "2022-10-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-09",
"last_updated_that_met_qc_criteria": "2022-10-03",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-04",
"first_submitted": "2022-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.
Detailed Description
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.
Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10).
For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.
Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
#Intervention
- DRUG : Bupivacaine
- Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
- Other Names :
- Marcaine
- DRUG : Normal Saline
- Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
- Other Names :
- Saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Female
* Age >= 18 years
* Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
* Surgery being performed for benign disease
Exclusion Criteria:
* Male
* Women under 18 years
* Pregnancy
* Suspected or known malignant disease
* Immunocompromised
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
|
NCT01534416
|
{
"brief_title": "Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery",
"conditions": [
"Postoperative Pain",
"Paracervical Block",
"Laparoscopic Gynecologic Surgery"
],
"interventions": [
"Drug: Bupivacaine",
"Drug: Normal Saline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01534416",
"official_title": "Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial",
"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)": "2011-09"
},
"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)": "2017-12-20",
"last_updated_that_met_qc_criteria": "2012-02-13",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-16",
"first_submitted": "2012-02-13",
"first_submitted_that_met_qc_criteria": "2017-12-18"
}
}
}
|
#Study Description
Brief Summary
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.
The investigational drug will be given as a single administration in a dose of \</= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
#Intervention
- DRUG : PET tracer (BAY94-9392)
- A radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
|
#Eligibility Criteria:
Inclusion Criteria:
* Males/females >= 18 years
* Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 <= age <= 2, determined within one week prior to treatment with BAY94 <= age <= 9392
* Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
* No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
Exclusion Criteria:
* Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94 <= age <= 9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation
* Previous treatment with BAY94 <= age <= 9392 in this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01186601
|
{
"brief_title": "Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer",
"conditions": [
"Neoplasms"
],
"interventions": [
"Drug: PET tracer (BAY94-9392)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01186601",
"official_title": "Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2010-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-11-13",
"last_updated_that_met_qc_criteria": "2010-08-20",
"last_verified": "2014-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-23",
"first_submitted": "2010-08-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Viral suppression among children and adolescents in Kenya is currently sub-optimal at 60% and 63% respectively. Under the current Kenya Ministry of Health Guidelines, clients with viral load of \>1000 copies/ml, should receive a minimum of three enhanced adherence counselling (EAC) sessions offered every two weeks and have a repeat viral load conducted 3 months after EAC completion. However, delivery of the EAC is not standardized and there is limited data available to evaluate the effectiveness of the three counselling sessions. Observational data from Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)-supported sites in Homa Bay and Turkana counties indicate that among children and adolescents with a viral load \> 1000 copies/ml, approximately 40% received the recommended three minimum EAC sessions and, after receiving EAC sessions, viral suppression was 33% in children aged below 9 years, 27% in adolescents aged between 10-14 years, 38% in adolescents aged 15 to 19 years and 53% in adults. The investigators propose to evaluate the implementation, effectiveness and acceptability of a standardized EAC package implemented at EGPAF-supported sites.
Methods: The investigators will use mixed methods to evaluate specific clinical outcomes (viral suppression) adherence, retention) among children and adolescents who receive the EAC package after suspected treatment failure, and if applicable, after switch to second and third line. The investigators will use a pre/post intervention assessment to evaluate the effectiveness of the EAC package, and qualitative methods (in-depth individual interviews (IDI) and focus group discussions (FGD)) to identify facilitators and barriers to accessing EAC. A process evaluation will be conducted to determine whether the standardized EAC package has been implemented as intended across sites. The study population is defined as children aged 0-19 years receiving Antiretroviral therapy (ART) in selected EGPAF supported sites.
Policy Significance:
Dissemination of findings will be done through: internal evaluation report shared with stakeholders, donors, and the Ministry of Health (MOH) and abstracts presented at local and international conferences; and, manuscripts for publication in peer-reviewed journals. Findings are expected to inform the continuous review and improvement of HIV Program delivery in Kenya, as the ministry of health and partners strive to meet international standards.
Detailed Description
BACKGROUND Viral suppression is a proxy for successful anti-retroviral therapy (ART) and is the '3rd 90' of the (Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 strategy. In Kenya, viral suppression among children and adolescents is sub-optimal at 60% and 63% respectively. Potential barriers to viral suppression can be individual (knowledge deficit, side effects, forgetting, substance abuse, depression, and pill burden), social (stigma, food insecurity, and family relationships) and structural (clinic frequency, school, relationship with health worker, long waiting times and lack of dose adjustment). Enhanced adherence counselling (EAC) aims to identify and address barriers to adherence to enable viral suppression. Following a client viral load of \>1000 copies/ml, the Kenyan 2016 antiretroviral therapy guidelines recommend a minimum of three EAC sessions offered two weeks apart. Changes in viral load are detected through a repeat test conducted 3 months after EAC. Clients with repeat VL \< 1000 are considered to be virally suppressed and are, therefore, maintained on the same Antiretroviral(ARV)drug regimen. Clients with persistent viral load above 1000 copies/ml are deemed to have failed first-line treatment, and are thereafter, switched to the appropriate second line or third line ARV drug regimen.
Delivery of the EAC is not standardized and there is limited data available to evaluate the effectiveness of the three counselling sessions. Observational data from EGPAF-supported sites in Homa Bay and Turkana counties indicates that for children and adolescents with a viral load \> 1000 copies/ml, approximately only 40 percent received the recommended three minimum EAC sessions. Following EAC, viral suppression was 33% in children aged below 9 years, 27% in adolescents aged between 10-14 years, 38% in adolescents aged 15 to 19 years and 53% in adults. The investigators propose to evaluate the implementation, effectiveness and acceptability of a standardized EAC package implemented at EGPAF-supported sites in Homa Bay County.
Adherence to ART among Children with HIV in Kenya An estimated 98,000 children aged between 0-14 years are infected with HIV in Kenya. HIV/AIDS accounts for 15% of mortality among children less than 5 years of age, while 50-60% of children infected with HIV at birth die before their second birthday.
Adherence to ART, retention in care and achieving viral suppression are substantial challenges in the management of infants and children on ART. Infants and children rely on others to administer their medications and to ensure clinic attendance. Caregivers may face barriers that can reduce medication adherence and clinic attendance. Some caregivers place too much responsibility for managing medications on older children and adolescents before they are developmentally able to undertake such tasks. Adherence may also be jeopardized by social and health issues within a family (e.g. substance abuse, poor physical or mental health, unstable family relations, and poverty). To improve outcomes for infants and children on ART, Kenya guidelines recommend provision of caregiver education to all parents/guardians of children receiving ART. To this end, a caregiver-specific treatment literacy curriculum has been developed by the MOH for caregiver training.
Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya.
The 2016 Kenya Ministry of Health guidelines on the use of ART for treating and preventing HIV recommend that ART should be started in all patients as soon as possible, preferably within 2 weeks after confirmation of HIV infection. A patient preparedness assessment is completed prior to initiating ART. Adherence support mechanisms need to be put in place for same day ART initiation. Routine monitoring of treatment response in adults, adolescents and children older than 2 years includes as assessment of VL at 6 months after ART initiation and 12 months after initiation of ART, and if suppressed (VL\<1000 copies/ml3), annually thereafter. Routine monitoring for infants, and children below 2 years is recommended at baseline, 6 months and 12 months after initiation of ART, then annually thereafter if the patient is stable and virally suppressed. Targeted VL is done for patients with suspected treatment failure. Targeted VL is also done when considering regimen change or single drug substitutions in patients who have been on ART for at least 6 months.
For patients with persistently high VL (\>1,000 copies/ml) after 6 months after initiating ART, and for those who were previously suppressed but found to have high viral load (VL\>1000 copies/ml) after more than 6 months after initiating ART, the guidelines recommend at least 3 patient-focused enhanced adherence counselling sessions within a 3-month period to address possible barriers before repeating the viral load test
Evaluation Goals and Objectives Goal: To evaluate clinical outcomes (viral suppression, adherence, retention) among children and adolescents with suspected treatment failure who receive the standardized enhanced adherence counselling package as compared to clinical outcomes for children and adolescents with suspected treatment failure who received services before standardization of enhanced adherence counselling package.
