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#Study Description
Brief Summary
The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.
Detailed Description
Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.
#Intervention
- DRUG : atamestane
- DRUG : toremifene
- DRUG : letrozole
- DRUG : aromatase inhibition
- PROCEDURE : hormone therapy
- PROCEDURE : endocrine therapy
- PROCEDURE : antiestrogen therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Women age >= 18 years
* Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases
* ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher
* Predicted life expectancy of 12 weeks or more
* Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago
* Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease
* At least one tumor localization measurable in 2 dimensions (one diameter at least 2 cm for soft tissue/visceral disease assessed by CT/MRI scan or conventional X-ray technique, one diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques)
* Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of initial diagnosis or determined during subsequent biopsy/surgery of metastases
* Written informed consent obtained
Exclusion Criteria:
* Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease
* Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment
* Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis)
* Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer)
* History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases
* Other active malignancy (except basal cell carcinoma of the skin or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years
* Renal insufficiency (serum creatinine > 2.0 mg/dL)
* Aspartate aminotransferase, alanine aminotransferase or serum bilirubin levels more than 2.5 times upper limit of normal
* Hemoglobin <9 g/dL
* Platelet count of less than 100,000 platelets per mm3
* Total white blood cell count of less than 2,000 cells per mm3
* Premenopausal endocrine status; pregnant or lactating females
* Usage of an investigational drug within the thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study
* Contraindication to use of toremifene, atamestane, letrozole or any of the inactive components of their formulations
* Prior enrollment in this study
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
|
NCT00044291
|
{
"brief_title": "Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer",
"conditions": [
"Breast Neoplasms",
"Neoplasms, Hormone-dependent"
],
"interventions": [
"Drug: atamestane",
"Procedure: endocrine therapy",
"Drug: letrozole",
"Drug: toremifene",
"Drug: aromatase inhibition",
"Procedure: antiestrogen therapy",
"Procedure: hormone therapy"
],
"location_countries": [
"Russian Federation",
"Canada",
"Ukraine",
"United States"
],
"nct_id": "NCT00044291",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-01",
"study_completion_date(actual)": "2006-01",
"study_start_date(actual)": "2002-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-31",
"last_updated_that_met_qc_criteria": "2002-08-26",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-08-27",
"first_submitted": "2002-08-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A monocentric, longitudinal, observational case-control study in patients with Myotonic Dystrophy type 2 (DM2). At least 60 DM2 will be evaluated through a battery of patients reported Outcomes (PROs) and clinical Outcome Measures (OMs), in order to define suitable OMs for DM2 and propose a disease specific severity scale. Patients will be re-evaluated after 6 months. An age and gender-matched control cohort will be assessed.
Detailed Description
Myotonic dystrophy type 2 (DM2) is an autosomal dominant, chronic progressive multisystemic disorder. Typical symptoms of DM2 include progressive proximal muscle weakness and wasting, often combined with axial and anterior neck muscles involvement, myotonia, muscular pain, fatigue and cataracts. The estimated prevalence is approximately 1 per 100,000 people, but in some nations as Germany the DM2 frequency is much higher than and close to 1.12.000. Compared to DM1 it has a relatively short history, as the genetic base and RNA pathogenesis have been clarified in 2003. In order to evaluate specific clinical aspects of DM2 and disease progression, the development and validation of ad-hoc tests is a unmet need in the neuromuscular field. Today, only a few outcome measures were used systematically in DM2 patients, and none of them provide so far a validation of a clinical meaningful difference for an interventional clinical trial.
The aims of this monocentric, observational, case-control study are:
1. select and validate patient reported outcomes (PRO) and outcome measures (OM) in a large group of DM2 patient
2. Propose a DM2-specific scale of disease severity
3. collecting additional information regarding the phenotype and the progression of the disease;
4. identify differences between subgroups (e.g. age, sex, years of disease).
Participants will be recruited from the German-Swiss Registry for Myotonic Dystrophy and the internal database of the Friedrich-Baur-Institute (FBI), Department of Neurology, Ludwig-Maximilian-University, Munich, Germany. A total of at least 60 male and female patients with no age limit and with genetically proven DM2 will be included. Forty age and gender-matched controls will be also assessed.
During the first evaluation of the DM2 and the controls group, the following PROs and OMs will be evaluated:
General survey (Comorbidity, BMI, familiarity, onset, etc...), DM1-ActivC, R-Pact, FDSS, McGill pain questionnaire - short form, Brief pain inventory - short form, Beck depression inventory, Myotonia behaviour scale, Myotonia subscale from INQoL, Hand opening time, pressure pain threshold, manual and quantitative muscle testing, SARA scale, Berg balance scale, QMFT, GSGC, 30 second sit and stand test, FI-2 (only for upper extremities), 6-MWT.
After six months a second evaluation of the DM2 group will be performed, in which all PROs and OMs except the general survey will be repeated.
Data analysis will provide descriptive statistic and a complete validity and reliability informations. On the basis of these results, a disease specific severity scale will be proposed for the clinical use.
#Intervention
- DIAGNOSTIC_TEST : DM1-ActivC
- A Rasch-built activity and participation scale for clinical use in myotonic dystrophy type 1 (DM1)
- DIAGNOSTIC_TEST : R-PAct
- A Rasch-built Pompe-specific activity scale.
- DIAGNOSTIC_TEST : Beck depression inventory
- A self-reported depression inventory administered verbally or self administered.
- Other Names :
- BDI-II
- DIAGNOSTIC_TEST : McGill pain questionnaire
- The short form of the MPQ, used to evaluate the qualitative aspect of pain and categorized in three dimensions of pain experience: sensory qualities, affective qualities and overall intensity.
- Other Names :
- MPQ-sf
- DIAGNOSTIC_TEST : Brief Pain Inventory Short-Form
- A 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning
- Other Names :
- BPI-sf
- DIAGNOSTIC_TEST : Fatigue and Daytime Sleepiness Scale
- A Rasch-built combined fatigue and daytime sleepiness scale (FDSS) specifically designed for patients with DM1.
- Other Names :
- FDSS
- DIAGNOSTIC_TEST : Myotonia Behaviour scale
- It consists of six framed sentences, which most closely describe the impact of the stiffness on everyday life
- Other Names :
- MBS
- DIAGNOSTIC_TEST : Hand opening time
- A simple test to evaluate clinical myotonia: the patient makes a tight fist for 5 seconds, then rapidly open them and the opening time is measured.
- DIAGNOSTIC_TEST : Pressure pain threshold
- Thresholds for pressure pain were obtained over eight muscles on the left and right side of the body: extensor digitorum communis, deltoid, quadriceps and anterior tibialis. The average value of two measurements will be recorded.
- Other Names :
- PPT
- DIAGNOSTIC_TEST : Manual muscle testing
- The patient is instructed to hold the corresponding limb or appropriate body part to be tested at the end of its available range while the practitioner provides opposing manual resistance. The strength is measured by the modified-MRC scale. The average value of two mesurements is considered. The following muscles were assessed: neck flexors and extensors, hip flexors and extensors, knee flexors and extensors, shoulder abductors, elbow flexors and extensors, ankle dorsiflexors and plantar flexors, wrist flexors and Extensors, digit flexors and extensors and thumb abductors.
- Other Names :
- MMT
- DIAGNOSTIC_TEST : Quantitative muscle testing
- Strength testing using sophisticated strength measuring devices during an isometric contraction. The average value of two measurements is considered; in case of difference \> 10% between measurements, a third attempt is performed. The following muscles are assessed: neck flexors and extensors, hip flexors and extensors, knee flexors and extensors, shoulder abductors, elbow flexors and extensors, ankle dorsiflexors and plantar flexors, wrist flexors and extensors and digit flexors.
- Other Names :
- QMT
- DIAGNOSTIC_TEST : Scale for Assessment and Rating of Ataxia
- SARA is a clinical scale which assesses a range of different impairments in cerebellar ataxia.
- Other Names :
- SARA
- DIAGNOSTIC_TEST : Berg balance scale
- It is a 14 item objective measure designed to assess static balance and fall risk in adult populations
- Other Names :
- BBS
- DIAGNOSTIC_TEST : Quick motor function test
- Assessment of proximal motor function.
- Other Names :
- QMFT
- DIAGNOSTIC_TEST : GSGC
- GSGC score provides a detailed picture of motor function by including quantitative measures of four main motor performances (Gait, Walking, Stair, Gower's) and a qualitative global assessment of the manner to accomplish them.
- DIAGNOSTIC_TEST : 30 seconds sit to stand test
- It is a measurement that assesses functional lower extremity strenght in older adults.
- Other Names :
- 30CST
- DIAGNOSTIC_TEST : Functional Index-2
- Disease-specific functional outcome assessing muscle endurance. In this trial, only the part of the test for the upper extremities is used.
- Other Names :
- FI-2
- DIAGNOSTIC_TEST : Six minute walking test
- It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
- Other Names :
- 6MWT
- DIAGNOSTIC_TEST : Myotonia (from Individualised Neuromuscular Quality of Life Questionnaire)
- A subscale derived from the Individualised Neuromuscular Quality of Life Questionnaire (INQoL). 3 questions reguarding stiffness/myotonia.
- Other Names :
- InQoL
|
#Eligibility Criteria:
Inclusion Criteria:
* Genetically confirmed myotonic dystrophy type 2
* Able to provide informed consent
Exclusion Criteria:
* Invalidating diseases not related with DM2 (e.g. Stroke).
* Subject participating in another clinical trial (other than registries) concurrently or within 30 days prior to screening for entry into this study.
* Unable to complete study questionnaires.
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:
Yes
|
NCT03603171
|
{
"brief_title": "Clinical Outcome Measures in Myotonic Dystrophy Type 2",
"conditions": [
"Myotonic Dystrophy Type 2"
],
"interventions": [
"Diagnostic Test: Quantitative muscle testing",
"Diagnostic Test: Functional Index-2",
"Diagnostic Test: Hand opening time",
"Diagnostic Test: Beck depression inventory",
"Diagnostic Test: Brief Pain Inventory Short-Form",
"Diagnostic Test: Fatigue and Daytime Sleepiness Scale",
"Diagnostic Test: McGill pain questionnaire",
"Diagnostic Test: Myotonia Behaviour scale",
"Diagnostic Test: Myotonia (from Individualised Neuromuscular Quality of Life Questionnaire)",
"Diagnostic Test: Berg balance scale",
"Diagnostic Test: GSGC",
"Diagnostic Test: Pressure pain threshold",
"Diagnostic Test: Manual muscle testing",
"Diagnostic Test: Scale for Assessment and Rating of Ataxia",
"Diagnostic Test: Quick motor function test",
"Diagnostic Test: 30 seconds sit to stand test",
"Diagnostic Test: Six minute walking test",
"Diagnostic Test: R-PAct",
"Diagnostic Test: DM1-ActivC"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03603171",
"official_title": "Observational Trial in Myotonic Dystrophy Type 2 to Define Specific Clinical Outcome Measures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-02-01",
"study_start_date(actual)": "2018-07-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-20",
"last_updated_that_met_qc_criteria": "2018-07-26",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-27",
"first_submitted": "2018-07-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD).
This is a 3 arm sequential phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation (alloHCT).
Detailed Description
GVHD is a common problem that occurs after transplant despite the use of standard immune suppressive medications (these are called sirolimus and tacrolimus). GVHD can result in skin rash, nausea, vomiting, diarrhea, and liver damage. Severe GVHD can be life-threatening.
In this study, investigators will add a medication called pacritinib to the combination of sirolimus and tacrolimus to see if this approach can more effectively prevent GVHD. Pacritinib is a medicine used to treat a disease of the bone marrow called myelofibrosis Pacritinib turns off a switch in cells called Janus Kinase 2 (JAK2). Pacritinib is an investigational medicine used in several clinical trials and not FDA approved. JAK2 is an important regulator of inflammation. This inflammation is thought to contribute to GVHD. Pacritinib is able to turn this inflammation off by inhibiting JAK2. Research has shown that blocking JAK2 prevents GVHD in mice and also reduces severe GVHD in transplant patients. Doctors at Moffitt have identified that inflammation from JAK2 is an important cause of GVHD, and is present well before patients develop GVHD symptoms. This trial will study how well pacritinib turns off inflammation during the transplant and if it prevents GVHD when added to our standard medicines.
Pacritinib will begin the day of the participant's transplant (Day 0) and will continue until 70 days after the transplant.
Sirolimus will be given the day before transplant and continued daily for at least one year.
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.
#Intervention
- DRUG : Pacritinib
- Pacritinib Dose and Schedule: 200 mg twice a day (BID) orally from day 0 until day +100. PAC will be tapered to 50% of the total dose at day +70, then 25% of total dose at day +84, then stop at day +100 (+/- 7 days).
- Other Names :
- PAC, tyrosine kinase inhibitor (TKI)
- DRUG : Sirolimus
- Sirolimus (SIR) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of SIR taper. SIR levels will be monitored according to program standard operating procedures. Dose modifications of SIR for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
- Other Names :
- Rapamune
- DRUG : Tacrolimus
- Tacrolimus (TAC) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of TAC taper. TAC levels will be monitored according to program standard operating procedures. Dose modifications of TAC for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
- Other Names :
- Prograf
- PROCEDURE : Allogenic hematopoietic cell transplant (alloHCT)
- Patients will undergo allogenic hematopoietic cell transplant (alloHCT) as a part of their standard of care treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.
* Signed informed consent.
* Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring a matched allogeneic hematopoietic stem cell transplantation (HSCT). Acute Leukemia (AML or ALL) must be in complete remission defined as: <5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow >20% cellular, and peripheral absolute neutrophil count >1000/uL (platelet recovery is not required). Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have <5% marrow blasts. Myeloproliferative neoplasms (MPN): Must have <5% peripheral / marrow blasts. Note: Prior use of a JAK2 inhibitor is allowed up to 4 weeks before day 0 of alloHCT. Hodgkin and non-Hodgkin lymphoma: Must have chemosensitive disease.
* Adequate vital organ function.
* Performance status: Karnofsky Performance Status Score >= 80%.
Donor Eligibility:
* Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing as defined by the Collaborative Trials Network.
Exclusion Criteria:
* Active infection not controlled with appropriate antimicrobial therapy.
* History of HIV, hepatitis B, or active hepatitis C infection.
* Anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis.
* Sorror's co-morbidity factors with total score >4.
* Any patient anticipating or scheduled to receive a tyrosine kinase inhibitor, FLT3 inhibitor, or JAK2 inhibitor (outside of this study) post-HCT.
* QTc>450ms per Fridericia's correction.
* Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) >2x upper limit of normal (ULN).
* Grade 3 or higher recent (within the past 6 months) or ongoing non-QTc cardiac adverse events/comorbidities.
* Grade 3 or higher recent or ongoing cardiac dysrhythmias, family history of long QT.
syndrome, or serum potassium <3.0 mEq/L that is persistent and refractory to correction.
* Grade 3 or higher recent or ongoing bleeding events.
* Symptomatic or uncontrolled cardiovascular disease, myocardial infarction or severe/unstable angina within the past 6 months, or New York Heart Association (NYHA) Class III or IV congestive heart failure.
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
|
NCT02891603
|
{
"brief_title": "A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression",
"conditions": [
"Graft Vs Host Disease",
"GVHD"
],
"interventions": [
"Drug: Pacritinib",
"Drug: Tacrolimus",
"Drug: Sirolimus",
"Procedure: Allogenic hematopoietic cell transplant (alloHCT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02891603",
"official_title": "A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-28",
"study_completion_date(actual)": "2022-04-18",
"study_start_date(actual)": "2017-06-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2016-09-06",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-07",
"first_submitted": "2016-09-01",
"first_submitted_that_met_qc_criteria": "2023-10-24"
}
}
}
|
#Study Description
Brief Summary
To assess the safety and immune response to two experimental vaccines when formulated with QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80 is less reactogenic than the QS-21 formulation used in AVEG Protocols 016, 016A, and 016B. To examine whether QS-21 is immunologically equivalent to that used in 16B. To determine if QS-21, when given with low doses of antigen, induces measurable HIV-1-specific CTL activity. To evaluate if the QS-21 dose-sparing effect extends to an antigen dose of 0.5 micrograms. To determine if the bivalent vaccine gives responses equivalent to the monovalent product or if a broadening of the HIV-1-specific binding and neutralizing antibody responses occurs.
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response. Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity, cytokines, chemokines, or other antiviral factors may also be critical in mounting protective immunity. Given the lack of a surrogate immunologic marker, the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible.
Detailed Description
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response. Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity, cytokines, chemokines, or other antiviral factors may also be critical in mounting protective immunity. Given the lack of a surrogate immunologic marker, the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible.
Volunteers in each of 5 groups receive vaccine or placebo by intramuscular injection at Months 0, 1, and 6. All patients receive one of two doses of QS-21 along with vaccine or placebo and some groups receive alum as follows:
Group 1: low-dose MN rsgp120/HIV-1 plus QS-21 (13 volunteers). Group 2: high-dose MN rsgp120/HIV-1 plus QS-21 (13 volunteers). Group 3: AIDSVAX B/E (injection contains each of the two vaccine components, HIV-1 MN rgp120 and A244 rgp120/HIV-1) plus QS-21 plus alum (13 volunteers).
Group 4: high-dose MN rgp120/HIV-1 plus QS-21 plus alum (13 volunteers). Group 5: placebo plus QS-21 (8 volunteers). Volunteers will be closely monitored after each immunization and followed for a minimum of 12 months after the initial immunization.
#Intervention
- BIOLOGICAL : MN rgp120/HIV-1 and A244 rgp120/HIV-1
- BIOLOGICAL : QS-21
- BIOLOGICAL : rgp120/HIV-1MN
|
#Eligibility Criteria:
Inclusion Criteria
Volunteers must have:
* Negative ELISA for HIV within 8 weeks prior to immunization.
* CD4 count greater than or equal to 400 cells/mm3.
* Normal history and physical examination. [Refer to Laboratory values for additional requirements.]
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions or symptoms are excluded:
* Medical or psychiatric conditions or occupational responsibilities which preclude subject compliance with the protocol.
* Recent suicidal ideation or psychosis.
* Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible.
* Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible.
* Positive for hepatitis B surface antigen.
Volunteers with the following prior conditions are excluded:
* History of immunodeficiency, chronic illness, or autoimmune disease.
* History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
* History of suicide attempts, recent suicidal ideation, or past or present psychosis.
* History of anaphylaxis or other serious adverse reactions to vaccines.
* History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
* History of reaction to thimerosal.
Prior Medication:
Excluded:
* Live attenuated vaccine within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
* Experimental agents within 30 days prior to study.
* HIV-1 vaccines or placebo as part of a previous HIV vaccine trial.
Prior Treatment:
Excluded:
* Blood products or immunoglobulin in the past 6 months.
* Experimental agents within 30 days prior to study.
Risk Behavior:
Excluded:
* Volunteers with an identifiable higher- or intermediate-risk sexual behavior for HIV infection (i.e., AVEG Risk Groups C or D ).
* History of intravenous drug use within 12 months prior to enrollment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00001096
|
{
"brief_title": "A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00001096",
"official_title": "A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2000-03",
"study_start_date(actual)": null
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-04",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
After spinal cord injury, patients develop a spastic syndrome that is characterized by hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The neuronal mechanisms behind the development of spasticity remain largely unknown, though animal experiments have shown that changes occur both at the level of the motoneuron and sensory neurons. This project aims to examine the changes that occur in the modulation of sensory afferent transmission after spinal cord injury, and how these changes can contribute to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.
It is known that after spinal cord injury, the majority of descending sources of monoamines, such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a result, after spinal cord injury these receptors are no longer activated below an injury, resulting in the production of large, long excitatory responses in the motoneuron when sensory are activated. This large sensory activation of the motoneuron can, in turn, activate a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our study is to determine whether, similar to animal experiments, the 5HT1 receptors are responsible for sensory inhibition in spinal cord injured subjects, and whether activating these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of sensory transmission that is lost after injury, thereby resulting in a decrease in the initiation of involuntary muscle spasms.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have suffered a trauma to the spinal cord at least 1 year prior. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score greater than 1 in the ankle or knee.
Exclusion Criteria:
* If patients have damage to the nervous system other than to the spinal cord
* Pregnant women
* Elderly Patients (> 65 years)
* Alcoholic Patients
* History of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
* Valvular heart disease or cardiac arrhythmias
* Other significant underlying cardiovascular disease (atherosclerotic disease, congenital heart disease)
* Uncontrolled or severe hypertension
* Hemiplegic, basilar or ophthalmologic migraine
* Hypersensitivity to Zolmitriptan or any component of the formulation
* History of Autonomic Dysreflexia
* Patients taking:
* Ergot-containing drugs
* Other 5HT1 Agonists
* MAO Inhibitors
* Cimetidine and other 1A2 Inhibitors
* Propranolol
* Selective Serotonin and Norepinephrine Reuptake Inhibitors
* Acetaminophen
* Metoclopramide
* Xylometazoline
* Oral Contraceptives
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01587170
|
{
"brief_title": "Effects of Zolmitriptan on Sensory Transmission After Spinal Cord Injury",
"conditions": [
"Spinal Cord Injuries",
"Muscle Spasticity"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT01587170",
"official_title": "Phase 2: Effects of Zolmitriptan on Sensory Afferent Transmission After Spinal Cord Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2012-01"
},
"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)": "2012-12-03",
"last_updated_that_met_qc_criteria": "2012-04-25",
"last_verified": "2012-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-30",
"first_submitted": "2012-04-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.
Detailed Description
Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.
Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.
A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).
|
#Eligibility Criteria:
Inclusion Criteria:
* regular cycles.
* normal thyroid function, prolactin and androgen levels.
* normal semen analysis of the partner.
* normal hysterosalpingography.
* normal transvaginal ultrasound examination.
Exclusion Criteria:
* possible uterine malformations or pathologies.
* presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
* presence of anti-sperm antibodies in serum.
* Male factor infertility.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02684604
|
{
"brief_title": "Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility",
"conditions": [
"Infertility, Female"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02684604",
"official_title": "Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-16",
"last_updated_that_met_qc_criteria": "2016-02-17",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-18",
"first_submitted": "2016-02-08",
"first_submitted_that_met_qc_criteria": "2016-03-03"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.
Detailed Description
BACKGROUND:
Trauma is the leading cause of death among Americans between the ages of 1 and 35 years. The majority of these deaths result from hypovolemic shock, a type of shock in which the heart is unable to supply enough blood to the body, and the resulting severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia with a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation of these patients involves the intravenous administration of a large volume of isotonic or slightly hypotonic (lactated ringers) solutions beginning in the pre-hospital environment. Previous studies have suggested that an alternative resuscitation fluid, HSD, may reduce mortality in these patients; but these studies have not been conclusive. Furthermore, HSD may have specific advantages in the brain-injured patient, as it may aid in the rapid restoration of cerebral perfusion, prevent extravascular fluid sequestration, and thus, limit secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, which may result in a reduction in subsequent organ injury following whole body ischemia/reperfusion and ultimately decrease nosocomial infection rates.
Blunt trauma victims with low blood pressures will be identified by pre-hospital providers (paramedics and flight nurses) and randomized to receive either 250 cc of HSD or 250 cc of isotonic solution (lactated ringer's solution). Lactated ringer's solution is the current standard of care with which the ambulances and helicopters will be supplied. All bags of study solution will be prepared by the Harborview Medical Center pharmacy.
DESIGN NARRATIVE:
This randomized clinical trial seeks to evaluate the clinical outcome and inflammatory cell function of patients in shock following blunt traumatic injury who are randomized to receive either 7.5% hypertonic saline/6% dextran (HSD) followed by lactated ringer's solution or lactated ringer's solution alone. It is hypothesized that HSD resuscitation will inhibit the initial excessive systemic activation of the inflammatory response, which will translate into a reduction in the incidence of organ dysfunction typically induced by this response. Furthermore, the study will evaluate the impact of HSD resuscitation on recovery following traumatic brain injury, as previous studies suggest that this subgroup has the greatest survival advantage from HSD intervention. The specific aims for this study include the following: Aim 1: To determine the impact of pre-hospital administration of HSD on the development of organ failure following blunt traumatic injury with hypovolemic shock. Aim 2: To determine the impact of pre-hospital administration of HSD on the neurologic outcome following brain injury for patients in hypovolemic shock. Aim 3a: To determine the effect of pre-hospital administration of HSD on the activation of circulating neutrophils and monocytes. Aim 3b: To determine the effect of pre-hospital administration of HSD on the activation of T lymphocytes. The study builds upon previous research that has demonstrated the safety and practicality of this resuscitation strategy in the pre-hospital environment. A more detailed understanding of the immuno-inflammatory effects of hypertonicity for all patients and the long-term neurologic outcome for patients with brain injury is critical for determining the role of this resuscitation approach in such critically injured patients.
#Intervention
- DRUG : Hypertonic Saline-Dextran Solution
- DRUG : Lactated Ringer's Solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Recent blunt trauma
* Of adult size if age is unknown
* Pre-hospital systolic bloood pressure 90 mm Hg or less
* Altered mental status
* Transported directly to Harborview Medical Center from the injury event
Exclusion Criteria:
* Ongoing CPR
* Transferred from outside hospitals
* Pregnant or suspected pregnancy
* Presence of injuries from penetrating trauma
* Receiving more than 2000 cc of crystaloid prior to study fluid administration
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00113685
|
{
"brief_title": "Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury",
"conditions": [
"Respiratory Distress Syndrome, Adult",
"Head Injuries, Closed",
"Shock",
"Shock, Traumatic"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00113685",
"official_title": "Effect of Hypertonic Resuscitation for Blunt Trauma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2003-04"
},
"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)": "2021-05-03",
"last_updated_that_met_qc_criteria": "2005-06-09",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-06-10",
"first_submitted": "2005-06-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib and crizotinib that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Dasatinib is designed to block certain proteins from causing cancer cells to grow out of control. This may cause the cancer cells to die.
Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause the cancer cells to die.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Crizotinib is FDA approved and commercially available for the treatment of lung cancer. The combination of dasatinib and crizotinib is currently being used for research purposes only.
Up to 176 participants will take part in this study. All will be enrolled at MD Anderson
Detailed Description
Study Groups:
Dose Escalation Group:
If you are found to be eligible to take part in this study, you will be assigned to a either Arm A or Arm B based when you joined this study, the disease type, and the drugs you have taken in the past. Up to 5 dose levels of the study drug will be tested in each arm. Up to 6 participants will be enrolled in each dose level of arms A and B. The first group of participants in Arm A will receive the FDA approved dose of crizotinib plus the lowest dose level of dasatinib. The first group of participants in Arm B will receive the FDA approved dose of dasatinib plus the lowest dose level of crizotinib. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
The dose level of the study drug combination that you receive may be lowered if you have intolerable side effects.
Dose Expansion Group:
After the highest tolerable dose level of the study drug combination for each arm is found, up to 10 additional participants will be enrolled in the dose expansion group and will receive the highest dose of the study drug combination that was tolerated in the dose escalation group.
Study Drug Administration:
Each study cycle is 28 days.
All participants will take dasatinib by mouth 1 time each day. You will take this drug alone on Day 1 of Cycle 1, before the first day you receive the study drug combination.
Then starting on Day 2 of Cycle 1, you will begin taking crizotinib by mouth 1 time daily, 1 time every other day, or 2 times daily depending on the dose level of the study drug you are assigned to. You should take dasatinib and crizotinib at least 1 hour before meals.
Study Visits:
You will have study visits on Days 1 and 15 of Cycle 1, and again before you begin each new cycle (once every 28 days). At each study visit, you will be asked about any drugs you may be taking and any side effects you may be having.
Blood/Tumor Samples and Imaging Scans
If you are in the dose expansion group:
* On Day 1 of each cycle, blood (about 1 teaspoon) will be drawn for pharmacodynamic (PD) testing before your take the first dose of study drug. PD testing measures how the level of study drug in your body may affect the disease.
* If you are one of the first ten patients enrolled in your cohort, you will take Dasatinib only on your first day of treatment (Day -1 of Cycle 1). On Day -1 and on Day 1 of Cycle 1, blood (about ½ teaspoon each time) will be drawn for pharmacokinetic (PK) testing before you take the drug and 1, 2, 4, and 8 hours after you take the drug. PK testing measures the amount of study drug in the body at different time points.
* If you are one of the first ten patients enrolled in your cohort, on Day 1 of Cycle 3 and beyond, blood (about ½ teaspoon) will be drawn for PK testing before you take the study drug.
* If you are one of the first 10 patients enrolled in your cohort, you will have a biopsy at screening and after Cycle 1. The type of biopsy you have will be based on the type of disease you have. The procedure, and its risks, will be discussed with you in more detail.
All study participants:
* On Week 3 of Cycle 1, blood (about 1 teaspoon) and urine will be collected for routine tests.
* On Day 28 of each cycle, blood (about 1 teaspoon) will be drawn for routine tests.
During Week 4 of Cycle 2 and then every 2-3 cycles:
* You will have a CT scan, MRI scan, PET scan, and/or a bone scan to check the status of the disease. The actual type of scan you have will depend on what types of scans were taken at screening.
* If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if intolerable side effects occur or if you are unable to follow study directions. If the disease gets worse, you may be eligible to continue taking the study drug. The study doctor will discuss this with you.
Your participation on the study will be over after you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will have an end-of-study visit and the following tests and procedures performed:
* Your medical history will be recorded.
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and side effects you may be having.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
* If the study doctor thinks it is needed, you will have a chest x-ray, CT scan, MRI scan, and/or PET scan to check the status of the disease.
#Intervention
- DRUG : Crizotinib
- Arm A Crizotinib dose: 250 mg by mouth twice a day in a 28 day cycle. Crizotinib Expansion dose: 250 mg by mouth twice a day in a 28 day cycle.
Arm B Crizotinib starting dose: 250 mg by mouth every other day in a 28 day cycle. Crizotinib Expansion Dose: MTD from dose escalation group.
- Other Names :
- PF-02341066, Xalkori
- DRUG : Dasatinib
- Arm A Dasatinib starting dose: 50 mg by mouth daily in a 28 day cycle. Arm A Dasatinib Expansion Dose: MTD from dose escalation group.
Arm B Dasatinib dose: 140 mg by mouth daily in a 28 day cycle. Arm B Dasatinib Expansion Dose: 140 mg by mouth daily in a 28 day cycle.
- Other Names :
- BMS-354825, Sprycel
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed solid malignancy that is metastatic or unresectable or lymphoma, for which standard curative or palliative measures that improve survival by at least three months do not exist or are no longer effective. For the purpose of this study patients with leukemia are not eligible.
* Age >= 16 years.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
* Patients must have normal organ and marrow function as followed defined: ANC >= 1,000/mcL; Plt >=75,000/mcL; total bilirubin <=2.0 mg/dL; AST (TGO)/ALT (TGP) <=2.5x upper limit of normal; if liver metastasis are present, then <= 5.0x upper limit; estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min
* The effects of Dasatinib and Crizotinib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Patients receiving palliative radiation will be eligible after a wash-out period of 2 weeks between finishing radiation and initiation of study drugs. Palliative radiation will not be allowed during cycle 1 of treatment but is permitted in this study during following cycles as long as there are evaluable lesions that are not being irradiated
* Signed informed consent approved by the Institutional Review Board prior to patient entry.
* Expanded cohort only: Cohort 1: patients with predominant metastatic bone disease; Cohort 2: patients with primary squamous head and neck cancers; Cohort 3: patients presenting any molecular abnormality of interest, which can include an ALK translocation, ALK amplification, ALK mutation and overexpression as determined by FISH, IHC, qPCR, qRT-PCR, array Comparative Genomic Hybridization or direct sequencing (aCGH); a c-MET abnormality, either c-MET amplification by FISH, overexpression by IHC or c-MET mutation; BRAF, DDR2 and CDKN2A mutations; and, finally, TRIM 16 expression and CCN2 expression.
Exclusion Criteria:
* Patient receiving any concurrent chemotherapy.
* Concurrent severe and/or uncontrolled medical disease including, but not limited to, ongoing or active infection requiring intravenous antibiotics.
* Symptomatic congestive heart failure (NYHA Class III or IV), or unstable angina pectoris.
* Presence of symptomatic pleural and/or pericardial effusion not appropriated treated.
* Prolonged QTc interval (>=500 msec), as calculated by Bazett's formula.
* Psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
* Known anaphylactic or severe hypersensitivity to Dasatinib or Crizotinib or their analogs.
* Patient has failed to recover from any prior surgery within 4 weeks of study entry.
* Patient is pregnant or lactating. Pregnant women are excluded from this study because dasatinib and crizotinib are agents with the potential for teratogenic or abortifacient effects (Pregnancy category D).
* Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents.
* Patient is not able to swallow oral medication.
* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 complex are ineligible.