Overview of Evaluation Design This study uses a mixed method design. The investigators will use a pre-post design to evaluate specific treatment outcomes among children and adolescents receiving the standardized EAC package after suspected treatment failure and after switch to second- and third-line drug regimens. The investigators will conduct qualitative interviews and abstract patient outcome data to evaluate the effectiveness of the standardized EAC package, and qualitative methods (in-depth individual interviews and focus group discussions) to identify facilitators and barriers to accessing EAC. A process evaluation will be conducted to determine whether the standardized package of EAC was implemented as intended.
The study will use both qualitative and quantitative data collection and analysis methods. Pre-intervention, the investigators will abstract patient level data retrospectively from the charts of patients with VL \>1000 copies/ml on demographic characteristics and clinical outcomes and facility level data from summary forms for up to 24 months prior to the implementation of the standardized EAC package. Viral suppression will be evaluated at 6 and 12 months. After implementation of the standardized EAC package, data will be prospectively collected from participants with high viral load (\>1000 copies). After receiving the standardized EAC package, participants who are not suppressed will be switched to either second or third line and data will be collected prospectively from them at every visit. The investigators will use quantitative and qualitative methods of individual interviews, focus group discussions, and patient satisfaction surveys to assess acceptability of EAC and related services, as well as perceptions of facilitators and barriers to services pre and post intervention. Data related to EAC coverage will be abstracted from facility records. Coverage is defined as the proportion of patients with suspected treatment failure (STF) who receive a repeat viral load. A repeat viral load is only done after the completion of EAC and good adherence. Timelines will be determined using time from date when first high VL is documented in patient's chart to date of standardized EAC intervention (initiation and completion). This information will be abstracted from patient charts.
Study Population The study population will include HIV-positive male and female children and adolescents aged 0-19 years who are enrolled on ART at EGPAF supported sites and have suspected treatment failure. The investigators will interview parents/caregivers, peer educators/adherence counselors and health care providers in the same facilities to assess the barriers and facilitators, including satisfaction with care, to accessing EAC, both pre and post-intervention. For children below 9 years, the investigators will interview their caregivers.
. Sites Selection There are 171 facilities supported by EGPAF under the Timiza90 project in Homa Bay County. Among these, the investigators purposively selected seven high-volume facilities in order to provide sufficient numbers of children and adolescents with suspected treatment failure to include in the evaluation.
Sample size and Sampling Strategy The investigators purposively selected facilities that had the greatest number of unsuppressed patients based on viral load tests done between October 2017 to September 2018. In the selected facilities, the investigators captured data from the records of all patients who were unsuppressed over the period Oct 2016 - Sep 2018, (pre-intervention). Similarly, investigators captured data from the records of all patients who were unsuppressed for the post-implementation period, February 2019 - September 2020.
Sample size was calculated with an estimated 80% power at a 95% confidence level to demonstrate a minimum 10% increase in viral suppression due to the standardized EAC, adjusted for facility clustering (design effect 1.5), and estimates of missing records or lost to follow-up (+20%). The investigators used probability proportional-to-size sampling, based on the volume of VL tests by facility and age group; 0-9, 10-14, 15-19 years.
The investigators assume a 4:1 pre/post implementation number of clients unsuppressed for the 0-9-year age group and 3:1 pre/post implementation number of clients unsuppressed for the 10-14- and 15-19- year age groups. Table 3 presents these data, considering missing records for the retrospective cohort, or lost-to-follow up/missing records for prospective/post-intervention cohort, which may subsequently reduce the power to be able to demonstrate a difference. These estimates are unadjusted for facility clustering; the investigators will adjust for any clustering in the analysis.
Challenges and limitations Challenges and limitations to the evaluation include the quality of the patient records and their potential for missing data, the potential for response and response bias, the need for skilled interviewers and facilitators for the interviews and FGDs.
Analysis of patients' record data may be limited by poor data quality including missing data and data entry error especially for the retrospective data. The amount and patterns of missing data will be evaluated and appropriate statistical methods, as they may be applicable, will be used to account for the missing data in the analyses. The investigators will mitigate error resulting from data entry by re-entering a 5 percent random sample of the records on an ongoing basis. This subsequent data entry will be carried out by a different data entry clerk from the original clerk. Deviations of \>10 percent will result in retraining of the data entry staff.
Challenges with FGDs and IDIs include the potential for response bias, (the respondents may report what the interview would like to hear), differential non-response, (participants who refuse to be interviewed may be different to those who agree), and recall bias, (participants may selectively recall stakeholders and events).
#Intervention
- OTHER : Standardized enhanced adherence counseling package
- A standardized package was developed to support the adherence counsellor and other cadres to ensure provision of quality EAC sessions for children, adolescents and their caregivers. The package included; 1) Orientation and on job mentorship on EAC processes to clinicians, nurses, peer educators and mentor mothers. 2) Using a communication's training curriculum, providers were trained on psychosocial support and communication skills for children and their caregivers. 3) Appointment management was done using appointment dairies or a digital platform that sends patients short message services (SMS) reminders 3 days and 1 day before a scheduled clinic day. 4)Home visits. - All home visits were done according to the EGPAF standard operation procedures (SOPs) drawn from the Kenya National guidelines. 5) Individualized case management -Each EAC client was allocated a case manager who ensured that the barriers to adherence were identified and tackled both at individual and community level.
|
#Eligibility Criteria:
Inclusion Criteria for children and adolescents
* Age 0 <= age <= 19 years
* HIV positive
* On ART for at least 6 months
* Last VL >1000 copies
* Parental/guardian consent
* Assent (for 10 <= age <= 17-year old)
* Consent (for 18 <= age <= 19-year old)
Inclusion criteria for parents/caregivers
* Parent/guardian to a child/adolescent on ART with VL>1000 copies
* Provides consent
Inclusion criteria for service providers, Peer educators, Adherence/Psychosocial support counselors
* Working in the facility for at least 3 months
* Provides services to HIV positive children and adolescents on ART
* Provides consent
Exclusion Criteria:
* Already receiving EAC
* Receiving services at non-participating facility
* Not providing HIV services to children and adolescent
Sex :
ALL
Ages :
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04915469
|
{
"brief_title": "Enhanced Adherence Counselling, Pre-Post Study",
"conditions": [
"HIV Infection"
],
"interventions": [
"Other: Standardized enhanced adherence counseling package"
],
"location_countries": [
"Kenya"
],
"nct_id": "NCT04915469",
"official_title": "Evaluation of Enhanced Adherence Counseling as a Strategy to Optimize Adherence, Retention and Viral Suppression Among Children and Adolescents, in Homa Bay County, Kenya",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-20",
"study_completion_date(actual)": "2020-09-20",
"study_start_date(actual)": "2019-03-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-07",
"last_updated_that_met_qc_criteria": "2021-05-31",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-07",
"first_submitted": "2021-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.
Detailed Description
Pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called VEGF). Pazopanib is not currently approved by the US Food and Drug Administration (FDA) and therefore considered an experimental medication.
High levels of VEGF cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. Previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. That is why we think pazopanib might be an effective treatment for lymphedema.
#Intervention
- DRUG : Pazopanib
- Pazopanib will be administered at a starting dose of 800 mg orally once each day.
- Other Names :
- GW786034
|
#Eligibility Criteria:
Inclusion Criteria:
* Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for cancer that is severe enough to warrant therapy in the opinion of the patient and treating physician.
* All patients must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points (see protocol).
* Be at least 18 years
* Have adequate organ function as specified in the protocol.
* Agree to use effective contraceptive methods during the course of the study if the patient has child-producing potential
* Have an ECOG performance status of 0 or 1
Exclusion Criteria:
* Pregnant, lactating, or unwilling to use appropriate birth control
* Active infection
* Patients may not have clinically significant cardiovascular disease including myocardial infarction within 6 months prior to initiation of therapy, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, grade II or greater peripheral vascular disease, uncontrolled hypertension defined as SBP>160 or DBP>90. Patients may not have any prior history of cerebrovascular disease including TIA or stroke.
* Locally recurrent or metastatic disease
* Concurrent therapeutic anticoagulation or any history of DVT or PE.
* Major surgery within 4 weeks of starting protocol therapy (non-operative biopsy or placement of a vascular access device is not considered major surgery)
* Radiation therapy or chemotherapy within the past 6 weeks or currently undergoing radiation therapy or chemotherapy (Concurrent adjuvant hormonal therapy is allowed.)