* Patients with known pulmonary hypertension.
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
|
NCT01744652
|
{
"brief_title": "Dasatinib and Crizotinib in Advanced Cancer",
"conditions": [
"Advanced Cancers"
],
"interventions": [
"Drug: Crizotinib",
"Drug: Dasatinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01744652",
"official_title": "A Phase I Trial of Dasatinib in Combination With Crizotinib in Patients With Advanced Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03",
"study_completion_date(actual)": "2019-03",
"study_start_date(actual)": "2013-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-07",
"last_updated_that_met_qc_criteria": "2012-12-06",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-07",
"first_submitted": "2012-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.
#Intervention
- BEHAVIORAL : ZETRA cognitive behavioral structural
- ZETRA cognitive behavioral structural
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-uninfected women, aged 15 <= age <= 24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.
Exclusion Criteria:
* presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Maximum Age : 24 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03203200
|
{
"brief_title": "A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers",
"conditions": [
"Sexually Transmitted Infection"
],
"interventions": [
"Behavioral: ZETRA cognitive behavioral structural"
],
"location_countries": [
"Uganda"
],
"nct_id": "NCT03203200",
"official_title": "A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-31",
"study_completion_date(actual)": "2021-10-31",
"study_start_date(actual)": "2015-08-24"
},
"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)": "2022-03-16",
"last_updated_that_met_qc_criteria": "2017-06-27",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-29",
"first_submitted": "2017-02-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.
From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).
Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.
This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.
Detailed Description
Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.
From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).
Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo. After signing an informed consent, BC will be estimated by bioelectrical impedance analysis and by reference method (DXA). The data obtained by both methods are statistically treated to obtain specific BIA prediction equations for the evaluation of cirrhotic patients.
This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population. Such knowledge, in turn, can serve as a new tool for nutritional assistance in treating this disease.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults (18 <= age <= 60 years) of both sexes;
* Signing the free and informed consent;
* Show interest, conditions and availability to participate in all procedures included in the study protocol;
* liver cirrhosis Carrier
Exclusion Criteria:
* Refusal to participate;
* Patients who have made liver transplantation;
* Physical Amputation;
* Swelling in the lower limb;
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02421848
|
{
"brief_title": "Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA",
"conditions": [
"Liver Cirrhosis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02421848",
"official_title": "Body Composition Evaluation of Cirrhotic Patients With Ascites",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-21",
"last_updated_that_met_qc_criteria": "2015-04-20",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-21",
"first_submitted": "2015-03-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose: The objective of our study was to assess the cardiovascular risk of a Cameroonian military population and compare it to the cardiovascular risk of the neighboring civilian population.
Patients and methods: We will conduct a cross-sectional study that involved subjects aged from 18 to 58 years, recruited from October 2017 to November 2018 at the Fifth Military Sector Health Center in Ngaoundéré. Data collection and assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors. Univariates analysis and multivariate logistic regression were carried out according to their indications.
#Intervention
- DIAGNOSTIC_TEST : STEPS and AUDIT questionnaires
- assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors.
|
#Eligibility Criteria:
Inclusion Criteria:
* agree to participate,
* had to be aged between 18 and 58 years,
* representing ages of enrollment and retirement for Cameroonian soldiers respectively.
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 58 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04315441
|
{
"brief_title": "Surveillance of Cardiovascular Risk Factors in Cameroonian Garrison",
"conditions": [
"Cardiovascular Risk Factor"
],
"interventions": [
"Diagnostic Test: STEPS and AUDIT questionnaires"
],
"location_countries": null,
"nct_id": "NCT04315441",
"official_title": "Surveillance of Cardiovascular Risk Factors in Cameroonian Garrison",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-12",
"study_completion_date(actual)": "2018-11-13",
"study_start_date(actual)": "2017-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-19",
"last_updated_that_met_qc_criteria": "2020-03-18",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-19",
"first_submitted": "2020-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a mutation in sodium and chloride transport channels that results in pancreatic insufficiency, chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic inflammation and oxidative stress are a part of the chronic exacerbations that are a part of cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and antioxidative properties can help dampen these stressors on the CF lung and potentially result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved well-being.
Detailed Description
Ten patients with steady-state cystic fibrosis (CF) - not hospitalized, not on intravenous antibiotics, with stable FEV1 40-100% predicted were enrolled in a four week long pilot study where-in each patient consumed 40 grams of flaxseed each day, in the form of finely ground flaxseed, however they wished. Prior to starting flaxseed, each week, and then four weeks after each patient had finished taking flaxseed, markers of inflammation and oxidative stress, as well as measurements of flaxseed metabolism were collected. F2-isoprostanes, 8-oxo-dGuo, as well as cytokines including IL-6, TNF-a, IFN-g among others were measured to trend flaxseed effects. Enterolignans - enterodiol and enterolactone (products of flaxseed metabolism) were measured each week as well.
#Intervention
- DIETARY_SUPPLEMENT : finely ground flaxseed powder
- 40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis
- Other Names :
- flaxseed, Flax, Linseed oil, SDG, Bene-flax
|
#Eligibility Criteria:
Inclusion Criteria:
* Genetic and clinical diagnosis of cystic fibrosis (CF)
* FEV1 predicted between 40 <= age <= 100%
* Age 18 <= age <= 64
* Pancreatic enzyme adherence (or pancreatic sufficiency)
* Demonstration of continued long-term dedication and follow-up with CF primary care provider
Exclusion Criteria:
* Prior or planned hospitalization or surgical procedure within one month of enrollment (other than simple dental procedure)
* An acute pulmonary exacerbation
* History of bowel resection, inflammatory bowel disease or distal intestinal obstruction syndrome
* Receiving broad spectrum intravenous antibiotics (other than maintenance azithromycin, inhaled tobramycin, or inhaled aztreonam within one month of enrollment)
* Current supplementation with FS or soy derivatives or allergies to them
* Active or prior ingestion of Vitamin E exceeding 30 IU within 21 days
* Significant liver disease (cirrhosis)
* Significant renal dysfunction (GFR below 50 ml/hr/m2)
* Poorly controlled diabetes (evidenced by HgbA1c>7.5% or consistently with blood glucose >250 mg/dl)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02014181
|
{
"brief_title": "Flaxseed Modulates Inflammation and Oxidative Stress in CF",
"conditions": [
"Cystic Fibrosis",
"Oxidative Stress",
"Inflammation"
],
"interventions": [
"Dietary Supplement: finely ground flaxseed powder"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02014181",
"official_title": "Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2012-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-07",
"last_updated_that_met_qc_criteria": "2013-12-11",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-18",
"first_submitted": "2013-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cirrhotic in intensive care unit have a very specific haemodynamic status. Cardiovascular abnormalities in advanced liver cirrhosis are characterized by a hyperdynamic circulation featuring increased heart rate and high cardiac output, concomitant with decreased systemic vascular resistance. As liver cirrhosis progresses, cardiac dysfunction, known as cirrhotic cardiomyopathy, is associated with prognosis of these patients.
Specifically, diastolic dysfunction has been more emphasized for estimating clinical outcome in cirrhotic patients, whereas systolic dysfunction has limited prognostic implications in hepatorenal syndrome patients.
However, in most cirrhotic patients, cardiac dysfunction is latent and only manifests under stressful conditions because reduced ventricular contractility in these patients is masked by pronounced arterial vasodilation and increased arterial compliance. Therefore, a load-dependent index such as left ventricular ejection fraction is insensitive to detect systolic cardiac impairment in the resting state in cirrhotic patients. Hence, a more appropriate index is required to evaluate the integration of the ventricular and arterial systems in cirrhotic cardiovascular disorders.
Interaction between the left ventricle and the arterial system has been explained on the basis of end-systolic pressure-volume relation. Left ventricular end-systolic elastance (Ees), as quantified by the ratio of end-systolic pressure to end-systolic volume, is an index of the load-independent ventricular contractile state. Given this pressure-volume relationship, effective arterial elastance (Ea) can be calculated by the ratio of end-systolic pressure to stroke volume, indicating a net measure of arterial load. The ratio of these values (Ea/Ees), designated ventriculo-arterial coupling (VAC), represents the integrated interaction of the ventricular and arterial systems.
We can evaluate it with non-invasive echocardiographic method.
We analyse VAC among cirrhotic patients admitted in intensive care unit, with non-invasive echographic method thanks to records made from August 2018 to April 2019.
Hypothesis: VAC decrease from the baseline value when mean arterial pressure is improved.
#Intervention
- PROCEDURE : Arterio ventricular coupling
- We analyse ventriculo arterial coupling (VAC) among cirrhotic patients admitted in intensive care unit, with non-invasive echography method
|
#Eligibility Criteria:
Inclusion Criteria:
* Liver cirrhotic patients (any cause, any level)
* With acute decompensation
* Admitted in intensive care unit in Croix Rousse Hospital, Lyon, France
* Who receive NOREPINEPHRINE as hemodynamic therapy
* Blood pressure monitoring thanks to an arterial line (radial, humeral or femoral)
* Urinary catheter, suprapubic catheter or any comparable device to monitor urine output.
* The patient did not object to take part of the study.
Exclusion Criteria:
* Acute hemorrhage (Clinical definition or hemoglobin lower than 70g/L at admission)
* Patient requiring kidney replacement therapy
* Patient requiring invasive mechanical ventilation
* Any pathology that makes non-invasive ventriculo arterial coupling assessment impossible (non-sinus rhythm, severe valvular disease)
* Patient who objects to take part of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03948659
|
{
"brief_title": "Ventriculo-arterial Coupling in Cirrhotics",
"conditions": [
"Cirrhosis"
],
"interventions": [
"Procedure: Arterio ventricular coupling"
],
"location_countries": [
"France"
],
"nct_id": "NCT03948659",
"official_title": "Non-invasive Assessment of Ventriculo Arterial Coupling Among Cirrhotics in Intensive Care Unit",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-30",
"study_completion_date(actual)": "2019-04-30",
"study_start_date(actual)": "2018-08-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-14",
"last_updated_that_met_qc_criteria": "2019-05-13",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-14",
"first_submitted": "2019-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group.
In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).
Detailed Description
The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A.
The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).
#Intervention
- DEVICE : Microcurrent therapy
- The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.
|
#Eligibility Criteria:
Inclusion Criteria:
* osteoarthritis of the knee
* pain intensity > 3 on the numerical rating scale (0 <= age <= 10)
Exclusion Criteria:
* knee arthroplasty
* gravity
* dermal Irritation at the skin of the knee
* carcinoma
* known osteoarthritis grade 4 (Kellgren and Lawrence score)
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
|
NCT03332914
|
{
"brief_title": "A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis",
"conditions": [
"Osteoarthritis, Knee"
],
"interventions": [
"Device: Microcurrent therapy"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03332914",
"official_title": "A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-27",
"study_completion_date(actual)": "2017-12-27",
"study_start_date(actual)": "2017-11-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-13",
"last_updated_that_met_qc_criteria": "2017-11-02",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-06",
"first_submitted": "2017-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied
Detailed Description
International outbreak of the novel coronavirus (2019- nCoV) raised intense attention of specialists worldwide, including psychiatrists. The five stages of shock-denial, anger, bargaining, depression, and acceptance are experienced by many patients. Coronaphobia is a novel term referring to excessive fear of being infected by coronavirus. The current pandemic necessitates research in different areas of psychiatry, including psychosocial and pharmacological interventions to find evidence-based ways of treatment.
This is a multi-center observational cross-sectional study with consecutive sample that will include patients quarantined due to COVID-19 infection. Adult Patients will be recruited consecutively (convenient sample). Data will be collected from patients in the form of:
Demographic data e.g. Age, Gender, Smoking history, exposure to source transmission Co-morbidities e.g. underlying chronic liver, lung, cardiac or kidney diseases, diabetes mellitus, hypertension Severity of COVID-19 infection: mild, moderate or severe
Psychiatric assessment of patients:
Patients will be subjected to the following questionnaires:
1. The General Health Questionnaire (GHQ-12), Arabic version:
It is the most extensively used screening instrument for common mental disorders, in addition to being a more general measure of psychiatric well-being. It asks whether the respondent has experienced a particular symptom or behavior recently. Each item is rated on a four-point scale (less than usual, no more than usual, rather more than usual, or much more than usual); it gives a total score of 36 based on the Likert scoring styles (0-1-2-3). It is a brief, simple, easy to complete, and its application in research settings as a screening tool is well documented. GHQ-12 is a consistent and reliable instrument when used in general population samples.
2. Taylor Manifest Anxiety Scale , Arabic version:
A person answers by reflecting on themselves, in order to determine their anxiety level. It is used to separate normal participants from those who would be considered to have pathological anxiety levels. It consists of 50 true or false questions. It has been proven reliable using test-retest reliability. O'Connor, Lorr, and Stafford found there were five general factors in the scale: chronic anxiety or worry, increased physiological reactivity, sleep disturbances associated with inner strain, sense of personal inadequacy, and motor tension .
3. Beck Depression Inventory (BDI) , Arabic version:
It is a self-report scale designed to assess symptoms of depression such as sadness, guilt, loss of interest, social withdrawal, increase and decrease in appetite or sleep, suicidal ideation, and other behavioral manifestations of depression over the previous 2 weeks. It can also be used over time to monitor symptoms and to assess response to therapeutic interventions. The inventory is composed of 21 groups of statements on a four-point scale with the patient selecting the one that best matches his or her current state.
4. The Brief-COPE scale , Arabic version :
It is an abbreviated version of the COPE (Coping Orientation to Problems Experienced) Inventory. It is a self-report questionnaire developed to assess a broad range of coping responses. It is one of the best validated and most frequently used measures of coping strategies. The instrument consists of 28 items that measure 14 factors of 2 items each, which correspond to a Likert scale ranged from 0 - 3.
from each center included in this study there is a person responsible for checking completeness of the collected questionnaires
Statistical Analysis Results will be evaluated statistically by the Statistical Package for the Social Sciences (SPSS) version 20 (IBM, 2011). Normality of data will be tested by Kolmogorov-Smirnov test. To describe the data, frequency (percent) and mean± SD will be used. T-test and Pearson correlation test will be used for comparisons and correlations respectively for normally distributed data. Mann-Whitney U test and Spearman correlation test will be used for comparisons and correlations respectively for non-normally distributed data. P-values less than 0.05 will be considered statistically significant and 95 % Confidence interval (CI) will be calculated.
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed cases with COVID-19 defined as a positive result to real-time reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for nasal and pharyngeal swab specimens
Exclusion Criteria:
* Patients who refuse to be included in the 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
|
NCT04459403
|
{
"brief_title": "Psychiatric Disturbances and COVID-19 Infection",
"conditions": [
"Corona Virus Infection"
],
"interventions": null,
"location_countries": [
"Egypt"
],
"nct_id": "NCT04459403",
"official_title": "Psychiatric Disturbances in Patients Infected With COVID-19: A Cross Sectional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-30",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2020-06-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-28",
"last_updated_that_met_qc_criteria": "2020-07-02",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-07",
"first_submitted": "2020-07-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The diagnosis, treatment and mechanism of pleural diseases
Detailed Description
The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases
#Intervention
- OTHER : Collection of pleural effusion
- Detection of pleural effusion
|
#Eligibility Criteria:
Inclusion Criteria:
Patients with pleural effusion, who has not been treated
Exclusion Criteria:
Patients with pleural effusion, who has already been treated
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
|
NCT03997669
|
{
"brief_title": "The Diagnosis and Mechanism of Pleural Effusion",
"conditions": [
"Pleural Diseases"
],
"interventions": [
"Other: Collection of pleural effusion"
],
"location_countries": [
"China"
],
"nct_id": "NCT03997669",
"official_title": "The Diagnosis and Mechanism of Pleural Effusion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-01",
"study_completion_date(actual)": "2021-10-01",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-16",
"last_updated_that_met_qc_criteria": "2019-06-22",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-25",
"first_submitted": "2019-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to compare the effect of open chain kinetic exercises and forward head posture correction on scapular symmetry and glenohumeral disability in office workers with type II scapular dyskinesis.
Detailed Description
The scapula plays a crucial role in coordinating and maintaining complex shoulder kinematics. The rotator cuff (RC) and the scapula control energy and force transfer for glenohumeral (GH) and scapulothoracic (ST) movements. From a biomechanical perspective, the shoulder range of motion (ROM) covers almost 65% of a spherical joint whose stability is ensured by several factors such as bone integrity, muscle activity, and ligaments.The RC and scapula allow for three-dimensional movements of the shoulder by limiting excessive translations that may compromise the joint integrity.The overall prevalence of scapular dyskinesis was 90.08%, and the highest frequency was found at the resting position.
Association between ergonomic risk level and scapular dyskinesis in office workers in 2020. It was a cross sectional study A lateral scapular slide test (LSST) was used to evaluate scapular dyskinesis, and the quick exposure check (QEC) method was used to analyze the ergonomic risk level. results indicate that patients with scapular dyskinesis have a high ergonomic risk level.
A defective scapular posture, caused by muscular imbalances, also generates imbalances of length and muscular strength in the muscles, altering the mechanics of the glenohumeral joint. A forward bending of the scapula is associated with a retracted minor pectoral muscle and possibly anterior serratus weakness or trapezius. This scapular posture alters the humeral posture on the glenoid, assuming a relatively abducted and internally rotated position, resulting in retracted glenohumeral internal rotators and elongated or weak lateral rotators.
SW Christensen et al has stated in an article that the key group that might be related with scapular dyskinesis and work-related pain in office workers is the axioscapular muscles. These muscles attach between the scapula to the axis of the body consisted of serratus anterior, Pectoralis minor, rhomboids, levator scapulae and three parts of trapezius.
Study in 2016 in which the deeper lying (Levator Scapulae, Pectoralis Minor (Pm) and Rhomboid major) and superficial lying (Trapezius and Serratus Anterior) scapulothoracic muscles' activity was investigated with fine-wire and surface EMG, concluded that In the presence of idiopathic neck pain, higher Pectoralis minor activity during the towel wall slide was found. Patients with neck pain and scapular dyskinesis showed lower MT(middle trapezius) activity in comparison with healthy controls with scapular dyskinesis during scaption.
In 2018 The results showed high incidence of axioscapular muscle adaptations including of decreased flexibility of pectoralis minor, upper trapezius and levator scapulae in all subtypes as well as decreased performance of serratus anterior, middle trapezius, lower trapezius and rhomboids. The high incidence of postural deviations including forward head, rounded shoulder and thoracic hyper-kyphosis were also found in all subtypes of scapular dyskinesis. The participants were symptomatic office workers with different subtypes of scapular dyskinesis. They were evaluated the subtypes of scapular dyskinesis corresponded with flexibility of pectoralis minor, upper trapezius and levator scapulae using muscle length tests. The performances of serratus anterior, upper trapezius, middle trapezius, lower trapezius and rhomboids were also examined using manual muscle test. The postural deviations of cervical, shoulder and thoracic were also investigated using postural analysis methods.
Conventional therapeutic exercise programs are commonly used to treat patients with scapular dyskinesis. It is common for physical therapists to treat patients with shoulder pain and scapular dyskinesis. Treatment techniques to address dyskinesis include manual neuromuscular facilitation, tactile cueing, visual feedback, electrical stimulation, supervised exercise, mobilization, strengthening, electromyography, and other interventions.
An RCT in which eleven asymptomatic university students representing 15 scapulae with a positive Scapular Dyskinesis Test were recruited as subjects. Participants were randomized into exercise and electrical stimulation (ESTherex) or exercise and sham electrical stimulation (ShamTherex) and stated that Electrical stimulation with exercises for scapular dyskinesis showed improvements in spine to scapula distance at 120 degrees of shoulder abduction.
The literature has proved that shoulder stabilization training strengthens the scapular muscles, closed chain and open chain kinetic exercises are also beneficial thereby resolving the SD. But as FHP can lead to SD, among the correction of FHP or open chain kinetic exercises which one is more effective to treat SD type II it has not been compared before. There is also paucity of literature available on open chain kinetic exercises and forward head posture correction exercises on scapular symmetry and glenohumeral disability in office workers with type II scapular dyskinesis. Hence this study aims to compare the effect of open chain kinetic exercises and forward head posture correction on scapular symmetry and glenohumeral disability in office workers with type II Scapular dyskinesis.
#Intervention
- OTHER : Open chain kinetic exercises
- Group A will perform open chain kinetic exercises Before the intervention all the participants will perform 20 minutes of warm up and 10 minutes of cool down. The Open kinematic chain exercises(Three sets of each exercise while one set of each exercise will be performed at the setup and remaining two sets will be guided to the patient as a home plan)-:Blackburn exercises ( 20 repetitions ) , Dynamic hug( 10 repetitions), W exercise(10 repetitions), lunges with dumbbells-forward(10 repetitions with half kg dumbbell), upward and diagonal, and Pectoralis minor stretching(3 to 5 stretches)will be performed
- OTHER : Forward head posture correction exercises
- PatienGroup B participants will perform forward head correction exercise(22) Chin tuck Patient will Stand with upper back against a wall, feet shoulder-width apart. • Face forward, tuck your chin down, and pull head back until it meets the wall. • t
|
#Eligibility Criteria:
Inclusion Criteria:
* Both male and female office workers
* In the age group of 20 <= age <= 40
* With at least one year work experience
* Individuals with Type II scapular dyskinesia (1 <= age <= 1.5 cm dif¬ference)
* Individuals with forward head posture
Exclusion Criteria:
* Any Congenital abnormality
* Neurological deficit
* Received physiotherapy treatment in past three months
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05044572
|
{
"brief_title": "Comparison of Open Chain Kinetic Exercises and Forward Head Posture Correction in Type II Scapular Dyskinesia",
"conditions": [
"Dyskinesias"
],
"interventions": [
"Other: Open chain kinetic exercises",
"Other: Forward head posture correction exercises"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05044572",
"official_title": "Comparison of Open Chain Kinetic Exercises and Forward Head Posture Correction on Scapular Symmetry and Glenohumeral Disability in Office Workers With Type II Scapular Dyskinesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-15",
"study_completion_date(actual)": "2022-02-25",
"study_start_date(actual)": "2021-09-15"
},
"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)": "2022-03-10",
"last_updated_that_met_qc_criteria": "2021-09-13",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-09-16",
"first_submitted": "2021-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia
#Intervention
- DRUG : pregabalin
- DRUG : placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of >40 mm on the Visual Analog Scale
Exclusion Criteria:
* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00230776
|
{
"brief_title": "A Controlled Pregabalin Trial In Fibromyalgia",
"conditions": [
"Fibromyalgia"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00230776",
"official_title": "A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2005-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-26",
"last_updated_that_met_qc_criteria": "2005-09-29",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-03",
"first_submitted": "2005-09-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear implantation on speech perception and localization tasks.
If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.
Detailed Description
The treatment for cases of vestibular schwannoma or Meniere's disease may require a translabyrinthine surgical approach. This surgical approach results in a complete loss of hearing in the surgical ear, leaving the patient with a unilateral hearing loss. Though assistive hearing technologies exist to route signals from the poorer hearing ear to the better hearing ear, affected patients continue to have limitations with localization and speech perception in noise. An alternative hearing device is a cochlear implant, which would provide the signal to the affected ear. This could potentially offer binaural cues, thus improving localization and speech perception in noise. Since the surgical procedures for a translabyrinthine approach parallel those for cochlear implantation, insertion of the cochlear implant could occur within the same surgery.
A vestibular schwannoma is a benign tumor on cranial nerve VIII that affects the vestibular and auditory systems. Hearing loss on the side of the vestibular schwannoma may result from degeneration of hair cells and spiral ganglia or growth of the schwannoma into the cochlear space. Treatment options include observation from routine imaging, radiation therapy, or surgical removal of the tumor. Despite treatment for the vestibular schwannoma, auditory sensitivity may be further reduced on the affected side as a result of the radiation therapy or compromises to the inner ear or cranial nerve VIII from surgical removal. Thus, in cases of unilateral vestibular schwannoma the patient is often left with a unilateral profound hearing loss.
Patients who are scheduled to undergo labyrinthectomy for intractable Meniere's disease are a second population with resulting unilateral profound hearing loss. These patients typically have non-functional hearing on the affected ear prior to the procedure. The main indication for the surgery is intractable vertigo and thus the loss of already non-functional hearing is typically well accepted.
Though hearing on the contralateral ear may be within normal limits, unilateral hearing loss is known to result in reduced speech perception in noise, variable abilities on localization tasks, increased report of hearing handicap, and reduced quality of life. Due to the severity of the hearing loss, these patient populations cannot utilize conventional amplification that would offer auditory input to the affected ear. The current hearing device options for this patient population include contralateral routing of signal (CROS) hearing aids and bone-conduction devices. With a CROS hearing aid, a microphone positioned near the affected ear picks up the signal and sends it to a hearing aid placed on the contralateral ear to present the signal to the unaffected side. Bone-conduction devices transmit the signal from the affected ear to the contralateral ear via transcutaneous vibrations. Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides, the ability to use binaural cues for localization and speech perception in noise is variable.
It is of interest as to the potential benefit of cochlear implantation in these populations considering the profound hearing loss resulting from surgical intervention. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the signal via electrical pulses within the cochlear space, which is interpreted by the brain as sound.
Cochlear implantation has been reported as a viable treatment option in other cases of unilateral hearing loss, including sudden sensorineural hearing loss, and severe tinnitus. Further, cochlear implantation has been shown to offer superior speech perception in noise, localization abilities, and subjective report in cases of unilateral sensorineural hearing loss as compared to CROS hearing aids and bone-conduction devices.
There is limited evidence as to the success of cochlear implantation in patients with unilateral profound hearing loss resulting from vestibular schwannoma. One study reported variable speech perception outcomes in five cochlear implant recipients with a history of vestibular schwannoma due to neurofibromatosis type 2 (NF2) or sporadic growth. Limitations of this study are the subjects underwent a range of treatments prior to cochlear implantation and the cases reviewed had profound hearing loss in both ears. A second study reported on a case study of unilateral vestibular schwannoma removal and simultaneous cochlear implantation. This subject reportedly experienced an improvement in speech perception abilities and quality of life postoperatively. Determining the preferred treatment option for patients suffering from unilateral vestibular schwannoma is still needed.
Further, there is limited evidence of the preferred treatment option for patients suffering from unilateral profound hearing loss after undergoing a labyrinthectomy for intractable Meniere's disease. One study reported on a patient who underwent bilateral labyrinthectomies for Meniere's disease. They reported an improvement in speech perception abilities and subjective benefit; however, there was a delay between the two surgeries. Allowing for a waiting period between the two surgeries is not ideal as cochlear ossification may occur, limiting the ability to successfully insert the electrode array. Another study also reported successful outcomes from cochlear implantation in subjects with bilateral Meniere's disease. However, there is no published report investigating whether cochlear implantation improves speech perception and/or localization abilities in unilateral cases of Meniere's disease.
The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear implantation on speech perception and localization tasks. If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.
#Intervention
- DEVICE : Cochlear Implant
- Cochlear implantation used a treatment for single-sided deafness resultant of labyrinthectomy or a translabyrinthine surgical approach
- Other Names :
- MED-EL CONCERT cochlear implant system, MED-EL SYNCHRONY cochlear implant system
|
#Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo a surgical procedure that will result in profound hearing loss in the surgical ear [unilateral vestibular schwannoma wtih planned translabyrinthine surgery or unilateral Meniere's disease with planned labyrinthectomy] [diagnosed by UNC investigators]
* Pure-tone average (PTA) less than or equal to 35 decibels Hearing Level (dB HL) in the contralateral ear [no evidence of retrocochlear dysfunction]
* Unaided consonant-nucleus-consonant (CNC) words score greater than or equal to 80% in the contralateral ear
* Greater than 18 years at implantation
* Realistic expectations
* Willing to obtain appropriate meningitis vaccinations
* No reported cognitive issues [pass the Mini Mental State Examination screener]
* Able and willing to comply with study requirements, including travel to investigational site
* Obtain Centers for Disease Control and Prevention (CDC) recommended meningitis vaccinations prior to surgery
Exclusion Criteria:
* History of implantable technology in either ear, such as a bone-conduction implant
* Non-native English speaker [speech perception materials presented in English]
* Inability to participate in follow-up procedures (unwillingness, geographic location)
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
|
NCT02309099
|
{
"brief_title": "Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach",
"conditions": [
"Unilateral Acoustic Neuroma",
"Meniere's Disease"
],
"interventions": [
"Device: Cochlear Implant"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02309099",
"official_title": "Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-08",
"study_completion_date(actual)": "2017-11-08",
"study_start_date(actual)": "2014-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-07",
"last_updated_that_met_qc_criteria": "2014-12-04",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-05",
"first_submitted": "2014-11-12",
"first_submitted_that_met_qc_criteria": "2018-12-07"
}
}
}
|
#Study Description
Brief Summary
The pragmatic issue at hand how to get physicians and nurses to use best practices... and how to measure consequences of their implementation. This is the science of 'knowledge translation', which we are realizing is an 'organic' entity. As part of our Critical Care Strategy our goal is to improve the quality and continuity of critical care within our health care system. Toward this goal we are implementing a program which links 16 Ontario hospitals through their critical care units in a Provincial Network.
#Intervention
- BEHAVIORAL : Focused knowledge translation strategies
|
#Eligibility Criteria:
Inclusion Criteria:
* Cohort of hospitals with Intensive Care Units in Ontario
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00332982
|
{
"brief_title": "Ontario ICU Clinical Best Practices Demonstration Project",
"conditions": [
"Ventilator Acquired Pneumonia",
"Catheter Related Blood Stream Infections",
"Pressure Ulcer Prophylaxis",
"DVT Prophylaxis",
"Restrictive Blood Transfusion Strategy",
"Daily Spontaeous Breathing Trials"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00332982",
"official_title": "Ontario ICU Clinical Best Practices Demonstration Project",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-09",
"study_start_date(actual)": "2005-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "ECT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2006-11-22",
"last_updated_that_met_qc_criteria": "2006-06-01",
"last_verified": "2005-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-02",
"first_submitted": "2006-06-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It is well known that following a single session of moderate-to-high intensity exercise individuals experience a temporary suppression of hunger and a delay in the commencement of eating. This effect is believed to be due to changes in blood concentrations of specific hormones released from the gut that influence appetite.
Individuals undertaking physical activity often consume foods immediately before exercise in order to improve their performance. However, it is currently unknown whether this eating practice influences the gut hormone response to exercise as well as how hungry an individual feels post-exercise.
Therefore, the aim of this study is to investigate the effect of consuming a sugary (carbohydrate) drink immediately before starting an exercise session on the concentration of these gut hormones as well as the amount of food eaten in the hours following exercise completion.
Detailed Description
It is well established that following an acute bout of moderate-to-high intensity exercise individuals experience a transient suppression of hunger and a delay in the commencement of eating - a phenomenon referred to as exercise-induced anorexia. Acute exercise modulates the concentrations of gut hormones known to influence satiety, including the anorexigenic hormones glucagon-like peptide 1 (GLP-1) and peptide tyrosine tyrosine (PYY), as well as the acylated form of the orexigenic hormone ghrelin. These alterations in gut hormone concentrations have consequently been hypothesised to play a key role in exercise-induced anorexia.
Despite suppressing hunger and delaying eating, acute exercise does not appear to alter short-term energy intake in the immediate hours following exercise completion. The absence of a compensatory response therefore creates an energy deficit capable of inducing weight loss. Strategies that augment the gut hormone response to acute exercise may thus increase the potency of exercise as a weight-loss tool.
Research investigating the effect of exercise on appetite has frequently utilised participants in a fasting state. Undertaking exercise in this physiological condition contradicts current practices, as athletes often consume a carbohydrate source immediately prior to exercise in an attempt to maximise performance. It is currently unknown as to whether the consumption of carbohydrate during this period may further enhance the gut hormone response to exercise, and thus research into a potential additive effect is warranted.
High-intensity exercise increases sympathetic nervous system activity and catecholamine release. Catecholamine concentrations are negatively correlated with acylated ghrelin concentrations and may directly stimulate GLP-1 and PYY release via activation of β-receptors located on L-cells. The decrease in gastric emptying rate that is observed during high-intensity exercise is also attributed to this increase in sympathetic activity. Consequently, an increase in sympathetic nervous system activity has been postulated as a key mechanism underlying exercise-induced changes in gut hormone concentrations. However, to our knowledge, no study has directly measured the relationship between sympathetic nervous system activity and anorexigenic gut hormone release during exercise.
Therefore, the aim of this study is to examine any potential additive effects of carbohydrate ingestion immediately prior to exercise on gut hormone release and post-exercise appetite suppression. Furthermore, this study will look to investigate the mechanisms underlying changes in gut hormone concentrations experienced during exercise.
#Intervention
- DIETARY_SUPPLEMENT : Maltodextrin (carbohydrate)
- A drink containing 300ml of water and 75g of maltodextrin
- OTHER : Exercise
- 30 minutes on a cycle ergometer working at 75% VO2 max
- OTHER : Rest
- 30 minutes laying on a bed
- OTHER : Water
- A drink containing 300ml of water
|
#Eligibility Criteria:
Inclusion Criteria:
* Male
* Age between 18 <= age <= 40 years (inclusive)
* Body mass index (BMI) of 18 <= age <= 30 kg/m2
* Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion Criteria:
* Abnormal ECG
* Screening blood results outside of normal reference values
* Current smokers
* Current or history of substance abuse and/or excess alcohol intake
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
* Participation in a research study in the 12 week period prior to entering this study.
* Any blood donation within the 12 week period prior to entering this study
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04019418
|
{
"brief_title": "Carbohydrate Intake and Gut Hormone Release During Exercise",
"conditions": [
"Obesity"
],
"interventions": [
"Other: Exercise",
"Dietary Supplement: Maltodextrin (carbohydrate)",
"Other: Rest",
"Other: Water"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04019418",
"official_title": "Carbohydrate Intake and Gut Hormone Release During Exercise",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-12",
"study_completion_date(actual)": "2020-02-12",
"study_start_date(actual)": "2019-02-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-09",
"last_updated_that_met_qc_criteria": "2019-07-12",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-15",
"first_submitted": "2019-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to measure the impact of maternal malaria on child growth in the two first years of life in relation to fetal growth.
This study is following a birth cohort of children born to pregnant women enrolled in the study 'Impact of malaria infection in pregnancy on fetal and newborn growth' (protocol OXTREC 14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years of age using routine anthropometric measurements such as weight, length, arm and head circumference. A few additional tests will enhance the sensitivity of the study outcomes with minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and neurodevelopmental assessment.
This study was funded by Wellcome Trust core funding, grant ref. number Wellcome Trust Major Overseas Program Grant no. 220211 (2020-2025)
Detailed Description
This is an existing on-going prospective birth cohort of children born to the pregnant women who had fetal growth assessed during pregnancy. In this cohort an expected 10% of pregnant women will be exposed to malaria while the remaining will be free of malaria. Their offspring are already followed up for growth monitoring from birth until 2 years of age with anthropometric measurements including weight, length, arm and head circumference at each scheduled visit. The investigator would like to enhance the sensitivity of the study outcomes with minimal risk for the child by proposing the following anthropometric and screening tests, nutrition questionnaire, and neurodevelopment assessment. In addition a prospective cohort of children born after study approval will be followed on both protocols. The additional measure include:
* Body fat composition (at birth, and monthly up to 4 months unless weight ≥ 8kg)
* Triceps and subscapular skinfold (at 1 and 2 years)
* Anemia, malaria and soil-transmitted helminths screening (every 3 months in first 12 months and 6-monthly 1-2 years)
* Buccal swab (at 1 and 2 years)
* Neurodevelopment (every 6 months)
* Food questionnaire (at 1 and 2 years)
Summary of results:
The beginning of the recruitment was delayed until the finalization and approval of the translated PIS/ICF; from then on, the recruitment was smooth. Overall, 201 children from the ongoing existing birth cohort were still present and eligible to participate in this part of the study; 173 completed 2 years of FUP 28 were lost. Data and samples from these 173 children were included in the analysis of a large, multi-center, study, the INTERBIO-21st.
The pooled findings show 1. Cognitive development, language, and visual skills at 2 years of age vary according to the trajectories of fetal cranial growth 2. There is a critical window period at 20-25 weeks gestational age when fetal cranial trajectories may diverge and when fetal abdominal circumference growth may accelerate or decelerate 3. Preterm newborn's growth and neurocognitive development vary according to their birth phenotype characteristics (i.e. those classified in the 'birth infections' phenotype were at higher risk for poor scoring in fine and gross motor development compared to term newborns) 4. An indication of a greater increase in weight in proportion to height during the 2 first years of life if there was a faltering growth phenotype observed during gestation.
Maternal malaria and anemia's role in the development of children were evaluated specifically for this study site and included all the children followed up to one year of age. Preliminary results show that 48% of children are stunted at 2 years of age and that malaria and anemia independently are significant contributors to the decline in growth z-scores during infancy (manuscript in preparation); that 66% of children have anemia (HCT\<33%) in the first year of life, the median age for a first HCT\<33% is 4 months of age and that moderate, but not mild anemia in infancy reduces the median neurodevelopment score at year of age. Maternal anemia but not malaria is a factor contributing to increased risk of anemia in infants. Results were presented at local and regional and international conferences and were part of a MSc thesis.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant's parent or legal guardian is willing and able to give informed consent for participation in the study
* Able (in the Investigators opinion) to comply with study requirements
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
* Medical or congenital complications which would (in the investigator's opinion) make it difficult to comply with study requirements
* Aged older than 2 years
Sex :
ALL
Ages :
- Maximum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02800109
|
{
"brief_title": "Child Follow-up Until 2 Years",
"conditions": [
"Malaria",
"Pregnancy"
],
"interventions": null,
"location_countries": [
"Thailand"
],
"nct_id": "NCT02800109",
"official_title": "Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth - Child Follow-up Until 2 Years of Age, in Relation to the Fetal Growth",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2018-02",
"study_start_date(actual)": "2016-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-28",
"last_updated_that_met_qc_criteria": "2016-06-09",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-15",
"first_submitted": "2016-05-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.
#Intervention
- OTHER : TUPLER exercises
- will be conducting tupler exercises, exercises that are designed to target core muscles in order to improve posture, regain core strength and reducing discomfort.
Each exercise will be repeated 10reps for 3 times on 3 days a week for 8 weeks.
- OTHER : SCOOP EXERCISES
- will be required to complete scoop exercises basically deals with Pilates which is deep core and hip strengthening and stability through breathing patterns with the utilization of transversus abdominis muscle majorly. In each exercise participant will be asked to hold pelvic floor muscles for 8sec, then relax the muscles and count to 10, repeat I for 10 times each day for 3 days a week for 8weeks. Basic commands about the positing, activation and engagement of core along with breathing control were given to the subjects.
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI 25kg\|m^2 to 30kg\\m^2or greater
* multiparous women
* Participants included will be 3 months post-partum females
* Caesarean delivery who will have with the presence of DRA >2 finger width and >2cm
Exclusion Criteria:
* patients who had hernia
* trauma to bowel or bladder
* malignancies
* neurologic disease and its associated balance disorders,
* pelvic or abdominal surgery (except for a caesarean section) were considered as the exclusion criteria of this study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06302816
|
{
"brief_title": "Effects of Tupler and Scoop Exercises in Diastasis Recti",
"conditions": [
"Diastasis"
],
"interventions": [
"Other: SCOOP EXERCISES",
"Other: TUPLER exercises"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06302816",
"official_title": "Comparative Effects of Tupler and Scoop Exercises on Inter-recti-distance, Low Back Pain, Abdominal Strength and Urogynecological Symptoms in Diastasis Recti",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-01",
"study_completion_date(actual)": "2024-09-01",
"study_start_date(actual)": "2023-02-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2024-03-04",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-12",
"first_submitted": "2024-03-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.
Detailed Description
This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated after treatment has ended. Both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.
#Intervention
- DRUG : Milnacipran
- Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
- Other Names :
- Savella
- DRUG : Placebo
- 2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
|
#Eligibility Criteria:
Inclusion Criteria:
* History of low back pain for a minimum of 6 months with radiation to leg or buttocks
* Over 18 years and under 70
* Must have a visual analogue scale (VAS) pain score >50mm
* Must be in generally stable health
* Must be willing to abstain from alcohol during the course of the study
* If female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study
* Must be able to read and understand instructions and the questionnaires
* Must be willing to participate in daily data collection requirements via telephone (IVRS)
* Must understand all aspects of the study, and willing to sign an informed consent form in that regard.
Exclusion Criteria:
* Low back pain associated with systemic signs or symptoms (e.g. fever or chills)
* Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back
* Involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain.
* Neurological disorder including history of seizures
* Major psychiatric disorder during the past six months
* Active suicidal ideation or recent suicidal behavior
* Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy
* Significant renal disease or severe renal insufficiency
* History of, or current, substance abuse/dependence
* Significantly abnormal laboratory values
* Pregnant or lactating any time during the course of the study
* Known sensitivity to Savella or other SNRI
* Glaucoma
* Taking any MAOI, sibutramine, digoxin, tricyclic antidepressants, other SNRI, Opioids.
* Beck Depression Inventory Score >30
* Current Sleep Disorder
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
|
NCT01225068
|
{
"brief_title": "Effect of Milnacipran in Chronic Neuropathic Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Drug: Placebo",
"Drug: Milnacipran"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01225068",
"official_title": "An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-04",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-17",
"last_updated_that_met_qc_criteria": "2010-10-19",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-20",
"first_submitted": "2010-10-13",
"first_submitted_that_met_qc_criteria": "2013-07-17"
}
}
}
|
#Study Description
Brief Summary
To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.
#Intervention
- DRUG : MENATETRANONE
|
#Eligibility Criteria:
Inclusion Criteria:
Inpatient or outpatient is not asked. If using any anti-osteoporotic agent other than calcium preparations (i.e., contraindicated for concomitant use stipulated in the protocol of this post-marketing study), such agent must be discontinued. Even after the discontinuation, calcium dosing is permitted with a condition that the subsequent use is started after a 8-week elapse from the discontinuation.
* Patients with primary osteoporosis (diagnosed according to 'Diagnostic Criteria for Primary Osteoporosis issued by the Japanese Society for Bone and Mineral Research (1995).'
* Post-menopausal patients aged >= 50 years.
* Patients who agree to participate in a 4-year follow-up observation.
* Patients who provide written informed consent.
Exclusion Criteira:
* Patients on warfarin potassium (Warfarin®) therapy.
* Patients with hypercalcemia.
* Patietns with renal calculus.
* Patients with a known history of hypersensitivity to calcium or menatetrenone preparations.
* Patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system.
* Patients who underwent bilateral ovariectomy.
* Patients with radiotherapy in the pelvis or para-aortic area.
* Patients with the following X-ray findings;
1. Patients showing osteophytes connecting with adjacent vertebral osteophytes
2. Patients showing hyperostosis of ligament around the vertebral body
3. Patients showing inter-body fusion
4. Patients who experienced surgical intervention(s) in the spine
5. Patients with scoliosis which disturbs a diagnosing of vertebral fracture
* Patients who have been treated with anti-osteoporotic agents, other than calcium preparation, within 8 months prior to the study treatment (but not applied to the following; if discontinued, non-treated, or shifted to calcium monotherapy for 8 weeks or longer before starting the study treatment).
* Patients who experienced bisphosphonates in the past.
* Patients who are likely to show insufficient absorption of liposoluble agents such as biliary atresia, impaired bile secretion, etc.
* Other patients who are judged to be ineligible for study entry by the investigator or investigator.
Sex :
FEMALE
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00165607
|
{
"brief_title": "Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)",
"conditions": [
"Osteoporosis"
],
"interventions": null,
"location_countries": [
"Japan"
],
"nct_id": "NCT00165607",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": null,
"study_start_date(actual)": "1996-04"
},
"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)": "2010-01-29",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2010-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant recipients within 10 weeks after transplantation, and has been associated with increased risk of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell and β-cell function.
The primary objective of the present study is to investigate whether hyperglucagonemia is present in renal transplant recipients with PTDM. Furthermore, the investigators aim to examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic clamp), respectively.
#Intervention
- DIETARY_SUPPLEMENT : Glucagon-like peptide-1 (GLP-1)
- OTHER : Isotonic saline
- OTHER : Hyperglycemic clamp
|
#Eligibility Criteria:
Inclusion Criteria:
* Renal transplant recipients more than 1 year post transplant with stable renal function (less than 20% deviation in serum creatinine within the last 2 months) and stable prednisolone dose (maximum 5 mg/day) the last three months before inclusion
* Diagnose of PTDM on standard clinical follow-up performed 8 weeks and 1 year post transplant at OUS-Rikshospitalet (fasting plasma glucose >= 7.0 mmol/l and/or 2-hour plasma glucose >= 11.1 mmol/l following an oral glucose tolerance test) OR
* Non-diabetic renal transplant recipients with a normal glucose tolerance test (control group)
* > 18 years
* BMI 18.5 <= age <= 29.9 kg/m2
* Signed informed consent
Exclusion Criteria:
* Severe liver disease
* Pancreatitis (chronic or acute), previous bowel resection, inflammatory bowel disease, malignancy (previous or actual)
* Estimated GFR < 25 ml/min/1.73 m2
* Pregnant or nursing mothers
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
|
NCT02591849
|
{
"brief_title": "GLP-1 Effects on Insulin and Glucagon in PTDM",
"conditions": [
"Post-transplant Diabetes Mellitus"
],
"interventions": [
"Other: Isotonic saline",
"Dietary Supplement: Glucagon-like peptide-1 (GLP-1)",
"Other: Hyperglycemic clamp"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT02591849",
"official_title": "GLP-1 Restores Altered Insulin and Glucagon Secretion in Post-transplantation Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03",
"study_completion_date(actual)": "2015-03",
"study_start_date(actual)": "2014-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-31",
"last_updated_that_met_qc_criteria": "2015-10-29",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-30",
"first_submitted": "2015-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.
Detailed Description
Outcome measurements:
The frequency of bowel movement; The bristol stool scale; SF-36 evaluation
#Intervention
- OTHER : acupuncture
- acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
- Other Names :
- Acupuncture at Shumu acupoints
- OTHER : acupuncture group2
- Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
- Other Names :
- Acupuncture at He acupoints
- OTHER : acupuncture group3
- All acupoints used in acupuncture group1 and group2 will be used in this group.
- Other Names :
- Acupuncture at Shumu and He acupoints
- DRUG : Loperamide
- Loperamide will be used in this group for a dose of 2mg a time, three time a day.
- Other Names :
- Luopaidingan
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
* Age between 18 and 65 years;
* Did not take any medicine for bowel symptoms and attend other clinical research;
* Have inform consent signed.
Exclusion Criteria:
* Diarrhea caused by diseases such as infection, etc.
* Patients can't express himself clearly or with mental diseases;
* Tumor and other infectious diseases;
* With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
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
|
NCT01350570
|
{
"brief_title": "Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial",
"conditions": [
"Diarrhea-predominant Irritable Bowel Syndrome",
"Functional Diarrhea"
],
"interventions": [
"Other: acupuncture group3",
"Other: acupuncture group2",
"Other: acupuncture",
"Drug: Loperamide"
],
"location_countries": [
"China"
],
"nct_id": "NCT01350570",
"official_title": "Acupuncture for Functional Bowel Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-10",
"last_updated_that_met_qc_criteria": "2011-05-09",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-10",
"first_submitted": "2011-05-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.
#Intervention
- BEHAVIORAL : pedometer-plus-email
- After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. During the intervention period, patients will receive 8 counselling emails based on behavioural techniques.
- BEHAVIORAL : pedometer-only
- After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. There will be no further interaction during the intervention period unless they fail to upload data, in which case they will be offered technical support.
|
#Eligibility Criteria:
Inclusion Criteria:
* physically inactive, i.e. takes less than 8,000 steps per day at baseline
* registered at the participating general practice,
* > 18 years,
* regular email user, and willing to use email for the purpose of the study,
* has a home computer with access to the Internet.
Exclusion Criteria:
* medical or psychiatric condition which the general practitioner considers as inappropriate for participating in the intervention (e.g., terminal illness, psychotic illness, chronic disorders or diseases that seriously influence the ability to be physically active, dementia or significant cognitive impairment, unable to move about independently),
* medical, personal of family condition which the general practitioner considers temporarily affects mean daily step count at baseline (e.g., acute illness, holiday or business trip),
* pregnant woman,
* currently engaging in regular sports or exercise (at least twice a week),
* failure to upload pedometer data to a website at baseline assessment,
* failure to give informed consent with the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03135561
|
{
"brief_title": "A Pedometer-based Intervention With and Without Email Counselling in General Practice",
"conditions": [
"Physical Activity",
"Primary Care",
"General Practice"
],
"interventions": [
"Behavioral: pedometer-only",
"Behavioral: pedometer-plus-email"
],
"location_countries": null,
"nct_id": "NCT03135561",
"official_title": "A Pedometer-based Walking Intervention With and Without Email Counselling in General Practice: a Pilot Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09-29",
"study_completion_date(actual)": "2016-12-09",
"study_start_date(actual)": "2015-11-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-01",
"last_updated_that_met_qc_criteria": "2017-04-26",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-01",
"first_submitted": "2017-04-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.
#Intervention
- DRUG : Ivabradine
- 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
- DRUG : Placebo
- Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic Chronic heart failure (NYHA II, III or IV)
* Left ventricular systolic dysfunction (LVEF <= 35%)
* Sinus rhythm and resting heart rate >= 70 bpm
* Optimal and unchanged CHF medications or dosages
Exclusion Criteria:
* Unstable condition within previous 4 weeks
* Myocardial infarction or coronary revascularisation within previous 2 months
* Stroke or transient cerebral ischaemia within previous 4 weeks
* Congenital heart disease
* Severe valvular disease
* Active myocarditis
* Permanent atrial fibrillation or flutter
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
|
NCT02441218
|
{
"brief_title": "Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study",
"conditions": [
"Chronic Heart Failure"
],
"interventions": [
"Drug: Placebo",
"Drug: Ivabradine"
],
"location_countries": [
"France",
"Sweden"
],
"nct_id": "NCT02441218",
"official_title": null,
"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)": "2006-09"
},
"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)": "2020-01-03",
"last_updated_that_met_qc_criteria": "2015-05-07",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-12",
"first_submitted": "2015-05-05",
"first_submitted_that_met_qc_criteria": "2015-06-22"
}
}
}
|
#Study Description
Brief Summary
This is a prospective, observational study of patients presenting to the emergency departments at 9 EMERGEncy ID NET sites. The objectives of the proposed study are to:
1. Describe the range and proportion of infectious agents in synovial fluid as detected by standard C\&S and investigational PCR testing, i.e., Biofire® Film Array® Bone and Joint Infection (BJI) Panel,
2. Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED),
3. Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and
4. Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis.
Study coordinators screen the ED log for adult patients presenting with joint pain and whose treating physician ordered an arthrocentesis. After confirming eligibility, study coordinators approach the patient to explain the study, and present the written consent form. If the patient agrees to participate and consent, the study coordinator completes an enrollment data collection using patient and treating physician interview to gather responses. After enrollment, the study coordinator will ensure that approximately 0.3-1.0 mL of leftover synovial fluid is saved and stored in a freezer for shipment to a central laboratory (Truman Medical Center hospital laboratory, Kansas City, MO) for testing. Approximately 30 days after enrollment, study coordinators complete an electronic medical record (EMR) review.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older;
* diagnostic arthrocentesis in the emergency department (ED) or during hospitalization if admitted from the ED;
* arthrocentesis and joint culture ordered; and
* provide written consent in English or Spanish
Exclusion Criteria:
* Unable to consent or no legal authorized representative is available; or
* prisoner or parolee
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
|
NCT05341908
|
{
"brief_title": "Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients",
"conditions": [
"Septic Arthritis",
"Joint Infection"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05341908",
"official_title": "Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2021-09-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-13",
"last_updated_that_met_qc_criteria": "2022-04-18",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-22",
"first_submitted": "2021-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.
#Intervention
- DEVICE : SleepStyle 200 Auto Series CPAP Humidifier
- The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine
- Other Names :
- HC254
|
#Eligibility Criteria:
Inclusion Criteria:
* AHI >15 on the diagnostic portion of the study
* >18 years
Exclusion Criteria:
* Significant Central Apnea
* Congestive Heart Failure
* Inability to give informed consent
* Patient intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate
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
|
NCT00750165
|
{
"brief_title": "Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)",
"conditions": [
"Sleep Apnea, Obstructive"
],
"interventions": [
"Device: SleepStyle 200 Auto Series CPAP Humidifier"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00750165",
"official_title": "Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2008-01",
"study_start_date(actual)": "2007-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-09",
"last_updated_that_met_qc_criteria": "2008-09-09",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-10",
"first_submitted": "2008-09-08",
"first_submitted_that_met_qc_criteria": "2019-03-20"
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.
Detailed Description
Imaging scans (computed tomography \[CT\]/magnetic resonance imaging \[MRI\]) to assess disease progression were to be completed within 28 days prior to first study drug administration, approximately every 8 weeks for the first 18 months and then approximately every 12 weeks until the patient showed progressive disease (PD) per the investigator, withdrew consent, was lost to follow-up or died. Per the original protocol, all patients were to be contacted by the study site every 12 weeks for survival following the end-of-treatment visit until death or for no more than 3 years after the end-of-treatment visit.
The interim futility analysis was conducted in December 2013, based on a pre-specified analysis cutoff date of 13 September 2013. The study was brought to a close as specified in the protocol due to the results of the interim futility analysis and only those participants who were deriving benefit (per the treating physician) from their current treatment remained on study until one of the discontinuation criteria was met.
Given the early closure of the study, no updated or additional efficacy analyses were performed after the interim analysis. A biomarker analysis was conducted in January 2014, based on the data from the cutoff date of 13 September 2013. The safety analysis was updated with a new cutoff date of 28 February 2014.
#Intervention
- DRUG : Tivozanib
- Capsules for oral administration
- Other Names :
- AV951, ASP4130
- DRUG : Bevacizumab
- Solution for intravenous infusion
- Other Names :
- Avastin
- DRUG : mFOLFOX6
- mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m\^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m\^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of metastatic colorectal cancer
* One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil containing adjuvant therapy in previous 6 months
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Exclusion Criteria:
* Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other agent or investigational agent targeting the VEGF pathway
* Primary Central Nervous System (CNS) malignancies or CNS metastases
* Hematologic abnormalities:
* Hemoglobin < 9.0 g/dL,
* Absolute neutrophil count (ANC) < 2000 per mm^3,
* Platelet count < 100,000 per mm^3,
* Prothrombin (PT) or Partial Thromboplastin Time (PTT) > 1.5 X Upper Limit of Normal (ULN)
* Serum chemistry abnormalities:
* Total bilirubin > 1.5 X ULN,
* Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 X ULN,
* Alkaline phosphatase > 2.5 X ULN,
* Serum albumin < 2.0 g/dL,
* Creatinine > 1.5 X ULN,
* Proteinuria > 2+ by urine dipstick
* Significant cardiovascular disease
* Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
* Non-healing wound, bone fracture, or skin ulcer
* Inadequate recovery from any prior surgical procedure or major surgical procedure within 8 weeks prior to administration, or anticipation of major surgical procedure during the course of the study
* History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within the last 6 weeks
* An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
* Serious/active infection or infection requiring antibiotics
* Significant bleeding disorders within 6 months prior to administration of first dose of study drug
* Active second primary malignancy, other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subject is not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for > 5 years
* History of allergic reactions, or intolerance, attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, history of Grade 3 hypersensitivity to oxaliplatin, history of allergic reaction to folic acid
* Female subject is pregnant or lactating
* Known history of genetic or acquired immune suppression disease including Human Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ transplant
* Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major resection of the stomach or small bowel, or gastric bypass
* Uncontrolled neuro-psychiatric disorder or altered mental status
* Peripheral neuropathy >= Grade 2
* Participating in another interventional 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
|
NCT01478594
|
{
"brief_title": "A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Drug: mFOLFOX6",
"Drug: Tivozanib",
"Drug: Bevacizumab"
],
"location_countries": [
"Italy",
"Netherlands",
"United States",
"Canada",
"Austria",
"Spain",
"Australia",
"Hungary",
"Finland",
"Czech Republic",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT01478594",
"official_title": "A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-08",
"last_updated_that_met_qc_criteria": "2011-11-21",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-23",
"first_submitted": "2011-11-21",
"first_submitted_that_met_qc_criteria": "2015-04-02"
}
}
}
|
#Study Description
Brief Summary
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.
Detailed Description
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.
#Intervention
- DRUG : Fluticasone furoate Nasal Spray 110 mcg
- Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.
- Other Names :
- Fluticasone Furoate Nasal Spray
- DRUG : Placebo
- Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
- Other Names :
- Placebo Veramyst Nasal Spray
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.
* Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.
* A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.
* Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.
* Ability to read, understand and give informed consent.
* Ability to understand and carry out responsibilities of the study
Exclusion Criteria:
* Any chronic disease or other acute disease, which could influence central nervous system.
* The use of any medication, which could affect central nervous system function.
* Unwillingness to participate in the study.
* Inability to understand testing procedures or use of medication.
* Hypersensitivity to fluticasone or vehicle of nasal sprays.
* Any sleep disorders including obstructive sleep apnea.
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
|
NCT00997620
|
{
"brief_title": "Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis",
"conditions": [
"Seasonal Allergic Rhinitis"
],
"interventions": [
"Drug: Placebo",
"Drug: Fluticasone furoate Nasal Spray 110 mcg"
],
"location_countries": null,
"nct_id": "NCT00997620",
"official_title": "A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-18",
"last_updated_that_met_qc_criteria": "2009-10-16",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-19",
"first_submitted": "2009-10-15",
"first_submitted_that_met_qc_criteria": "2018-05-14"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to investigate the effect of watching a television show with healthy food commercials, unhealthy food commercials, or neutral commercials on the consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1) Women exposed to a television show with commercials imbedded advertising food will consume more food than women exposed to a television show with non-food related commercials.
2) Women will consume more food when exposed to a television show with commercials advertising 'unhealthy' food as compared to a television show with commercials advertising 'healthy' food.
3) Women will consume the most food when exposed to a television show with 'unhealthy' food commercials and have 'unhealthy' snack foods available to consume.
Detailed Description
The objective of this investigation is to investigate the effect of television shows with commercials perceived as advertising healthy foods and television shows with commercials perceived as advertising unhealthy foods on the intake of either perceived healthy snack foods or perceived unhealthy snack foods in normal weight, dietary restrained females.
Forty-eight women will participate in this study and will be randomized to one of six conditions where they will be exposed to a 30-minute television show (Saturday Night Live) during which they will be given two different pre-measured snack foods to eat. The television show will have eight commercials imbedded within it. Of the eight commercials, five commercials will represent the study condition (five advertising healthy food, five advertising unhealthy food, or five non-food related commercials). The three additional commercials will advertise neutral products (banks) and will remain the same in each condition. Snack foods being used in this investigation are red grapes and baby carrots for the perceived healthy snack foods; and chocolate chip cookies and potato chips for the perceived unhealthy snack foods. The television commercials representing the unhealthy category include commercials advertising M\&M's candies, Oreo cookies, Cheez-it crackers, 3 Musketeers chocolate bars, and Doritos chips. The television commercials representing the healthy category include commercials advertising Fiber One bars, Honey Bunches of Oats cereal, Nature's Path granola, Nestle fruit yogurt, and Musselman's apple sauce. The non-food related television commercials include commercials advertising All-State car insurance, Geico car insurance, State Farm car insurance, Travelers car insurance, and Liberty Mutual car insurance. The three neutral non-food related commercials that will remain the same in each condition are commercials advertising Fifth Third bank, Ally bank, and Capital One bank.
The specific aims and hypotheses are:
1. Women exposed to a television show with commercials imbedded advertising food will consume more food than women exposed to a television show with non-food related commercials.
2. Women will consume more food when exposed to a television show with commercials advertising 'unhealthy' food as compared to a television show with commercials advertising 'healthy' food.
3. Women will consume the most food when exposed to a television show with 'unhealthy' food commercials and have 'unhealthy' snack foods available to consume.
#Intervention
- OTHER : Healthy Foods
- While watching the tv show, participants will receive a healthy snack to eat (grapes and baby carrots).
- OTHER : Unhealthy Snack Foods
- While watching the tv show, participants will receive an unhealthy snack to eat (potato chips and chocolate chip cookies).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 30 years
* have a body mass index between 18.5 and 24.9 kg/m2
* Be a restrained eater (scoring >12 on Three Factor Eating Questionnaire
* Report being a non-smoker
* Perceive foods and commercials used in the study as appropriately classified in the study.
Exclusion Criteria:
* Currently dieting for weight loss
* Currently taking any medications that affect appetite or food intake
* Have a medical condition affecting eating or are currently following a therapeutic diet
* Report disliking foods used in the investigation
* Report having allergies to foods used in the investigation
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01694043
|
{
"brief_title": "The Effect of Watching a Television Show on the Liking of Snack Foods",
"conditions": [
"Measure Grams and Kcals of Snack Foods Consumed in Each Condition"
],
"interventions": [
"Other: Healthy Foods",
"Other: Unhealthy Snack Foods"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01694043",
"official_title": "The Effect of Perceived Healthy and Unhealthy Commercials on Intake of Perceived Healthy and Unhealthy Snack Foods in Normal Weight, College-Aged, Dietary Restrained Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-07",
"study_start_date(actual)": "2012-08"
},
"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)": "2018-04-05",
"last_updated_that_met_qc_criteria": "2012-09-24",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-26",
"first_submitted": "2012-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.
Detailed Description
The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.
Tolerability and blinding will also be evaluated using standard side effect questionnaires.
#Intervention
- DEVICE : Active HD-tDCS
- Participants will receive active HD-tDCS at 3mA for 20 minutes
- Other Names :
- HD-tDCS
- DEVICE : Sham HD-tDCS
- Participants will receive sham HD-tDCS
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals with intact cognitive functioning.
* Participants will be age >= 50 years.
Exclusion Criteria:
* Individuals with a documented history of cognitive impairment.
* A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
* Sensory or motor impairments that limit the ability to take part in the study
* A significant history or current use of alcohol or drug abuse/dependence
* Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
* Participants with an Mini Mental State Examination score <24 at screening.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03034954
|
{
"brief_title": "Patient Centered-Rehabilitation ver111090.1",
"conditions": [
"Cognitive Change"
],
"interventions": [
"Device: Sham HD-tDCS",
"Device: Active HD-tDCS"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03034954",
"official_title": "Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-10",
"study_start_date(actual)": "2016-10"
},
"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)": "2018-08-16",
"last_updated_that_met_qc_criteria": "2017-01-26",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-27",
"first_submitted": "2016-10-24",
"first_submitted_that_met_qc_criteria": "2018-07-17"
}
}
}
|
#Study Description
Brief Summary
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 64Cu-TLX592.
Detailed Description
The optimisation dose and imaging conditions will be conducted in prostate cancer patients with with oligometastatic disease ( (defined as 5 sites or less outside of the prostate bed). On determining the optimal dose and imaging conditions, an additional cohort of patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions will be assessed.
Study conduct:
Nine, prostate cancer patients with oligometastatic disease as detected using 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning (defined as 5 sites or less outside of the prostate bed) will be randomised to one of three treatment groups to receive a single injection of:
* Group 1: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu.
* Group 2: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
* Group 3: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg). If one of the three patients in a specific group experiences a dose-limiting toxicity, three more patients will be treated at the same dose level.
Patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions \[regions: prostate bed, pelvic lumph nodes, skeleton, distant sites (including viscera)\] as detected on 68Ga-PSMA or 18F-DCFPyl PMSA imaging agent will be allocated to a fourth group.
• Group 4: based on the result of Groups 1-3, the optimal dose and imaging timepoints will be selected to treat 3 patients with higher tumour burden (≥10 metastatic sites and/or visceral disease as detected on a 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CTscan).
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours post administration of the investigational product. The additional scans after the 20h timepoint will be at the discretion of the investigator. Patients will be imaged on a Siemens Biographe scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 0, 1 and potentially at 36-120h the biodistribution and tumour imaging will be performed using gated or list mode acquisition, for generation of sub-partitioned data.Such data will allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial.
An end of study visit will be conducted on Day 28 ± 2 days. 64Cu-TLX592 images will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to TLX592). All image data analyses will be performed / confirmed centrally.
Pharmacokinetic analysis:
Blood samples will be taken at the following times and counted in a gamma counter:
* Pre-dose
* 1, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592.
#Intervention
- DRUG : 64Cu-DOTA-TLX592
- TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
- Other Names :
- 64Cu-TLX592
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Biochemically recurrent metastatic adenocarcinoma of the prostate, or metastatic primary adenocarcinoma of the prostate.
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
* PSMA-expressing prostate adenocarcinoma as seen on 68Ga-PSMA-11 or 18F- DCFPyl PSMA PET/CT scanning within the last 1 month showing PSMA-avid disease.
* ECOG performance status of 0 - 1.
* Normal organ function and marrow reserve:
* White blood cell (WBC) count >= 2.5 x 109/L or absolute neutrophil count (ANC) >= 1.5 x 109/L.
* Platelets >= 100 x 109/L.
* Haemoglobin >= 90g/L.
* Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5 - 2x ULN, must have a normal conjugated bilirubin).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 2.0 x ULN (or
* 5.0 x ULN in the presence of liver metastases).
* Serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 mL/min.