* Altered the physical therapy regimen within the past month
* Indwelling venous device in the ipsilateral arm
* Bilateral lymphedema
* Concomitant requirement for medication classified as substrates for the CYP450 enzymes and listed as prohibited in 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
|
NCT00827372
|
{
"brief_title": "A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer",
"conditions": [
"Lymphedema"
],
"interventions": [
"Drug: Pazopanib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00827372",
"official_title": "A Phase II Study of VEGF Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-16",
"last_updated_that_met_qc_criteria": "2009-01-21",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-22",
"first_submitted": "2009-01-20",
"first_submitted_that_met_qc_criteria": "2014-10-15"
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.
Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.
Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
#Intervention
- BIOLOGICAL : Simtuzumab
- Other Names :
- GS-6624
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females 18 - 65 years
* Chronic liver disease of any etiology
* Stage 1 <= age <= 3 fibrosis by Metavir score on a liver biopsy.
* Body mass index <36 kg/m2
Exclusion Criteria:
* Any evidence of hepatic decompensation past or present
* Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
* Clinically significant cardiac disease
* History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
* Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the Pre-treatment Phase
* Pregnant or lactating
* History of bleeding diathesis within the last 6 months of study Day 1
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
|
NCT01452308
|
{
"brief_title": "Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis",
"conditions": [
"Liver Fibrosis"
],
"interventions": [
"Biological: Simtuzumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01452308",
"official_title": "A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2011-11"
},
"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)": "2014-02-03",
"last_updated_that_met_qc_criteria": "2011-10-11",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-14",
"first_submitted": "2011-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
People who has been in a fire accident have been shown often to be cyanide poisoned as well as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to see if HBO treatment can also treat cyanide poisoning.
The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will be detached from the mitochondria like CO and diffuse back to the blood.This way it will be easier to treat with hydroxycobalamin.
#Intervention
- PROCEDURE : HBO - hyperbaric oxygen treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* Going to receive HBO treatment for carbon monoxide poisoning from fire accidents
Exclusion Criteria:
* Under 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00399100
|
{
"brief_title": "Is it Possible to Treat Cyanide Poisoning With HBO?",
"conditions": [
"Carbon Monoxide Poisoning From Fire Accidents"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00399100",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-11",
"study_completion_date(actual)": "2006-11",
"study_start_date(actual)": "2006-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-21",
"last_updated_that_met_qc_criteria": "2006-11-13",
"last_verified": "2006-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-14",
"first_submitted": "2006-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients will undergo a professional oral hygiene procedure, followed by irrigation with ozonized water.
Patients will be randomly divided into two groups:
* Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care
* Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care.
The variations of the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
Detailed Description
The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure; then, ozonized water (aquolab) will be used to irrigate periodontal pockets for 1 minute.
Then, patients will be randomly divided into two groups:
* Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care until the end of the study;
* Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care until the end of the study.
Changes in the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
#Intervention
- OTHER : Peribioma Toothpaste and Mousse
- Use of Peribioma Toothpaste and Mousse for home oral care.
- OTHER : Standard toothpaste
- Use of Biorepair Plus Parodontgel for home oral care
|
#Eligibility Criteria:
Inclusion Criteria:
* patients suffering from Diabetes Mellitus Type 1
* adult patients
* patients who agreed to participate to the study and that signed the informed consent.
Exclusion Criteria:
* patients taking intravenous or oral Bisphosphonates at the study begin or in the previous 12 months
* patients with low compliance and motivation to participate
* pazienti irradiati alla testa o collo negli ultimi 12 mesi
* pregnant or breastfeeding women
* alcohol and drug abuse
* patients with psychiatric diseases
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
|
NCT04865809
|
{
"brief_title": "Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.",
"conditions": [
"Diabetes Mellitus With Periodontal Disease"
],
"interventions": [
"Other: Peribioma Toothpaste and Mousse",
"Other: Standard toothpaste"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04865809",
"official_title": "Professional and Home Oral Care With Non Surgical Periodontal Therapy for the Evaluation of Glycosylated Hemoglobin (HbA1c) in Patients Suffering From Diabetes Mellitus Type 1: a Randomized Clinical Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-13",
"study_completion_date(actual)": "2022-01-16",
"study_start_date(actual)": "2021-05-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-29",
"last_updated_that_met_qc_criteria": "2021-04-26",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-29",
"first_submitted": "2021-04-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The use of complete removable dental prostheses (CRDP) is a reliable and effective treatment option for the rehabilitation of edentulous persons.
In recent years, the use of computer-aided design/computer-aided manufacturing (CAD/CAM) methods has become more popular for the fabrication of CRDPs, including subtractive methods (milling) from a prefabricated resin puck. They present various advantages compared to conventional fabrication methods, namely improved mechanical properties, superior surface characteristics, shortened manufacturing time and lower cost for the patient.
However, one of the shortcomings in the manufacturing of CRDPs from a single block of resin is obtaining an adequate esthetic outcome, as the transition between the gingiva-colored (pink) and tooth-colored (white) resin is not as precise as with prefabricated prosthetic teeth which are incorporated into a denture base. A novel technology has recently been launched on the market and includes a new design of distribution of pink and white resin inside a prefabricated resin puck, which would allow a superior esthetic outcome than previous techniques.
The aim of this pilot study is to assess the end result of one of the available systems used for fabricating digital dentures (Ivoclar® Digital Denture®), while using the corresponding monolithic resin puck (Ivoclar® Ivotion Denture System®), and therefore determining whether this new technique is an adequate option for treating edentulous patients.
#Intervention
- DEVICE : Ivoclar Ivotion Denture System
- Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Informed Consent as documented by signature
* Healed edentulous maxilla and mandible (minimum one year since last extraction)
Exclusion Criteria:
* Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
* Vulnerable subjects
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the investigation
* Participation in another investigation with a MD in the field of dentistry
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Reported severe bruxism or clenching habits, clinically present oro-facial pain
* Width of edentulous maxilla > 80 mm
* Width of edentulous mandible > 80 mm
* Vertical height needed for maxillary prosthesis > 38 mm
* Vertical height needed for mandibular prosthesis > 38 mm
* Depression: Geriatric Depression Scale > 9
* Xerostomia: SSFR <= 0.7ml/min
* Dementia: Clock-Drawing Test <= 5
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
|
NCT05443048
|
{
"brief_title": "Evaluation of Monolithic Milled Complete Removable Dentures",
"conditions": [
"Complete Edentulism"
],
"interventions": [
"Device: Ivoclar Ivotion Denture System"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT05443048",
"official_title": "Evaluation of Monolithic Milled Complete Removable Dentures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-31",
"study_completion_date(actual)": "2023-08-31",
"study_start_date(actual)": "2022-09-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-17",
"last_updated_that_met_qc_criteria": "2022-06-28",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-05",
"first_submitted": "2022-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.
Detailed Description
The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.
#Intervention
- PROCEDURE : Nipple Sparing Mastectomy
- Skin sparing mastectomy with preservation of the nipple areolar complex
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients requiring mastectomy for cancer and/or prophylaxis
* Age greater than or equal to 18 at time of surgery
* BMI less than or equal to 35
* If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2
Exclusion Criteria:
* Currently smoking
* Prior radiation to the affected breast
* Systemic lupus erythematosus
* Central tumor location and/or tumor within 2 cm of NAC
* Paget's disease of the nipple
* Clinical evidence of tumor involvement in the nipple
* Clinical evidence of axillary nodal tumor involvement
* Lymphovascular invasion of the tumor on core biopsy
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
|
NCT01002014
|
{
"brief_title": "Nipple Sparing Mastectomy - Cosmetic Outcomes",
"conditions": [
"Breast Cancer",
"Breast Reconstruction",
"Cosmesis"
],
"interventions": [
"Procedure: Nipple Sparing Mastectomy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01002014",
"official_title": "Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08-24",
"study_completion_date(actual)": "2018-09-20",
"study_start_date(actual)": "2009-01-21"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-21",
"last_updated_that_met_qc_criteria": "2009-10-26",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-27",
"first_submitted": "2009-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using pre/post design will be conducted.
The hypothesis is that children participating in Community-AHF will demonstrate a reduction in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with pre-intervention
Detailed Description
To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using a pre/post design will be conducted.
As this is a pilot study, we will not be powered to detect statistically significant differences pre- and post- intervention. We will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. Without a counterfactual (control group) we will not be able assign responsibility to Community-AHF for any observed improvements. Change in %BMIp95 across the study period will provide data to test our hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and post-intervention data is ideal for generating sample size estimates for a larger randomized control trial in the same population.