Exclusion Criteria:
A patient is excluded from participation in the trial if one or more of the following criteria are met:
* Known active brain metastases.
* Serious active infection (as assessed by investigator).
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or haematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Known or suspected allergies, hypersensitivity, or intolerance to the IMP or its excipients.
* Other investigational agents within 4 weeks of randomization.
* Radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 64Cu-TLX592 or continuing adverse effects (> grade 1) from such therapy [Common Terminology Criteria for Adverse Events (CTCAE) version 5].
* Previous administration of any radionucleotide within 10 half-lives of 64Cu.
* Inability to understand, or unwilling to sign, a written informed consent document or to follow investigational procedures in the opinion of the investigator.
* Patients who are unable to maintain self-care.
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04726033
|
{
"brief_title": "64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)",
"conditions": [
"Metastatic Prostate Cancer"
],
"interventions": [
"Drug: 64Cu-DOTA-TLX592"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT04726033",
"official_title": "A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-30",
"study_completion_date(actual)": "2024-01-29",
"study_start_date(actual)": "2021-08-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-01",
"last_updated_that_met_qc_criteria": "2021-01-22",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-27",
"first_submitted": "2020-10-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The current study concerns Cardiags Trimod, a new non-invasive medical device for cardiac examinations. The evaluation of its effectiveness is done relative to specific standard devices.
Detailed Description
Cardiags Trimod, the subject of this study, is a new medical device for rapid and early detection of some of cardiac abnormalities, easy to use by non-cardiologists and portable wherever the patient is. Cardiags Trimod, consisting of a device and software, allows simultaneous recording, visualization and analysis in real time of signals characteristic of cardiac function. It assists healthcare professionals by measuring characteristic time intervals of cardiac function by crossing the various signals, by detecting abnormal rhythms, and murmurs.
The study aims to assess the essential requirements : the effectiveness and safety of the device. The study is a research involving the human person.Cardiags Trimod is a medical device with low risk. There is no identified risk for the patient.The patient sample tested consists of sick and healthy individuals. The use of Cardiags Trimod is part of the patient's usual consultation. The identified Gold standards are EKG and echocardiography.
#Intervention
- DEVICE : Diagnostic study, experimental evaluative cross-sectional study
- This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device
- Other Names :
- Noinvasive multisensors cardiac examination
|
#Eligibility Criteria:
Inclusion Criteria:
* Persons suitable for receiving an echocardiogram and an electrocardiogram,
* People who signed the consent form,
Exclusion Criteria:
* Protected and vulnerable people,
* People refusing to participate in the study,
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05162599
|
{
"brief_title": "Evaluation of Cardiags Trimod for Analysis of Cardiac Activity",
"conditions": [
"Murmur, Heart",
"Rhythm; Abnormal"
],
"interventions": [
"Device: Diagnostic study, experimental evaluative cross-sectional study"
],
"location_countries": [
"France"
],
"nct_id": "NCT05162599",
"official_title": "Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-08",
"study_completion_date(actual)": "2023-06-08",
"study_start_date(actual)": "2022-06-08"
},
"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)": "2024-01-25",
"last_updated_that_met_qc_criteria": "2021-12-06",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-17",
"first_submitted": "2021-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.
Detailed Description
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option. All patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50 mg administered either once, twice or three times a day. In this study a maximum tolerated dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3 patients will be added. If the dose is intolerable for \>3/6 patients then the previous level will be declared the MTD. Once an MTD has been determined an additional 10 patients will be added at the MTD to better define the expected toxicities.
#Intervention
- DRUG : Perifosine
- DRUG : Gemcitabine
|
#Eligibility Criteria:
Inclusion Criteria
* Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent gemcitabine would be an appropriate treatment option
* At least 18 years
* Patients may have received no more than two prior chemotherapy regimens
* Patients must have a life expectancy of more than 3 months.
* Patients must have a performance status of 0 to 2 according to the ECOG criteria
* Patients must have normal organ and marrow function as defined in the protocol.
* Patients must have recovered from any acute toxicity related to prior therapy, including surgery or radiotherapy.
* Patients must be able to ingest oral medications.
* Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception.
* Patients must have ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Patients may not be receiving any other investigational agents or devices.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine. HIV-positive patients not receiving combination anti-retroviral therapy must be approved by the study chair prior to entry.
* Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
* Radiation therapy to > 50% of marrow producing sites.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00398697
|
{
"brief_title": "Phase I Perifosine and Gemcitabine Study",
"conditions": [
"Neoplasms"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00398697",
"official_title": "Phase 1 Trial of the Combination of Perifosine and Gemcitabine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-01",
"study_start_date(actual)": "2004-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-02-13",
"last_updated_that_met_qc_criteria": "2006-11-13",
"last_verified": "2007-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-14",
"first_submitted": "2006-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.
Detailed Description
A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.
#Intervention
- DRUG : letrozole
- Letrozole 2.5 mg daily
- Other Names :
- Femara
|
#Eligibility Criteria:
Inclusion Criteria:
* evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
* on hormone replacement therapy
* postmenopausal
* increased risk of developing breast cancer based on personal or family history
* never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
* women who have a high risk of breast cancer
* older than 18 years
Exclusion Criteria:
* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth
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
|
NCT00291135
|
{
"brief_title": "Protocol for Women at Increased Risk of Developing Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: letrozole"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00291135",
"official_title": "Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2003-01"
},
"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)": "2016-06-15",
"last_updated_that_met_qc_criteria": "2006-02-10",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-13",
"first_submitted": "2006-02-10",
"first_submitted_that_met_qc_criteria": "2014-01-08"
}
}
}
|
#Study Description
Brief Summary
This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.
#Intervention
- DRUG : Standard chemotherapy
- As prescribed
- DRUG : bevacizumab [Avastin]
- 7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
|
#Eligibility Criteria:
Inclusion Criteria:
* childhood and adolescent patients aged >=6 months to 18 years
* metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
* adequate bone marrow function
* adequate renal and liver function
* adequate blood clotting
Exclusion Criteria:
* previous malignant tumors
* tumor invading major blood vessels
* prior systemic anti-tumor treatment
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00643565
|
{
"brief_title": "A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.",
"conditions": [
"Sarcoma"
],
"interventions": [
"Drug: Standard chemotherapy",
"Drug: bevacizumab [Avastin]"
],
"location_countries": [
"France",
"Israel",
"Netherlands",
"Poland",
"Chile",
"Germany",
"Canada",
"Russian Federation",
"Spain",
"Brazil",
"Italy",
"Belgium",
"Czechia",
"United Kingdom"
],
"nct_id": "NCT00643565",
"official_title": "An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05-31",
"study_completion_date(actual)": "2019-04-30",
"study_start_date(actual)": "2008-07-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-22",
"last_updated_that_met_qc_criteria": "2008-03-25",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-26",
"first_submitted": "2008-03-20",
"first_submitted_that_met_qc_criteria": "2016-01-15"
}
}
}
|
#Study Description
Brief Summary
This clinical observational study investigates perioperative oxygen consumption and delivery in elderly patients undergoing major surgery. The primary objectives are to characterise the perioperative oxygen delivery, consumption and potential markers of oxygen debt. Secondary objective is to estimate the correlation between oxygen delivery/consumption and postoperative outcomes to guide the design of a future trial.
Detailed Description
Background Intra- and postoperative fluid therapy aims to achieve or maintain pre-specified thresholds of oxygen delivery/blood flow which can be accomplished by use of fluids with or without inotropic drugs. The used thresholds of oxygen delivery were suggested over 40 years ago, in considerably younger patients compared to the current patients. Update of the characteristics of perioperative oxygen delivery and consumption is reasonable in modern clinical settings.
Primary outcome:
relative changes of oxygen consumption induced by anaesthesia
Secondary outcomes:
relative changes of oxygen consumption and delivery during surgery and postoperatively, oxygen extraction ratio (measured and estimated), potential markers of oxygen debt frequency of in-hospital postoperative complications, mortality (30 Days)
Population:
Men and women ≥65 years undergoing major/complex surgical procedures, when intra-operative cardiovascular monitoring is justified according to clinical decision.
Intervention: no study related intervention, general anaesthesia and surgery according to clinical routine
Blinding: no blinding
Study size:
Pilot study 1: feasibility assessment of study protocol of intra-operative measurements (n= max 10) Pilot study 2: feasibility assessment of study protocol of postoperative measurements (n= max 10) Main study: 60 subjects (20+´40) Planned analysis of oxygen consumption after 20 monitored subjects
Study duration:
Duration of haemodynamic monitoring 24-36 hours Duration of observation of clinical outcomes: 7-10 days, mortality at 30 days postop.
Investigational events:
monitoring of oxygen consumption and delivery monitoring of postoperative clinical outcomes monitoring of markers of tissue injury
Assessments, Procedures and Schedule of Investigational Events:
Subjects are identified by the operation planning list and assessed for eligibility. The study information will be given verbal during the first hospital visit. Subjects who give written informed consent will be included in the study.
Measurements:
oxygen consumption by indirect calorimetry via face mask (in awake state) and via expiratory extension tube of anaesthesia machine (unconscious state) cardiac output monitoring via arterial line (LiDCO) blood samples: arterial and venous blood gase samples, Troponin-T urine samples: N-gal
Clinical outcomes:
Data collection from medical records on postoperative complications using the POMS (postoperative morbidity survey) screening survey at days 3,7 and 10. Postoperative mortality at day 30.
#Intervention
- OTHER : General anaesthesia and major surgery
- The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged >=65 years
* Major/complex surgery (BUPA AXA classification of surgical severity)
* Central and arterial venous catheterization for hemodynamic monitoring.
* Written informed consent
* Available research team for the measurements If two subjects are eligible the elder one will be chosen. If there are two subjects eligible of different gender and almost the same age, the subject with a gender that is underrepresented by two or more will be chosen. This is consistent with the purpose of including subjects with as high age as possible without interfering with recruitment.
Exclusion Criteria
* Concomitant medication with Lithium (interferes with calibration of the LiDCO monitor)
* Weight<= 40 kg.
* Not possible to establish arterial or central venous line.
* Planned postoperative care at high-dependency unit (POP/IMA) <12hrs.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03355118
|
{
"brief_title": "Oxygen Extraction and Delivery in Elderly During Major Surgery",
"conditions": [
"Impaired Oxygen Delivery",
"Surgery",
"Postoperative Complications",
"Peroperative Complication"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT03355118",
"official_title": "Exploring New Grounds in Physiology of the Elderly- Oxygen Extraction and Delivery During Anaesthesia and Major Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-23",
"study_completion_date(actual)": "2018-04-04",
"study_start_date(actual)": "2017-11-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-30",
"last_updated_that_met_qc_criteria": "2017-11-22",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-28",
"first_submitted": "2017-11-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
Detailed Description
Subacromial pain syndrome (SAPS) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. Repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain.
Studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. In addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. These kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. This change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. In addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. Kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula.
Exercise and mobilization applications are frequently applied in subacromial pain syndrome. Strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. Studies on increasing thoracic mobilization are limited in number. In these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. There is only one pilot study that examined the effect of mobilization applied to the thoracic region. The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
#Intervention
- OTHER : Exercise Group
- The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes.
- OTHER : Thoracic Mobilization Group
- The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes. Thoracic mobilization will be applied to segments where passive accessory movement is insufficient or painful. 30 repetitions/4 sets will be applied to each determined segment. Thoracic mobilization will be performed with the patient lying prone position.
|
#Eligibility Criteria:
Inclusion Criteria:
* Thoracic kyphosis angle > 40°
* Full active shoulder abduction
Exclusion Criteria:
* Bilateral shoulder pain
* Rotator cuff tear
* Shoulder/cervical injury other than SAPS
* Surgery history
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
|
NCT06374004
|
{
"brief_title": "The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome",
"conditions": [
"Subacromial Pain Syndrome"
],
"interventions": [
"Other: Exercise Group",
"Other: Thoracic Mobilization Group"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06374004",
"official_title": "The Effect of Thoracic Mobilization on Pain Intensity, Muscle Tone, Functional and Muscle Activity Level in Individuals With Subacromial Pain Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-05",
"study_completion_date(actual)": "2024-07-05",
"study_start_date(actual)": "2024-04-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-26",
"last_updated_that_met_qc_criteria": "2024-04-16",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-18",
"first_submitted": "2024-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Irish Potato (IP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron IP variety and a normal market level IP variety. The study is conducted in Peruvian women of reproductive age with marginal iron status.
Detailed Description
The 40 women enrolled will consume test meals consisting of 500g steamed and mashed high iron Irish potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57 for a period of 10 days. The order of test meal type is random. A baseline blood sample will be taken on the first meal feeding day prior to consumption of any test meals, study day 15 (before switching to the other test meal IP variety), on study day 26 (14 days after completion of the first test meal period) and on Day 40 (14 days after completion of the second test meal period). Erythrocyte incorporation of the stable isotope labels will be measured in these blood samples using an ICPMS and will be used to calculate fractional and total iron absorption from the two different type of test meals.
#Intervention
- OTHER : High Fe IP meal labelled with Fe-58
- 500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
- OTHER : Control OFSP meal labelled with Fe-57
- 500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Woman aged 18 <= age <= 25 years.
* Low/marginal iron status: serum ferritin (SF) <= 25 μg/L.
* Normal BMI for age (18.5 <= age <= 25.0 kg/m2).
* Weight less than 65 kg. We will give equal amounts of stable isotopes to each study participant and therefore need to set a limit on body weight in order to achieve measurable isotope enrichment in erythrocytes.
* Willing and able to commute to the meal distribution/health centre site.
* Able to understand and to sign written concept prior to trial entry.
* Informed consent signed.
* Prepared to use contraceptives for the duration of the study
Exclusion Criteria:
* Severe anaemia Hb <107.2 g/L (adjusted for meters above sea level)
* Inflammation/infection (CRP > 5 mg/100 ml).
* Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, and any other problem that will interfere with the study as determined by the screening visit and by self-report from the subjects.
* Pregnant (urine test before entering the study) or breast-feeding.
* Any medication or supplement which may impact iron metabolism.
* Unwilling to discontinue vitamin and minerals supplements at least two weeks prior to the study start, as ascertained at the screening visit.
* Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation).
* Subject who cannot be expected to comply with study procedures.
* Presence of fever (>37.5 °C) on the first study day
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04216030
|
{
"brief_title": "IP Peru, Bioavailability of Iron From Potatoes",
"conditions": [
"Iron-deficiency",
"Iron Deficiency Anemia",
"Iron Deficiency (Without Anemia)"
],
"interventions": [
"Other: High Fe IP meal labelled with Fe-58",
"Other: Control OFSP meal labelled with Fe-57"
],
"location_countries": [
"Peru"
],
"nct_id": "NCT04216030",
"official_title": "Iron Bioavailability From Iron Bio-fortified Irish Potato in Peruvian Women Between 18-25 Years of Age.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-08",
"study_completion_date(actual)": "2019-08-08",
"study_start_date(actual)": "2019-05-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-13",
"last_updated_that_met_qc_criteria": "2019-12-29",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-02",
"first_submitted": "2019-12-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
First aim is to determine the effect of mother and father kangaroo care on the premature baby's Comfort Behavior level and physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature). Second aim is to determine the effect of mother and father kangaroo care on Parental Satisfaction and Neonatal Intensive Care Parental Stress level.
The study was a a randomized crossover study with pretest-posttest design. It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 19 mother and 19 father and their premature newborns between February 2023 and August 2023.
Detailed Description
In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes. The order of mother and father application was determined randomly.
Data were collected using Physiological Parameters Form, Neonatal Comfort Behavior Scale, Parental Satisfaction Scale and Neonatal Intensive Care Unit Parental Stress Scale.
In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Neonatal Intensive Care Unit Parental Stress Scale and Parental Satisfaction Scale scores of parents were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.
#Intervention
- OTHER : kangaroo care application
- In the study, the mother applied kangaroo care to her premature baby for 65 minutes, and after a 24-72 hour washout period, the father applied kangaroo care for 65 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
For premature infants;
* The baby is born before 36+6 weeks of gestation Stability of vital parameters at the time of application, Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),
For parents;
* Willingness to participate in the research
* Being able to read and write Turkish
Exclusion Criteria:
For premature infants;
* Being connected to a mechanical ventilator
* Congenital or chromosomal abnormality
* Being with deprivation syndrome
* Having a history of intraventricular hemorrhage
For parents:
* Not being willing to care for kangaroos
* Having a physical disability to care for kangaroos
Sex :
ALL
Ages :
- Minimum Age : 26 Weeks
- Maximum Age : 37 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06195410
|
{
"brief_title": "The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants",
"conditions": [
"Kangaroo Care"
],
"interventions": [
"Other: kangaroo care application"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06195410",
"official_title": "The Effect of Mother and Father Kangaroo Care on Newborn and Parent Outcomes in Premature Infants: A Randomized Cross Over Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-12",
"study_completion_date(actual)": "2023-08-18",
"study_start_date(actual)": "2023-02-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-10",
"last_updated_that_met_qc_criteria": "2023-12-22",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-08",
"first_submitted": "2023-12-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study to compare AZD4831 pharmacokinetic (PK) parameters between participants with severe renal impairment and matched healthy volunteers following a single dose administration.
Detailed Description
All participants will receive a single oral dose of AZD4831 under fasted conditions and will be involved in the study approximately 2 weeks after dosing and up to approximately 38 days from screening.
Approximately 10 participants will be enrolled into each of the 2 cohorts parallelly and receive the study intervention to achieve 8 evaluable participants in each cohort.
* Cohort 1: 10 participants with severe renal impairment (Estimated glomerular filtration rate \[eGFR\] of ≥15 to \<30 mL/min/1.73m\^2)
* Cohort 2: 10 matched healthy volunteers with normal renal function (eGFR of ≥90 mL/min/1.73m\^2).
The study will comprise of the following study periods:
* Screening period (21 days): participants will be screened for eligibility.
* Treatment period (3 days): participants will be admitted to the study centre in the evening of (Day -1) the day before administration of a single oral dose of AZD4831 (Day 1), and will be discharged after at least 24 h post-dose (Day 2).
* Follow-up period (13±2 days): participants will attend 5 visits at the study centre for PK sampling and safety assessments on Days 3, 5, 8, 11 and 15.
#Intervention
- DRUG : AZD4831
- Participants will receive a single dose of AZD4831 administered with 240 mL of water after an overnight fast of at least 10 hours.
|
#Eligibility Criteria:
Inclusion Criteria:
* All participants must be 18 to 80 (inclusive) years of age, at the time of signing the informed consent.
* The age of participants in Cohort 2 (matched healthy volunteers) must not be lesser than 10 years below the lowest age in Cohort 1 (participants with severe renal impairment) or greater than 10 years above the highest age in Cohort 1.
Healthy volunteers only (Cohort 2):
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* An eGFR of >=90 mL/min/1.73m^2 as determined at screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Participants with severe renal impairment only (Cohort 1):
* An eGFR of >=15 to <30 mL/min/1.73m^2 as determined at screening using the CKD-EPI formula.
* Stable renal function.
* If participants are on statin, ACEi/ARB, beta-blocker, diuretic or on any other cardiorenal relevant treatment, the dose should be stable at least 2 weeks prior to screening (Visit 1).
* Body weight of at least 50 kg and body mass index (BMI) within the range >=18 to <=35 kg/m^2.
* BMI of participants in Cohort 2 (healthy volunteers) must not be more than 20% below the lowest BMI in Cohort 1 (participants with severe renal impairment) or more than 20% above the highest BMI in Cohort 1.
* Male or female of non-childbearing potential.
* There should be an equal number of male and female participants in Cohort 2 (healthy volunteers) as in Cohort 1 (participants with severe renal impairment).
1. Male participants: All male participants should use methods of contraception consistent with local regulations for those participating in clinical studies.
2. Highly effective birth control methods are defined as those that can achieve a failure rate of less than 1% per year when used consistently and correctly
3. Female participants: Must have a negative serum pregnancy test at screening and admission to the study centre (Day -1), must not be lactating and must be of non-childbearing potential confirmed at screening.
* Male participants should not donate sperm for the duration of the study and for at least 90 days after the last study follow-up visit.
* Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research.
Exclusion Criteria:
* Any evidence of a clinically significant disease or disorder.
* Positive hepatitis C antibody, hepatitis B virus surface antigen, hepatitis B virus core antibody, or human immunodeficiency virus I or II at screening (Visit 1).
* History of drug or alcohol abuse within 1 year of screening or positive test for drugs of abuse and alcohol at screening and admission to the study centre.
* History of allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD4831or any of the excipients of the product.
* Any of the following signs or confirmation of Corona Virus 2019 (COVID-19) infection
a. Participant has a positive severe acute respiratory syndrome coronavirus 2 reverse transcription-polymerase chain reaction test result within 2 weeks before screening (Visit 1) or between screening and admission to study centre (Visit 2).
(i) Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnoea, sore throat, fatigue) 2 weeks before screening (Visit 1) or between screening and admission to study centre (Visit 2).
(ii) Participant has been previously hospitalised with COVID-19 infection within the last 3 months.
Healthy volunteers only (Cohort 2):
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Participants with severe renal impairment only (Cohort 1):
* Renal transplant participants or participants on dialysis.
* Use of concurrent medication, which affect creatinine clearance such as cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, or quinine within days of admission to the study centre (Day -1).
* Use of drugs with enzyme-inducing properties such as St John's Wort within 7 days or 5 half-lives (whichever is longer) prior to screening (Visit 1).
* Any concomitant medications known to be associated with Torsades de Pointes or strong cytochrome P450 3A4 (CYP3A4) inducers or inhibitors.
Healthy volunteers only (Cohort 2):
* Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol), herbal remedies, megadose vitamins and minerals within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the study intervention and until completion of the follow-up visits.
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
|
NCT04949438
|
{
"brief_title": "A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers",
"conditions": [
"Renal Impairment"
],
"interventions": [
"Drug: AZD4831"
],
"location_countries": [
"Bulgaria"
],
"nct_id": "NCT04949438",
"official_title": "A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-04",
"study_completion_date(actual)": "2022-03-04",
"study_start_date(actual)": "2022-01-21"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-05",
"last_updated_that_met_qc_criteria": "2021-06-25",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-02",
"first_submitted": "2021-06-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Percutaneous nephrolithotomy (PCNL) is the surgical standard for treating large or complex renal stones. The stones are removed by passing a small telescope through the side of the patient directly into the kidney, so the stone can be broken up and the fragments are removed .PCNL can be performed under general anesthesia or spinal anesthesia. SA has some advantage over GA, such as lower postoperative pain, lower consumption of analgesic drugs and avoidance of side effects from multiple medications used in GA.However, SA induced sympathetic block leads to a decrease in the systemic vascular resistance and subsequent drop in the arterial blood pressure. Furthermore, anesthesia for PCNL usually requires a high sensory level reaching T4,resulting in a high incidence (nearly 33%) of hypotension. Also, to meet the long duration of surgery, drugs, ;like dexmedetomidine, are added to intrathecal local anesthetics , increasing the incidence of hemodynamic instability induced by the spinal anesthesia.
Decreasing the systemic vascular resistance (SVR) and the venous return to the heart result in a reflex vasodilation, bradycardia and hypotension. This reflex is called Bezold -Jarisch reflex and is mediated by serotonin receptors (5_HT3) located on the vagus nerve and within the wall of the cardiac ventricles.
Ondansetron; an antiemetic drug used for treatment of perioperative nausea and vomiting, was investigated as a 5HT antagonist for inhibition of Bezold - Jarisch reflex. While some studies proved its efficacy in prevention of spinal anesthesia induced hypotension , other studies could not support this conclusion .
Detailed Description
This study aims to assess the effect of Ondansetron on spinal induced hypotension when bupivacaine and dexmedetomidine are used intrathecally during spinal anesthesia for percutaneous nephrolithotomy.This prospective randomized double-blinded study will be carried out at Urology and Nephrology center, Mansoura University after approval of Institutional Research Board, Faculty of Medicine, Mansoura University. Written informed consents will be obtained from participants after explanation of the used drug and its possible consequences.
Basal readings for blood pressure, heart rate, and ECG analysis and oxygen saturation will be recorded before the start of spinal anesthesia.
Upon arrival to OR, wide bore intravenous access (20 gauge cannula) will be secured for preoperative fluid preloading (10 ml/kg ringer solution intravenously).All patients will be monitored for non-invasive blood pressure (BP), Heart rate (HR) , ECG and pulse oximetry , measurements will be recorded every 5 min for first 30 minutes then every 15 min till the end of surgery .Patients will be randomly divided into two groups, using a computer generated random table;
* Group S:patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
* Group O:patients will be injected with 4mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia Spinal anesthesia will be delivered in the sitting position under complete aseptic condition using 25-gauge spinal needle (quinckle type), the needle will be advanced at level L 4-5 or L 3 - 4. After a clear flow of CSF, 3ml 0.5 % hyperbaric bupivacaine (15mg)will be injected followed by 5 Mcg dexmedetomidine in insulin syringe diluted to 1ml .After anesthesia, patients will be positioned supine immediately, sensory level will be assessed each 2 minutes by pinprick test, a sensory block at T4-6 will be considered sufficient to start surgery.o BP, HR and oxygen saturation will be recorded every 5 minutes for first 30 minutes then every 15 minutes till the end of surgery. Hypotension will be defined as a decrease blood pressure more than 20% of basal BP or decrease systolic than 90 mmHg and will be treated with IV ephedrine (5mg bolus). Bradycardia will be defined as heart rate less than 50 beat / min and will be treated with IV atropine (0.5mg).The maximum level of sensory block will be assessed every 2 minutes till reaching maximum level of sensory block by pin prick test or cold sensation using alcohol swab.The incidence of ECG changes(dysrhythmia, ST changes).The incidence of pruritus.The incidence of nausea and /or vomiting.Postoperative data( HR, BP, SPo2) will be measured every 15 minutes for 2 hours.
#Intervention
- DRUG : Ondansetron group
- patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
- DRUG : Saline group
- patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for PCNL surgery.
* ASA classification I or II
Exclusion Criteria:
* Patient refusal
* Contraindication to spinal anesthesia.
* Known allergy to Ondansetron.
* Uncontrolled hypertensive patient.
* Ischemic heart diseases.
* Moderate to severe stenotic valve lesion.
* Atrial fibrillation.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04891484
|
{
"brief_title": "Effect of Ondansetron on Spinal-induced Hypotension for Percutaneous Nephrolithotomy",
"conditions": [
"Percutaneous Nephrolithotomy"
],
"interventions": [
"Drug: Ondansetron group",
"Drug: Saline group"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04891484",
"official_title": "Effect of Ondansetron on Spinal-induced Hypotension by Using Bupivacaine -Dexmedetomidine Mixture Intrathecally for Percutaneous Nephrolithotomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-01",
"study_completion_date(actual)": "2022-09-01",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-26",
"last_updated_that_met_qc_criteria": "2021-05-13",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-18",
"first_submitted": "2021-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.
Detailed Description
It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.
#Intervention
- OTHER : shotblocker
- shotblocker device
- OTHER : palm stimulator
- palm stimulator
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteering to participate in the research,
* Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
* Conscious and oriented,
* Able to understand and speak Turkish,
* Age range is between 18 <= age <= 65,
* Having no vision or hearing problems,
* Pain score of 2 or less when evaluated with a visual analog scale,
* Able to lie in the right lateral position where injection can be administered,
* Those who have not had an IM injection into the right ventrogluteal area in the last week,
* Body mass index is within the normal range (25.0 <= age <= 29.9 kg/m2) according to WHO,
* Those who have not used any analgesics or muscle relaxants in the last 24 hours,
* Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
* According to his own statement, he has no psychiatric diagnosis,
Exclusion Criteria:
* Having pain anywhere in the body,
* Narcotic type or different analgesic area before application,
* Pregnant or suspected of pregnancy,
* Individuals in menstrual period,
* Receiving chemotherapy and radiotherapy treatment,
* Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
* Those who have disabilities in grasping their hands,
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
|
NCT06381804
|
{
"brief_title": "Effect of Shotblocker and Palm Stimulator",
"conditions": [
"Pain"
],
"interventions": [
"Other: palm stimulator",
"Other: shotblocker"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06381804",
"official_title": "Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-23",
"study_completion_date(actual)": "2024-05-23",
"study_start_date(actual)": "2024-04-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-24",
"last_updated_that_met_qc_criteria": "2024-04-19",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-24",
"first_submitted": "2024-04-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.
#Intervention
- DRUG : Bendamustine hydrochloride
- 70 mg/m2 by intravenous (IV) infusion for up to 2 cycles
- Other Names :
- Ribomustin
- DRUG : Gemcitabine 500 mg
- 500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
- Other Names :
- Gemzar
- DRUG : Gemcitabine 700 mg
- 700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
- Other Names :
- Gemzar
- DRUG : Gemcitabine 1000 mg
- 1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
- Other Names :
- Gemzar
- DRUG : Nivolumab
- 1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles
- Other Names :
- Opdivo
- DRUG : Rituximab
- 375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis: Histologically confirmed diffuse large B-cell lymphoma
* Refractory or relapsed after at least two prior lines of treatment (i.e. induction and salvage regimen) for diffuse large B-cell lymphoma.
* Age 18 <= age <= 70 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 <= age <= 2
* Signed informed consent
* No severe concurrent illness
Exclusion Criteria:
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index <30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.
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
|
NCT03259529
|
{
"brief_title": "Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL",
"conditions": [
"Diffuse Large B Cell Lymphoma"
],
"interventions": [
"Drug: Rituximab",
"Drug: Gemcitabine 500 mg",
"Drug: Gemcitabine 700 mg",
"Drug: Bendamustine hydrochloride",
"Drug: Gemcitabine 1000 mg",
"Drug: Nivolumab"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT03259529",
"official_title": "A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab Combination (BeGeRN) in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-27",
"study_completion_date(actual)": "2020-01-27",
"study_start_date(actual)": "2017-03-27"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"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": "2017-08-22",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-23",
"first_submitted": "2017-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.
Secondary Objectives:
* To assess the pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters.
* To assess the immunogenicity of a single SC dose of alirocumab.
Detailed Description
Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).
#Intervention
- DRUG : alirocumab SAR236553 (REGN727)
- Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
- DRUG : placebo
- Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy male or female subjects.
* Aged 18 <= age <= 45 old.
* Low-density lipoprotein cholesterol >100 mg/dL (2.59 mmol/L).
Exclusion criteria:
* Subjects with any history or presence of clinically relevant illness.
* Serum triglycerides >200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02979015
|
{
"brief_title": "A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: placebo",
"Drug: alirocumab SAR236553 (REGN727)"
],
"location_countries": [
"China"
],
"nct_id": "NCT02979015",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-27",
"study_completion_date(actual)": "2017-11-27",
"study_start_date(actual)": "2016-11-29"
},
"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)": "2017-12-05",
"last_updated_that_met_qc_criteria": "2016-11-29",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-01",
"first_submitted": "2016-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
* To describe the immune response induced by quadrivalent recombinant influenza vaccine (RIV4) and Quadrivalent-inactivated Influenza Vaccine (IIV4) in 18-49 and greater than or equal to (\>=) 50 years of age participants by hemagglutination inhibition (HAI) measurement method.
* To describe the safety profile of all participants in RIV4 and IIV4 groups.
Detailed Description
The duration of each participant's participation was approximately 6 months.
#Intervention
- BIOLOGICAL : Quadrivalent Recombinant Influenza Vaccine (RIV4)
- Solution for intramuscular injection
- BIOLOGICAL : Quadrivalent inactivated influenza vaccine (IIV4)
- Suspension for intramuscular injection
- Other Names :
- Fluarix®
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >=18 years on the day of inclusion.
* Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination.
* Able to attend all scheduled visits and complied with all study procedures.
* Informed consent form was signed and dated.
* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential must had a negative highly sensitive pregnancy test (urine) before the first dose of study intervention.
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria applied:
* Participation at the time of study enrollment, or in the 6 months preceding the study vaccination, or planned participation during the present study period in another clinical study investigating involving an Investigational Medical Product (IMP) (vaccine, drug), medical device, or medical procedure or in any other type of medical research.
* Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.
* Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
* Known or suspected abnormal immune function: immunosuppression, suspected congenital or acquired immunodeficiency based on medical history and physical examination, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
* Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on the Investigator's judgment.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction that in the opinion of the Investigator might interfere with the study conduct or completion.
* Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion (Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection).
* Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
* Personal or family history of Guillain-Barré syndrome.
* Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease-free for >= 5 years).