We will conduct within-individual analyses for each outcome of interest. We will only analyze participants who contribute pre and post measures in order to avoid biases that can occur when analyses are conducted with all available data. For each outcome for which a participant contributes pre and post measurements, we will calculate pre and post means, standard deviations, differences in means and the p-value of the difference. We will conduct preliminary analyses of outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, we will explore the possibility of a nonresponse analysis.
#Intervention
- BEHAVIORAL : Community Active and Healthy Families
- Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Child age 5 <= age <= 12 years with Parent/Caregiver age of 18 or more years
* Child BMI >= 85th percentile for age
* Parent is foreign-born, self identifies as Latino/Hispanic and speaks Spanish
* Parental commitment to participate in a 4-month intervention
Exclusion Criteria:
* Child health condition that prevents diet modification or engaging in physical activity
* Child BMI >40kg/m2
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04414553
|
{
"brief_title": "Community Active and Healthy Families",
"conditions": [
"Obesity, Childhood"
],
"interventions": [
"Behavioral: Community Active and Healthy Families"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04414553",
"official_title": "Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-23",
"study_completion_date(actual)": "2023-11-03",
"study_start_date(actual)": "2023-03-10"
},
"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)": "2024-02-08",
"last_updated_that_met_qc_criteria": "2020-05-29",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-04",
"first_submitted": "2020-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.
Detailed Description
Plantar fasciitis is one of the main causes of heel pain. it is caused by the micro trauma to the site of attachment of plantar fascia at its origin on the medial tubercle of calcaneus resulting in inflammation. Plantar fascia is a fibrous band present at the bottom of foot which attaches heel to each of the toes.plantar fascia has a windlass mechanism which continuously stretches and shortens facilitating foot movements during walk.
During the standing phase all the tension forces are gathered at calcaneal tuberosity, which is a site of attachment for plantar fascia on heel. Pain is generally present at the medial side of heel to the medial arch of the foot.
Plantar fasciitis is often caused in people who have long periods of standing, involved in activities like running, jumping or other repeated activities. After knowing the exact mechanism it is suggested that it should be termed as planter fasciosis.Plantar fasciitis accounts for almost 80% of the total heel pain experienced by the people.
Planter fasciitis is treated with various treatment options. Initially it is treated by conservative treatments such as, rest, ice massage, foot ware modification, oral analgesics, stretching techniques, physical therapy modalities, and night splinting. If pain do not resolve with conservative treatment then further treatment options will be extracorporeal shock wave therapy, cortisone injections and surgery.
Diana et al concluded that addition of manual techniques for trigger point release along with stretching of plantar fascia is more effective than stretching alone. In a randomized control trial with a follow up of 12 months high load strength training was found to be quicker and more efficient treatment for plantar fasciitis. another RCT conducted in 2017 reported that stretching of Achilles tendon along with plantar fascia is twice effective than only plantar fascia stretching.
Immobilization done by using splints at night is one of the best treatments to avoid contracture in plantar fascia during night. But they are also related to sleep disturbances and discomfort during night. By using night splint there has been a pain relief for shorter period of time. Night splints used alongside custom foot orthotics have better results than used alone. Controlled Ankle Movement is very effective in reducing pain in heel. It can be done by using walking boots and casts. These boots and casts will help to reduce over stretching of plantar fascia with unloading mechanism over heel. The reported reduction of pain by this mechanism of controlled ankle movement is in up to 40% of individuals.
Jonathan et al reported that there is a role of hamstring tightness in plantar fasciitis. A correlation study found a strong relationship between hamstring tightness and plantar fasciitis. patients having hamstring tightness are 8.7% more prone towards developing planter fasciitis.
Hamstring is found to be affected in patients with plantar fasciitis. Many studies found relationship of hamstring tightness with plantar fasciitis. Hamstring tightness affects the posterior muscles increasing load on plantar fascia. There is scarce evidence about the hamstring stretching in patients having plantar fasciitis. So this study will focus on hamstring stretching along with plantar fascia stretching and strengthening to improve pain, range of motion and disability.
#Intervention
- OTHER : Experimental Group
- Hamstring stretching is the main intervention which is being used along with convention protocol for plantar fasciitis.
- Other Names :
- Hamstring Streching
- OTHER : Control Group
- Control group included Cold pack for 7 to 10 mins. Followed by stretching of plantar fascia .
- Other Names :
- cold pack, calf and plantar fascia stretchings and strenthening exercises
|
#Eligibility Criteria:
Inclusion Criteria:
* Both Genders
* 25 <= age <= 45 of age
* Participants having heel pain for more than one month.
* Participants having Windlass positive test.
* Participants having hamstring tightness.
* sit and reach test positive.
* Bilateral plantar fasciitis.
Exclusion Criteria:
* Patients with corticosteroid injection
* Fracture around ankle and Calcaneal
* Any soft tissue injuries around ankle.
* Other Neurological/ Musculoskeletal disorder
* Congenital foot anomalies
* Systemic medical illness
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06139822
|
{
"brief_title": "Hamstring Stretching in Plantar Fasciitis",
"conditions": [
"Plantar Fasciitis of Both Feet"
],
"interventions": [
"Other: Experimental Group",
"Other: Control Group"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06139822",
"official_title": "Effects of Hamstring Stretching With Conventional Physical Therapy in Plantar Fasciitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-01-25",
"study_start_date(actual)": "2022-02-01"
},
"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)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2023-11-15",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-18",
"first_submitted": "2023-01-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.
Detailed Description
This study is an outpatient, randomized, double-blind, placebo-controlled trial in which adult subjects with ADHD will be randomized to either oral mazindol controlled release or placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks with visits occurring weekly to measure efficacy and any adverse events with adjustment of medication dosing as necessary.
#Intervention
- DRUG : mazindol
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject has a primary diagnosis of ADHD established by a comprehensive psychiatric evaluation based on DSM-5 criteria.
* Subject is functioning at an appropriate level intellectually as judged by the investigator.
* Subject has a minimum baseline score of 28 at screen and at baseline using the ADHD-RS-DSM5
* Subject has a minimum score of 4 (moderate) on the CGI-S at screening.
* Women of child-bearing potential must be non-pregnant, non-lactating, and agree to be on an acceptable method of contraception. Acceptable methods of contraception include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
* In good general physical health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
* Subject is fluent in written and spoken English and is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
* Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Exclusion Criteria:
* Any primary DSM-5 Axis I disorder other than ADHD or any comorbid DSM-5 disorder that currently requires treatment.
* Lifetime history of any DSM-5 bipolar disorder
* Treatment with medications for any psychiatric or neurologic condition (e.g., amphetamines, MPH products, antidepressants, antipsychotics, mood stabilizers, anti-epileptics) or pressor agents concurrently or within 14 days of randomization.
* Concurrent medical illness that would interfere with the conduct of the study in the opinion of the investigator.
* History of significant cardiovascular disease, structural cardiac abnormality, cardiomyopathy, heart failure, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke, or other serious cardiac problems.
* Family history of sudden cardiac death.
* Clinically significant ECG abnormality or a QTc (Bazett correction) interval >450 msec.
* Resting sitting systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg.
* BMI <18 or >40 kg/m2.
* Other medications that have CNS effects on cognition or attention (e.g., sedating antihistamines or decongestants).
* Positive drug screen (UDS) at screening (with the exception of current ADHD medication).
* Concomitant use of sensitive CYPA4/5 or CYP2D6 substrates with narrow therapeutic indices.
* Pregnant or lactating.
* Ongoing psychotherapeutic treatment for the treatment of ADHD begun less than three months before entry into this study.
* Recent or current DSM-5 Substance Use Disorder of moderate or greater severity (i.e., > 4 SUD symptoms), excluding nicotine.
* Suicidal ideation within past 3 months, suicidal behavior within the past year, or a C-SSRS score of 3, 4 or 5 on ideation item.
* Evidence of any out-of-range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Study Investigator.
* A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis), or any known/suspected hypersensitivity to any form of mazindol.
* Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Study Investigator, would make the subject unsuitable for the study or put them at additional risk.
* Treatment with an investigational drug within 30 days preceding the first dose of study medication.
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
|
NCT02808104
|
{
"brief_title": "Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)",
"conditions": [
"Attention Deficit Disorder With Hyperactivity"
],
"interventions": [
"Drug: mazindol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02808104",
"official_title": "A Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults With DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-28",
"study_completion_date(actual)": "2017-03-28",
"study_start_date(actual)": "2016-08"
},
"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)": "2017-04-06",
"last_updated_that_met_qc_criteria": "2016-06-16",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-21",
"first_submitted": "2016-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obliterative arterial disease of the lower limbs (AOMI) is associated with a high risk of cardiovascular events, with a linear relationship between a fall in the systolic pressure index and a risk of cardiovascular morbidity and mortality. Critical ischemia is the most severe stage of AOMI, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, as well as the patient's vital prognosis. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Consequently, the goal of management in a multidisciplinary setting is threefold: the treatment of pain, improvement of the functional prognosis and improvement of the patient's vital prognosis. Revascularization should be attempted as often as possible for the purpose of limb salvage and improvement of patient survival.
In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed at a multidisciplinary consultation meeting. The medical-radiological-surgical expertise takes into consideration the patient's terrain and comorbidities and the technical possibilities according to the arterial damage. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. foot with a lower morbidity-mortality compared to surgery, especially in the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with critical ischemia hospitalized in the vascular medicine department.
In patients with critical ischemia at high risk of major amputation and without the option of traditional endovascular or surgical revascularization, an endovascular revascularization technique for leg rescue is discussed as a last resort in multidisciplinary staff. This technique, performed by the interventional radiology team (MDP and GA), consists of an extra-anatomic endovascular femoro-popliteal bypass. We wish to describe the limb salvage rate and the preservation of autonomy in the 15 patients treated with this revascularization technique since 2013 in the vascular medicine department of the GHPSJ.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient whose age >= 18 years
* Patient with critical ischemia at high risk of amputation without the option of 'traditional' surgical or endovascular revascularization after multidisciplinary staff discussion
* Patient treated by the non-surgical technique called 'endovascular bypass'
* Patient with preserved autonomy
Exclusion Criteria:
* Patient presenting a loss of autonomy, genu flessum analgesic
* Patient with a contraindication to antithrombotic therapy
* Patient with infectious complications of life-threatening ischemic wounds
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient opposing the use of his data for this research
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04066387
|
{
"brief_title": "Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients",
"conditions": [
"Limb Ischemia"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04066387",
"official_title": "Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-31",
"study_completion_date(actual)": "2019-09-01",
"study_start_date(actual)": "2019-05-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-03",
"last_updated_that_met_qc_criteria": "2019-08-22",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-26",
"first_submitted": "2019-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Psychological stress is an independent cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could one of the mechanisms linking psychological stress and cardiovascular diseases
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy subjects
* No smokers
* Written informed consent
Exclusion criteria:
* Smoking
* Alcohol- or Drug Abuse
* Pregnancy
* Use of benzodiazepins, Aspirin or NSAIDs in the last week before inclusion
* Participation to another study within the last month
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00621738
|
{
"brief_title": "Effect of Mental Stress on Platelet Function in Healthy Subject",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT00621738",
"official_title": "Effect of Mental Stress on Platelet Function in Healthy Subject",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-12"
},
"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)": "2010-02-10",
"last_updated_that_met_qc_criteria": "2008-02-21",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-22",
"first_submitted": "2008-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Probiotics are viable commensal microorganisms that promote the establishment of beneficial microflora. Animal and human studies demonstrate that probiotics can enhance body's immune response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide \[FOS\], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human volunteers, over 65 years of age, is designed to study the safety of this probiotic when patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then our aim is to do a larger study to see if we can improve influenza vaccine immune response while taking the probiotic compared to placebo.
#Intervention
- BIOLOGICAL : Synbiotic AKSB
- AKSB is a novel synbiotic that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide \[FOS\], NutraFlora®).
|
#Eligibility Criteria:
Inclusion Criteria:
* Persons, male and female, 65 years and older.
* Eligible and willing to receive the influenza vaccine and take the study drug.
* Not currently on immunosuppressive drugs such as chemotherapy, oral or parenteral prednisone or Tumor Necrosis Factor-alpha (TNF-α) inhibitor therapy.
* Not allergic to chicken/egg protein.
* Willing to have blood drawn (4 times) during the study.
* Willing to complete a simple diary documenting toxicity, pill count and any side effects of the medication and any reported illnesses during this period.
* Willingness to take 4 capsules per day, keep a symptom and capsule diary, and return these materials to the clinic at the conclusion of the study.
* Willingness to avoid all over the counter nutritional supplements, probiotics, and yogurts containing probiotics during the duration of the study.
* Patients who have provided their written informed consent prior to participation in the study and have signed and dated an appropriate Health Insurance Portability and Accountability Act (HIPAA) authorization form.
* Blood laboratory results within the 7 days of starting study drug
* Normal liver function as shown by:
* serum AST within upper limits of normal
* Adequate renal function as shown by :
* serum creatinine <= 2.0 mg/dL
* Hemoglobin > 11gm/dL; WBC: > 3.5X109 /L and platelets > 100 X 109 /L
Exclusion Criteria:
* Antibiotic use - current or within 2 weeks prior to start of the study.
* Chicken/Egg hypersensitivity or hypersensitivity to influenza vaccine components such as bactopeptone, beta-propiolactone, neomycin, gentamicin, monosodium glutamate, formaldehyde or formalin, gelatin, polyethylene glycol p-iso-octylphenyl ether (Triton X-100), polymyxin B, polyoxyethylene 9 <= age <= 10 nonyl phenol (Triton N-101, octoxynol 9), or thimerosal.
* Talc allergy
* Influenza vaccine within the prior 12 months.
* Immunosuppressed status either from illness such as acquired immunodeficiency syndrome (AIDS), or with concomitant chemotherapy, or iatrogenic immunosuppression such as prednisone or other drugs such as TNF-α inhibitor therapy.
* History of known serious illness such as active cancer (except localized skin or non-metastatic prostate cancer), poorly controlled congestive heart failure, poorly controlled diabetes, acute or progressive renal or hepatic failure, chronic obstructive lung disease requiring oxygen.
* Ongoing anti-influenza therapy with amantadine, rimantadine, oseltamivir or zanamivir
* Active or recent (within last 6 months) history consistent with acute influenza illness. Febrile illness with headache, sore throat and temperature more than 37.5C on the day of enrollment.
* Known chronic inflammatory bowel disease such as Crohn's disease, active bowel cancer (defined as being on chemotherapy or having an untreated bowel cancer)
* Hypersensitivity to any components of the AKSB, placebo or the vaccine.
* Oral typhoid vaccine use in the last 2 weeks.
* Patients who have participated in a clinical study and/or received any investigational medication during the last month (30 days) preceding study Day 1; or currently enrolled in an investigational study.
* Patients who, in the opinion of the investigator, possess insufficient mental or reading ability that prevents their understanding and providing informed consent and appropriate HIPAA authorization;
* Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
* Patients who are unwilling or unable to comply with the study protocol for any other reason.
* History of Guillain-Barré Syndrome within 6 weeks following a previous dose of the inactivated vaccine.
* Allergy or contraindication to two or more of the following: vancomycin, penicillins, daptomycin, linezolid
* Allergy or contraindication to two or more of the following: fluconazole, deoxycholate amphotericin B, liposomal amphotericin B, itraconazole or voriconazole
* Blood laboratory results within the 7 days of starting study drug
* Abnormal normal liver function as shown by:
* serum AST above the upper limits of normal
* Impaired renal function as shown by :
* i. serum creatinine > 2.1 mg/dL
* Hemoglobin < 11gm/dL; WBC: < 3.5X109 /L and platelets < 100 X 109 /L
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01304771
|
{
"brief_title": "Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Synbiotic AKSB"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01304771",
"official_title": "A Phase I Trial of the Safety and Efficacy of Adjuvant AKSB (Agri-King Synbiotic) Synbiotic in Patients 65 Years of Age and Older Receiving the Influenza Vaccine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04",
"study_completion_date(actual)": "2011-04",
"study_start_date(actual)": "2010-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-06-20",
"last_updated_that_met_qc_criteria": "2011-02-24",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-25",
"first_submitted": "2010-12-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB).
The purpose of this study is to compare active measurement of MRA compliance with patient's self-report.