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a 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:
Yes
|
NCT05144945
|
{
"brief_title": "Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea",
"conditions": [
"Influenza (Healthy Volunteers)"
],
"interventions": [
"Biological: Quadrivalent inactivated influenza vaccine (IIV4)",
"Biological: Quadrivalent Recombinant Influenza Vaccine (RIV4)"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05144945",
"official_title": "A Phase III Randomized, Modified Double-blind, Active-controlled, Multi-center Study to Describe the Immunogenicity and Safety of the Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-01",
"study_completion_date(actual)": "2022-09-01",
"study_start_date(actual)": "2021-12-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-02",
"last_updated_that_met_qc_criteria": "2021-11-17",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-06",
"first_submitted": "2021-11-17",
"first_submitted_that_met_qc_criteria": "2023-08-31"
}
}
}
|
#Study Description
Brief Summary
There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias.
Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is superior to standard therapy based on an association of beta-blockers and Angiotensin-Converting-Enzyme inhibitor (ACE).
Detailed Description
It is a Double Blind Randomized clinical trial Phase IIb of superiority, enrolling two groups: one group treated with the standard of care, defined as the maximum tolerated dosage of any beta blockers and ACE, and placebo versus ANAKINRA in addition to the standard of care in patients treated for an acute Myocarditis.
Patients will be randomized to receive ANAKINRA 100 mg/daily or placebo subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months. Randomization 1:1 will be conducted centrally using the electronic Case Report Form (eCRF).
As an exploratory analysis, a second randomization for ACE discontinuation in patients without left ventricular dysfunction (LVEF \> 50%) at one month post discharge will be performed.
One group will stopped the treatment at one month and the second group will continued the ACE for 6 months. This second randomization is in open label.
#Intervention
- DRUG : ANAKINRA 100 mg/daily subcutaneously
- ANAKINRA 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
- Other Names :
- Kineret
- DRUG : Placebo
- PLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients hospitalized for Acute myocarditis defined as:
* Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) AND Myocarditis proven by MRI in the first 72h after admission
* Age > 18 and <65 years
* Accepting effective contraception during treatment duration (men and women childbearing potential)
* Signed informed consent Normal Coronary angiography or coronary CT Scan (made during the previous year is acceptable) (normal is defined as stenosis < 50%) (In the case of patients under 40 with typical MRI of myocarditis, coronary angiography is not mandatory and left to the doctor's discretion)
Exclusion Criteria:
* Active coronary disease
* Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, treated chronic inflammatory disease, tuberculosis, HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV), Hepatitis B virus (HBV) infection,
* Latex allergy
* Pregnancy, breastfeeding
* Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients, neutropenia < 1,5.10^9/L)
* Renal failure, Creatine Clearance (CrCl) < 30 ml/min (MDRD)
* Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
* History of malignancy
* Non Steroidian Anti Inflammatory drug within the past 14 days
* Anti Tumor Necrosis Factor (TNF) within the past 14 days
* No affiliation to the French Health Care System 'sécurité sociale'
* Hepatic impairment = Child-Pugh Class C
* Mechanical ventilation
* Circulatory assistance
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03018834
|
{
"brief_title": "Anakinra Versus Placebo for the Treatment of Acute MyocarditIS",
"conditions": [
"Acute Myocarditis"
],
"interventions": [
"Drug: Placebo",
"Drug: ANAKINRA 100 mg/daily subcutaneously"
],
"location_countries": [
"France"
],
"nct_id": "NCT03018834",
"official_title": "Anakinra Versus Placebo Double Blind Randomized Controlled Trial for the Treatment of Acute MyocarditIS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-28",
"study_completion_date(actual)": "2022-05-30",
"study_start_date(actual)": "2017-05-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-06",
"last_updated_that_met_qc_criteria": "2017-01-10",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-12",
"first_submitted": "2016-12-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
#Intervention
- DRUG : ALKS 3831
- Oral capsule, daily administration
|
#Eligibility Criteria:
Inclusion Criteria:
* Has a body mass index (BMI) of 18.0 <= age <= 35.0 kg/m^2, inclusive
* Has a primary diagnosis of schizophrenia
* Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
* Appropriate for outpatient treatment
* Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
* Willing and able to provide government-issued identification
* Is in good physical health
* Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
* Additional criteria may apply
Exclusion Criteria:
* Is currently pregnant or breastfeeding
* Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
* Poses a current suicide risk at Visits 1 or 2
* Has a history of poor or inadequate response to treatment with olanzapine
* Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
* Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
* Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
* Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
* Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
* Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
* Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
* Additional criteria may apply
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:
No
|
NCT02804568
|
{
"brief_title": "A Phase 1 Safety Study in Adults With Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: ALKS 3831"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02804568",
"official_title": "A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-22",
"last_updated_that_met_qc_criteria": "2016-06-15",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-17",
"first_submitted": "2016-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Detailed Description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
#Intervention
- OTHER : Pars Plana Vitrectomy
- vitrectomy with and without ILM peeling
|
#Eligibility Criteria:
Inclusion Criteria:
* All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
Exclusion Criteria:
* Complicated cases with advanced proliferative vitreoretinopathy (PVR).
* Patients with retinal vascular disorders and other macular disorders.
* Combined tractional and rhegmatogenous detachment.
* Previous retinal reattachment surgery or Intravitreal injections.
* Glaucomatous patients.
* Patients with corneal opacity which impairs good visualization.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04139811
|
{
"brief_title": "Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD",
"conditions": [
"Retinal Detachment"
],
"interventions": [
"Other: Pars Plana Vitrectomy"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04139811",
"official_title": "Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-15",
"study_completion_date(actual)": "2019-08-15",
"study_start_date(actual)": "2017-03-15"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-25",
"last_updated_that_met_qc_criteria": "2019-10-23",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-25",
"first_submitted": "2019-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.
Detailed Description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: telephone intervention or standard care. You have an equal chance of being assigned to either group.
No matter which group you are assigned to, you will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing during your regularly scheduled visits. You will also be asked to call your doctor and/or nurse right away when your symptoms are severe. The doctor and/or nurse will give you instructions about calling when your symptoms are severe.
You will receive educational material about emotional distress, sadness, and depression in people who are being treated for cancer. The material also will tell you about community resources that are available for people with cancer.
Feedback Group:
If you are assigned to the feedback group, your symptom information will be collected using a telephone system. You will be asked to rate 13 symptoms, such as sadness, emotional distress, and fatigue, on a scale of 0 to 10 using the touch tone key pad of your telephone. The 0 means that you are not having the symptom at all, and the 10 means that the symptom is as bad as you can imagine.
If you rate either of the 2 symptoms of sadness and/or emotional distress as moderate or severe, then the telephone system will send a message to the research staff and your doctor or nurse right away. Only the symptoms of sadness and emotional distress will be reported right away to the doctor or nurse and the research staff. If you answer moderate to severe to any other questions, it will not be sent right away to the doctor, nurse or study staff. The telephone system usually works very well. But, if for any reason the telephone system is not working, the research staff will report any moderate or severe sadness or distress to your doctor or nurse. Your doctor or nurse also will receive a written summary of your symptom ratings before your next clinic visit.
Standard Care Group:
If you are assigned to the standard care group, your symptom information will not be collected using the telephone system. You will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing.
Telephone System:
For patients in the feedback group, the research staff will teach you how to use a telephone system for measuring your symptoms. The research staff also will ask you to practice using the telephone system. The telephone system will call you 1 time a week for 16 weeks. You will be asked to rate your symptoms and how much the symptoms interfere with your life. You can set up a time to receive the phone calls that works best for you. Rating your symptoms using the telephone system will take about 5 minutes for each call.
If you do not answer the telephone system on the first call, then the system will try to reach you 3 more times. If you do not answer after the fourth try, then the research staff will call you to find out why you could not answer the telephone system. If you prefer, the research staff will change the day or time that the telephone system calls you.
Questionnaires and Interviews:
You will be asked to fill out 3 questionnaires during 3 regularly scheduled clinic visits. These questionnaires ask questions about pain, stress, sadness, quality of life, and other symptoms you may be experiencing. You will also compete an interview at the first and third visit. During the interview, you will be asked questions about your feelings and emotions. The questionnaires and interview will be completed at the following times:
* At the first visit when you enroll in the study, 8-10 weeks after the study begins, and 14-16 weeks after the study begins, you will complete the questionnaires. This will take about 45 minutes.
* At the first visit and 14-16 weeks after the study begins, you will complete a short interview. Completing the interview will take about 15 minutes.
Length of Study:
Your participation in this study will last up to 16 weeks.
This is an investigational study.
Up to 166 patients will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- BEHAVIORAL : Telephone Intervention
- Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.
- Other Names :
- Interactive voice response, IVR
- BEHAVIORAL : Questionnaires & Interviews
- 3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.
- Other Names :
- Survey
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cancer
* Self-identified as African American or Latino
* English or Spanish speaking
* 18 years or older
* Receiving treatment in the medical oncology, genitourinary oncology, or gynecologic oncology clinics at LBJ General Hospital
* Reports a level of '4' or greater on the MDASI 'sadness' and/or 'distress' items.
Exclusion Criteria:
1) Not willing to use a telephone to report symptoms.
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
|
NCT00863200
|
{
"brief_title": "Identification and Treatment of Depression",
"conditions": [
"Cancer"
],
"interventions": [
"Behavioral: Telephone Intervention",
"Behavioral: Questionnaires & Interviews"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00863200",
"official_title": "Identification and Treatment of Depression in Underserved African American and Latino Patients With Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-12",
"study_completion_date(actual)": "2019-02-12",
"study_start_date(actual)": "2009-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-28",
"last_updated_that_met_qc_criteria": "2009-03-16",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-17",
"first_submitted": "2009-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The research project aims to understand how pharmacies can be involved in the identification and treatment of hepatitis C (hep C). The study will look at the effectiveness of hep C testing and treatment through pharmacies with support from the Cool Aid Community Health Centre (CACHC). The study will also evaluate the readiness of pharmacies to take on these extra tasks at the pharmacy. This information will be used to develop future strategies to better detect, treat and prevent hep C.
Detailed Description
The primary objective of this project is to decrease barriers to care for hepatitis C (HCV) treatment for people who use drugs through the use of rapid diagnostic testing technologies, and task shifting HCV testing and treatment follow up to include trained pharmacy staff. Secondary objectives are to evaluate interest, readiness, and effectiveness of community-based pharmacies as a location for the screening and treatment of HCV.
A prospective, longitudinal interventional cohort design will be used to enrol people who access community-based pharmacies and have tested for HCV RNA. Persons with untreated chronic HCV infection will receive direct acting antiviral treatment. This is a trial of pharmacist-led HCV testing and treatment versus conventional care in HCV positive patients.
#Intervention
- DIAGNOSTIC_TEST : Hepatitis C Point of Care Testing and Treatment
- Pharmacy led hepatitis C point of care testing
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* Age > 18 years
* Documented HCV RNA test, interested in being tested for HCV antibody or at risk for HCV (ie. 'Baby boomers': anyone born between 1945 <= age <= 1965, anyone known to currently (past 6 months) or have a history of injecting drugs, including anyone receiving Opiate Agonist Therapy (OAT), any gay or bisexual men who have sex with men (gbMSM))
Exclusion Criteria:
1) Declined to provide informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05412017
|
{
"brief_title": "EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV",
"conditions": [
"Hepatitis C"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT05412017",
"official_title": "EPIC: Evaluation of Pharmacy-based Identification and Treatment of HCV",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-30",
"study_completion_date(actual)": "2023-07-30",
"study_start_date(actual)": "2020-07-13"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-07",
"last_updated_that_met_qc_criteria": "2022-06-06",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-09",
"first_submitted": "2022-05-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
#Intervention
- DRUG : Xanomeline and Trospium Chloride Capsules
- Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
- DRUG : Placebo
- Placebo Capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is aged 18 <= age <= 65, inclusive, at screening.
* Subject is capable of providing informed consent.
1. A signed informed consent form must be provided before any study assessments are performed.
2. Subject must be fluent (oral and written) in English or local language to consent
* Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
* Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
1. The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms.
2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
* Positive and Negative Syndrome Scale total score between 80 and 120, inclusive. Score of >=4 (moderate or greater) for >=2 of the following Positive Scale (P) items:
1. Item 1 (P1; delusions)
2. Item 2 (P2; conceptual disorganization)
3. Item 3 (P3; hallucinatory behavior)
4. Item 6 (P6; suspiciousness/persecution)
* Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
* Subject has a CGI-S score of >=4 at screening and baseline (Day -1) visits.
* Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
* Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA) before baseline visit (Day -1).
* Subject is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
* BMI must be >=18 and <=40 kg/m2.
* Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator.
* Subject has an identified reliable informant/caregiver.
* Women of childbearing potential, or men with sexual partners of childbearing potential, must be able and willing to use at least 1 highly effective method of contraception during the study and for 30 days after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of study drug.
Exclusion Criteria:
* Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening). Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment. A screening subject with mild substance abuse disorder within the 12 months before screening must be discussed and agreed upon with the medical monitor before they can be allowed into the study.
* Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
* Subjects with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
* History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
* Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
* Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening.
* Subjects cannot currently (within 5 half-lives or 1 week, whichever is longer, before baseline [Day -1]) be receiving oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (eg, lamotrigine, Depakote); tricyclic antidepressants (eg, imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam, chloral hydrate).
* Pregnant, lactating, or less than 3 months postpartum.
* If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
* Positive test for coronavirus (COVID-19) within 2 weeks before screening and at screening.
* Subjects with extreme concerns relating to global pandemics, such as COVID-19, that preclude study participation.
* Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
* Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or required clozapine within the last 12 months.
* Subjects with prior exposure to KarXT.
* Subjects who experienced any adverse effects due to xanomeline or trospium.
* Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months before screening.
* Risk of violent or destructive behavior.
* Current involuntary hospitalization or incarceration.
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
|
NCT04738123
|
{
"brief_title": "A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)",
"conditions": [
"Schizophrenia",
"Schizophrenia; Psychosis"
],
"interventions": [
"Drug: Placebo",
"Drug: Xanomeline and Trospium Chloride Capsules"
],
"location_countries": [
"Ukraine",
"United States"
],
"nct_id": "NCT04738123",
"official_title": "A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-29",
"study_completion_date(actual)": "2022-12-07",
"study_start_date(actual)": "2021-04-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-09",
"last_updated_that_met_qc_criteria": "2021-02-01",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-04",
"first_submitted": "2021-02-01",
"first_submitted_that_met_qc_criteria": "2024-12-03"
}
}
}
|
#Study Description
Brief Summary
SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects.
Detailed Description
This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment 5. Each subject will participate in only 1 treatment group. The total length of the study for each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study visits).
#Intervention
- DRUG : SHR-1703
- SHR-1703
- DRUG : Placebo
- Placebo of the SHR-1703
|
#Eligibility Criteria:
Inclusion Criteria:
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Able to read, comprehend and write at a sufficient level to complete study materials.
* Aged 18 <= age <= 55 (inclusive).
* Body weight equal or more than 45.0 kg and BMI within the range between 19 and 24kg/m2 (inclusive).
* AST, ALT, alkaline phosphatase and bilirubin equal or less than ULN.
* Healthy Chinese as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Jiangsu HengRui Medicine Co Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Subjects must commit to consistent and correct use of an acceptable method of birth control from the start of trial to the next month after the last visit.
* A negative pre-study drug/alcohol screen.
Exclusion Criteria:
* Allergy/intolerance to the SHR-1703 and/or excipients in the formulation, or any other Biologics
* Positive Hepatitis B surface antigen or positive Hepatitis C antibody or human immunodeficiency virus - HIV antibody or Syphilis serological test at screening
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months, 5 half-lives or fellow-up period of the investigational product (whichever is longer).
* Use of any medicines, including prescription or Over-the-Counter drugs (including herbal and dietary supplements, not including regular vitamins and paracetamol which be used occasionally in the recommended dose) within 1 month or 5 half-lives (whichever is longer) prior to the administration.
* Subjects who have received immune inhibitors within 6 months prior to screening
* Subjects who have had severe trauma or surgery within 6 months prior to screening, or who plan to undergo surgery during the trial.
* Blood donation history within 1 month prior to screening ,or severe blood loss(total blood volume>=400 ml)，or blood transfusion within 2 months
* Subjects who are inoculated live (attenuated) vaccine within 1 month prior to screening or during the trial.
* Subject who is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
* At the discretion of the investigator, a subject will not be eligible for this study if he/she is in the following cases: the subject is not able to complete the study, or present a significant risk to the subject, or present other factors(e.g. infirmity. etc.) that may prevent the enrolment.
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
|
NCT04480762
|
{
"brief_title": "A Trial of SHR-1703 in Healthy Adults",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: SHR-1703",
"Drug: Placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT04480762",
"official_title": "A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1703 Injection Administered Subcutaneously in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-21",
"study_completion_date(actual)": "2021-09-21",
"study_start_date(actual)": "2020-08-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-14",
"last_updated_that_met_qc_criteria": "2020-07-17",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-21",
"first_submitted": "2020-07-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Investigators used in-house-designed radiotherapy red and green light markers to distinguish individual measures after the provision of the initial nursing care to participants, added a homemade health education leaflet to collect data via actual observation, and counted the disappearance or fading of participants' body markers
Detailed Description
From January 1, 2023 to June 30, 2023, a total of 200 participants were enrolled and undergoing radiation therapy. Inclusion Criteria: clear consciousness who could understand and comprehend Mandarin Chinese. Exclusion Criteria: patients with impaired consciousness or decreased cognitive abilities.
Investigators proposed a set of strategic initiatives :
1. Consistent Schedule for the Replacement of Positioning Line Pens: Consistent Schedule for the Replacement of Positioning Line Pens: Investigators recommend implementing a standardized replacement schedule for positioning line pens, with replacement performed after every 50 uses.
2. Tailored Educational Content: Investigators created personalized educational content tailored to each patient's educational background. This approach ensures that participants can easily understand their treatment plan.
3. Hypoallergenic Adhesive Patches: Investigators offered a variety of hypoallergenic adhesive patches, catering to the skin characteristics of individual participants.
4. Enriched Treatment Care Platform: Investigators commitment extended to creating a comprehensive treatment care platform, which provided guidance on positioning line usage, interactive community features, and practical information.
5. Participants with BMI \> 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI \< 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.
6. After implementing the red-green light differentiation for radiation therapy and individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.
The number of times the surface marks disappeared or faded during treatment was recorded on the day the participants completed treatment.
#Intervention
- OTHER : Nursing care
- 1. Consistent Schedule for the Replacement of Positioning Line Pens
2. Tailored Educational Content
3. Hypoallergenic Adhesive Patches
4. Enriched Treatment Care Platform
5. Participants with BMI \> 25 and an education level of high school or below, without specific caregivers, were identified by placing a red dot on the treatment record and on the patient's happiness card. Patients with BMI \< 25 and an education level of high school or above, with specific caregivers, were identified by placing a green dot on their records.
6. Individual interventions, educational pamphlets prepared in-house were added, to assess the maintenance status of the positioning marks.
|
#Eligibility Criteria:
Inclusion Criteria:
* participants with clear consciousness.
* participants could understand and comprehend Mandarin Chinese.
Exclusion Criteria:
* participants with impaired consciousness or decreased cognitive abilities.
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
|
NCT06132295
|
{
"brief_title": "Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer",
"conditions": [
"Radiation Therapy",
"Cancer Patients",
"Tattooing"
],
"interventions": [
"Other: Nursing care"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT06132295",
"official_title": "Adoption of Multiple Strategies to Reduce the Rate of Marker Detachment During Radiotherapy in Patients With Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-30",
"study_completion_date(actual)": "2023-06-30",
"study_start_date(actual)": "2023-01-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-15",
"last_updated_that_met_qc_criteria": "2023-11-13",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-15",
"first_submitted": "2023-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.
Detailed Description
C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease has increased in this population. Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50% of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma. To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection, a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection. In order to show 30% difference between the two groups in reducing one point of fibrosis score (METAVIR scale), 150 patients are needed. The duration of the study is 96 weeks
#Intervention
- BIOLOGICAL : Peginterferon alpha-2a (Pegasys®)
- Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly
- DRUG : Ribavirin
- Ribavirin: tablet oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over 75 kg, once daily
- DRUG : HIV antiretroviral therapy
- All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
- DRUG : HIV antiretroviral therapy
- All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV infection (Western Blot +)
* C hepatitis (RNA viral hepatitis C [VHC] +)
* Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1 and F over or equal to 2) on biopsy performed at least 18 months before the expected date of inclusion
* Previous treatment for C hepatitis for at least 3 months including peg-interferon and ribavirin or peg-interferon alone if counterindication for ribavirin occurred
* Failure to eradicate C hepatitis virus after well conducted treatment
* The liver biopsy should have been realised at least 18 months before inclusion :
Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6 months after anti HCV treatment in patient treated for more than 7 months (wash out period)
* Regular follow up in an outpatient clinic for HIV
* Unchanged antiretroviral treatment the last 3 months before inclusion
* Inform consent
Exclusion Criteria:
* History of transplantation or clinical hepatic failure
* Opportunistic infection in the past three months before inclusion
* Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)
* Diabetes mellitus
* Immunocompromised treatment
* Active intravenous drug addiction
* Alcohol consumption of more than 50 g per day
* Counterindication for the use of interferon
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
|
NCT00122616
|
{
"brief_title": "Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C",
"conditions": [
"HIV Infections",
"Hepatitis C, Chronic"
],
"interventions": [
"Drug: HIV antiretroviral therapy",
"Drug: Ribavirin",
"Biological: Peginterferon alpha-2a (Pegasys®)"
],
"location_countries": [
"France"
],
"nct_id": "NCT00122616",
"official_title": "Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV. ANRSHC12 Fibrostop",
"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)": "2003-11"
},
"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)": "2012-02-22",
"last_updated_that_met_qc_criteria": "2005-07-19",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-07-22",
"first_submitted": "2005-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fasting conditions.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
#Intervention
- DRUG : Lamotrigine 25 mg Chewable Tablets
- 2 x 25 mg, single-dose fasting
- DRUG : Lamictal® 25 mg Chewable Tablets
- 2 x 25 mg, single-dose fasting
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects will be females and/or males, non-smokers, 18 years and older.
* Female subjects will be post-menopausal or surgically sterilized.
* Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
* Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Exclusion Criteria:
* Clinically significant illnesses within 4 weeks of the administration of the study medication.
* Clinically significant surgery within 4 weeks prior to the administration of the study medication.
* Any clinically significant abnormality found during medical screening.
* Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
* Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
* Abnormal laboratory tests judged clinically significant.
* Positive urine drug screen at screening.
* Positive testing for hepatitis B, hepatitis C or HIV at screening.
* ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.
* Subjects with BMI >= 30.0.
* History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit - 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
* History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PVP) and crack) within 1 year of the screening visit.
* Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
* History of allergic reactions to lamotrigine.
* Use of any drugs known to induce or inhibit drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
* Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
* Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
* Subjects who have dentures or braces.
* Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follow: less than 300 mL of whole blood within 30 days; 300 mL to 500 mL of whole blood within 45 days; more than 500 mL of whole blood within 56 days.
* Positive alcohol breath test at screening.
* Subjects who have used tobacco in any form within 90 days preceding study drug administration.
* Female subjects: breast-feeding subjects.
* Female subjects: positive urine pregnancy test at screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00838279
|
{
"brief_title": "Lamotrigine 25 mg Chewable Tablets, Fasting",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Lamictal® 25 mg Chewable Tablets",
"Drug: Lamotrigine 25 mg Chewable Tablets"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00838279",
"official_title": "Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fasting Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-03",
"study_completion_date(actual)": "2002-03",
"study_start_date(actual)": "2002-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-19",
"last_updated_that_met_qc_criteria": "2009-02-05",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-06",
"first_submitted": "2009-02-05",
"first_submitted_that_met_qc_criteria": "2009-06-30"
}
}
}
|
#Study Description
Brief Summary
With increasing demands on the environment people are looking in different ways to decrease their carbon footprint. Protein is an important part of human diets a it provides building blocks for growth and helps to ensure people stay health. Animal protein is one of the primary sources of of protein from our diets but it is also known that farming cattle for example places a lot of pressure on the environment. As a result of this new protein sources are being looked at that can take the place of animal protein. Insects have been consumed on many civilisations for a long time and they are slowly making their way into the western diets.
At this time the investigators however do not know very much about how well insect protein compares to animal protein as a nutritious food source. This research project is therefore one of the first to compare some of the nutritional properties between animal and insect proteins.
In brief, this study involves eating a sweet breakfast muffin made of either whey (animal) protein powder or cricket flour (very finely ground whole adult crickets) and then breathing into test tubes at various time points for a few hours as well as collecting some small amounts of blood using a finger stick to measure blood glucose and fats.
Detailed Description
Insects have been used as protein source for many years in East-Asian and African populations, and more recently the interest in this potential protein source has been growing in Western countries due to the issues outlined above and increased awareness of animal welfare issues in the food chain. However, up until now there is no clear evidence that insect-derived protein has the same nutritional properties as its animal counterpart. Even though nutritional composition of insects can be similar or sometimes even better to support a healthy diet certain properties of the insects (such as the chitin in their exoskeleton) could have detrimental effects on their bioavailability. Gastric emptying (GE) describes the process of food being digested and absorbed by the controlled delivery from the stomach into the duodenum (1.). In the field of nutrition, GE is important, since a slower rate of GE can lead to a lower postprandial rise in macronutrients, and consequently a lower postprandial burden on their clearance. To date it is known that certain food properties such as volume, calories, and viscosity, as well as physiological factors such as age and gender can influence the gastric emptying rate (1.). However, the interaction between human physiology and different food in the stomach is widely unknown.
A slower GE rate is particularly important regarding postprandial plasma triacylglycerol concentrations, with impaired clearance being related to inflammation and cardiovascular disease. The attenuation of the postprandial increase in blood glucose has long been a goal for improved metabolic health. As reviewed, small differences in GE can have a major impact on postprandial glycaemia in health and type 2 diabetes (2.). Furthermore, a slowed gastric emptying rate as a result of certain types of food is associated with a delayed reoccurrence of feeling of hunger and can influence satiation.
The 13C octanoic acid breath test is a relatively cheap, non-invasive, and simple test to measure GE. The test is performed via the ingestion of a controlled meal containing the commercially available non-harmful stable isotope 13C in a short chain fatty acid (C8) and the following detection of the 13Clabelled CO2 in the breath (3.).
The data generated by the breath test is commonly analysed with a one compartment model based on Ghoos et al (1993) (4.) to generate parameters such as half time and lag time. More advanced semi mechanistic models are used in pharmacokinetics and could be applied to the breath test.
#Intervention
- DIETARY_SUPPLEMENT : Cricket Protein
- Participants are provided with muffins containing either whey or cricket protein.
|
#Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy adult males and females between 20 and 55 years
* BMI between 18.5 and 35 kg/m2
* Weight stable for 3 months (± 2 kg)
* Volunteers must be able and willing to give informed written consent
* Volunteers must be able to eat egg (because egg is required for preparation of the stable isotope dosage see section experimental design).
Exclusion Criteria:
* Previous or current medical conditions, including heart disease, diabetes, gastrointestinal diseases (for example Crohn's disease, Coeliac disease, Inflammatory Bowel Disease), liver disease, endocrine diseases - assessed via a health questionnaire (appendix)
* Those taking (or have been taking within the past 6 months) regular medication, excluding contraceptive medication, or food supplements (e.g., vitamins, minerals, fish oil, fibre supplements, antioxidant tablets) - assessed via a health questionnaire (appendix) Those smoking, using nicotine products (e.g., e-cigarettes, patches) or not abstained from these activities for more than 6 months
* Pregnant or lactating
* Volunteers with a habitual caffeine intake > 300 mg/day (more than 5 cups standard coffee)
* Drug or alcohol abuse in the last 2 years
* The principal investigator considers it unsafe / unsuitable for the volunteer to be in the study
* Those who are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
* Those who do not refrain from alcohol, caffeine containing drinks (e.g., coffee, coca cola, tea, Red Bull) and strenuous exercise 10 hours before the laboratory session
* Those with food allergies, dietary intolerance (especially for egg), or Coeliac disease
* Those following weight reducing diets
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
|
NCT06771804
|
{
"brief_title": "Cricket Flour Metabolism in Humans",
"conditions": [
"Nutrition, Healthy"
],
"interventions": [
"Dietary Supplement: Cricket Protein"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT06771804",
"official_title": "Cricket Flour Metabolism in Humans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-01",
"study_completion_date(actual)": "2025-01-08",
"study_start_date(actual)": "2022-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-16",
"last_updated_that_met_qc_criteria": "2025-01-07",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-13",
"first_submitted": "2025-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative procedure for hematological malignancies. It is now well known that this property is related to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in or generating from the donor graft. For years, however, and despite this unique antitumoral activity, Allo-HSCT has been restricted to a limited number of patients due to two major limitations: the toxicity of the procedure and the absence of a donor for every single patients. More recently the stage has dramatically changed with respect to these two restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT in older patients but the availability of MRD is even less frequent in elderlies, likely related to medical contraindication for graft donation or sibling deaths. UD are routinely used but associated with a high incidence of GVHD. As compared to younger populations, unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with age due to the feared risk of supposed increased lethal infectious complications related to the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative donors allowing for a safe and efficient transplantation is still unmet. In consequence, overall, despite the fact that Allo-HSCT feasibility has been established in the oldest patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT performed in a population with the higher incidence of hematologic malignancies that usually present with the poorest prognosis.
Thus it is critical developing innovative efficient therapeutic strategies answering this unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in this aged population. It offers the potential advantage to offer a rapid donor determination for virtually every single patient. In addition, our data suggest that in elderlies haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower costs (no graft purchase and low post-transplant complications rate) and better QOL likely related to low cGVHD-rate. In addition the conduct of such trial at a time when the diffusion of the strategy in this population is just starting is really crucial before widespread uncontrolled dissemination.
The investigators propose to address this question by prospectively comparing these 2 strategies in elderly patients without MRD, in terms of efficacy, safety and including the prospective evaluation study of quality-of-life (QOL). They will conduct a national, multicenter, open-label, comparative, randomized phase III trial in patients with hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has not been identified.
When MRD search is recognized to be a failure, patients will be included in the clinical trial after informed consent and randomized in the two strategies based on donor search:
* Reference group: Unrelated Donor group
* Investigational group: Haplo Donor Group
Investigators will use a composite end-point embracing the three main causes of failure: death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT usual objectives as GHVD, NRM, relapse and survival. A specific study of patients' health related quality of life will also be conducted using the FACT-BMT questionnaire. In addition, the success of the two strategies in term of transplant completion (donor determination, transplant realization and time to do so) will be compared.
#Intervention
- BIOLOGICAL : Allogeneic (Allo) hematopoietic stem cell transplantation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged of 55 years or up to 70 years.
* Patients with hematological malignancy
* Patients without a matched related donor
* Patients eligible for an allogeneic HSCT from an alternative donor
* Able to comply with the protocol
* Written informed consent
* Affiliation to Social Security System
Exclusion Criteria:
* Clinical or biological contraindication to allogeneic HSCT
* Other evolutive cancer
* Positive serology for HIV, hepatitis B or chronic active hepatitis C
* Pregnant or breast-feeding women.
* Emergency
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02623309
|
{
"brief_title": "Studyof Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor in Elderly Patients",
"conditions": [
"Hematologic Neoplasms"
],
"interventions": [
"Biological: Allogeneic (Allo) hematopoietic stem cell transplantation"
],
"location_countries": [
"France"
],
"nct_id": "NCT02623309",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-02",
"study_completion_date(actual)": "2021-03-12",
"study_start_date(actual)": "2016-02-23"
},
"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)": "2023-01-31",
"last_updated_that_met_qc_criteria": "2015-12-02",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-07",
"first_submitted": "2015-11-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to measure perioperative anxiety in children from 2 to 10 years old in two distinct homogeneous groups before and after the ride in electric cars versus bed travel in the operating room.
The secondary objectives will be to measure the anxiety at the induction, the pain and the agitation of the children in SSPI as well as the satisfaction and the lived experience of the parents during the ambulatory stay of their child in the two groups journey in electric cars versus trip in bed.
It is a prospective, randomized, single-centric observational study (small electric cars versus bed-ridden), focusing on children during their stay in the operating theater at the CHU Nord of Marseille for ENT and ophthalmic surgery.
This study on the use of electric cars as a means of locomotion within the block may lead to other multicenter studies.
Detailed Description
Peri operative anxiety is one of major issues of pediatric anesthesia. Our efforts to decrease children anxiety improve pain, agitation ans behavioral changes during post operative period. Guidelines in pediatric anesthesia are to take into account anxiety in order to enhance recovery after anesthesia and to develop ambulatory surgery.
Pharmacological and non pharmacological tools are used. Midazolam is a benzodiazepin widely used but its indesirable effects such as paradoxical reactions, prolonged sedation and adverse behavioral changes are a brake to enhance recovery after anesthesia programs. Non pharmacological procedures are more promising (parental presence, behavioral preparation programs and distraction) but their etablishment is time consuming, requiring teaching programs, and changing habits. To our knowledge, distraction with ride-on car has not been studied yet.