Detailed Description
Background Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a conservative treatment option for sleep-disordered breathing (SDB).
Up to this date, no objective method is available to measure compliance during oral appliance treatment for SDB.
As with CPAP in the early years, the sleep apnea community nowadays has a strong interest in the objective measurement of oral appliance use and adherence. Subjective measures and self-report commonly result in overestimation of compliance.
Methods We will perform a 12-week clinical trial comparing active/objective measurement of compliance with subjective self-reported usage.
We will enroll 50 patients with an established diagnosis of SDB that received treatment with a titratable, duobloc MRA (RespiDent Butterfly® MRA, RespiDent, Nijlen, Belgium).
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Oostenrijk) are provided by the Handelsagentr Gschladt (Hargelsberg, Oostenrijk) without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.
The microsensors are intercalated into the MRA devices by the dental technician.
Participants receive explanation to the purpose of the study, in the fact that the investigators want to study temperature fluctuations during the night in the oral cavity. As a result, the subjects are unaware that their MRA use and compliance is being measured.
A first follow-up appointment is scheduled after the first 4 weeks. A second and final follow-up visit is scheduled again 12 weeks after the start of the study.
During each follow-up visit patients are asked to fill out a questionnaire containing questions about MRA wear during the last 4 or 8 weeks (mean hours/night, mean nights/week), respectively. The objective measurement of MRA wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MRA has been worn when the chip records a temperature intraorally.
This study design will provide a 12-week evaluation of all patients (n=50).
Perspective and Hypothesis The removable nature of an oral appliance warrants an objective assessment of the effective use and compliance with overnight MRA treatment for SDB.
We hypothesize that objective compliance might turn out to be significantly lower compared to the subjectively reported compliance.
#Intervention
- DEVICE : MRA
- daily wear overnight
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of sleep-disordered breathing
* started treatment with oral appliances, such as mandibular repositioning appliances
Exclusion Criteria:
* dental exclusion criteria for MRA
* medical contra-indications for MRA
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
|
NCT01284881
|
{
"brief_title": "Self-Reported Versus Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome",
"conditions": [
"OSAHS"
],
"interventions": [
"Device: MRA"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01284881",
"official_title": "Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2010-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-02",
"last_updated_that_met_qc_criteria": "2011-01-26",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-27",
"first_submitted": "2011-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
Detailed Description
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H\&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
#Intervention
- DRUG : ChiNing decoction
- ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
- Other Names :
- Addition and subtraction of Liangge San
|
#Eligibility Criteria:
Inclusion Criteria:
* Head and neck cancer patients with pathology and / or cytologic diagnosis;
* Age 18~75 years;
* The expected life is more than 3 months;
* The Karnofsky score (Karnofsky) >=70 points;
* The first course of radiotherapy in patients;
* Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
* Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme;
* No history of oral ulcer and salivary gland diseases
Exclusion Criteria:
* That do not meet the above the inclusion criteria;
* Advanced critical cases, the expected survival is less than 3 months;
* The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
* The submandibular gland pathological changes;
* During radiotherapy taking other drugs in patients with treatment of stomatitis;
* The patients with serious heart, brain, liver, kidney function
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
|
NCT02303197
|
{
"brief_title": "Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis",
"conditions": [
"Head and Neck Cancer"
],
"interventions": [
"Drug: ChiNing decoction"
],
"location_countries": [
"China"
],
"nct_id": "NCT02303197",
"official_title": "A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2014-05"
},
"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)": "2015-12-22",
"last_updated_that_met_qc_criteria": "2014-11-26",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-27",
"first_submitted": "2014-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective observational study. Eligible women undergo ART treatment in our centre will be recruited for the study and each woman will only be included in the study once. Informed written consent will be obtained. Blood serum for hCG level is performed 14 days after the embryo transfer i.e. week 4. If the serum hCG level is \>10IU/L, the women are considered pregnant and blood will be saved and checked for kisspeptin level, Another blood test is repeated 1 week later i.e. week 5. A transvaginal ultrasound and blood test will be performed 1 week later i.e. week 6 to confirm the fetal viability and the number of gestational sacs and locate the pregnancy.
Blood for hCG and kisspeptin levels are checked at weeks, 4, 5 and 6. Ultrasound will be performed at gestational 8 weeks and 11 weeks. They will be referred for antenatal care when the pregnancy is confirmed on-going at 11 weeks.
The purpose is to determine whether serum kisspeptin level in women who conceive in IVF is associated with an increased risk in first trimester miscarriage and compare with serum hCG level in the prediction of the first trimester miscarriage.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women who have a positive pregnancy test following IVF or frozen-thawed transfer
Exclusion Criteria:
* Women with renal failure are excluded due to assay interference with kisspeptin measurement
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03940495
|
{
"brief_title": "Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?",
"conditions": [
"Miscarriage"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT03940495",
"official_title": "A Prospective Study to Evaluate Whether Serum Kisspeptin is a Marker Predictive of the First Trimester Miscarriage of Women Who Conceive in IVF",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-08-01",
"study_start_date(actual)": "2019-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-18",
"last_updated_that_met_qc_criteria": "2019-05-04",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-07",
"first_submitted": "2019-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate whether mindfulness-based stress reduction (MBSR) is a viable community program for enhancing wellbeing among older adult immigrants from low income neighborhoods. Half of the sample will be randomized to receive the 9-week mindfulness program and the other half will be randomized to a wait list control condition. Primary outcomes of interest will include perceived stress and self-report depressive symptoms. Secondary outcomes will include trait mindfulness and self-care, self-compassion, emotion regulations, and attentional skills. Participants will also be invited to engage in a 30-minute interview to discuss their lived experience as an immigrant in Canada and their experience in the MBSR program. Due to COVID-19, all sessions will be held virtually.
Detailed Description
Adults aged 65 years and older are the fastest growing segment of the Canadian population. In the 2006 Census, 43% of older adults in Ontario identified as being a Canadian immigrant, a statistic which continues to grow in the context of an aging population. Aging is commonly associated with declines in physical and cognitive capacity, which is significantly accelerated by chronic perceived stress. Lower income older adults are particularly vulnerable to accelerated aging and disease onset due to the stress of economic insecurity. In 2012, the highest low-income rates in Canada were reported among immigrants 65 years of age and older. Accordingly, it is important to investigate programs that can support the wellbeing of aging Canadian immigrants.
The principal investigator (PI) and her research team will conduct a one-factor between-subjects design with two conditions - a mindfulness-based intervention and a waitlist control - to examine the benefits of mindfulness training on indices of wellbeing, including perceived stress, depressive symptoms, emotion regulation, self-compassion and self care. It is hypothesized that mindfulness training will enhance indices of wellbeing compared to a wait-list control. Employing a mixed-methods approach, participants will also engage in a qualitative interviews to provide insight into the lived experience and how mindfulness may serve Canadian immigrants.
#Intervention
- BEHAVIORAL : Mindfulness-based Stress Reduction
- Mindfulness-based stress reduction is a manualized mindfulness training protocol that has been researched for over 20 years. The original protocol will be used, with the exception of the prescribed home practice duration (i.e. 30 mins of practice). Rather, the program will be modified to set up participants for success by providing them with instruction to 'build' on their meditation practice, beginning with 8 minutes a day.
|
#Eligibility Criteria:
Inclusion Criteria:
* 60+ years of age; Canadian immigrant; low socioeconomic status; immigrated to Canada within last 15 years; reports experiencing stress in their daily life.
Exclusion Criteria:
* existing contemplative practice; currently enrolled in a research study; non-fluency in English; neurological disorder that prevents participation in the 9-week program or testing procedures; plans to vacation during the study period/unable to attend 9 program sessions and 2 testing sessions; existing substance abuse (last 6 months); psychiatric disorder that may prevent participation in 9-week program or testing procedure.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03923452
|
{
"brief_title": "Mindfulness Training for Older Adult Canadian Immigrants",
"conditions": [
"Stress"
],
"interventions": [
"Behavioral: Mindfulness-based Stress Reduction"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03923452",
"official_title": "Mindfulness Training for Low-Income Older Adult Canadian Immigrants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-30",
"study_completion_date(actual)": "2023-04-30",
"study_start_date(actual)": "2022-06-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-09",
"last_updated_that_met_qc_criteria": "2019-04-18",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-22",
"first_submitted": "2019-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.
Detailed Description
The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.
Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.