Little electric car can carry children aged 2 years and more, it can be driven by children under adult distant command. Weight is limited to 35 kg (x pounds). Our hospital has 3 differents car models which allow children to choose for their prefered one et to become part of the adventure. Parental separation could be favored by this device.
Surgical procedures are ophtalmologic and oto rhino laryngologic, in an ambulatory ward receiving children ASA 1 to 3. Anesthesic procedure is the same for every child, inhalatory induction with sevoflurane following by perfusion for morphinic administration and oral intubation. To note, premedication is avoided and replaced by important information and reinsurrance of parents.
Chlidren will be randomised by block every week to go to operating room using gurney (goup a) or ride-on electric car (group b). Primary outcome is peri operative pediatric anxiety measured by Yale validated scale (m-YPAS). Other outcomes concern post opérative period (anxiety, pain, agitation), parental lived and satisfaction.
PTIBOLID is a monocentric prospective randomised controlled open study wich will include 110 patients in hopital Nord, Marseille, AP-HM.
#Intervention
- BEHAVIORAL : Using electric car
- Child will use little electric cars to go to the reception of operating theatre to operating room.
|
#Eligibility Criteria:
Inclusion Criteria:
* Children operated in ENT and ophtalmology
* Max 35 kg (advice from little electric car manufacturer)
* 2 years minimum (psychomotor coordination)
* 10 years maximum
* Ambulatory unit
Exclusion Criteria:
* < 2 years
* Cognitive and physical impairment that forbids the use of cars
* Refusal of cooperation of the child
* Emergency surgery
* Consent of one of the parents for the study
* Refusal of cooperation of the parents
* Lack of understanding of the study
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03961581
|
{
"brief_title": "Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery",
"conditions": [
"Anxiety"
],
"interventions": [
"Behavioral: Using electric car"
],
"location_countries": [
"France"
],
"nct_id": "NCT03961581",
"official_title": "Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery: a Randomised Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-08",
"study_completion_date(actual)": "2021-04-08",
"study_start_date(actual)": "2019-08-30"
},
"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)": "2022-07-28",
"last_updated_that_met_qc_criteria": "2019-05-22",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-23",
"first_submitted": "2019-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.
Detailed Description
There is presently no efficient therapy available in progressive MS, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. There are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. One specific feature of long-standing MS is that inflammatory cells accumulate in the central nervous system(CNS) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. Administration of substances via the Intrathecal (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery
#Intervention
- DRUG : Rituximab
- 25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.
- Other Names :
- Mabthera
|
#Eligibility Criteria:
Inclusion Criteria:
* Between the age of 18 and 65 years (nonfertile women or fertile women with effective contraceptive methods)
* Progressive MS since at least three years
* Some kind of documented progression of neurological symptoms during the previous two years.
* Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)
* Conventional therapy not indicated, contraindicated or failed
* Judged as compliant with the protocol
Exclusion Criteria:
* Eligible for any of the conventional MS therapies
* Relapsing remitting multiple sclerosis (RRMS)
* Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
* Cognitive defect making informed consent unreliable
* Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist
* Severe, uncontrolled heart disease
* Pregnant or lactating women
* Patients having contraindication for or otherwise not compliant with MRI investigations
* Documented vulnerability to infections
* Simultaneous treatment with other immunosuppressive drugs
* Documented allergy or intolerance to Rituximab
* Severe psychiatric condition
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01719159
|
{
"brief_title": "Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis",
"conditions": [
"Progressive Multiple Sclerosis"
],
"interventions": [
"Drug: Rituximab"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT01719159",
"official_title": "Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2009-11"
},
"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)": "2016-11-22",
"last_updated_that_met_qc_criteria": "2012-10-29",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-01",
"first_submitted": "2012-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. There will be two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.
Detailed Description
This is a First Time in Human (FTIH) study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single, escalating doses of intranasal (i.n.) GSK2245035 in healthy male volunteers (HVT) and male subjects with allergic rhinitis (AR). The safety and tolerability of single i.n. GSK2245035 dosing will be assessed and established in HVT before the initiation of evaluation in AR.
GSK2245035 is a highly selective Toll-like Receptor 7 (TLR7) agonist capable of preferentially inducing the production of IFNα rather than TNFα. Activation of TLR7 is known to result in upregulation of co-stimulatory signals on antigen-presenting cells and in generation of pro-inflammatory mediators that can shift bystander immune responses towards a Helper T-cell Type 1/ Regulatory T cell (Th1/Treg) phenotype and therefore reduce the magnitude of Helper T-cell Type 2 (Th2) reactivity. In this context, it is proposed that i.n. GSK2245035 administration may alter the airways immune environment in a way that results in long-lasting control of AR symptoms and potentially disease remission through persistent modification of the underlying aberrant Th2 responsiveness to aeroallergens.
The aim of this study is to collect tolerability, PK and PD information to enable the identification of appropriate safe doses of i.n. GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. The study will be divided in to two parts. Part 1, involving only healthy volunteers, will consist of 8 cohorts receiving doses from 2 nanograms (2 ng) to 4000ng or a placebo dose. Administration within each cohort will be staggered so that two subjects (one receiving drug and one placebo) will be dosed and monitored for 24 hours before any subsequent doses.
Screening for part 2 of the study will begin once data from cohort 4 in part 1 has been found to be satisfactory. Part 2 will involve subjects with Allergic Rhinitis and be divided into three cohorts receiving doses between 20ng and 4000ng or a placebo dose.
#Intervention
- DRUG : 2 ng GSK2445053
- 2ng GSK2445053 administered intranasally
- DRUG : 20ng GSK2445053
- 20ng GSK2445053 administered intranasally
- DRUG : 100ng GSK2445053
- 100ng GSK2445053 administered intranasally
- DRUG : 200ng GSK2445053
- 200ng GSK2445053 administered intranasally
- DRUG : 400ng GSK2445053
- 400ng GSK2445053 administered intranasally
- DRUG : 1000ng GSK2445053
- 1000ng GSK2445053 administered intranasally
- DRUG : 2000ng GSK2445053
- 2000ng GSK2445053 administered intranasally
- DRUG : 4000ng GSK2445053
- 4000ng GSK2445053 administered intranasally
- DRUG : Placebo
- Placebo administered intranasally
|
#Eligibility Criteria:
Inclusion Criteria for all subjects (parts 1 and 2)
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history,physical examination, laboratory testsand cardiac monitoring. A subject with a clinical abnormality or laboratoryparameters outside the reference range for the population being studied may be included only if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Male between 18 and 55 years inclusive, at the time of signing the informed consent.
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1 of the protocol. This criterion must be followed from the time of the first dose of study medication until one week post-dosing.
* Body weight greater than or equal to 50 kilograms (kg) and Body Mass Index (BMI) within the range 19 - 29.9 kilograms per square metre (kg/m2) inclusive.
* 12 lead Electrocardiogram without any clinically significant abnormality as judged by the Investigator, and average QT interval (QTc), QT interval corrected for Basett (QTcB) or QT interval corrected for Fredericia (QTcF) less than 450 milliseconds
* Aspartate transaminase (AST), alanine transamine (ALT), alkaline phosphatase and bilirubin less than 1.5 x Upper Limit of Normal (ULN) (isolated bilirubin greater than1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
* Subjects have a screening pre-challenge Forced Expiratory Volume in 1 second (FEV1) greater than or equal to 80% and a baseline FEV1/FVC greater than or equal to 70% of the predicted value.
* Subjects should refrain from smoking between screening and the end of the study, and have a negative test for cotinine/ carbon monoxide (CO) at pre-dose.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Available to complete all the required study measurements.
Inclusion Criteria for Allergic Rhinitics only (Part 2)
* History and diagnosis of symptomatic seasonal allergic rhinitis to pollen, for more than 3 years.
* Positive skin allergy test (wheal greater than or equal to 4miliimetres) or radioallergosorbent test (RAST) greater than or equal to Class 2, for pollen allergens.
* Subjects have a Total Nasal Symptom Score (TNSS) score of greater than or equal to 3 during the current pollen season (Total nasal symptom score is the sum of nasal congestion, rhinorrhoea, nasal itch and sneeze, each of which are scored on a scale from 0 to 3).
Exclusion Criteria for all subjects (Parts 1 and 2):
* History of immunologic or haematologic deficiencies or diseases, except conditions that in the opinion of the Investigator and the GSK Medical Monitor are unlikely to introduce additional risk factors.
* Current diagnosis of asthma.
* Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
* History of haematologic, gastro-intestinal, hepatic, renal or other condition that may influence the absorption, distribution, metabolism, excretion or action of the drug.
* History of frequent headaches and/or migraine.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive test for Human Immunodeficiency Virus antibody
* A positive screening or pre-dose drug/alcohol screen, or a positive pre-dose smoking test
* History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 grams (8g) of alcohol: a half-pint or approximately 240 millilitres (240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* The subject has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
* Exposure to more than four new chemical entities within 6 months prior to the first dosing day.
* History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in this study.
* Donation of blood or blood products in excess of 500 mL within a 90-day period.
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated
Exclusion Criteria for healthy volunteers only (part 1)
* History of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry to the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Exclusion criteria for Allergic Rhinitics only (part 2)
* Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry into the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Subjects using treatment for allergies and AR may participate in the study if they remain free of medication for the following periods of time prior to entry into the clinic:
* Nasal antihistamines: 48 hours
* Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 72 hours
* Oral antihistamines B (all others): 72 hours
* Nasal decongestants: 24 hours
* Oral decongestants: 24 hours
* Nasal glucocorticosteroids: 4 weeks
* Oral glucocorticosteroids: 12 weeks
* Oral leukotriene receptor antagonists: 7 days
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01480271
|
{
"brief_title": "An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics.",
"conditions": [
"Rhinitis, Allergic, Seasonal"
],
"interventions": [
"Drug: 2000ng GSK2445053",
"Drug: 400ng GSK2445053",
"Drug: 20ng GSK2445053",
"Drug: 2 ng GSK2445053",
"Drug: 100ng GSK2445053",
"Drug: 1000ng GSK2445053",
"Drug: 4000ng GSK2445053",
"Drug: 200ng GSK2445053",
"Drug: Placebo"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01480271",
"official_title": "A Randomized, Double-blind, Placebo-controlled First Time Into Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Dosing With GSK2245035, a TLR7 Agonist, in Healthy Volunteers and Allergic Rhinitics",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09-30",
"study_completion_date(actual)": "2011-09-30",
"study_start_date(actual)": "2011-05-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"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": "2011-11-23",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-28",
"first_submitted": "2011-11-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized double-blind, placebo-controlled trial with individuals who have chronic Achilles tendinopathy (AT). This study investigates the effects of education on outcomes (specified in hypotheses below) related to participation in an exercise program. Participants will be randomized to one of two educational programs. All participants will receive the same exercise intervention. This study will consent and randomize 66 participants, who will complete 2 in-person evaluation sessions (baseline, 8-week follow-up), 8 treatment sessions with a physical therapist (between baseline and 8-week follow-up), and 1 online evaluation sessions (12-week follow-up).
We hypothesize that 1) a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT, 2) exercise will improve all three pain mechanisms examined in this RCT (increased PPT, decreased kinesiophobia, increased number of heel raises).
Detailed Description
This feasibility randomized controlled trial was designed to address the following aims:
Specific Aim 1 examines if education on central pain mechanisms (i.e. biopsychosocial approach) compared to education on peripheral pain mechanisms (i.e. standard of care utilizing a biomedical approach) is more effective at reducing pain and disability in a pilot RCT exercise program for Achilles tendinopathy. We hypothesize that a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT.
Specific Aim 2 determines which central pain mechanisms (nociplastic pain, pain psychology, motor dysfunction) are improved by an exercise program, regardless of education group. We hypothesize that exercise will improve all three central pain mechanisms (increased PPT, decreased kinesiophobia, increased number of heel raises).
A total of 66 adults with chronic Achilles tendinopathy (AT) will be enrolled (consented and randomized) in this single-site pilot randomized controlled trial (RCT). All data will be collected at a single site within an academic medical center. A pilot RCT comparing effectiveness of exercise with pain education to standard of care, i.e. exercise with biomedical education. Participants will be randomized to treatment group using a permuted block randomization scheme stratified by sex and AT type (insertional and midportion). Participants will complete up to 7 treatment sessions over an 8-week period. With an anticipated 10% dropout rate, we plan to analyze data on 30 adults with chronic AT per group.
Participants will complete 2 evaluation sessions at baseline and 8-week follow-up. Evaluation sessions will involve the following 4 types of testing.
1. Clinical exam (including ultrasound imaging)
2. Questionnaires (demographics, symptom description, and psychological) Private, identifiable information will be collected via questionnaires administered online and in-person. All data will be entered into a University of Iowa REDCap database, which is maintained by University of Iowa ITS staff.
2) Movement analysis and verbal pain rating Participants' motion and force will be captured as they walk, perform heel raises, hop, and do calf stretches within a 3-dimensional motion analysis with force plates flush with the floor. To monitor pain level throughout participation, we will have participants verbally rate their pain with each task.
3) Sensory testing (Pain pressure threshold at the hamstring and Achilles bilaterally; Conditioned pain modulation at the Achilles)
In addition, participants will complete questionnaires at 12-weeks. Participants will attend 7 treatment sessions over approximately 8 weeks. Over this time period participants will complete the following procedures
1. Questionnaires (exercise adherence, educational quizzes, symptom description) This private, identifiable information will be collected via questionnaires administered online and in-person. All data will be entered into a University of Iowa REDCap database, which is maintained by University of Iowa ITS staff.
2. Exercise participation Participants will be given exercises to do at home in between treatment sessions. Participants will receive instruction from a physical therapist prior to doing the exercise at home.
3. Education Participants will be given homework and online quizzes to do at home in between treatment sessions. The physical therapist will review the educational material with the participant at each visit.
In addition, a research team member will access the medical records of participants with Achilles tendinopathy to gain information about the participant's medical history and imaging related to Achilles tendinopathy.
The sample size was based on a power analysis for the primary outcome measures of Specific Aims 1 and 2.
Specific Aim 1: This analysis will compare the between group (biopsychosocial vs biomedical approach to education) changes in pain and disability scores from baseline to 8 weeks and to 12-week follow-up for participants with AT participating in an exercise program. Based on findings from Moseley et al. for an RCT comparing a 4-week exercise program with education on central pain mechanisms to standard of care in 49 patients with chronic low back pain, we anticipate between group differences with Cohen's d greater than or equal to 0.36 for pain (between group difference across 2 time points=0.75, SD of 1.05 on the NPRS, effect size of f=0.36) and disability (between group difference across 2 time points=1.95, SD of 2.33 on low back pain-specific measure, effect size of f=0.42). Under these assumptions, a sample size of 30 patients per group would be needed to reach 80% power for the time averaged difference between two group means in a repeated measures design with alpha equal to 0.025 (Bonferroni correction of 0.05/2 for 2 outcomes in Aim 1) to detect a between group effect size of 0.36.
Specific Aim 2: This analysis will compare the within group changes (baseline to 8-weeks and to 12 weeks) in central pain mechanisms (nociplastic pain, psychosocial factors, motor dysfunction) with an exercise intervention for participants with AT, regardless of educational group. The power analysis for this aim is based on data from 3 studies that have had a moderate to large (Cohen's d greater than or equal to 0.51) treatment effects on central pain mechanisms. A study led by Dr. Sluka previously found that massage improved PPTs 2 days after an intense exercise protocol with a large effect size (27.6%, SD=14.7%, effect size= 1.88). Cai et al. found that a 4-week cognitive behavioral therapy program reduced fear of movement by 8.1 points with a SD of 5.44 (effect size= 1.5). Based on our preliminary data from the K99 phase, there was a mean improvement of 3.4 repetitions (SD of change= 6.7) in heel rise performance after an anesthetic injection for the AT group (effect size=0.51). We used the smallest and population-specific anticipated effect size of 0.51 to calculate the sample size for Aim 2. Type I error rate of alpha equal to 0.017 (Bonferroni correction of 0.05/3 for 3 outcomes in Aim 2) will be used for this aim to adjust for the multiple comparisons. The sample size of 60 patients calculated for Aim 1 would allow us to detect an effect size of d greater than or equal to 0.43 with 80% power under these assumptions.
The normality of the continuous data will be tested by the Shapiro-Wilk test and by examining the quantile-quantile plot. Normally distributed Continuous variables will be presented as mean plus or minus SD for normally distributed data and median with interquartile ranges for non-normally distributed data. When the normality assumption is not met, transformation, such as log, will be used to complete planned parametric analyses. Type I error rate will be maintained at 0.05 by using Bonferroni adjustment for multiple comparisons. First, potential differences between group demographics at baseline will be examined univariately using two independent samples t-tests and chi-square tests, as appropriate. If differences are observed, these variables will be used as covariates in the multivariable models.
A modified intention-to-treat principle will be followed, which will include outcome data on all participants based on the group they were randomized and complete evaluation at 8 weeks. We will also compare patient characteristics of those who remained in the study to those who dropped out to determine if data at subsequent time points is consistent with missing at random.
For Aim 1 we will assess the effect of the interventions on the primary outcomes for pain (NPRS) and disability (PROMIS physical function) from baseline to 8-weeks and to 12-week follow-up using linear mixed model for repeated measures. Similarly, for Aim 2 a linear mixed model for repeated measures will assess the effect of the interventions by group on the primary outcomes for central pain mechanisms (nociplastic pain: PPT, psychosocial factors: TSK, motor control: heel raises) from baseline to 8 weeks. For Aims 1 and 2, the factors in the linear mixed model will include group and time effects. In addition, the significance of the group\*time interaction term, where the group\*time interaction tests if the change over time differs between groups, will also be tested. We will also assess for normality, linearity, homoscedasticity, and independence of residuals for the multiple regression models (dependent variables: pain and disability). Statistical significance will be defined by alpha greater than or equal to 0.05.
Analyses for secondary outcome measures of central sensitization, psychological factors, motor control, pain and disability for Aims 1 and 2 will be performed using the same statistical tests described above. Secondary analyses on sex will examine potential sex-based differences in both Aims 1 and 2 to inform sample size estimates for future clinical trials. The analyses described above for each aim will be expanded to explore the effect of sex as a fixed factor and examine interactions with group and time. Using the same data analysis strategy as described for sex, a secondary analysis on AT type (insertional vs. midportion) will also be assessed for Aims 1 and 2 to inform recruitment strategies for future clinical trials.
#Intervention
- OTHER : Pain Education and Exercise
- Participants will be randomly assigned to a pain education group, following biopsychosocial model, or standard of care education, following biomedical model. The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. Participants will be given weekly online exercises to promote engagement with the material, give individual feedback to participants, and assess understanding. In person sessions with the physical therapist will reinforce self-learning and application to a home exercise program.
- OTHER : Standard Education and Exercise
- The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary source of pain localized to Achilles tendon insertion or midportion
* Localized pain at least 3/10 in the Achilles tendon (midportion, insertion, unilateral or bilateral) during walking, heel raises, or hopping
* Pain that increases (>1 point on 11-point scale) with increasing load
Exclusion Criteria:
* Younger than 18 years
* Inability to read and write in English
* Achilles tendon pain for less than 3 months
* History of Achilles tendon rupture that was verified with surgical or conservative management
* History of invasive intervention (surgery, tenex) for AT on more painful side
* Non-invasive treatment (physical therapy, nitroglycerine patch, iontophoresis, injection) for AT in the past 3 months
* Diagnosed with systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g. Uncontrolled Type I or II diabetes, Diabetic peripheral neuropathy), connective tissue disorder (e.g. Marfan's syndrome)
* Cardiovascular conditions that may be exacerbated by a 90 second submersion of hand in cold water (Raynaud's, cold contact uticaria)
* History of taking fluoroquinolones within the past 3 months
* History of corticosteroid injection to foot/ankle/leg within the past 3 months
* Foot and ankle pain primarily due to other pathology, such as posterior impingement, bursitis, paratendonitis, sural nerve injury, ankle osteoarthritis, or radicular/referred symptoms (pain, altered sensation, weakness, altered reflexes) from lumbar spine into lower extremities
* Four step square test >15 seconds
Additional exclusion criteria for online only visits:
* Unable to successfully complete virtual visits with a webcam and/or Prefer only in-person visits
* Virtual Fall risk assessment: Stay Independent score >4[56]
* Symptoms indicating need for in-person blood pressure monitoring: 1) Inconsistent use of HTN meds, and/or 2) any recent/current associated symptoms with uncontrolled HTN
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
|
NCT04059146
|
{
"brief_title": "Tendinopathy Education on the Achilles",
"conditions": [
"Achilles Tendinopathy"
],
"interventions": [
"Other: Pain Education and Exercise",
"Other: Standard Education and Exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04059146",
"official_title": "Tendinopathy Education on the Achilles",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-09",
"study_completion_date(actual)": "2021-03-10",
"study_start_date(actual)": "2019-09-18"
},
"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)": "2024-03-01",
"last_updated_that_met_qc_criteria": "2019-08-14",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-16",
"first_submitted": "2019-08-12",
"first_submitted_that_met_qc_criteria": "2022-04-12"
}
}
}
|
#Study Description
Brief Summary
A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.
#Intervention
- DRUG : Levetiracetam
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.
* Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.
* Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.
* Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1.
* Male/female children >= 12 years or adult <= 65 years at Visit 1.
* Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.
Exclusion Criteria:
* Previous exposure to levetiracetam.
* History of partial seizures.
* History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1.
* Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.
* Subject taking any drug (except the concomitant AEDs) with possible CNS effects.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00150774
|
{
"brief_title": "Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults",
"conditions": [
"Generalized Convulsive Epilepsy"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00150774",
"official_title": "A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Years) Suffering From Idiopathic Generalized Epilepsy With Myoclonic Seizures.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-12",
"study_completion_date(actual)": "2004-12",
"study_start_date(actual)": "2001-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-17",
"last_updated_that_met_qc_criteria": "2005-09-06",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-08",
"first_submitted": "2005-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty.
The study evaluates tools, supported by the latest scientific advances in 'machine learning' to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.
Detailed Description
The 5P research program is a 6-years program that started in 2016.
Its objective is to set up tools, supported by the latest scientific advances in 'machine learning' to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.
The diversity and transversal nature of the research disciplines in this program make it original. This allows it, through common protocols, to explore the concept of frailty and the care pathway of the elderly through different prisms of complementary observations.
This program is deployed in three stages: proof of principle, proof of concept (called 5P-PILOT) and 'the Scaling up' (called 5P-ECHELLE). It combines an evaluation of the acceptability of technological detection tools, a measurement of the impact of prevention workshops on the loss of autonomy among independent frail elderly people and an evaluation of tools to help detect frailty.
The ageing of the population poses a real societal challenge. The loss of autonomy, which is the result of multiple individual or environmental factors for the ageing person, has a costly impact in terms of recourse to care and on the people around them. It is therefore urgent to act on the levers of frailty by acting as early as possible to prevent its irreversibility.
The '5P ECHELLE' project aims to develop a semi-automatic and non-medical method for detecting weak signals of frailty in older people, by combining standardized clinical indicators for assessing their state of robustness with large-scale intelligent detection devices that allow for longitudinal monitoring, while integrating the necessary participatory dimension of the subject.
#Intervention
- DIAGNOSTIC_TEST : Instrumental measurement of balance and gait
- The balance measurement was performed on a force platform. The walk test was carried out using sensors to analyze and retrieve data from the participant's walk (gait speed, step length, duration of the double support phase).
|
#Eligibility Criteria:
Inclusion Criteria:
* Persons > 65 years
* Retired persons
* Person affiliated to or benefiting from a social security scheme.
* Free and informed consent given
Exclusion Criteria:
* Persons referred to in Articles L1121 <= age <= 5 to L1121 <= age <= 8 of the French Public Health Code (corresponding to all protected persons), pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
* Difficulty in understanding the French language
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05090241
|
{
"brief_title": "Frailty Prevention in Elders From Reunion Island",
"conditions": [
"Geriatric Assessment",
"Frail Elderly Syndrome",
"Prevention",
"Fall Patients"
],
"interventions": null,
"location_countries": [
"Réunion"
],
"nct_id": "NCT05090241",
"official_title": "Frailty Prevention in Elders From Reunion Island: Detection of Frailty, Age-related Issues and Risk of Falling Among Community Dwelling Elderly",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-27",
"study_completion_date(actual)": "2023-12-27",
"study_start_date(actual)": "2021-11-01"
},
"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)": "2024-05-13",
"last_updated_that_met_qc_criteria": "2021-10-11",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-22",
"first_submitted": "2021-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.
#Intervention
- DRUG : SGN-00101
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.
* Patients with documented RRP
* Subject is surgically debulked within 7 days before the first dose of SGN-00101.
* Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries.
* Subject is free of life threatening or serious concomitant disorders other than the disease under study.
* Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator.
Exclusion Criteria:
* Subject has disease or status that causes compromise of the immune system.
* Subject has a history of ionizing radiation therapy to the respiratory tract.
* Patient has used concomitant medications that may suppress the immune system.
* Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study.
* Subject has participated in a past study with SGN-00101
* Pregnancy and lactation.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00038714
|
{
"brief_title": "A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis",
"conditions": [
"Papilloma",
"Recurrent Respiratory Papillomatosis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00038714",
"official_title": "A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-01",
"study_start_date(actual)": "2001-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-06-27",
"last_updated_that_met_qc_criteria": "2002-06-04",
"last_verified": "2007-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-06-05",
"first_submitted": "2002-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ventriculoperitoneal shunting (VPS) was first described at the beginning of the 20th century as a diversionary procedure in patients with a hydrocephalus. After the introduction of silastic catheters in the 1970's this method became the treatment of choice for children and adults with communicating hydrocephalus. The average patient necessitating VPS will undergo at least two shunt revisions every three years, with some patients requiring more than twenty revisions within the first year. Therefore, any technical improvement with a positive impact on the revision rate not only benefits the patient through a reduction of the surgical burden but may also have economic advantages.
Distal shunt failures - either due to improper placement or secondary dislocation of the distal catheter out of the peritoneal cavity - have been reported in 10-30% of cases. Catheter placement in obese patients and in patients with adhesions owing to previous abdominal surgery remains challenging. Most neurosurgeons will carry out a mini-laparotomy to allow for the placement of the distal catheter end within the peritoneal cavity, which rarely requires the help of a general or visceral surgeon.
An alternative to laparotomy is the laparoscopic placement of the peritoneal catheter in VPS. Retrospective series have since shown the safety of this procedure and suggested an advantage of laparoscopic VPS in terms of operation duration, length of hospital stay and the rate of distal (and thus potentially overall) shunt dysfunction.
The evidence concerning the effect of laparoscopic surgery for VPS placement is so far based on non-randomized studies, in which a selection bias may have influenced the outcomes.
Detailed Description
Background
Ventriculoperitoneal shunting (VPS) as diversionary procedure in patients with hydrocephalus was first described in 1908. After the introduction of silastic catheters during the 1970s this method has become the treatment of choice for children and adults with communicating hydrocephalus. However, the average patient having had VPS will undergo 2.1 shunt revisions every 3 years of life, with a wide range from no revisions during the first decade to up to 21 revisions within the first year. For this reason technical improvements impacting positively on the revision rate and on the surgical burden are strongly needed.
In the standard VPS procedure the proximal part of the shunt is first placed in one of the lateral ventricles. The distal part of the shunt is then tunneled subcutaneously from the head to the abdomen, where 20-25 cm of the distal catheter and the tip are introduced in the peritoneal cavity through a paraumbilical mini-laparotomy. The intraperitoneal placement of the distal catheter is performed blindly, whereby the tip of the catheter is directed caudally in direction of the pelvis in order to avoid kinking and potential strangulation of the catheter. In this setting the functionality of the system can be estimated by feeling the resistance to out- and inflow while manually pumping the reservoir near the valve at the cranial level.
Distal shunt failure has been reported to occur in 10-30% of cases. Secondary dislocation of the peritoneal catheter in the subcutaneous tissue or its improper placement in the peritoneal cavity during the procedure both contribute to this high shunt failure rate. Furthermore, blind catheter placement in obese patients and in patients with adhesions from previous abdominal surgery can be a challenge and may lead to injuries of the intra-abdominal organs.
In 1993, Bassauri et al reported on the laparoscopic placement of the peritoneal catheter in VPS. Since then several, small retrospective series have shown good results in laparoscopic VPS, both in terms of efficacy and safety, in adults and in children. Two larger series were published recently. Schubert et al. reported a prospective study on 50 adult patients using the laparoscopically assisted peritoneal shunt insertion. A retrospective cohort of 50 matched patients served as a control. They reported no intraoperative complications, a longer operation time in the laparoscopic group (59 versus 49 minutes), 2 malfunctions (4%) and 1 infection in the laparoscopic group (2%) and 6 malfunctions (12%) and 6 infections (12%) in the historic cohort, the difference being statistically significant in favour of the laparoscopic group. In the most recent and largest series published to date, Bani et al. report on their experience with 151 patients, where the peritoneal catheter was implanted using a laparoscopic technique. They also used a retrospective cohort of 50 non-laparoscopy patients as a control. The operation time was slightly longer using the laparoscopic technique (35-130 versus 30-120 minutes), the infection rate was 2% in both groups. They describe no dislocation of the distal catheter in the abdominal wall and no malpositioning of the distal catheter in the laparoscopic group and 4 such cases in the non-laparoscopy group (8%).
In summary, these non-randomized trials suggest the safety of the procedure. The laparoscopic technique offers at least theoretically some significant advantages over the standard technique. The laparoscopic introduction of the peritoneal catheter allows for intra-abdominal inspection, lyses of adhesions whenever necessary, confirmation of the catheter position, and the visual assessment of cerebrospinal fluid (CSF) flow through the catheter tip during the procedure. Due to the minimal trauma to the abdominal wall the laparoscopic access also has the potential of reducing postoperative adhesions, wound complications and the overall postoperative morbidity. Despite these theoretical advantages, however, comparative, randomized data are lacking and ventriculoperitoneal shunting is still performed through a minilaparotomy in the vast majority of neurosurgical centres. The absence of scientific evidence favouring the laparoscopic technique, the lack of training of neurosurgeons in laparoscopic techniques and the potential prolongation of the operating time (and potentially a higher risk of infection) are probably the main reasons to explain why the shift to the laparoscopic technique has not yet taken place. Also, theoretically, the inflation of the peritoneal cavity for laparoscopy could potentially generate an acute hydrocephalus (e.g. during a distal revision) due to the elimination of the pressure gradient necessary to obtain flow of CSF into the peritoneal cavity.
These potential limitations warrant, in our view, a prospective, randomized, controlled trial comparing the standard (minilaparotomy) technique. The demonstration of the superiority of the laparoscopic technique in a prospective, randomized study has the potential of changing the standard of care for patients with hydrocephalus needing shunting.
Methods
120 patients scheduled for VPS surgery were randomised for laparoscopic or open insertion of the peritoneal catheter. The primary endpoint was the rate of overall shunt complication/failure after 12 months. Secondary endpoints were distal shunt failure rate at 6 weeks, 6 months and 12 months, overall complication/failure at 6 weeks and 6 months, duration of surgery and hospitalisation, and morbidity.
#Intervention
- PROCEDURE : VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter
- Patients in this Study Arm will receive a VP Shunt inserted laparoscopically
- PROCEDURE : VP Shunt Surgery for open insertion of the peritoneal catheter
- Patients in this Study Arm will receive a VP Shunt inserted openly
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* newly diagnosed hydrocephalus needing VP Shunt according to a board certified neurosurgeon
* Patients with shunt-malfunction needing VP Shunt revision and replacement of the peritoneal catheter
* Written Informed Consent
Exclusion Criteria
* Age younger than 18 years
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01739179
|
{
"brief_title": "Keyhole Surgery for the Positioning of the Distal Catheter in Ventricular Peritoneal Shunt Placement",
"conditions": [
"Ventricular Peritoneal Shunt",
"Shunt Complications",
"Shunt Failure",
"Randomized Controlled Trial"
],
"interventions": [
"Procedure: VP Shunt Surgery for open insertion of the peritoneal catheter",
"Procedure: VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01739179",
"official_title": "Laparoscopically Assisted Ventriculoperitoneal Shunt Placement: A Prospective, Randomized Two-arm Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-12-18",
"last_updated_that_met_qc_criteria": "2012-11-27",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-03",
"first_submitted": "2012-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a research study to understand and determine the effectiveness of electronic cigarettes versus nicotine replacement therapy in adults who smoke and also live with HIV/AIDS in effort to reduce cigarette smoking.
Detailed Description
People living with HIV/AIDS (PLWHA) are known to have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. Although a primary rationale for conducting this study is reducing health disparities among PLWHA, there is a potential benefit of the proposed work from a prevention perspective given that combustible cigarette smoking is an independent risk factor for non-adherence to ART and may decrease the effectiveness of HAART. Smoking-related illnesses are leading causes of non-HIV/AIDS-related deaths among People Living with HIV/AIDS (PLWHA). Electronic cigarettes (E-cigarettes) could help people reduce the harm of combustible cigarette (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely by addressing both nicotine and behavioral dependence. Unlike CC, EC are not associated with coronary heart disease or myocardial infarction. The purpose is to identify barriers and facilitators, as well as assess preliminary effectiveness of e-cigarettes as a harm reduction strategy among PLWHA.
#Intervention
- OTHER : Nicotine patch and gum
- Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
- BEHAVIORAL : Minnesota Nicotine Withdrawal Scale (MNWS)
- The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
- BEHAVIORAL : ASSIST (the Alcohol, Smoking and Substance Involvement Screening)
- The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).
- BEHAVIORAL : Counseling
- At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
- OTHER : NIDA Standardized Research E-cigarettes (SREC)
- NIDA SREC has a case with a liquid tank. The e-liquid is supplied in sealed disposable cartridges that deliver \>300 puffs / cartridge. The SREC uses a battery recharged via a micro USB port. A single charge is designed to outlast the capacity of an e-liquid cartridge. The e-liquid is 'tobacco' flavored and contains nicotine.
|
#Eligibility Criteria:
Inclusion Criteria:
* Current Combustible Cigarette (CC) smokers (more than 5 packs in a lifetime; smokes 4 or more days/week),
* Smokes at least 10 cigarettes per day on days they smoke CC.
* Motivated to quit smoking (at least a 5 on a 10-point Likert scale).
* Must be able to provide consent
* Agree to be randomized and followed-up with,
* Reside in New York City
* Be willing to use an e-cigarette or NRT for 12 weeks.
Exclusion Criteria:
* Are pregnant (as determined by urine test) or breastfeeding (self-reported),
* State diagnosis of any medical condition (angina/heart disease) precluding use of nicotine patch or gum, or by self-report in screening questionnaire
* Reporting using NRTs or e-cigarettes or within the last 30 days
* Have untreated/are undergoing current treatment for psychiatric illness or cognitive impairment at time of initial screening as determined by the subjects' primary care doctor or a licensed study team member in screening
* Report a history of severe or untreated cardiopulmonary disease such as asthma or emphysema.
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
|
NCT04218708
|
{
"brief_title": "Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS",
"conditions": [
"Nicotine Addiction"
],
"interventions": [
"Behavioral: Counseling",
"Behavioral: Minnesota Nicotine Withdrawal Scale (MNWS)",
"Other: Nicotine patch and gum",
"Other: NIDA Standardized Research E-cigarettes (SREC)",
"Behavioral: ASSIST (the Alcohol, Smoking and Substance Involvement Screening)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04218708",
"official_title": "Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-15",
"study_completion_date(actual)": "2024-03-08",
"study_start_date(actual)": "2021-06-17"
},
"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)": "2024-12-20",
"last_updated_that_met_qc_criteria": "2020-01-03",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-06",
"first_submitted": "2020-01-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
Detailed Description
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
#Intervention
- DRUG : brentuximab vedotin
- Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
- Other Names :
- Adcetris
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with relapsed or refractory EBV- and CD30-positive lymphomas
* Age >= 18 years
* ECOG performance status 0 <= age <= 2
* At least one measurable lesion based on revised Cheson's or modified SWAT criteria
* Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
* Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
* Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
* Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
* Adequate hematologic function: absolute neutrophil count (ANC) >=1,500/µL, platelet count >= 75,000/µL, and hemoglobin >=8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC >= 1,000/µL and platelet count >= 50,000/µL if there is known bone marrow involvement)
* Adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST < 3 x ULN (AST and AST < 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
* Adequate renal function: serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
* Expected survival > 3 months
Exclusion Criteria:
* Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
* Any serious medical or psychiatric illness
* Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
* Symptomatic neurologic disease compromising normal activities or requiring medication
* Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
* Known history of myocardial infarction within 1 year, NYHA class III/IV heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
* Any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
* Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
* Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
* Prior exposure to CD30-targeted agents
* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
* Known human immunodeficiency virus (HIV) positive
* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
* Another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
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
|
NCT02388490
|
{
"brief_title": "Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas",
"conditions": [
"Relapsed or Refractory EBV-and CD30-positive Lymphomas"
],
"interventions": [
"Drug: brentuximab vedotin"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02388490",
"official_title": "A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-02",
"study_completion_date(actual)": "2019-04-02",
"study_start_date(actual)": "2016-03-25"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-23",
"last_updated_that_met_qc_criteria": "2015-03-09",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-17",
"first_submitted": "2015-02-04",
"first_submitted_that_met_qc_criteria": "2024-05-28"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.
Detailed Description
In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.
Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.
#Intervention
- BIOLOGICAL : MV
- MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
- OTHER : standard treatment
- Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
|
#Eligibility Criteria:
Inclusion Criteria:
* 1.Patients diagnosed with breast carcinoma based on histology
* 2.Evaluable lesions on imaging study
* 3.Without known immunodeficiency
* 4.Age >18 and <80 years ago
Exclusion Criteria:
* 1.Patients is unable or unwilling to sign informed consent
* 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
* 3.Positive HIV and/or RPR (rapid plasma reagin)
* 4.Female patient who is pregnant or breast feeding
* 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study
* 6.Prior anti-cancer vaccine or biological immunotherapy
* 7.Allergic to any known ingredient of the MV compound
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
|
NCT02338804
|
{
"brief_title": "Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient",
"conditions": [
"Breast Neoplasms"
],
"interventions": [
"Biological: MV",
"Other: standard treatment"
],
"location_countries": [
"China"
],
"nct_id": "NCT02338804",
"official_title": "Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-09-10",
"last_updated_that_met_qc_criteria": "2015-01-13",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-14",
"first_submitted": "2015-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.
#Intervention
- DRUG : Methylphenidate
- Patients are tested for their normal prescription methylphenidate medication
|
#Eligibility Criteria:
Inclusion Criteria:
* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen
Exclusion Criteria:
* Having previously undergone resections in the GI-tract
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
|
NCT03440190
|
{
"brief_title": "Bariatric Surgery and Pharmacokinetics of Methylphenidate",
"conditions": [
"Obesity, Morbid"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT03440190",
"official_title": "Bariatric Surgery and Pharmacokinetics Methylphenidate: BAR-MEDS Methylphenidate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-25",
"study_completion_date(actual)": "2021-06-25",
"study_start_date(actual)": "2018-01-02"
},
"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)": "2024-11-14",
"last_updated_that_met_qc_criteria": "2018-02-14",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-22",
"first_submitted": "2018-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will investigate the effect of smartphone addiction on neck disability during pregnancy and its mediating role on stress. The study will be conducted between September 2023 and April 2024. Data will be collected using the information form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale (PSS-10) and Neck Disability Index (NDI). Multiple regression and structural equation modeling will be used in the analysis of the data.
Detailed Description
Objective: After reviewing the relevant studies, we thought that smartphone addiction may negatively affect neck injury and perceived stress may play a mediating role in this relationship. In this context, our research questions are as follows:
* Do smartphone addiction and certain characteristics significantly predict stress in pregnant women?
* Do smartphone addiction and certain characteristics significantly predict neck injury in pregnant women?
* Does stress have a mediating effect on the relationship between smartphone addiction and neck injury in pregnant women? The research is a cross-sectional, analytical and screening study. The research will be conducted face-to-face with pregnant participants who apply to the pregnancy follow-up clinic of a public hospital and meet the research criteria and voluntarily participate in the research. Verbal and written consent will be obtained from all participants before data collection. The principles of the Declaration of Helsinki will be followed throughout the study. Data of the study will be collected using the Information Form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale-10 (PSS-10) and Neck Disability Index (NDI). Statistical analyses will be given as mean, standard deviation, median, minimum and maximum. T-tests will be used to compare categorical variables with scale scores, Pearson correlation to examine the relationship between scales and ANOVA to compare scale scores with three or more groups of categorical variables. Linear regression analysis will be used to examine the effects of SAS-SV scores and sociodemographic characteristics on PSS-10 and NDI. In addition, the mediating effect of PSS-10 on SAS-SV and NDI will be examined using a linear regression model. Analysis results will be considered significant at p \< 0.05.
#Intervention
- OTHER : Filling out the survey
- Data were collected using an information form, the Smartphone Addiction Scale-Short Version (SAS-SV), the Perceived Stress Scale (PSS-10), and the Neck Disability Index (NDI).
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals aged between 18 and 49 years,
* With a gestational age of 20 weeks or more,
* No pregnancy complications,
Exclusion Criteria:
* Those with musculoskeletal system diseases (such as rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, Ehlers-Danlos syndrome, spinal surgeries, nerve root compression, spondylolisthesis comorbidities)
* Those with diagnosed mental disorders
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06725394
|
{
"brief_title": "Effect of Smartphone Addiction on Pregnancy",
"conditions": [
"Smartphone Addiction",
"Neck Disability",
"Stress"
],
"interventions": [
"Other: Filling out the survey"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06725394",
"official_title": "Effect of Smartphone Addiction on Neck Disability During Pregnancy: the Mediating Role of Stress",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-30",
"study_completion_date(actual)": "2024-04-30",
"study_start_date(actual)": "2023-09-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-10",
"last_updated_that_met_qc_criteria": "2024-12-04",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-12-10",
"first_submitted": "2024-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate safety, tolerability, and pharmacodynamic parameters of RVT-1401 in graves' ophthalmopathy (GO) patients.
#Intervention
- DRUG : RVT-1401
- RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female >= 18 years.
* Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe GO with a Clinical Activity Score (CAS) >= 4 for the most severely affected eye at Screening (on the 7-item scale) and Baseline (on the 10-item scale).
* Onset of active GO within 9 months of screening.
* Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction >= 2 mm, moderate or severe soft tissue involvement, proptosis >= 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
* Other, more specific inclusion criteria are defined in the protocol
Exclusion Criteria:
* Use of any steroid (intravenous [IV] or oral) with a cumulative dose equivalent to >= 1 g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.
* Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
* Total IgG level < 6g/L at Screening.
* Absolute neutrophil count <1500 cells/mm3 at Screening.
* Participants with decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months at Screening.
* Previous orbital irradiation or surgery for GO.
* Other, more specific exclusion criteria are defined 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
|
NCT03922321
|
{
"brief_title": "Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)",
"conditions": [
"Graves' Ophthalmopathy"
],
"interventions": [
"Drug: RVT-1401"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03922321",
"official_title": "A Phase 2a, Multicenter, Open-Label Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-29",
"study_completion_date(actual)": "2020-05-21",
"study_start_date(actual)": "2019-04-22"
},
"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)": "2022-01-24",
"last_updated_that_met_qc_criteria": "2019-04-17",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-19",
"first_submitted": "2019-04-17",
"first_submitted_that_met_qc_criteria": "2021-12-24"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.
#Intervention
- OTHER : Fluid Resuscitation
- In the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is 'fluid responsive' (FR).
- OTHER : Standard of Care
- Standard of Care
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients > 18 years with old suspected or confirmed infection
* At least two of the following four criteria (SIRS):
1. Temperature > 38 or < 36o C
2. Heart rate > 90 bpm
3. Respiratory rate > 20 bpm or PaCO2< 32 mmHg
4. White blood cell count >12,000 or <4,000 per mm3; or >10% bandemia
* Lactate >=2.0 and <=4.0 mMol/L
* Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
Exclusion Criteria:
* Age < 18 years
* On vasopressor therapy
* Systolic blood pressure < 90 mmHg
* Received more than 3-liter crystalloid fluid prior to randomization
* Patient presenting with pulmonary edema
* Patient presenting with acute coronary syndrome
* Patient presenting with new onset cardiac arrhythmia
* Patient presenting with trauma, including burns
* Patient requires immediate surgery
* Patient presenting with stroke
* Patient with end stage renal disease on renal replacement therapy
* Patient with known pregnancy
* Patient being treated with immunosuppressive therapy for organ transplant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01484106
|
{
"brief_title": "Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis",
"conditions": [
"Sepsis"
],
"interventions": [
"Other: Standard of Care",
"Other: Fluid Resuscitation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01484106",
"official_title": "Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2011-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-21",
"last_updated_that_met_qc_criteria": "2011-11-30",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-02",
"first_submitted": "2011-11-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
to measure kidney function by measuring blood creatinine and to compare it to the measurment of GFR by Nanotechnology
|
#Eligibility Criteria:
Inclusion Criteria:
adults between 18 <= age <= 70 yrs
Exclusion Criteria:
subject under 18
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
|
NCT01274169
|
{
"brief_title": "Measurment of GFR by Nasal Sensors",
"conditions": [
"Measure GFR by Nasal Sensor"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01274169",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2008-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-01-11",
"last_updated_that_met_qc_criteria": "2011-01-10",
"last_verified": "2008-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-11",
"first_submitted": "2011-01-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease.
#Intervention
- DRUG : Amrubicin
- Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of SCLC; extensive-disease (ED) at time of study entry
* Refractory to first-line platinum-based chemotherapy (i.e., has received one prior platinum-based chemotherapy regimen) defined as one of the following:
* Best response to first-line chemotherapy is radiographically documented progression (refractory disease)
* Best response to first-line chemotherapy is radiographically documented response or stable disease, with subsequent documented progression during continuing chemotherapy (resistant relapse)
* Documented progression within 90 days of completion of first-line chemotherapy (last dose of chemotherapy), regardless of best response to treatment (resistant relapse)
* At least 18 years
* ECOG Performance Status of 0, 1, or 2
* Measurable disease defined by RECIST criteria
* Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
* Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter >=20mm using conventional techniques or >=10mm using spiral CT scans.
* CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the lesions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
* Adequate organ function including the following:
* Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1500 cells/μL, platelet count >=100,000 cells/μL and hemoglobin >=9g/dL.
* Hepatic: bilirubin <= 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 X ULN.
* Renal: serum creatinine < 2.0 mg/dL or calculated creatinine clearance >60 mL/min.
* Cardiac: Left ventricular ejection fraction (LVEF) >= 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study).
* Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-bearing potential, use of effective contraceptive methods during the study.
* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
Exclusion Criteria:
* Pregnant or nursing women
* Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to < 25% of the bone marrow.
* More than 1 prior chemotherapy regiment for SCLC
* Prior anthracycline treatment
* Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effecxts of prior therapies, excluding alopecia
* Patients with secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 2 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time)
* Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
* Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for >= 2 weeks and off corticosteroids for >= 1 week.
* History of interstitial lung disease or pulmonary fibrosis.
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
|
NCT00375193
|
{
"brief_title": "Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy",
"conditions": [
"Small Cell Lung Cancer"
],
"interventions": [
"Drug: Amrubicin"
],
"location_countries": [
"United Kingdom",
"Netherlands",
"United States"
],
"nct_id": "NCT00375193",
"official_title": "A Phase 2 Trial of Single-Agent Amrubicin in Patients With Extensive Disease Small Cell Lung Cancer That is Refractory or Progressive Within 90 Days of Completion of First Line Platinum-based Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05-01",
"study_completion_date(actual)": "2009-03-01",
"study_start_date(actual)": "2006-11-01"
},
"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)": "2019-10-24",
"last_updated_that_met_qc_criteria": "2006-09-09",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-12",
"first_submitted": "2006-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.
#Intervention
- PROCEDURE : lower segment cesarean section and double lock closure of rectus sheath
- PROCEDURE : lower segment cesarean section and continuous non-locking closure of rectus sheath
|
#Eligibility Criteria:
Inclusion Criteria:
* first cesarean section
Exclusion Criteria:
* urgent cesarean section
* previous abdominal surgery
* previous cesarean section
* obstetric and medical complications
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02679365
|
{
"brief_title": "Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Procedure: lower segment cesarean section and double lock closure of rectus sheath",
"Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheath"
],
"location_countries": null,
"nct_id": "NCT02679365",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-07",
"study_start_date(actual)": "2016-03"
},
"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)": "2017-08-01",
"last_updated_that_met_qc_criteria": "2016-02-09",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-10",
"first_submitted": "2016-02-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively
Detailed Description
PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction
#Intervention
- PROCEDURE : application of PRF
- PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7
- PROCEDURE : application of conventional surgicel
- it will be a control group in which extraction sockets will be left to heal with the natural blood clot.
|
#Eligibility Criteria:
Inclusion Criteria:
* Both male and female patients
* Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
* Patients with 3rd molar impactions
* Absence of systemic diseases
* age ⩾18 years and the ability to cooperate with the requirements of the study protocol.
Exclusion Criteria:
* Medically compromised patients.
* Immunocompromised patients.
* Patients that do not consent.
* Patients that are below the age of 17.
* Patients that are pregnant.
* Fully erupted molars will be excluded. smokers (&gt; 5 a day) will be excluded as well.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06609967
|
{
"brief_title": "Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction",
"conditions": [
"Pain, Postoperative",
"Post Operative Swelling",
"Trismus",
"Soft Tissue Healing"
],
"interventions": [
"Procedure: application of PRF",
"Procedure: application of conventional surgicel"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06609967",
"official_title": "Effect of Autologous Platelet Rich Fibrin (PRF) on Post-Operative Complications and Healing Following the Extractions Impacted Mandibular Wisdoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-01",
"study_completion_date(actual)": "2022-08-30",
"study_start_date(actual)": "2021-11-15"
},
"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)": "2024-09-24",
"last_updated_that_met_qc_criteria": "2024-09-20",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-09-24",
"first_submitted": "2021-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary objectives:
1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers
2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
#Intervention
- DRUG : Bupropion
- Phase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO)
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female (approximately 1:1) volunteers between the age of 18 and 55 years and within 32% of your ideal body weight.
* Judged healthy without any significant medical condition as determined by and decided from a pre-enrollment screening session that include medical history, laboratory tests such as blood and urine tests, and an electrical tracing of the heart beat (electrocardiogram, EKG).
* Individuals who agree to refrain from taking any prescriptions medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion.
* Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study (the entire study lasts for approximately 32 days).
* Willing to commit the time requested for this study
Exclusion Criteria:
Subjects will be excluded from the study if they:
* Are underweight (weigh less than 52 kg or 114 lb) or overweight [body mass index (BMI) greater than 32].
* Have laboratory results that do not fall in a healthy range (e.g., blood hemoglobin less than 12.0 mg/dl).
* Have baseline EKG readings that are abnormal that could place the patient at the higher risk as decided by the study medical doctor (MD)
* Have history of intolerance, allergic reactions (e.g. rash) or other forms of hypersensitivities to any of the study medications (dextromethorphan and bupropion).
* Have current alcohol (more than 4 alcoholic drinks per day on a regular basis) or drug abuse.
* Have history or current gastrointestinal (digestive) disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs
* Have history or current seizures, hypertension and heart disease or any other cardiovascular disorders
* Have history or current psychiatric (mental or brain) disorders (e.g., feeling sad or unhappy, loss of interest in normal activities, worried) such as depression, anxiety, or suicidality or suicide attempts.
* Have significantly compromised liver and/or kidney functions.
* Have participated in a research study involving intensive blood sampling or have donated blood within the past two months
* Are unable or unwilling to stop taking other substances that may interfere with the metabolism of the study drugs (bupropion and dextromethorphan) two weeks prior to and during the entire study period, including prescription medications, over-the-counter medications, herbal or dietary supplements, and alternative medicines.
* Are employees or students under supervision of any of the study investigators.
* Cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
* Cannot commit the time requested for this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03420469
|
{
"brief_title": "Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers",
"conditions": [
"Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)"
],
"interventions": [
"Drug: Bupropion"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03420469",
"official_title": "Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-01",
"study_completion_date(actual)": "2019-05-01",
"study_start_date(actual)": "2018-06-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-23",
"last_updated_that_met_qc_criteria": "2018-02-01",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-05",
"first_submitted": "2018-01-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.
The most commonly reported adverse reactions (\> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (\> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.
The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.
The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.
Detailed Description
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.
These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.
The most commonly reported adverse reactions (\> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (\> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.
The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.
Two studies on Vemurafenib as monotherapy have demonstrated these results. One study concerns 468 patients from a randomized, open-label Phase III study in adult patients with non-resectable melanoma or stage IV with a BRAF V600 mutation, the other is a study Phase II study in a single group of patients with stage IV melanoma carrying a BRAF V600 mutation after failure of at least one prior systemic treatment. The study on the combination of Vemurafenib and Cobimetinib is a randomized, double-blind, placebo-controlled phase III study (GO28141), which evaluated Cobimetinib in combination with vemurafenib compared to vemurafenib alone Of patients with non-resectable (stage III) or metastatic (stage IV) melanoma carrying a BRAF V600 mutation naive from any treatment.
The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.
The objective of the study is to demonstrate that the application of Photoderm Max SPF50 + Milk (UVA / UVB broad spectrum sunscreen) associated with the application of the Photoderm Max SPF50 + stick (SPF ≥ 50) on the first day of treatment with Vemurafenib or its combination with cobimetinib reduces the occurrence of this adverse event from a frequency (≥ 1/10) to a frequency (≤ 1/10) with regular application to all exposed areas.
#Intervention
- OTHER : Photoderm Max lait SPF50+
- Subjects apply Photoderm Max lait SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities
- OTHER : Photoderm Max Stick SPF50+
- Subjects apply Photoderm Max Stick SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject naive of i-BRAF treatment, receiving a Vemurafenib treatment in association or not with Cobimetinib in 1st or 2nd line of treatment in non resecable metastatic melonoma with BRAF V600 mutation;
* Subject aged >= 18 years ;
* Subject who can be follow regularly by the investigator ;
* Informed and consent subjects who read and signed the ICF ;
* Subject who does not participate in another study, exepted therapeutic clinical trial with Vemurafenib in association or not with Cobimetinib ;
* Compliant subject, left to the discretion of the investigator.
Exclusion Criteria:
* Pregnant or lactating women
* Women of reproductive age without contraception deemed effective for at least 1 month
* For women of reproductive age receiving Cobimetinib treatment, lack of use of two effective methods of contraception, such as a condom or other barrier method (with spermicide if available).
* Subject having a history of allergy to an ingredient of the tested products
* Subject with skin sensitivity to sunscreens or any of the components of the products under investigation
* Subjects taking another photosensitising treatment (left to the discretion of the investigator)
* Subject presenting a concomitant pathology which may interfere with the course of the study (left to the discretion of the investigator)
* Subjects with cutaneous photosensitivity or systemic disease including: lupus, dermatomyositis, porphyria, lucite ... (non-exhaustive list left to the discretion of the investigator).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03108209
|
{
"brief_title": "Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment",
"conditions": [
"Phototoxicity"
],
"interventions": [
"Other: Photoderm Max lait SPF50+",
"Other: Photoderm Max Stick SPF50+"
],
"location_countries": [
"France"
],
"nct_id": "NCT03108209",
"official_title": "Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2016-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-22",
"last_updated_that_met_qc_criteria": "2017-04-05",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-11",
"first_submitted": "2017-03-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
Detailed Description
DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness.
Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.
#Intervention
- DRUG : Hypoglycemic Agents
- Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
- DRUG : Standard glycemia control
- A strategy of glycemia drugs for HbA1c 7% - 7.9%
- DRUG : Intensive BP treatment
- A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
- DRUG : Standard BP control
- A strategy of BP drugs for SBP less than 140 mm Hg
- DRUG : Fenofibrate
- Blinded fenofibrate
- DRUG : Simvastatin
- Simvastatin 20-40 mg/d
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Participating in the ACCORD study
Exclusion Criteria:
* Has had laser photocoagulation for DR
* Has had vitrectomy surgery for DR
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00542178
|
{
"brief_title": "Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)",
"conditions": [
"Diabetic Retinopathy"
],
"interventions": [
"Drug: Intensive BP treatment",
"Drug: Standard glycemia control",
"Drug: Hypoglycemic Agents",
"Drug: Standard BP control",
"Drug: Fenofibrate",
"Drug: Placebo",
"Drug: Simvastatin"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00542178",
"official_title": "Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-24",
"last_updated_that_met_qc_criteria": "2007-10-09",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-10",
"first_submitted": "2007-10-09",
"first_submitted_that_met_qc_criteria": "2013-11-22"
}
}
}
|
#Study Description
Brief Summary
This study investigates the presence of a possible link between treatment with danazol and expression of endometrial αvβ3 integrin which might allow tailoring of danazol treatment to the subset of repeated IVF/ET failure that might benefit most from it.
38 eligible ovulatory women were recruited aged 20 - 38 years with unexplained recurrent implantation failure (RIF). Timed suction endometrial biopsy was obtained from participants during the implantation window of the pretreatment cycle, followed by immunohistochemical staining for endometrial αvβ3 integrin expression, scored using H-score.
Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in daily dosage of 400 mg for 12 weeks. Post-treatment suction endometrial biopsy was obtained during the implantation window following the first ovulation after danazol treatment and endometrial αvβ3 integrin expression was compared to the pretreatment cycle.
#Intervention
- PROCEDURE : Pre-treatment endometrial biopsy
- Timed suction endometrial biopsy was obtained from participants via Wallach Endocell® 908014A endometrial cell sampler timed during the implantation window of the pretreatment cycle; followed by immunohistochemical staining using immunoperoxidase staining incorporating avidin-biotin complex (ABC) method.
- DRUG : Danazol
- Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in daily dosage of 400 mg for 12 weeks.
- PROCEDURE : Post-treatment endometrial biopsy
- Post-treatment suction endometrial biopsy was obtained during the implantation window following the first ovulation after danazol treatment, timed, processed and stained as described previously.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 20 <= age <= 38 yrs
* Unexplained recurrent implantation failure (RIF), defined as failure to achieve an intrauterine gestational sac recognized by ultrasonography after transfer of at least four good-quality embryos (defined as those with four or five blastomeres on day 2, seven or more cells on day 3, <= 20% anucleated fragments and absence multinucleated blastomeres) in a minimum of three fresh or frozen IVF cycles after exclusion of other causes of RIF (as depicted by normal transvaginal ultrasonography, hysteroscopy, hysterosalpingography, laparoscopic findings, male and female karyotypic examination, endocrinological profile during ovarian stimulation and negative anti-cardiolipin antibody IgM/IgG, lupus anticoagulant, thrombophilia screening (including protein C, protein S, anti thrombin III and factor V leiden) and normal male semen analysis as depicted by 2010 WHO criteria for semen analysis and sperm DNA fragmentation testing).
Exclusion Criteria:
* Anovulation
* Contraindications to treatment with danazol (including chronic liver disease, congestive heart failure, dyslipidemia or history/current thrombo-embolic disease)
* Medical comorbidities (e.g. autoimmune disorders, diabetes mellitus, etc)
* Patients who underwent induction of ovulation / received hormonal treatment during the previous three months
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 38 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03563664
|
{
"brief_title": "Effect of Danazol on Endometrial αvβ3 Integrin Expression in Patients With Unexplained Recurrent Implantation Failure",
"conditions": [
"Unexplained Infertility"
],
"interventions": [
"Procedure: Post-treatment endometrial biopsy",
"Procedure: Pre-treatment endometrial biopsy",
"Drug: Danazol"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03563664",
"official_title": "Effect of Danazol on Endometrial αvβ3 Integrin Expression in Patients With Unexplained Recurrent Implantation Failure - A Self-controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08-15",
"study_completion_date(actual)": "2017-08-15",
"study_start_date(actual)": "2015-08-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-21",
"last_updated_that_met_qc_criteria": "2018-06-10",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-20",
"first_submitted": "2018-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was organized to investigate the real upper limb use in persons after stroke. Persons after stroke often have problems moving their affected arm, leading to limitations in performing simple tasks. In previous research in a group of 60 patients post stroke the investigators investigated two things: they observed how patients can move their affected arm, and the investigators asked patients to indicate how they think they can use their affected arm. Surprisingly, the investigators concluded that in patients with a similar, good observed arm use there were two groups: (1) a 'match' group, reporting they can use their arm well, and (2) a 'mismatch' group, reporting they can not use their arm well. This project will further investigate this last group. The investigators will now use sensor technology to investigate the actual daily life arm use during daily life. The investigators hypothesize this daily arm use will be lower in the mismatch group than in the group with good observed and perceived ability.
Detailed Description
The investigators will perform a cross-sectional study to acquire insight into the actual daily-life UL activity profile of patients in the chronic phase post stroke. A sample of 60 community-dwelling patients more than six months after stroke will be recruited and will be investigated with both standardized clinical, patient-reported and sensor-based UL assessments. Our sample will include three groups of 20 patients with (1) both low observed and perceived function; (2) both good observed and perceived function; and (3) good observed but low perceived function, i.e. the mismatch group.
To better understand this mismatch group, it is pivotal to investigate daily arm and hand use in patients in the chronic phase after stroke as the investigators expect patients in the mismatch group to have significantly reduced arm and hand use throughout the day. After all, stroke rehabilitation interventions intend to improve patients' performance in daily life, but the objective evaluation of this aim is a challenge. Standardized assessments performed in the rehabilitation environment or patients' home do not validly reflect daily-life upper-limb use. To achieve insight into the observed upper limb function, apart from using internationally accepted observation-based assessments such as the FMA and SIS hand function, monitoring patients after stroke will also be performed using sensor-based systems.
The investigators hypothesize the mismatch group will show a comparable daily-life UL activity profile compared to patients with both low observed and perceived function. However, when compared to patients with good observed and perceived function, the mismatch group shows significantly reduced daily-life UL activity by means of sensor-based evaluation.
#Intervention
- OTHER : "Class 1 Medical Device' CE certified devices: ActiGraph wGT3X-BT accelerometer
- Accelerometers on both patients' wrists will give insight into the daily life upper limb use.
|
#Eligibility Criteria:
Inclusion Criteria:
(1) unilateral, supratentorial stroke as defined by WHO; (2) minimum 6 months after stroke, and living in the community; (3) >= 18 years; and (4) informed consent.
Exclusion Criteria:
(1) a musculoskeletal and/or other neurological disorder such as previous stroke, head injury, or Parkinson's disease that interfere with the protocol; and (2) severe communication or cognitive deficits.
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
|
NCT04430153
|
{
"brief_title": "What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke",
"conditions": [
"Stroke"
],
"interventions": [
"Other: 'Class 1 Medical Device' CE certified devices: ActiGraph wGT3X-BT accelerometer"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT04430153",
"official_title": "Investigating the Actual Daily-life Upper Limb Activity Profile in Relation to Observed and Perceived Function in the Chronic Phase Post Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-30",
"study_completion_date(actual)": "2021-05-30",
"study_start_date(actual)": "2020-10-01"
},
"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)": "2021-06-09",
"last_updated_that_met_qc_criteria": "2020-06-11",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-12",
"first_submitted": "2020-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in Japan.
The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to improve signs and symptoms and to prevent secondary disease complications. However, no Japanese patients have been included in those studies. This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen.
#Intervention
- DRUG : canakinumab
- canakinumab
|
#Eligibility Criteria:
Inclusion Criteria:
* At study entry, patients should have a clinical diagnosis of FCAS, MWS or NOMID and require medication. At the time of screening, patients can be either untreated or treated with other medication.
* Presence, or history of at least 2 of the following symptoms:
* For NOMID patients:
* Typical NOMID urticarial rash
* Signs of central nervous system (CNS) involvement such as increased intracranial pressure and/or papilledema and/or cerebral spinal fluid pleiocytosis and/or stroke and/or seizures, and/or sensorineural hearing loss
* Typical arthropatic changes on X-rays: epiphysal and/or patellar overgrowth With start of NOMID symptoms before or at 6 months of age
* For MWS patients:
* periodic fever
* headache/migraine
* arthralgia
* urticarial skin rash
* conjunctivitis
* myalgia
* sensorineural hearing impairment
* For FCAS patients:
* urticarial skin rash
* fever/chills
* conjunctivitis
* joint pain
* Patients requiring oral steroids, NSAIDs and/or disease-modifying antirheumatic drugs (DMARDs) can be enrolled if they are on a stable dose (oral steroids: < 20 mg/day or < or = 0.4 mg/kg prednisone or prednisone equivalent, whichever applies) for at least 4 weeks prior to the screening visit.
* Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary).
Exclusion Criteria:
* Pregnant or nursing (lactating) women.
* All women capable of becoming pregnant unless they are postmenopausal or are using one or more methods of contraception.
* Participation in any other study within 30 days
* Infection with HIV, Hepatitis B or C.
* Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing for adults.
* History of significant medical conditions, which in the doctor's opinion would exclude the patient from participating in this trial.
* History of renal transplantation.
* Presence of any additional rheumatic diseases or significant systemic diseases. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus in addition to the autoinflammatory disease).
* Presence of any of the following laboratory abnormalities: ALT or AST greater than 2 times the upper limit of normal (ULN), platelet count less than 100x109/L.
* History of recurrent and/or evidence of clinically significant active bacterial, fungal, or viral infections.