#Intervention
- DRUG : Venlafaxine HCl
- Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug
- Other Names :
- Effexor XR
- OTHER : Placebo
- Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
|
#Eligibility Criteria:
Inclusion Criteria:
* Having sustained an SCI at least six months prior to enrollment.
* Neurological impairment ASIA Grades A-D.
* Mild to moderate depressive symptoms.
* English speaker
* Age >= 18 years
* Able to communicate with study personnel
Exclusion Criteria:
* No neurological impairment due to SCI.
* Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
* Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
* Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
* Pregnant or unwilling to use birth control if female and sexually active.
* Presence of glaucoma.
* Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
* Willing to travel to Ann Arbor Michigan.
* Expecting to take or currently taking another experimental study within 30 days
* Major surgery scheduled within 12 weeks
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
|
NCT00735670
|
{
"brief_title": "Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury",
"conditions": [
"Spinal Cord Injury"
],
"interventions": [
"Other: Placebo",
"Drug: Venlafaxine HCl"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00735670",
"official_title": "Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-13",
"last_updated_that_met_qc_criteria": "2008-08-14",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-15",
"first_submitted": "2008-08-14",
"first_submitted_that_met_qc_criteria": "2016-10-07"
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
Detailed Description
People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.
#Intervention
- DRUG : Codeine (30 mg)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Sickle cell disease (HbSS)
* Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past
Exclusion Criteria:
* Renal dysfunction, serum creatinine (SCr) > 2.0 mg/dl
* Hepatic dysfunction, AST, ALT or direct bilirubin > 3 x upper limit of normal (ULN)
* Codeine allergy
* Medications shown to induce or inhibit CYP2D6
* Women who are pregnant or breast feeding
* Unable to provide written, informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00174538
|
{
"brief_title": "Codeine in Sickle Cell Disease",
"conditions": [
"Sickle Cell Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00174538",
"official_title": "The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-12",
"study_start_date(actual)": "2005-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-30",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2005-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-15",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
#Intervention
- DRUG : Cocaine
- DRUG : Sustained Release d-Amphetamine
- Other Names :
- Dexedrine Spansule SR
|
#Eligibility Criteria:
Inclusion Criteria:
* Recent cocaine use, otherwise healthy
Exclusion Criteria:
* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02383043
|
{
"brief_title": "Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer",
"conditions": [
"Active Cocaine Users"
],
"interventions": [
"Drug: Cocaine",
"Drug: Sustained Release d-Amphetamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02383043",
"official_title": "Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-05",
"study_completion_date(actual)": "2018-04-05",
"study_start_date(actual)": "2015-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-11",
"last_updated_that_met_qc_criteria": "2015-03-03",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-09",
"first_submitted": "2015-02-27",
"first_submitted_that_met_qc_criteria": "2019-03-17"
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the efficacy of the reminder device Remind Cap® in improving patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the treatment of hypertension
#Intervention
- DRUG : Valsartan+/- Hydrochlorothiazide
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with hypertension that have newly started using Valsartan+/-HCTZ
Exclusion Criteria:
* Pregnancy or Hypersensitivity to Valsartan+/-HCTZ
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00487123
|
{
"brief_title": "Efficacy of the New Closure Device in Improving Patient Compliance in Treatment of Hypertension With Valsartan+/-Hydrochlorothiazide (HCTZ) at 6 Months",
"conditions": [
"Hypertension"
],
"interventions": null,
"location_countries": [
"Singapore"
],
"nct_id": "NCT00487123",
"official_title": "A Multi-Center, Randomized, Proof-of-Concept, Parallel Control Study With Remind Cap® in Patients With Essential Hypertension and Newly Treated With Valsartan+/-Hydrochlorothiazide (HCTZ)",
"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)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-06-17",
"last_updated_that_met_qc_criteria": "2007-06-13",
"last_verified": "2008-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-15",
"first_submitted": "2007-06-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
Detailed Description
There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation \<32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.
#Intervention
- DEVICE : Bubble CPAP
- Bubble CPAP will be delivered using Fischer \& Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%.
- Other Names :
- Fisher & Paykel Bubble CPAP System
- DEVICE : Conventional CPAP
- Conventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator.
|
#Eligibility Criteria:
Inclusion Criteria:
* Gestation less than 32 weeks
* Birth weight less than 1500 g
* Age less than seven days
* First extubation attempt.
Exclusion Criteria:
* A neonate having any of the following will be excluded from the study-
* Severe birth asphyxia defined as need for chest compression for more than 30 seconds
* Suspected congenital neuromuscular disorder
* Major congenital malformation
* Grade 3/4 interventricular haemorrhage
* Hydrops.
Sex :
ALL
Ages :
- Maximum Age : 7 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00979433
|
{
"brief_title": "Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants",
"conditions": [
"Extubation Failure"
],
"interventions": [
"Device: Conventional CPAP",
"Device: Bubble CPAP"
],
"location_countries": [
"India"
],
"nct_id": "NCT00979433",
"official_title": "Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2007-09"
},
"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)": "2013-02-26",
"last_updated_that_met_qc_criteria": "2009-09-17",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-18",
"first_submitted": "2009-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This 2-phase study will determine the safety of treating patients with malignant melanoma with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed melanoma cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.
Patients 18 years of age or older with malignant melanoma may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.
Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 3 months for the remaining first year (6 months) after vaccination and then every 6 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:
Medical history and physical examination Blood tests X-rays and various scans (nuclear medicine/CT/MRI) FACT-G Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, monthly during treatment, and during follow-up visits after completing the treatment. It includes questions on the severity of cancer symptoms and the ability to perform normal activities of daily life.
Detailed Description
According to statistics of the American Cancer Society, an estimated 55,000 individuals will be diagnosed with malignant melanoma and 8,000 will die of the disease this year in the Unites States despite all current therapy. This protocol attempts to exploit an approach to melanoma vaccine therapy using a naturally occurring barrier to xenotransplantation in humans in attempt to vaccinate patients against their melanoma The expression of the murine alpha(1,3)galactosyltransferase \[alpha(1,3)GT\] gene results in the cell surface expression of alpha(1,3)galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man. Human hosts often have pre-existing anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora leading to chronic immunological stimulation. These antibodies may comprise up to 1% of serum IgG. In this Phase I/II trial, patients with advanced stage melanoma will undergo a series of twelve intradermal injections with a trivalent vaccine composed of irradiated allogeneic melanoma cell lines (HAM-1, HAM-2 and HAM-3). These cell lines have been transduced with a recombinant Moloney murine leukemia virus (MoMLV)-based retroviral vector expressing the murine alpha(1,3)GT gene. Endpoints of the study include determination of dose-limiting toxicity (DLT), maximum tolerated dose (MTD), tumor and immunological responses.
#Intervention
- BIOLOGICAL : HyperAcute-Melanoma Vaccine
- Cells will be injected intradermally every two weeks for twelve vaccinations. If the patient completes all twelve vaccinations, dosage will vary from a total of 1.3 x 109 to 3.8 x 109 HyperAcute™-Melanoma Vaccine cells administered.
- Other Names :
- HAM-1, HAM-2, and HAM-3
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological diagnosis of malignant melanoma. (pathology must be reviewed by Pathology Department)
* AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, any N, M1), metastatic, progressive, refractory, recurrent, or high risk of recurrence malignant melanoma.
* Adult patients > or = to 18 years
* Measurable or non-measurable disease.
* Patient is > or = to 4 weeks past major surgery, radiotherapy, chemotherapy. (6 weeks if treated with a nitrosureas) or biotherapy/targeted therapies and has recovered from the toxicity of prior treatment to < or = to Grade 1, exclusive of alopecia or fatigue.
* Hemoglobin > or = to 10.0 gm/dL, absolute granulocyte count > or = to 1500/ mm3,platelets > or = to 100,000/ mm3, absolute lymphocyte count > or = to 475/ mm3.
* Total Bilirubin < or = to 1.5 ULN (mg/dL), ALT (SGPT) and AST (SGOT) < or = to 2.5 x ULN.
* Serum creatinine < or = to 1.5 x ULN, or creatinine clearance > or = to 50 mL/min.
* Serum albumin > or = to 3.0 gm/dL.
* ECOG performance status < or = to 2.
* All On-Study Test results are < or = to Grade I toxicity for patient to be eligible for study, except for serum LDH. PT, PTT must be < or = to 1.5 x ULN except for patients who are on therapeutic anticoagulant therapy.