* History of contact with patients with suspected tuberculosis symptoms; or history or complication of tuberculosis infection.
* Use of the following therapies:
* Etanercept in the 4 weeks prior to the baseline visit (Day 1) and thereafter
* Adalimumab in the 8 weeks prior to the baseline visit (Day 1) and thereafter
* Infliximab in the 12 weeks prior to the baseline visit (Day 1) and thereafter
* Rituximab in the 26 weeks prior to the baseline visit (Day 1) and thereafter
* Tocilizumab in the 3 weeks prior to the baseline visit (Day 1) and thereafter
* Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1) and thereafter (with the exception of anakinra therapy-see below)
* Anakinra therapy after the baseline visit (Day 1). Last anakinra injection should occur not less than 6 hours prior to the canakinumab injection at Day 1
* Leflunomide in the 4 weeks prior to the baseline visit (Day 1) and thereafter. After the completion of leflunomide treatment a cholestiramine in dose 8 g 3 times per day for 14 days is recommended.
* Thalidomide in the 4 weeks prior to the baseline visit (Day 1) and thereafter
* Cyclosporine in the 4 weeks prior to the baseline visit (Day 1) and thereafter
* i.v. immunoglobulin (i.v. Ig) in the 8 weeks prior to the baseline visit (Day 1) and thereafter
* 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1) and thereafter
* Dapsone, mycophenolate mofetil in the 3 weeks prior to the baseline visit (Day 1) and thereafter
* > or = 20 mg/day or >0.4 mg/kg, whichever applies, of prednisone or prednisone equivalent in the 4 week prior to the baseline visit (Day 1) and thereafter
* Methyl prednisone pulse therapy in the 4 weeks prior to baseline visit and thereafter
* History of allergic reaction to similar drugs. No additional exclusions may be applied by the doctor, in order to ensure that the study population will be representative of all eligible patients.
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00991146
|
{
"brief_title": "Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase",
"conditions": [
"Cryopyrin-associated Periodic Syndromes",
"Familial Cold Autoinflammatory Syndrome",
"Muckle-Wells Syndrome",
"Neonatal Onset Multisystem Inflammatory Disease"
],
"interventions": [
"Drug: canakinumab"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00991146",
"official_title": "An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan",
"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)": "2009-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-25",
"last_updated_that_met_qc_criteria": "2009-10-06",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-07",
"first_submitted": "2009-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to define the intermuscular bridges between the scalene muscles at the interscalene groove (around neck area) using high definition US imaging in a cohort of volunteers.
Detailed Description
The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve sparing interscalene approach, has better safety profile than before and because of this, it is often the technique of choice for anaesthesia and/or analgesia during shoulder and proximal arm surgery. Anatomical variations at the interscalene groove are not uncommon and few have been described in the literature. Understanding the anatomy of the brachial plexus and its sheath at the interscalene groove is vital for the success of the block and to reduce the risk of complications during ultrasound (US) guided ISBPB. Recently, with the use of high definition ultrasound, using high frequency linear transducer, the principal investigator have identified intermuscular bridges appearing between the ventral rami of the brachial plexus at the interscalene groove. These intermuscular bridges may affect the spread of local anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics of ISBPB. Therefore, this prospective observational study aim to define the intermuscular bridges at the interscalene groove using high definition ultrasound imaging in a group of healthy volunteers.
#Intervention
- OTHER : Ultrasound scan
- Volunteers will have an ultrasound scanning of both sides of their neck lying in supine position. Sequentially the scanning will start from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. Images will be recorded as video loops.
|
#Eligibility Criteria:
Inclusion Criteria:
* volunteers consented for the scanning
Exclusion Criteria:
* prior surgery on either side of the neck
* presence of obvious deformity
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04547270
|
{
"brief_title": "High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT04547270",
"official_title": "High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove: A Prospective Observational Volunteer Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2020-09-23"
},
"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)": "2021-06-18",
"last_updated_that_met_qc_criteria": "2020-09-07",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-14",
"first_submitted": "2020-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
Detailed Description
European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.
In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.
Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.
No data are available on the combined effects of these dietary supplement in humans.
#Intervention
- DIETARY_SUPPLEMENT : Combined nutraceutical
- Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day
- OTHER : Placebo
- Oral administration: 1 tablet per day
|
#Eligibility Criteria:
Inclusion Criteria:
* Suboptimal LDL level (115 <= age <= 160 mg/dL)
* TG<400 mg/dL
* Signed informed consent form
Exclusion Criteria:
* Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years
* LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL
* Obesity (BMI>30 kg/m2) or diabetes mellitus
* Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
* Antihypertensive treatment not stabilized since at least 3 months
* Known current thyroid, gastrointestinal or liver diseases
* Any medical or surgical condition that would limit the patient adhesion to the study protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03065491
|
{
"brief_title": "Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Dietary Supplement: Combined nutraceutical",
"Other: Placebo"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03065491",
"official_title": "Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-15",
"study_completion_date(actual)": "2017-02-17",
"study_start_date(actual)": "2016-11-15"
},
"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)": "2017-02-28",
"last_updated_that_met_qc_criteria": "2017-02-22",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-28",
"first_submitted": "2017-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.
#Intervention
- DRUG : Lidocaine 5% patch with Dexmedetomidine Bupivacaine
- 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports
- DRUG : Dexmedetomidine Bupivacaine
- 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients
* ASA I & II
* Aged between 18 <= age <= 60
* Weight between 60 to 100 kg
* Scheduled for elective arthroscopic knee surgery
Exclusion Criteria:
* patient refusal.
* history of cardiac disease.
* impaired renal or hepatic function.
* hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
* if they have used opioid analgesics within the previous 24 hr.
* previous sensitivity to local anesthetics.
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
|
NCT04322760
|
{
"brief_title": "Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery",
"conditions": [
"Dexmedetomidine",
"Lidocaine 5% Patch",
"Arthroscopic Knee Surgery",
"Intra-articular"
],
"interventions": [
"Drug: Lidocaine 5% patch with Dexmedetomidine Bupivacaine",
"Drug: Dexmedetomidine Bupivacaine"
],
"location_countries": null,
"nct_id": "NCT04322760",
"official_title": "Effect of Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery Under General Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-30",
"study_completion_date(actual)": "2017-12-01",
"study_start_date(actual)": "2016-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-27",
"last_updated_that_met_qc_criteria": "2020-03-25",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-26",
"first_submitted": "2020-03-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to investigate the effectiveness of an Internet-based behavioural parent training intervention on children's ADHD symptoms and children's and parents' mental health status.
Detailed Description
The study design was a 2-parallel-group experimental longitudinal study. Firstly, the children received a diagnostic interview by an experienced child and adolescent psychiatrist at Wuhan Mental Health Centre for confirmation of inclusion and exclusion criteria. Parents who were eligible for the inclusion criteria and interested in the internet-based behavioural Parent Training (I-BPT) program were recruited. After the assessments of ADHD symptoms and psychiatric comorbidity, participants were randomly assigned in a 1:1 ratio to either the routine clinical care (RCC) group or I-BPT+RCC group using computer-generated randomization numbers. Participants in the I-BPT+RCC group were offered 2 months (8 weeks) of internet-assisted parent training in addition to routine outpatient treatment. The RCC group initially received only routine outpatient treatment, yet, after post-follow-up assessment, they were provided with the same I-BPT intervention for ethical considerations. Both groups were followed up after intervention by electronic questionnaire.
#Intervention
- BEHAVIORAL : Internet-based behavioral parent training (I-BPT)
- Internet-based behavioural parent training in a group format, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.
|
#Eligibility Criteria:
Inclusion Criteria:
* 1.Meeting the diagnostic criteria for ADHD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* 2.Total IQ greater than 70 as measured by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV)
* 3.Child and their parents consent to the study
Exclusion Criteria:
* 1.Children or parents with severe organic encephalopathy and other severe mental disorders
* 2.Has received or is receiving behavioral treatment (parent training)
* 3.Parents who could not understand or lacking of access to computers and the Internet
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06170996
|
{
"brief_title": "Internet-Based Behavioural Parent Training Intervention for Children With Attention Deficit/Hyperactivity Disorder",
"conditions": [
"Attention Deficit Hyperactivity Disorder (ADHD)"
],
"interventions": [
"Behavioral: Internet-based behavioral parent training (I-BPT)"
],
"location_countries": [
"China"
],
"nct_id": "NCT06170996",
"official_title": "Internet-Based Behavioural Parent Training Intervention for Children With Attention-Deficit/Hyperactivity Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-01",
"study_completion_date(actual)": "2024-01-01",
"study_start_date(actual)": "2023-03-12"
},
"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)": "2024-07-19",
"last_updated_that_met_qc_criteria": "2023-12-06",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-14",
"first_submitted": "2023-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Non-arthritic anterior ischemic optic neuropathy is the most common cause of sudden visual loss due to optic nerve involvement in patients above 50 years old. As this problem can be considered as a sclera out let syndrome an there is no effective and successful treatment for it, we decided to do a neurotomy procedure and relax the involved optic nerve in order to achieve acceptable treating outcome.
#Intervention
- PROCEDURE : optic nerve neurotomy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with non-arthritic anterior ischemic optic nerve
Exclusion Criteria:
* Visual acuity more than 20/200
* Other intra occular operations
* Passing more than 4 weeks of the problem
* Arthritic anterior ischemic optic nerve
* Age under 50 years
* Consumption of previous pharmaceutical treatment
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00372021
|
{
"brief_title": "Neurotomy of Optic Nerve in Non-Arthritic Anterior Ischemic Optic Neuropathy",
"conditions": [
"Non Arthritic Anterior Ischemic Optic Neuropathy"
],
"interventions": null,
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT00372021",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2003-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2006-10-12",
"last_updated_that_met_qc_criteria": "2006-09-05",
"last_verified": "2002-11"
},
"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
This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the objective response rate to the combination of cixutumumab and temsirolimus in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma.
II. To further describe the toxicities (including dose-limiting toxicities) of cixutumumab and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
I. To assess the progression-free survival for patients treated in each disease stratum with this drug combination.
II. To assess the incidence of insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) pathway activation in archival tumor material, and correlate with response.
III. To evaluate minimal residual disease and IGF-1R tumor cell expression in the blood and bone marrow of Ewing sarcoma patients using flow cytometry.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (osteosarcoma vs Ewing sarcoma/PNET vs rhabdomyosarcoma vs non-rhabdomyosarcoma soft tissue sarcoma).
Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples from most recent biopsy are collected and analyzed for IGF-1R, insulin receptor, AKT, ERK, mTOR, and S6 kinase pathway activation by immunohistochemistry (IHC) and banked for future correlative studies. Blood and bone marrow samples, from patients with Ewing sarcoma, may be collected at baseline and periodically during treatment for minimal residual disease analysis by flow cytometry.
After completion of study treatment, patients are followed up periodically for 5 years.
#Intervention
- BIOLOGICAL : Cixutumumab
- Given IV
- Other Names :
- Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Temsirolimus
- Given IV
- Other Names :
- CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, are eligible:
* Osteosarcoma
* Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
* Rhabdomyosarcoma
* Non-rhabdomyosarcoma soft tissue sarcoma
* Patients must have had histologic verification of malignancy at original diagnosis or relapse
* All patients are required to submit archival tumor samples for immunohistochemical analysis (either paraffin-embedded tumor blocks or unstained slides)
* Tissue samples collected at original diagnosis or at relapse or at any subsequent resections or biopsies should be available and ready for shipment to the Biopathology Center (BPC) at time of study enrollment; the samples are required even if tissue samples have previously been sent to the BPC for other purposes or studies; blocks or slides should be shipped to the BPC within 7 days of study enrollment
* Patients must have radiographically measurable disease
* Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
* The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration
* Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
* Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
* Previously radiated lesions that have not demonstrated clear progression post radiation
* Leptomeningeal lesions that do not meet the measurements noted above
* Patient?s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Patients with known central nervous system metastases are excluded unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
* Patients must have a Lansky or Karnofsky performance status score of ? 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1, or 2; use Karnofsky for patients > 16 years and Lansky for patients ? 16 years
* Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* For patients with solid tumors without bone marrow involvement:
* Peripheral absolute neutrophil count (ANC) ? 1,000/?L
* Platelet count ? 100,000/?L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
* Hemoglobin ? 8.0 g/dL (may receive red blood cell [RBC] transfusions)
* For patients with solid tumors and known bone marrow metastatic disease:
* ANC ? 750/?L
* Platelet count ? 50,000/?L (may receive platelet transfusions)
* Hemoglobin ? 8.0 g/dL (may receive RBC transfusions)
* For patients with known bone marrow metastatic disease, transfusions are permitted to meet both platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions
* Creatinine clearance or radioisotope GFR ? 70 mL/min OR a serum creatinine based on age/gender as follows:
* 0.6 mg/dL (1 to < 2 years)
* 0.8 mg/dL (2 to < 6 years)
* 1.0 mg/dL (6 to < 10 years)
* 1.2 mg/dL (10 to < 13 years)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to < 16 years)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) ( ? 16 years)
* Total bilirubin ? 1.5 times upper limit of normal (ULN)
* Serum glutamic pyruvate transaminase(SGPT) (alanine aminotransaminase [ALT]) ? 2.5 times ULN (for the purpose of this study, the ULN for SGPT is 45 U/L)
* Serum albumin ? 2 g/dL
* Patients with seizure disorder may be enrolled if receiving non-enzyme-inducing anticonvulsants and well controlled
* Patients with known type I or type II diabetes mellitus are not eligible
* Serum glucose values must be within the normal limits for age; if the initial blood glucose is a random sample that is outside normal limits, then a follow-up fasting blood glucose should be obtained and must be within the normal limits for age
* Serum cholesterol levels must be < grade 2 (< 300 mg/dL), and serum triglyceride levels must be < grade 2 (< 2.5 times ULN)
* Patients who are pregnant or breast-feeding are not eligible for this study
* Negative pregnancy tests must be obtained in girls who are post-menarchal
* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study and for 3 months after the last dose of cixutumumab
* Patients who have an uncontrolled infection are not eligible
* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible
* See Disease Characteristics
* There is no limit to the number of prior treatment regimens; however, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
* Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea)
* At least 7 days must have elapsed since the completion of therapy with a growth factor; at least 14 days must have elapsed after receiving pegfilgrastim
* At least 7 days must have elapsed since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur
* At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
* ? 2 weeks must have elapsed since local palliative radiotherapy (XRT) (small port); 3 months must have elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if therapeutic doses of metaiodobenzylguanidine(MIBG) or other substantial bone marrow irradiation was given
* No evidence of active graft-vs-host disease and 2 months must have elapsed since stem cell transplant or rescue
* Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if Neulasta?)
* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible
* Patients who are currently receiving another investigational drug are not eligible
* Patients who are currently receiving other anti-cancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy, are not eligible
* Patients receiving insulin or growth hormone therapy are not eligible
* Patients who are receiving enzyme-inducing anticonvulsants are not eligible
* Use of warfarin is not allowed while on study; patients already on warfarin should use alternative anticoagulants while on this study; warfarin must not have been administered within 7 days of starting protocol therapy
* Patients who have received prior therapy targeting IGF-1R with either monoclonal antibodies or small molecule tyrosine kinase inhibitors are NOT eligible
* Prior treatment with mTOR inhibitors (e.g., rapamycin, temsirolimus, everolimus, deforolimus) is NOT allowed
* Patients who have had major surgery within 3 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter or limited tumor biopsy are not considered major surgery
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01614795
|
{
"brief_title": "Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma",
"conditions": [
"Childhood Alveolar Soft Part Sarcoma",
"Childhood Angiosarcoma",
"Childhood Epithelioid Sarcoma",
"Childhood Fibrosarcoma",
"Childhood Gliosarcoma",
"Childhood Leiomyosarcoma",
"Childhood Liposarcoma",
"Childhood Malignant Peripheral Nerve Sheath Tumor",
"Childhood Synovial Sarcoma",
"Previously Treated Childhood Rhabdomyosarcoma",
"Recurrent Childhood Rhabdomyosarcoma",
"Recurrent Childhood Soft Tissue Sarcoma",
"Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor",
"Recurrent Osteosarcoma",
"Rhabdomyosarcoma"
],
"interventions": [
"Other: Laboratory Biomarker Analysis",
"Drug: Temsirolimus",
"Biological: Cixutumumab"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT01614795",
"official_title": "A Phase II Study of Cixutumumab (IMC-A12) in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04-01",
"study_completion_date(actual)": "2014-04-01",
"study_start_date(actual)": "2012-06-18"
},
"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)": "2018-12-11",
"last_updated_that_met_qc_criteria": "2012-06-06",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-08",
"first_submitted": "2012-06-06",
"first_submitted_that_met_qc_criteria": "2015-03-19"
}
}
}
|
#Study Description
Brief Summary
Tuberculosis in children is a major public health problem and it contributes 10% of the total TB cases worldwide. TB treatment outcomes in children are challenged by insufficient consideration of the relationships between doses administered, concentrations achieved and eventual desirable and undesirable effects (pharmacodynamics) of TB drugs. Rifampicin is a pivotal TB drug and data from adults suggest that a much higher dose of rifampicin (35 mg/kg instead of 10 mg/kg), resulting in much higher rifampicin exposures in plasma, is safe and tolerable and may provide a higher efficacy. The dose needed in children to achieve the same exposure in plasma is unknown.
Detailed Description
Tuberculosis (TB) in children is a major public health problem . It has a global estimate of \>100,000 deaths per year and is included in the top ten causes of mortality in children worldwide. Children contribute 10% of the total TB cases worldwide. More than 75% of the worldwide estimated cases of TB in children occur in the 30 high burden countries, Tanzania being one of them. The enormous burden of pediatric TB in these countries is due to the TB epidemic amongst adults and the simultaneous HIV pandemic and a child less than 14 years of age whether HIV infected or not is at a high risk of developing the disease. Subsequent dissemination of the mycobacterium and progression of the disease is also fast in children.
Knowledge on the efficacy and safety of medicines for children is still very limited and sometimes children are still being treated as small adults. However, adult dosing cannot be logically extrapolated to children according to weight or age because of different pharmacokinetics, i.e. the relationship between doses administered and exposures (drug concentrations) achieved, in children as compared with adults . More specifically, these pharmacokinetic differences occur in the subsequent processes of absorption, distribution, metabolism and elimination of drugs, which are subject to physiological changes due to growth and development in children. Especially in young children, maturation of liver metabolism pathways and renal function are not completed.
In contrast, the pharmacodynamics of a drug, i.e. the relationship between concentrations achieved and eventual response is generally considered similar between adults and children, although differences in drug metabolism between children and adults may lead to differences in susceptibility to some adverse drug reactions. Thus, because of the differences in pharmacokinetics in children with different ages, they should not receive the same drug doses on mg/kg base as adults, and drug dosage selection in children should rather be based upon stages of growth and development. These drug doses should target the exposures that are efficacious in adults.
#Intervention
- DRUG : Evaluation of high dose rifampicin in children
- Evaluation of severity of adverse event from grade 1 to 5
- Other Names :
- Safety monitoring
|
#Eligibility Criteria:
Inclusion Criteria:
* Children aged 1 <= age <= 14 with newly diagnosed Tuberculosis
Exclusion Criteria:
* Children with elevated liver function
* Children allergic to first line anti-TB drugs
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04437836
|
{
"brief_title": "Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic",
"conditions": [
"Clinical Trial"
],
"interventions": [
"Drug: Evaluation of high dose rifampicin in children"
],
"location_countries": [
"Tanzania"
],
"nct_id": "NCT04437836",
"official_title": "Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampicin in Children With Newly Diagnosed Uncomplicated Tuberculosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-30",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-15",
"last_updated_that_met_qc_criteria": "2020-06-18",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-18",
"first_submitted": "2020-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses.
Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines.
The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.
#Intervention
- BIOLOGICAL : DNA
- DNA co-administered with protein at month 0, 1 and 6
- Other Names :
- DNA-HIV-PT123
- BIOLOGICAL : AIDSVAX B/E
- Protein co-administered with DNA at month 0,1 and 6
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-1 uninfected adults aged 18 <= age <= 45 years, as confirmed by a medical history, physical exam, and laboratory tests during screening
* In 50% of study volunteers, positive for S. mansoni infection but negative for other helminth infections.
* In 50% of study volunteers, negative for S. mansoni and other helminth infections
* Willing to forgo treatment with praziquantel until after completion of week 26 visit in the trial.
* Able and willing to provide written informed consent prior to screening
* Aged 18 through 45 years on the day of first vaccination
* Able and willing to complete screening (about 1 month) and available for the planned follow-up period (9months)
* Willing to undergo HIV testing, risk reduction counselling, receive HIV test results and committed to maintaining low risk behaviour for the trial duration
* If female of childbearing potential (not menopausal or sterilised), willing to use a non-barrier contraceptive method from screening through the end of the study. Acceptable contraceptive methods include hormonal contraceptives (injection, transdermal patch, or implant) and intrauterine device (IUD).
* Willing to provide blood, urine and stool samples for laboratory examination
Exclusion Criteria:
* HIV-1 infection
* Infection with other helminths
* Symptomatic and asymptomatic malaria infection (presence of malaria parasites on thick blood smear)
* Treatment with praziquantel in the past 3 months
* S. mansoni egg count of>2000 eggs per gram of stool
* Clinically significant acute or chronic illness at the time of randomization.
* Any clinically relevant abnormality on history or examination
* Use of immunosuppressive medication (other than inhaled or topical immunosuppressants)
* Receipt of immunoglobulin within past 60 days
* Abnormal laboratory values as specified below from blood collected within 28 days prior to randomization:
1. Hematology
* Haemoglobin <9.0 g/dL or<5.59 mmol/L
* Absolute Neutrophil Count (ANC): < 1000/mm3or < 1.0 x 109/L
* Absolute Lymphocyte Count (ALC): <= 500/mm3or <= 0.5 x 109/L
* Platelets: <= 90,000 >= 550,000/mm3or <= 90 x 109 >= 550 x 109/L
2. Chemistry
* Creatinine: > 1. 1 x ULN
* AST: >2.6 x ULN
* ALT: >2.6 x ULN
3. Urinalysis: abnormal dipstick confirmed by microscopy
* Protein 2+ or more
* Blood 2+ or more (not due to menses)
* Reported high-risk behaviour for HIV infection within 3 months prior to first vaccination, as defined by:
* Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk of HIV infection or a casual partner
* Unprotected sexual intercourse with more than one sexual partner
* Engagement in sex work for money or drugs
* Use of recreational drugs (e.g. marijuana) and/or weekly or more frequent alcohol use
* Current or past STI
* History or evidence of autoimmune disease.
* Positive for Hepatitis B surface antigen (HbsAg), positive for antibodies to Hepatitis C virus (HCV) or active syphilis.
* Receipt of blood or blood products within the previous 6 months
* History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
* Prior or current participation in another investigational agent trial
* Current anti-tuberculosis (TB) prophylaxis or therapy
* If female, currently pregnant (positive serum or urine pregnancy test), planning to get pregnant in the next 9months or lactating
* History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the volunteer's safety or interfere with the evaluation of the safety or immunogenicity of the vaccine
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
|
NCT02376582
|
{
"brief_title": "Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS",
"conditions": [
"HIV/AIDS"
],
"interventions": [
"Biological: AIDSVAX B/E",
"Biological: DNA"
],
"location_countries": [
"Uganda"
],
"nct_id": "NCT02376582",
"official_title": "A Phase I Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Combination of DNA-HIV-PT123 and AIDSVAX®B/Ein HIV-1-uninfected Adult Participants With or Without Underlying Schistosoma Mansoni Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2014-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-22",
"last_updated_that_met_qc_criteria": "2015-03-02",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-03",
"first_submitted": "2014-07-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection. The investigators will accomplish this using a novel patient centered mobile health platform called Hugo that will allow them to engage patients in an entirely novel manner.
Detailed Description
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. It is a complex and chronic illness, and patient journeys vary considerably. However, to date, guidance about how to best treat patients has relied on large clinical international trials that do not represent contemporary patients and only include snapshots of the syndrome-at times when the patients interact with the health care system. Additionally, patient participation in clinical research in the US is extremely low, approximated at 3% in cancer and far lower for disease states such as heart failure.
One of the key reasons for this is a lack of patient engagement and trust in the research enterprise, especially among the elderly and minorities, groups that are disproportionally impacted by heart failure. To address this, the investigators plan to test a novel patient-powered, smartphone-based mobile health platform (called Hugo) developed at Yale School of Medicine for real-world surveillance of patient reported outcomes in heart failure patients treated at 3 Major Academic Medical Centers. Participants will then be queried about specific symptoms and health conditions at enrollment and prespecified time points for 2 years. The subgroup of participants who own devices that track their activity data will have the option of syncing them to this mobile health platform to provide additional insights into their health and health outcomes. Additionally, participants will have the option to learn about opportunities to participate in heart failure clinical research. This digital registry will also allow seamless integration of patient reported outcomes, electronic health record (EHR) data, and pharmacy information into data collection.
Overall, the aim for this study is to create a digital registry using a novel patient centered mobile health platform of heart failure patients across large health care systems that allows investigators to engage patients in an entirely novel manner.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age> 18 Years
* English Speaking
* Diagnosis of heart failure
* Participant is willing and able to read and sign consent and participate in study
* Participant has an email account
Exclusion Criteria:
* Unable to participate in registry
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
|
NCT03810638
|
{
"brief_title": "Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF",
"conditions": [
"Heart Failure"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03810638",
"official_title": "Creation of a Digital Heart Failure Registry Using a Novel Mobile Health Platform: HUGO-HF",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-25",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2019-01-15"
},
"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)": "2020-08-04",
"last_updated_that_met_qc_criteria": "2019-01-17",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-22",
"first_submitted": "2019-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.
Detailed Description
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.
#Intervention
- DEVICE : comfilcon A
- contact lens
- DEVICE : senofilcon C
- contact lens
|
#Eligibility Criteria:
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
* Is between 18 and 34 years (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Has a contact lens prescription that fits within the available parameters of the study lenses.
* Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
* Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Presents with slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Significant pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization > 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (or history in past year)
* Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Is currently wearing daily disposable lenses
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 34 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02920957
|
{
"brief_title": "Performance Comparison Between Comfilcon A and Senofilcon C Lenses",
"conditions": [
"Myopia"
],
"interventions": [
"Device: senofilcon C",
"Device: comfilcon A"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02920957",
"official_title": "Performance Comparison Between Comfilcon A and Senofilcon C Lenses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11-23",
"study_completion_date(actual)": "2016-11-23",
"study_start_date(actual)": "2016-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-09",
"last_updated_that_met_qc_criteria": "2016-09-29",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-30",
"first_submitted": "2016-09-29",
"first_submitted_that_met_qc_criteria": "2017-12-11"
}
}
}
|
#Study Description
Brief Summary
Given (1) the high volume of women on reproductive age that have a clinical diagnosis of endometriosis and (2) the poor management of symptoms that medical treatment usually achieves, new therapeutic interventions need to be evaluated in order to improve pain and quality of life in those patients. Therefore, 'Physio-EndEA' study has been designed to evaluate whether therapeutic exercise could help on the management of endometriosis-related symptoms
Detailed Description
Background: Prevalence of endometriosis is approximately 10% of women of childbearing age. Pain, considered in its multiple versions (dysmenorrhea, dyspareunia, dyschezia, dysuria and, in general, chronic pelvic pain) is the most common and disabilitating symptom in affected women. Usual care, consisting on palliative pharmacological treatment in combination with surgery, is clearly insufficient and physical therapies need to be explored in order to reduce pain and to improve quality of life in affected women.
Objective: The overall objective of 'Physio-EndEA' study will be to explore potential short and mid-term benefits of a rehabilitation program on the quality of life of symptomatic women.
Methods: A total of 26 symptomatic endometriosis women will be recruited. Inclusion criteria includes: aged 18-50, clinical diagnosis of endometriosis and interested in improving lifestyle while exclusion criteria includes: diagnosed chronic disease or orthopaedic issues that would interfere with ability to participate in a physical activity program. Women will be randomized to either intervention (n=13) or usual care group (n=13). Intervention group will receive twice weekly session for 9 weeks and control group will receive recommendations about healthy lifestyle and usual care.
Discussion: This study attempts to improve the quality of life of symptomatic endometriosis women by reducing musculoskeletal and occupational impairments. Findings will offer a new therapeutic approach for a better pain control.
#Intervention
- BEHAVIORAL : Lumbopelvic, stretching, aerobic and relaxation exercises
- Intervention program will comprises brisk walks and small choreographies, global and analytical stretching exercises, as well as lumbopelvic stabilization exercises (with intensity and volume progression)
|
#Eligibility Criteria:
Inclusion Criteria:
* Premenopausal status
* Clinical diagnosis of endometriosis by laparoscopy, magnetic resonance imaging or ultrasound imaging
* History of clinical symptoms
* To be able to walk without assistance
* To be able to read and write enough
* To be capable and willing to provide consent
* Interested in improving lifestyle
Exclusion Criteria:
* Acute or terminal illness
* Presence of any chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program
* Unwillingness to complete the study requirements
* Be registered in other exercise program
Sex :
FEMALE
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
|
NCT03979183
|
{
"brief_title": "Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)",
"conditions": [
"Endometriosis"
],
"interventions": [
"Behavioral: Lumbopelvic, stretching, aerobic and relaxation exercises"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03979183",
"official_title": "'Physio-EndEA' Study: a Randomized Controlled Trial to Evaluate the Effect of a Supervised and Adapted Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-01",
"study_completion_date(actual)": "2021-12-01",
"study_start_date(actual)": "2020-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-11",
"last_updated_that_met_qc_criteria": "2019-06-06",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-07",
"first_submitted": "2018-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.
#Intervention
- DEVICE : Repetitive transcranial magnetic stimulation (rTMS)
- rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
|
#Eligibility Criteria:
Inclusion Criteria:
* SCID confirmed diagnosis of SUD, severe
* Last use of stimulants >1 and <6 weeks
* Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
* Stable social environment and housing to enable regular attendance at clinic visits.
* Ability to undergo cognitive testing, fMRI scans, and rTMS (no contraindications)
* IQ > 80
* Stable medical health
* Veteran at Palo Alto VA's Addiction Treatment Services
Exclusion Criteria:
* Pregnant or lactating female
* History of prior adverse reaction to TMS
* On medications thought to significantly lower seizure threshold, e.g.:
* clozapine
* chlorpromazine
* clomipramine
* bupropion > 400 mg/day
* Use of direct dopaminergic antagonists or agonists
* History of seizures or conditions known to substantially increase risk for seizures
* Implants or medical devices incompatible with TMS
* Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:
* active current suicidal intent or plan
* severe psychosis
* Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
* Other substance use disorder not in sustained remission
* Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD
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
|
NCT04228276
|
{
"brief_title": "Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation",
"conditions": [
"Stimulant Use Disorder",
"Substance-related Disorders"
],
"interventions": [
"Device: Repetitive transcranial magnetic stimulation (rTMS)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04228276",
"official_title": "Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-30",
"study_completion_date(actual)": "2024-06-01",
"study_start_date(actual)": "2021-02-05"
},
"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)": "2024-12-02",
"last_updated_that_met_qc_criteria": "2020-01-10",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-14",
"first_submitted": "2020-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
Detailed Description
When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or 'waveform'. This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.
This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.
|
#Eligibility Criteria:
Inclusion Criteria:
Asthma Cohort:
* A confirmed clinical diagnosis of asthma for >= 6months
* Moderate to severe asthma defined as British Thoracic Society stages 3 <= age <= 5
* 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
* Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
Breathing Pattern Disorder Cohort
* A Clinical diagnosis of a Breathing Pattern Disorder (BPD)
Chronic heart failure Cohort:
* A confirmed clinical diagnosis of chronic heart failure with both of the following:
1. A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months.
2. New York Heart Association Class 2 <= age <= 4
* Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
Motor Neurone Disease Cohort:
* A confirmed clinical diagnosis of Motor Neurone Disease
* Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.
* Established on Home Non-Invasive Ventilation.
Pneumonia Cohort:
* A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.
Healthy Cohort:
* No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.
Exclusion Criteria:
* Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.
* In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
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:
Yes
|
NCT03356288
|
{
"brief_title": "The General Breathing Record Study",
"conditions": [
"Asthma",
"Heart Failure",
"Pneumonia",
"Motor Neuron Disease",
"Vocal Cord Dysfunction",
"Breathlessness"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03356288",
"official_title": "An Observational Proof-of-concept Study to Explore the Waveform Characteristics of Tidal Breathing Carbon Dioxide (CO2), Measured Using the N-Tidal C™ Device, in Different Breathing Conditions.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-04",
"study_completion_date(actual)": "2018-07-04",
"study_start_date(actual)": "2017-08-09"
},
"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)": "2018-09-20",
"last_updated_that_met_qc_criteria": "2017-11-28",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-29",
"first_submitted": "2017-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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