* Negative serologies for Hepatitis B, Hepatitis C, and HIV
* Ability to give informed consent and express a willingness to meet all the expected requirements of the protocol including using contraception as outlined in the consent form.
* Expected survival > 6 months. NOTE: Prior therapy for melanoma may include surgery, radiation therapy, immunotherapy including interleukins and interferon, and/or < or = to 2 different chemotherapy regimens and other experimental therapies.
Exclusion Criteria:
* Subject has an active CNS metastases or carcinomatous meningitis. Subjects with CNS lesions that have been treated and show no evidence of progression on CT/MRI for > or = to 3 months are eligible.
* Hypercalcemia > 2.9 mmol/L, unresponsive to standard therapy (IV hydration, diuretics calcitonin and/or bisphosphate therapy)
* Subject is any of the following: HIV positive, history or hepatitis C virus infection, acute or chronic active hepatitis B virus infection (HbsAg positive).
* Subject has had splenectomy.
* Subject has had other malignancy within five years, and probability of recurrence of prior malignancy is >5%. (if less than 5% subject is eligible) SEE NOTE1
* Subject has history of organ transplant or currently taking active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
* Subject is currently receiving systemic corticosteroid therapy for any reason. SEE NOTE2
* Subject has significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
* Subject has an active infection or antibiotics within 1-week prior to study,including unexplained fever (temp > 38.1C)
* Subject has an autoimmune disease (systemic lupus erythematosis, active rheumatoid arthritis, etc.) with the exception of vitiligo. SEE NOTE3.
* Subject has a serious medical condition that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis)
* Subject has any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with an aspect of the study.
* Subject has a known allergy to a component of the alpha(1,3)galactosyltransferase tumor vaccine or cell lines from which it is derived.
* Subject is pregnant or nursing.
NOTE1: Subjects curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or subjects with a history of malignant tumor in the past that has been disease free for at least five years are also eligible for this study.
NOTE2: Subject's receiving inhaled or topical corticosteroids are eligible. Subjects who require systemic corticosteroid therapy after beginning vaccination will be removed from the study.
NOTE3: Subjects with a remote history of asthma or mild active asthma are eligible.
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
|
NCT00300612
|
{
"brief_title": "Vaccine Treatment for Advanced Malignant Melanoma",
"conditions": [
"Malignant Melanoma"
],
"interventions": [
"Biological: HyperAcute-Melanoma Vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00300612",
"official_title": "A Phase I/II Study of Dorgenmeltucel-L (HyperAcute Melanoma) an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Malignant Melanoma",
"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)": "2006-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-28",
"last_updated_that_met_qc_criteria": "2006-03-07",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-09",
"first_submitted": "2006-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.
#Intervention
- DRUG : insulin detemir
- Start dose and frequency at the discretion of the physician following clinical practice
- DRUG : biphasic insulin aspart 30
- Start dose and frequency at the discretion of the physician following clinical practice
- DRUG : insulin aspart
- Start dose and frequency at the discretion of the physician following clinical practice
|
#Eligibility Criteria:
Inclusion Criteria:
* Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator
Exclusion Criteria:
* In accordance with approved label
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00771680
|
{
"brief_title": "Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: biphasic insulin aspart 30",
"Drug: insulin detemir",
"Drug: insulin aspart"
],
"location_countries": [
"Russian Federation",
"Ukraine"
],
"nct_id": "NCT00771680",
"official_title": "Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2008-10"
},
"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)": "2016-10-28",
"last_updated_that_met_qc_criteria": "2008-10-10",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-13",
"first_submitted": "2008-10-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment
Detailed Description
We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases
#Intervention
- DRUG : risedronate
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (>=0.8mg/kg/day) or equivalent for at least 6 weeks.
* Age>=18 years and <75 years.
Exclusion Criteria:
* Pregnant or lactating women.
* Uncorrected hypocalcemia.
* History of esophageal stricture.
* Previous intolerance or hypersenstivity to biphosphonates.
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
|
NCT00372372
|
{
"brief_title": "The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment",
"conditions": [
"Osteoporosis"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT00372372",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-04",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-09-28",
"last_updated_that_met_qc_criteria": "2006-09-05",
"last_verified": "2007-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-06",
"first_submitted": "2006-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.
#Intervention
- PROCEDURE : bone marrow aspirate
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 70 years
* Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
* Stadiums <IIIC ARCO ranking
Exclusion Criteria:
* Those on investigator judgment not in a good position to tolerate the procedure.
* Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
* Serious illness uncontrolled
* Pregnant women
* Patients with HIV infection +
* Acute infection (in the previous 15 days) or chronic (other than HIV)
* Previous treatments of osteonecrosis
* Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
* Lack of informed consent or revocation thereof.
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
|
NCT01700920
|
{
"brief_title": "PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells",
"conditions": [
"Osteonecrosis of the Femoral Head"
],
"interventions": [
"Procedure: bone marrow aspirate"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01700920",
"official_title": "PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2012-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-30",
"last_updated_that_met_qc_criteria": "2012-10-02",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-04",
"first_submitted": "2012-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.
Detailed Description
Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used once daily for a period of at least 24 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.
Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.
Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.
#Intervention
- DRUG : 5% minoxidil topical foam
- 5% minoxidil topical foam
- Other Names :
- Rogaine 5% minoxidil foam, Regaine 5% minoxidil foam
|
#Eligibility Criteria:
Inclusion Criteria:
* Females in overall good health
* Age: >= 18 years
* Female pattern hair loss
* Willing to have a mini dot tattoo placed in the target area of the scalp
* Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
* Able to give informed consent
* Able to comply with the study requirements for 24 consecutive weeks
* Willing to use an adequate method of birth control (if applicable)
* Negative urine pregnancy test
Exclusion Criteria:
* Previous adverse event from topical minoxidil treatment
* History of hypotension
* Uncontrolled hypertension
* Pregnant, nursing, or planning a pregnancy during the study
* Prior hair transplant
* Uses wigs or hair weaves
* Have used minoxidil (topical or oral) anytime during the past 6 months
* Chronic scalp disorders that require medications
* Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
* Folliculitis
* Scalp psoriasis
* Seborrheic dermatitis
* Inflammatory scalp conditions such as lichen planopilaris
* Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months
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
|
NCT02206802
|
{
"brief_title": "Minoxidil Response Testing in Females With Female Pattern Hair Loss",
"conditions": [
"Alopecia",
"Female Pattern Hair Loss"
],
"interventions": [
"Drug: 5% minoxidil topical foam"
],
"location_countries": [
"Italy",
"India",
"Australia",
"United States"
],
"nct_id": "NCT02206802",
"official_title": "Minoxidil Response Testing in Females With Female Pattern Hair Loss",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10",
"study_completion_date(actual)": "2018-10",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-05",
"last_updated_that_met_qc_criteria": "2014-07-31",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-01",
"first_submitted": "2014-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally.
Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.
Detailed Description
Children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. Informed consent/assent will be obtained.
Breath samples will be collected by children blowing into test tubes before and after eating a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics.
Researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.
#Intervention
- DIAGNOSTIC_TEST : 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- Diagnostic test
- DIAGNOSTIC_TEST : 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
- Diagnostic test - repeat for biological variability deterination
|
#Eligibility Criteria:
Inclusion Criteria:
* Children ages 7 <= age <= 18 who provide written assent and whose parents provide written consent for participation
* Healthy and without any significant prior medical history or developmental delays
* Able to eat the test meal and provide breath samples.-
Exclusion Criteria:
Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease
* Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler
* Type 1 or 2 Diabetes
* Chronic gastrointestinal symptoms or functional gastrointestinal disorders
* Mental retardation or pervasive developmental disorder
* Currently receiving prescription drug therapy that may affect gastric motor function or sensation
* Any over-the-counter or herbal supplements that may affect gastric motor function or sensation
* Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal
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:
Yes
|
NCT06004596
|
{
"brief_title": "Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)",
"conditions": [
"Gastroparesis"
],
"interventions": [
"Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT)",
"Diagnostic Test: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06004596",
"official_title": "Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-31",
"study_completion_date(actual)": "2024-09-30",
"study_start_date(actual)": "2023-03-17"
},
"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)": "2024-10-03",
"last_updated_that_met_qc_criteria": "2023-08-21",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-22",
"first_submitted": "2023-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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